Country guide: India
Cleanroom contractor in India: Schedule M and buyer rules
In India drug regulators inspect the owner's factory against revised Schedule M, not the contractor. A government upgrade scheme lists clean rooms as eligible work for pharmaceutical units with turnover below ₹500 crore.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your factory
Revised Schedule M, titled Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products, was notified on 28 December 2023 (India Briefing; PIB, 12 February 2025).
Small and medium units had three months from 11 February 2025 to file an upgrade plan in Form A (PIB, 12 February 2025). In November 2025 the Drugs Controller General (India) asked states and Union Territories to start inspections for compliance with revised Schedule M (PTI, 10 November 2025).
| Manufacturer | Compliance date |
|---|---|
| Large, turnover above ₹250 crore | 28 June 2024 |
| Small and medium, ₹250 crore or less | 31 December 2025, if Form A was filed |
Who builds cleanrooms here
Pharmaceutical manufacturing units are the clearest buyers. India Briefing reports that Schedule M upgrades include physical infrastructure and air handling systems (India Briefing, checked 31 October 2026).
Government support for upgrades
The Department of Pharmaceuticals announced a revamped Pharmaceutical Technology Upgradation Assistance Scheme on 11 March 2024. Eligible work includes HVAC systems, water and steam utilities, testing laboratories, stability chambers and clean room facilities (PIB, 11 March 2024).
Any pharmaceutical manufacturing unit with turnover below ₹500 crore can apply, and MSMEs are preferred (PIB, 11 March 2024). Check the current scheme guidelines before you plan around it.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State the owner's turnover band and whether Form A was filed. Say which state drug regulator will inspect.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does CDSCO approve cleanroom contractors?
No. Drug regulators inspect the owner's factory against revised Schedule M. The owner chooses the contractor.
What was the Schedule M deadline for small units?
31 December 2025 for units with turnover of ₹250 crore or less that filed Form A (PIB, 12 February 2025).
Can a scheme part-fund a cleanroom in India?
The revamped scheme lists clean room facilities as eligible work for units under ₹500 crore turnover (PIB, 11 March 2024). Rules can change, so read the current guidelines.
Who inspects for revised Schedule M?
State and Union Territory drug regulators, after the Drugs Controller General's request of November 2025 (PTI, 10 November 2025).
Related guides
- How to choose a cleanroom contractor: questions and evidence
- How long does it take to build a cleanroom?
- How to Import a Cleanroom from China
- How to audit a cleanroom panel factory, on site or by video
- Turnkey cleanroom contractor
- Room list builder
Sources
- PIB, Conditional extension of timeline to small and medium pharmaceutical manufacturers for compliance with revised Schedule M (12 February 2025)
- India Briefing, Pharmaceutical SMEs in India gain time to meet enhanced GMP standards under revised Schedule M (checked 31 October 2026)
- PTI via The Week, DCGI orders inspections of pharma units to ensure compliance with revised Schedule M norms (10 November 2025)
- PIB, Department of Pharmaceuticals announces the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (11 March 2024)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184