Published on November 17, 2014

On 6th November, 2014 the Union Minister for Health & Family Welfare Dr. Harsh Vardhan had said that in order to make sure on the quality in production standards, the Union government has scheduled to set up a different Central Drug Controller for traditional medicines. Moreover, in the global traditional medicines market India has still not deciphered into market shares, although it has a huge experience and strengths in this sector. However

According to the sources, US Food and Drug Administration (USFDA) has send a warning letter to one of the major Gujarat based pharmaceutical company Cadila Pharmaceuticals for not meeting the terms with the Current Good Manufacturing Practice (CGMP) for production of Active Pharmaceuticals Ingredients (APIs) at its Ankleshwar, Gujarat facility.

According to the FDA, the entity has several manufacturing dilemmas and has specified the presence of more than permissible number of impurities on manifold occasions, which had not been satisfactorily investigated.

On the other hand the USFDA has approved for making generic version of Roche Holding AG's antiviral Valcyte to one of the Hyderabad based major pharmaceutical company Dr Reddy's Laboratories Ltd. and apart from Indian Pharma firms,  Endo International Plc which a US drug regulator, has also been granted approval.

Whereas, due to quality control issues at the manufacturing plants of Ranbaxy which is an Indian multinational pharmaceutical company and was one of the first company to receive tentative approvals to launch generic versions of the two drugs, USFDA has revoked six months inimitability for generic version of Valcyte. However one of its manufacturing sites of Ranbaxy which is based in US has not been banned, while the remaining facilities has been banned from supplying drugs to the US by USFDA owing to quality issues.