The Central Drugs Standard Control Organization (CDSCO) has released new guidelines for the transfer of drugs from Special Economic Zones (SEZ) to the Domestic Tariff Area (DTA). These guidelines aim to ensure that drugs meet quality, safety, and efficacy standards as per the Drugs and Cosmetics Act and Rules.
The Central Drugs Standard Control Organization (CDSCO) has issued a circular detailing the procedure for transferring drugs from Special Economic Zones (SEZ) to the Domestic Tariff Area (DTA).
The guidelines specify that banned drugs manufactured in SEZs for export cannot be transferred to the DTA.
For unapproved and approved new drugs, compliance with the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Drugs Rules, 1945, is mandatory.
Additionally, APIs imported to SEZs for formulation must have a Registration Certificate and Import License before being sold in the DTA.
These measures are intended to streamline the process and ensure that all drugs meet the required quality, safety, and efficacy standards.