Medical Device Firms Challenge New Sterilisation Label Rule

Medical device manufacturers in India are expressing concerns over a recent amendment to the Medical Devices Rules, 2017, which mandates that companies outsourcing sterilisation must display the facility's licence number on their product labels. This new rule, issued by the health ministry on August 14, 2026, will become compulsory six months from the notification date.

Industry Concerns Over Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to the rule, arguing that it adds an unnecessary layer of compliance for manufacturers. According to AiMeD, companies are already required to obtain 'loan licences' for using external gamma radiation or ethylene oxide sterilisation facilities. The association contends that the new labelling requirement complicates this process further.

AiMeD has highlighted potential delays in export shipments as a significant concern. If a sterilisation facility indicated on the packaging is unavailable or experiences a backlog, manufacturers may face shipment delays of up to three weeks, compared to the current average of one week.

Questions of Traceability and International Implications

The industry body has questioned the necessity of including subcontractor details on product labels, pointing out that manufacturers are already responsible for quality control and traceability through batch-level records. These records, AiMeD argues, sufficiently track the sterilisation process without the need for additional labelling requirements.

Further clarification is sought regarding whether international manufacturers and their sterilisation facilities must also comply with this rule. AiMeD is also seeking guidance on managing existing packaging stocks before the new requirements take effect.

Government's Stand and Industry's Appeal

The notification was issued following consultations with the Drugs Technical Advisory Board and after considering public objections and suggestions on the draft rules. Despite these discussions, AiMeD has urged the government to reconsider the new requirement, emphasizing the importance of balancing patient safety and traceability with the competitiveness of Indian manufacturers in the global market.

The six-month transition period provided by the government is intended to allow manufacturers to adjust to the new rule. However, AiMeD maintains that this timeframe may not be sufficient to address all the concerns raised by the industry.