CDSCO extends consent to import drugs with less than 60% till 31st October 2022.

LegalitySimplified

The Central Drugs Standard Control Organization on 6th May 2022, has extended the timeline for import of drugs with less than 60% residual shelf life till 31st October 2022 in view of the representations received and due to the Covid-19 pandemic situation.

According to the provisions of Rule 31 of the Drugs and Cosmetics Rules, 1945, no drug will be imported unless it complies with the standard of strength, purity, and quality when the drug licensing authority will not allow the import of a drug with a less than 60 percent residual shelf life on the date of import of the drug.

In exceptional cases, the drug licensing authority may allow the import of any drug with a lesser shelf life for reasons to be recorded in writing. But before its expiry, the authority will not allow the import of a drug with a less than 60 percent residual shelf life on the date of import.

Therefore, based on various representations received from the industry and industry organisations that owing to Covid-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. CDSCO granted permission for import of drugs with residual shelf life of less than 60 per cent till 31st October 2022 or till further order whichever is earlier.

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