CDSCO has created a procedure for companies to move medicines and active pharmaceutical ingredients (APIs) from special economic zones (SEZs) to domestic tariff areas (DTAs).
Materials imported into and manufactured in India’s SEZs are exempt from aspects of the Drugs and Cosmetics Act and Rules. The exemption applies because the materials cannot be diverted for sale in India. However, the law does permit the sale and distribution of the materials in the domestic area, provided they meet the standard requirements for import and registration.
CDSCO has created a process to streamline the transfer of drugs from a SEZ to a DTA. The process prohibits companies from transferring banned drugs made for export to a DTA. API, semi-finished and finished dosage forms in bulk packs that lack registration certificates or import licenses cannot be sent to a DTA. Transfers of other unapproved and approved drugs are possible, provided conditions are met.
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