Indian Regulator to Look at Quality of Ranbaxy Drugs

Fri, 08/23/2013 - 9:23am
Matthew Dennis, First Word Pharma

The Indian government on Friday asked the Drug Controller General of India (DCGI) to assess the quality of medicines produced by Ranbaxy to see if the company is meeting manufacturing standards. Srikant Kumar Jena, Minister of State for Chemicals and Fertilisers, noted that the regulator has been asked "to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market."

In May, Ranbaxy pled guilty to US felony charges in connection with the manufacture and distribution of certain adulterated drugs made at its Paonta Sahib and Dewas production facilities in India. The drugmaker, which is majority owned by Daiichi Sankyo, also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims for $350 million under the False Claims Act and related state laws. The drugs involved in the case included acne therapy Sotret (isotretinoin), epilepsy and nerve pain drug gabapentin, and the antibiotic ciprofloxacin.

In response to whether Ranbaxy is selling some of the same drugs in India that were involved in the US probe, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice regulations of the FDA. "However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity...with GMP is viewed non compliance to GMP," Jena added.


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