New Sterilisation Labelling Rule Sparks Debate Among Device Makers

Medical device manufacturers in India are voicing concerns over a recent government mandate requiring the inclusion of sterilisation facility licence numbers on product labels. The rule, issued by the health ministry on August 14, 2026, amends the Medical Devices Rules, 2017, and will become mandatory six months from the notification date.

Industry Pushback on Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has been vocal in its opposition to the new rule, arguing that it imposes additional compliance burdens on manufacturers. Currently, companies using external sterilisation services, such as gamma radiation or ethylene oxide (EO), are already required to obtain 'loan licences'. AiMeD contends that the added requirement of printing licence numbers could complicate logistics and delay export processes.

The association highlights potential disruptions in export shipments, particularly if a sterilisation facility listed on a product's packaging faces delays or backlogs. Such situations could extend shipment delays from the current one week to as long as three weeks, impacting the competitiveness of Indian manufacturers in the global market.

Call for Clarity and Exemptions

AiMeD has sought clarification on several aspects of the new rule. They have questioned whether international manufacturers and their sterilisation facilities will need to comply with the Indian licensing requirements and if these rules apply to their packaging as well. Additionally, the industry body is seeking guidance on how to manage existing packaging stock that may not meet the new labelling requirements before the rule takes effect.

The health ministry's notification followed consultations with the Drugs Technical Advisory Board and considered feedback from various stakeholders. However, AiMeD has called for a reconsideration of the rule, emphasizing that patient safety and traceability should be achieved without compromising the industry's global competitiveness.

Balancing Safety and Market Competitiveness

The debate highlights the ongoing challenge of balancing regulatory compliance with market efficiency. While the new rule aims to enhance traceability and safety in the medical device sector, industry leaders fear it may inadvertently hinder their ability to operate effectively in international markets. AiMeD insists that existing batch-level records already enable adequate tracking of the sterilisation process, questioning the necessity of further labelling requirements.

The health ministry has provided a six-month transition period for manufacturers to adapt to the new rule, allowing time for adjustments and dialogue between industry stakeholders and regulators. As the deadline approaches, medical device manufacturers are likely to continue advocating for modifications that align regulatory objectives with operational realities.