Industry

DCGI extends drug imports deadline on shelf-life rule

File photo for representation.   | Photo Credit: S. Siva Saravanan

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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Printable version | Oct 16, 2021 5:38:37 AM | https://www.thehindu.com/business/Industry/drug-imports-gain-time-on-shelf-life-rule/article36723916.ece

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