The Hindu Business Line : Procurement of generic AIDS drugs — Indian drug cos hope for change in Bush's stand

INDIAN pharmaceutical companies are likely to gain if the US administration succumbs to public pressure on using George Bush's $15 billion worth of the President's Emergency Plan for AIDS Relief (PEPFAR) fund, for procuring anti-retro viral (ARV) drugs used to treat HIV/AIDS from generic companies in the developing world.

This optimism has emerged after US Food and Drug Administration (USFDA) and other government officials, including special envoys of Mr Randall Tobias (head of the administration's global AIDS policy) and Mr Tommy Thompson (the Health and Human Services Secretary and Chairperson of the Global Fund), met with representatives of generic companies such as Ranbaxy Laboratories, Aurobindo Pharmaceuticals, Pune-based Emcure and others in India recently.

For starters, Ranbaxy has said that it has initiated a programme to file its ARV products under the expedited review process of the USFDA for the US PEPFAR. "The first filing is likely to take place before the end of 2004. The first study for bio-equivalence is being planned at a Contract Research Organisation in North America," said a company statement.

Sources in the pharma industry said this is a significant development since Washington has continuously refused to permit US aid money to be used to buy generic ARV drugs manufactured in developing countries such as India, Thailand, and Brazil. This, despite the fact that they are much cheaper than branded drugs of major pharma companies in the West.

"The US Government's stand received criticism by the WHO and the World Bank which had indicated the importance of cheaper versions. At the Botswana meeting on HIV/AIDS held earlier this year, it was felt that the WHO-approved fixed dose combinations (FDCs) of drugs offered by the generic companies would have to take a separate clearance from the USFDA. Subsequently, officials from the US regulator came to India for negotiations with the Indian companies," they added.

Even as companies may file under the quick clearance process in the hope of speedy approvals, companies have expressed doubts over the process. Since the large US pharma companies do not offer FDCs, which are mainly three ARV drugs formulated into one pill, what would the USFDA compare these with. "Though these drugs may be put on the fast-track clearance procedures, the regulator could continue to delay giving clearances. Also, if FDA approval is stalled, other markets could be impacted despite the drug having received an WHO approval," industry sources said.

Industry analysts felt that Indian pharma companies had managed to clinch good deals after the Clinton Foundation, Gates Foundation and the Global Fund decided to procure ARVs from India for other developing nations. "If they can meet USFDA standards and get even some portion of the $15-billion fund, it would be good for the generic companies. And Ranbaxy seems to be the first company off-the-block," the analyst said.

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