By :- Team VOH
7 May 2024
The national drug regulator has revoked the authority previously granted to State and Union Territory (UT) Licensing Authorities for issuing No Objection Certificates (NOCs) for the manufacture of unapproved, banned, or new drugs intended solely for export purposes. Effective May 15, the industry is instructed to submit fresh applications online to the central authority for obtaining NOCs.
Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India), has issued a notice directing all manufacturers to obtain NOCs from the respective zonal offices of the Central Drugs Standard Control Organisation (CDSCO) via the Sugam Portal starting May 15. This NOC must be secured before obtaining a manufacturing license from the State Licensing Authorities (SLAs) for the production of unapproved, banned, or new drugs meant for export.
This decision aligns with a directive from the Union Health Ministry to the DCGI on June 21, 2023, instructing the facilitation of fresh online applications from mid-May this year.
Previously, as per the DCGI's notification on August 2, 2018, export NOCs and manufacturing licenses were granted by State Licensing Authorities (SLA) for the manufacture of unapproved, banned, or new drugs solely for export. However, this power has now been withdrawn from State/UT Licensing Authorities, effective May 15, 2024, with NOCs to be granted by the head of respective CDSCO Zonal Offices from the same date.
The Ministry has designated Joint Drugs Controller (India), Ranga Chandrashekar Rao, as the nodal officer and designated person at CDSCO headquarters for the issuance of NOCs.
This decision follows an earlier proposal from the national drug regulator, endorsed by the Ministry in a communication to the DCGI on June 21, 2023, which stated that the industry must be facilitated to file fresh applications for NOCs for the manufacture of unapproved, banned, or new drugs solely for export purposes starting May 15, 2024, through a designated person at CDSCO headquarters, with applications processed by CDSCO through their respective zonal offices.
Additionally, the Drugs Consultative Committee (DCC) has recommended the formation of a sub-committee to examine the feasibility of issuing one-time export NOCs and manufacturing licenses for certain categories of drugs, excluding banned drugs, solely for export purposes. The sub-committee will also evaluate industry requests for relaxation of NOC conditions regarding the destruction of excess quantities of unapproved drugs and approved new drugs intended for export.
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