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Sun Feb 3, 2019, 09:29 PM

Culture of Bending Rules in India Challenges U.S. Drug Agency

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India is the world’s largest exporter of generic drugs, making almost 40 percent of all new generics the FDA approved in 2018 through October. The FDA has found cause for alarm over the years at Indian factories across companies and around the country, from open toilet drains found at a sterile facility owned by Mumbai-based Wockhardt Ltd. to malfunctioning equipment at one of Dr. Reddy’s Laboratories’ plants in south India. Since then, a Dr. Reddy’s spokesperson said, the company has strengthened “laboratory practices and procedures, quality control data security’’ and other critical areas. Wockhardt didn’t respond to a request for comment.

While bad laboratory practices are usually at the root of the suspect data that inspectors are finding all over the world, in India there have also been high-profile cases of “overt and deliberate fraud,” bringing the manufacturing culture there under particular scrutiny, said Janet Woodcock, the head of the FDA’s center that reviews drugs. Woodcock didn’t identify specific companies.

India Inspections

The agency increased inspections in India by 18 percent last year after two years of declines, underscoring the fact that India may pose the FDA’s biggest challenge as it struggles to ensure drugs are cheaper but also safe.

“I don’t think everything’s fine, and I’m upset about it, but there’s not much you can do,” because India’s low production costs makes its pharma industry “enormously important” to the U.S., said Bruce Downey, former chairman of an industry lobbying group who now sits on the board of Momenta Pharmaceuticals Inc., the Cambridge, Massachusetts-based generic drugmaker. “In New Jersey, there’s dozens of FDA inspectors. In India, there’s a dozen for the entire country.”

https://www.bloomberg.com/news/features/2019-01-31/culture-of-bending-rules-in-india-challenges-u-s-drug-agency

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