Indian Medical Device Makers Challenge New Sterilisation Label Rule

The Indian health ministry has introduced a new regulation requiring medical device manufacturers to include the licence number of outsourced sterilisation facilities on product labels. This amendment to the Medical Devices Rules, 2017, was notified on August 14, 2026, and will become mandatory six months from the notification date.

Industry Concerns Over Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has expressed significant concerns regarding the new rule. Manufacturers argue that this requirement increases compliance challenges and could potentially delay export processes. According to AiMeD, the new rule adds an unnecessary layer of complexity, especially since manufacturers are already required to obtain 'loan licences' for using external sterilisation facilities such as gamma radiation or ethylene oxide (EO).

One of the primary concerns is the potential impact on export logistics. AiMeD has highlighted that if the sterilisation facility named on the packaging faces delays or backlogs, manufacturers might struggle to switch facilities quickly, which could extend shipment delays from one week to up to three weeks.

Call for Exemptions and Clarity

AiMeD is calling on the government to reconsider the new labelling requirement. The industry body argues that patient safety and traceability are already maintained through batch-level records, which track the sterilisation process effectively. Moreover, AiMeD is seeking clarity on whether the rule will apply to international manufacturers and their facilities, and how to manage existing packaging stock prior to the rule's enforcement.

The health ministry's notification followed consultations with the Drugs Technical Advisory Board and took into account feedback on the draft rules. Despite this, AiMeD insists that the new requirement could undermine the competitiveness of Indian manufacturers in the global market without significantly improving safety or traceability.

Government's Stance and Industry's Next Steps

The government has provided a six-month transition period for manufacturers to comply with the new labelling rule. This period is intended to allow companies to adjust their processes and packaging to meet the new requirements. However, the industry remains concerned about the practical implications of the rule, especially in terms of export logistics and compliance costs.

AiMeD has urged the health ministry to engage in further dialogue with industry stakeholders to address these concerns and explore possible exemptions or alternative solutions that would not compromise competitiveness while ensuring safety and traceability.