The Central Drug Standard Control Organisation (CDSCO) has issued new directives mandating import registration and licensing for drugs being transferred from Special Economic Zones (SEZs) into the Domestic Tariff Area (DTA), marking a significant regulatory update to prevent the sale of illegal or unapproved medicines in the country.
Previous Exemptions No Longer Apply
Currently, SEZ units are exempt from import registration requirements if their drugs are intended solely for export. However, the CDSCO circular dated April 8 introduces new checks for drugs manufactured in SEZs that are later proposed to be sold within India.
Mandatory Licensing for APIs and Formulations
As per the new rules, any Active Pharmaceutical Ingredients (APIs) imported into SEZs and used to manufacture formulations intended for sale in the DTA must now be accompanied by a valid registration certificate and import licence issued by the regulator.
Additionally, the CDSCO mandates that both approved and unapproved new drugs manufactured in SEZs must comply with the standards laid out under the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Drugs and Cosmetics Rules, 1945.
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Ban on Transferring Certain Drugs
The circular also strictly prohibits transferring any drugs that are banned in India from SEZs into the domestic market, even if they were originally manufactured for export purposes.
To enforce compliance, CDSCO has directed its port, zonal, and sub-zonal offices to review documents submitted on the ICEGATE portal related to drug consignments meant for Indian markets. Regulatory officials must also maintain a detailed record of bills of entry and communicate them to the Drug Controller General of India (DCGI) when requested.
These measures are intended to ensure that only drugs that meet established standards of quality, safety, and efficacy enter the Indian domestic market, bolstering public health safeguards.
