Public Notice No- 60/2010 dated 30.06.2011
Procedure relating to export of pharmaceuticals and drugs
In exercise of the powers conferred under Paragraph 2.4 of the
Foreign Trade Policy, 2004-2009, as amended from time to time, Director General
of Foreign Trade, notifies with immediate effect, 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.
2. Procedure for export of Drugs & Pharmaceuticals, covered under the provisions
of Drugs & Cosmetics Act, 1940 and the rules made there under, shall be as given
below:
3. 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 there under.
4. Wherever required the officials of the Drug Control Department posted at the
port offices may retain a sample of the subject consignment for the purpose of
reference and tracking of the manufacturer / exporter of the subject product.
(Anup K.Pujari)
Director General of Foreign Trade
(Issued from F.No 01/91/180/648/AM 09/ Export Cell)