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INTERVIEWS

 

 

Excerpts from the Interview with Dr. Hari Menon, Haemato-Oncology, Cytecare Hospital, Bangalore, with The Pharma Review

 
The human body is the most complex machine that anyone can ever imagine, and it consists of numerous organs and tissues. This is why plenty of things can go wrong with our body, in which case we have to take the help of specialist doctors to solve our problems. Among the most vital tissues in the body is our blood, which transports oxygen and nourishment (in the form of glucose) to each and every cell of the body. The doctors who specialize in disorders of the blood are known as hematologists, while those who specialize in cancer are known as oncologists. Quite clearly, there would be a group of doctors who have dedicated themselves to the study and treatment of various forms of cancer of the blood. They are known as haemato-oncologists.

 
Please tell us about your work at Cytecare Hospital and how is it different from Tata Memorial Hospital?
At Cytecare Hospital, I have got a unique opportunity to set up the department of haemato-oncology from the very inception. This poses its own set of challenges and offers its own level of satisfaction. At Tata Memorial Hospital, the work load was quite heavy but it was a kind of routine. I had to handle as many as 100 patients each and every day. Very often, I would be able to devote just five minutes to a new patient, who had come to me for the first time. This would obviously not be sufficient.
Here at Cytecare, I have a more peaceful time, being compelled to deal with fewer patients, and I can devote some time to research as well. This is important because in most cancer departments, the treatment approach is rather haphazard. Some hospitals like the Apollo, Chennai and Christian Medical College, Vellore are of course doing a lot of good work.

 
But your career was shaped and developed at Tata Memorial Hospital, wasn’t it?
Yes indeed. In 1999, I first came to TMH as a junior registrar in the medical oncology department, almost immediately after completing my MD (General Medicine) from KEM Hospital and the associated G S Sheth Medical College. In fact, I was able to obtain a seat in KEM in my second attempt at the All India Postgraduate Entrance Examination. The first time, I was allocated a seat somewhere in Odisha, which I was not willing to join. I worked in medical oncology in the beginning and then on Stem Cell Transplants.
After that, I shifted base to the All India Institute of Medical Sciences (AIIMS) for my DM in Medical Oncology, which was completed in 2004. Soon afterwards, I was offered a Fellowship in Cellular Therapy, which was a more advanced form of treatment than what we were giving in India. The Fellowship was from the American Cancer Society and would have enabled me to do further research at Duke University. I thought deeply about but passed it up at the end, and accepted a position as a faculty member at Tata Memorial.

 
Let us go back a little. What prompted you to adopt the medical profession in the first place?
I come from a family in which there are many doctors; so the idea was planted in my head right from early childhood. It was not really a conscious choice that I had made.

 
Your MD was in General Medicine. What led you into a difficult branch like haemato-oncology?
Well, my MD thesis topic was aplastic anemia, which led to an interest in haematology. At KEM there was an ICMR (Indian Council for Medical Research) laboratory, where a lot of exciting science was happening. Then I worked with Tata Memorial for some months which initiated me into oncology. That was why I chose medical oncology as a subject in my DM.

 
And then you returned to TMH?
As a faculty member in Tata Hospital, I was deeply into academic work. One aspect was teaching postgraduate students, which was really satisfying. But there was very little scope of moving into a higher plane of cancer research; service for the patients and teaching came ahead of research. Besides, I was working 12-13 hours a day and I did not think I could sustain the punishing schedule all the way to my retirement which more than 10 years away!

 
So how long were you with Tata Memorial?
I was on their teaching faculty for almost 12 years – Nov 2004 to Aug 2016.

 
Do you miss it sometimes?
Perhaps, the teaching part, I certainly miss that. But not much else, I think.
  

 


 

Quality - Within Quality Throughout
 

Please find Below Excerpts from an Interview with Mr. Neeraj Ahuja, Director of Harrison's Pharma Machinery Pvt. Ltd., with The Pharma Review

 
Q1. You are among the pioneers in the Pharma Machinery Industry in North India?
Yes, the Harrison’s Pharma Machinery Pvt. Ltd was established in 1983 and since then we been marked successfully in the Pharmaceutical as well as in Cosmetic Industry for machinery and technical consultancy services.

 
Q2. Please tell us about how you started and the achievements of your company today?
We started in 1983 at a very small scale and as the years passed by we have emerged as the leading manufacturer and supplier of a superior quality range of Pharmaceutical Machinery With the help of a team of highly qualified engineers and R&D experts, we are able to bring forth an upgraded range of machines & equipment for patrons. These pharmaceutical machines are timely and safely delivered at clients' end. Today we have managed to be such a recognised & leading name in this industry because of our quality products; infrastructure;
Experienced workforce; competitive prices; timely delivery of products& ethical business practices.

 
Q3. What kind of machinery do you specialise in?
We specialise in all kind of pharmaceutical; cosmetic; herbal; canteen equipments. We have expanded our specialisation in lab tools also.
Some of our clients are Patanajali Ayurveda ltd. ; Ranbaxy laboratories; Dabur India ltd.; Medicamen Biotech ltd; Tirupati Medicare ltd; BAFCO Pharmaceuticals ltd.; Albert David ltd.; SBL PVT. LTD.; Lotus Herbal and many more.

 
Q4. Quality control would be your top priority. Would you please elaborate on this?
Quality of our products has been always our priority. And I believe that quality of our products is one of the factors which has helped us in being such a successful name in the Pharma industry. Our policy Quality - within Quality Through out," is strictly followed in all the business operations. Commitment from bright and talented employees help in sharing a common goal, and ensure to meet our customer’s expectations. We are known among our clients as a progressive and quality & service-driven organisation. As a part of our quality control approach, we test the entire range of Pharmaceutical Machinery manufactured by us on defined parameters. Moreover, with the aid of our quality controllers, we ensure that only superior quality raw material and components are used in the manufacturing process.
 

Q5. How has the technology changed in this field in the in the last few years?
Today’s world is a technology driven world where technology is updating itself day by day and everyday we get to know about new technologies. In Pharma industry also technology has been updated from manual machines to semi-manual machines and to fully automatic machines.

 
Q6. Which countries do you export your machinery to?
We export to every country. Some of our international clients are located in the following countries
U.S.A; Argentina; Italy; Turkey; Nigeria; Zimbabwe; Sudan; U.A.E; Sri Lanka; Nepal; Afghanistan; Bhutan; Bangladesh; Myanmar; Philippines; Malaysia; New Zealand.

 
Q7. What are your future Plans?
Our future plans is to expand our pharmaceutical business world wide. And to make expansion in our business by entering the herbal industry as the world is going more towards the herbal products and its creating awareness among people about the herbal products.
 

Q8. How do you see the Indian Pharma sector vis-a-vis Vision 2020 ?
I firmly believe that Indian Pharma sector by 2020 will grow and expand to its fullest. There will be more upcoming Pharma industries by 2020 in India which will help our country develop.
 

Q9. What are your Success Factors?
Our success factors are quality of our products; performance; durability; client satisfaction; timely delivery of our orders; and my team.
  

 


 

Excellence at Your Doorstep
 

Please find Below Excerpts from an Interview with Mr. Vishal Warke, Director of HiMedia Laboratories Pvt. Ltd., with The Pharma Review

 

1. You are one of India's leading companies in your field today, can you tell us about your journey so far?
With the vision of ‘Excellence at your Doorstep’ HiMedia began its journey 40 years ago under the stewardship of Dr. G. M. Warke. This vision has enabled HiMedia to bring to our patrons excellence in quality and service, coupled with excellence in innovation and topicality. The journey continues from Microbiology to Animal Cell Culture,Plant Tissue Culture, Molecular Biology and so on. HiMedia Labs is one of the few companies in India which focuses on microbiological culture media. Today, the company has over 5,000 products in microbiology. On the whole, the company caters both to the private and public sector. The journey so far is challenging and satisfying as we are providing world class quality service to our satisfied customers. ‘BioSciences in the service of humankind’ - has been our mission and we are committed to serve. This mission has enabled us to surmount challenges and trials to bring quality to you at most affordable prices. The transformation of India's health sector to serve the common man has HiMedias's diagnostic media as its prime mover. Now the same zeal motivates us to expand our reach to encompass entire humanity.

 
2. What is the range of products you specialize in?
We have a wide range of products catering in the areas of Pharmaceutical industry, agriculture, Brewery & fermentation, Environmental and sanitary industries, Textile & Petroleum, Cosmetics industry, Molecular biology growth media, clinical microbiology, veterinary science, vaccine productions. A comprehensive range of Media, conforming specifications of pharmacopoeia guidelines is available with HiMedia for complete testing methods in pharmaceutical laboratories. With the harmonization of USP/EP/BP/JP/IP, newer testing protocols have to be implemented for testing of non-sterile drug products and HiMedia today has a complete range of harmonized compendial grade media.
We also have granulated media and protein hydrolysates, the use of which avoids the aerosolization that generally happens with powder media and thus makes the work environment dust free and pleasant to work in. Moreover, we have gone a step further and created a broad range of capsulated media that have pre-weighed amounts of media in them, which again avoids the hassle of weighing the media and of dust cloud formation.
Another unique range of HiMedia produces HiVeg Peptones (hydrolysates prepared from non-animal sources, such as wheat, corn and soy) that are manufactured by its independent sister-concern company, Warkem Biotech. HiMedia Labs has started manufacturing media (MEM Eagle) for vaccine products. This media is exported to vaccine companies in SE Asia, East Europe and Latin America. The company is now looking at providing stem cell and primary cell lines at affordable costs to the scientific community.

 
3. Where are your main units / R&D centres located?
HiMedia Company today has eight manufacturing facilities. Our R & D centre is located in Mumbai. We are currently in the process of upgrading our manufacturing facility in Mumbai.

 
4. What measures do you take for quality control of your products?
With firm commitment to excellence in work Culture and products, HiMedia has its own in-house bulk raw materials manufacturing plant. This enables us to deliver consistent quality products that conform to ISO 9001:2008 and ISO 13485:2003 and WHO: GMP. The technical product-service package offered by HiMedia globally enables patrons to tap the expertise of HiMedia's Central Laboratory in matching products to their precise needs. We make constant efforts for innovation through Research and Development activity for increasing the range of HiMedia products by developing 15 new products and up-gradation of existing products every year. We have developed culture of commitment to Quality by up-gradation of skills and improvement in work methods to restrict the rejection level below 0.5%.

 
5. How are you currently placed in the domestic/ International market?
The overall CAGR for HiMedia has been 18% since last five years. Growth in domestic segment has been 25% since last three years. Domestic market share is about 60% and 40% in international market. Rapid growth of the organization has increased the need for delivery time. To address this we are setting up ware-houses in Middle East and Europe. We already have HiMedia Laboratories, LLC based at Pennsylvania, USA. It has been operational since last four years and managed well by our USA team.

 
6. What are your future plans?
We are in aggressive expansion phase for future, with multiple new sites under construction. This is basically to enhance our product range and also to increase capacities to accommodate accelerating demand.

 
7. How do you see the Indian Pharma sector vis-a-vis Vision 2020?
As I understand, most of the professional reports envisage that by 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size. Market is expected to expand at a CAGR of 15.92 per cent to US$ 55 billion by 2020. This exciting for us as well to gear up at the higher pace. The pharmaceutical segment for HiMedia has been about 20% with annual increase in absolute market by about 22%.

 
8. What are your Success Factors?
Key factors contributing to our success are highly quality conscious, highly customer-supportive & customer friendly sales-marketing team and broad portfolio in biosciences which encompasses wide range of products. We being multidisciplinary, we can leverage strength of one division against other. For example in many chemicals not only we have LR, GR, ACS grade but also due to our diverse profile, we have grades such as ‘Plant tissue culture tested’, Animal Cell Culture Tested’, ‘Molecular Biology grade’. These test chemicals get tested and verified in their respective labs at HiMedia. Also the Top management is comprised of six technically sound doctors and doctorates, this indicates the technical focus of the organisation and this also keeps the organisation at the advanced cutting edge of developments in biosciences. Thus, it is a very effective, ‘Top Driven’ approach.

 
9. Please tell about your awards and accolades.
With a presence in more than 125 countries HiMedia is amongst the top three brands in microbiology in the world. It gives us an immense pleasure and pride to mention that HiMedia was selected at Maharashtra State Level under BioSciences category by Government of India, and was invited to attend the “Make in India Week” in Mumbai for a meeting with the Chief Minister Shri Devendra Fadnavis, an event held on February 17, 2016. Memorandum of understanding (MOU) was signed between HiMedia Laboratories Pvt Ltd and Government of Maharashtra, for facilitation of HiMedia Laboratories Pvt Ltd to obtain necessary permissions / registrations / approvals / clearances/ fiscal incentives etc. from the concerned departments of the state, as per the rules and regulations of Government of Maharashtra.
In 2014 HiMedia has been nominated in the Cell Culture Media & Reagents catagory for the prestigious “Life Science Industry Awards-2014” held in Washington DC and has been recognised as one of the eight best companies in the world.
 

We have been twice recipient of India’s highest quality honour, the ‘Rajiv Gandhi National Quality Award’ in 2011 and 2007. In the past two decades we have been appreciated and adored with several other awards IES Udyog Shree Award, CHEMEXCIL First Export Award, Certificate of Outstanding Performance in the Export of DCM.  

 


 

"Gandhi Automations has become Synonymous with Quality and Service Excellence. Our Core Strength has been Product Innovation and The Latest Technology"
 

Find below excerpts from an Interview with Mr. Samir Gandhi, Director of Gandhi Automations Pvt. Ltd., with The Pharma Review

You being one of the Leaders in the Automation, Loading Bay Equipment, Clean Room & Doors Systems in Pharma/Chemical/Food etc Industries in India, please tell us about the beginning of your company and the journey till today. 

The 1990s post liberalised era and the advent of the internet, which brought about a revolution of sorts. I spend a lot of time looking at the global trends and latest developments in the more advanced markets where even the smallest companies and commercial establishments had motorised shutters and automated entrance systems. The Indian industry too was experiencing these winds of change. The automotive and consumer goods segments were booming and a revolution in retail was underway, and there was also the scaling up of infrastructure to facilitate all this growth. This opened up several opportunities for the products I was planning to manufacture and thus began the quest for appropriate technology and components.
We have a very wide range of products under major heads like doors/high speed doors, loading bay equipment, rolling shutters and boom barriers, but there are numerous types under each of these, e.g., under doors, there are high speed doors, sectional overhead doors, hangar doors, rolling doors, fire rated shutters and doors, industrial sliding doors, commercial doors, garage doors, etc. Then there are specialised applications like clean rooms, freezers, etc., that need different materials and specifications. Similarly, loading bay equipment comprises dock levellers, sectional overhead doors, dock shelters and lift tables.
As for popular products, high speed doors and dock levellers are the fast moving products.

 

Kindly tell us about any specific achievements of your company?
Company is certified to ISO 9001:2008 quality management system by TUV Nord and all products manufactured are CE marked.
 

What are the fields you specialize in?
We specialize in manufacturing of products like High Speed Doors, Dock Levelers, Dock Shelters, Rolling Shutters, Fire Rated Rolling Shutters, Sectional Overhead Doors, Mega Industrial Sliding Doors, Aircraft Hangar Doors & Shipyard Doors, Motorised Gates & Boom Barriers. Out of these Dock Leveler, Dock Shelter and Sectional overhead doors are important material handling equipment, our expertise is strictly related to providing loading bay solutions, we have 70% market share in this segment, all the products are designed and manufacture by our skilled engineers.

 
Quality control would be your top priority. Would you please elaborate on this?
Gandhi Automations has become synonymous with quality and service excellence. Our core strength has been its product innovation and the latest technology. Without innovation an organization may make sustainable, stable growth, but to achieve the desired growth rate, innovation is the key to maintain one’s leadership in the market. To achieve its strategic goals, the production processes are made as efficient as possible and the products are technically superior, hence possessing a natural advantage in the market. For Gandhi Automations research is an on-going commitment, a large share of resources is invested to continue producing winning solutions in terms of functionality, safety, energy efficiency and design.

 
How are you currently placed in the Indian and the international market?
We have 70% market share in India, domestic is market is not a challenge for us anymore our current export volumes are approximately 5% of total, we plan to increase it gradually to 50% in coming years.

 
Any specific future Plans?
“We are number 1 in the domestic market. There’s huge untapped international market for our products. Our products meet international safety standards and with right kind of product portfolio, we are ready to export to this huge international market.”
With increased globalization and countries opening up for business we see a great opportunity in neighboring countries also. For instance in Myanmar, last few years foreign investments has increased from few million to several billions dollars (300 million dollar 2009 to 5 billion 2014). The government has relaxed import restrictions and abolished export taxes. Such polices boost our confidence and we will venture in such countries. “Our current target for export is Gulf Countries and European Countries. In coming years we will be targeting neighboring countries like Bangladesh, Indonesia, Bhutan, Sri Lanka and few African countries. I have visited few of these countries and we have better products to offer them, than the ones they are currently using. By 2018 years we are targeting 50% revenue from export.” 
  

 


 

Excerpts of our Interview with Mr. Apoorva Shah, Managing Director of TSA Process.
 

You being one of the Leaders in the Water purification Systems in Pharma/ Food etc Industries in India, please tell us about the beginning of your company and the journey till today.

 
In 2004 TSA stated with focusing on providing solutions for purified water distribution systems. It later expanded to Designing & Manufacturing Pure water treatment system. Over the period of decade TSA has almost all the top Pharma companies in its folds. It has been a wonderful journey with enriching experience with ever changing demands and norms for Water system as guidelines of USP/IP/BP. We had an opportunity to increase our knowledge and build quality systems. With this in mind we started a new manufacturing facility to cater the demands for pharma industry in international market and today we have more than 50 installation in above 20 countries. Today we are a team of 150 members and growing.
 

Kindly tell us about any specific achievements of your company?
TSA Achievement was to design, manufacture, install and operate one of the largest Water treatment plant in pharma industry for a very reputed company. Capacity was 0.5 MLD(Million Liters per day). The USP for this project was that it was executed and complete system was shipped from our Manufacturing unit in 47 Days.

 
What are the fields you specialize in?
Our specialization is Pure Water Generation and distribution System, WFI distribution system, Sterile Manufacturing vessels, Sanitary Heat Exchnagers.

 
How has the technology changed in this field in the in the last few years?
Change is eminent and as largest Export for pharmaceutical products from India; Pharma companies have taken onus to improvisation with quality system and concurring with demands from Auditors like US FDA/ WHO. There has been a lot of emphasis on automation with new GAMP’s playing a very major role.

 
How are you currently placed in the Indian and the international market?
Domestically we can say we would be in top 5 to provide pure water solutions for pharma industry, however we have long way to go and our mission is to be the Topmost solution provider in the said industry. Internationally we can easily say that we might be topmost exporter for pure water systems from India as our 50% revenues are from export.

 
Which countries do you export your products to?
We have supplied and successfully commissioned in over 20 countries ranging from Gulf and Middle East, East and North Africa, South East Asia, USA, Brazil, Iran, Turkey, East European and CIS countries.

 
Any specific future Plans?
Future plans are to add new products to pharma segment and focus on pure water demands from Food and Beverage industry. With regards to pharma we intend to roll out complete line for sterilization Equipment in the very near future. There are 3 Products which are in the final stages of R& D which we will bring out soon.

 
Any suggestions for change in any Govt policy with relation to your industry.
We are very much looking forward to GST implementation.

 
What are your Success Factors.
Quality.

 
Please tell about your awards and accolades.
We have not received any awards but we have been nominated for Udyog Ratna, India achievers award. However we failed to go and receive the awards.

    


 

Multisorb StripPax® Packet Dispensers are Engineered to Manage all Regulatory Concerns Regarding Desiccant Handling SOPs and Their Efficacy While Dispensing
 

Excerpts from an exclusive Interview with Mr. Adrian T. Possumato, Vice President, Healthcare Packaging, Multisorb Technologies.

What Ongoing Challenges is The Generic Industry Facing?

Rising development costs coupled with the price erosion of both generic and branded drugs are creating significant challenges for pharmaceutical manufacturers. Three primary challenges generic manufacturers face today are:

1) FDA actions and concerns,
2) speed- to-market,
3) maintaining quality while reducing cost. In this marketplace, the effective use of sorbent technology represents an untapped area for many companies to help overcome these challenges.

 

 

What are The FDA’s Concerns Regarding Desiccant Handling and Dispensing?
One of the FDA’s primary concerns is the efficacy of the sorbent being used given that the sorbent contributes to the chemical and/or physical stability profile of a drug product. Managing FIFO (first-in-first-out) through dispensing equipment is critical to maintaining sorbent quality. During pharmaceutical audits, the FDA will review FIFO procedures are being correctly followed and take random samples of desiccants for testing.

 
How Can Multisorb Help with Compliance with FDA Requirements?
Multisorb StripPax® packet dispensers are engineered to manage all regulatory concerns regarding desiccant handling SOPs and their efficacy while dispensing. This is accomplished by Multisorb’s SMART dispensing technology, which ensures proper FIFO control through a dry-air purge system to protect the desiccant adsorption capacity, and full integration with the packaging line to ensure line downtime is within desiccant handling parameters. Multisorb’s SorbiCap® canister dispenser uses dual hoppers, which run alternately, thereby ensuring continuous operations for optimal efficiency while providing FIFO control.

 
Can Simulations Provide Faster Market Access?
Simulations are an invaluable tool for generic drug manufacturers looking to obtain first-to-file advantage and the six months of market exclusivity provided by the Hatch-Waxman Act. Accurately and quickly predicting drug product stability through the use of simulations can save approximately 6-12 months of development time by eliminating desiccant ranging studies. This time savings allows pharmaceutical companies to expedite regulatory filing and get to market faster with a stabilized product.

 
Are Pharmaceutical Companies Using Simulations? Are There Any Concerns Regarding Their Use?
Increasingly, we see companies taking advantage of simulations to decrease time to market. However, simulation programs differ and not all offer the same level of expertise, experience and capabilities. Understanding how the simulations are conducted and their history is important. For example, Multisorb’s SimuOxSM and SimulSorbSM simulations are Quality by Design (QbD) based programs used by its scientists since 2004 to successfully stabilize over 1,000 packaging presentations.

 
Can Simulations Help With Brittle or Cracking Capsules?
Multisorb’s simulations can help companies quickly identify the optimal sorbent to help eliminate cracking or brittle capsules. We have worked with a number of companies to resolve this issue resulting in the use of IntelliSorb® moisture regulating packets or canisters. Should oxidative degradation also be an issue, StabilOx® packets and canisters can be employed for both moisture and oxygen regulation.

 
How Can Sorbent Costs be Reduced and/or Better Managed?
Taking a comprehensive approach to sorbent technology is crucial. The price per piece can be a deceptive measure of cost savings when disruptions, FDA actions, decreased quality or inefficiencies result. Poorly designed sorbents can cause downstream quality issues such as cracking or brittle capsules and increase overall costs. Faulty or under performing equipment and product can often mean lost productivity that becomes a hidden cost.
Using Multisorb’s Success through EfficiencySM program can help companies address these issues. It examines the entire development process in three key areas: Identify, Select and Dispense. At each stage, we optimize the process to help you better achieve desired results for healthcare product protection and shelf life while reducing your overall costs. Our MultiSystems™ approach delivers an industry leading output efficiency of >99.997% that delivers the lowest total cost of ownership for sorbent dispensing applications.
 
  


 

All Big Pharma Companies Always look Forward to Hear from Akums on Its New Approvals to Further Strengthen Their Products’ Portfolio
 

Please find below excerpts from an Interview with Mr. Sanjeev Jain, Director of Akums Drugs & Pharmaceuticals Ltd., with Mr. Faroukh Debu, Editor, The Pharma Review

 

Akums Drugs & Pharmaceuticals has achieved several milestones in sectors of Healthcare and Pharmaceuticals and a credible position.  We would like you to share some views and ideas about your company, plans, future and your outlook to the industry?

In a span of 10 years, Akums group has set up 10 world class units with a vast portfolio covering almost all therapeutic segments & dosage forms. Akums has become an icon of India’s healthcare industry and known around the world for its high quality products, transparency in dealing & sticking to its commitments. Akums currently manufactures over 10% of India’s total medicinal consumption, which is likely to go up to 20 % in very near future.

Akums manufactures TOP ORG brands for all big Pharma Companies and Multi National Companies on Party to Party and Loan License basis to their utmost satisfaction. There is hardly any retail chemist in the country where a product manufactured by Akums group is not available.

Akums Business Covers:

Contract Research & Manufacturing Services (C.R.A.M.S) and is actively engaged in domestic, export & institutional business.

Formulation & Development of Novel Drug Delivery System (N.D.D.S) products.

Technical Collaboration & Joint Ventures.

Akums’ unique competence lies in developing specialized new formulations, conducting stability studies, undertaking bio-equivalence studies, clinical trials and obtaining DCGI approvals for manufacturing new Fixed Dosage Combinations & Molecules and thereby offering new formulations to its clients with Akums’ technology under their brand names.  Akums has already got 500 DCGI approvals , which is highest in number awarded to any company in the country and large number of applications are in the pipeline.

Akums plans to set up  units as per US-FDA /UK-MHRA norms in near future to cater its world class formulations to US & UK markets.

 

What are The Quality Certifications Held by Company?

Our plants are WHO-GMP, GMP, ISO 9001-2008, ISO 14001-2004 ,ISO 17025-2005 (NABL), QMS-HACCP, GLP, US-NSF & DSIR Certified.

Our different plants have also been approved by regulatory bodies of – ANVISA-Brazil, NAFDAC-Nigeria, PPB-Kenya, NDA-Uganda, FDB-Ghana, PMPB-Malawi, MOH-Libya, CD & DA-Sri Lanka, DPM-Ivory Coast, MOH-Vietnam, MOH-Cambodia, MOH-Myanmar, MOH-Belarus, DDA-Nepal, MOH-Bhutan, MOH-Afghanistan, MOH-Yemen etc.

 

Give Us an Insight To Akums Working Culture?

We have a healthy work culture environment with  open and progressive approach that  inspires and motivates the entire staff, whether technical, commercial or operational to work with dedication, diligence, devotion, dynamism, determination, discipline and direction to convert resource into results and vision into reality. We believe in maintaining  homely & friendly atmosphere in our corporate office as well as at all the  10 plants where more than  8000 people are working. We spend a reasonable amount of money in our CSR activities and for the development of our employees at all levels by imparting trainings from time to time.

 

Contract Manufacturing is a Very Competitive Space. What are Your Policies to Compete With Competitors?

We in fact do not keep a track of our competitors & their policies but concentrate on our own policies of dealing with clients with transparency, provide the best quality products and stick to our commitments, whether its quality or timely deliveries. Due to these business traits of Akums, our clients do not easily switch over even if lesser rates are offered by the competitors to allure them.

 

How Akums Works on Products and Processes?

As mentioned above, Akums is not merely a contract manufacturing company but it is a technology driven & research oriented organization. Our R&D and F&D Departments with cream of industries personnel keep working on improvising the existing formulations, whether in dosage forms or drug delivery system and offer new improved products to its clients for their marketing for the benefit of masses through medical fraternity. We have well qualified & experienced PMT team and provide marketing inputs to our marketing associates for new DCGI permissions obtained by us from time to time.

 

Tell us About Your Experience of Operating in Excise free Zones?

Initially, Excise free zone has really helped us to get clients who wanted to get their products manufactured in excise free zone and save money  but over the period of time we have not only developed good relationship with our clients but have also earned their full trust on our products’ quality & commitments and this how it continues. More & more number of Multinational, National & Regional pharmaceutical companies are joining Akums’ client list and getting their leading brands manufactured at Akums Group of Companies for their domestic as well as export requirement.

 

Your Effective Marketing Strategies - Some Insights?

We have single window system for each customer to handle & co-ordinate all matters relating to legal, agreements, licenses, artworks, manufacturing & sales status, accounts etc.

We deal  small & big companies alike without any disparity, give them due respect and prompt attention at all times. We keep all our clients updated on the newer developments and also take their feedbacks/ suggestions on our working style from time to time for self improvement.

 

Top Leadership Plays a Big Role. Share Some Insights About Your Key Managerial Staff?

Directors and Senior Mangers keep personal touch with all the clients on a regular basis and give patient hearing  to their complaints/ grievances, if any and take prompt action to provide fruitful & workable solution to resolve the issues at an earliest possible. We have a dedicated team of Business Development personal for each marketing company, who collectively look after their accounts and take care of  companies as if they are working for them.

 

How do You Work for Customer Relationship Enhancement?

We keep in regular contact with all our customers through mails, telephones and senior managers as well as dealing business development executives visit them periodically to know their feedbacks on our overall performance, scope for improvement and discuss newer developments in the company. We make it a point to wish all our customers (key persons) on their birthdays, marriage anniversaries etc. to give a personal touch as we consider all our clients as  family members.

 

Give us an Insight About Your Customers Both National and Inter-National

We are manufacturing TOP ORG brands of TOP Pharma Companies of India , some of our esteemed clients include;

Sun Pharma, Abbott, GSK, Torrent, Sanofi, Aventis, UCB, Aristo, Cipla, Cadila, Wockhardt, Novartis, A. Menarini, Emcure, INTAS, Dr. Reddy’s Lab, Unichem,Merck, FDC, Mankind, Ferring, MSD, Dabur, Lupin, Pharmed, Blue Cross, IPCA, TTK, Glenmark, Hetero, Alkem, Deys, Sanzyme, Ajanta, Albert David, Eris, Allergen, Fourrts, Lundback, Apex, Provimi, Besins, 4-Life, Medley, Micro, Mapra, Biochem, Panacea, Piramal, Medreich, Entod, Zuventus, Bayer, Mylan, Avon, P&G and many more.

We are exporting our formulations through our export subsidiary company; Unosource Pharma Limited, Mumbai to Libya , Nigeria, Ghana, Kenya, Uganda, Myanmar, Ethiopia, Liberia, Malawi, Phillipines, Vietnam, Sri Lanka, Nepal, Bhutan,Afghanistan,Malaysia,Venezuela,Belarus,Ukraine,Tajakistan,Honudrus,Francophone countries and many others.

 

What Do You Feel are The Main Factors for Your Success?

We firmly believe in transparency in dealing, living upto our commitments and do not compromise in the quality of products under any circumstances. We are although a contract manufacturing company but are highly technology driven & research oriented  and our R&D and F&D departments are always working on improvising old molecules to provide convenience of dosage schedule and develop new FDCs and offer to  clients after getting permission from DCGI for manufacturing and marketing. All Big Pharma companies always look forward to hear from Akums on its new approvals to further strengthen their products’ portfolio.

 

Please Tell About Your Awards And Accolades?

·          National Award for “Excellence in Product Quality” ( Govt. of India).

·          Best Emerging Company Award 2103 by Business Today India’s most admired company in CRAMS Market 2013 by Pharma Leaders.

·          India’s most technically & scientifically advanced pharmaceutical manufacturing company in 2014 Pharma Leaders.

·          “Excellence in Contract Research –Formulation Development” –by UBM India.

·          Corporate Governance Award 2103 by Business Today.

·          “Zee Business Brand Excellence Award” in 2013 by CMO Asia.

·          Most Trusted Manufacture & Exporter of Pharmaceutical Medicines in 2013 by Indian Achievers Podium.

·          Largest Manufacturer of Best Quality Pharmaceutical Formulations by FOPE.

·          “Business Leadership “ award in the category of “Business Excellence in Outsourcing Pharma Company” in 2013 by World Wide Achievers.

·          Asia’s Best & Fastest Growing Healthcare & Wellness Brand 2015 by World Consulting & Research Corporation, Singapore.

·          Most Admired Quality Pharmaceutical Manufacturer of India-2015 – Pure & Cure Healthcare Pvt. Ltd. by Pharma Leaders.

·          Most Promising Company in Nutraceuticals & Herbal Manufacturing 2015  - Maxcure Nutravedics Ltd. by Pharma Leaders.

·          Excellence In Pharmaceutical Innovation Award For The Year 2015- Malik Lifesciences Ltd. by Pharma Leaders and many more.

  


 

"We are NOT in the Pursuit of Success – Rather We are in the Pursuit of Excellence"
 

SSPM Systems & Engineers, based in Ahmedabad, India has a global presence with an extended sales network which spreads over 3 continents. The manufacturing facility is spread over an area of more than 40,000 Sq. Ft. and a built-up area 20,000 Sq. Ft. The facility houses the latest set of manufacturing machinery. SSPM has embraced a total quality philosophy with an emphasis on prevention rather than detection. State - of - Art manufacturing and testing equipment and procedures are used in every step of SSPM’s manufacturing operation. SSPM has a “robust communication infrastructure. Since its inception, SSPM has been committed to continuous research to meet the challenging technical problems that arise in Pharmaceuticals and Drug Manufacturing and has developed a working partnership with many of its clients.

 

 Excerpts of our Interview with Mr. J. J. Shah, Director of SSPM Systems & Engineers

 

Please Tell us Briefly About Your Company and Your Achievements Till Date?
“SSPM SYSTEMS & ENGINEERS” was established in the Year 2000. We have now been serving the pharma industry in India and worldwide for the last 15 years with total dedication and commitment. SSPM is engaged in manufacturing of pharmaceutical Solid Dosage Equipment (both Wet & Dry Granulation), Liquid Filling Equipment, Packaging Machines & Pneumatic Conveying System for Pharmaceuticals, Food & Beverages Industries.
Since its inception, SSPM has been committed to continuous research to meet the challenging technical problems that arise in Pharmaceuticals and Drug Manufacturing. SSPM has developed a working partnership with many of its clients, listens to their problems and are continually striving to find the right solution. SSPM spends significant resources to develop better process and equipments.
As a policy of SSPM we provide products which are reliable and consistent with the expectations and requirements of our customers. SSPM focuses on technology, quality, reliability and service in order to provide the most innovative quality solutions for its customers at the lowest possible cost. SSPM has earned a reputation for high quality and responsiveness among its customers. The highly skilled SSPM workforce utilizes the latest manufacturing machineries, CAD/CAM systems and adheres to cGMP standards to meet its customer’s stringent requirements in drug manufacturing.

 
What Kind of Pharmaceutical Machinery do you Specialize in?
We specialize in the manufacture of :
Solid Dosage Equipment (Wet Granulation & Dry Granulation).
Full Liquid Manufacturing Plant - Liquid Filling, Sealing, Labelling & Packaging Equipment.
Pneumatic Conveying System/ Vacuum Transfer System.

 
Quality Control would be your Top Priority. Would you Please Elaborate on this?
SSPM follows a policy based on the concept of dynamic quality. The purpose of this policy is to ensure total satisfaction for all of our customers, suppliers and employees through the continuous development and improvement of products, services and the skill set of our employees.
Our Quality Policy Consists of the following principles.
Continuous improvement in product quality by in-process control.
By upgrading our manufacturing technology and Employee Skills.
Constantly listening to our customers to ensure the sustainable improvement of their satisfaction.
Systematic measurement and communication of performance.

 
How has The Technology Changed in This Field in The Last Few Years?
Technology has played an important role in mordernizing equipment, processes and quality.
We use 3 D Modelling as a tool for equipment development and design.
Process Automation has changed with up gradation in PLC & HMI through latest software and its process.
SCADA connectivity has greatly influenced Remote Support.
New Containment Technology (OEL LEVEL) provides strategies by providing integrated concepts for pharmaceutical production of machines.
Implementation of 21 CFR Part 11. Compliance is mandatory for pharmaceutical companies and their suppliers to sell products into the global market. Achieving compliance with 21 CFR Part 11 is best accomplished by a partnership between the user and the vendor. The user knows how they want the system to fit into their Quality Management System (QMS) and operate on a day-to-day basis in their organization. The vendor knows how the system achieves compliance within its functionality.

 
How are you Currently Placed in The Indian and The International Market?
At present we have very good installation base and excellent client satisfaction in India as well in the International market and we are hoping to further develop the markets in coming years.

 
Which Countries do you Export Your Machinery to?
Algeria, Brazil, Bangladesh, Dubai, Egypt, Iran, Iraq, Indonesia, Jordan, Kenya, Kazakhstan, Malaysia, Nepal, Nigeria, Russia, Saudi Arabia, Sri Lanka, Syria, Sudan, Tanzania, Thailand, Turkey, USA, Vietnam, Yemen, etc.

 
What are your Future Plans?
Innovation is the main stay of business in the current scene. We plan to serve our existing customers as well as prospective customers with upgraded features. More specific customer satisfaction by re-design and modification of products as per customer requirements is in the pipeline. In order to further improve client satisfaction, we plan to listen to the problems of our clients and spend significant resources to develop better process and equipment.

 
How do you see The Indian Pharma Sector vis-à-vis Vision 2020?
Indian Pharma sector is presently in a good and healthy situation. The sector is growing at a rapid pace and Indian companies are using innovative methods for developing new products and services. Still lots of work needs to be done in terms of modification & replacement in existing facility to match with international standard. There is no doubt that the Indian Pharma sector will do India proud and be a leading sector in industry.

 


 

Combination Sterile Connections for Single-Use Applications
Todd Andrews

 

The Indian biotechnology industry is expected to grow at an average rate of 30% per annum to reach USD$100 billion by 20251. According to a research done by YES BANK Ltd, India is one of the top 12 biotechnology destinations in the world and ranks third in the Asia-Pacific region2. However, in today's world of fierce competition and strong regulatory compliance pressure, whether India will sustain as a key player remains a concern. Considering that bioprocessing is the discipline which puts biotechnology to work3, Indian companies will need to be major leaders of innovation in the bioprocessing field to remain competitive. Essentially, this means adopting relevant technologies to develop processes that enhance the fundamental basis of bioprocessing – accuracy, sterility and flexibility.

 
Single-use applications are examples of such technology that is widely adopted in the bioprocess industry. Interest in innovative disposable connectors in particular, has risen over the years as the industry recognizes the crucial role these devices can play4. The Pharma Review magazine spoke with Todd Andrews, Bioprocessing Global Sales & Business Development Manager of CPC to understand more about innovative single-use integrated combination connectors and how it contributes to a hassle-free and efficient bioprocess.

 
What are Combination Connections and Why are They Used in Single-Use Bioprocessing?
Combination connections combine two or more specialty connectors to enhance process flexibility while minimizing risk and complexity. Specialty connectors for single-use systems have been integral to the success of single-use processes over the past decade and will continue to be over the next decade. These connectors are designed to meet a single, specific operational need. Examples include sterile connectors, sterile disconnects and steam-in-place (SIP) connectors. Sterile connectors allow users to connect two pre-sterilized systems in a non-controlled environment. Sterile disconnects are used to separate two parts of a system in a process without introducing contamination to either part. SIP connectors link pre-sterilized single-use systems with fixed process equipment such as stainless steel bioreactors via a steam-in-place process. In many cases, however, bioprocess engineers may want to combine two of these technologies at the same point in a process. For example, combining a sterile connector and sterile disconnect into one connector creates a combination connection meeting two critical needs all-in-one.

 
How Can Single-Use Systems be Designed for Combination Connections?
Until recently, combination connections have been assembled by linking two specialty connectors in series with a flexible tubing junction. For example, several integrators have developed custom assemblies that consist of a SIP connector and a sterile connector with a length of tubing in between. While custom assemblies can address a need for combining connection technology, they do have their disadvantages that include the higher cost for custom assemblies and the additional potential leak points at the ends of the tubing. These disadvantages can be minimized with the use of integrated combination connectors.
 

What are Some Examples of Integrated Combination Connectors?
A connector which adopts two single use connection technologies into one connector is an example of an integrated combination connector. Such connectors can combine sterile connect and disconnect functionality all in one connector eliminating the need for a custom assembly with tubing. An example of this type of connector is CPC’s AseptiQuik DC. With this connector, a sterile connection can be established in a simple, three-step process that allows sterile liquid transfer in a few seconds. After liquid transfer, an aseptic disconnect can be made in a single step that takes just a second or two to complete.
Similarly, a connector that combines sterile connect and SIP (steam-in-place) capability is also an integrated combination connector. Such connectors are typically needed in biopharmaceutical processes using a hybrid combination of stainless equipment and single-use systems. Using CPC’s AseptiQuik STC as an example, a 3/4-inch mini sanitary junction is used to integrate a sterile connector directly with a SIP connector. The sanitary junction provides a more secure connection and reduces the number of potential leak points associated with use of a length of tubing between the connectors.
AseptiQuik STC’s can be pre-sterilized by either gamma irradiation or autoclaving. The pre-sterilized connector is attached to stainless steel equipment during system preparation and the connection point is sterilized with the system via SIP. The final sterile connection is completed by attaching a standard sterile connector body any time after the SIP cycle. Notably, if such combination connectors come with the genderless option, it adds further flexibility and ease of use by not having to worry about gendered “male” and “female” halves. Genderless connection technology reduces the number of SKU’s needed and greatly reduces the risk of operator error.

 
How Would You use an All-in-One Single-Use Sterile Connect and Disconnect Technology in a Bioprocess Manufacturing Environment?
Some applications for connectors with the all-in-one single-use connection technology include sterile supply bags, sterile hold bags and inlets/outlets for single-use bioreactors. For these applications it is important to consider process flow when designing your single-use system. For example, when connecting a sterile harvest bag to a single-use bioreactor, the best option is to specify a combination connector, such as the AseptiQuik DC, on the harvest bag, and a standard sterile connector on the bioreactor harvest line. This configuration is best for ensuring process integrity and sterility.

 
What Applications Benefit from The Utilization of Integrated Combination Connectors That Combine Sterile Connect and SIP Capability?
Additions to and transfers from stainless steel bioreactors are the most common applications for such connectors, especially for time and temperature sensitive materials. Consider transferring inoculum from a single-use, seed bioreactor into a production scale stainless steel bioreactor. In theory, this could be accomplished by specifying a SIP connector as part of a custom single-use bioreactor. However, waiting to complete the SIP cycle for that connection could disrupt process flow. In this case, an integrated combination connector like the AseptiQuik STC acts as an adaptor that is steamed-on in advance, allowing almost immediate inoculum transfer at the proper time.

 
How Relevant are Integrated Combination Connectors in India’s Bioprocessing Industry?
In recent years, many foreign drug manufacturers have either acquired Indian firms or outsourced their bioprocesses to India due to the country's pool of scientists and engineers and availability of cost-effective manufacturing capabilities. With the influx of foreign investments, India's bioprocessing industry has advanced, changing the competitive landscape. Higher standards are being expected from the region and Indian firms are challenged with having to keep up with foreign standards and regulations. In order to comply and compete effectively, the Indian bioprocessing industry will require solutions that enhance process accuracy and flexibility. Integrated combination connectors are examples of such solutions; allowing manufacturers to establish combination connections with greater peace of mind by reducing risks of contamination and ensuring that chemical reactions are not damaged by prolonged holding times as might be encountered in traditional stainless steel systems.
Another uprising trend in India's bioprocessing industry is generic drug manufacturing. Unlike Active Pharmaceutical Ingredient (API) manufacturing where sterile conditions are not strictly enforced, it is a requirement that generic drug manufacturing is carried out under sterile conditions. The uses of disposable, single-use instruments help manufacturers achieve these conditions while meeting the requirements of low cost. As generic drug manufacturing gains traction in the Indian bioprocessing industry, the use of disposable bioreactors and single-use integrated combination connectors will become increasingly widespread.
For Indian bioprocessing manufacturers looking to venture into the more lucrative global market, integrated combination connectors can also play a significant role. Apart from contributing to regulatory compliance, the ability of integrated combination connectors to enhance process flexibility and minimize complexity can help firms manufacture products of better first-time quality. With compliance assured and rework eliminated, Indian bioprocessing manufacturers can reduce unnecessary costs, focus their resources on profitable research and carve a competitive edge.

 
Conclusion
Scientific American recently ranked the countries of the world according to their capacity to support biotechnology innovation, and India was placed third from the last . The Indian bioprocessing industry has vast potential for improvements in this area. That said, Indian firms need not fret over having to make hefty investments and installing revolutionary changes. Todd has reminded us that small changes, such as taking note of critical links, can help Indian bioprocessing firms attain efficiency and flexibility that are of global standards.
 

References
1. http://www.assocham.org/userfiles/YES_BANK_-_ASSOCHAM_Knowledge_Report_-_Make_in_India_-_Presing_the_Pedal.pdf
2. http://www.assocham.org/userfiles/YES_BANK_-_ASSOCHAM_Knowledge_Report_-_Make_in_India_-_Presing_the_Pedal.pdf
3. https://www.nae.edu/Publications/Bridge/BiotechnologyRevolution/TheRoleofBioprocessEngineeringin Biotec hnology.aspx
4. http://www.bioprocessonline.com/doc/innovation-in-disposable-connectors-0001

 


 

VRP-007 Will be a Life-Saving Drug Within the Common Man’s Reach
Manu Chaudhary

 

While a million new cancer cases are diagnosed every year in India, a major deterrent in dealing with the dreaded disease is the high cost of treatment, which only a few can afford. Others have no option but to prepare themselves for a slow and painful death. But now there is hope with Venus Remedies Ltd., a global R&D-driven pharmaceutical company, coming up with a patent-protected Drug which will help in curing cancer through specific and selective targeting with lesser side-effects. In an interview with Pharma Review, Dr Manu Chaudhary, Director, Research, Venus Medicine Research Centre, tells more...

 
How is the Drug-Protein-Polymer Conjugate technology of Venus Remedies different from other drugs available in the market?
While the market is flooded with a number of anti-cancer drugs, molecular targeted therapies are still not available. Drugs including Monoclonal antibodies (MAB) are to some extent considered as targeted but have serious limitations. The utility of MABs is limited by a variable pharmacokinetic distribution and a limited ability to diffuse across tumours. Treatment with these drugs is costly as the cost of development and therapy is very high and the process is complicated. Moreover, these drugs cause adverse effects such as breathlessness, faintness, fluctuations in blood pressure and sometimes fatal allergies. While providing limited relief, these drugs also cause adverse side-effects as they tend to damage the healthy cells along with the cancerous ones. On the other hand, our novel, patent-protected platform technology, a triple conjugate therapy will help in curing cancer through specific and selective targeting of small molecules directly at targeted (Cancer) site.
Additionally, due to delivery of drug directly at the cancer site, the amount of drug required for cure will be drastically reduced. This will not only improve the patient compliance but will also reduce the cost of therapy, hospitalisation charges, treatment durations and expenses required to control side effected.
This platform technology holds its essence in its significant potential to conjugate a wide range of drugs. VRP-007 will be a life-saving drug within the common man’s reach. Targeted delivery of the drug will bring about a huge reduction in side-effects, one of the main causes of cancer-associated mortality.

 
What is the clinical trial status of this product? When is it likely to be introduced in the market?
VRP-007 is in the stage of pre-clinical development, and the results have been quite encouraging. It will take us about three to five years to launch this drug in the market.

 
How do you rate the performance of Indian companies when it comes to R&D in the oncology segment?
The alarming rise in cancer cases has triggered heavy investments in R&D of advanced solutions, but a lot of ground remains uncovered in India where the oncology market remains largely generic. Indian pharma companies are doing reasonably well despite the stiff competition from their foreign counterparts. Most of the R&D (except that at Venus) is being done either on biologicals or new chemical entities. To the best of our knowledge VMRC is the only working towards targeted delivery of small anticancer molecules.

 
How strong is your product portfolio in the oncology space?
An emerging player in the oncology segment, Venus Remedies has carved a niche for itself in this segment with a portfolio of 21 injectables for practically all cancer types, including star products like Taxedol, Gemcitabine, Bortezomib, Pemeterxed and Paclitaxel to name a few. We are also coming up with a novel chemical entity for cancer detection. This revolutionary research product will be a first-of-its-kind advanced technology for the early detection of cancer. An affordable cancer detection kit, VRP1620 will bring down the healthcare costs for cancer patients substantially as the treatment of first-stage cancer works out to be much cheaper.

 


 

Anchrom is dedicated to the TLC/HPTLC field and has been associated with Camag, Switzerland since 1978
Excerpts of an Interview with Mr. Akshay Charegaonkar, Director of Anchrom Enterprises, Specialist for HPTLC, since 1978.

 

Q : Tell us about HPTLC.
A : High Performance Thin Layer Chromatography (HPTLC) is the modern instrumental version of Thin Layer Chromatography (TLC) the traditional method. Here sample mixtures are separated into individual fractions by chromatography on a thin layer of adsorbent, for the purpose of identification, quantification, fingerprint etc.

 
Q : What are its uses?
A : HPTLC is used in analysis of non - volatile organic mixtures, pharmaceuticals, herbals, foods, pesticides etc. in fact all branches of organic chemistry to check purity, impurities, similarity etc use HPTLC.

 
Q : How does it compare with HPLC?
A : HPLC and HPTLC are complimentary techniques depending on the aim of analysis, one is better than the other. Compared to HPLC, HPTLC is very rast, “Visible”, low cost, low maintenance, high throughput technique. HPLC has better resolution and precision.

 
Q : How does that affect end users in India?
A : Well, wherever HPTLC is proved to be applicable ( most of the time, it is), it proves to be an asset. HPTLC’s main advantages in India are simplicity, ease of use & maintenance, flexibility of detection, modular investment in instrumentation. Multiple users can use one HPTLC at the same time. Once a HPTLC is purchased, a second one is seldom required due to high throughput. ( In HPLC, as the no. of samples increase, more and more machines have to be bought). HPTLC can accept any sample without worry, about system contamination. In fact, sample clean up is minimum.
 

Q : Is HPTLC an official pharmacoperial method?
A : Quantitative TLC was the method of choice in all pharmacopeias in the 80’s before HPLC crept in. But as 2015, the USP and PhEure have decided to use it for “identification of materials of botanical origin”.

 
Q : So that is a qualitative test?
A : Yes. But the SOP prescribed in chapter 203 will be same for quantitative analysis, when it comes, sooner or later. There are hundreds of quantitative HPTLC publications and so of it is a matter of time. Interview of Mr. Akshay Charegaonkar, Director
 

Q : Why is ( or was) HPTLC not so popular in the west?
A : Mainly for commercial reasons. HPTLC is not automated “on line”. Each of its step is individually automated, which gives it unique features. In the west, labour is very expensive, materials are cheap and vice versa in developing countries. They want one analyst to handle several instruments while we can afford several analysts to run one high throughput instrument.

 
Q : In the light of HPTLC’s acceptance in USP/PhEur, what should the Indian chromatographers do?
A : They should read and follow the USP/PhEur SOP in all their HPTLC work. Such analysis methods will be readily welcome all over the west, due to its USP/PhEur backbone.

 
Q : Chromatographer from which fields of application?
A : Herbal and foods, to begin with.

 
Q : Is HPTLC being used by the regulatory authorities in India?
A : Whether so called “official” or not, most of them rely on HPTLC, especially those who have installed it, know its indispensability.

 
Q : And finally, what is your message to the Indian chromatographers community?
A : Make ( analytical methods) in India! After all, we have Indian herbs and Indian foods. Why depend on the west for their analysis methods? They are not interested because they do not have problems like poor quality consciousness, adulteration, substitution, mislabelling, use of banned chemicals etc.

 


 

"Hard Work and Focus on The Goal is The Key of Success for Any Person"
Dr. B. D. Miglani in an exclusive inteview with Ms. Shruti Tandon from Pharmacy Department at GLA University, Mathura.

 

In India the first degree course of Pharmacy had been formally started in 1937 and after 76 years what is your opinion about the present scenario of Indian Pharmacy Education?
The root of pharmacy education is Diploma in Pharmacy, however, you have started asking me about the degree course of Pharmacy. I would rather highlight that the pharmacy education starts from diploma in pharmacy. I consider the diploma in pharmacy as root of the pharmacy education/profession. You shall appreciate that 60-70% of the pharmacists get placement in community and hospital pharmacy. The pharmacists on the counter of retail pharmacy and hospital pharmacy are holding diploma in pharmacy. Almost every patient needs some or other medicine which they get from the retail chemist shop or hospital pharmacy. These pharmacists are not provided with enough knowledge to cope up with the challenging duties of providing drug information and counselling. The course contents of the diploma in pharmacy have not been revised since 1991 and thus, have become obsolete. We should, therefore be more concerned with imparting sound knowledge to the pharmacists at this level. We have to find out mechanism of revising the course contents frequently so as to cope up with new responsibilities. There have been rapid academic progress in pharmaceutical sciences and I do believe that the present duration of the course is not enough. We have to give top priority in upgrading the diploma in pharmacy to degree level as minimum qualification for registration of pharmacists. An attempt was made in 2001 in this respect, however, it failed due to the strong opposition by traders, politicians and even our academic intellectuals. To overcome the opposition of having 4 year degree course as minimum qualification for registration we may, as a compromise, think in term of having 3 years degree course in pharmacy practice after 10+2 which would go a long way in improving the pharmaceutical knowledge of the pharmacists to take care of the pharmaceutical care efficiently. I cannot elaborate more due to time limitation and conclude that unless and until we strengthen our roots as suggested above, the profession of pharmacy will go on declining.

 
Since Pharmacy education is coming under technical course but why it’s not matches it’s part with B.Tech courses in spite of the nobleness of profession.
Pharmacy education was taken over by AICTE though basically it is pharmaceutical course since pharmacist is an integral part of health care. The AICTE took over since they had lot of funds and wanted to expand their activities. The stalwarts of pharmacy profession accepted this take over since they were not getting funds from the Health Ministry to expand pharmacy education institutions to provide required number of pharmacists for the various fields of pharmacy profession. This take over had been at a very high cost as the Ministry of Health discontinued accepting the pharmacists as a member of health team. Therefore, there is no question of comparing pharmacy course with B.Tech. course.

 
According to 2010-2011 annual reports of Ministry of Chemical and Fertilizers the growth rate of Indian Pharmaceutical companies is increasing; then also this fact fails to attract many students to choose pharmacy as profession. Why so?
The pharmaceutical industry requires personnel with specialization in basic sciences to take care of research activities, engineers to take care of installation of machinery, its running and maintenance. Analytical work in standardization of product is taken care by the scientists having knowledge in chemistry as well as in electronic equipment. It is mandatory provision of the Drugs & Cosmetics Act to have pharmacists with experience to take charge of the formulation activities. You will appreciate that the demand of pharmacists in pharmaceutical industry is limited one and, therefore, fails to attract many students for the same. The real growth of pharmacists requirement would be seen in the field of pharmacy practice which is being ignored for the present.

 
What are the effects of Generic Drugs on Pharmacy Growth?
Generic drugs which are manufactured in our country are very much in demand all over the world because of its less cost and better quality. We are doing well in this field and thus, it provides unlimited scope of pharmacy growth in India.
 

What should be done in order to spread awareness about benefits of pharmacy education among general public?
The general public has poor image about the quality of pharmaceutical services being provided at the retail pharmacy and hospital pharmacy. The pharmacists at the counter do not turn up to their expectations in terms of meeting drug information requirement or counselling. I would, again stress that we have to upgrade the educational level of the registered pharmacists serving at these centres. Once the image of the pharmacy is improved in general public, only then they will think in terms of sending their wards to pharmacy profession. The message to spread awareness that pharmacy education provides numerous job opportunities should be communicated amongst general public through printing and electronic media.

 
How the upgradation of pharmacy education can be carried out along with the changing scenario?
I am again stating that the future of pharmacy lies in its roots, i.e., pharmacy practice. I will briefly say that the minimum education for registration of pharmacist should be degree in pharmacy, may be of three years duration, though preferably it would be of four years duration, to be known as Bachelor in Pharmacy Practice who would be on the counter of retail pharmacy and hospital pharmacy. These pharmacists with sound pharmaceutical knowledge will be in a position to earn good image from general public.

 
There should be effective accreditation system for pharmaceutical teaching institutions.
The Pharmacy Council of India, who are basically responsible for pharmacy education should ensure proper inspection of the pharmacy teaching institutions. I may say that teachers are made and not born. We should, therefore, think in term of having institute to train pharmacy teachers. Any aspirant joining teaching profession should mandatorily be sent to this institute for training for a period of six to one year before he is allowed to undertake teaching activity. Such aspirants may have to give a bond for continuing teaching profession for say at least five years. Alternatively we may think in term of instituting diploma/degree/post-graduate course in pharmaceutical education of a suitable duration which should be the mandatory qualification for joining any teaching job in pharmacy.

 
How can the upcoming institute like GLA University, modify the techniques of imparting education to aspirant pharmacist. Please give us some piece of advice?
The teaching faculty may be deputed to well established/outstanding teaching institutions to get acquainted with various new techniques adopted by such institutions for imparting education to the students. Teaching faculty should be encouraged to participate in workshops, seminars, and conferences on pharmaceutical education from time to time. They should also be encouraged to present their research work in various conferences. If GLA University provides teachers with excellent academic qualification and experience they will be doing justice of imparting excellent education to aspirant pharmacists in their institution. GLA University may have visiting professor who would interact with the teaching faculty of the University.

 
What changes are you experiencing in than now and 50 years from now in Hospital Pharmacy practice?
Fifty Years back the hospital pharmacy services in India were in pathetic condition. The hospital pharmacists were mainly compounders. These compounders were registered as pharmacist on the basis of some training and experience. Its only on implementation of Pharmacy Act 1948, that person possessing 2 years diploma in pharmacy after 10+2 were registered as pharmacists. You will appreciate that this is a good progress made so far. With the advent of time, many missionary hospitals, prestigious institutes, AIIMS &like AIIMS and corporate hospitals in Private Section like Appolo, Max, Fortis, etc. have introduced modern hospital services in many ways. In 1982 the first PG course in hospital pharmacy was started in Delhi College of Pharmacy [Now DIPSAR, Delhi]. Thereafter PG course in pharmacy practice has been started in number of pharmaceutical teaching institutions. Lately, Pharm.D course has also been started in many pharmaceutical teaching institutions. These pharmacists once they get position in hospital and in community pharmacy, the situation will improve exorbitantly and we may be at par with the developed countries in hospital pharmacy.
In India we must have backing of legal system to make any headway in any filed. For the present, the hospital pharmacy is exempted from all the provisions of Drugs & Cosmetics Act, vide Schedule ‘K’. We have to bring changes in the Drugs & Cosmetics Act so as to provide the minimum standard in term of staff, space, equipment requirement and making good pharmacy practices as mandatory. Once this is done, I am sure hospital pharmacy shall be at the top in time to come.

 
The Pharmacy community is celebrating 52nd National Pharmacy Week. What is your message for the young pharmacist on this celebration?.
Since 1962 National Pharmacy Week is being celebrated across the country every year. I think, this year’s theme is, “Pharmacists: A Healthcare Professional”. Pharmacists are professionals, uniquely prepared and available, committed to public service and to the achievement of the goal of heath care. Unfortunately, this does not get well reflected in society.
My message to the young pharmacists is to remain committed and dedicated to the profession of pharmacy by providing efficient pharmaceutical care to ailing community. Such commitment and dedication shall ultimately procure good image of pharmacy in general public.

 
Why should the youngsters choose pharmacy as a profession?
Pharmacy is noble profession and it directly related with the welfare of human life. This profession provides you good opportunity for job placement as well to serve the community by providing proper pharmaceutical care. The pharmacy profession provides you job opportunities in pharmaceutical industry, hospitals and other health care institutions. One can open their retail outlet and earn a lot of money. Marketing also offers good opportunities. Presently, post graduate and research scholars are enjoying a good position in various pharmaceutical industries, research institutes, and educational institutes.
 

Kindly give some piece of advice for students and young pharmacist.
Hard work and focus on the goal is the key of success for any person. You have to choose one or other speciality as your career and the proceed for higher studies accordingly. Your commitment, dedication and hard work will definitely bring laurels of success.

 


 

"We Are Focusing to Develop Different SBUs to Diversify and Expend Brands and to Reach to Every Corner of The Country"
Excerpts of an Interview with Mr. Asheesh Roy of Stadmed Pvt. Ltd., with Mr. Faroukh Debu, Editor, The Pharma Review

 

Stadmed Pvt Ltd is one of the leading pharmaceutical house of Eastern India. The company started its operation in the year 1940 in the name of Standard Medical Research Institute founded by entrepreneur Late Gour Gopal Saha.
Later the name changed into Stadmed Pvt Ltd.
Under the able leadership and vision of the Founding Father, Gour Gopal Saha, the organisation earned the reputation of not only being one of the pioneers , but also one of the most innovative organisation in the Eastern Region. The company was also the first to produce Amino Acids cum enzyme preparation in India.The block buster brands which gained recognition from the medical fraternity like "ALKASOL, PULMOCOD CG/PLAIN, AMINOZYME, ENTROZYME, are still satisfying the ailing patients.
Stadmed owns two most modern state of the art manufacturing plant with GMP and ISO 9001 : 2008 accredited by JAS-ANZ.producing formulations of different speciality drugs.
Stadmed has initiated an R & D department to design and develop different drug delivery system. The company has a footprint across most of the states except few and trying to expand its business across all parts of the country.
The company believes in providing quality healthcare products at most affordable price and extends social welfare activities for economically backward classes of patients also round the year.
Stadmed is the only pharmaceutical house of Eastern India which had shown its courage to enter into the chronic segments like Cardiology, Diabetology, Psychiatry besides non chronic segments including Gynaecology, Paediatrics, Surgery and Urology etc. ZOLAM, BETA, LAMA, EMFOR, GLIZA MF, URISOL and URSOLIC are few among them.

You are one of the oldest pharmaceutical manufacturers in West Bengal. Please brief us about your beginning and the journey so far.
Evolution of concept of serving ailing mass in modern India took place in Kolkata ‘The City of Joy’, way back in 1901 by Late Acharya Prafulla Chandra Ray by setting up Bengal Chemicals & Pharmaceutical Works Ltd. The untiring dedication to produce quality medicines has showed the entire country a new path for better health care system. Kolkata has been the origin of many pharmaceutical companies in pre-independence era, STADMED is one of them.
Standard Medical Research Institute was established in the year 1940 by Late Gour Gopal Saha later the name changed into STADMED Pvt. Ltd. I feel proud to bear the torch and the mission to produce quality medicines to provide better health that contributes to build healthier nation. In STADMED we give emphasis on value system for better implementation and coordination.

What is the range of products you specialize in?
STADMED has brands of wide range in segments viz. Urology, Gynaecology, Pediatrics, Surgery, Cardiology, Diabetology, Neurology, Psychiatric & Gastroenterology.

Where are your units located and briefly describe the facilities available?
STADMED owns two most modern state of the art manufacturing plant with GMP and ISO 9001 : 2008 accredited by JAS-ANZ.producing formulations of different specialty drugs.

What measures do you take for quality control of your products?
STADMED has initiated an R & D department to design and develop different drug delivery system.

How are you currently placed in the domestic market? And your strategy in this competitive environment?
At present STADMED is driving to increase its prescriber base. Competition is intense but STADMED with its capable field force trying to reach maximum number of doctors. The activities are being performed to build strong and good relationship with the core prescribers.

Exports is a major focus area of Indian Pharma. Which countries do you export to and what growth do you see your position and plans for the international market?
Presently we are concentrating in domestic market considering the huge opportunity that exists.

What are your future plans?
We are more focusing to develop different SBUs to diversify and expend brands and to reach to every corner of the country. The highly accepted brands like Alkasol, Pulmocod, Zolam, Pedic Drops/Syrup and Entrozyme are growing and increasing market share rapidly.

How do you see the Indian Pharma sector vis-a-vis Vision 2020?
STADMED is having vision to achieve Rs.200 Crore by 2020. Present pharmaceutical market in India shows positive sign for growth. The small and medium size Pharma Companies will play crucial role to drive the market growth. STADMED is looking to consolidate the market share with modern marketing tools and better customer/doctor satisfaction.

 


 

Our Product Quality Is Assured As We Practice Quality Approach In All The Areas of Manufacturing Operation
Excerpts of an Interview with Mr. Pranay Patel of NPM Machinery Pvt. Ltd., with Mr. Faroukh Debu, Editor, The Pharma Review

 

Give us a background about your company?
NPM Machinery Pvt. Ltd. was incepted way back in 2004-05 with its ever famous name National Pharma Machinery and kept operative with the same name till 2012. I believe evolution is a must wherever positive energy floats. Enjoying a uniform trend of progress and development in all the areas of operation, National Pharma Machinery also got rechristened in year 2012 as a Private Limited entity keeping “NPM”, an abbreviated form of the earlier name National Pharma Machinery, as a main part of the new name.
Today, NPM is operative with a state of the art manufacturing unit spread over around 70000 sq.ft at Changodar, an industrial hub of the state of Gujarat. Our core strength is a well-tuned work force of around 110 dedicated and skilled personnel and a highly equipped manufacturing unit. Starting with the Pharmaceutical industry, today NPM provides packaging solutions for bottling lines in almost every industry where one or the other form of liquid or powder products are being packed. Following the success in Pharmaceutical industries, NPM has achieved noticeable stand in many other industries like Food & Beverages, Agro Chemicals, Lube Oil, Edible Oil, Cosmetics, Home Care etc.
A healthy designing & development facility, modern CNC machine shop & faster assembly lines are some of the parameters enabling NPM to be the front line company in its category of operation. Ensuring the best quality, NPM is entrusted among its clientele for fastest deliveries. Quality & Services too are areas where in NPM always tends to be one step ahead than expected. Following all the essential engineering requirements of any machine building industry and the stringent norms and qualification criteria of the market, NPM is having a rich basket of around 130 different models separated in over 20 diverse categories covering basic applications of washing, filling, capping, labelling, conveying etc.
Above 700 small, medium & large national & multinational companies are in NPM’s customer family which is wide spread on the world map covering around 30 countries.

 
What specific machine / production lines does your company specialize in?
Complete lines for packaging of various liquid & powder products.

 
What is your company's top priority?
Customer satisfaction. We precisely monitor that when a client enters in our family, never does he/she exit. We ensure it too.
 

What measures does your company take to maintain quality control?
All the best standards of industry are being followed in our regular practice. However, there exists our own method of identifying & understanding the quality parameters, establishing control parameters for them and following all of them strictly to achieve best final quality product. Our product quality is assured as we practice quality approach in all the areas of manufacturing operation.
 

Give us a brief of the markets you are you catering to?
We enjoy our market share in more than 30 countries of Asia, Africa, Middle East, America, Europe and Russia. Still our major market is our own country and we serve around half of our production to our clients based in India being a front runner in our segment.
 

What are your expansion plans?
We are instrumental in expanding the range of our products for Pharmaceutical Industry introducing some more equipment to cover the areas of packaging where we still have huge scope. Besides this, further infrastructural & personnel expansion is also lined up this year.
 

A brief on the company's achievements / awards till date?
Every single client’s faith in it is the biggest achievement for NPM till now. NPM is less concentrated towards it’s own achievement but more focused on the achievements what it’s every single client gets after getting associated with it. As a result, we, from time to time get rewarded by our clients in form of testimonials which we believe are not less than any recognized award.

 
Where do you think India stands today in the international market?
Indian products of our segment are well accepted and entrusted by almost all the continents today. Whole world has its eyes on India for the best solution with reasonably justifiable prices.
 

What are India's short comings according to you?
Not many but when we talk about overseas market, most of the Indian products are lacking in features related to sophistication & automation. On a positive note, I believe this is one of the cause which makes Indian products bit economical with almost similar performance.
 

Where do you see us by 2020?
We must expect some great change in India’s position worldwide under the leadership of new government having revolutionary thoughts. We are confident as we already have witnessed it in our state in the last decade.

 


 

Quality Is Investment And Good Investments Always Pay

Mr. Manish Agarwal (COO) Kevin Process Technologies Pvt. Ltd., in an exclusive interview with Mr. Faroukh Debu, Editor, The Pharma Review

Give us a short brief about your company and the group?
Kevin is one of the leading pharmaceutical machinery manufacturer with specialization in process equipment, coating solutions, material conveying & packaging and inspection. In India we are partners to number of international market leaders in various fields of Pharma applications, one of which is Uhlmann Pac System GmbH, Germany, a world leader in the field of pharmaceutical packaging.

 
What is your present role?
As a Unit Head (COO) of Kevin Packaging and Inspection Division, I am responsible for Uhlmann operations in India along with which I also head our manufacturing of Blister Format Parts for Uhlmann and other international blister machine suppliers.

 
Being purely a marketing person how difficult was it to play a role in the production side?
It was a steep learning curve. If you want to grow, you need to take up challenges and ensure you move with changing times. In today’s environment unless you do things which are different you can’t grow beyond a point. I enjoyed every bit of it; working with people makes you understand them better.

 
What specific machine/production lines does your company specialize in?
As mentioned our core specialisation is in the field of process equipment, coating solutions, material conveying & packaging and inspection.
 

Give us a brief of the markets you are you catering to?
We are leading exporters of our machinery across the globe and domestic markets are also in our focus. We are committed to provide best of products and services to our customers. Today Indian markets are recognised as some of the highest potential markets globally and being an Indian company it is our responsibility to offer solutions which can meet our customer requirements. This is a big opportunity and we are aware it.

 
Uhlmann being the best company in its field in the world, give us a short synopsis of the structure of the Uhlmann Group?
Uhlmann is respected globally for what they do, a highly committed company to pharmaceutical packaging, most innovative and always aspiring to beat the set standards. They are dedicated to pharmaceutical packaging and do not compromise on any aspect of it.

 
How has the experience been working with the best? And what specific difference can you measure?
You have to be lucky to be associated to the best, you also carry a lot of responsibility as you are believed for what you are and it takes immense efforts and hard work to stay ahead of competition. You have to think ahead, you have to be truthful to your customers, even if it means losing business. The word best does not only means best product, it also means the best buying experience, dealing with some of the best people in the industry. Finally the company becomes best because of its people, its systems and procedures and of course its product line. I am proud of my company and its product line.

 
How different & difficult/easy is it to sell in the market when you working for the best?
Selling is difficult, and when you are working in price conscious markets it becomes all the more important. But you have to understand that you are selling a complete solution, not just a product. It’s a concept selling and you need to match your advantages to customer requirements. In most of the cases it might look a costly product, but if you indulge in cost vs advantage analysis it might look different. You need to consider you payback periods, cost of non-compliance, breakdown time and you will realise that a good product will always score.
But, I do agree it’s not easy, you have to work hard - very hard.

 
What measures does your company take to maintain quality control?
We are very conscious about our quality standards; we have a full-fledged quality assurance department which is provided with some of the best and most advance instruments to ensure that whatever rolls out meets our set standards. In today’s market conditions with so many available options, the thing which will keep you in business is good quality and consistency. Quality is an investment and good investments always pay.

 
What is your company's top priority?
At Kevin, our top priority is to be a leading global player with respectable market share, be respected for whatever we produce and most important be good employers. You can’t win unless you have a winning team.

 
Where do you think India stands today in the international market?
Pharma machinery segment is fully dependent on the progress of pharmaceutical industry in India, and the situation is not bad at all. Today our industry is showing a steady growth and consolidation of its position in global markets. We are one of the leading manufacturers of quality pharmaceuticals and currently stand 4th with respect to installed capacities. Our focus to exports has resulted in substantial exports to developed markets. This has resulted in demand for quality equipment and services, that’s where we have an opportunity and path to excel.
Indian equipment are well accepted internationally and respected for their quality price ratios. Our equipment are reliable and meet regulatory requirements.

 
What are India's short comings according to you?
We have a long way ahead of us. Though we are considered reliable suppliers, but when it comes automation and aesthetics we need to improve. Secondly, we are still not selling much to big multinationals where the preference is still for European machines.
 

Where do you see us by 2020?
Next six years we need to invest on quality, up gradation, consolidation and market creation. We have to establish ourselves as leading global players not only in pharmaceuticals but also in field of machinery and other related fields. The market is wide open, the margins for all major international players is shrinking, and with our cost advantage clubbed with reliable quality can make all the difference. Next few years are important for us both for domestic and international business. We need to focus on our core strengths and be aggressive and committed in markets.

 


 

Quest PharmaTech Pipeline of Oncology Products
Investorideas.com, a global news source for leading sectors including biotech and pharma issues an exclusive interview with Dr. Madi R. Madiyalakan, Ph.D., Chief Executive Officer of Quest PharmaTech Inc. (TSX.V: QPT). Dr. Madiyalakan shares insight into the Company’s pipeline of oncology products. The Company takes a unique approach to cancer treatment that capitalizes on the recent major advances in the understanding of immune physiology and developing proprietary next generation cancer immunotherapy treatments using select antibodies, adjuvants and photosensitizers.

 
1. For readers unfamiliar with your company, can you give a brief introduction on your background in the biotech space and the formation of Quest PharmaTech?
I have been involved in the Biotech industry for over 27 years, first as a scientist at Biomira Inc (now known as Oncothyreon) and then as a founding executive team member of several biotech companies including, AltaRex Corp., CanBiocin Inc. and SonoLight Pharmaceuticals Corp. My relationship with Quest began when Quest PharmaTech acquired SonoLight Pharmaceuticals in 2001. That acquisition provided a path forward for technology I had invented and championed ([Dr. Madiyalakan holds 10 primary U.S. patents and eight pending patents]). I have been instrumental in raising more than $200 million through private placement and public offerings for those companies. I specialize in advancing novel technologies with great therapeutic potential in areas of unmet medical need.
Quest was started as a research and development company in 1998 and was listed on the TSX Venture Exchange in 1999. I have been CEO of the Company since 2006.

 
2. Can you briefly describe the current product portfolio and the primary oncology focus for each?
Our technology is focused on the immunotherapy of cancer. We utilize tumor directed monoclonal antibodies to activate the specific immunity; however we recognize that successful therapy requires orchestrated combination with chemotherapy, photodynamic therapy and select additional immune modulators or adjuvants. Our lead product, Oregovomab, which is currently completing a phase II clinical trial in both Italy and the U.S., is used in combination with standard chemotherapy in ovarian cancer patients. It is also being tested in combination with other immunotherapeutic agents for use in treating pancreatic cancer patients. Our pipeline also includes proprietary antibodies against other cancer markers, most notably MUC1, PSA and HER2. We expect to advance our MUC1 targeting antibody into the clinic in the coming year. MUC1 expressing cancers include many commonly occurring solid cancers such as breast, pancreatic and lung cancers.
We are also very excited about our new pipeline of therapeutic IgE antibodies, which we recently acquired from Advanced Immune Therapeutics, Inc. and for which we obtained license rights from UCLA and Stanford University. In addition to their immunotherapeutic potential, these molecules also have the potential to act in the tumor micro-environment to augment the effectiveness of chemotherapy. We truly believe that the IgE technology will be a breakthrough for the treatment of cancer.

 
3. Can you discuss the current status of your flagship product OREGOVOMAB and its applications in immune therapy?
Quest’s proprietary approach uses antibodies to modulate and enhance specific immunity to the target tumor antigen and associated tumor. Recent insights into the ability of cytotoxic therapy to enhance immunity, and the development of novel adjuvant approaches, suggests that a simple and artful approach using a combination of components for specific cancer immunotherapy can change the clinical course of cancer. We are using our lead product Oregovomab as an example to demonstrate the proof of concept for the combinatorial immunotherapeutic approach and trying to identify ideal combinations by conducting three different clinical trials. The most advanced of these is an 80 patient phase II clinical trial in advanced ovarian cancer patients that is being conducted in 13 clinical centers in Italy and the U.S. We hope the results from this trial will confirm the findings in an earlier study that shows combining chemotherapy with Oregovomab leads to the generation of specific anti-cancer T-cells and the potential for clinical benefits. We are also conducting another clinical trial in the U.S. using Oregovomab in combination with another chemotherapeutic agent, Gemcitabine, together with radiation therapy for treating pancreatic cancer. The trial will help us to expand the market opportunities for Oregovomab to other CA125 expressing cancers as well as to evaluate immunotherapy in combination with chemo radiotherapy. We are also looking at the addition of an immunoadjuvant, Hiltonol, a TLR3 agonist, which we have licensed from a U.S based company, Oncovir, to further augment the immune response. The completion of these 3 clinical trials will provide us with the roadmap for commercialization of this product. To summarize, Quest’s approach has created an opportunity to mobilize immunity, better, more precisely and for less cost than other methods that are in development, and, or, recently approved.
 

4. Can you give us some background on the key members of your team and the scientific board and the expertise they bring to the company?
Working with me on the management team, I have Thomas Woo, Vice President of Product Development since 2002. Thomas honed his drug development skills at Biomira, AltaRex and Cytovax. My CFO, Pierre Vermette, comes with extensive experience gained at the Alberta Securities Commission and has been with the Company since 2003.
On the Board of Directors, I have Lorne Meikle, our Chairman, Ian McConnan, our Audit Committee Chair and Paul Van Damme, our Corporate Governance Chair.
Mr. Meikle has an extensive background in the life sciences area, Mr. McConnan is a former partner of several public accounting firms, and Mr. Van Damme has acted in the CFO role for a number of public and private companies.
On the Company’s Scientific Advisory Board, I have internationally known scientists who occupy important positions in various institutions around the world. Dr. Samuel Abraham, Ph.D., is the Vice President of Research with the British Columbia Cancer Agency. Professor Ki-Jun Hwang is a well respected medicinal chemist at Chonbuk University in South Korea. One of the clinicians, Dr. Ronald Moore, who is developing a unique treatment for prostate cancer at the Cross Cancer Institute in Canada, is also one of our scientific advisory board members. Dr. Moore, along with Dr. Gerald Miller in Australia, provide a strong scientific direction to our photodynamic therapy program.
On the Company’s Clinical Advisory Board (CAB), I have Dr. Christopher Nicodemus, a clinical expert in tumor immunology and drug development who has been championing the combinatorial immunotherapeutic approach supported by numerous publications and patents. He relies on the advice of his fellow CAB members, key opinion leaders such as Professor William McGuire in the U.S, Professor Ignace Vergote in Belgium and Dr. Thomas Ehlen in Canada.
All members of the CAB have a keen interest in innovative improvements in the area of ovarian cancer and see a great opportunity to advance the previous learning with Oregovomab in the context of combination therapies that will better access the immune response and limit immune suppression that has impeded earlier efforts to vaccinate against cancer.

 
5. Can you share with readers the significance of some of your key relationships including Stanford University and UCLA?
We are very pleased to be licensing IgE technologies developed by the distinguished scientists from these prestigious institutions. In addition, we are also working closely with the Eppley Cancer Institute at the University of Nebraska to develop animal models and complete pre-clinical testing of potential drug candidates.

 
6. With all biotech companies, funding is a key factor to success; last November you announced a $1million placement for Quest PharmaTech. Can you explain the significance of this round of financing and where this takes you to?
We wanted to strengthen our relationship with our long term investment partner, AD Biotech Co., Ltd. AD Biotech has committed $12 Million to fund our ongoing clinical programs during the next two years. We were pleased with their confidence in Quest as demonstrated by their investment of $1 Million at a premium share price.

 
7. In closing what are some of the key milestones for 2014 for Quest PharmaTech?
Some of the key 2014 milestones we hope to achieve in the coming year include completing patient enrollment of the Oregovomab clinical trial and obtaining preliminary data for the Oregovomab clinical trial in Italy and US; initiating a clinical study combining Oregovomab with immuno-adjuvants; expanding the Company’s opportunities for revenue generation through product sales of some evidence based over-the-counter nutraceutical and cosmetic products licensed from our joint venture partner; generating critical additional data demonstrating the therapeutic potential of our proprietary IgE portfolio; and, pursuing out-licensing arrangements as a source of additional revenue and validation for our technologies.

 


 

Quality Product is Our Speciality Which Made Us Leader in Different Pharma Packaging Products

 
Excerpts From an Exclusive Interview with Mr. Jayesh Shah of the Bharat Rubber Works Pvt Ltd.

1. You being one of the pioneers in the Pharma Packaging Industry in India, please tell us about the beginning of your company and the journey till today?
Our Company Bharat Rubber works started in 1978 and we have focused on Primary Pharmaceutical Packing items in Rubber and Plastic. According to the times and availability of technology we always stayed ahead by upgrading our company and ourselves. We believe in top most quality and make high quality products to satisfy our customers. Our Customers who has made us Number 1 in Asia for products like Dropper Sets and Rubber Stoppers as well Plastic Products widely used by National and International Pharma companies in India and around the world.

2. Kindly tell us about any specific achievements of Bharat Rubber?
Till 1999 the turnover was 8 to 9 cr with 5% of turnover contributed by exports of our products but post 1999 the company started moving on the fast trackand today our company has reached a turnover of 40 cr with 40% of it from exports in different parts of the world.We have also achieved the certificate as Govt. Recognized Export House. The company has ultra modern facility for manufacturing the products as per International standards with highly qualified working team.

3. What is the range of products you specialize in?
We manufacturer the entire range of Dropper Assembly in Plastic and Glass, all kinds of Rubber Stoppers and Diagnostics Rubber Parts. We are also into the different type of Plastic articles like cups, spoons and caps and have around 80% of the Pharma packaging under one roof with state of art facility.

4. Quality control would be your top priority. Would you please elaborate on this?
Quality Products is our speciality which made us leader in different Pharma packaging products. We are maintaining very high standards of Quality and our products pass through long and detailed quality checks during the manufacturing process till the product packing stage. In Rubber stoppers we are maintaining very high standards and provide Ready to Sterile Rubber Stoppers & Ready to use Rubber Stoppers which is the need of today’s Pharma Industry. Our company is certified with ISO 9001:2008 certification and we are in process of ISO 15378, even we are DMF registered company.

5. How has the technology changed in this field in the last few years?
Regarding technology we always look forward to see what is next and constantly upgrade ourselves to meet the future needs of Pharma companies. We have high speed modern machines which gives us ‘No man Touch Products’ to avoid contamination. I would like to thank all our customers whose support has helped us in upgrading our facilities.

6. How are you currently placed in the Indian and the international market?
In India we are leaders in the market with best of Quality and best manufacturing facilities. In local market we are catering to more than 60% share. Our packaging products used by Indian Pharma Companies are well accepted by the countries where they export their Finished Formulations.
In exports we have many countries where we are supplying 80% of their requirement of their Pharma companies. As I mentioned earlier we are Number 1 in Asia for products like Dropper Sets and Rubber Stoppers.

7. Which countries do you export your products to?
We are presently exporting to South East Asia, all over African countries, Dubai, Saudi Arabia, Egypt, Yemen, Muscat, Iraq, Bangladesh, Germany, Belgium, South America etc.

8. Any specific future Plans?
We have already started our New Plant in October, 2013 with the Name of BHARAT PLASTOPACK PVT. LTD. with increased Production Capacity and some New Products. By 2017 we target to be a 100 Cr company.
DRYTECH PROCESSES (I) PVT. LTD. is also our group company having 5 different spray drying plants. The facilities are dedicated for different individual category of products. We are specialized in art of spray drying which is Asia’s largest manufacturer of Spray dried Gum Arabic / Gum Acacia.
We also manufacture fruit and vegetable powders, seasoning ingredients, milk proteins / caseinates, natural colourants, fat powders, soluble dietary fibre & nutraceutical products etc.,
We are the best co-partners for spray drying and co-packing of infant and clinical nutrition. Our range of products serves various segments of the food industry such as flavor, beverages, confectionery, bakery, savory, infant – sports nutrition etc., shortly we will be coming up with expanded capacity to cator the consistently rising market.

9. Any suggestions for change in any Govt. policy with relation to your industry.
Government should give us better incentives in exports and try to keep control in local raw material market price. They can also reduce import duty of our raw materials, so that we can be more competitive in local as well International markets.

 


 

Engineering Company Believes in Building Relationships Rather Than Clients or Customers

1. Congratulations on completing 50 years in the Industry. You are known as the pioneer in the Pharma Machinery Industry in India. Please tell us about the achievements of your company.
Thank you very much Faroukh for the honour and thank you for having this session. It’s always a pleasure talking to you.
From the very beginning at UEC we tried to build relationships rather than clients or customers. We always try to provide the best quality in all aspects of the business be it machines, service or relations.
Our clients are our achievements. Most pharmaceutical companies in India being a UNITED machine user, does add to the credentials of the company.
And definitely, the hard work and efforts of the members of the company does play a very crucial role in making The United Engineering Company, what it is today.

 
2. What kind of machinery do you specialize in?
We specialize in machinery for packaging ampoules, vials and bottles. We provide a complete solution for the whole production line. Our product ranges from semi-automatic to fully automatic machines. We also specialize in machines for tablet coating.
‘UNITED’ machines are versatile in nature and thus can accommodate containers of different shapes & sizes.
Pharma engineering being our forte, we have also been at the service of other industries.
We also provide our customers the best and advanced customized engineered solution.

 
3. What are your latest developments?
We are always keen on upgrading our existing machines in parlance to the new developments. We believe that tomorrow’s technology should be a standard in every UNITED machine produced today.
Our latest development is the UNITED ‘EAC’ - Automatic External Cleaning & Drying Machine for Ampoules & Vials. This machine plays a very big role in improving the productivity of an automatic inspection machine in the production line. We have developed High Speed Automatic Sticker Labelling Machines for Vials & Ampoules, with special unique features as well.
We are also are planning for developing Automatic Cartoning Machines for containers of various sizes in the near future.
Presently, we are working on the development of a High Speed Rotary Ampoule Filling and Sealing Machine with features galore. It would be the most compact machine, in fact the first of its kind in India.

 
4. Quality control would be your top priority, would you please elaborate on this.
From a nut to the main component of the machine, we provide the best quality material complying with the highest standards of manufacturing guidelines. We perform on quality checking program for each & every machine before being dispatched.
Hence, Quality Control does form a crucial part of our validation program.

 
5. Which countries do you export your machines to?
We are doing well in the overseas market. We export mostly to South African & Asian countries. Yet we have supplied a few machines to U.S.A and Canada as well. Presently we are looking forward to extend our horizons to the European and other markets.

 
6. How has technology changed in this field in the last few years?
In the last few years, this field has seen a favorable metamorphosis in technology. Automation of machines have improved to a new dimension which adds a lot to the productivity of the machines. This also helps the user to get a clear view on the overall performance and utility of the machines.

 
7. How are you currently placed in the Indian & the International market?
In India, we are considered to be one of the best and trusted brands in the Industry. Internationally, ‘UNITED’ machines also has a good reputation.

 
8. 50 years, a long time, what are your future plans?
We are planning to increase our production capacity by starting a new plant, incorporating modern equipments and state of the art facilities.
50 years is a long time, but for UEC, entering the 50 years, is the beginning of a new journey. Much more to do and many lucrative avenues to explore. The only plan is to work harder, beating the present and excel much more in future.

 
9. How do you see Indian Pharma Vis-à-vis Vision 2020?
As per the reports of 2013, the Indian Pharma Industry ranks 3rd in terms of volume and 13th in terms of value compared to other countries. Within seven years, we hope that there would be a huge penetration of modern medical facilities, development of new generics which would help in curing deadly diseases, thus leading Pharma Industry to its peak.

 


   

An exclusive interview with Dr. Bhavana Pharik, Consultant, Medical Oncologist, BNH HCG Cancer Center, Mumbai

 

1. What are the causes for the rising incidence in Mumbai?

The causes: there are certain external factors like adoption of westernized lifestyle. Lack of physical activity, obesity, excess of unhealthy food, use of tobacco and alcohol, late pregnancies or no pregnancies, exposure to some form of radiation. All these put together have increased risk of cancer for people in Mumbai.

 

2. The first 3 a common cancers found in women---what about the others --the causes?

The three most common cancers in women are: Breast cancer, Cervical Cancer and tobacco related cancer. The causes are same as mentioned above.

 

3. What is optimal therapy?

Today, treatment of any patient with cancer requires multi disciplinary team approach. This includes comprehensive diagnostic facilities, team of Medical oncologist, Surgical Oncologist and Radiation oncologist. Targeted therapy is a newer type of cancer treatment that uses drugs or other substances to identify precisely and attack cancer cells, with minimal damage to normal cells. Targeted therapy is a growing part of the multi-modality cancer treatment regimens that include chemotherapy, surgery, and radiation therapy. Now the world is moving to targeted therapies, which is the practice at BNH HCG Cancer Center . Targeted therapies have limited toxicity and target the cancer cells which carries the specific receptors. We need to assess the presence of the receptors prior to start of therapy with these targeted drugs.

 

4.  What is breast conservation surgery?

For a patient diagnosed with breast cancer, losing the breast affects her psychologically, physically and mentally. With advancements in cancer care treatment, we are able to preserve the breast as quality of life is as important as survival. Also, currently we have better screening modalities, where we can diagnose the disease in early stages. Breast conservation surgeries will improve the quality of life and social well being. Advances in chemotherapy have also benefitted, where we can shrink large size tumors and with breast conservation protocols we can preserve the organ, with better medical outcomes.

 

5.  Does the centre also counsel patients post-surgery?

Counselling and rehabilitation are part and parcel of treatment! We have a team of counsellors who help patients go through the treatment as well as recover from this illness.

 

6. What is the cost involved?

The cost can vary depending on the stage of the disease, chemotherapy drugs required, type of surgery as well as radiation. For an early stage disease, the cost may be approximately Rs. three lakhs.

 

7. Please share a few case studies.

Case studies:

A. A woman presented with ascites which was found to be malignant. On further investigations, it was confirmed to be primary ovarian cancer. She was treated successfully with surgery as well as chemotherapy. Within a period of six months of completion of her treatment, the patient's daughter presented with a lump in her left breast. This was confirmed to malignant. The daughter was also treated with surgery, chemotherapy and radiation. Thus, this is a classic example of a Familial Cancer (Breast Ovarian cancer syndrome).

 b. A middle-aged man presented with a non-healing ulcer over his left chest wall. The biopsy confirmed it to be Breast cancer! Male Breast Cancer occurs rarely but must be kept in mind. This patient underwent surgery as well as chemotherapy just like any woman with breast cancer.

 


   

An exclusive interview with Mr Lee Eng Keat, International Director, Asia Pacific, SEDB Singapore

 

1. How have the research institutes and research consortia in Singapore contributed to growth in the pharma sector?

 

2. What kind of progress has been achieved in the field of clinical research?

 

Singapore’s vision is to be the Biopolis of Asia, a leading international biomedical sciences cluster where companies can impact global health by achieving excellence and synergies across R&D, manufacturing and headquarter activities. Currently, global companies and Asian enterprises alike are already using Singapore as a beachhead in Asia. This includes 8 of the top 10 pharmaceutical and all of the top 10 medical technology companies, which have their regional headquarters in Singapore, from which to drive business expansion in Asia., Today, more than 7,100 researchers carry out biomedical sciences R&D – across drug discovery, translational and clinical research – in more than 50 companies, our universities and 30 public sector institutes under the Agency for Science, Technology and Research (A*STAR) and the Ministry of Health (MOH). Collectively, more than S$1.51 billion is spent on biomedical R&D annually. To support the growing outsourcing needs of pharmaceutical firms, Singapore is also home to more than 14 Contract Research Organisations (CROs) including Quintiles’ Asia-Pacific Innovation Centre, ICON, Covance, PPD and Paraxel.

Looking ahead, Singapore has committed S$16.1 billion in continued support of research, innovation and enterprise activities between 2011 and 2015. Out of the S$16.1 billion, S$3.7 billion (23%) is dedicated to enhancing existing biomedical R&D infrastructure, integrating multi-disciplinary research and translating basic science into tangible outcomes.

The Singapore government has provided leading infrastructure to facilitate translational and clinical research, such as the three Investigational Medicine Units (IMU) dedicated for early-phase trials in public hospitals, as well as the Singapore Clinical Research Institute (SCRI), which focuses on supporting later-stage trials.

On top of the local clinical networks, Singapore established Clinical Trials Networks across the Asia-Pacific, including the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, Family Medicine Research Network (FMRN), Pan-Asian Resuscitation Outcomes Study (PAROS) Clinical Research Network (CRN) and the Cancer Therapeutics Research Group (CTRG), a multi-institutional research collaboration in global oncology development which involves international institutions like the National University Hospital/National University of Singapore, Sydney Cancer Centre/University of Sydney, Johns Hopkins Singapore International Medical Centre, Chinese University of Hong Kong and Singapore National Cancer Centre.

 

3. Which factors have attributed to global companies like GlaxoSmithKline and Novartis setting up their clinical centres in Singapore?

Singapore’s ongoing commitment to develop translational and clinical research capabilities and interdisciplinary research for drug development, maintain a pool of global R&D talent located in world-class research infrastructure, and upkeep a strong IP regime to protect R&D outcomes gives companies the confidence to internationalise through Singapore.

With a reputation for its clinical research and clinical trials management activities in Asia, Singapore is also the secretariat for the APEC Coordinating Centre for Good Clinical Practice (GCP), playing a major role in developing GCP in Asia, initiatives to train of clinical research personnel and developing a conducive environment for multi-site clinical trials in the region. Due to all these factors, global pharmaceutical brands such as GSK, Novartis and Sanofi have set up their regional clinical trial centres in Singapore. Efficient regulatory approvals in Singapore now take between 3 to 6 weeks to receive approval for clinical trials.

Singapore’s multi-racial population representative of the population in Asia serves as a good test bed for different Asian disease burdens. These factors coupled with Singapore’s high level of quality and medical standards are factors that attract global MNCs to base their clinical centres here. Many global pharmaceutical brands have set up their regional clinical trial centres in Singapore, which include: GSK established its first Academic Centre of Excellence in Singapore and its first four projects were focused on early-stage research in ophthalmology, regenerative medicine and neuro-degeneration to elucidate new mechanisms of action for innovative medicines. Also partnering with A*STAR, research institutes and hospitals, Novartis had joined hands with the Swiss Tropical and Public Health Institute, and The Scripps Research Institute and developed a new drug against malaria.

 

4. How has A*Star contributed to clinical research in Singapore?

Over the past 20 years, Singapore has steadily built a strong foundation of basic and clinical research through its 30 research institutes under the Agency for Science, Technology and Research (A*STAR).

One such institute is the Bioinformatics institute (BII) which was established for computational biology research and postgraduate training as well as a national resource centre in bioinformatics. Another institute is the Bioprocessing Technology Institute (BTI) whose mission is to develop manpower capabilities and establish cutting-edge technologies relevant to the bioprocess community. Spearheading bioprocess R&D, the BTI specializes in expression engineering, animal cell technology, stem cells, microbial fermentation, product characterisation, downstream processing, purification and stability, with supporting proteomics and microarray platform technologies. Also, the Genome Institute of Singapore (GIS) is a national flagship initiative with a global vision that seeks to use genomic sciences to improve public health and prosperity.

In June 2013, Pfizer, GSK and Siemens signed on as founding members of a new consortium set up by Singapore’s A*STAR’s Institute for Chemical and Engineering Sciences (ICES)’s Innovative Processing of Specialties and Pharmaceuticals (iPSP) to address various challenges such as costs, regulatory compliance and responsiveness in production and processes to bring drugs from trials to markets.

 

5. What initiatives have been undertaken by the government of Singapore to provide a strong foundation to the pharma and healthcare sector?

Rising healthcare costs in the G3, and emerging Asian markets, have payers and regulators demanding safe and cost-effective products. This provides an impetus for companies to transition from selling drugs/devices to selling positive treatment outcomes that are cost effective. Decreasing R&D productivity & continuing sales drop off from blockbusters due to the patent cliff mean that pharmaceutical companies are transitioning from blockbuster drugs to precision medicine, and restructuring their R&D organizations. This includes smaller in-house teams and a greater reliance on external partners to accelerate commercialization and co-share risk. This is where Singapore, a trusted location from which companies can manufacture high quality drugs for global and Asian markets across various modalities with peace of mind, can play a role.

Companies can better assess and access diverse Asian markets, by partnering with Singapore’s public and private sector players to improve understanding of market needs, regulatory landscapes and policies.

Singapore offers an integrated Translational Clinical Research (TCR) ecosystem for companies to access cutting edge and targeted R&D by establishing new models of public and private collaborations.

S$600m in the Industry Alignment Fund (IAF) to support public sector researchers in their collaborations with industry

A Biomedical Sciences Industry Partnership Office (BMS IPO) was set up as a single point of contact for matching companies’ R&D needs, to expertise in Singapore’s research hospitals, as well as academic and public research institutions.

In 2011, Maccine inked a collaboration with A*STAR’s Singapore Bioimaging Consortium to form a comprehensive Translational Imaging Industrial Lab (TIIL) to push the boundaries in state-of-the-art preclinical imaging to enhance the drug development process.

The government has undertaken numerous initiatives to provide a strong footing to the pharmaceutical industry in Singapore. The government provides awards like the Singapore Translational Research (STaR) Investigator Award, to recruit and nurture world-class clinician scientists to undertake translational and clinical research in Singapore. Another initiative is the Clinician Scientist Award (CSA), which provides research funding and salary support to enable medical researchers to devote more time to research.

The Competitive Research Programme helps to identify new potential strategic research areas in which Singapore can invest, particularly the biomedical sciences translational and clinical research areas. Each award is for a maximum of S$10 million per programme, over three to five years. Also, The Health Services Research (HSR) Competitive Research Grants were established in 2009 to promote the conduct of HSR and enable the translation of HSR findings into policy and practice.

For Asian and global companies in the pharmaceutical and biotechnology sectors, Singapore represents a thriving global R&D hub that stands at the forefront of innovative solutions in the field of drug development and discovery.

 

6. Where do India or Indian pharmaceutical companies stand in your entire global profile?

 

7. Does SEDB have any plans of setting up any joint ventures in India in the research field - bio and nano technology?

Singapore is a trusted location for Indian companies to access and manage global markets. More than 4,000 Indian enterprises have incorporated in Singapore, with a growing number basing their regional or international headquarters there to coordinate overseas operations.  Indian companies tap on Singapore’s strong pool of multi-disciplinary talent and business-friendly policies to drive their growth. For example, Fortis Healthcare, one of India’s largest healthcare companies, has established its international headquarters in Singapore and recently announced plans to list its clinical establishment division on the Singapore Stock Exchange.

In Singapore, Indian companies can access a global talent base, unique patient pools representative of all major Asian genotypes (Chinese, Malay and Indian) and forge collaborations with the Singapore-based research community. Notably, in August 2012, Singapore’s Agency of Science, Technology and Research (A*STAR) signed an MOU with India’s Department of Science and Technology to drive greater cooperation between the two countries with joint workshops and grant calls.  Indian companies can partner Singapore institutions for innovative development of new medicines, formulation capabilities and drug delivery mechanisms.  Singapore has invested heavily in Asia-prevalent diseases such as cardiovascular disease, diabetes, gastric cancer and dengue.  As some of these diseases have a high incidence in Indians, leading Indian pharmaceutical companies have expressed interest to work with Singapore clinical institutions to develop new drugs for these diseases.

EDB continues to engage and understand leading Indian pharmaceutical companies’ evolving internationalisation needs in order to explore win-win partnerships with Singapore. With Asia's best healthcare system and world-class medical practice, Singapore continues to be committed to co-create innovative healthcare solutions with leading company partners.

 


 

With the rise of Ideal Cures as a major player in film coating industry, the monopoly of MNC has been broken down which has immensely benefitted the Indian Pharma industry.

 

On receiving of US patent relating to aqueous film coating composition based on sodium alginate of application in pharmaceutical and Nutraceutical – tablets, caplets, pellets and granules, Mr.Suresh Pareek MD. and Mr. Chetan Rajsharad (VP-Technical) Ideal Cures, gave an exclusive interview to The Pharma Review.

 

 

To begin with we would like to congratulate you on receiving the US patent in film coating technology. What does it simply?

The US patent awarded to Ideal Cures in Feb. 2012 is the first US patent awarded to any Indian company dealing with film coating technology. This is a major achievement for the company as it provides a booster shot to our R&D team. The company which has been focusing on developing newer products and has taken a challenge to become a science driven world class organization, this is a milestone recognisation to our vision and efforts & investments in R&D. We already have a strong R&D team and IPR department which are committed to bring out newer, user friendly and cost effective products for solving any film coating related problems for Food and Pharma industry. Today Ideal Cures is the only company who has been able to formulate a very user friendly aqueous film coating product using a natural polymer – Sodium Alginate and put such a product in market.

 

Could you please tell us little more about this technology ?

As I said Sodium Alginate is a natural polymer, it was thought to be difficult to use it for robust coating process. Infact there are reports available in literature where scientists have tried to use it for film coating but failed without the use of some additional synthetic polymer. Mr Chetan Rajsharad (VP-Technical) says that Sodium Alginate is a natural polymer whereas almost all the commonly used polymers for film coating are synthetic ones, we took it as a challenge to develop Sodium Alginate as a suitable polymer for film coating. I am proud on my R&D team which has come out with an excellent product in which all the ingredients used have GRAS status and is equally useful for Pharma as well as Food industry. This technology has been recognized as a significant advancement in film coating as we have been awarded an Indian patent and now a US patent for this product."

 

How is this technology going to help your overall business ?

This technology is based on water as the solvent, hence, it is environment friendly (not using any toxic solvents), moreover, this is more productive than commonly used HPMC based coating technology. We have run coating trials in the same set-up using this technology as well as the HPMC based systems, this new technology was found to be significantly faster and productive. We expect that this technology will prove to be a problem solver on shop-floor. Further, being GRAS material, the registration process for new products as well as the re-registration of older products should be smooth and faster when the user industry adopts this technology. Having said that we expect significant increase in our business prospects with our increased product range. Infact we have already started getting enquires based on this new product.

 

How is the coating market doing otherwise ?

With the rise of Ideal Cures as a major player in film coating industry, the monopoly of MNC has been broken down which has immensely benefitted the Indian Pharma industry. This has also opened the gates for many other entrepreneurs to start such business activity resulting this segment of industry to become very competitive. The market size for pre-mix coating compositions has grown many folds during last few years , so as the competition. Today many MNCs are entering this field, I am sure all these developments will provide greater opportunities for further innovations in the field of film coating.

 

Do you plan to file more patents in the near future ?

We have recently filed 3 new PCT applications for 3 new products our R&D has developed; these are related to immediate release coating, moisture barrier coating and programmable delayed release coating. Our R&D team is continuously working on many other novel ideas and I am sure that we will continue to add value to our product range and will be able to provide better and better solutions to our customers.

 

The Indian Pharma industry has been growing at an exceptional pace over the last few years. How do you see the future growth ?

The whole Pharma industry as well as the related excipient industry has realized the importance of R&D and are continuously making fresh investments in R&D. The trained scientific manpower also is no less capable than anywhere else in world. Therefore, the future of Indian Pharma industry is very bright. Though the competition has grown many folds but till we continue to look for innovations, industry will keep growing. There are difficult times especially when the European economy is in trouble and may affect the exports to Europe but as the Indian Pharma industry is not exposed to only one region, the overall impact on Indian companies may not be very significant.

 

You have been a regular participant in major Pharma Expo in India and abroad. From a marketing prospective what has been your experience and gains from such participation ?

Continuous participation in such Pharma Expos has been quite useful to us. We have been able to meet different people from different regions which has helped in better understanding their needs and thereby developing suitable products for their specific requirements. This has also helped us to understand the market trend and possible future requirements. Networking with our customers and distributors is another big benefit from such exhibitions.

 

Where does Ideal Cures position itself 10 years from now ?

Ideal Cures is committed to make fresh investments in R&D, new products and trained manpower, therefore, I am sure that we will keep developing newer technologies and thereby expanding our business prospects. We have already started working on diversification and have already made significant investment in backward integration as we have already started manufacturing acrylic polymers for our captive consumption. We will thereby continuously upgrade our facilities and business potential. I see a very bright future for Ideal Cures in the coming years.

 

It was a pleasure speaking to both of you and we wish Ideal Cures all the very best for all your future ventures

 


 

Good Quality Products Sell by Themselves

 

An Exclusive Interview with Mr. Ratan U. Bhatia, Co-Founder, of Magumps

You are amongst the pioneers in the Pharma Machinery Industry in India. Please tell us about how you started and the achievements of your company today?

Thank you for the recognition.

Our story dates back to 1962, when one of Magumps Co-Founder Late Mr. G. L. Bhatia was a freelancer after completing his studies as a B.Sc.Tech ( Oil Technology ) from U.D.C.T, Mumbai. One of his friend owned an Oil Mill where in they used to process different oils and for every batch they used to send the sample for color testing to an outside laboratory. Mr. G L. Bhatia noticed this and advised against spending these high expenses and instead put a small testing laboratory for this process at a fractional of the annual costs. The owner of the mill liked the idea but was reluctant to move forward citing that they were very occupied with their ongoing work and would go ahead if helped technically by Mr. G.L.Bhatia. Mr. G.L Bhatia being young and dynamic took this as a challenge. At that time, I was in college and after college I used the time to help Mr. G.L. Bhatia. Within 3 months, the testing laboratory with all the instruments was ready and was generating in-house testing reports, which saved him enough to recover the entire cost of laboratory including all the instruments and accessories for the first year of operation. The friend appreciated his efforts and wanted to pay him for this, which he did not accept. So to reciprocate the favors the owner forced him to supply all the recurring glass apparatus. This was the beginning of start of our business on a very small scale.

Then in the year 1965 we entered in to the supply of laboratory equipments which gave us good understanding of the domestic market and we were approached by an leading International manufacturers to market their powder drying equipment in India. During this time, it became necessary to establish our company " Magumps " with additions of various other equipments within the same line. Those were the days when we both Co-founders were individually working as ' Peons to Managers/ Partners '. We used to hire bicycles for making deliveries ourselves as well as giving free demonstration of our equipment to the customers at their premises to showcase our equipment and to win their confidence. Mr. G.L.Bhatia always believed that if our equipment are good, the customers will find the value and come searching for the same. Hence one does not need any effort to market it. Originally we started dealing in glass apparatus plus laboratory instruments. We also helped various manufacturers in marketing their instruments and testing equipment. Then we added self manufacturing of Label Gumming Machines, Mini Print Masters, Tablet Disintegration, Hardness, and Friability Test Machines. We also expanded the range, by marketing quality machines such as Rotary tabletting by M/s. Cadmach & Clit, High speed labeling machines by Ambica Group, Rorer bottle washing machines, Dry syrup Powder filling machines, complete line equipment from bottle washing to packing.

 

What kind of machinery do you specialize in?

Currently our specialization is in Tray Driers, Rotary Vacuum Cone Driers, Vacuum Tray Driers, Sifters and Multi-Mills. Our range of supply includes Granulators, Tabletting Machines, Dry Heat Sterilizers, Octagonal / Double Cone / & Drum Blenders, Vacuum Shelf Driers, Sparkler Filter Press, Stirrers, Homogenizers, Liquid Filling, Capping, Inspection & Labeling lines, Belt-Conveyors, Capsule filling & Loaders, Capsule & Tablet Counting Machines, Filtered hot air blowers to dry wet equipment, in addition of all types of Stainless Steel clean-room furniture & accessories, etc.

 

Quality control would be your top priority. Would you please elaborate on this?

Yes. We believe there is no compromise on quality. As Mr. G.L Bhatia use to say this to our team that "Good Quality Products Sell by Itself”. To follow this we get involved personally in internal inspection, testing of each equipment by taking multiple trials before installing at a customer’s site. We subsequently follow up with the customer’s team to check the performance and constantly seek their feedback and suggestions for improvements.

 

How has the technology changed in this field in the last few years?

Technology has changed immensely. We have seen the time from fully manual processing to semi-automatic to fully automatic controlled machines with use of software managed by Programmable Logic Controls (PLC) based panels with pneumatic, hydraulic and safety instrumentation. With changing times, we have constantly innovated, improvised, and upgraded our manufacturing processes and machines we offer for the Pharmaceutical Industries.

 

How are you currently placed in the Indian and the international market?

Due to our commitment to Quality, Long standing, Ethical Business Practices we have earned the trust and business of top National and Multi National Companies, having many satisfactory installations in domestic companies such as Torrent Pharmaceuticals Ltd., Ranbaxy Laboratories Ltd., Cadila Pharmaceuticals Ltd., Lupin Laboratories Ltd., Dr. Reddys Laboratories Ltd., Divis Laboratories Ltd. to name a few.

 

Which countries do you export your machinery to?

Over the years, we have indirectly supplied to customers in Nigeria, Malaysia, Bangladesh, America, Middle East, and Nepal.

 

What are your future Plans?

We are looking to starting direct exports in the near term and would like to be leading supplier of quality equipment in domestic markets.

 

How do you see the Indian Pharma sector vis-a-vis Vision 2020?

We see the Indian Pharma sector to continue to grow. Already Indian manufactured products have found good place domestically as well as in International market. Due to the opening up of Foreign Direct Investments (FDI) in India many Multi National Companies are looking forward to invest in India, accordingly there is a good potential of growth in Pharma sector.

 


 

NEOCOTA’’ Is the Pioneer of Automatic Tablet Coating System

 

Excerpts of an exclusive Interview done by The Pharma Review
with Anup Maitra, Managing Director, Neomachine, Kolkata

 

You are amongst the pioneers in Coating Machinery. Please tell us how you started and the achievements of your company today?

We started our company in the year 1973 with a mission to manufacture Pharmaceutical Machinery for Tablets, Liquid, Injectables, Bandage and ointment sections. In the year 1984, we introduced and subsequently solely concentrated on Automatic Coating System, suitable to coat tablet & pallet under the brand name of ‘’NEOCOTA’’ in India market of Pharmaceutical Industry. Subsequently, ‘’NEOCOTA’’ became the pioneer of Automatic Tablet Coating System and got overwhelming response from almost all the leading Pharmaceutical companies in India. Later we started with standard control panels, then developed the same to Microprocessor based control panels Thereafter we introduced PLC with HMI based control panels to run our NEOCOTA machines smoothly. Till date, we are engaged in upgrading our machine to cater to the present need and demand of the pharmaceutical industry complying WHO, CGMP & USFDA norms.

 

How has the technology changed in the Coating field in the manufacturing of medicine in the last few years?

Introduction of WHO, CGMP & USFDA norms and subsequently introduction of Instrumentation as per need with our Machines suitable for Film and Sugar Coating and for both Aqueous & Non-aqueous.

 

What kind of medicines is this coating system is applied to?

Hygroscopic tablets, Bitter test tablets, Enteric type tablets, Time reduced tablets, Specific site of action tablets, Brittle hardness tablets, and for Colouring of tablets etc.

 

What is the various types of provision in NEOCOTA?

Enteric Coating, Pallet Coating, Sugar Coating, Hormone Coating, Aqueous & Non-Aqueous Coating, can be done in NEOCATA.

 

Is there any ‘Automatic Loading & Unloading’ facility’ can provided in NEOCOTA?

Yes, ‘Automatic Loading & Unloading Facility can be provided in NEOCOTA. We also provide Liquid Flow Rate Indication, Air Flow Rate Indication and Humidity Rate on HMI Screen along with Interlocking System between Pan, Blower And Spray Pump.

 

Quality Control will be your top priority. Would you please elaborate on this?

By maintaining the standard practices like checking of all inward materials as per specified guidelines as well as checking of related certificates and documents. Checking of buyers URS while manufacturing of machines, load test before despatch, providing IQ, OQ & DQ to the buyers of our machines.

 

You are amongst the few reputed companies working out of West Bengal. How has that given you an edge?

Our main strength is our Professional Management and vastly experienced technical team to cater our coating systems to Gujarat and Maharashtra.

 

How are you currently placed in the Indian and International market?

Through we are facing stiff competition from the other manufacturers who came into the scenario later than us, but still, we are enjoying the major share of the pharmaceutical market in India and abroad.

 

What is the range of products you manufacture? Which countries did you export your machinery?

Presently we are a single product company i.e. NEOCOTA Automatic Tablet Coating System We have exported our NEOCOTA Coating Systems to Australia, Austria, Bangladesh, Brazil, China, Cyprus. Egypt, Jordan, Kenya, Malyasia, Siberia, Sudan, Saudi Arabia, Tunisia, Uganda, USA, UAE & Yemen.

 

How do you see the Indian Pharma sector vis-à-vis 2020?

We are very much optimistic that India will emerge as one of the top five global markets of pharmaceutical products by 2020, up from 20% at the present market share.

 


 

Mettler-Toledo’s Policy is to Invest Greatly in Research and Development (R&D) and to Continually Strengthen our Product Portfolio.

 

An Exclusive Interview with Mr. Neil Giles, Marketing Communications Manager, Product Inspection Division, Mettler - Toledo

 

Can you talk about the Indian pharmaceutical industry in terms of current challenges as well as future trends?

In terms of the future trends for the Indian market, we see these following a similar path to those we have experienced in Western markets. Many pharmaceutical manufacturers are already facing challenges to increase productivity, reduce costs and improve the overall quality of products required against a backdrop of increased regulatory compliance. As a result, the Indian market will continue to adopt technology developed in traditionally more tightly regulated regions in terms of pharmaceutical safety, such as Europe and North America. This will help deliver on both producer and consumer expectations as well as meet regulations.

We expect the Indian pharmaceutical industry to be an area of strong growth for Mettler-Toledo in the next couple of years as manufacturers invest further in product inspection technology that enables them to fulfill the demands of regulations. Overall, manufacturers have looked to increase detection sensitivity and traceability as they strive to comply with regulations set by the country’s Central Drugs Standard Control Organisation (CDSCO), World Health Organisation (WHO) guidelines and other global regulation and legislation. Using a product range that complies with such standards will help Indian pharmaceutical producers to expand their business and grow market share.

 

What are some of the products and services Mettler-Toledo provides that will help Indian pharmaceutical manufacturers comply with the regulations? What are key products, services and areas that Mettler-Toledo Product Inspection Division offers?

Our product inspection portfolio includes metal detection, x-ray inspection, check weighing and vision inspection technology, which incorporates serialisation and track and trace solutions. These technologies enhance the safety and quality of pharmaceutical products by:

·         Detecting and removing foreign bodies including metals, glass, stones and dense plastics.

·         Ensuring that pack contents are correct. This can include checking the weight or quantity of product per pack and for the inclusion of documentation and leaflets. All of this compliant with global regulation and legislation.

·         Confirming correct product presentation, labelling and bar code information.

·         Checking the integrity of the product within the package including mass, fill level, product count and inspecting for broken products.

·         Safeguarding medical supplies by confirming the quantity of medical instruments such as needles within a package. This can include product verification - for example checking the correct position of the locking lever in medical devices such as asthmatic inhalers, or inspecting transfusion bags for contaminants.

·         Providing serialisation solutions to show products are genuine, reducing instances of product counterfeiting.

 

Our Tablex-Pro and Pharma GF-Pro product ranges have been very successful in Western markets as they help to meet safety challenges in the pharmaceutical industry - and this is also the case in India. The Tablex-PRO metal detection system, from Mettler-Toledo Safeline combines our advanced metal contaminant detection technology with sophisticated software enabling pharmaceutical manufacturers to enhance compliance while improving product safety and productivity. Tablex-PRO is equipped with a unique Condition Monitoring feature which contributes to the prevention of unscheduled downtime and increases process efficiency.

With the XS1, a highly precise checkweighing system from Mettler-Toledo Garvens, pharmaceutical manufacturers can minimise the number of over- and underweight products, reduce product waste and save production costs. The checkweigher is able to weigh small and lightweight products (up to 200g) at high throughput speeds of up to 600 products per minute with unprecedented accuracy. The technology achieves this thanks to the improved conveyor and weigh cell design as well as its lightweight belt material, ensuring the checkweigher is accurate up to ±0.015g. This precision ensures that Indian pharmaceutical manufacturers can set tighter tolerances for their products than ever before.

Earlier this year, we acquired Pharmacontrol Electronic Gmbh (PCE) that specializes in intelligent vision inspection solutions. PCE provides comprehensive track and trace and serialisation solutions for every step of the packaging line including full aggregation and enterprise system connectivity. The technology will enable Asian pharmaceutical manufacturers to comply with the latest serialisation and track and trace regulations.

To further help pharmaceutical manufacturers meet compliance requirements, Mettler-Toledo provides services such as the fully documented Equipment Qualification EQ-Pac package. This provides the necessary documentation including the Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) & Maintenance Qualification (MQ) essential for manufacturers to meet the needs of regulatory compliance. As we are present in all major countries we provide valuable instruction in the local language. In many countries we even offer 24/7 service, something we will be extending even further in the future.

We see ourselves as playing a very critical part in the processes of pharmaceutical manufacturers by providing products that are built and supported with these requirements in mind.

 

When it comes to the inspection of pharmaceutical products, what trends can we see currently? Also, what would you say are pressing needs for the industry when it comes to technology and equipment?

There is a growing demand in the region for track and trace technologies for pharmaceutical products. Industry regulations regarding counterfeit drugs are becoming more stringent, with new directives coming into force in the US and the European Union (EU) over the next few years and standards expected to be tightened in India and China. Vision inspection technology, such as that offered by PCE, is located at every Critical Control Point (CCP) in the packaging line to track each pill or caplet, from initial manufacture to shipping, will help pharmaceutical manufacturers protect their brand by minimizing the possibility of counterfeit products entering the supply chain. Such comprehensive traceability solutions will also enable pharmaceutical manufacturers to export goods to Western markets that require such due diligence.

Many of the traditional or small- to medium sized companies (SMEs) in the pharmaceutical industry do not require a complex bespoke detection system. As lines speed up and the throughput increases, the manufacturer needs to inspect pharmaceutical products at ever growing volumes with greater levels of sensitivity. Reliable, accurate machines with high-speed capability are therefore needed for pharmaceutical manufacturers to remain competitive. Our machines are designed so that as volume increases, product inspection speeds can compensate.

 

What will be Mettler-Toledo’s focus for the development of the Indian market next year? Are there any further development plans?

We have a number of new products in the pipeline, working alongside our customers to ensure that as they modify their lines and product offerings we too adapt our production inspection technologies to meet ever-changing regulations. Checkweigher innovations will be focused on weighing even more items in a shorter time, whereas metal detection and x-ray systems will be able to detect smaller and more diverse foreign bodies at higher speeds. We will also continue to enhance our real-time connectivity solutions for new levels of reporting and transparency. India and Asia is our key focus; this is where we have continually grown our business, not only in terms of the number of factories, but service stations as well. Since 2009, we have managed to double our production capacity in Asia, which to a great extent has been fuelled by our strong expansion in China and India. We are also looking to continue our expansion across South-East Asia. Asia is a buoyant marketplace for product inspection and we are at the forefront of developments there by offering customised solutions. Mettler-Toledo’s policy is to invest greatly in research and development (R&D) and to continually strengthen our product portfolio. We are constantly tracking market trends and partnering with leading pharmaceutical device manufacturers, industry associations and educational establishments to develop innovative solutions to new challenges, whether inspecting new pack styles or new materials at higher speeds or with higher sensitivity.

We feel it is our responsibility as an innovative product inspection partner to educate new customers on the various inspection technologies through tools such as seminars, webinars and white papers. We are continually researching new and improved detection technologies in order to serve our Asian customers to the very best of our abilities and more importantly to their increasing needs.

 


 

Quality Has Always Been Our Top Priority

 

In an exclusive Interview, Mr. Manohar Kothari of Indo German Pharma, Spoke with Faroukh Debu Editor The Pharma Review

 

1. You are one of the leading manufacturers & pioneers of Pharmaceutical Machinery in Indian Industry. Can you just share about your companies today’s standings compared to that in the beginning?

INDO GERMAN was established in the year 1981 with an aim to serve the Pharmaceutical Industry with machinery products.

Starting with a small product, today INDO GERMAN has achieved leadership status and reputation in manufacturing of various sophisticated and high valued machineries in various PHARMA sections like INJECTABLE, GRANULATION, LIQUID ORAL, OINTMENT and Allied Industries in FOOD, COSMETICS, CHEMICALS & BULK DRUGS. We are in this field from last 30 years. Keeping in mind at all times our motto “ WE WORK FOR YOUR BETTER TOMORROW”  we are enjoying the respect of the industry and this is mainly because of our approach towards customer satisfaction.

 

2. What kind of machinery do you specialize in?

We are specialized in machineries for INJECTABLES, LIQUID ORAL, TABLET (GRANULATION) & OINTMENT SECTION  such as the Multi Column Distillation Plant, Super Heated Water Spray Sterilizer, Autoclaves & Sterilizers and the Sterile Manufacturing Vessels, Liquid Oral Process Plant, Automatic Ointment Manufacturing Plant, Fluid  Bed Dryers, Rapid Mixer Granulators etc….etc….

 

3. Quality would be your top priority. Would you please elaborate on this?

Quality always being our top priority and has the crucial importance being Pharmaceutical Industry. cGMP guidelines makes quality aspects truly clear in respect of equipment validation, functioning, and desired performance. This leads to achieve basic goal of supplying the products those meet specific requirements and of specific standards. We have a team of quality conscious experts, working hard to ensure product quality. We adopt day to day technological advancement in close co-ordination with our clientele on the existing equipment and with respect to automation, keeping international standards in mind.

 

4. How has the technology changed in this field in the in the last few years?

The enhanced awareness about cGMP with WHO standards & norms, the technology in the last 2 decades have advanced.  We have stringent norms and set procedures for each and every step of designing and  testing our equipment.

 

5. How are you currently placed in the Indian and the international market?

Being the recipient of the “LIFE TIME ACHIEVEMENT AWARD” for excellent services to the Pharma Industries during the year 2010, we are receiving repeated orders from our domestic  and international customers.   Customer satisfaction has been our main motto and we always see to achieve it. Currently we are enjoying  the respect of established National & Multinational Companies because of our approach towards Customer Satisfaction. Various efforts in innovating and adopting latest technologies in product design to cater increased quality demands for maintaining quality, consistency and honest customers centric approach has earned us a huge client base spread across the globe.

 

6. Which countries do you export your machinery to?

We export our machineries to South Africa, Egypt, Turkey, Georgia, Saudi Arabia, Dubai, Malaysia, Bangladesh, Philippines, Kenya, Botswana, Nigeria, Ghana, Yemen, Georgia, Canada, Russia and many more…

 

7. What are your future Plans?

With a focus to cater mainly to PHARMA & ALLIED SECTOR, our vision is to become a recognized global player based on world class research & development. We plan to expand our existing unit by developing few more machines with overseas collaboration and have our own marketing offices in some parts of the world.

 

8. How do you see the Indian Pharma sector vis-a-vis Vision 2020?

India is regarded as one of the fastest growing PHARMA HUB  globally. With International Competitive power taking the mission of innovation the Indian Pharmaceutical Industry is expected not only to contribute to the improvement of the level of medical treatment for health of citizens but also to largely contribute to economic growth.

 

 


 

Ayurvedic Sector has a very Bright Future

 

Mr. Rajesh Puri of BACFO Pharmaceuticals, Spoke to The Pharma Review in an exclusive interview

In the last few years alone, your company has achieved dazzling heights in the field of finished Herbal Products? Please tell us something more about your work and your company?

Bacfo manufactures Research Based Herbal (Ayurvedic) health & personal care products. We have implicit faith in the oldest known Medical Science – Ayurveda but the same needs to be understood from today’s perspective and standardized using technology available today. It is our firm belief that the end Quality can only be achieved with Quality Management Systems. BACFO was among the first Ayurvedic manufacturer to have got ISO, HACCP and WHO GMP certifications. Our in-house R&D is duly recognized by DSIR (Department of Scientific & Industrial Research), Ministry of Science & Technology. BACFO is the only Ayurvedic manufacturer to have introduced the concept of Dry Syrup within Ayurveda and the same has been patented. We believe that to understand Ayurveda and its benefits we need to go deeper and use modern technology to standardize the products. For example, the benefits of Garlic are well known and established in Ayurveda. We even find common people using Garlic every day and then being told by the Physicians that the same did not give any benefit. So, is the Garlic to be blamed or the medical science? The truth is neither! Probably when Ayurveda was written the atmosphere was so pure that all the medicinal herbs had the medicinal value. With passage of time, soil contaminations, cross pollination, etc we today need to verify the same. So, if the concentration of ‘allicin’ in Garlic which was taken was nil, would you still blame Ayurveda? We at BACFO have worked on this principle where we look at the ‘actives’ in the raw material and standardize our products on this basis. Today, we are proud that our products have been giving assured results and we have so many satisfied customers not only in India but around the world.

 

What is the range of products you deal in?

We have a vast range of products both in the patent formulations and in the Classical Ayurvedic range. We are concentrating on the modern life style problems and have a product for a number of such problems, for example, Diabetes today is so common and our product DIABAC has improved the lives of so many. Our RESPICARE for Respiratory allergies has been very popular and recently we introduced the RESPICARE Dry Syrup for children. Our IMMUNOCARE for immune modulation has a double blind clinical trial undertaken at AIIMS, New Delhi. Our JOINTCARE range of tablets, oil and Gel has proved very popular. Our STREX-5M has been reducing the stress factor not only among the elderly but even among our youth. Each of our formulations is derived from extensive Research and has been standardized for optimum efficacy. Our website, www.bacfo.com provides complete information on every product. We also have a wide range of “Organic Herbs” that we export and are certified by ECOCERT for both EU & USA Guidelines for this range.

 

Where are your main units located?

We have a unit at Sector 2 NOIDA at present. However, our new production unit spread over more than 8000 sq.mt. will soon be operational at Phase II, NOIDA.

 

What measures do you take for quality control of your products?

BACFO was established in 1994 and after extensive Research started commercial production in the year 2000. Given the international exposure of our management team (combined we have over 35 years of experience in operating businesses in Europe, North America, Africa and Asia), we wanted to bring a unique product to the market – highly researched, manufactured in world-class automated machinery, attractive packaging, standardized to maintain high efficacy. The first products that left our factory about a decade ago had bar codes, were packed in blisters and cartons and included a precise description of all ingredients.

Quality is our paramount driving force. We ensure Quality at each step, from Raw Materials to finished products.  Even when you look at our packaging, it speaks of Quality starting from the ITC Pearl graphic paper to the bottles sourced from Cincorp – a company producing HDPE bottles in clean room environment. How many Pharma companies leave aside Ayurvedic manufacturers go through such pains? Every raw material is tested for the ‘Actives’ and other essential in-house parameters. These have been made essential in BACFO even though they are not mandatory for Ayurvedic products. We are in a sacred business of ‘Health care’ and the onus of the product efficacy lies on us. Hence, we ensure complete Quality in every thing that we do. Herbs become ‘Medicinal’ if they have the medicinal values, otherwise these should be considered as ‘spices’. We ensure that the raw material used has the appropriate medicinal values and every Batch manufactured by us is standardized on this principle.

 

How are you currently placed in the domestic market?

We are not pan India at present. Our operations are mainly confined to North & Central India. But consciously we are present in Gujarat & Kerala, the State where Ayurveda is still the major medical form of treatment among people. However, we have a very active ‘Online Store’ on our website and we are sending our products to all over the country free of shipping charge.

 

Tell us about your position and plans for the international market?

BACFO is already exporting to more than 25 countries where we have our Distributional network. We are expanding our network to other countries as well. Incidentally, BACFO was awarded for “Outstanding Exports – Herbal Products” by PHARMEXCIL. The process for registration in International Markets is not only exhaustive but also time consuming. However, we have satisfied the requirements and are at advance stage for approvals from several other countries. We do not differentiate in Quality for exports and domestic market. It is the same Quality we give to domestic that is exported.

 

What are your future plans?

We wish to consolidate our distribution in domestic market and be pan India by year 2013. We are working on new products to be introduced shortly. We are at an advanced stage of Registrations of our products in several other countries. Our expansion will be multiplying once the construction of the new factory is completed.

 

How do you see the Indian Pharma (Ayurvedic) sector vis-a-vis Vision 2020?

Well, the Ayurvedic sector has a very bright future but the industry needs to make more use of the technology available to us. We need to provide standardized products that have undergone extensive clinical study. We need to integrate the ‘traditional’ with ‘modern’. Why can the two medical systems not co-exist? Each one has an important role to play. After all, both look at improving health! So there is a common goal. Why should it matter if the raw material is from chemical or natural source? Why should there be always a controversy between the two systems of medicine if both are working towards ‘health’! It is only that the approach is different in the two systems, where one has a holistic approach while the other has symptom related approach. Let there be a ‘common knowledge’ and an integration of the two. It will only help to improve health for all. We think the Ayurvedic sector will be playing a very positive role towards Vision 2020 and there will be a tremendous growth in this sector. People have understood the benefits of ‘Natural’ products and also realized the price that needs to be paid for chemicals. The world has been moving towards higher antibiotics and the life of such drugs is around a decade before resistance starts building up. Is it not ‘food for thought’ that even after thousands of years there is no resistance to any of the Ayurvedic products?

The market for herbal products has evolved over the years. The consumers are more Quality conscious now. There is far greater awareness and acceptability of herbal products in the young generation now than what it was when we started. Earlier, the majority of users for Herbal products were from 50+ age group. This has changed dramatically over the years. Today it is 25+ age group that has become the ‘essential driver’ for the herbal industry. This shift has brought a welcome change and improvements in the presentation, packaging and Quality of herbal products.

 


 

Finecure Awarded Arch of Europe Award in Quality and Excellence

 Finecure Pharmaceuticals Ltd. received the Arch of Europe Award in Quality and Excellence in the Gold category for the year 2012 for showing commitment to quality, exemplary leadership and technology and innovation. This award was given to Finecure during 38th International Quality Convention held at Frankfurt. The Pharma Review spoke to Mr. Vikas Rajgarhia (Executive Director) Finecure Pharmaceuticals Ltd, India.

Finecure Pharmaceuticals achieved several milestones in sectors of Healthcare and Pharmaceuticals and a credible position.  We would like you to share some views and ideas about your company, plans, future and your outlook to the industry.

Finecure Pharmaceuticals Ltd develops and markets pharmaceutical formulations for treatment of various ailments. Finecure is one of the Leading Pharma Manufacturers and was founded by promoters to penetrate in growing pharmaceutical market with expertise and an winning edge with a vision to provide novel and better drug delivery systems. The company has PAN-INDIA presence with products prescribed by around 18,000 Doctors and available at over 40,000 Pharmacies and Medical stores, with a product sold every second in INDIA. The company exports to various countries.

 

What are the quality certifications held by company

The company is certified for WHO GMP, ISO 9001: 2008, ISO 22000: 2005, ISO 14001: 2004, OHSAS 18001: 2007. Also the company is CE certified and FDA registered.

 

How does Finecure make working culture policies

Finecure makes all policies and strategy with a view to satisfy all employees, partners and associates as best company to work with and Cultivates high partner satisfaction.

Policies include to recruit and retain talented employees, promote healthy work environment and foster a learning organization.

 

What are your Success Factors

Our Success Factors include:

Clear goals and aligned strategies

Build lasting relationships with all  stakeholders and product prescribers and distribution channels.

Increased brand trust and marketing.

Motivation, training and promotion of employees including work balancing of employees.

 

How do you make your policies to compete with competitors

Our policies made keeping in view to competitors include:

Brand Building

Technical Enhancement and Development of New Technology

High Quality Products

Wide Distribution Network and Representation

Fostering of Effective Corporate Compliance Program

Competitiveness

 

What had been your financial success

The company been rated NSIC CRISIL SE 1A rated company for Highest Performance Strength And High Financial Capability. The Company has maintained double digit growth rate, higher than overall Indian Pharma Industry indicating company’s policies implementation and performance strength. According to CRISIL Research the pharmaceutical industry is expected to grow at a CAGR of 17 to 19% and Finecure Business model reflected in a compounded annual growth rate (CAGR) of 28.36% cent in revenues over the past three years.

 

What is the role of the top managment of your Company

We at the top provide leadership, develop the mission, vision, values and ethics and act as role models.

Define, monitor, review and drive the improvement of management systems and performance.

Reinforce a culture of excellence with the organisaton’s people.

Ensure flexibility in organisation and manage change effectively

 

How do you make effective strategies.

Strategy is made after understanding the needs and expectations of stakeholders, customers and the external environment including competition and regulatory. Also market surveys, interactions and industry reports make contribution to strategy. The strategies focus on strategic, financial, technology, human resource, marketing, facility, and quality planning to ensure Finecure’s strength and viability and enhance its position as leader in Pharmaceuticals. People at Finecure are aligned, trained, involved and empowered for effective strategy implementation and review.

 

How do you build partnerships

Partnership are built for sustainable mutual benefits.

Partnership is an asset to our organization. Timely delivery and delivery of quality materials are key objectives. These factors contribute to timely production and improved productivity of the company.

Our partnership is based on parameters like:

Competency

Flexibility

Competitiveness

 

How does Finecure work on Products and Processes

The processes are designed to manufacture and market pharmaceutical formulations and full stability throughout product shelf life cycles. FINECURE defines value creation processes as those that help produce value - products and services – for its stakeholders. Innovation is done through outcomes of inputs received through processes as SWOT, market research, customer and market needs. The processes of the company are guided through Process, Products, Value Creation

 

How do you work for Customer Relationship Enhancement

Finecure puts care for customers by developing long-term relationships. Our people have a clear picture of customer needs which enables them to have long term relations and happy customers and significantly higher customer retentions and excellent brand loyalty, which helps in long term growth and happy customers.

Finecure ensures customer relationship management through following:

Multichannel Support

Automated Support Process

Dedicated Support Manager

Feedback / Suggestion Mechanism

 

What are your future plans

The company has charted growth plan by focusing into new geographies and better penetration in existing geographies including increase in product portfolio.

 

Please tell us about your awards and accolades

The company is awarded with "Arch of Europe Award" 2012 and recognized for Quality and Excellence by FICCI, ASSOCHAM and IDMA.

 

It was a pleasure speaking to you and we wish Finecure all the very best for all your future ventures.

 

 


 

 

Looking Ahead for Advanced Product Inspection Technologies

                                                                       

Introduction: Today's consumers have more sophisticated preferences than ever before. Even during turbulent economic times, they insist that brands exhibit genuine commitment to quality, innovation and product safety, whilst simultaneously maintaining low prices. Pharmaceutical manufacturers must look to adapt their production processes if they are to keep pace with these market changes. Equally, manufacturers can never lose sight of increasingly stringent regulations and safety standards. Failure to meet the necessary industry standards can really hit manufacturers where it hurts: as well as eroding trust in their brand, they risk damaging profitable relationships with major retail organisations. In this Interview, John Coleman, Marketing Manager from the product inspection division at Mettler Toledo, joins us to discuss the latest consumer trends, how they are influencing product inspection technology, and how pharmaceutical manufacturers can stay ahead of the game.

 

What are the Latest Trends in The Pharmaceutical Industry that are Influencing Product Inspection?
In such a dynamic market, the large number of emerging trends can be difficult to untangle from one another. However, we're seeing two particular consumer trends really begin to stand out: one is the demand for greater variety; the other is demand for increased quality, or, put another way, increased manufacturer responsibility.
In terms of variety, we see an ever-increasing array of packaging shapes and materials in our medicine cabinets. Growing demand for these new packages presents us with a challenge in product inspection, as unstable products often result in difficult product transfer and transport. The production of a wider variety of products, packaging materials and pack sizes presents further challenges as this requires more frequent setting changes, which can increase downtime and erode efficiency. Equally, growth in the number of demographics targeted, both niche and mainstream, requires greater flexibility from pharmaceutical manufacturers. The trend is towards integrating flexible production lines that can handle smaller batch sizes of a wider number of products and packages, and it's our job to provide the product inspection technology to support this without slowing throughput.
Looking at product quality, we've seen an explosion in the amount of regulations and legislation that manufacturers must meet. Governments and regulatory bodies across the globe - the FDA, the standards covered by the GFSI such as  BRC, IFS, SQF and ISO 22000 and the SQF to name a few - are increasingly joined by leading retailers in their demands for better product safety.
For us, regulations are nothing new – ensuring that manufacturers meet safety requirements is what we do. Yet, the increased stringency of regulatory demands, coupled with the ever-present need for higher manufacturing throughput, influences all of our product inspection innovations.
Additionally, we can see the continued growth of sustainability as a factor.  Pressure from retailers, consumers and activist groups alike is forcing manufacturers to re-evaluate how they produce and package their products.

 
What does this Mean for your Customers?
For pharmaceutical manufacturers, the trend towards greater variety demands greater versatility from product inspection systems. Our customers need equipment that can handle
a wide range of different  packaging types, detect physical contaminants regardless of their shape or location within the product, whilst also achieving accurate weighing results at high speeds. Machinery must be easy to change over, environmentally sustainable and energy efficient, and incorporate increased automation and ease-of-use.
To ensure higher quality, companies must have top-level quality checks on their manufacturing lines. All processes must meet industry standards, but not at the expense of efficiency.
It must be added that pharmaceutical manufacturing lines should have systems in place to meet new serialisation requirements and prevent the spread of counterfeit drugs. Lines must be designed and approved to take account of this specific problem, which causes great damage to the industry.

 
How do you help Companies Meet these Challenges?
A key philosophy of ours is flexibility. We are continuously developing and refining our product inspection solutions to allow our customers to do more with fewer systems. Our systems have evolved into multi-tasking defenders of product and brand quality, so to speak. And we often provide guidance to select the best combination of technology, whether x-ray systems, metal detectors or checkweighers, to meet our customers’ needs.  Our consultation focuses on helping companies meet all industry regulations, improve traceability, optimise processes to boost efficiency, minimise downtime and reduce waste.
From a technology perspective, our adaptable x-ray and metal detection systems are able to inspect a vast array of product and packaging types, including pumped products, packaged products like metal cans, glass jars, cartons and bags, as well as conveyorised or gravity fall bulk loose products. At the same time as checking for contaminants, x-ray systems can ensure product quality by offering mass measurement, ensuring that no product is trapped in the seal, identifying missing items and measuring fill levels. Also, our checkweighers are designed to provide more than weight control capability; they can provide product stability while ensuring weighing accuracy on the production line.  By integrating our x-ray and metal detection technology with our portfolio of checkweighing systems, we provide our customers with complete and tailored solutions that can handle products of all different shapes and sizes.
We also design our systems with sustainability and hygiene in mind. Product inspection technologies feature a robust housing to protect against dust and water and comply with the IP69k standard. 

 
How has Product Inspection Technology Evolved?
Across industries, there has certainly been a shift towards usability and higher speed. We've identified the need for greater ase-of-use, ease-of-changeover, ease-of-maintenance and auto-setup options in pharmaceutical packaging operations and these factors have become our focus in recent times. Companies also want streamlined solutions, both in their interface (with simple settings and displays) and physical design (with increasingly compact systems). This is not to forget higher line speeds and throughput, which remain a constant priority. Specific innovations like Condition Monitoring improve efficiency by providing advance warning of potential line stopping issues before they occur, enabling planned maintenance when offline.
We have initiated a shift towards systems with multi-function capabilities and improved accuracy. As I said before, our x-ray systems are now so much more than just a contaminant detector. We’re seeing more versatile systems that guarantee the uniformity and quality of products in a variety of packaging, such foils, blister packs, cartons, pouches, bags, medical devices, glass, plastic  in the pharmaceutical industry. Similarly, checkweighers have evolved into, what we're calling, 'quality stations' - with highly advanced equipment for Track & Trace, such as vision inspection systems. Previously unattainable accuracy can now be achieved through higher machine stability and extremely powerful inspection, which can identify even the most minor traces of contamination.
What are Some Common Problems you Encounter when Counselling Customers on Product Inspection Technologies?
Mostly, any problems stem from misconceptions about the uses, safety and effectiveness of product inspection systems, or from a lack of knowledge about industry standards and regulations. We find that many new customers have been using an inappropriate inspection system for their requirements, and this is something we seek to rectify immediately.
When counselling customers on a new solution, we often have to combat the falsity of a number of misconceptions.  For example, many believe products in metalized film cannot be inspected by metal detection systems, but this is false.  There’s also a misconception that x-ray systems are not completely safe to use and that they can only do contamination detection, but these are false as well.
We also help our customers to gain knowledge about product inspection and how it works. We can counsel them on the differences between x-ray and metal detection and when to use each. Equally, we help manufacturers understand the effects of their production processes on checkweighing accuracy, for example, and on how to meet the particular standards imposed by their industry.

 
How do you Edu-cate your Customers and Prospects?
We use different techniques and different media – hopefully reaching and engaging as many people as possible. Much of our information is now displayed or distributed online - on our website, through newsletters or via online seminars (webinars). We also like to provide 'hands-on' information through our demonstration vans so that customers can get a close look at inspection systems in action, as well as at group seminars, guidance visits and training courses either at Mettler Toledo facilities or customer sites. Moreover, we regularly develop white papers in order to share our expertise in the industry and release detailed guides about the different technologies we offer.
We present information in different formats, and have found that this really appeals to different readerships. Product inspection guides and white papers are therefore supplemented by more immediately accessible case studies and animations.

 
What is the Future of Product Inspection?
This is an exciting time for the industry. As we look to meet market demands, we're also setting agendas and pushing forward-thinking innovations. We want to be alive to new consumer trends, and at the same time be proactive.
In future years, new packaging materials will play an increasingly influential role in the development of product inspection technologies. We’ll continue to adapt our product portfolio to provide rigorous quality assessment of varied packages. Similarly, continued globalisation of consumer markets will change the face of brand strategy and behaviour. We currently have the largest network of field-based engineers that provide on-call support and after-sales service for customers, and we will continue to adapt to provide even-more widespread local support.
In terms of proactive innovations, the focus will be, as ever, on sensitivity and stability, speed, accessibility, accuracy and productivity. Inspection systems will be able to detect smaller contaminants and contaminants that are not high in density. In spite of their increased capabilities, advanced inspection machines will be easier-to-use, even with a lower-skilled workforce. Lastly, advanced data collection software and systems integration tools will be required to strengthen compliance and provide proof of due diligence.

 

 


 

 

OTC Drugs vs Prescription Drugs Branding vs Any Other Category Branding 

Abstract: “___________  ki goli lo, khich, khich duur karo” “Yeh kya haal bana rakha hai, kuch lete kyun nahin? __________li?”
If you have grown up in the days when TV was Chitrahaar, The World This Week and Imran Khan galloping on a saddle-less horse selling soap, you will know that the gaps in the above sentences belong to Vicks and Coldarin respectively.

Yes, those were the days of less fragmentation, etc but for these brand lines to have withstood the test of time and hazy memories, tells us that there is something they did amazingly right. They recognized the power of branding in a category otherwise left to the doctor and the chemists’ wisdom; they used the concept of consumer pull. If they needed the pull 20 years ago, do OTC drugs need the pull today? Rhetorical question, right?

So did Vicks and Coldarin branding do anything different than detergents or soaps or toothpaste? Yet again, rhetorical question. Like any and all other well branded products they played on human insights,  evoked emotional reactions and reassured that the price paid for the brand is more than the relief promised: pretty much the codes of brand building espoused by FMCG brands.

 

Prescription Drug Branding, however, follows relatively complicated codes due to:

  • The consumer microcosm at play: rational, stressed out, cynical of most pharma communication

  • The specificity of the solution: de rigueur for any success are the support of clinical trials, being published in journals of repute and success in other geographies

  • The narrow window of opportunity: of the 2 minutes a typical representative gets there is a ‘lean-in-6-seconds’zone which is critical. If the doctor leans back in that time you might as well move on!

  • The unreliable medium: regardless of what ammunition you clad your medical representative with (including ipads), unless he has the drive, personality and/or attitude, the presentation will fall. And though most companies train to the nth degree, the control over the medium is always middling to low.

Branding for Prescription drugs, thus, requires a lot more attention to detail and grounded in reality messaging which can be translated seamlessly verbally, in give-aways / leave behinds, collateral and seminars / conferences (which form a large part of where the brand world gets communicated).

At DY Works we cut our OTC branding teeth on Dr. Morepen (wherein we made products like antacids and Isabgol more acceptable than they were ever before) and continue to hone our skills with partners like Pfizer on My Pal (a contraceptive pill which took the diametrically opposing stand to the dark and foreboding world of i-pill and Unwanted 72) and Gelusil.

Our recent Prescription Drug branding projects have been with Boehringer Ingelheim in their launch of one of their blockbuster drugs into the India market and with Mercury Pharma, in their launch of Bufyl, an IV infusion drug in the UK market.

In both categories, offering solutions that are at the cusp of category, consumer and brand are critical: same-same as any other branding project yet different.

In an exclusive interview with The Pharma Review, Alpana Parida, Spoke with Faroukh Debu, Editor

 

Please Explain the Concept of Brand Building.

A brand is an intangible value add that happens to a product when it is positioned to fulfill a need, desire, fear that the consumer has about the category. It helps in creating distinction with other products as well as seeking a premium price in the market place. The tangible assets of most well known brands are far less in valuation when compared to the brand’s value. In overcrowded and fragmented market situation as ours, brands are what swing consumer preferences in more cases than ever.

 

How do you think Branding is Beneficial for Pharmaceutical Companies?

For generic drugs the answer is but obvious: when a product delivers the same benefit as 5 others, then the brand offers the trust, reassurance and efficacy credentials the consumer seeks. In the case of prescription drugs, the windows of blockbuster drugs being copied are reducing, price is becoming an important criterion for gaining short term numbers, branding is critical for the short and the long term salience and credibility with doctors and patients.

 

What is the way forward for Pharma Companies in Brand Management?

Internationally pharma as a sector when allowed by regulatory bodies has quite evocative and evolved communication for its brands. Some majors in India are seeing the merit of relevant and engaging communication and willing to pay for better services and give enough time for better work. These are of course the leaders in the category. It is high time the rest followed suit for their own growth as well as to ensure that their marketing (and thus sales) is not stuck in an past time.

 

What does Successful OTC Branding Constitute of?

OTC branding pretty much follows the norms of regular FMCG branding. It is important to understand all aspect of the consumer: articulated or behavioral or cultural in the context of the problem the brand offers to resolve. The other aspect that requires detailed investigation is the competition and what they are using to garner attention and create disposition. And then comes the brand and what it stands for, not as a product but as a higher order representation. In simple terms, if the consumer were to close his eyes and hear the brand name what is the image that would emerge… the more specific, clear and distinctive the image is the better the branding has been.

 

In Terms of value Creation how can a Company Rationalize the Investment in Brand Building?

Given that branding is pretty much evident in quite a few players of the pharma industry a study of the brand sales over a 2-3 year window before branding and after would give a great barometer of the impact. The logic is fuzzy but then we are discussing an intangible benefit which ultimately works hare than the products tangible delivery. And before the need for results becomes overbearing companies HAVE to keep in mind, that brands are like Rome, they aren’t built in a day.

 

In the Present Scenario what are the Challenges that Pharmaceutical Companies face with Regards to branding?

A look at the the consumer and the category will reveal that the need for branding is a rhetorical question. The challenges for branding are more internal than external. Company management and marketing departments need to agree on the need for branding and the benefits it will accrues to them as a company and to them as professionals (the value of someone who has built a brand as opposed to sold a product is significantly higher even in the job market!).

 

Do you have any Pharmaceutical Company as your client? If yes, how have you helped them in the brand Building Exercise?

At DY Works we cut our OTC branding teeth on Dr.Morepen (wherein we made products like Antacids and Isabgol more acceptable than they were ever before) and continue to hone our skills with partners like Pfizer on My Pal (a contraceptive pill which took the diametrically opposing stand to the dark and foreboding world of i-pill and Unwanted 72) and Gelusil. Our recent Prescription Drug branding projects have been with Boehringer Ingelheim in their launch of one of their blockbuster drugs into the India market and with Mercury Pharma, in their launch of Bufyl, an IV infusion drug in the UK market.

 

 
 
 
 

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