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Health ministry counters charges of quality of Indian drugs raised by US pharma industry
Joseph Alexander, New Delhi | Tuesday, July 10, 2007, 08:00 Hrs  [IST]

With the US Pharma industry expressing concerns on the quality of Indian low-cost drugs sold to American consumers, the Union Government made it clear that it was willing to support more frequent quality control inspections by the US FDA in the facilities of Indian exporters here.

Reacting to the concerns, which some claimed as motivated by vested market interests there, a Union Health Ministry official said that India was exporting only quality medicines and there are enough safeguards to check the quality and efficacy already, besides the facilities follow the US FDA standards.

"Still, if they want to go for regular on-site checks in our plants, we welcome it and we can give our full support, if it will help protect image of Indian pharma industry,'' the official said, responding to the reports of FDA being under pressure for more inspections.

Recent reports in the US had raised concerns over the quality of drugs and drug ingredients from India and China sold to Americans. There is a campaign going on to put pressure on the FDA to go for more quality inspections. According to a report in the Washington Post, products from the two countries were becoming pervasive in the generic and OTC market.

Sources in the DCGI's office also reiterated that Indian companies usually had sufficient mechanism to do own quality and safety testing before exporting the products and the claims by the US industry could not be taken on their face value.

Though FDA conducted over 1200 quality assurance inspections in the United States, only a handful were done by them in India last year. Over the last seven years, FDA conducted just 200 inspections of plants in India and China, according to the reports.

Though only eight generic drugs from India were sold in the American market 10 years ago, now over 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs are available. India sold $800 million worth of finished drugs and ingredients here in 2006, according to US Commerce Department records.

The Bulk Pharmaceuticals Task Force, a group representing the American drug-ingredient makers, has been in the forefront of mounting campaign to seek more aggressive checking by the FDA in overseas plants. It also sometime back filled a citizen's petition with the FDA.

The Indian industry, on its part, also welcomed the idea of more checks by the FDA if it could improve the standards and it would encourage more companies to seek FDA approval of their products. But it is also pointed out that it is nearly impossible for the FDA to send their people frequently to India for inspections, unless major issues or controversies come up.

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