Medical device makers warn new sterilisation label rule may hit exports

NEW DELHI: The health ministry's recent amendment to the Medical Devices Rules, 2017, requiring manufacturers to print the licence number of outsourced sterilisation facilities on device labels has drawn strong opposition from the medical device industry. The Association of Indian Medical Device Industry (AiMeD) says the new requirement adds to the compliance burden and could delay export shipments.

The notification, dated August 14, 2026, makes the labelling rule mandatory six months after its issuance. Manufacturers that outsource sterilisation to a licensed facility must now include that facility's licence number on the device label. The rule is intended to improve traceability and patient safety, according to the ministry.

However, AiMeD argues that manufacturers are already required to obtain “loan licences” when using external gamma radiation or ethylene oxide (EO) sterilisation facilities. Loan licences are issued to manufacturers who do not have their own sterilisation infrastructure and must rely on third-party facilities. The industry body had previously sought an exemption through the Medical Device Technical Advisory Group (MDTAG), a government advisory body, but instead the new labelling requirement has been imposed.

AiMeD has raised specific concerns about the practical impact of the rule. If a sterilisation facility named on a product's packaging becomes unavailable or develops a backlog, manufacturers would not be able to switch to an alternative facility without changing all labels, which could delay shipments by two to three weeks. Earlier, such delays typically lasted about a week, the association said.

The industry body also questioned the necessity of printing the subcontractor's details on the product itself. It pointed out that manufacturers remain ultimately responsible for quality and traceability, and that batch-level records already allow the sterilisation process to be tracked in detail. Adding the licence number to labels, they argue, is redundant and burdensome.

Further, AiMeD has sought clarity on several unresolved questions. These include whether overseas manufacturers and their sterilisation facilities will also need Indian licences, and whether the requirement will apply to their packaging. The industry is also seeking guidance on how to handle existing packaging stock that does not have the new labelling once the rule takes effect.

The health ministry, on its part, says the amendment was issued after considering objections and suggestions received on the draft rules and consulting the Drugs Technical Advisory Board. The six-month transition period is meant to give manufacturers time to comply. The government maintains that the rule enhances accountability in the medical device supply chain, which ultimately benefits patient safety.

AiMeD has urged the government to reconsider the requirement, saying that patient safety and traceability can be ensured without compromising the competitiveness of Indian manufacturers or their exports. The industry is seeking a dialogue with the ministry to address these concerns before the rule becomes mandatory.