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US FDA to source anti-HIV drugs from Indian firms
12 June, 2005
United States Food and Drug Administration (USFDA) has initiated the process to source anti-HIV drugs from Indian drug makers.
BY OUR PHARMA CORRESPONDENT
Several of the anti-retrovirals (ARV) producers from India including the leading players like Cipla & Ranbaxy stand to benefit from this US dollar 15 billion President's Emergency Plan for AIDS Relief.
Under this scheme, the drug suppliers will get an expedited review and a waiver on the fee normally charged on new drug applications.
In an effort to source cheaper ARVs, a high profile FDA delegation was recently in Mumbai, holding talks with a couple of city-based drug makers.
According to sources, FDA is expected to complete the review process on ARV combinations within six weeks after receiving an application. The expedited review process would ensure that the US is providing safe, and effective combination, and single ingredient HIV therapies.
The expedited review process, combined with the work of local drug regulatory authorities in the affected countries, will provide a mechanism to ensure that safety, efficacy and quality standards are met and maintained by companies providing drugs for the President’s Emergency Plan.
In order to obtain approval of new products, manufacturers could cite existing clinical data to demonstrate the safety and efficacy of the individual drugs in the new product.
The FDA had also pledged to work with companies in assuring that necessary data are developed rapidly if the companies do not already have access to such data, sourced said.
BY OUR PHARMA CORRESPONDENT
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