NEW DELHI: The commerce and industry ministry on Monday strongly defended the domestic pharma industry, blaming 'vested interests' for questioning the quality of Indian drugs and maligning the country that has emerged as source of quality low-cost drugs. Concerns about the quality of Indian drugs have been raised after the US drugs regulator took stiff action against two of India's leading generics companies —Ranbaxy LaboratoriesBSE 2.51 % and Wockhardt.
"There are reasons to believe that vested interests are raking up isolated issue on reports regarding technical deficiencies on manufacturing and good manufacturing practices," the commerce and industry ministry said in a statement on Monday citing the hundreds of approvals for Indian drugs by foreign regulators. Ranbaxy Labs had last month pleaded guilty and paid a fine of $500 million to the US authorities to settle criminal and civil charges against it. It admitted that the company had falsified data and deviated from good manufacturing practices prescribed by the US Food and Drug Administration.
US FDA has also banned WockhardtBSE 2.89 % from exporting products from its Aurangabad factory to the US citing concerns over the quality of drugs manufactured at the plant.
The two instances had received wide attention in international media, some questioning quality of drugs coming out of the country. The commerce ministry said USFDA's penalty on Indian companies is an aberration rather than the norm, as the country had proven international quality standard capabilities. The ministry said the instance of spurious drugs found in the international markets and blamed on India were work of others. "Government has strong reason to believe that some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries getting affected by the strength of the Indian pharma industry," it said in a statement.
There are over 550 manufacturing sites registered with US FDA out of which 323 sites are approved by USFDA as on March 31, 2013. There are more than 350 manufacturing sites endorsed by EU for their GMP in India as on April 30, 2013, the ministry said. "Companies and importers from all over the globe are encouraged to visit the manufacturing facilities in India to satisfy themselves of the quality of production of drugs," the statement said.
Government and the industry are already working on a 'trace-and-track' mechanism which would make it easy to monitor each drug throughout the supply chain.