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 The Central Drugs Standard Control Organisation (CDSCO) has revised the procedure to issue export No Objection Certificate (NOC) to manufacture unapproved and approved new drugs solely for the purpose of exports, with changes including discontinuation of quantity specific and purchase order specific NOCs except for Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs.
The regulator has issued a revised guidance document for issuance of NOC for manufacture of unapproved and new drugs, a process which was centralised last year.
According to the revised guidance document, the export NOC will have one year validity from the date of registration or exhaustion of the sanctioned amount, whichever is earlier.
In case of formulation, allowance of usage of un-exported quantity for next export order within 60 percent residual shelf life. If the shelf life is below 60 per cent, the same shall be destroyed in the presence of the State Licensing Authority (SLA).
In case of active pharmaceutical ingredients (APIs), allowance of usage of un-exported quantity for next export order is within three months of residual shelf life. If the shelf life is below three months, the same shall be destroyed in the presence of the (SLA).
The guidance document also fixes the timeline for issuance of the NOC, which is streamlined as a two-step procedure, as seven days. For the issuance of export NOC for NDPS drugs and banned drugs, a quantity-specific and purchase order-specific NOC will be issued for each order or consignment.
The first step of the two-step procedure is registration by the company at zonal office, including one-time online registration, submission of export NOC or the Integrated Registration Form, legal undertakings, submission of copy of manufacturing license, reconciliation data, NRA approval status of importing country with separate set of documents for APIs, finished formulations, and R&D and new chemical entity batches.
The second step includes the procedure for release of consignment at the port office, including submission of documents online.
The legal undertakings for APIs and formulations to be submitted by the companies also undergo subsequent changes.
The legal undertaking for APIs has additional points such as an undertaking that in the event of submission of falsified document, the previously issued NOC shall be cancelled and will be barred from reapplying export NOC for a period of one year for any product; an undertaking that the company will submit label as per Rule 94 of Drugs and Cosmetic Act, 1940; and the inclusion of timeline for physical destruction of stocks (of stocks with shelf life less than three months).
The legal undertaking for finished formulations has additional points such as an undertaking that in the event of submission of falsified document, the previously issued NOC shall be cancelled and will be barred from reapplying export NOC for a period of one year for any product; an undertaking that the company will submit label as per Rule 94 of Drugs and Cosmetic Act, 1940; and the inclusion of timeline for physical destruction of stocks (of stocks with shelf life less than 60 per cent).
It may be noted that the CDSCO has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs in July, last year, after the process was centralised.
On April 30, 2024, the CDSCO said that the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates for manufacture of unapproved, banned or new drugs solely for export purpose will be withdrawn from May 15, 2024.
The Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi issued a notice on the day, asking all manufacturers to obtain NOC from respective zonal offices of the Central Drugs Standard Control Organisation through online mode, using Sugam Portal, from May, 15. The NOC should be obtained before getting a manufacturing license from the State Licensing Authorities for manufacture of unapproved, banned, or new drugs for export purposes.
"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," said the DCGI in a communication to all SLAs in April, 2024.
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, 2024, on online mode.
Till then, as per the DCGI's notification on August 2, 2018, export NOC and manufacturing license was granted by State Licensing Authority for manufacture of unapproved/banned/new drugs solely for export purpose.
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 the respective zonal offices."
It may also be noted that the Drugs Consultative Committee (DCC), in a meeting held in 2024, recommended constitution of a sub-committee to examine the pros and cons involved in grant of one-time export NOC and manufacturing license for unapproved, new drugs solely for the purpose of exports.
The decision followed 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 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.
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