CDSCO Issues Guidelines on Transfer of Drugs from SEZ to DTA

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has issued a detailed circular (IMP/141/2024) dated April 8, 2025. This circular addresses the critical issue of transferring drugs (Active Pharmaceutical Ingredients – APIs/Formulations) from Special Economic Zones (SEZ) to the Domestic Tariff Area (DTA).

Key Points of the Circular:

Compliance with Drugs and Cosmetics Act:

Drugs imported into India, including those transferred from SEZs to the domestic market, must have import registration and licenses as mandated by the Drugs and Cosmetics Act and Rules.

2. Exemption Conditions for SEZ Units:

SEZ units typically have exemption from specific provisions under Chapter III of the Act for drugs imported for manufacturing and export.
However, if these drugs are to be transferred to the DTA, they must adhere to the standard import and registration procedures under the Act.

3. Procedure for Drug Transfer from SEZ to DTA:

Banned Drugs: Drugs banned in India but manufactured in SEZs solely for export cannot be transferred to the DTA.
New Drugs: Both approved and unapproved new drugs produced in SEZs must comply with the New Drugs and Clinical Trials (NDCT) Rules 2019 and Drugs Rules 1945 for DTA transfers.
Other Drugs: Drugs not falling into the above categories must meet manufacturing requirements specified under Drugs Rules 1945.

4. Import of APIs:

APIs imported into SEZs for formulation manufacturing require valid Registration Certificates and Import Licenses if the formulations are subsequently diverted to DTA for sale and distribution.
API, semi-finished, or finished dosage forms imported without appropriate licenses are prohibited from sale or distribution in the DTA.

5. Clearance and Documentation:

Port officers must review and verify documents submitted through the ICEGATE portal before allowing the entry of SEZ-manufactured drugs into the domestic market.
Records of clearances must be maintained, and details should be periodically communicated to the Office of the Drugs Controller General of India (DCGI).

Compliance and Monitoring:

CDSCO’s port, zonal, and sub-zonal offices have been directed to strictly adhere to these guidelines.
The Ministry of Health and Family Welfare has been kept informed of these new guidelines.

Impact and Importance:

This directive ensures stringent quality, safety, and efficacy standards for drugs transferred from SEZs to India’s domestic market, protecting public health and strengthening regulatory oversight.

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Source: CDSCO

CDSCO CircularDownload

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