Govt mandates naming sterilisation subcontractors on medical device labels

Domestic firms have raised concerns, saying the move could make Indian medtech exports less competitive

In a bid to improve traceability, the Ministry of Health and Family Welfare has mandated that medical device manufacturers outsourcing sterilisation must disclose the licence number of the subcontractor on medical device labels.

 

Through a gazette notification amending the Medical Devices Rules, 2017, the ministry modified Rule 44, which governs mandatory labelling requirements for medical devices.

 

“In the case of a medical device manufacturer who outsourced the sterilisation activity at the site of another facility having a valid licence to carry out the sterilisation process of medical devices, the licence number of the sterilisation site should be mentioned on the label of the device,” the notification stated.

   

Sterilisation is the process of eliminating or reducing microbial contamination to a level that ensures medical devices are safe for use in healthcare settings.

 

Domestic medical device manufacturers have raised concerns over the move, calling it a fresh compliance burden that does not address their concerns regarding outsourced sterilisation.

 

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), said the requirement could be particularly troublesome for export shipments because it would limit manufacturers’ ability to shift production between approved sterilisation providers, depending on turnaround time and available capacity.

 

“Depending on cobalt strength and backlog, shipments could be delayed by two to three weeks, instead of being dispatched within a week,” he added.

 

Globally, regulations place the onus of quality and traceability on manufacturers, whose documentation provides batch-level accountability.

 

“No other jurisdiction requires subcontractor details to be printed on packaging,” AiMeD claimed, adding that the rule could make Indian medical device manufacturers less globally competitive.

 

The move comes a year after the Central Drugs Standard Control Organisation (CDSCO) informed drug authorities in all states and Union Territories that a loan licence might not be necessary for medtech firms outsourcing sterilisation to another facility holding a valid licence to undertake the process.

 

The regulator further relaxed the loan-licence requirement for outsourced sterilisation, allowing manufacturers to undertake such activities through an agreement with a third-party facility.

 

A subcommittee constituted by the CDSCO’s Drugs Consultative Committee (DCC) had recommended that, since sterilisation is a critical activity, manufacturers must include on the label the licence number of the site to which the process was outsourced.

 

The recommendation was subsequently approved by the Drugs Technical Advisory Board (DTAB) in April 2025, subject to the inclusion of an appropriate mechanism for submitting documentary evidence to licensing authorities in support of the proper sterilisation of the products.

 

However, Nath claimed that the CDSCO had recently been insisting that manufacturers obtain loan licences for outsourced gamma-radiation or ethylene oxide (EO) sterilisation facilities.

 

“Manufacturers sought exemption through the Medical Devices Technical Advisory Group (MDTAG), but instead of relief, the industry is now facing a new burden of compulsory labelling of subcontractor facility details on each product,” he added.

 

The industry body has sought the suspension of the mandatory requirement to disclose sterilisation subcontractors on product labels.