DCGI permits import of drug with residual shelf life less than 60 pc

In view of the COVID-19 pandemic, the country's top drug controller has granted permission for the import of drugs with residual shelf life less than 60 per cent under special conditions. This will be effective for a period of three months or till further orders.

This, the drug regulator has permitted in accordance with the rules after taking undertaking form the importers by the port officers of Central Drug Standard Control Orgsation (CDSCO) that the drug will be utilised or consumed before the expiry date and no part of the drug will be available for sale and distribution after its expiry.

Issuing a circular to all port officers of CDCSO, the Drug Controller General of India (DCGI) Dr VG Som said: "In the light of present situation due to the spread of COVID-19 outbreak, the Health Ministry has instructed to take various steps in order to ensure availability of sufficient quantity of drugs in the domestic retails market, besides ensuring that the product conforms to be the prescribed specification. And, one of the steps includes issuing immediate approvals to applications for the registration, manufacture, and import of pharmaceuticals."

"Further, we have received representation from the industry association that there are challenges in clearance at port offices due to COVID-19 outbreaks and many products are losing shelf life and getting below the threshold of 60 per cent."

"It has, therefore, been requested for relaxing the requirement of minimum 60 per cent residual shelf life of all drugs including vaccine/biological products at the time of import temporarily, for period three months until normal supply resumes."

It is pertinent to note that as per the Rule-31 of Drugs and Cosmetic Rule, 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 drug having less than 60 per cent residual shelf life period an on the date of import.

However, in exceptional cases the licensing authority may, for reasons to be recorded in writing may allow, the import of any drug having a lesser shelf life period, but before the expiry, as declared on the container of the drug.

( With inputs from ANI )

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