loan license to obtain in India, medical device manufacturers must adhere to regulatory requirements.
A loan license in the context of medical devices involves an arrangement where a company without manufacturing capabilities can partner with another manufacturer possessing the necessary facilities. This agreement, sanctioned by the State Licensing Authority (SLA) or Central Licensing Authority (CLA), allows the former to utilize the latter’s infrastructure for production. This ensures compliance with the regulatory standards set by the Central Drugs Standard Control Organization (CDSCO) for manufacturing and marketing medical devices in India.
- Purpose: A loan license allows a company that lacks manufacturing facilities to partner with another manufacturer to produce medical devices.
- Regulatory Oversight: The issuance of a loan license is overseen by the State Licensing Authority (SLA) or Central Licensing Authority (CLA) depending on the jurisdiction. It ensures that the manufacturing process complies with the stringent regulatory standards set by the Central Drugs Standard Control Organization (CDSCO) in India.
- Agreement Details: The agreement between the two manufacturers specifies that the licensee (the company without manufacturing capabilities) can use the facilities and infrastructure of the licensor (the manufacturing partner) for production purposes. This includes utilizing equipment, premises, and expertise required for manufacturing medical devices.
- Quality Control and Compliance: Both parties must adhere strictly to quality control measures and regulatory guidelines throughout the manufacturing process. This ensures that the medical devices produced meet safety, efficacy, and quality standards before they can be marketed and distributed in India.
- Market Access: By obtaining a loan license, the licensee gains access to the Indian market for their medical devices without needing to invest heavily in establishing their own manufacturing facilities from scratch.
- Renewal and Compliance Updates: The license typically requires periodic renewal to ensure continued compliance with evolving regulatory requirements and quality standards.
Manufacturers often choose the loan license pathway for several reasons. It allows them to navigate regulatory hurdles, reducing the initial investment needed to enter the Indian market. This approach is particularly beneficial for manufacturers facing limitations in production capacity.
Various entities stand to benefit from the loan license option, including startups, foreign companies, Indian firms, and manufacturers holding manufacturing licenses but lacking essential sterilization facilities.
Here are the requirements for obtaining a loan license, rephrased:
Before applying for approval of a loan license, ensure the manufacturing site complies with local Quality Management System (QMS) standards for medical devices.
Appoint qualified technical personnel to supervise and manage the manufacturing process.
Additionally, appoint technical personnel with at least two (02) years of experience in medical device
Here are the key elements typically included in a loan license agreement:
- Facilities and Infrastructure: The Indian manufacturer (licensor) provides necessary facilities and infrastructure to the foreign company (licensee) for manufacturing the medical device.
- Technology Transfer: The Indian manufacturer transfers technical know-how and expertise to the foreign company to enable the manufacturing process.
- Regulatory Compliance: The foreign company assumes responsibility for obtaining Regulatory approvals from the CDSCO (Central Drugs Standard Control Organization) to manufacture and market the medical device in India.
- Quality Control: The foreign company ensures that the medical device complies with all required quality and safety standards.
- Compensation: The foreign company pays a fee to the Indian manufacturer for using their facilities and infrastructure.
These elements outline the terms and responsibilities involved in a loan license agreement between an Indian manufacturer and a foreign company for the production and marketing of medical devices in India.
Manufacturers of low- and moderate-risk medical devices seeking loan licenses to produce Class A and B devices must submit applications to the SLA. Applications are processed through an online portal using Form MD-4, accompanied by a processing fee. Approval notifications for manufacturing, selling, or distributing Class A or B medical devices will be issued via Form MD-6 upon application review.
Loan License Authorization for Manufacturing Class C and D Medical Devices
Manufacturers seeking licenses to manufacture Class C and D medical devices must apply through the CLA. The application process involves submitting form MD-8 via an online portal and paying the required processing fee. Approval of the application, indicated by Form MD-10, follows after the submission. Within sixty (60) days of application submission, medical device officers conduct an inspection of the manufacturing facility before granting the license.
Loan License Validity
Loan licenses issued for Class A, B, C, and D medical devices are valid indefinitely, provided that the license maintenance fee is paid within five (05) years from the date of issue. The validity may be suspended or canceled by the SLA/CLA under certain circumstances.
Conclusion
In conclusion, manufacturers seeking loan licenses from the SLA and CLA must adhere to CDSCO’s regulatory requirements. They must maintain comprehensive documentation throughout the application process. The stringent regulatory framework of CDSCO may present challenges for manufacturers in obtaining loan license certification for their medical devices.