DCGI extends drug imports deadline on shelf-life rule

With the existing deadline till October 31, the latest extension is for six months

The Drugs Controller General of India (DCGI) has extended till April 30 the deadline for allowing import of drugs with residual shelf life less than 60%.

Sharing the DCGI notification with its members, Pharmaceuticals Export Promotion Council of India (Pharmexcil) said import of drugs with less than 60% residual shelf life was being permitted since April 2020. It followed representations from the importers citing delay in clearances at port offices close on the heels of the COVID-19 outbreak. With the existing deadline till October 31, the latest extension is for six months.

Under the Drugs and Cosmetics Act 1945, import of a drug with less than 60% residual shelf life, as on the date of import, should not be permitted by the licensing authority. In exceptional cases, however, the authority can allow import of any drug with a lesser shelf life, but before its expiry date.

Pharmexcil director general Ravi Uday Bhaskar said the decision of the DCGI is bound to come as a relief for importers who are already grappling with a global shortage of containers, including reefer boxes used to ship pharmaceuticals, and a sharp increase in the freight tariff.

He said India’s pharma imports consists primarily of bulk drugs, formulations, vaccines and surgicals. Imports have increased amid a need for drugmakers to stockpile more raw materials to meet enhanced demand both in the domestic as well as export markets. In particular, demand for anti-virals had risen during the second wave of the pandemic.

On vaccines, he said with the focus of manufacturers in the country shifting to COVID-19 jabs, there was need to import certain other vaccines and their components.

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