Budget 2018 presented in the 1st week of February, was passed in mid March 2018 in the Lok Sabha without discussion as the Govt. and opposition remained at logger heads with each other. Approx. Rs. 82 lakh core income / expenditure plan of the country was not even debated for a day. Even the smallest of organisations will debate and discuss in great details, their annual income and expenditure plans for optimum utilization. But our parliamentarians think otherwise.

The Budget did not really have any positive provisions for the Pharma Sector apart from the health insurance plans and new medical colleges. The industry is facing challenges to stay competitive globally, to transit form generic to branded players and development of R&D.

Clinical trials has remained a hotly debated topic across the world and more so in India. Only 1.4% of global clinical trials are done in India, while the country has 16% of the world’s population and carries 20% disease burden in the world. With our huge and diverse genetic pool of population, chronic diseases, largest number of FDA approved manufacturing plants outside the USA, we make the ideal platform for clinical trials. But, lack of clear policies and changing regulations along with social difficulties, considerably affected the growth of this sector. In 2010, more than 500 clinical trials were done in India; the number dropped to less than 200 thereafter. Efforts are now being made to make the regulations more rationale and balanced. The timeline for the approval of clinical trials research has been reduced by the Central Drugs Standard Control Organization. Another important question is Patient Centricity in Clinical Trials. Our lead article in this issue attempts to address the core issues.

Last month the Hon. Supreme Court of India legalized passive euthanasia by allowing withdrawal of life support to patients in permanent vegetative state. In a historic judgment, the law places the choice in the hands of the individual. This judgement brings relief to thousands of suffering patients and their families.

The recently concluded Asia Pharma Expo in Dhaka, Bangladesh saw some 600+ exhibitors, over 11000 visitors from 31 countries making it a single point solution for buyers, sellers and technology partners. The Pharma Review has been associated with this event since the beginning and we once again had an excellent exhibition.

We congratulate Dr. S. Eswara Reddy on his appointment as interim Drug Controller General of India (DCGI). Prior to this appointment, Dr. Reddy was serving as Joint Drug Controller of India, CDSCO, Ministry of Health and Family Welfare, New Delhi.



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