The U.S. Food and Drug Administration has recently banned import of drugs from Sun Pharma ‘s Karkhadi facility in Gujarat for violation of manufacturing norms. The U.S. had also raised concerns over issuance of a compulsory license (CL) by India to Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar. Indian authorities have expressed their concern over the USFDA’s audit inspections of Indian pharmaceutical companies and the disproportionate penalties imposed in some instances. The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the U.S., their largest export market. The U.S. health regulator on January 23 banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company’s fourth plant to face regulatory action from the USFDA, after Mohali, Paonta Sahib and Dewas plants. Another Indian firm, Wockhardt , had its two plants put under import alert by the USFDA.
According to sources, such steps by the USFDA would fect India’s pharma exports to the U.S. India’s pharma exports increased 10 percent to USD 14.6 billion during 2012-13, with shipments to the U.S. accounting for about 26 percent of the total. India is the largest exporter of generics to the US by volume, with supplies from 35 companies in the country. The nation has around 320 USFDA- approved pharma facilities, the largest number outside the U.S. (PTI)