CDSCO Releases SOPs for Transferring Drugs from SEZs to Domestic Markets

Standard Operating Procedures (SOP) have been framed by the CDSCO for drugs manufactured in Special Economic Zones for transfer to the domestic market for sale and distribution. These drugs, being exempt from import registrations, have now been provided with a specific governing protocol.

In accordance with a circular issued by the DCGI's office, all port, zonal, and sub-zonal offices are instructed to clear such drugs for sale in India only after inspection of the documents submitted through the ICEGATE Portal. The records of Entry Bills have also been instructed to be maintained and submitted to the DCGI, as and when required.

As per the SOPs, both approved and unapproved new drugs manufactured in Special Economic Zones will be governed by the NDCT Rules of 2019 and the Drugs and Cosmetics Rules, 1945.

Formulations manufactured by using the APIs, which are imported into Special Economic Zones, are allowed to be diverted to the Domestic Tariff Area only after obtaining a registration certificate along with the import license.

However, the transfer of any banned drugs produced in Special Economic Zones shall not, under any circumstance, be allowed to move into the Domestic Tariff Area.

The apex drug regulator issued a circular stated, "SEZ units are exempted from the mandatory registrations required for importing a drug into the country, subject to the condition that these drugs shall not be diverted for sale within the country and must be used solely for export purposes".

Also it added, "Such imported drugs may be permitted for sale and distribution in the domestic area if they meet the requirements of the standard procedure for import and registration, as specified under Chapter II of the Drugs and Cosmetics Act and Rules".