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
Inspection Framework:
Inspections include: pre-grant inspection (mandatory before licence issuance); routine inspections (conducted at least once every 2 years); and surprise inspections (for compliance verification). Inspectors assess GMP compliance, quality system implementation, and record-keeping. Inspection reports are communicated to applicants with timelines for remedial action. Non-compliance may result in licence suspension or cancellation.