Drug Companies in India and China Lack FDA Oversight
June 24th, 2007
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A Washington Post investigative report has slammed the Food and Drug Administration (FDA) for its failure to adequately monitor drug companies in India and China.
Yet on-the-ground inspections of Indian and Chinese plants remain rare and relatively brief and are always scheduled in advance, unlike the surprise visits that FDA inspectors pay to domestic manufacturers. FDA records show that 32 inspections were carried out last year in India, and most were for companies seeking approval to sell a drug or ingredients, not to check on the quality of manufacturing. Fifteen visits were made to Chinese plants.
Even these small numbers overstate the FDA’s oversight. Some of the 32 India inspections — the agency would not say how many — involved drugs that, by law, cannot be sold to Americans. They were to review companies that wanted to take part in President Bush’s program to supply cheap AIDS drugs to Africa.
With ever-increasing drug prices in America, and the growing demand for generics, drugs exports from both India and China have recently boomed. And so have the concerns for quality of imported cheap drugs–especially after the recent pet drugs scandal which has rocked the Chinese drug industry.
Some of this concern is being orchestrated by American pharmaceutical companies who are afraid of cheaper generics flooding the American market. America remains by far the most profitable market for drug companies worldwide, and any dent in this market can seriously affect their bottomline. Having said that, it is in the interest of Indian drug companies to follow FDA regulations. Drug market is highly sensitive and even a single scandal can affect Indian exports. Dr Reddy’s initiative to engage US Pharmacopoeia–a non-profit organization which monitors drug quality is laudable, and should be followed by the rest of the industry.
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2 Responses to “Drug Companies in India and China Lack FDA Oversight”
Mike Murphy June 27th, 2007 at 8:19 am #
This us probably justification for the concern about quality in the Indian generic drug industry. I think that in the 1980’s a major scandal came out about the quality of generics that were being produced by some in the Indian generic drug industry. Mylan Pharm was instrumental in obtaining documentation about the problem. Hearings were held and the Indians disappeared from the generic scene.
With that as background, I think it is essential that FDA closely monitor the Indian generic drug scene with unannounced inspections and close oversight. The same rules should apply to them as to the generic producers in the US.
Rohit June 27th, 2007 at 1:18 pm #
Mike,
I agree, I think Indian industry would also benefit from adopting FDA regulations–its credibility would significantly increase.