CDSCO allows import of drugs with residual shelf life less than 60 percent till Oct 31

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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 the COVID-19 outbreak and the shelf life of many products are dropping below the threshold of 60 percent. Hence the CDSCO had allowed the import of drugs with less than 60 percent residual shelf life, reports Express Pharma.

For instance, 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 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.

Accordingly, the latest decision to permit and extend the date for the import of drugs with residual shelf life less than 60 % has been taken by the CDSCO under the special condition; and has indeed brought cheers to the pharmaceutical industry as the decision will ensure the availability of drugs to patients in a timely manner.

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