NEW DELHI: To cut avoidable wastage of imported medicines, the Centre has proposed replacing a complex shelf-life rule with a simple requirement — drugs should have at least one year of shelf life left when they enter India. Health ministry has issued a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, and invited public comments. Under the proposal, most imported medicines will need to have at least 12 months of shelf life remaining at the time of import instead of complying with the existing requirement of having more than 60% of their approved shelf life left. Under the current rule, the requirement depends on the total shelf life of each medicine, meaning different drugs have to meet different remaining shelf-life requirements before they can be imported. The proposed change is expected to benefit imports of a range of medicines, including certain specialised cancer medicines, treatments for rare diseases and other high-value medicines, by making the import norms simpler and reducing avoidable wastage. “The proposed amendment is a pragmatic step towards improving access to specialised and high-value medicines, particularly for patients with cancer and ranature and public health importance justify retaining the requirement that more than 60% of their approved shelf life remain. The amendment could improve efficiency across the pharmaceutical supply chain by reducing avoidable wastage of medicines, improving inventory management, lowering logistics costs and strengthening the availability of essential medicines in the country, according to the ministry. It clarified that the proposal only changes the shelflife requirement applicable at the time of import and does not alter any standards relating to the quality, safety or efficacy of medicines under drug rules.
