Indian generics makers face US recalls

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Indian generics makers face US recalls

Genéricos/Novedades | Posted 21/03/2014 0 Post your comment

Indian generics makers are once again coming under US Food and Drug Administration (FDA) scrutiny.

Several manufacturers, including Dr Reddy’s Laboratories (Dr Reddy’s), Sun Pharmaceutical (Sun Pharma), Ranbaxy Pharmaceuticals (Ranbaxy) and Teva Pharmaceuticals (Teva), are facing individual Class II U.S. recalls related to product mix-ups, good manufacturing practice (GMP) deviations, to name just a few. The recalls were included in FDA’s 5 and 13 March 2014 enforcement reports.

Dr Reddy’s recall of 58,656 bottles of its lansoprazole delayed release capsules, used to treat gastric reflux, was initiated after out-of-specification results for microbial count were observed.

A total of 2,528 bottles of metformin hydrochloride extended-release tablets manufactured by Sun Pharma and distributed by US-based Caraco Pharmaceuticals have also been recalled. The recall came as a result of Gabapentin (neurontin) tablets, used to treat epilepsy, being found in a bottle instead of diabetes medication metformin.

Troubled Ranbaxy’s recall comes as a result of the discovery by a pharmacist of a 20 mg atorvastatin calcium tablet in a bottle that was supposed to contain 10 mg doses. It affects 64,626 bottles manufactured by Ranbaxy at its Jacksonville, USA plant.

Teva, meanwhile, is facing no less than four separate recalls for its products, which include ethambutol hydrochloride tablets, hydroxyzine pamoate capsules in both 25 mg and 100 mg doses and dextroamphetamine saccharate/amphetamine asparate/dextroamphetamine sulfate/amphetamine tablets. The recalls come as a result of GMP deviations.

The quality of Indian generics has been high on the FDA’s agenda lately. FDA Commissioner Margaret Hamburg, on a visit to India, signed an agreement with India’s Ministry of Health designed to forge ties between the two countries and enable sharing of data from inspections of clinical sites, laboratories and manufacturing plants. FDA has also created an Office of Pharmaceutical Quality, in response to quality concerns. The office will oversee quality throughout the lifecycle of a pharmaceutical product [1].

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA increases oversight of drug safety in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 21]. Available from: www.gabionline.net/Generics/General/FDA-increases-oversight-of-drug-safety-in-India

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Source: FDA