Compliance
Revised Schedule M Compliance & Plant Upgradation
Revised Schedule M is now the mandatory GMP standard for every licensed drug manufacturer in India. If your facility was built to the older standard you need a gap assessment, a costed upgrade plan, and a documentation system that matches the new requirements. Pharmateq does all three.
Last updated: 14 August 2026
Does this sound like your plant?
- You have received an inspection observation and do not know where to start
- Your HVAC and water systems were designed under the old Schedule M
- You have SOPs, but not a Pharmaceutical Quality System
- You have been quoted crores for an upgrade and cannot tell what is essential
- Your qualification and validation records will not survive scrutiny
What we do
- Gap assessment (2-4 weeks). We inspect your facility against every clause of Revised Schedule M and give you a prioritised written gap report, not a verbal opinion.
- Costed remediation roadmap. Every gap is classified Critical, Major or Minor, with the specific fix, estimated cost and timeline.
- Engineering execution. Revised layouts, HVAC redesign, water system upgrades and environmental controls, designed, specified and supervised through commissioning.
- Documentation build. PQS, SOPs, BMRs, qualification protocols, validation protocols, QRM files, data integrity controls.
- Training and handover. Your team trained on the new systems, with documented effectiveness evaluation.
- Inspection support. We are present when the regulator arrives.
Typical remediation runs 6 to 18 months depending on how much civil and utility work is required.
Questions
The five we are asked most
How long does Revised Schedule M compliance take?
A gap assessment takes 2-4 weeks. Full remediation typically runs 6 to 18 months, depending on how much civil, HVAC and utility work your facility needs. Documentation-only gaps can be closed in 3-4 months.
What does a Schedule M upgrade cost?
Industry estimates for a full MSME facility upgrade commonly fall between Rs 10 and Rs 15 crore, but that figure assumes a complete rebuild. Most plants we assess need considerably less once mandatory items are separated from optional ones. We give you a costed breakdown before you commit to anything.
Do you work outside Gujarat?
Yes. We are based in Ahmedabad and work across India, including Baddi, Indore-Pithampur, Hyderabad and Mumbai. For clients outside Gujarat we typically combine monthly on-site visits with continuous remote documentation support.
Will you be present during the actual inspection?
Yes. Presence and support during customer and regulatory audits is part of our standard engagement.
What is the difference between Schedule M and WHO-GMP?
Revised Schedule M is India statutory GMP requirement under the Drugs and Cosmetics Rules, and mandatory for every licensed manufacturer. WHO-GMP certification is a separate, voluntary certification usually required for export markets. The revised Schedule M was aligned with WHO standards, so a compliant plant is well positioned for WHO-GMP, but they are not the same thing and require separate documentation.
Start here
Find out what your plant actually needs.
A 30-minute call, no charge, no obligation. Tell us your dosage form, your licence status and your deadline. We will tell you honestly whether you have a documentation problem, an engineering problem, or both.
- A senior consultant on the call, not a salesperson
- A written summary of what we discussed within 48 hours
- No proposal until you have seen a gap report
Request a free gap assessment
We reply within one working day.