CDSCO allows import of drugs with residual shelf life less than 60 percent till October 31, 2021
New Delhi: With an aim to ensure drug availability in sufficient quantity in the domestic market, the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO), has extended the deadline for allowing import of drugs with a residual shelf life of less than 60 percent till October 31, 2022, via a recent notification.
The move is made in continuation to the circulars released on April 17, 2020, July 10, 2020, and December 18, 2020, September 13, 2021, 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 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.
Taking serious note of this, earlier, the CDSCO on September 13, 2021 had extended the deadline till April 30, 2022 for allowing import of drugs with residual shelf life less than 60 per cent.
Now in continuation, in light of the representation received and Covid 19 pandemic situation, the CDSCO has againextended the date for allowing import of drugs with residual shelf life less than 60 per cent till October 31, 2022.
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.
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 13.09.21 issued on the subject cited above is extended up to 31st October 2022, or till further order whichever is earlier."
