The move is aimed at promoting ease of doing business in the pharmaceutical sector while ensuring that patients continue to receive medicines with adequate usable shelf life remaining, the health and family welfare ministry said.
The government has invited comments on a draft notification proposing the amendment published on June 22.
The current percentage-based rule can work against medicines with longer shelf lives. A drug valid for five years, for instance, would need more than three years of shelf life remaining at the time of import under the existing norm-a bar that industry has argued is unnecessarily stringent and contributes to avoidable wastage.
A fixed 12-month period, the ministry said, provides sufficient time for distribution and consumption without imposing such restrictions.
“The amendment is also expected to improve utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements,” the ministry said.
The relaxation, however, will not apply uniformly.Biological products and radiopharmaceuticals will continue to be subject to the existing requirement for a shelf life of more than 60%, given their specialised nature and the public health considerations involved.
The ministry also clarified that the amendment is limited in scope. It pertains solely to the residual shelf-life requirement at the point of import and leaves all other regulatory standards governing the quality, safety, and efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, unchanged.