Medical Device Makers Criticize New Sterilization Labeling Rule

The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has sparked dissent among medical device manufacturers. As per the notification issued on August 14, 2026, companies must now include the license number of any outsourced sterilization facility on their device labels. This new requirement is set to become mandatory after a six-month transition period.

Industry Concerns Over Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced significant opposition to the rule, citing concerns over increased compliance burdens. According to AiMeD, manufacturers are already required to secure "loan licenses" for utilizing external gamma radiation or ethylene oxide (EO) sterilization services. The additional labeling requirement, they argue, exacerbates the situation.

AiMeD has highlighted potential disruptions in export operations, pointing out that if a sterilization facility listed on the packaging faces backlogs or unavailability, manufacturers might encounter shipment delays extending up to three weeks, in contrast to the current one-week delay.

Call for Clarity and Exemptions

The industry body is also seeking clarity on several aspects of the new rule. Questions remain regarding whether foreign manufacturers and their sterilization facilities must obtain Indian licenses and if these requirements will extend to their packaging. Additionally, manufacturers are anxious about handling existing packaging stock that might not meet the new labeling criteria before the rule takes effect.

The health ministry's notification followed consultations with the Drugs Technical Advisory Board and considered public objections and suggestions on the draft rules. Despite these consultations, AiMeD has urged the government to reconsider the rule, emphasizing that patient safety and product traceability should not come at the cost of the industry's competitiveness and export efficiency.

Balancing Safety and Industry Competitiveness

AiMeD contends that the responsibility for product quality and traceability already lies with manufacturers, who maintain detailed batch-level records. They argue that the new labeling requirement is redundant and does not significantly enhance traceability. Instead, it may hinder the operational flexibility of manufacturers in managing their supply chains.

The health ministry's decision aims to increase transparency in the sterilization process, but AiMeD believes it could inadvertently place Indian manufacturers at a disadvantage in the global market. As the industry awaits further guidance on the implementation of this rule, the call for a balanced approach that safeguards both public health and industry growth remains strong.