GOVERNMENT OF INDIA
MINISTRY OF COMMERCE AND INDUSTRY
DEPARTMENT OF COMMERCE
DIRECTORATE GENERAL OF FOREIGN TRADE
PUBLIC NOTICE NO. 173 (RE-2008) /2004-2009
NEW DELHI, DATED THE 13TH APRIL, 2009
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.
- 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:
- 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 / FDA; Or
- 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 issues in Public Interest.
(R.S. GUJRAL)
DIRECOR GENERAL OF FOREIGN TRADE
And Ex-Officio Additional Secretary to the Govt. of India
(Issued from F.No.01/91/180/648/AM09/Export Cell)