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CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

The Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi has issued a notice asking all manufacturers to obtain NOC from respective zonal offices of the Central Drugs Standard Control Organisation (CDSCO) through online mode, using Sugam Portal, with effect from May 15. The NOC should be obtained before getting a manufacturing license from the State Licensing Authorities (SLAs) for manufacture of unapproved, banned, or new drugs for export purposes.

The decision is in line with an instruction from the Union Health Ministry to the DCGI, on June 21, 2023, that the industry must be facilitated to file fresh applications from the middle of May, this year, on online mode.

So far, as per the DCGI’s notification on August 2, 2018, export NOC and manufacturing license are granted by State Licensing Authority (SLA) for manufacture of unapproved/banned/new drugs solely for export purpose.

“Accordingly, power delegated to State/UT Licensing Authority stands withdrawn with effect from May 15, 2024 and such NOC’s shall be granted by the head of respective CDSCO Zonal Office with effect from May 15, 2024,” said the DCGI in a communication to all SLAs.

“Further, all State/UT Drugs Controllers are required to handover all NOCs issued from August 20, 2018 to May 14, 2024 to respective Zonal Offices of CDSCO,” he added.

Joint Drugs Controller (India), Ranga Chandrashekar Rao will be the nodal officer and designated person at CDSCO headquarters for the issuance of NOC, said the DCGI.

The Ministry decided to withdraw the powers and handover the powers to the CDSCO, based on an earlier proposal from the national drug regulator.

Based on the proposal, the Ministry in a communication to the DCGI on June 21, 2023, said, “matter has been examined by this ministry and it is to inform you that industry must be facilitated to file fresh applications for NOC for manufacture of unapproved, banned or new drugs solely for export purpose from May 15, 2024 at a single designated person only on online mode to a point of contact at CDSCO headquarters and the applications can be disposed by CDSCO through their respective zonal offices.”

The Drugs Consultative Committee (DCC), in its latest meeting held earlier this year, has recommended constitution of a sub-committee to examine the pros and cons involved in grant of one-time export No Objection Certificate (NOC) and manufacturing license for unapproved, new drugs solely for the purpose of exports.

The decision is followed by the industry request to grant a one-time export NOC and manufacturing license followed by Certificate of Pharmaceutical Product (CoPP) for pharmaceutical and biological products under unapproved or banned or new drugs category, only for exports.

“The Committee deliberated the matter and discussed that grant of such one-time export NOC may be considered for certain categories of drugs like approved/unapproved new drugs, and not for the banned drugs,” said the DCC after its 63rd meeting held in January, this year.

The DCC also recommended the sub-committee to examine the industry’s request for relaxation of NOC conditions on destruction of excess quantities of unapproved drugs and approved new drugs for exports, since it leads to economic loss to the industry and the country.