New Sterilisation Labelling Rule Sparks Concerns Among Device Makers

The Indian health ministry has introduced an amendment to the Medical Devices Rules, 2017, mandating that medical device manufacturers include the licence number of outsourced sterilisation facilities on product labels. This new requirement, announced on August 14, 2026, will become compulsory six months from the notification date.

Industry Pushback and Concerns

The Association of Indian Medical Device Industry (AiMeD) has expressed significant concern over this rule, arguing that it could exacerbate compliance challenges and potentially delay export processes. According to AiMeD, manufacturers already face regulatory demands, such as obtaining 'loan licences' for using external sterilisation services like gamma radiation or ethylene oxide (EO). The new labelling mandate adds another layer of complexity that could impact the industry's efficiency and global competitiveness.

AiMeD highlighted the potential for export delays, suggesting that shipments might be held up by two to three weeks if manufacturers cannot promptly switch to alternative sterilisation facilities when those listed on the packaging face backlogs. Previously, such disruptions typically caused about a week’s delay.

Call for Clarifications and Adjustments

The industry body is seeking clarity on whether the rule applies to international manufacturers and their sterilisation facilities, questioning if they would also need to obtain Indian licences. Additionally, AiMeD has requested guidance on managing existing packaging stocks before the regulation’s full implementation.

Despite these concerns, the health ministry proceeded with the rule after consulting the Drugs Technical Advisory Board and considering public feedback. AiMeD, however, continues to advocate for a reconsideration, emphasizing that patient safety and traceability can be maintained without imposing undue burdens on manufacturers.

Government's Position

The government insists that the updated labelling requirement is a necessary step towards enhancing traceability and accountability in the medical device sector. By ensuring that all sterilisation processes are transparent and verifiable through labelling, the ministry aims to uphold high standards of patient safety.

The six-month transition period is intended to give manufacturers adequate time to adjust their processes and comply with the new regulation. However, AiMeD argues that more time and flexibility might be needed to ensure a smooth transition that does not disrupt industry operations or competitiveness.