1-Year Ban for Fake Docs, Mandatory Disposal of Near-Expiry Stock: CDSCO Revises Pharma Export Rules
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a revised guidance document detailing the procedure for the issuance of No Objection Certificates (NOCs) for the manufacture of unapproved and approved new drugs exclusively for export purposes. The document introduces stricter compliance requirements, including a one-year ban on applicants submitting falsified documents and mandatory destruction of drug consignments that fall below specified shelf-life thresholds.
As per the document, “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.” This clause appears in the legal undertakings annexed to the guidance and applies to both API and formulation manufacturers.
Additionally, the document mandates destruction of expired or near-expiry stock under official supervision. Specifically, it states, “In case of formulation, allowance of usage of un-exported quantity for next export order within 60% residual shelf life. If the shelf life is below 60%, the same shall be destructed in the presence of the State Licensing Authority.” Similarly, for active pharmaceutical ingredients (APIs), “allowance of usage of un-exported quantity for next export order within 3 months of residual shelf life. If the shelf life is below 3 months, the same shall be destructed in the presence of the State Licensing Authority.”
The revised guidelines apply to manufacturers holding valid licenses in Form 25, Form 28, or Form 28D, including their respective loan licenses. “A manufacturer holding a valid license copy in Form -25/ Form-28/ Form 28 D and their respective loan licenses can obtain a No Objection Certificate from Zonal offices of the Central Drugs Standard Control Organisation (CDSCO) for export purpose only for Unapproved / approved new drugs in India.”
The application process for obtaining an Export NOC has been streamlined into two steps. “The requirement of online submission of Application for issuance of a No Objection Certificate for manufacture for export of unapproved / approved new drugs involves 2 steps i.e. Registration at zonal office followed by procedure for release of consignments at port.” The first step requires a one-time online registration with the zonal office through an Integrated Registration Form (IRF), which is to be verified by the concerned office. “NOC may be issued with 1 year validity for the applied products within 7 working days from the date of Application.”
Once the NOC is granted, the applicant must proceed to Step II, which covers the clearance of consignments at the port office. “Thereafter, the applicant needs to fill out the reconciliation details in the prescribed format, along with the requisite documents, and obtain clearance for the consignments from the concerned port office for its release in Step -II.” The reconciliation module will remain open for the validity period of the NOC to facilitate multiple releases of consignments under the same certificate.
The guidance document also notes that “Qty specific/PO Specific NOC is being discontinued except for NDPS and banned drugs.” This means that except for narcotic drugs and psychotropic substances or banned products, applicants will not need to seek NOCs tied to specific purchase orders or quantities.
Furthermore, the validity of the NOC is set at one year or until the exhaustion of the sanctioned amount, whichever is earlier. “Issuance of Export NOC with 1-year validity from date of Registration or exhaustion of the sanctioned amount, whichever is earlier.”
The guidance includes detailed instructions regarding required documents, including the need for an online IRF, a legal undertaking, manufacturing license copies, reconciliation data, and National Regulatory Authority (NRA) approval status from the importing country. In cases where NRA approval is unavailable, the guidance outlines alternative documentation paths based on whether the product is an API or formulation, approved or unapproved in India, or falls under R&D or NCE category.
The guidance also specifies that for NDPS and banned drugs, the earlier requirement of a quantity-specific and PO-specific NOC will remain. “For the issuance of an Export NOC for NDPS drugs and banned drugs, a quantity-specific and PO-specific NOC will be issued for each order/Consignment.”
