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
Processing Timeline and Validity:
Applications are typically processed within 90 days of receipt of complete documentation. Manufacturing licences are valid for 5 years from the date of issue and must be renewed before expiry. License renewal applications should be submitted at least 6 months before the expiry date.