India Mandates Sterilisation Subcontractor Disclosure on Medical Device Labels

The Ministry of Health and Family Welfare has mandated a significant change for medical device manufacturers in India. Companies outsourcing sterilisation processes must now disclose the licence number of the subcontractor directly on device labels to enhance traceability.

This new requirement comes as an amendment to the existing **Medical Devices Rules, 2017**. Its primary objective is to improve the oversight and accountability within the medical device supply chain, ensuring that every stage of production, including sterilisation, is transparent.

Industry Concerns Over New Compliance Burden

Domestic manufacturers, represented by the **Association of Indian Medical Device Industry (AiMeD)**, have voiced strong concerns regarding this mandate. They fear it will introduce a new and substantial compliance burden on companies operating within the sector.

AiMeD specifically highlights that this requirement could diminish the global competitiveness of **Indian medtech exports**. They argue that other international jurisdictions do not impose such detailed disclosure requirements on packaging.

The industry body also warns that the new rule could lead to significant delays in product shipments. Such delays could impact the timely delivery of crucial medical devices to markets.

Policy Evolution and Board Approval

This move by the Ministry follows a period where the **Central Drugs Standard Control Organisation (CDSCO)** had previously relaxed regulations concerning loan licenses for outsourced sterilisation. The current mandate, however, aligns with a recommendation from a subcommittee.

The **Drugs Technical Advisory Board (DTAB)** formally approved this specific disclosure recommendation in **April 2025**. This indicates a structured process behind the implementation of the new labelling requirement.