CDSCO extends timeline for importing of drugs with shelf life less than 60%

This is the fourth time the timeline has been extended by the regulator,

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CDSCO DCGI FDA

Download DCGI Circular, link given below: The Central Drugs Standard Control Organisation (CDSCO) has extended the permission it has granted to the industry to import drugs with residual shelf life less than 60 per cent for another six more months, in view of the representations received and due to the C-19 pandemic situation vide circular dated 06-05-2022.

This is the fourth time the timeline has been extended by the regulator, after it has first announced the permission in April 17, 2020, based on the industry representations.

VG Somani DCGI CDSCO
Dr. VG Somani, DCGI CDSCO

The timeline has not been extended up to October 31, 2022, or till further order whichever is earlier, said a circular issued by Dr V G Somani, Drugs Controller General (India), with a copy to all port offices and all zonal, and sub-zonal offices of the CDSCO.

The drug regulator, in April, 2020, said that it has received various representations from the industry and industry organisations that owing to C-19 challenges, there is a delay in clearance of drug consignments at port offices and this is resulting in many products witnessing the shelf life declining to below the threshold of 60 per cent.

The industry requested the regulator to take appropriate measures so that these drugs can be cleared from the port office without regulatory issues.

Given the special condition, the DCGI granted permission for import of drugs with residual shelf life of less than 60 per cent, on April 17, 2020.

The timeline for the permission was extended through circulars on July 10, 2020, December 18, 2020 and April 13, 2021, and the timeline for the last circular was scheduled to end on April 30, 2022.

It is in this context, the regulator has decided to extend it further to six more months, “in light of representation received and C-19 pandemic situation,” said the latest circular issued on May 6, 2022.

The C-19 pandemic and the coinciding supply chain bottlenecks across the world has impacted the imports of drugs as per the schedule, since the year 2020.

Considering that the drugs have specified shelf life and the regulations restrict import of drugs which have a residual shelf life of below 60 per cent, the industry found it an additional challenge to do business during the period.

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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