The import of such drugs may be permitted after taking an undertaking from the importers by the port officers of CDSCO that the drug will be utilised or consumed before the expiry date and no part of it will be available for sale and distribution after its expiry
The Central Drugs Standard Control Organisation (CDSCO) has allowed import of drugs with less than 60 per cent residual shelf life on the condition that importers give an undertaking that the drug would be utilised or consumed before the expiry date.
According to rules, the import of such drugs may be permitted after taking an undertaking from the importers by the port officers of CDSCO that the drug will be utilised or consumed before the expiry date and no part of it will be available for sale and distribution after its expiry, informed a circular issued to all port offices of CDSCO.
“In the light of the present situation due to the COVID-19 outbreak, the health ministry has instructed to take various steps in order to ensure availability of a sufficient quantity of drugs in the domestic retail market, besides ensuring that the product conforms to be of the prescribed specification. One of the steps is issuing immediate approvals to applications for registration, manufacture and import of pharma,” said the Drug Controller General of India (DCGI).
“Further, we have received a representation from the industry association that there are challenges in the clearance at port offices due to the COVID-19 outbreak and many products are losing their shelf life and getting below the threshold of 60 per cent,” he added in the circular.
Therefore, it has been requested to relax the requirement of minimum 60 per cent residual shelf life of all drugs, including vaccines and biological products, at the time of import for a period of three months until normal supply resumes, the circular added.
According to rule 31 of the Drugs and Cosmetics Rules, 1945, “No drug shall be imported unless it complies with the standard of strength, quality and purity,” provided that the licensing authority shall not allow the import of a drug with a less than 60 per cent residual shelf life as on the date of import.
However, in exceptional cases, the licensing authority may, for reasons to be recorded in writing, allow the import of any drug with a lesser shelf life, but before its expiry.