Device Makers Alarmed by New Sterilisation Label Rule
Indian medical device makers oppose a rule mandating sterilisation facility licence numbers on labels, citing export delays.
In a recent development, the Indian Ministry of Health has amended the Medical Devices Rules, 2017, imposing a new requirement for medical device manufacturers. As per the notification dated August 14, 2026, manufacturers outsourcing sterilisation must now include the licence number of the sterilisation facility on their product labels. This rule is set to become mandatory six months from the notification date.
Industry Concerns Over Compliance and Export Delays
The new regulation has sparked concerns among manufacturers, who argue that it adds to their compliance burden. The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition, highlighting potential delays in export shipments. Manufacturers have expressed worries that the inability to promptly switch sterilisation facilities in case of backlogs could extend delivery timelines from one to up to three weeks.
AiMeD has underscored that manufacturers are already required to obtain 'loan licences' for using external sterilisation methods like gamma radiation or ethylene oxide (EO). The association believes that the new labelling requirement introduces an unnecessary layer of complexity, as manufacturers are already accountable for quality and traceability through batch-level records.
Call for Exemptions and Clarifications
The industry body is actively seeking exemptions and clarity on several fronts. One major concern is whether the new rule will apply to international manufacturers and their sterilisation facilities, potentially requiring them to obtain Indian licences. Additionally, AiMeD is requesting guidance on managing existing packaging stock before the rule takes effect.
Despite these concerns, the Ministry's notification indicates that the decision was made after consulting the Drugs Technical Advisory Board and considering feedback on the draft rules. The six-month transition period is intended to allow manufacturers time to adapt to the new requirements.
Balancing Safety and Competitiveness
AiMeD has urged the government to reconsider the rule, arguing that patient safety and traceability should not come at the expense of the competitiveness of Indian manufacturers. The association advocates for a regulatory environment that ensures safety while facilitating smooth operations and exports for the industry.
The debate over this new regulation highlights the tension between regulatory compliance and operational efficiency in the medical device sector. As the deadline approaches, manufacturers will need to navigate these changes while continuing to meet global standards and market demands.