New Sterilization Label Rule Sparks Concerns Among Device Makers
Indian medical device manufacturers express concerns over new sterilization labeling rules, citing export delays and compliance burdens.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, requiring the inclusion of sterilization facility licence numbers on device labels, has stirred concerns among manufacturers. The notification, issued on August 14, 2026, mandates that any manufacturer outsourcing sterilization must display the licence number of the facility on the product label. This new regulation will be enforced six months from the notification date.
Industry Reactions and Concerns
The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition to the new rule, arguing it imposes additional compliance burdens on manufacturers already required to secure 'loan licences' for using third-party sterilization services like gamma radiation or ethylene oxide. AiMeD has highlighted potential disruptions to export operations, suggesting that the requirement could extend shipment delays from one week to up to three weeks if manufacturers cannot promptly switch sterilization facilities due to backlog issues.
Moreover, AiMeD questioned the necessity of including subcontractor details on product packaging, given that manufacturers are already responsible for ensuring quality and traceability through batch-level records. The association has called for clarity on several points, including whether international manufacturers and their facilities will require Indian licences and how to handle existing packaging stock before the rule takes effect.
Government's Stance and Industry Appeals
The health ministry has allowed a six-month transition period for the implementation of these changes, following consultations with the Drugs Technical Advisory Board and after addressing feedback on the draft rules. Despite this, AiMeD has urged the government to reconsider the requirement, emphasizing the need to balance patient safety and traceability with the competitiveness of Indian manufacturers in the global market.
The industry body maintains that the new labeling requirement could hinder exports and affect the operational flexibility of manufacturers. By advocating for a reconsideration, AiMeD aims to ensure that regulatory measures do not compromise the efficiency and competitiveness of the Indian medical device industry.