Stakeholders raised concerns about whether a loan license is required when a medical device manufacturer outsources sterilization to a licensed third-party facility. The issue was examined by a sub-committee formed after the 61st Drugs Consultative Committee (DCC) meeting. The recommendations were subsequently accepted by the DCC in its 65th meeting and ratified by the 92nd DTAB meeting held on 24 April 2025.

The sub-committee concluded that a loan license need not be required for outsourcing sterilization, provided the manufacturer retains control over quality checks and the final product release. Manufacturers may outsource sterilization to a third-party facility holding a valid sterilization license under Medical Devices Rules, 2017, through a mutual agreement. However, the third-party facility must be licensed to carry out sterilization of the specific category of medical device.

Further, it was recommended that the license number of the sterilization site should be mandatorily mentioned on the product label due to the critical nature of sterilization. Additionally, manufacturers are required to submit documentary evidence to the Licensing Authority before obtaining the manufacturing license. These documents include the mutual agreement, QMS documents (such as Plant Master File and Device Master File) clearly reflecting the outsourced activity.