Last Updated on April 20, 2025 by The Health Master
CDSCO
New Delhi: In a significant move aimed at simplifying the process for making pharmaceuticals manufactured in Special Economic Zones (SEZs) available to the Indian domestic market, the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulatory body, has unveiled new Standard Operating Procedures (SOPs).
These guidelines address the transfer of drugs manufactured in SEZs – which are exempt from standard import registration requirements—for sale and distribution within India.
Easing the Path to Domestic Markets
According to a previous circular from the CDSCO, SEZ units enjoyed exemption from the mandatory registrations needed for importing drugs, this was contingent on the condition that these drugs were strictly intended for export and not for domestic sale.
This new circular from CDSCO comes with a pathway for these imported drugs to enter the Indian market, with the condition that they adhere to the established procedures for import and registration as detailed in Chapter II of the Drugs and Cosmetics Act and Rules.
Detailed Procedures for Domestic Clearance
The circular, issued by the office of the Drugs Controller General of India (DCGI), lays down a clear set of procedures that all port, zonal, and sub-zonal offices of the drug regulatory authority are now mandated to follow.
These above-said offices will review the documents submitted through the ICEGATE portal for the clearance of drugs for sale within India.
Furthermore, the SOPs highlight the importance of data management.
Officials are also instructed to maintain detailed records of all invoices of entry related to these drug transfers.
They must also ensure that the detailed information from these invoices is informed to the DCGI as and when required, facilitating effective monitoring.
Compliance with Stringent Regulatory Standards
The newly notified SOPs clearly state that for both unapproved and already approved new drugs that are manufactured within SEZs and intended for domestic sale, the respective manufacturers must fully comply with the stringent requirements laid down under the New Drugs and Clinical Trials (NDCT) Rules, 2019, as well as the Drugs and Cosmetics Rules, 1945.
Mandatory Requirements for APIs
The guidelines also have the details for the specific case of Active Pharmaceutical Ingredients (APIs) that are imported into SEZs for the purpose of manufacturing drug formulations.
If these formulations are subsequently proposed to be diverted to the Domestic Tariff Area (DTA) for sale and distribution within India, it is now mandatory for manufacturers to possess both a registration certificate and a valid import license issued by the drug regulator.
This measure aims to maintain strict control over the quality and source of the raw materials used in domestically sold medications.
Absolute Prohibition on Banned Drugs
Importantly, the new guidelines explicitly and unequivocally state that any drugs manufactured in SEZs that are classified as banned for sale within India are strictly prohibited from being transferred to the DTA under any circumstances.
This reinforces the commitment to safeguarding public health by preventing the entry of prohibited substances into the domestic supply chain.
Q. What is the significance of these new SOPs?
A. These SOPs streamline the process for drugs manufactured in SEZs to be sold in the Indian domestic market, provided they meet the necessary regulatory standards. This can potentially increase the availability of certain medications within the country.
Q. Do SEZ units still need import registration?
A. SEZ units are still exempt from mandatory import registrations as long as the manufactured drugs are solely for export purposes. However, if they intend to sell these drugs domestically, they must adhere to the standard import and registration procedures.
Q. What documents are required for domestic clearance of SEZ drugs?
A. The guidelines require a review of documents submitted on the ICEGATE portal. Specific documentation details will likely be outlined in further communications from the CDSCO.
Q. Are there specific rules for new drugs manufactured in SEZs?
A. Yes, both approved and unapproved new drugs manufactured in SEZs must comply with the requirements specified under the NDCT Rules, 2019, and the Drugs and Cosmetics Rules, 1945, before they can be sold domestically.
Q. What about APIs imported into SEZs?
A. If formulations manufactured using APIs imported into SEZs are to be sold domestically, the manufacturer needs to have a registration certificate and an import license from the CDSCO.
Q. Can banned drugs manufactured in SEZs be sold in India?
A. No, the guidelines explicitly state that banned drugs manufactured in SEZs for export are not permitted to be transferred to the DTA for any reason.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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