New Sterilisation Labelling Rule Sparks Concerns Among Device Makers
Medical device firms worry new labelling mandates could slow exports and increase compliance burdens.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has sparked apprehension among medical device manufacturers. The regulation, notified on August 14, 2026, requires that the licence number of an outsourced sterilisation facility be displayed on the device label. This rule will become compulsory starting six months from the notification date.
Industry Pushback on Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition, citing concerns that the requirement imposes an additional compliance burden on manufacturers. They argue that this could lead to delays in export shipments. Manufacturers currently using external gamma radiation or ethylene oxide sterilisation facilities already face the obligation to obtain 'loan licences'.
AiMeD expressed that the added necessity to label the subcontractor's licence number might restrict manufacturers' flexibility. In situations where the named sterilisation facility experiences backlogs or becomes unavailable, the inability to switch facilities could extend shipment delays from the current one week to potentially two to three weeks.
Calls for Clarity and Exemptions
AiMeD has requested the government provide clarity on whether this rule will also apply to overseas manufacturers and their sterilisation facilities. The association is also seeking guidance on managing existing packaging stock before the new rule's enforcement.
The industry body maintains that the responsibility for quality and traceability remains with the manufacturers, as batch-level records already track the sterilisation process. AiMeD advocates for patient safety and traceability to be ensured without compromising the competitiveness of Indian manufacturers in the global market.
Government's Response and Transition Period
The government introduced the six-month transition period after considering feedback and consulting the Drugs Technical Advisory Board. Despite this, AiMeD continues to urge reconsideration of the rule, arguing that the regulation does not align with the current operational practices and could hinder the industry's growth and export capabilities.