Central Drugs Standard Control Organisation (CDSCO) has laid down a clarified procedure for transferring drugs (both APIs and formulations) from Special Economic Zones (SEZs) to the Domestic Tariff Area (DTA). While SEZ units are exempted from import registration and licensing requirements under Chapter III of the Drugs and Cosmetics Act for manufacturing and export, any transfer to the domestic market must comply with standard import norms.

Key decisions include:

• Banned drugs manufactured in SEZs cannot be transferred to DTA.
• Approved and unapproved new drugs from SEZs must follow the manufacturing norms under the NDCT Rules, 2019 and Drugs Rules, 1945.
• All other drugs from SEZs must comply with manufacturing requirements under the Drugs Rules, 1945.
• If an API is imported to SEZ and its formulation is intended for sale in DTA, both Registration Certificate and Import License are mandatory.
• APIs or dosage forms imported without required registrations and licenses are barred from DTA sale.

Port officers must verify relevant documents through the ICEGATE portal and maintain bill of entry records for reporting to the Drug Controller General of India (DCGI) as needed.