India’s drug regulator finds no problem at Ranbaxy sites

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India’s drug regulator finds no problem at Ranbaxy sites

Home/Policies & Legislation | Posted 11/10/2013 0 Post your comment

India’s drug regulator has found no major discrepancies at the Mohali manufacturing unit of Ranbaxy Laboratories (Ranbaxy) in contrast to FDA findings.

Ranbaxy has been in trouble with FDA since 2008, when FDA put two of its manufacturing sites (Dewas and Paonta Sahib) on import alert. As a result, Ranbaxy agreed to pay US$500 million in civil and criminal fines to resolve the litigation [1]. Then, FDA announced on 16 September 2013 that it was issuing an import alert banning drugs manufactured at Ranbaxy’s Mohali plant in India due to good manufacturing procedure (GMP) violations at the site [2].

As a result, the Indian Government asked the Drugs Controller General of India (DCGI) to investigate the quality, safety and efficacy of drugs manufactured by Ranbaxy for the domestic market at these facilities.

Despite FDA’s findings, Mr G N Singh, India’s DGCI said at a conference on Accountable Health held in New Delhi, India, that ‘inspections of products and services in the concerned manufacturing units of Ranbaxy have found no major discrepancies’. Since ‘there are no violations by the company under the Drugs and Cosmetics Act’ Mr Singh said that ‘Ranbaxy operations will continue in India as usual’.

Mr Singh added that ‘whatever medicines are placed in the Indian market are safe. Otherwise, they would have been withdrawn.’ In fact, Mr Singh emphasized that this applies not only to medicines manufactured by Ranbaxy but all drugs being sold in India.

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References

1. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy pays US$500 million to resolve US litigation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 11]. Available from: www.gabionline.net/Generics/News/Ranbaxy-pays-US-500-million-to-resolve-US-litigation

2. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy receives another import ban from FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 11]. Available from: www.gabionline.net/Generics/News/Ranbaxy-receives-another-import-ban-from-FDA

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Source: The Hindu Business Line, The Indian Express