Revised Schedule M (GMP) 2026: What It Is, Deadlines, Key Requirements and What PCD Partners Should Check
By the Trumac Healthcare team, Panchkula · PCD pharma franchise company since 2007 · Updated 14 November 2026 · About us · WhatsApp +91 90416 77932
हिंदी में: शेड्यूल M दवा बनाने वाली फैक्ट्रियों के लिए GMP (गुड मैन्युफैक्चरिंग प्रैक्टिस) के नियम हैं। संशोधित शेड्यूल M 28 दिसंबर 2023 को आया और 1 जनवरी 2026 से सभी यूनिटों पर लागू है।
Revised Schedule M timeline and deadlines
| Date | What happened | Detail |
|---|---|---|
| 28 Dec 2023 | Revised Schedule M notified – G.S.R. 922(E), Drugs Rules, 1945 | Replaces the old Schedule M; aligns Indian GMP with WHO-GMP |
| 28 Jun 2024 | Deadline for large manufacturers (turnover above ₹250 crore) | Six months from notification |
| 28 Dec 2024 | Original deadline for small and medium units (₹250 crore or less) | Still the date for units that did not apply for extension |
| 11 Feb 2025 | G.S.R. 127(E): conditional extension for MSMEs | Units filing Form A with an upgrade plan within three months (by 11 May 2025) got until 31 Dec 2025 |
| 7 Nov 2025 | CDSCO letter to State Drug Controllers | Inspect units that did not apply; plan inspections of the rest; monthly action reports |
| 1 Jan 2026 | Binding on every drug manufacturing unit | MSME extension window closed on 31 Dec 2025 |
| Feb 2026 | DCGI: audits benchmarked to revised Schedule M | Reported as fully in force with no further extensions or relaxations |
What changed: key requirements of revised Schedule M
The old Schedule M focused mainly on premises and basic records. The revised schedule adds a full quality system. Inspectors now look at these areas:
| Area | What the unit must have |
|---|---|
| Pharmaceutical Quality System (PQS) | A documented quality system covering the whole product life cycle, with management responsibility |
| Quality risk management | Risk-based decisions on processes, changes and suppliers, with records |
| Product quality review | Yearly review of each product’s batches, deviations, complaints and stability data |
| Qualification and validation | Equipment, HVAC, water systems, processes, cleaning and test methods qualified or validated |
| Computerised systems and data integrity | GMP software validated, access-controlled, with audit trails – records attributable, legible and contemporaneous |
| Change control, deviations and CAPA | Every change and deviation recorded, investigated and closed with corrective and preventive action |
| Vendor qualification | Approved suppliers for APIs, excipients and packing material, backed by audits or assessments |
| Stability and QC laboratory | Stability studies to protocol; qualified instruments; out-of-specification results investigated |
| Complaints, recalls and self-inspection | Complaint handling, a tested recall procedure, internal audits and pharmacovigilance links |
| Premises and product-specific rules | Layouts, area classification and extra requirements for sterile, hazardous and other special product types |
Premises, HVAC and water systems take the longest to fix because they need civil work and re-qualification; documentation gaps can usually be closed faster.
Revised Schedule M vs WHO-GMP
- Schedule M is the legal minimum for every licensed unit in India – without it a unit should not be manufacturing.
- WHO-GMP certification is granted after inspection against WHO guidelines, mainly for exports; the revised schedule closes most of the earlier gap.
- India is not a PIC/S member, so meeting revised Schedule M does not by itself make a plant PIC/S compliant.
What it means for PCD partners and marketing companies
A PCD or marketing company sells brands made by licensed manufacturing units, so the GMP standard of those units decides the quality behind your brand name. Before you sign up with any PCD company, check:
- The manufacturing licence of the unit printed on the pack (Mfg. Lic. No.) and the unit’s GMP or WHO-GMP certificate.
- Whether the unit has been inspected or upgraded under revised Schedule M since 2026.
- Batch test reports (certificate of analysis) on request, and whether any of the company’s brands appear in CDSCO’s monthly not-of-standard-quality (NSQ) alerts.
- Correct labels – Schedule H, H1 and Schedule G boxes, and the QR code for antimicrobials from July 2028 (Schedule H2).
- Your own paperwork: a wholesale drug licence and GST – see how to choose a PCD company.
Trumac Healthcare’s products are made at WHO-GMP certified partner manufacturing units. Ask us for the manufacturing details of any product before you order.
Frequently asked questions
What is Schedule M?
Schedule M of the Drugs Rules, 1945 lays down Good Manufacturing Practices (GMP) and the requirements for premises, plant and equipment that every licensed drug manufacturing unit in India must follow.
What is revised Schedule M?
It is the updated GMP schedule notified by G.S.R. 922(E) on 28 December 2023. It adds a pharmaceutical quality system, quality risk management, product quality reviews, qualification and validation, computerised-system controls and stronger supplier, complaint and recall systems – bringing Indian GMP close to WHO-GMP.
When did revised Schedule M come into force?
For large manufacturers (turnover above ₹250 crore) from 28 June 2024. Smaller units had until 28 December 2024, or until 31 December 2025 if they applied in Form A under G.S.R. 127(E). From 1 January 2026 it binds every manufacturing unit.
Is there any extension of revised Schedule M in 2026?
No further extension has been notified. The DCGI said in February 2026 that audits are benchmarked against revised Schedule M with no extensions, and State Drug Controllers are inspecting units under CDSCO’s letter of 7 November 2025.
What is the difference between Schedule M and WHO-GMP?
Schedule M is India’s legal GMP standard for every licensed unit. A WHO-GMP certificate is issued after inspection against WHO’s GMP guidelines, usually for exports. Revised Schedule M brings the two very close, but holding one is not automatically the other.
Does a PCD pharma company need to follow Schedule M?
Schedule M applies to manufacturing premises. A PCD or marketing company that does not manufacture works on a wholesale drug licence, but its brands are made by licensed units – so it should buy only from units that meet revised Schedule M.
What happens if a unit does not comply with revised Schedule M?
Inspectors can issue observations, stop production or suspend or cancel the manufacturing licence, depending on how serious the gaps are. Products that fail quality tests also face recalls and CAPA notices.
Is there government support for Schedule M upgrades?
Yes. The Department of Pharmaceuticals’ Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) supports upgrades by units with turnover below ₹500 crore, with MSMEs preferred.
General guidance for PCD partners and distributors, not legal advice. Sources: G.S.R. 922(E) (28 Dec 2023), G.S.R. 127(E) (11 Feb 2025), CDSCO letter of 7 Nov 2025 and 67th DCC minutes, Business Standard (23 Feb 2026), Department of Pharmaceuticals RPTUAS guidelines. Check CDSCO and the Gazette for later notifications.
Looking for a PCD company with WHO-GMP partner units? WhatsApp +91 90416 77932 with your district – 3000+ products in 15 divisions, no franchise fee, first order from ₹25,000. Trumac Healthcare, Panchkula – supplying 4000+ partners since 2007. Related: PCD pharma franchise · start a medical agency.