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US nod for drug trials in India must: Brar

Mumbai, Dec. 12: Even as domestic pharmaceutical companies have carved out a notable presence in developed countries, a key hurdle remains—securing the approval of the US Food & Drugs Administration (FDA) for clinical research done here.

D. S. Brar, CEO and managing director of Ranbaxy Laboratories Ltd—itself a research powerhouse—pointed out that the ‘Made in India’ label on pharmaceutical products was no longer derided in the developed world. However, the formidable task that remained was ensuring that clinical trials conducted by Indian companies are accepted by the FDA, Brar told a select gathering of newspersons at a conference organised by the Indian Pharmaceutical Alliance, of which Ranbaxy is a member.

“The domestic industry should work towards this target. Already, multinationals like Pfizer, Eli Lily and Novartis have achieved it,” he noted.

Analysts here noted that the US regulator, which follows high standards is still not comfortable with data submitted by Indian companies on clinical trials done in the country.

Other leading lights that accompanied Brar included K. Anji Reddy, chairman, Dr Reddy’s Laboratories, D. B. Gupta, chairman Lupin Laboratories, Dilip Sanghvi, chairman, Sun Pharmaceutical Industries, Swati Piramal from Nicholas Piramal India Ltd, and Habil Khorakiwala, chairman and managing director of Wockhardt Ltd among others.

Encapsulating the strengths and weakness of the domestic pharmaceutical sector, Brar averred that growth rates in the industry have come down to 9 per cent from double-digit figures.

This, he said, was due to a combination of factors that included higher level of competition from regional players and complete genericisation of new products. Further, the absence of a “not too robust product pipeline” was also hindering growth rates. This factor, Brar added, was due to the country being TRIPs compliant, as a result of which the generic version could be made available for patents after 1995.

The Ranbaxy chief further noted that Indian companies could now face even tougher times ahead as tariff barriers are set to come down to 15 per cent by 2005 from 35 per cent now. This is set to enhance imports of finished products into the country, whose figures have already touched Rs 1,000 crore. “We would need to go in for research collaborations, marketing alliances, co-promotions and co-marketing,” he added.

However, he lamented that the industry was still constrained by slow liberalisation process in the sector, particularly the delay in implementation of the new drug policy and prevailing ambiguity in the policy and laws regarding the crucial research and development efforts.

“Though we are one of the fastest growing industries in the country, we face several constraints as the pharma industry seems to be left out by the government in its liberalisation process...It still hurts us,” he said.

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