Medical Device Firms Concerned Over New Sterilisation Label Rule
New sterilisation labelling rules prompt concerns among medical device manufacturers over compliance costs and export delays.
Medical device manufacturers are expressing concerns over a recent amendment to the Medical Devices Rules, 2017, issued by the health ministry on August 14, 2026. The new regulation mandates that manufacturers outsourcing sterilisation services to licensed facilities must include the facility's licence number on the product labels. This requirement will take effect six months from the notification date.
Industry Reaction and Concerns
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new labelling rule, citing potential compliance burdens and export delays. According to AiMeD, manufacturers already face challenges in obtaining 'loan licences' for using external sterilisation facilities, such as gamma radiation or ethylene oxide (EO) sterilisation. The association argues that the additional requirement to label the facility's licence number could further complicate the process.
AiMeD highlighted concerns that the rule might disrupt export operations. If a sterilisation facility is unavailable or experiences a backlog, manufacturers may face difficulties switching to another facility, potentially delaying shipments by two to three weeks, a significant increase from the previous one-week delay.
Call for Clarity and Exemptions
The industry body has requested clarification on several aspects of the rule. It questions whether overseas manufacturers and their sterilisation facilities will need to comply with Indian licensing requirements and whether the new labelling rule will apply to their packaging. Additionally, AiMeD seeks guidance on handling existing packaging stock before the new requirement becomes mandatory.
AiMeD argues that manufacturers already ensure product quality and traceability through batch-level records, which track the sterilisation process. They believe that printing subcontractor details on labels is unnecessary and burdensome. The association has urged the government to reconsider the rule to maintain the competitiveness of Indian manufacturers in the global market without compromising patient safety and traceability.
Government's Position
The health ministry's notification was issued after considering objections and suggestions from stakeholders and consulting the Drugs Technical Advisory Board. The ministry has provided a six-month transition period to allow manufacturers to adjust to the new requirements.
Despite AiMeD's concerns, the government maintains that the rule is essential for ensuring transparency and accountability in the sterilisation process. The ministry believes that the inclusion of the sterilisation facility's licence number on product labels will enhance traceability and safeguard public health.
As the implementation date approaches, manufacturers are closely monitoring developments and continuing discussions with the government to address their concerns and seek possible amendments to the rule.