Last Updated on September 30, 2024 by The Health Master
Export
In a significant shift for export of Indian pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) will now be the sole authority for issuing No Objection Certificates (NOCs) for the manufacture of unapproved, banned, or new drugs solely for export purposes.
This change, effective May 15, 2024, streamlines the application process and centralizes control under the CDSCO.
Previously Decentralized System
Prior to May 15, 2024, State and Union Territory (UT) Licensing Authorities held the power to grant these NOCs.
This meant manufacturers needed to navigate a decentralized system, potentially leading to inconsistencies and delays.
Centralized Online Applications via Sugam Portal
The new system offers a more efficient approach. Starting May 15th, manufacturers must obtain their NOCs through the online Sugam Portal from the respective zonal offices of the CDSCO.
This online application process removes geographical limitations and ensures a standardized approach.
Key Points for Manufacturers:
- Effective Date: May 15, 2024
- Application Platform: Sugam Portal
- Issuing Authority: CDSCO Zonal Offices
- Hand-over of Existing NOCs: All NOCs issued between August 20, 2018, and May 14, 2024, by State/UT authorities will be transferred to the relevant CDSCO Zonal Offices.
Industry Request for One-Time NOC and Manufacturing License
The decision follows industry requests for a simplified process involving a one-time export NOC and manufacturing license.
This request also included the issuance of a Certificate of Pharmaceutical Product (CoPP) for exports of unapproved/banned/new drugs.
DCC Recommendation
The Drugs Consultative Committee (DCC) acknowledged industry concerns and recommended the formation of a sub-committee.
This sub-committee will specifically explore the pros and cons of a one-time export NOC and manufacturing license system for unapproved new drugs.
Focus on Approved, Unapproved New Drugs, Not Banned Drugs
The DCC clarified that their discussions focused on granting one-time export NOCs for approved and unapproved new drugs, excluding banned drugs.
Relaxation of NOC Conditions for Destroyed Drugs?
The DCC will also examine the industry’s request for relaxed NOC conditions regarding the destruction of excess quantities of unapproved drugs and approved new drugs intended for export.
This request aims to address potential economic losses for manufacturers and the country.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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