PXL/HO/Cir-079/2021-22 Date: 18.09.2021
Subject: Extension of deadline till April 30, 2022 for allowing import of drugs with residual shelf life less than 60% by DCGI
Members are kindly aware that DCG(I) has earlier allowed import of drugs with residual shelf life less than 60 per cent following representations from importers on delay in clearances at port offices in the wake of Covid-19 pandemic from 17th Apr 2020 onwards until 31st Oct 2021.
Drugs and Cosmetics Act 1945, Rule 31 states no drug shall be imported unless it complies with the standard of strength, quality and purity. Provided further 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 licensing authority may allow the import of any drug with a lesser shelf life, but before its expiry.
We would like to bring to the kind notice of member companies that the DCGI vide circular dated September 13 2021 has extended the deadline till April 30, 2022 for allowing import of drugs with residual shelf life less than 60%. A copy of the notification from DCGI is enclosedfor kind information.
Encl: DCGI notification