Indian Pharmaceutical Alliance Pitches for Exception of GST on Expired and Damaged Drugs
Hyderabad: The Indian Pharmaceutical Alliance has been pitching with the government to exempt Goods and Services Tax (GST) on drugs that are expired or damaged. As per the new GST rules, there is no exemption for expired or damaged drug products from GST preview, because of which the industry is expected to lose Rs. 500 crore annum. In view of this, the Alliance has given its representation to the GST Council to find a way out and save the pharma industry from losing hundreds of crores for the medicinal goods that are not sold or consumed. Usually the retailers send back all their expired or damaged stocks to the pharma companies. However while doing so they will generate an invoice which will again attract a GST on the date expired and damaged drugs, because of which an additional cost burden is being imposed on the pharma companies in the form of GST. “Our contention is that, why should there be a GST for the goods that are not sold and that are damaged. We feel that it is a very serious concern and have already written to the GST council to look into the matter and find a way out. We are hoping that the GST council will come out with positive terms and conditions favouring the pharma companies,” said D. G. Shah, Director General of the Alliance. The Alliance, which is a conglomeration of big pharmaceutical companies across the country, have been arguing that GST must be imposed on product sales and on their consumption but that may not be applicable in cases, where medicines overshoot their expiry date or are damaged. This is a major issue, says Shah, since, under the current provisions, there is GST imposed on these too and this means, based on current estimates, it costs about Rs.500 crore per annum for the industry. We have been continuously giving our representations and issues being faced by the pharma companies to the government from time to time. We are hoping that the GST council will definitely come out with positive solutions and save the pharmaceutical industry from the loss, says the Director General.


GST Makes ‘Orphan Drugs’ Prices Soar
Mumbai: Prices of exorbitantly-priced life-saving medicines, used to treat rare diseases have increased by 12%, with implementation of Goods and Services Tax, resulting in skyrocketing bills and leaving many patients in the lurch. These high-value 'orphan' drugs used in bone marrow transplant, classical Hodgkin Lymphoma, Crohn's disease and melanoma, prescribed usually lifelong with certain treatment running into crores, have now been burdened with the 12% additional levy, which was nil before July. While no specific details are available, the market size is estimated between Rs 50-60 crore, with 100-odd life-saving drugs imported to treat rare diseases mainly genetic disorders, that affect a small percentage of population. According to Rare Diseases and Disorders — Research, Resource & Repository of South Asia, 2011, there are over seven crore patients suffering from these diseases in India. As against this, GST impact on drugs sold in the country has largely been neutral, with no significant increase in prices as domestic companies absorbed the increased tax liability of around 2.29%. According to guidelines, patients can import these lifesaving medicines (for personal use) which are not approved in India, by applying for an import permit and custom duty exemption. In addition to the 12% levy, patients need to cough up the freight cost of 200 euros for normal and 650 euros for cold chain shipment of drugs being imported. Often debilitating lifelong disease or disorder condition with a prevalence of 1or less, per 1000 population is defined by the WHO as a rare disease. Considering the sheer number of identified rare and ultra rare diseases and their varying prevalence, it becomes nearly impossible to ascertain the total number of rare (and ultra rare) disease patients in the world, experts pointed out. "In most cases, the import quantity is not available, but the burden of additional 12% is high, when the patient has to take the medicine lifelong," says Praveen Sikri of Ikris Pharma Network, a firm which connects patients with overseas suppliers.


Impact of GST on Pharma Industry
The Indian healthcare sector is likely to touch $150 billion by the end of 2017, witnessing an increase of $70 billion since 2012. The Goods and Services Tax (GST) undoubtedly is the most important indirect tax reform measure taken by the Government since our Independence. This is going to be a game-changer for many industries, including Indian Pharmaceutical industry. Nearly 17 federal and state taxes will be replaced with one uniform tax, thereby eliminating the troubles arising out of multiple taxes. This is also going to simplify the process of tax filing and in general the taxation system. Kiran Mazumdar-Shaw, head of India’s leading biotechnology company, Biocon, sees this as the means to rationalise the tax structure and optimize distribution. Reduction in cost of production and distribution will help the industry to pass on the benefits to the buyers. Healthcare and pharmaceutical industry is one of the leading contributors with respect to revenue and employment and therefore revenues from taxes. GST will subsume various taxes to make it simple and cost effective. Dilip Sanghvi of Sun Pharma also openly applauded the introduction of GST and feels that it will have a positive impact on Indian industry and specifically Pharmaceuticals. Suneeta Reddy of Apollo Hospitals Group sees this as a bold step towards universal health coverage. With ease of doing business in the country with one country one tax and create an equal level playing field for the pharma companies in the country. Ramesh Swaminathan of Lupin Ltd. hopes this will make healthcare more affordable. GST will also encourage local manufacturing sector to step into producing products that will be more affordable for the local consumers. Rekha Ranganathan, of Philips Healthcare Innovation Center takes this as a strengthening move towards our Prime Minister’s ‘Make in India’ initiatives. Indian Pharmaceutical sector is fragmented and complex with more than 20,000 registered units. There are critical issues like managing perishable items, stopping degradation of medicines, maintaining temperature controlled storage facility etc. make its supply chain even more sensitive to time-bound delivery. This wide supply chain has to be supported with multiple storage locations as well making tax-related issues extremely complex. Marketing and distribution takes nearly 30-35% of the entire value chain. It has been observed that an efficient SCM can result in an overall reduction of 25-50% reduction in total supply chain costs along with another 25-60% drop in inventory holding and hence cost. This will also result in increased forecast accuracy, better and improved order-fulfillment cycle time and approximately 20%-increase in after-tax free cash flow. Cost of maintaining inventory is estimated to be 10-18% of net revenues. It is also critical to determine optimal inventory levels because of various stochastic variables influencing the supply chain. All these factors will be impacted with the introduction of GST and if industry stalwarts to be believed, in a positive way. Implementation of GST will result in an efficient supply chain. Inter-state transaction between two dealers will become tax neutral, replacing traditional C&F distribution model. Most of the companies will have to realign their current distribution models by reducing the dependency on multiple states and increasing the focus on regional hubs. This will not only make the process lean and alleviate the complexities involved but will also reduce the SCM cost considerably. Many pharmaceutical companies currently work on traders-of-goods model in which quite a few services they avail becomes a cost for them with service tax implications involved. But with seamless credit mechanism to be introduced by GST the service tax paid by the companies will come back to them as a refund and in that way saving the cost. Cascading taxes across different states like Octroi in Gujarat, Maharashtra and Punjab will no longer exist. GST is also going to positively impact the Cenvat because of inverted duty structure faced by the companies now reducing the pressure on working capital and again overall cost reduction that would benefit the end consumers. Inverted duty structure impacts the domestic manufacturers quite adversely where the duty on the inputs (raw materials) is much higher than the duty applicable on the output (finished product). With proposed GST this structure will either be disposed or introduce a refund of the accrued credit. Another positive impact of GST will be in terms of compliance, smoother operation and curbing corruption. Duty levied on import of costly machinery and equipment does not receive tax credit as of now and that may change with introduction of GST and should bring down the cost of technology and investment. GST is also going to help our thriving Medical Tourism industry in an indirect way. It already enjoys competitive advantage over other First world nations with revenue of over $2 billion presently. With GST it will grow by manifold. Cost of medicines and services, insurance and international travel will reduce resulting in better prospects of attracting medical tourists more to the country. Many experts however have pointed out to the negative impacts GST would have on the prices of some medicines that are taxed currently at the rate of 5% but may attract a tax of 12% post GST. The same effect can be seen on Active Pharmaceutical ingredients or raw materials that will have an impact on the cost. Uncertainty on the prices of life-saving drugs and healthcare services post-GST is another matter of concern. Exemptions in Excise and Customs Duties on such medicines and services may not exist in this post GST era. Impact of GST on the free drug samples, existing bonus schemes and the inter-state movement of expired products or stock transfers are still not transparent. Also, if the area-based exemptions enjoyed by the pharma companies by setting up their units in some specific locations no longer exist, this increased cost will be burdening the end consumers. These are the factors that have to be renegotiated by the companies so that it does not affect the overall cost making it difficult for the users. The impact of GST on the pharmaceutical industry is still not very transparent. But both end consumers and industry players hope this to culminate in a win-win situation. With reduced complexities and overall reduction in cost this translates to be a profitability and promising development.


Government to Form Expert Panel for Drug Pricing, New Launches
New Delhi: The government will set up a panel of experts for consultation on matters pertaining to the implementation of drug price control order, including technicalities involved in pricing and new launches. The Department of Pharmaceuticals (DoP) said the "multi- disciplinary committee of experts" will have member secretary of National Pharmaceutical Pricing authority (NPPA) as its convener. It will also have representatives from Central Drugs Standard Control Organisation (CDSCO), Department of Health Research/Indian Council of Medical Research and NIPER as members, DoP said in an order. DoP said the decision has been made in view of the experience gained from the implementation of Drugs Price Control Order, 2013 for "consultation on all technical issues related to pricing, launch of new drugs with ancillary provisions where more clarity may be required..." The NPPA will decide and refer relevant issues within four weeks of receiving the applications, to the committee for its opinion, it said. In turn, the panel will submit its report along with its findings within four weeks. "The recommendations of this committee shall be considered by the NPPA which shall pass a reasoned order within four weeks from receiving the recommendations of the committee, deciding the issue(s) finally," said the order. It added that the committee will be empowered to invite or co-opt any other specialist depending on exigencies of circumstances requiring resolution of any specific matter arising out of implementation of various provisions of DPCO 2013. The panel will also opine on matters referred to it by the NPPA, it said. The committee is mandated to recommend its opinion on the claims of pharma companies about any additional therapeutic features associated with any formulation and recommending separate ceiling price of scheduled formulations or retail price of any new drug with specified therapeutic rationale. It will also give its opinion on claims of pharma firms about additional pharma-coeconomics features associated with any formulation/API, the order said. Besides, it will also give opinion on technical related issues such as whether a drug is scheduled or non-scheduled on the basis of ingredients used in formulation, it added. The technical issues will also include claims by pharma companies about novelty associated with indigenous research and development of their products, for granting exemption from the price control order for a period of five years.


Government Needs Proactive Approach to Boost Pharma Sector: Industry
Mumbai: Union and state governments needs to develop a proactive approach towards building better quality compliance and become a facilitator of funds and platforms, leaving the mechanism of delivery to the private sector to help the pharma sector grow faster, according to industry experts. The Indian pharmaceutical industry, with current market size of USD 27.57 billion is expected to reach USD 55 billion by 2020 growing at a CAGR of 15.92 per cent. "We have to strengthen and define the government and the private sector's role in developing the industry. The government needs to act as the provider and the private sector should deliver," industry veteran and Salus Lifesciences director Kewal Handa at 'CPhI CEO Roundtable Conference' here. The government has shown willingness to collaborate with the industry to create a favourable ecosystem for the sector, Handa said. Industry leaders discussed vital issues of Make in India - ensuring country's pharma supremacy with a special focus on affordable healthcare in the urban and rural areas. While India ranks amongst the top four pharma terms of volume of produced drugs, certain challenges continue to surround its pharma industry. India faces issues including a time-consuming approval process, dependence on China for cheaper API sources, sub-optimal infrastructure, lack of funding avenues, and a shortage of highly skilled talent, among others, UBM India managing director, Yogesh Mudras said. The US - the largest importer of Indian generics -- has started looking inwards at its own domestic market, Mudras pointed out. "There are quite a few issues that ail the sector and the industry should accept existing challenges and find ways to change the ecosystem," EY partner Sriram Shrinivasan said. Speaking on the occasion, Indian Pharmaceutical Alliance secretary general D G Shah said, for 'Make in India', certain standards need to be set. It needs to take the initial steps and gain the confidence of the regulators and also understand that the industry culture and behavior are inter-linked. The pharma industry has grown at an exponential rate and people have moved in the hierarchy, unfortunately without acquiring the requisite skill sets. Thus, emphasis of the industry should be on people management along with controlling the quality of the product output, he said.


Government Need Not Consult Statutory Board to Ban Combo Drugs: Supreme Court
New Delhi: The Supreme Court on recently said the central government need not consult the statutory board on drugs before banning any fixed-drug combinations, an observation that goes against a major legal plank of companies battling against a ban on 344 such products. Fixed-dose combinations (FDCs) are cocktail drugs of two or more therapeutic ingredients packed in a single dose. A central government notification banning the 344 fixed-dose combinations in 2016 was set aside by the Delhi High Court in December. The government had banned these combinations in public interest, claiming they were unsafe and "irrational". The ban had hit several popular brands like Corex, Saridon, D’Cold Total and Vicks Action 500 Extra, prompting pharma companies to submit over 500 petitions at around 10 high courts, with Delhi receiving a sizeable chunk. The government challenged these in the top court on the ground that the ban was necessary in public interest, prompting the top court to stay the order. Pharma companies such as Glenmark, Pfizer and Procter & Gamble had contended that the principle of natural justice required some kind of hearing from stakeholders before the government can take a call on a technical subject like this one. Before prohibiting fixed-dose combination drugs, the government must consult the statutory bodies provided for in the Drugs and Cosmetics Act, the companies had argued before a bench of Justices RF Nariman and Sanjay Kishan Kaul. “Otherwise the power would be unfettered, unlimited,” senior advocate Abhishek Manu Singhvi had said. “This cannot be done without consulting the stakeholders. Public safety, public risk can only be assessed on the basis of expert inputs.” In the absence of an emergency, such a consultation should be made mandatory, he had argued. Justice Nariman, however, said such consultations were not specified in Section 26A of the act, which defines the power of the Central government to regulate the manufacture and sale of drugs and cosmetics in public interest. “If we hold otherwise, we will neither be reading the law up or down but reading in, which is legislating,” Nariman said. Justice Kaul also said the arguments would have been appealing had the subject matter been anything but drugs. The court said it was with the government on this legal point. The companies will now likely argue the other legal points against the ban at the next hearing, scheduled for Dec 6. "Arguments on December 6 will look at how many FDCs can be excluded from the ban and how many we are not able to justify entirely," a lawyer involved in the case told ET, speaking on the condition of anonymity. The industry is positive about the court's decision to allow further arguments in this case. “The judge is open to hearing a little bit from our side as well, which is positive," said RK Sanghavi of pharmaceutical lobby group Indian Drug Manufacturers Association. The association on Wednesday submitted a list of around 175 FDCs out of the original list of 344 that it had determined were not only safe for consumption but needed for specific patients, he said. This list excluded the FDCs approved before 1988 and those already approved by the Drug Controller General of India, he added. "The judgment will definitely have an impact depending on how much commercials are at stake and more importantly on the patients' dependency on such FDCs, especially in cases of chronic diseases," said Ashish Prasad, partner at Economic Laws Practice.


DCGI Mandates Risk-Based Inspections for All Schedule M Units as Grant of Licenses Becomes Valid Forever
Mumbai: The Drug Controller General of India (DCGI) has mandated risk-based inspections for all the Schedule M units in the country following notification for grant of licenses till perpetuity. The Union health ministry had recently notified Drugs and Cosmetics (Tenth Amendment) Rules, 2017 doing away with renewal of licences for the manufacture, sale and distribution of pharmaceutical products every five years. “These risk-based inspections are meant to ensure that drug makers comply with GMP notwithstanding the fact that there is now no need to renew license every five years. Non-compliance to GMP would immediately attract strict penalties under the law and even cancellations based on the severity of the case,” said DCGI Dr. G N Singh. The notification which is effective from October 27, 2017 says manufacturing and sale of licences, once issued, shall remain valid forever unless suspended or cancelled by the licensing authority. The relevant rules have been amended for this purpose. Risk-based inspections are based on a checklist issued for the state drug regulators aimed at streamlining uniform inspection procedures across the country related to GMP. CDSCO recently concluded 185 risk-based inspections in 8 phases based on a checklist issued for the state drug regulators and will soon roll out another phase of risk-based inspections. The checklist and tool is meant to help CDSCO and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. The inspections are planned and carried out jointly by the CDSCO officials and state drug controllers concerned. “A mechanism to do self auditing by manufacturers has also been devised to check the compliance levels,” Dr. Singh concluded. The Union health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products. As per the new notification, an inspection of drug manufacturing plants will be conducted by both central and state inspectors every three years to verify compliance with the conditions of licence and provisions of the Drugs and Cosmetics Act, 1940. The manufacturers will have to inform the regulator and apply for a no-objection certificate in case of any minor or major changes made by them in their unit. Aimed at enhancing ease of doing business in India, government amended rules for manufacturers to grant licenses that will remain valid as long as they comply with GMP.


AYUSH Industry May Create 26 mn Jobs by 2020
New Delhi: The AYUSH industry is expected to grow in double digits and provide direct employment to 1 million people and indirect jobs to 25 million persons by 2020, Union minister Suresh Prabhu said recently. The government is eyeing a three-fold increase in the AYUSH sector by 2022. AYUSH stands for traditional systems of medicine and healthcare such as Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy. "The Indian domestic market of AYUSH is estimated to be Rs 500 crore, while exports amount to Rs 200 crore. Young Indian entrepreneurs planning a start-up could find a lot of opportunities in holistic healthcare," Prabhu said. Addressing the conference on wellness, Arogya 2017, here, the commerce and industry minister said the government will be happy to work with all countries to create a good proposition wherein knowledge of traditional medicine can be transmitted to people, whereby a win-win situation can be developed. He pointed out that the government has allowed 100 per cent foreign direct investment (FDI) in AYUSH, and highlighted the need for stakeholders to pool in their resources to harness the sector's vast potential.


Ayush Ministry Revises Provision of Printing Format of Manufacturing and Expiry Dates of ASU Medicine
Mumbai: The Union Ministry of Ayush has revised the provisions for the printing of manufacturing and expiry dates of Ayurveda, Siddha and Unani (ASU) medicines. The format needs to be implemented on all labels of the ASU drugs from 1st January, 2018. As per the circular, the new format to write the ‘date of manufacture’ and ‘date of expiry’ on the primary and secondary labels/packs of Ayurveda, Siddha and Unani medicines shall be displayed in the ‘numerical month and year i.e. MM/YYYY format’. Precisely, the month shall be printed as two digits and the year as four digits with a slash (/) in between. For example, for a medicine manufactured in September, 2018, the manufacturing date shall be written as ‘09/2018’. The provision according to the Ministry of Ayush is effective from 1st January, 2018 and will not affect the batches of Ayurveda, Siddha and Unani drugs that are already manufactured and available in the market. This notification has brought to the notice of all licensed ASU drug manufacturers and the concerned regulatory personnel for compliance and enforcement respectively. The circular has been sent to regulators of all state departments of Ayush and related offices. In the previous notification, it was specified that dates of manufacture and expiry of all products needs to be incorporated on the labels of all packs of the Ayurveda, Siddha and Unani drugs. It needs to be written in month and year format. The month will be printed using the first three alphabets in capital font followed by a full stop and the year as four digits, both separated by a slash. For example, JUN/2018 may be written for a medicine manufactured in June 2018.


India’s Grooming and Cosmetic Market to Touch $35 Billion by 2035: Study
Mangaluru: The market size of India's beauty cosmetics and grooming is expected to touch $35 billion by 2035 from the current level of $6.5 billion says the joint study undertaken by The study has revealed that the consumption the consumption pattern of cosmetics among teenagers went up substantially between 2005 and 2017 because of increasing awareness and due to the desire to look good and over 68 per cent of young adults feel that using grooming products boost their confidence. Also about 62 per cent of young consumers in big cities prefer to buy online beauty and grooming products 45 per cent of consumers tend to buy cosmetics and apparels from any shop of their convenience rather than a single shop. The chamber spokesman said, the Indian men's grooming market witnessing a growth of more than 42 per cent in the last five years the growth is faster than the growth rate of the total personal care and beauty industry in India. Since the Indian consumers tend to purchase natural and herbal cosmetics products, the herbal cosmetic industry is expected to grow at a rate of 12 per cent in India. The overseas markets have great demand for Indian herbal and natural cosmetic products and exports to countries like the UAE, the USA, the Netherlands, Saudi Arabia, Germany, Japan, Malaysia, Nepal, Sri Lanka, UK, China, Indonesia, France, Russia, and Italy. According to CHEMEXCIL, the exports of cosmetics, toiletries and essential oils during 2015-16 was around $1,007.20 million. The import during the same period was $703.58 million. Among all the Indian cosmetic industry, the best-selling and the most popular items are color cosmetics, of which nail varnish, lipsticks and lip glosses. Indian products have gained the demand due to their experience in extraction of the best from natural dyestuff, flowers, roots, oils, etc. Indian market has herbal cosmetic brands like Forest Essentials, Biotique, Himalaya Herbals, Blossom Kochhar, VLCC, Dabur, Lotus, Jovees, Kama Ayurveda, Patanjali, Just Herbs, and many more. The major factors behind the preference for personal care products include the words such as 'natural', 'organic', 'botanical', 'free from' some harsh chemical, and even 'religious compliance'. Over half of Indian consumers reported 'natural or organic' features influencing hair and skin care purchase decisions. According to 71 per cent consumers they would prefer 'natural' face cream or lotion over other similar products. About 38 per cent said they would buy hair products containing 'botanical' ingredients. Even 'religious compliance' has swayed 17 per cent consumers’.


Zydus Cadila Gets USFDA Nod for Skin Ointment
New Delhi: Zydus Cadila has received approval from the US health regulator to market Clobetasol Propionate ointment, used to treat a range of skin conditions, in the American market. The company has received final approval from the US Food and Drug Administration (USFDA) to market its product, Zydus Cadila said in a statement some time back. The ointment will be manufactured at the company’s Ahmedabad-based facility. The Zydus group has now more than 165 product approvals. Stock of Cadila Healthcare, the listed entity of the Zydus group, was trading 0.32 per cent up at Rs. 492.95 on the BSE.


Eris Lifesciences Buys Strides' Branded Generic Biz for Rs. 500 cr
Ahmedabad: A move that will strengthen the position of the Ahmedabad-based Eris Lifesciences Limited in the Central Nervous System (CNS) segment, the company recently announced signing of a definitive agreement with Strides Shasun Limited to acquire its branded generics business. The deal - likely to be closed in two weeks - is estimated at around Rs. 500 crore. To be funded by a mix of internal accruals and debt, the acquisition - fourth and the largest in 18 months - will put Eris among the top ten companies in the CNS segment. Eris, having a market cap of Rs. 8045 crore as on November 17, already has strong presence in the cardiology segment and ranks among the top ten in the diabetology segment. Strides’ India branded generics business comprise of a portfolio of over 130 brands in the domains of Neurology, Psychiatry, Nutraceuticals, Gastro etc. along with the employees forming part of the business. As per the terms of agreement.


Morepen ties up with Belgium’s Vesale Pharma to Tap Probiotics Market
New Delhi: Delhi-based Morepen Labs has tied-up with Belgium’s Vesale Pharma to aggressively tap the growing probiotics market in India. The move is expected to contribute Rs.100 crore to the Indian company’s topline in five years. “We will soon be launching four major probiotics developed by Vesale Pharma in the Indian market. We hope to add Rs.100 crore to the company’s top line in five years,” Said Sushil Suri, Chairman and Managing Director, Morepen Labs.


Italian Packaging Machinery Turnover Tops 7 Billion Euros
The Italian packaging machinery industry is set to complete another year of growth. According to the preliminary figures published by the Research Department of Ucima (Italian Automatic Packaging Machinery Manufacturers’ Association), the sector’s year-end turnover is expected to reach 7.045 billion euros, 6.7% up on 2016. Both the Italian and international markets have contributed to these results. Exports continue to drive the sector with international sales of 5.6 billion euros in 2017, 6.3% up on the previous year and an 80% share of total turnover. According to the latest disaggregated data available for the first eight months of the year, all geographical areas have seen strong performances. The only exception is the African continent which has experienced an overall 6.2% decline. In detail, the best-performing area is non-EU Europe at +14.6%, with 25% growth in the Russian Federation but a two percentage point decline in Turkey. Next comes Central and South America (+17.7%), with 33.6% growth in Mexico and a turnaround in Brazil with +17%. In third position is North America with +12.1%. The United States remains the largest country of export for Italian technologies with sales of more than 300 million euros, up 6.2%. The European Union also reported an excellent performance (+9.5%), with sales in France and Germany growing by +7.8% and +5.8% respectively. The region confirmed its position as the top area of export by value. Asia and the Middle East, the second largest market for Italian technologies, saw 3.9% growth with China and India both marking up increases of more than 25%. The Italian market also saw a record performance for the second year running. After an 9.8% upturn in 2016, this year is expected to see further 8.2% growth to 1.4 billion euros. “This is certainly in part due to the Industry 4.0 Plan which has facilitated the adoption of our companies’ most innovative technologies by an Italian clientele, although the market recovery is another contributing factor,” said Ucima’s Chairman Enrico Aureli. According to the forecasts published by the Ucima Research Department, the Italian market is set to grow on average by 4% annually until 2019. “For 2018 our Research Department expects our international penetration to strengthen further with average growth of +5%,” continued Aureli. “The best performances are projected to be in Asia and Africa with growth of between 6% and 6.5%,” he said.


Revised IDMP Standards to Improve Description of Medicinal Products Worldwide
A series of standards called IDMP (Identification of Medicinal Products) standards is under revision and will bring a host of benefits to patients and the healthcare community. Implementing these standards should simplify the exchange of information between stakeholders and enhance the interoperability of systems in the medical field. IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. These cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, as well as pharmacovigilance and risk management. Christian Clay, Senior Consultant Healthcare for GS1 Global Office and Convenor of working group 6, Pharmacy and medicines business, of ISO technical committee ISO/TC 215, Health informatics, explains: “IDMP standards are essential for the world’s increasingly integrated healthcare. They provide the precise architecture for the computerization of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to inter-operate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records.” To meet the primary objectives of the regulation of medicines and pharmacovigilance, the reliable exchange of medicinal product information in a robust and consistent manner is essential. IDMP standards fully support this and that is why a revision of the standards was deemed opportune. “The revision has become necessary as a consequence of the development of IDMP implementation guides (which take the form of four CEN1) ISO technical specifications). The overall standard has not really changed but has gained in usability for implementers. By developing implementation guides, it has been possible to shift some detailed information from the standard itself to its corresponding implementation guide,” says Christian Hay. “By publishing the ISO IDMP standards in 2012, the community has been able to understand a potential fundamental change in each respective data model – which are currently very diverse. Having learned from users’ reactions, the IDMP project leaders have initiated an ambitious standards development programme, which consists of working on implementation guides (namely, the four CEN ISO technical specifications). Now, one can expect the creation of educational material and a uniform implementation both on the part of the manufacturer and the regulator. In parallel, IDMP provides a basis for existing or new IT solutions, such as prescriptions, medication reports, medicinal product dictionaries for clinical use, and more,” he adds. Using ISO IDMP within regulatory activities brings benefits to regulators, industry and, ultimately, patients. “The trend towards global standards continues to increase. I cannot imagine the world without IDMP, whose implementation programme is going to last several years. Without IDMP, the existing information fragmentation by country or region would cause increasing risks to patients globally – not only those who travel, but those who are faced with mobile health or because of the globalization of supply chains,” explains Christian Hay.


Celonic Acquires Glycotope’s Bio-manufacturing Facility
Basel, Switzerland, (B3C newswire): Celonic AG, a leading global biologics development and manufacturing services provider, and Glycotope, a clinical stage immune-oncology company, recently announced the successful completion of Celonic’s acquisition of Glycotope’s bio-manufacturing facility in Heidelberg, Germany. The acquisition is in line with Celonic’s vision to strengthen its position as a premier global player in the high-growth CDMO market, with continued investment in strategic assets and innovative technology platforms. The acquisition is expected to accelerate topline growth, driven by expanded GMP manufacturing assets and by an immediate investment in capacity for late-stage and commercial supply. Dr. Konstantin Matentzoglu, Celonic's Chief Executive Officer, said "With on-boarding of almost two decades of invaluable experience in optimization of perfusion continuous manufacturing processes, Celonic is well positioned to offer our customers the flexibility and the advantages of perfusion and fed-batch manufacturing – from pilot to commercial scale.”.


NBE-Therapeutics Appoints Dr. Nicole Onetto to Its Board of Directors
Basel, Switzerland, B3C newswire: NBE Therapeutics AG, a biopharmaceutical company developing next-generation antibody drug conjugates (ADCs) carrying highly potent, immune-stimulatory anthracycline toxins, announces the appointment of Dr. Nicole Onetto to its Board of Directors. Nicole is a medical doctor with over 20 years of industry experience in clinical development of targeted cancer therapies. She has held senior medical positions at Hoechst/Canada, Immunex, Bristol-Myers-Squibb, Gilead, OSI Pharmaceuticals and Zymogenetics. In addition, she served on the Board of Immunogen Inc. for eleven years, one of the pioneers in the ADC field. Most recently Nicole was the Deputy Director and Chief Scientific Officer at the Ontario Institute for Cancer Research.


Orchard Therapeutics Announces Expansion of Technical Operations in California
London, UK, B3C newswire: Orchard Therapeutics (“Orchard”), a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, recently announced the opening of a second facility for technical operations in the San Francisco Bay Area. In combination with the existing Foster City site, the new facility located at 1360 O’Brien Drive, Menlo Park, Calif., quadruples Orchard’s laboratory footprint for the technical operations that support development and validation of processes and controls for the manufacture of the Company’s ex-vivo lentiviral gene therapy products. Stewart Craig, Ph.D., chief manufacturing officer of Orchard, said, “Since the start of its technical operations in April 2016, Orchard has made significant progress in building a world-class team of experts for the development, manufacture and delivery of our ex-vivo gene therapy product pipeline. Opening of the new Menlo Park facility represents the next step of a phased plan to establish a fully integrated infrastructure for the company’s Technical Operations.” Dr. Craig added that “Even as we open the new Menlo Park site, we are already evaluating sites for a further custom-built facility in the Bay area to provide another threefold increase in our overall capacity with additional operational capabilities by 2019.”.


Venezuela’s Emerging Pharmaceutical Markets Threatened by Economic and Political Turmoil, Says GlobalData
Venezuela is one of the emerging pharmaceutical markets in South America, with a major dependence on imports. However, economic and political turmoil along with inefficient patent laws and drug pricing policies are major barriers according to GlobalData, a leading data and analytics company. The company’s latest report: ‘CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Venezuela’, reveals that the country’s total pharmaceutical market value was $12.6 billion in 2015, increasing from $5.7 billion in 2009, at a Compound Annual Growth Rate (CAGR) of 14.1%. However, Venezuela’s current economic crisis may reverse this healthy growth rate with healthcare services now becoming more expensive in the country. In 2015, the average price of healthcare services increased by 38.5% from the previous year. Out of pocket expenditure in 2015 was also high at 67.3% and drug prices are now considerably higher than the region average of $7.86. In 2016 the average drug price in Venezuela was $21.95, the highest in the entire Latin America region. The supply of pharmaceuticals in the country is heavily dependent on imports with the market growing significantly from 2009 to 2012. Since then pharma imports have dipped with pharmacies facing a shortage of essential medicines despite the efforts of the government to maintain supply. As of May 2017, about 85% of the country’s required drug demand was not being met. Tathagata Ghosh, Healthcare Analyst at GlobalData commented: ‘As well as pharmaceuticals, the medical device market is heavily dependent on imported products. The US is the major supplier for medical devices, although in recent times Cuba, Mexico and Brazil have replaced some US exports. Disposable healthcare items such as syringes, surgical clothes and hospital furniture are all manufactured domestically.’ Inefficient healthcare infrastructure, shortage of medicines in pharmacies and a high level of private healthcare expenditure leave plenty of room for improvement in the healthcare system. Venezuelan healthcare facilities are mainly limited to primary hospitals, due to a high share of primary care in the overall healthcare provision. The number of secondary and tertiary hospitals is very low. The government provides easy access to primary hospitals through the Misión Barrio Adentro (In the Neighbourhood Mission). Under this program, primary care contents are available in rural and urban areas to provide healthcare services to the whole population. Tathagata continued:


NeuroVive Reports Promising Progress in its Clinical Project for Genetic Mitochondrial Diseases, KL1333
LUND, Sweden, PRNewswire: NeuroVive Pharmaceutical AB(Nasdaq Stockholm: NVP, OTCQX: NEVPF) and Yungjin Pharm today announced that the phase I clinical study in Korea within the companies' joint project KL1333, an investigational treatment for genetic mitochondrial disorders, including MELAS (Mitochondrial Myopathy, Encephalopahty, Lactic Acidosis and Stroke-like episodes), is proceeding according to plan. The first part of the study has been successful. The pharmacokinetic data was in line with expectations and no adverse safety signals were detected. The study's remaining higher dose-cohorts have now been approved by the Korean medicinal authority, the Ministry of Food and Drug Safety (MFDS). "We are very excited about the progress of the first KL1333 clinical study. Along with the recent positive opinion on European orphan drug designation, it brings us one step closer to initiating our own clinical phase Ib study, and to our ultimate goal of providing a treatment opportunity to patients with different genetic mitochondrial disorders, where there is a high medical need and in most cases no specific treatments available," commented Magnus Hansson, M.D., Ph.D., Chief Medical Officer and VP of Preclinical and Clinical Development at NeuroVive.


Mundipharma Acquires Middle East and Africa Licensing and Distribution Rights for NTC's Ophthalmology Portfolio
Dubai, United Arab Emirates, PRNewswire: Mundipharma has expanded its ophthalmology portfolio in the Middle East and Africa by agreeing a new commercial partnership with NTC -- an Italian pharmaceutical company with deep experience in research and development -- to license and distribute a range of ophthalmic medicines in the region. NTC's portfolio was developed to address unmet medical needs in the treatment of several ophthalmic diseases, including blepharitis, dry eye, allergies and glaucoma. "The addition of the NTC medicines complements Mundipharma's current ophthalmology porfolio in the Middle East and Africa," said Mundipharma CEO, Raman Singh. "It's another bold and important step in our efforts to establish market leadership in the region backed by a strong and diversified portfolio of medicines."






Back To Top