State drug controllers get power to issue NOCs for drugs meant for export

To promote ease of doing business, the DCGI has discontinued the earlier practice of such NoCs being granted by the Central Drugs Standard Control Organisation

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