New Sterilisation Labelling Rule Sparks Concerns Among Device Makers
India's new rule mandates labelling of sterilisation facility licenses, raising compliance concerns among medical device manufacturers.
The Indian health ministry has introduced a new amendment to the Medical Devices Rules, 2017, requiring medical device manufacturers to include the license number of any outsourced sterilisation facilities on their product labels. This regulation, announced on August 14, 2026, will become mandatory six months from the date of notification.
Industry Concerns Over Compliance and Export Delays
Medical device manufacturers have expressed apprehension about the new rule, highlighting potential increases in compliance burdens and the risk of delayed exports. The Association of Indian Medical Device Industry (AiMeD) has voiced opposition, noting that manufacturers are already required to acquire 'loan licenses' for using external sterilisation services like gamma radiation or ethylene oxide (EO).
AiMeD argues that the rule might complicate logistics, particularly if the named sterilisation facility on the packaging encounters backlogs or unavailability, potentially extending shipment delays from one week to up to three weeks. The association also questions the necessity of printing subcontractor details on packaging, considering manufacturers are already accountable for quality and traceability through existing batch-level records.
Calls for Clarity and Reconsideration
The industry body has requested clarification on whether international manufacturers and their sterilisation facilities will need to comply with the Indian licensing requirements and how this rule will apply to existing packaging stock before the rule's enforcement. AiMeD is urging the government to reassess the labelling requirement to ensure it does not undermine the competitiveness of Indian manufacturers in the global market.
The amendment comes after the government reviewed objections and suggestions on the draft rules and consulted the Drugs Technical Advisory Board. Despite the six-month transition period, AiMeD insists that while patient safety and traceability are paramount, these should not come at the cost of hindering the operational efficiency and international competitiveness of the industry.