The Central Drugs Standard Control Organisation (CDSCO) has notified all State and Union Territory drug controllers that a loan license will no longer be mandatory for medical device manufacturers outsourcing sterilisation activities to licensed third-party facilities.

This decision comes after the Drugs Technical Advisory Board (DTAB), in its April 2025 meeting, approved recommendations from a sub-committee formed by the Drugs Consultative Committee (DCC) in June 2023. The move addresses longstanding concerns from industry stakeholders about the need for a separate loan license under the Medical Devices Rules (MDR), 2017, when outsourcing sterilisation to another licensed facility.

The DCC-appointed sub-committee recommended that, as long as all Quality Management System (QMS) protocols are followed and the final product is released from the original manufacturing site under proper quality checks, a loan license should not be insisted upon. Manufacturers may instead enter into third-party agreements with licensed sterilisation facilities.

Critically, the sterilisation facility must hold a valid license specific to the types of medical devices being sterilised. To ensure transparency and traceability, the license number of the sterilisation site must be included on the device label as part of regulatory labelling requirements.

The DCC, in its December 2024 meeting, further advised that manufacturers submit appropriate documentary evidence to the licensing authority before obtaining the manufacturing license. This should include the third-party agreement, the manufacturer's QMS documentation reflecting the outsourced activity, and other supporting records.

The CDSCO confirmed that the DTAB has deliberated on and agreed to the sub-committee’s recommendations, thereby formalising the regulatory relaxation. This is expected to streamline compliance while maintaining safety and quality standards for sterilised medical devices in India.