CDSCO extends consent to import drugs with less than 60 per cent residual shelf life by three months

The Central Drugs Standard Control Organisation (CDSCO) has given an extension of three months for the import of drugs with less than 60 per cent residual shelf life. The move is appreciated by the industry as well as regulators.

On April 17, 2020, the DCGI office had issued a letter stating that it has received the representations from industry associations’ informing that there are challenges in clearance at port offices due to COVID-19 outbreak and the shelf life of many products are dropping below the threshold of 60 per cent. Hence the CDSCO had allowed the import of drugs with less than 60 per cent residual shelf life. (https://www.expresspharma.in/covid19-updates/industry-lauds-move-to-allow-import-of-drugs-with-60-per-cent-residual-shelf-life/)

But, as per the issued circular, the permission to import these drugs was set to expire in July 2020. So, the industry had requested the authorities to extend this deadline. Understanding the situation caused by the COVID-19 pandemic in the country and need for uninterrupted supply of medicines in the country, the DCGI has heeded the request and allowed a three-month extension i.e. up to October 31, 2020, which has been appreciated by all the stakeholders.

Commenting on the DCGI’s decision, Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, Panchkula said, “There are so many drugs with expiry between three to five years as provided in the Schedule-P appended to Drugs and Cosmetics Rules, 1945. So, I see no harm in allowing the import of drugs or formulations with a residual shelf life lesser than 60 per cent until the pandemic continues.”