New Sterilisation Labelling Rule Sparks Concerns Among Device Makers

Medical device manufacturers are expressing significant concerns over a new regulation introduced by the Indian health ministry. The regulation, announced on August 14, 2026, mandates that manufacturers outsourcing sterilisation processes must include the licence number of the sterilisation facility on their product labels. This amendment to the Medical Devices Rules, 2017, will become compulsory six months from the notification date.

Industry Pushback on Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new labelling requirement. The industry body argues that it adds an unnecessary compliance burden on manufacturers who already have to obtain 'loan licences' for using external sterilisation methods such as gamma radiation or ethylene oxide (EO). The association suggests that this rule could disrupt export operations, as manufacturers may not easily switch facilities if the one listed on the label becomes unavailable or backlogged.

AiMeD claims that the new rule could extend shipment delays from around one week to as much as three weeks. They also question the necessity of printing subcontractor details on the labels, arguing that manufacturers already ensure quality and traceability through batch-level records that track the sterilisation process.

Calls for Clarification and Exemptions

In addition to raising concerns about compliance, AiMeD has requested clarity on several aspects of the new regulation. The association has asked whether the requirement will apply to foreign manufacturers and their sterilisation facilities. They also seek guidance on managing existing packaging stock before the regulation comes into effect.

The health ministry's notification includes a six-month transition period, allowing manufacturers to adjust to the new requirements. The rule was implemented after considering feedback from stakeholders and consulting the Drugs Technical Advisory Board.

AiMeD is urging the government to reconsider the regulation, arguing that patient safety and product traceability can be maintained without imposing additional burdens that threaten the competitiveness of Indian manufacturers in the global market.