New Sterilisation Labelling Rule Sparks Concerns Among Device Makers
Medical device firms worry new labelling rules may delay exports, citing compliance burdens.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017 has stirred concerns among medical device manufacturers. The new regulation, announced on August 14, 2026, mandates that devices sterilised by outsourced licensed facilities include the facility's licence number on their labels. This requirement will come into effect six months from the notification date.
Industry Opposition to New Rule
The Association of Indian Medical Device Industry (AiMeD) has expressed apprehensions about the new rule, arguing it could exacerbate compliance challenges and lead to export delays. Currently, manufacturers are already required to secure 'loan licences' for employing external sterilisation methods, such as gamma radiation or ethylene oxide (EO). Adding the facility's licence number to the label, AiMeD argues, introduces another layer of complexity.
AiMeD raised concerns that this rule could disrupt export operations. If a listed sterilisation facility faces backlogs or is unavailable, manufacturers may encounter shipment delays, potentially extending from one week to two or three weeks. AiMeD also questioned the necessity of printing subcontractor details on labels, emphasizing that manufacturers are already accountable for quality and traceability through batch-level records.
Calls for Clarification and Reconsideration
The industry body has sought clarity on several fronts, including whether international manufacturers and their sterilisation facilities will need Indian licences and how the rule applies to their packaging. Additionally, AiMeD has requested guidance on managing existing packaging stock before the rule's implementation.
Despite the six-month transition period offered in the notification, AiMeD has urged the government to revisit the requirement. They argue that while ensuring patient safety and traceability is crucial, it should not compromise the competitiveness of Indian manufacturers or impede their export capabilities.
The health ministry's decision followed a review of objections and suggestions regarding the draft rules, with input from the Drugs Technical Advisory Board. However, AiMeD contends that the new labelling rule could hinder operational flexibility and efficiency in the sector.