DCGI amends rules, state drug controllers can now issue NOCs for drug exports

Earlier any such order had to go through the scrutiny by the Central Drugs Standard Control Organization which now has been abolished to grant a sort of independent powers to state drug controllers

0
50
Download PDF

New Delhi: The Drug Control General of India (DCGI) has discontinued the earlier practice in which the no objection certificates (NOCs) for the drugs meant for exports, issued by the state drug controllers, had to be vetted by the Central Drugs Standard Control Organisation (CDSCO).

This order will come into effect from August 20, 2018.

The fresh move by DCGI means that State drug controllers have now been given power to issue NOCs for the manufacture of unapproved, banned or new drugs that are solely meant for exports.

“In order to streamline the process and facilitate the ease of doing business, it has been decided that the process of grant of such NOCs by the CDSCO shall be discontinued and such NOCs shall be granted by the state licensing authorities themselves,” the DCGI stated in a communication sent to all states and Union Territory drug controllers on 2nd August.

The drug controller, however, laid down certain guidelines for grant of such licenses to ensure that these products are strictly utilised for the purpose of export.

In case of drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, the applicant will have to obtain NOC from the Narcotic Commissioner of India, according to the latest orders.