PUBLIC NOTICE NO. 173/2008, DT. 13/04/2009
- Document type
- Circular
- Reference no.
- L
- Dated
- Category
- Public Notices w.e.f 01/04/2008
Export of Drugs & Pharmaceuticals covered under the provisions of Drugs & Cosmetics Act 1940
PUBLIC NOTICE NO. 173/2008, DT. 13/04/2009
Export of Drugs & Pharmaceuticals covered under the provisions of Drugs & Cosmetics Act 1940
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
And Ex-Officio Additional Secretary to the Govt. of India