Import of drugs with residual shelf life: Deadline extended: DCGI

This is in continuation to the circulars issued on April 17, 2020, July 10, 2020, December 18, 2020 and April 13, 2021

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DCGI CDSCO

Last Updated on September 17, 2021 by The Health Master

In a bid to ensure continuity in the supply and availability of medicines amid looming threat of third wave of C-19, the Drugs Controller General of India (DCGI) has extended the deadline till April 30, 2022 for allowing import of drugs with residual shelf life less than 60 per cent.

The C-19 pandemic has created extreme challenges for the supply chain causing delay in delivery of imported drugs and healthcare products. Drugs are losing their shelf life due to delay in clearances at port offices in the wake of C-19 pandemic.

Taking serious note of this, the CDSCO on September 13, 2021 came out with a notification extending the deadline for importing drugs with residual shelf life less than 60 per cent till April 30, 2022.

This is in continuation to the circulars issued on April 17, 2020, July 10, 2020, December 18, 2020 and April 13, 2021.

It had earlier extended the deadline till October 31, 2021 for allowing import of drugs with residual shelf life less than 60 per cent following representations from importers on delay in clearances at port offices in the wake of C-19 pandemic.

CDSCO had granted importers permission to import medicines having residual shelf life under 60 per cent on the condition that they give an undertaking that the drug would be consumed before the expiry date in the light of the pandemic situation.

As per 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.

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