New Sterilisation Labelling Rule Faces Pushback from Device Makers

The Indian health ministry has introduced a new regulation mandating that medical device manufacturers include the licence number of any outsourced sterilisation facility on their product labels. This amendment to the Medical Devices Rules, 2017, was officially notified on August 14, 2026, and will become mandatory in six months, creating waves of concern within the industry.

Industry Concerns Over Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition to the new labelling requirement, highlighting the additional compliance burdens it imposes on manufacturers. According to AiMeD, companies are already required to obtain ‘loan licences’ for using external sterilisation facilities like gamma radiation or ethylene oxide (EO). The association argues that the new rule could complicate export processes, as manufacturers may face delays if the specified sterilisation facility on the packaging becomes backlogged or unavailable, potentially postponing shipments by two to three weeks.

Questions of Necessity and Implementation

AiMeD has questioned the necessity of including subcontractor details on product labels, suggesting that existing batch-level tracking already ensures quality and traceability. The industry body has also sought clarification on several fronts, including whether the rule applies to international manufacturers and their facilities, and how to manage existing packaging stocks ahead of the new requirement.

The health ministry's notification follows a period of consultation with the Drugs Technical Advisory Board and incorporates feedback from various stakeholders. Despite this, AiMeD is urging the government to reconsider the rule, emphasizing that patient safety and traceability should not come at the cost of the industry's competitiveness, particularly in exports.

Transition Period and Future Implications

The notification allows for a six-month transition period, providing manufacturers time to adjust their processes and packaging. However, AiMeD warns that the rule could have significant implications for the industry if not carefully implemented. The association continues to advocate for a balance between regulatory compliance and maintaining the agility and competitiveness of Indian medical device manufacturers in the global market.