State drug controllers have been given complete jurisdiction to issue no objection certificates (NOCs) for the manufacture of unapproved, banned or new drugs that are solely meant for exports.
The Drug Control General of India (DCGI) has discontinued the earlier practice wherein the grant of such NoCs was being overseen by the Central Drugs Standard Control Organisation (CDSCO). This order will come into effect from August 20, 2018.
The Pharmaceutical Export Promotion Council of India (Pharmexcil) had recently approached the drug regulator seeking a waiver on bioequivalence (BE) studies for granting a license to the oral dosage form of drugs specified under BCS category 2 and 4 for the purpose of export.
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Drug controllers in some states were insisting on submission of results of BE studies endorsed by the CDSO for grant of the license to manufacture such drugs for export purpose and this had been causing difficulties to exporters, according to Pharmexcil.
"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 August 2.
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.