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Ranbaxy spurious drugs case: Indian pharma laws different from that of USFDA

The Drug Controller General of India (DCGI) Dr GN Singh said that all the approvals given to Indian drugs manufactured by Ranbaxy Laboratories were in order. As per the laws, there was no indication of any company violating the Indian laws, including Ranbaxy. However, Dr Singh admitted that all matters including approvals in the past would be examined again.

Ranbaxy Laboratories had recently pleaded guilty to federal charges of selling adulterated drugs with intent to defraud and agreed to pay $500 million to resolve false claim allegations. This in turn led to other allegations by its current owner Japanese company Daiichi Sankyo that the former stake holders particularly the Singh brothers weren t completely honest about investigations.

Dr Singh added that appropriate action would be taken and a special team would be set up to examine the case. They would send officials to the US if the situation demands it. My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty, Dr Singh told Pharmabiz.

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When asked about the possibility of Indian regulators giving clearance to documents by an Indian company before filing them with an agency abroad, Dr Singh said that his hands were tied by the existing laws. We cannot dictate the norms and requirements set by another country. Our task is to ensure the safety of our people and make sure that approvals to the drugs here are given as per the rules and stringent measures, he said.

Dr Singh also told the Economic Times that they were working on a clear policy on how it should respond to safety alerts by foreign regulators on medicines manufactured in India. The current tenets in the Drugs and Cosmetics Act don t allow drug regulators in the country to take any action based on foreign misgivings.

While the Indian law is based purely on science, law and 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 drug-makers export to over 200 countries, most of which have their own laws and regulators to keep a check on the drugs being imported to their countries.

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