Home » Medicine » Indian drug regulator asks pharma companies to disclose restrictions abroad

Indian drug regulator asks pharma companies to disclose restrictions abroad

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India’s federal drug regulator swung into action, to ensure “quality, safety and efficacy of the drugs available in the country,” with some pharma companies coming under the scanner of United States and UK.  Drugs Controller General of India (DCGI) has asked drug manufacturers to notify any “restrictions/alerts issued by any drug regulatory authorities abroad, in respect of drugs manufactured and exported from India”.

drugsRanbaxy Laboratories agreed to pay a penalty of 500 million US dollars after US Food and Drugs Administration (FDA) found its drugs were ‘adulterated’.  Ranbaxy had pleaded guilty of charges of falsification of data and marketing adulterated drugs in the US. Another drug manufacturer – Wockhardt is also facing an import alert.

Drug Controller General has asked state drug controllers to ask pharma companies in their respective states to bring details of any restrictions or alerts to the notice of DCGI, so that its “impact in Indian scenario can be assessed and necessary action is taken to ascertain the quality, safety and efficacy of the drugs available in the country.”

Ranbaxy is also facing probe in UK after the revelations in US. However, a spokesperson of Medicines and Healthcare products Regulatory Agency (MHRA) of UK said, “We have no evidence that any of the products on the UK market manufactured by Ranbaxy are or have been of unacceptable quality.  There is no evidence that patients in the UK have been put at risk.”

“In light of the recent declaration made by Ranbaxy, we are consulting with other EU and international regulators including the FDA to review whether any further action is deemed appropriate,” added the spokesman in a statement issued earlier in June.

Ranbaxy is also facing the heat in the domestic market, with Mumbai-based Jaslok Hospital asking its doctors to be careful in prescribing Ranbaxy products. Drug-chain Apollo Pharmacy has also put Ranbaxy products on the watch list, though it has not stopped sale of products manufactured by the pharma major.

FDA had also issued an import alert against drugs manufactured by Wockhard at its Waluj facility in Maharashtra.

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1 Comment

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    Pharmaceutical Products Manufacturers in India

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