he whistleblower who exposed quality problems at one of India’s largest generic drug makers is now taking on the Indian government.
Dinesh Thakur, whose work helped US authorities obtain a $500 million fine from Ranbaxy Laboratories three years ago, wants to force the Indian government to follow safety laws and create one central regulator for the entire country.
He claims the country’s fractured system of separate regulators for 37 states and territories not only leads to inconsistent and spotty oversight, but also violates the constitution, according to one of two petitions he filed in January (here is one and here is the other). A hearing at the Indian Supreme Court is scheduled for Friday.
“Ever since the Ranbaxy case, regulators in the US and Europe have put much pressure on Indian companies, and they’re beginning to acknowledge there’s a problem and trying to fix it,” said Thakur, a former Ranbaxy research director, who spent some of the $48 million he was awarded as a whistleblower on pressing the court case. He now describes himself as a public health activist.
“But they’re only taking measures for facilities from which exports are sent to these places,” he added. “Unfortunately, for the people living in India, Africa, and Latin America, manufacturing continues to be not in compliance, resulting in drugs of questionable quality. And the only way to correct this problem is to make local regulatory standards the same as global standards.”
We asked the Drugs Controller General of India, which approves the licenses for certain categories of drugs in the country, for comment and will pass along any reply.
India is considered to be something of a medicine chest to the world, given the large number of generic drug makers headquartered there, including Cipla, Dr. Reddy’s Laboratories, and Sun Pharmaceutical, which purchased Ranbaxy.
But the Ranbaxy episode helped focus attention on Indian manufacturers after Thakur helped expose a laundry list of longstanding problems. These included manipulating safety data, failing to conduct safety and quality tests, and making false statements to the US Food and Drug Administration.
The scandal prompted growing concern about the veracity of the pharmaceutical supply chain, especially as the FDA devoted more attention to India and increasingly cited still more drug makers there for quality-control problems. In some cases, the agency banned products from entering the United States.
In his first petition, however, Thakur argued that poor oversight extends to all drug makers doing business in India. And he claimed the government has illegally approved existing medicines, and that “substandard” drugs have led to unnecessary deaths and antimicrobial resistance that promotes disease.
In his second petition, Thakur contends that it is “blatantly unconstitutional” for the central government to delegate regulatory authority to the 29 states and seven territories because the Indian Parliament never expressly authorized the government to do so.
A key problem is explained in the petition. For instance, one state authority that has concerns about a drug does not have the power to suspend or cancel a manufacturing license in another state, or even inspect those facilities. “Predictably, such a cumbersome legal framework with multiple regulators has led to poor coordination and often inconsistent application of law,” he charged in his petition.
Thakur also charged that different recruitment and training standards in each state leads to differing standards for enforcing laws: there is poor interstate coordination of drug recalls, and different states suspend licenses for different time periods.
Of course, the outcome of the proceeding is unknown at this point, but any moves to tighten oversight could have a significant effect on supplies, given that the FDA has banned dozens of drugs from entering the US. This might also enhance FDA’s efforts to coordinate inspection oversight. The agency has just three inspectors in India on a full-time basis.