New Sterilisation Labelling Rule Raises Concerns Among Device Makers
Indian medical device firms voice concerns over new sterilisation labelling, citing compliance burdens and potential export delays.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, is causing unease among medical device manufacturers. The new regulation, announced on August 14, 2026, mandates that companies using outsourced sterilisation must print the facility's licence number on device labels. This requirement is set to become mandatory six months from the notification date.
Industry Pushback Over Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has expressed opposition to the rule, arguing that it adds an unnecessary compliance burden. Manufacturers are already required to obtain 'loan licences' for using external sterilisation methods like gamma radiation or ethylene oxide (EO). AiMeD has highlighted that the additional labelling requirement could complicate processes, especially for export shipments. The association warns that the inability to switch quickly between sterilisation facilities, due to packaging constraints, might extend shipment delays from one week to two or three weeks.
Concerns Over Export Impact and Traceability
AiMeD questions the necessity of including subcontractor details on product labels, emphasizing that manufacturers are already accountable for product quality and traceability. Current batch-level records, they argue, sufficiently track the sterilisation process. There are calls for clarification on whether this rule applies to foreign manufacturers and their facilities, as well as guidance on handling existing packaging stock before the rule's implementation.
Government Response and Industry's Call for Reconsideration
The notification includes a six-month transition period and follows consultations with the Drugs Technical Advisory Board, as well as feedback from the draft rules. Despite these considerations, AiMeD has urged the government to reassess the rule, advocating for patient safety and traceability without compromising the competitiveness of Indian manufacturers in the global market.
As the industry grapples with the implications of this policy, the call for a balanced approach that ensures compliance while safeguarding business interests remains strong.