Jul. 5 – According to a survey from the Associated Chambers of Commerce and Industry of India (ASSOCHAM), India’s pharmaceutical industry may be in trouble as many companies are deciding to relocate their research and development (R&D) operations further south towards the ASEAN region. 250 of the top officials and representatives from India’s pharmaceutical industry based out of Andhra Pradesh, Gujarat, Karnataka, Maharashtra and Tamil Nadu took part in the survey.
“Various Southeast Asian countries are wooing India’s R&D industry by offering sops and transparent regulations as regulatory bottlenecks, and a plethora of committees have slowed permissions/approvals for trials or marketing drugs to more than 12-15 months back home in India while such permissions are given by the USFDA, EU and Singapore within a month’s time,” stated the ASSOCHAM survey.
The survey also notes that Southeast Asian countries have become the destination of choice for India’s pharmaceutical companies as they all share similar population levels which are prone to similar diseases. In addition, these countries all have more conducive environments for their operations with fewer regulatory uncertainties.
Most of the survey’s participants also noted that “Gazette Notification (No: GSR 53 (E) dated January 30, 2013)”, which was issued by India’s Department of Health and Ministry of Health & Family Welfare, has basically put a stop to all related R&D activity in the country.
According to ASSOCHAM, the gazette notification places incredibly strict laws on the pharmaceutical industry that are not in line with internationally established regulations. This makes it almost impossible to conduct investigational new drug studies. The gazette also makes it mandatory for a study drug to be completely efficacious – a condition that is nearly impossible.
ASSOCHAM even relayed the message to India’s Prime Minister, Dr. Manmohan Singh, with their official statement.
“[Gazette Notification (No: GSR 53 (E)] is not in line with the established international standards, and is likely to have a cascading effect on the future of clinical trials in India as the flaws in the gazette could negatively impact the future growth of R&D as well as development of low cost high quality medicines in the country,” said the statement.
India’s pharmaceutical industry reached Rs. 1,000,000 crore (US$3.5 billion) last year, with over Rs.40,000 crore (US$665.5 million) of exports. With a global market share of 20 percent in the generic pharmaceutical market, India is the world’s single largest supplier of vaccines.
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