The Union commerce ministry has asked the pharma exporters to comply with more stringent quality guidelines to ensure that no counterfeit drugs are exported from the country. India has been facing unfair criticism in this regard from the European nations for some time.
As per the new notification issued by the directorate general of foreign trade (DGFT),every exporter of drugs and pharmaceuticals at the time of shipment shall submit, along with other required documents, a copy of Certificate of Analysis issued by the manufacturer for the subject product; or a copy of Certificate of Analysis issued by approved laboratory of the importing country/US FDA: or a copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs and Cosmetics Act, 1940 and the rules made thereunder.
Besides, the ministry has said that wherever required the officials of the Drug Control Department posted at the port offices shall retain a sample of the subject consignment for the purpose of reference and tracking of the manufacturer/exporter of the subject product.
The government's new initiative comes in the wake of widespread criticism by the foreign countries, especially from Europe, that India is a major source of counterfeit drugs. More recently, the United States had raised the issue by expressing concern on the 'weak intellectual property rights protection and enforcement' in India.
The manufacture and distribution of counterfeit pharmaceuticals is a growing problem that poses special concerns for consumer health and safety. The United States notes its concern with the proliferation of the manufacture of counterfeit pharmaceuticals in Brazil, China, India, Indonesia, and Russia, and the sale and distribution of counterfeit pharmaceuticals in many countries. A significant contributing factor in this problem is the unauthorized use of active pharmaceutical ingredients (APIs) to manufacture counterfeit pharmaceuticals, a US report had said.
In this background, the Indian government wanted to take some measures to check the export of counterfeit drugs from the country. The government thinks that by strengthening the enforcement mechanism it will, to an extend, be able to ensure that counterfeit drugs do not get exported out of the country.