Manufacturing Licences in India
India's manufacturing licence framework splits authority between CDSCO (Class C/D) and State Licensing Authorities / SLAs (Class A/B).
Manufacturing licence types
| Form | Purpose | Issuing authority |
|---|---|---|
| Form MD-5 | New manufacturing licence | CDSCO (Class C/D) or SLA (Class A/B) |
| Form MD-9 | Loan / contract manufacturing | CDSCO or SLA |
Key requirements
- Premises must comply with Schedule 5 GMP requirements;
- Technical staff qualifications as specified in MDR 2017;
- Full quality system documentation;
- CDSCO/SLA inspection prior to grant of licence.
Official source: Medical Devices Rules 2017, Chapter IV; CDSCO
Loan Manufacturing Definition:
Loan (contract) manufacturing allows a licensed manufacturer to produce devices for another entity. Form MD-9 is used for such arrangements. Both the licensee and the contract manufacturer must maintain full traceability and quality documentation. The contract manufacturer assumes responsibility for GMP compliance during production, while the licensee remains responsible for product quality and regulatory compliance.