Medical Device Makers Challenge New Sterilisation Label Rule
New labelling rules for sterilisation facilities spark concerns among device manufacturers over compliance and export delays.
The Indian health ministry has introduced a new amendment to the Medical Devices Rules, 2017, mandating that manufacturers outsourcing sterilisation processes must include the sterilisation facility's licence number on product labels. Announced on August 14, 2026, this rule will become compulsory six months from the notification date.
Industry Concerns Over Compliance and Exports
The Association of Indian Medical Device Industry (AiMeD) has voiced its concerns regarding the new labelling requirement, arguing that it could result in increased compliance costs and potential delays in export shipments. AiMeD highlighted that manufacturers are already required to obtain 'loan licences' when using external gamma radiation or ethylene oxide (EO) sterilisation services.
Manufacturers worry that being tied to a specific sterilisation facility could lead to logistical challenges. If a facility experiences backlogs or becomes unavailable, switching to an alternative could delay exports by up to three weeks, compared to the current one-week delay.
Calls for Exemption and Clarification
AiMeD has requested an exemption from this requirement through the Medical Device Technical Advisory Group (MDTAG). The association argues that current batch-level records already ensure traceability and quality control, making the additional labelling redundant.
Further clarity is being sought on several aspects, including whether overseas manufacturers and their facilities will need to comply with Indian licensing requirements and how existing packaging stock should be handled before the rule takes effect.
Government's Position and Industry's Response
The government issued the notification after considering feedback on draft rules and consulting the Drugs Technical Advisory Board. The six-month transition period is intended to allow manufacturers to adjust to the new requirements.
AiMeD has urged the government to reconsider the rule, emphasizing that while patient safety and traceability are paramount, these should not compromise the competitiveness of Indian manufacturers in the global market.