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G. Naga Sridhar

Hyderabad, Sept 17 The ‘conservative’ approach of US Food and Drug Administration in granting new drug approvals and quality norms can have a long-term impact on the drug industry, according to Mr G.V. Prasad, Vice-Chairman and Chief Executive Officer, Dr Reddy’s Laboratories Ltd.

“There has been a significant (about 50 per cent) reduction in the number of drug approvals by FDA this year compared to the same period last year along with a renewed focus on quality compliance. Earlier there were 40-50 approvals, which have come down to 20-25 approximately,” Mr Prasad told Business Line.

As India is a major exporter of generic drugs to US markets, the ‘conservatism’ may have an adverse impact in the long run, he said.

The industry needs to focus on meeting compliance norms and achieving manufacturing excellence in general. “Even though Dr Reddy’s has no issues with FDA and maintains high quality, we are still trying to achieve higher levels of manufacturing excellence,” he said.

The Hyderabad-based pharma major has hired a Japanese consultant for best manufacturing practices. “There is still a long way to go in this regard. We are trying to emulate some of the best practices adopted by auto companies in manufacturing,” Mr Prasad said.

According to Mr Venkat Jasti, CEO of Suven Life Sciences and Chairman, Pharmaceuticals Export Promotion Council (Pharmexcil), the decrease in approvals was due to the FDA’s heightened focus on efficacy.

“Now, they are not approving ‘me-too’ kind of drugs based on analogue research. With just intellectual property a company may now not be able to get approval for entirely similar generic drug. FDA is looking for things like betterment in terms usage (number of required dosage, for instance) and less side-effects,” he said.

According to industry figures, USFDA approved 132 Abbreviated New Drug Applications (ANDAs) from India in 2007, which formed 38 per cent of total approvals globally. Out of 656 Drug Master Files approved, 274 were from India.

Mr Bhaskara Narayana, Vice-President (Finance), Natco Pharm Ltd, however, has a different view. “I don’t see any new conservatism in FDA now. They have been like that from the beginning,” he said.

More Stories on : Pharmaceuticals | Regulatory Bodies & Rulings

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