Medical Device Makers Cry Foul Over Sterilisation Labelling Rule, Seek Rethink

India’s medical device industry has raised strong objections to a new labelling requirement that mandates manufacturers to print the licence number of an outsourced sterilisation facility on every medical device package, arguing that the move could complicate exports, increase compliance costs and undermine the competitiveness of domestic manufacturers.

The Association of Indian Medical Device Industry (AiMeD), representing a large number of companies from the sector, said the amendment, notified by the Union Health Ministry on August 14, has added to concerns that manufacturers had already raised with regulators over outsourcing sterilisation activities. The association described the latest requirement as a move that has left the industry “from the frying pan into the fire”.

Under the amendment to the Medical Devices Rules, 2017, manufacturers that outsource sterilisation to another facility holding a valid licence for sterilising medical devices will have to mention the licence number of that sterilisation site on the device label. The number may appear as “Sterilisation Sites Manufacturing Licence Number”, “Ster. Mfg. Lic: No.” or “S.M.L.”

The industry, however, argues that the requirement could have consequences beyond labelling. AiMeD said manufacturers often use external facilities for processes such as gamma radiation and ethylene oxide (EO) sterilisation and need flexibility to select facilities depending on capacity, turnaround time and logistics.

“This requirement is especially troubling for export shipments. It will reduce customer service flexibility, as manufacturers will be forced to wait for sterilisation by the subcontractor whose licence number is printed on the packaging, rather than choosing the facility with the fastest turnaround time,” the association said.

According to AiMeD, delays could be significant in cases where a particular sterilisation facility has a backlog or where cobalt strength affects processing capacity. It said shipments that could otherwise be dispatched within a week may face delays of two to three weeks.

AiMeD contended that international regulatory systems generally place the responsibility for quality, safety and traceability on the manufacturer. Batch-level documentation and records can provide information on outsourced processes without requiring subcontractor details to be printed on every package.

The association said it was not opposing traceability or patient-safety requirements. Rather, it was seeking a regulatory mechanism that provides authorities with adequate information while allowing manufacturers operational flexibility.

The issue has its roots in an earlier regulatory debate over the requirement for medical device companies to obtain “loan licences” when outsourcing sterilisation. Industry stakeholders had argued that such a requirement was unnecessary when the external sterilisation facility already possessed a valid licence to undertake the activity.

The Central Drugs Standard Control Organisation (CDSCO) had subsequently informed drug controllers in the states and Union territories that the requirement for a loan licence need not be insisted upon when sterilisation was outsourced to a facility holding a valid licence for the relevant device.

The regulator had said manufacturers could instead include at least the sterilisation site's licence number on the device label as part of labelling requirements.

The recommendation followed deliberations by a sub-committee constituted under the Drugs Consultative Committee in June 2023. It was subsequently agreed to by the Drugs Technical Advisory Board in April 2025.

The latest amendment, however, has reopened the debate.

AiMeD said both Indian and overseas manufacturers had raised objections during discussions with the Medical Devices Technical Advisory Group (MDTAG). The association has now urged regulators to reconsider the provision and provide clarity on several practical issues.

One major question concerns imported devices. If Indian manufacturers are required to identify sterilisation facilities on their packaging, the industry wants to know whether overseas manufacturers and their subcontracted sterilisation facilities would be subjected to comparable requirements.

Another concern is the transition period. Existing packaging material may already have been printed and stocked. Manufacturers could face additional costs if packaging has to be redesigned, printed and replaced merely to incorporate the new licence details.

The issue is particularly important for an industry seeking to expand India's medical device manufacturing and export footprint. India has been attempting to reduce import dependence, strengthen domestic production and position itself as a global medical technology manufacturing hub.

AiMeD said regulatory measures should therefore strike a balance between patient safety and ease of doing business.

“Both Indian and overseas manufacturers had opposed this move at the MDTAG meeting, but our pleas were ignored,” the association said, urging regulators to suspend and revise the decision.

The debate also highlights a broader challenge facing India's medical device sector: regulation must keep pace with increasingly complex manufacturing and supply chains without creating requirements that make Indian products less competitive internationally.

For manufacturers, sterilisation may happen at a specialised external facility, but responsibility for the finished device remains with the manufacturer. The industry now wants the regulatory framework to recognise that distinction while ensuring that regulators retain access to complete traceability records, said the AiMeD.