New Sterilisation Labelling Rule Raises Concerns Among Device Makers
Medical device firms worry new labelling rule could increase compliance costs and delay exports.
The health ministry's recent amendment to the Medical Devices Rules, 2017, has sparked concern among manufacturers. The change, announced on August 14, 2026, mandates that medical device labels include the licence number of any outsourced sterilisation facility. This addition to the labelling requirements will become obligatory six months following the notification.
Industry Pushback on Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to this new rule. The association argues that manufacturers already face significant compliance demands, including obtaining 'loan licences' for using external sterilisation facilities such as gamma radiation or ethylene oxide (EO). AiMeD suggests that the new requirement could further complicate compliance, potentially delaying export shipments by several weeks.
AiMeD also questions the necessity of printing subcontractor details on product labels, emphasizing that manufacturers are responsible for quality and traceability. They argue that existing batch-level records suffice for tracking sterilisation processes.
Concerns Over Export Delays and International Manufacturers
The industry body has raised concerns that the labelling requirement could adversely affect exports. If a named sterilisation facility faces backlogs, manufacturers might struggle to switch to another facility without relabelling, leading to shipment delays.
Additionally, AiMeD is seeking clarity on whether international manufacturers and their sterilisation facilities will require Indian licences, and if these rules apply to their packaging. They also seek guidance on how to handle existing packaging stock before the rule takes effect.
Government's Position and Industry Requests
The notification, which allows a six-month transition period, was issued after considering feedback on draft rules and consulting the Drugs Technical Advisory Board. Despite these considerations, AiMeD has urged the government to reconsider the requirement. The association argues that patient safety and product traceability can be ensured without imposing additional burdens that might undermine the competitiveness of Indian manufacturers in the global market.
The ongoing dialogue between the health ministry and industry representatives highlights the need for balancing regulatory compliance with the practical realities of manufacturing and export logistics.