TwoCircles.net presents “Agenda for India”. Series editor is Charu Bahri.

Challenges & Solutions

Dr Khalid Khan, Managing Director, Fermish Clinical Technologies Pvt. Ltd. is also a regulatory consultant to the Indian pharmaceutical industry. He draws on his experience of seventeen years, during which period he has actively championed the cause of drug development in India through his interactions with the office of Drug Controller General (India), to infer the three greatest challenges facing the pharmaceutical industry.

“The lack of research and development (R &D) by Indian pharmaceutical companies poses a huge challenge to the industry,” he says.

“Indian companies spend very little on R & D, in comparison with similar sized companies in other countries and multinational corporations. Most major discoveries in global pharma industry come from developed nations. India’s contribution is barely 4 to 5 percent. Consequently, the Indian pharma sector has no significant breakthrough discoveries under its belt. One possible cause for this lackluster state-of-affairs is the high cost of R & D in the pharma sector vis-à-vis the industrial sector. The government should adopt a realistic approach to solve this pressing issue, by offering the industry financial support to create the infrastructure needed to conduct research.”

“The Indian Drug Regulatory Authority faces challenges on three fronts – manpower, infrastructure and finance. The Indian pharmaceutical industry is comprised of around 10,000 manufacturing units producing inexpensive quality drugs not only for India but for the entire world. In the terms of value, the annual output of the Indian pharma sector is worth around 40,000 to 45,000 crore. Hence, the industry mandates a large, robust, well-equipped regulatory authority to deal with a plethora of regulatory aspects. Fortunately, the Government of India’s Ministry of Health has taken a realistic view of this problem and the situation is improving on all fronts. We look forward to a world class, information technology-enabled regulatory authority.”

“Prices of pharmaceutical products in India are controlled by the Drug Price Control Order, which is regulated by the National Pharmaceutical Pricing Authority, under the Ministry of Chemicals & Fertilizers. It had been observed that sometimes, the pricing mechanism is not justified. Most products are under-priced, thus hampering the growth of the industry, while a few products are over-priced. In my opinion, the National Pharmaceutical Pricing Authority should work in close coordination with industry representatives and associations so that on the one hand, the growth of the industry does not suffer, and on the other hand, Indian patients can avail of reasonably priced quality pharmaceuticals.”

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