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
Schedule 5 GMP Scope:
Schedule 5 GMP requirements cover: personnel and training; premises and equipment; documentation and records; production and in-process controls; quality assurance; storage and distribution; and post-market surveillance. Facilities must maintain detailed standard operating procedures (SOPs) for all manufacturing processes and conduct regular internal audits.