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 The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for issuance of No Objection Certificate (NOC) for manufacture of unapproved or approved new drugs for export purpose to bring in a couple of changes including in the document required for export NOC for unapproved fixed dose combinations (FDCs) in India under the finished formulation category.
The revision has been announced on the guidance document the drug regulator has issued in May, this year, mandating that the export NOC for manufacture of unapproved or approved new drugs for export purpose may be obtained from the zonal offices of the CDSCO through a two-step process.
The revised guidance document clarifies that for export NOC for the unapproved formulation including FDC in India need to submit the approval status in Stringent Regulatory Authority (SRA) country (United States, European Union Member States, Canada, Japan, Australia, or Switzerland) or the importing country.
In the previous document, the CDSCO has stipulated that for the unapproved FDCs in India, unapproved NDPS drugs and banned drugs in the country, an approval from the National Regulatory Authority (NRA) of the importing country is mandatory.
Interestingly, the clause for such a document was included in the guidance document as an alternative in case NRA approval of the importing country is not available. With the revised guideline, the manufacturer or the exporter of a finished formulation of FDC can submit the approval of SRA country instead of the NRA approval, if the latter is not available.
Similarly, the CDSCO added that the New Chemical Entity (NCE) batches of other research activities can also submit the International Union of Pure and Applied Chemistry (IUPAC) name details, Coenzyme A (CoA) and Standard Temperature and Pressure (STP), in case if the NRA approval of the importing country is not available.
While in the previous document, the option was provided to NCE batches for clinical trials and Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDA), it was not elaborate on providing the same option to other NCE research activities.
The CDSCO has released the guidance document in May, this year, putting a timeline for approval and a duration of validity for the NOC. It stipulated that the export NOC will have one year validity from the date of registration or exhaustion of the sanctioned amount, whichever is earlier.
The guidance document also fixed 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.
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).
It may be noted that the drug regulator has centralised the process of issuance of export NOC for manufacture of unapproved and new drugs last year.
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