Indian herbal drugs may get easier entry into US
Indian drug makers, who have so far been restricted to labelling their traditional medicines as dietary supplements in the US, can now claim therapeutic properties and get doctors to prescribe them in the world’s largest pharmaceutical market.
By Gireesh Chandra Prasad, TNN |
MUMBAI: Indian drug makers, who have so far been restricted to labelling their traditional medicines as dietary supplements in the US, can now claim therapeutic properties and get doctors to prescribe them in the world’s largest pharmaceutical market.
The US Food and Drugs Administration have approved the first prescription herbal drug, confirming its safety and efficacy under a new review process. This cuts short a mainstream herbal drug’s journey from lab to market by relying on the safety and efficacy data documented in ancient texts.
If it is strong enough, the FDA may even grant over the counter (OTC) status, which allows the companies to advertise the drug directly to the consumer.
Indian drug makers such as Ranbaxy and Lupin, who have their traditional medicine arms, can now combine their chemistry skills with the knowledge of traditional drug makers for tapping this huge opportunity in the US, which already has a $65 billion pharmaceutical market — the largest in the world.
The new review process treats herbal drugs with adequate data as mainstream drugs and not as alternative therapies or as nutritional supplements. Veregen, the first botanical drug approved in the US last month, is derived from green tea leaf extracts and is used in treating genital warts.
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The drug is manufactured by German drug maker CPM Contract Pharma GmbH and would be marketed by Bradley Pharmaceuticals. The US FDA is learnt to be reviewing 286 such applications now. “If the herb is known and there is considerable documented safety data, then the US FDA may either reduce the pre-clinical study requirement or straight away allow phase one or two clinical studies. This means, respecting traditional knowledge for granting herbal medicine the status of modern drugs and exempting certain requirements needed for approving a new synthetic molecule/allopathy drug,” a senior scientist with a large Indian corporate told ET.
The new system may also provoke intellectual-property-benefit-sharing demands from countries like India and Brazil for a part of the profits of MNCs.
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