The Ministry of Health and Family Welfare has introduced a requirement obligating manufacturers of medical devices that outsource sterilization to indicate the subcontractor's license number directly on the device labels. This measure is aimed at enhancing traceability.
The changes were made to the Medical Devices Rules of 2017 through a notification in the government gazette, which amended Rule 44 governing mandatory labeling requirements for medical devices. According to this notification, if a manufacturer outsources the sterilization process to an institution with a valid license, the number of this license must be indicated on the product label.
Sterilization is defined as the procedure for eliminating or reducing microbial contamination to a level that guarantees the safety of medical devices for use in healthcare facilities.
Problems for domestic manufacturers
However, domestic manufacturers of medical devices have expressed concern about this decision, calling it an additional regulatory compliance burden that does not solve their previous issues related to sterilization outsourcing.
Rajiv Nath, coordinator of the Indian Medical Industry Association (AiMeD) forum, noted that this requirement could create specific difficulties for export supplies. He explained that it would limit manufacturers' ability to redistribute production among approved sterilization suppliers based on available capacity and turnaround times.
Nath added that due to cobalt strength and accumulated orders, shipments might be delayed by two to three weeks instead of being sent out within a week.
AiMeD stated that globally, regulations place the responsibility for quality and traceability on the manufacturers themselves, whose documentation ensures accountability at the batch level. The association asserted that no other jurisdiction requires printing subcontractor data on packaging, and that the new rule could reduce the global competitiveness of Indian medical device manufacturers.
This change occurred a year after the Central Drugs Standard Control Organization (CDSCO) notified drug authorities in all states and territories that for companies outsourcing sterilization to another institution with a valid license, a credit license might not be required. The regulator also relaxed the credit license requirement for outsourced sterilization, allowing manufacturers to conduct such operations through mutual agreement with a third party.
A subcommittee established under the CDSCO Drug Consultative Committee (DCC) recommended that, since sterilization is a critical process, manufacturers should include the license number of the location where the procedure was transferred on the label. This recommendation was subsequently approved by the Drug Technical Advisory Board (DTAB) in April 2025, provided that a corresponding mechanism for providing documentary evidence to licensing authorities in support of proper product sterilization is included.
Nevertheless, Nath reported that CDSCO had recently insisted that manufacturers obtain credit licenses for external gamma irradiation or ethylene oxide (EO) sterilization facilities.