New Delhi: The Ministry of Health and Family Welfare has mandated medical device manufacturers that outsource sterilisation to disclose the licence number of the facility carrying out the process on the labels of their devices, in a move aimed at strengthening traceability and accountability in the medical device sector.
The ministry has amended Rule 44 of the Medical Devices Rules, 2017, through a gazette notification to make the disclosure mandatory where a manufacturer outsources sterilisation to another facility holding a valid licence to undertake the sterilisation of medical devices.
The amended provision states that in cases where a medical device manufacturer outsources sterilisation to a licensed facility, the licence number of the sterilisation site must be mentioned on the label of the device.
Sterilisation involves eliminating or reducing microbial contamination to a level that ensures medical devices are safe for use in healthcare settings. The government’s move is aimed at improving the traceability of devices and identifying the facility responsible for the critical sterilisation process.
However, domestic medical device manufacturers have raised concerns over the new requirement, arguing that it could add to their compliance burden without addressing their broader concerns around outsourced sterilisation.
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), said the requirement could create particular difficulties for export shipments by limiting manufacturers’ ability to shift production between approved sterilisation facilities based 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,” Nath said.
AiMeD argued that quality and traceability are generally placed on manufacturers in global regulatory frameworks, with documentation maintained by companies providing batch-level accountability. The industry body claimed that no other jurisdiction requires subcontractor details to be printed on medical device packaging.
According to AiMeD, the requirement could therefore put Indian medical device manufacturers at a competitive disadvantage in international markets.
The latest amendment comes nearly a year after the Central Drugs Standard Control Organisation (CDSCO) informed drug authorities across states and Union Territories that a loan licence may not be required for medical technology companies outsourcing sterilisation to another facility that holds a valid licence for the process.
(IANS)
