New Sterilisation Labelling Rule Sparks Concerns Among Medical Device Makers
Medical device makers are worried about a new rule requiring sterilisation facility licence numbers on product labels, citing export delays.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has stirred concerns among medical device manufacturers. The change, announced on August 14, 2026, mandates that any outsourced sterilisation facility's licence number must be included on the product labels. This requirement will become compulsory six months from the notification date.
Industry Opposition to New Labelling Requirement
The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to the new rule. They argue that it imposes an additional compliance burden on manufacturers, who are already required to obtain 'loan licences' for using external sterilisation methods like gamma radiation or ethylene oxide (EO). AiMeD suggests that this could complicate export processes, as switching sterilisation providers in response to backlogs or unavailability might now delay shipments by up to three weeks, compared to the usual one-week timeframe.
Concerns Over Quality and Traceability
Manufacturers are questioning the necessity of printing subcontractor details on labels, emphasizing that they remain responsible for product quality and traceability. According to AiMeD, existing batch-level records already facilitate tracking of the sterilisation process. The association is also seeking clarity on whether this requirement will extend to overseas manufacturers and their sterilisation facilities, potentially affecting international operations and packaging.
Industry Seeks Clarity and Reconsideration
The notification provides a six-month transition period, allowing time for manufacturers to adapt. However, AiMeD has urged the government to reconsider the rule, stressing that patient safety and traceability can be maintained without impacting the competitiveness of Indian manufacturers in global markets. They have also requested guidance on managing existing packaging stock before the new rule takes effect.
The rule was finalized after considering public objections and suggestions on the draft, following consultations with the Drugs Technical Advisory Board. As the industry grapples with this impending change, the dialogue between manufacturers and the government continues, highlighting the balance needed between regulatory compliance and market agility.