Certificate of Analysis Must for Drug Exports

The following Public Notice was issued by the Commissioner of Customs (Export) Air Cargo Complex, Mumbai on 3rd September 2009

[Customs Public Notice No. 26 dated 3rd September 2009]

Subject: Procedure to strengthen the enforcement mechanism under Drugs and Cosmetics Act, 1940.

F.No. S/6-Misc-581/08 Exp. Shed./ACC

Attention of all Exporters, CHAs and members of the Trade is invited to the DGFT Public Notice No. 173 (RE-2008)/2004-2009 dated 13.04.2009.  By the said Public Notice, the Ministry of Commerce and Industry has notified the procedure / guidelines to strengthen the enforcement mechanism available under Drugs and Cosmetics Act, 1940 to ensure that counterfeit drugs do not get exported out of the Country.

Every exporter at the time of shipment of Drugs and Pharmaceuticals shall submit to the Customs officers at export shed along with other required document, the following:

1.   A copy of Certificate of Analysis issued by the manufacturer for the subject product; OR

2.   A copy of Certificate of Analysis issued by approved laboratory of the importing country / FDA; OR

3.   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 Drugs Control Department posted at the port office (ACC) shall retain a sample of the subject consignment for the purpose of reference and tracking of the manufacturer / exporter of the subject product.