Saturday, February 15, 2014
FDA Raises Safety Concern on Drugs Made in India
FDA wants to keep the quality imported drugs from country like India in check, they will establish an Office of Pharmaceutical Quality that will enhance their inspection of brand-name, generic and over-the-counter drugs.
This was announced by FDA’s Center for Drug Evaluation and Research director Janet Woodcock at the Bloomberg Health care summit on Friday.
India is one of the major players in drugs, their drugs export to the US market is one of the largest. Many local pharmaceutical plants in India have been inspected by the FDA to make sure that they are following the guidelines and quality of the drugs they export.
FDA has been calling the attention of manufacturing plants in India regarding good manufacturing practices not being followed that includes Ranbaxy Laboratories and Wockhardt.
Japanese pharmaceutical Daiichi Sankyo took over Ranbaxy Laboratories but the quality and condition has not improved FDA has ban three facilities over the few years, and added another one this year.
One facility of Wockhardt Limited was banned by the FDA from selling their products in the US.
However, drug regulators in India do not see any reason to ban these companies they say that they are following good manufacturing practices. The do not agree with the FDAs reason.