CDSCO Eases Loan License Requirement for Medical Device Sterilisation

CDSCO Eases Regulations for Medical Device Sterilisation

The Central Drugs Standard Control Organisation (CDSCO) has recently relaxed the requirement of a loan licence for outsourcing the sterilisation of medical devices to other facilities. Manufacturers can now carry out these activities via a mutual third-party agreement, provided that these facilities hold a valid licence to undertake the sterilisation process.

Overview of Sterilisation Process

The sterilisation of medical devices is crucial as it ensures the elimination or reduction of microbial contamination to safe levels for use in healthcare.

Changes in License Requirement

• Previously, manufacturers without in-house sterilisation facilities required a loan licence to use other manufacturers' facilities.
• A subcommittee of the Drug Consultative Committee (DCC) proposed that loan licences are not necessary if the outsourced facility holds a valid licence for the same medical device.

The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, indicated that this change will significantly facilitate the process, especially for smaller companies facing delays.

Expected Benefits of Changes

• Reduction in time and administrative burdens for manufacturers.
• Enhanced overall supply chain efficiency.

As emphasized by Himanshu Baid, managing director of Poly Medicure, these adjustments will promote swift operations and improve product availability in the market.

Next Steps and Compliance

Manufacturers must include the licence number of the sterilisation site on product labels, ensuring compliance and traceability.