India To Flag Market Access Of Drugs And Spices With U.S.

By siliconindia | Monday, 10 February 2014, 12:55 Hrs

India-U.S. cooperation has been wide-ranging, from sharing information on the conduct of clinical trials to jointly addressing product safety issues that have an impact on consumers in the two countries.

Hamburg's visit is taking place at a time when India-based drug companies are coming under stringent U.S. regulatory scrutiny on "good manufacturing practices". Last month, the FDA inspected Ranbaxy's active pharmaceutical ingredient (API) manufacturing facility at Toansa, Punjab, and decided to bar the plant from supplying to the US.

Earlier three other Indian factories of Ranbaxy, at Mohali, Paonta Sahib and Dewas, were stopped from supplying to the U.S.

Also, other Indian companies like Wockhardt, RPG Life Sciences and Agila Specialities have come under the FDA lens.

Drug Controller General of India G.N. Singh says that every country has different measures and "we cannot judge Ranbaxy by standards set up by the American drug regulator".

Health Minister Ghulam Nabi Azad has said India is a victim of cartelisation by developed nations which "lay down such strict parameters to bar manufacturers from developing countries from global competition."

Source: PTI