Measures to Prevent Export of Counterfeit Drugs- DGFT PN
THE DGFT has issued a Public Notice prescribing the procedures/guidelines to strengthen the enforcement mechanism available under the Drugs and Cosmetics Act, 1940, to ensure that counterfeit drugs do not get exported out of the country.
Every exporter of Drugs & Pharmaceuticals at the time of shipment shall submit, along with other required documents, the following:
(i) A copy of Certificate of Analysis issued by the manufacturer for the subject product; Or
(ii) A copy of Certificate of Analysis issued by approved laboratory of the importing country/FDA; Or
(iii) A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act 1940 and the rules made thereunder.
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.
This comes into force with immediate effect.
DGFT Public Notice No. 173 (RE-2008) /2004-2009, Dated: April 13, 2009