Indian regulators unsure how to react to USFDA actions

India is trying to figure out what its response should be to the fact that two of its largest generic drugmakers have been targeted by the FDA because of serious manufacturing lapses. Problems at Ranbaxy Laboratories were identified years ago but culminated this month with its record-setting settlement with U.S. authorities. Then last week, the agency slapped a ban on one of Wockhardt's Indian plants, again suggesting shortcomings in how India oversees its industry. 

G.N. Singh, the Drug Controller General of India (DCGI), told The Economic Times that India's laws do not require that it act in the face of actions by foreign regulators, but his agency is working on a standard policy for whether and how to respond to safety alerts by foreign regulators for pharmaceuticals manufactured by Indian companies. "My mandate is to ensure quality, safety and efficacy of drugs marketed in the country. While alerts by other regulators can help raise scrutiny levels here, our decisions would strictly be based on what has been clearly laid down as the law of the land," Singh said. 

Last week, Bloomberg cited a confidential official source that said India's Ministry of Health and Family Welfare had asked the DCGI to examine U.S. court documents in which Ranbaxy admitted to sales of improperly manufactured and tested drugs, asking it to present a plan for dealing with the situation. The Business Standard newspaper reported that the DCGI had been ordered to start a probe.

Singh told The Economic Times he had not launched a probe into Ranbaxy's problems but was collecting information to determine what should be done. Indian authorities investigated Ranbaxy in 2008 after the FDA first suggested the drugmaker had manufactured adulterated drugs and lied to the FDA to cover it up, but they decided not to act. Ranbaxy signed a 5-year consent decree last year with the U.S. agreeing to strict oversight and reporting, but just two weeks ago, it pleaded guilty to felony charges related to the long-running problems and agreed to pay $500 million in penalties. The FDA issued the alert against Wockhardt after a routine inspection found manufacturing issues with a plant in Aurangabad in Maharashtra, a move that could cost the company $100 million in lost sales.

- see the Economic Times story
- read the Bloomberg piece

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