WHO-GMP certification, plant readiness and Schedule M compliance
A WHO-GMP certificate and Certificate of Pharmaceutical Product are issued in India by the State Licensing Authority following an inspection against WHO TRS guidance and Schedule M of the Drugs and Cosmetics Rules. Many importing countries require one or both before they will register a product, which makes this an export prerequisite rather than an optional credential.
| WHO-GMP | Certificate issued by the State Licensing Authority |
|---|---|
| COPP | Certificate of Pharmaceutical Product |
| Schedule M | Good manufacturing practices, revised 2023 |
Who issues it, and why that surprises people
Not CDSCO. WHO-GMP certificates and COPPs are issued by the State Licensing Authority for the state in which the plant sits, typically following a joint inspection. Exporters who go to CDSCO first lose time.
The certificate is site and product specific. It names the manufacturing premises and the products covered, which means a new product or a new block needs an amendment rather than riding on the existing certificate.
Revised Schedule M
Schedule M was substantially revised in December 2023, moving Indian GMP requirements considerably closer to WHO expectations. The revision brought in a pharmaceutical quality system, quality risk management, product quality review, computerised system validation and tighter requirements on data integrity.
Compliance timelines have been phased, with different dates applying by manufacturer size, and those dates have been revisited more than once. Confirm the position that currently applies to your unit before planning capital expenditure around it. We track this and will tell you where you stand.
Plant readiness work
Where a plant is being built or a block added, we work on layout before construction: material and personnel flow, classified area design, airlock strategy, HVAC zoning and pressure cascade, water system design, and segregation for products requiring dedicated facilities.
For existing plants, the work is a gap assessment against the current requirements followed by a remediation plan, usually covering qualification and validation documentation, the quality management system, and data integrity across laboratory and production systems.
Data integrity is where the modern findings concentrate. Audit trails that are not reviewed, shared logins, and standalone instruments with no controlled backup will be found.
What you need to supply
- Existing manufacturing licence in Form 25 or Form 28
- Site master file
- Plant layout drawings with classified areas marked
- Validation and qualification master plan and reports
- List of products for which certification is sought
- Quality management system documentation index
- Water system and HVAC qualification records
Questions we get asked
Do we need WHO-GMP certification to export?
Not universally, but many importing countries ask for a WHO-GMP certificate or a Certificate of Pharmaceutical Product before they will register your product. In India these are issued by the State Licensing Authority following an inspection against WHO TRS guidance and Schedule M.
Who issues the WHO-GMP certificate in India, CDSCO or the State authority?
The State Licensing Authority for the state where the plant is located, ordinarily following a joint inspection. This surprises exporters who approach CDSCO first. The certificate names the specific premises and products it covers.
What changed in the revised Schedule M?
The December 2023 revision introduced a formal pharmaceutical quality system, quality risk management, product quality review, computerised system validation and stronger data integrity requirements, moving Indian GMP closer to WHO expectations. Compliance deadlines are phased by manufacturer size and have been revised, so confirm the current position for your unit.
This page is orientation, not advice on your specific product. Statutory periods, fee schedules and compliance deadlines change. Confirm the current position before you plan around it. Last reviewed 23 August 2026.