DCGI working on policy to respond to safety alerts

India's drug regulator is working on a policy on how to respond to safety alerts raised foreign regulators on drugs manufactured by Indian companies

New Delhi: India's drug regulator is working on a clear policy on how it should respond to safety alerts by foreign regulators on medicines manufactured by Indian companies after two of the country's biggest drug manufacturers landed in trouble with the US watchdog.

Last week, the US Food and Drug Administration (US FDA) blocked imports of all but one drug manufactured at the Aurangabad facility of Wockhardt. Earlier this month, Ranbaxy had pleaded guilty and agreed to pay a $500-million fine to the US government to settle criminal and civil charges against it. Wockhardt's chairman Habil Khorakiwala on Thursday projected that the firm may take an annual hit of $100 million as a result of the US FDA action.

The Drugs and Cosmetics Act does not empower the drug regulator to take action based on a red-flag raised by a foreign counterpart. In future, Indian government may take a cue from the action of foreign drug regulators, but it would assess the good manufacturing practices of Indian firms according to the Indian law (Drugs and Cosmetics Act).

"While the Indian law is based purely on science and law; actions of other countries may be influenced by several factors, including patent policies and commercial interests of respective countries," GN Singh, the Drug Controller General of India (DCGI) told ET. Indian drugmakers export to over 200 countries, most of which have their own laws and regulators to keep a check on the quality of drugs.

"The regulatory regimes of different countries vary. There is no one set of globally harmonised good manufacturing practices, against which one can benchmark and pronounce verdicts which can apply universally," said Singh. "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," the drug regulator added.

Indian drugmakers also feel that DCGI should act as per the mandate defined by Parliament for the regulator, which reflects "national needs". "Our drug regulator acts on behalf of Parliament and has a clear remit under the Drugs and Cosmetics Act. It is important that the underlying sanctity of that law is preserved," said DG Shah, Secretary General, Indian Pharma Alliance, an industry body representing domestic drugmakers.

When asked about the protocol in these cases, where an overseas regulator like US FDA raises a warning signal, Singh said that the DCGI office can act on the lead suo moto or on the direction of the health ministry. On the Ranbaxy issue, the DCGI clarified on Saturday that there has been no probe order yet. "It is a sensitive issue and the way forward would only be decided after an initial study of facts of the matter. Health ministry and DCGI office are on the same page," Singh said.

India had in late 2008 probed the FDA's charges against Ranbaxy relating to the quality of drugs but decided not to impose a ban on the firm's drug.

Credit and Source: Economic Times

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