Whistleblower sues Indian drug regulators for poor oversight
- Well-known Indian whistleblower Dinesh Thakur has filed suit against India's drug regulatory authority, the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO), for failing to police safety rules. A Friday hearing is scheduled in the Supreme Court, according to Reuters.
- Thakur exposed Ranbaxy Labs in 2013 for its failure to properly test drugs to assess quality and safety. The result was a $500 million fine and a decision by the FDA to ratchet up its inspections at Indian pharma manufacturing facilities.
- Rather than hoping for a financial award, Thakur's wants to to create a more rigorous framework for the recall of drugs and a commission to examine faulty drug approvals.
Thakur's Ranbaxy case has had a profound effect on the level of FDA oversight trained on the Indian pharmaceutical and biotech industries. The stakes are high, considering that India's $15 billion pharma industry is one of the fastest growing in the world.
Although Takur says that he has no financial motive in this case, he made $48 million from the U.S. government after the case was settled in 2013. In response to questions from Reuters about this situation, the head of CDSCO, GN Singh said the following: “We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic... I don't have any comment on this guy."
The FDA has sent a number of Indian drug manufacturers warning letters citing good manufacturing practices (GMP) violations, including top flight firms like Sun Pharma and Dr. Reddy's. Currently, 42 Indian firms are listed on the FDA's import ban list.
But, the US regulator has also sought to improve its relationship with the Indian pharma industry. "The inspections can yield also carrots, and not just sticks," Deputy Commissioner Howard Sklamberg said in a blog post last year.