In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2004-2009, as amended from time to time, it has been decided to notify, 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. Export of Drugs & Pharmaceuticals covered under the provisions of Drugs & Cosmetics Act 1940 and the rules made thereunder, which is being regulated by Drugs Controller General of India (DCGI) in the Ministry of Health & Family Welfare, shall be as per the requirements given hereunder:

Every exporter of Drugs & Pharmaceuticals at the time of shipment shall submit, alongwith 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.

3. This issues in Public Interest.
 

(R.S. GUJRAL)
DIRECOR GENERAL OF FOREIGN TRADE

(Issued from F.No.01/91/180/648/AM09/Export Cell)

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