New Sterilisation Labelling Rule Sparks Concerns Among Medical Device Makers
Medical device makers worry a new sterilisation labelling rule may increase compliance costs and delay exports.
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 device labels must now include the licence number of any outsourced sterilisation facility. This requirement will become compulsory six months from the notification date.
The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to this amendment, citing potential compliance burdens and export delays. According to AiMeD, manufacturers are already required to secure 'loan licences' for engaging external sterilisation services like gamma radiation or ethylene oxide (EO) facilities.
Industry Concerns Over Compliance and Exports
AiMeD has expressed that the new rule could disrupt export timelines. Under the current system, manufacturers can face delays of about a week if their chosen sterilisation facility is unavailable or backlogged. However, the new labelling requirement could extend these delays to two or three weeks, as switching facilities would necessitate new packaging.
The industry body raises questions about the necessity of printing the subcontractor's details on product labels, emphasizing that manufacturers are already accountable for quality and traceability. Existing batch-level records suffice for tracking sterilisation processes, according to AiMeD.
Calls for Clarity and Reevaluation
AiMeD is seeking clarification on whether the rule will also apply to foreign manufacturers and their sterilisation facilities. Additionally, they are concerned about how to manage current packaging stocks before the new rule is enforced. The association has urged the government to ensure that patient safety and traceability do not hinder the competitiveness of Indian manufacturers in the global market.
The amendment was issued after the government reviewed objections and suggestions from stakeholders and consulted the Drugs Technical Advisory Board. AiMeD has requested a reconsideration of the rule, advocating for a balance between regulatory compliance and industry viability.