New Sterilisation Labelling Rule Raises Concerns Among Device Makers
Medical device firms worry about compliance and export delays due to new sterilisation labelling rules by India's health ministry.
The Indian health ministry has issued a new amendment to the Medical Devices Rules, 2017, requiring that medical device manufacturers include the licence number of any outsourced sterilisation facility on their product labels. This change, announced on August 14, 2026, has raised concerns among manufacturers who fear it could increase compliance obligations and delay export processes.
Industry Concerns Over Compliance and Export Delays
The Association of Indian Medical Device Industry (AiMeD) has expressed opposition to the new rule, highlighting the potential for increased compliance burdens. According to AiMeD, manufacturers are already required to obtain 'loan licenses' when using external gamma radiation or ethylene oxide (EO) sterilisation facilities. The new requirement to print the sterilisation facility's licence number adds another layer of complexity.
Manufacturers have voiced concerns that the rule could hinder their ability to switch to alternative sterilisation facilities if the one specified on the packaging faces delays or backlogs. This situation could extend shipment timelines from the current one week to as long as two to three weeks, impacting the timely delivery of exports.
Questions on Implementation and International Impact
AiMeD has sought clarity on several aspects of the new regulation. They question whether overseas manufacturers and their sterilisation facilities will also need to comply with the Indian licensing requirements and if these rules will extend to their packaging. Additionally, there is uncertainty about how to manage existing packaging stock before the new rules take effect.
The association argues that manufacturers already maintain quality and traceability through batch-level records, which track the sterilisation process. They question the necessity of printing subcontractor details on the product label, suggesting that this step could be redundant.
Government Consultations and Industry Response
The health ministry's notification follows consultations with the Drugs Technical Advisory Board and consideration of objections and suggestions on the draft rules. Despite these discussions, AiMeD continues to urge the government to reconsider the requirement, emphasizing the need to balance patient safety and traceability with the competitiveness of Indian manufacturers on the global stage.
The new labelling rule will become mandatory six months from the date of notification, allowing a transition period for manufacturers to adapt. However, the industry remains concerned about the potential impact on their operations and international competitiveness.