Device Makers Challenge New Sterilization Labeling Regulation
Indian medical device makers oppose new labeling rule citing compliance burdens and export delays.
The Indian health ministry has introduced a new regulation requiring medical device manufacturers to include the license number of outsourced sterilization facilities on product labels. Announced on August 14, 2026, this amendment to the Medical Devices Rules, 2017, will become mandatory in six months.
Industry Concerns Over Compliance and Exports
The Association of Indian Medical Device Industry (AiMeD) has expressed strong opposition to this new requirement, arguing that it adds unnecessary compliance burdens. Manufacturers are already required to obtain 'loan licences' for utilizing external gamma radiation or ethylene oxide (EO) sterilization facilities.
AiMeD warns that the regulation could disrupt export processes, as it limits manufacturers' flexibility to switch facilities if the listed sterilization center faces backlogs or other issues. Such situations could extend shipment delays from one week to up to three weeks.
Calls for Clarity and Exemptions
The association has requested clarification from the government on several points, including whether international manufacturers and their sterilization facilities must also comply with this Indian regulation. Additionally, AiMeD seeks guidance on managing existing packaging inventories ahead of the rule's enforcement.
The health ministry issued the notification after considering feedback from stakeholders and consulting the Drugs Technical Advisory Board. Despite these consultations, AiMeD continues to advocate for the rule's reconsideration, highlighting that current batch-level records already ensure quality and traceability.
Balancing Safety and Competitiveness
AiMeD contends that while patient safety and traceability are paramount, these goals should not come at the expense of the competitiveness of Indian manufacturers in the global market. The industry body is urging the government to find a balanced approach that maintains safety standards without imposing additional burdens on manufacturers.