Indian Device Makers Criticize New Sterilization Label Rule
New labeling rules require device makers to list sterilization facility licenses, raising compliance concerns.
The Indian health ministry has introduced a new rule mandating that medical device manufacturers include the license number of any outsourced sterilization facility on their product labels. This amendment to the Medical Devices Rules, 2017, was announced in a notification dated August 14, 2026. The regulation will become mandatory six months from the notification date, prompting concerns from industry stakeholders.
Industry Concerns Over Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has expressed significant concerns about the new labeling requirement. According to AiMeD, this rule adds an unnecessary compliance burden on manufacturers who already navigate complex licensing processes for using external sterilization services like gamma radiation or ethylene oxide (EO). The association argues that this could delay export processes, as manufacturers might face logistical issues if the named sterilization facility is unavailable or backlogged.
Manufacturers have reportedly sought exemptions through the Medical Device Technical Advisory Group (MDTAG), but the new rule has instead introduced another layer of compliance. AiMeD warns that the regulation could extend shipment delays from one week to as long as three weeks, impacting the industry's competitiveness.
Calls for Clarity and Reconsideration
AiMeD has also raised questions about the rule's application to international manufacturers and their sterilization facilities. The industry body seeks clarification on whether overseas facilities will require Indian licenses and how the rule will impact existing packaging stocks.
While the government has considered previous objections and consulted the Drugs Technical Advisory Board before implementing the rule, AiMeD urges a reevaluation. The association stresses that while patient safety and traceability are paramount, they should not come at the cost of hindering the competitiveness of Indian manufacturers.
The health ministry's decision follows a period of consultation and feedback, but the industry remains worried about the practical implications of the new requirement. As the six-month transition period progresses, stakeholders are keenly watching for any adjustments or further guidance from the authorities.