CDSCO Allows Import Of Drugs With Residual Shelf Life Less Than 60 Percent Till October 31, 2021

The move is made in continuation to the circulars released on April 17, 2020, July 10, 2020, and December 18, 2020 in response to importer's complaints regarding delays in clearances at port offices due to a staffing crisis in the wake of the COVID-19 pandemic.

As the current scenario of the COVID-19 pandemic has led to disruption in freight movement causing delays in the delivery of imported drugs, there are reportedly a lot of drugs and medical devices stuck at ports due to lockdown situations in certain parts of the country and are losing shelf life.

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 less than 60 percent 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. Residual Shelf Life means the remaining length of time before the expiration date set forth in the applicable Product Specifications for the Product.

The Medical Dialogues team had earlier reported that on April 17, 2020, the DCGI office issued a letter stating that it had received representations from industry associations informing them that there are challenges in clearance at port offices due to the COVID-19 outbreak and that the shelf life of many products is falling below the 60 percent threshold. Hence, the CDSCO had allowed the import of drugs with less than 60 percent residual shelf life.

Furthermore, the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) had extended the deadline for allowing import of drugs with a residual shelf life of less than 60 percent till October 31, 2020, which had been extended further till 30th April 2021.

Now, as per the latest DCGI notice,

" In light of representation received and Covid-19 pandemic situation the effective date of the circular of even no. dated 17.04.2020, 10.07.2020, and 18.12.2020 issued on the subject cited above is extended up to 30st October 2021 or till further order whichever is earlier."

Also Read: DCGI Approves Extension Of Shelf Life Of Covishield From 6 To 9 Months: Report