Four pharma cos get nod to conduct clinical trials for Viagra

NEW DELHI, MAY 2: The race to launch the desi version of wonder drug Viagra has intensified with top pharma companies including Ranbaxy, A...

NEW DELHI, MAY 2: The race to launch the desi version of wonder drug Viagra has intensified with top pharma companies including Ranbaxy, Alembic, Cadila and Unichem getting the nod from the Drug Controller General of India to conduct clinical trials.

If all goes well, the Indian version of Viagra will hit the market by the end of the year, which is being tipped to be a major revenue spinner. The drug in the overseas has already received encouraging response.

The Drug Controller General of India (DCGI) has also given permission to these companies to send samples to Central Drug Laboratories (CDL), Calcutta, for testing before the lauch of formulations in India for the first time.

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Pharma industry sources said clinical trials are being conducted by Ranbaxy, Alembic, Cadila and Unichem under the supervision of the Indian Council for Medical Research (ICMR).

Sildenafil citrate is an active ingredient used in the impotence drug, Viagra.

The pharma majors are fast gearing to launch the wonder drug, Sildenafil Citrate tablet in India. According to industry sources, the wonder drug in the desi version will be available in the domestic market by the end of this year, which is expeceted to be comparatively cheaper than the one available in the domestic market routed through the grey market.

Ranbaxy Labs, Alembic Limited, Cadila and Unichem have been in the past exporting such drug in bulk form. The exports began after the ban was lifted on export of drug molecules not registered for marketing in India.

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The DCGI for the first time has issued a common protocol for the pharma companies to conduct clinical trials for formulations. The clinical research study aims to confirm the value of a new drug Sildenafil Citrate, which is available in other countries.

The protocol calls for conducting the clinical trials as per the set format and calls for the clinical trials to study various aspects of the drug, including possible side-effects in the Indian context. The trial process will take 6-8 months before a final report is submitted to ICMR and the drug is finally launched.

Pfizer Inc, the original manufacturer of Viagra, introduced the drug in the world markets about two years ago. In 1999, Viagra generated sales of $1 billion for Pfizer. Viagra in overseas markets already boasts of an efficacy rate of 80 per cent though it has more recently been associated with side-effects such as myocardial infarction, temporary vision loss etc under specific circumstances.