CDSCO Schedule M – Indian GMP Requirements for Pharmaceutical Manufacturers

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, QMS, QRM, Process Validation, CSV, PQR • Regulatory Affairs, QA, Operations, Engineering, IT

CDSCO Schedule M sets the Indian GMP requirements for pharmaceutical manufacturers under the Drugs and Cosmetics Rules. Issued under the authority of the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers, Schedule M spells out expectations for premises, equipment, documentation, utilities, quality systems and product controls. Recent revisions have pushed Schedule M closer to WHO, PIC/S and ICH expectations, adding explicit requirements for product quality review, quality risk management, lifecycle validation and computerised systems. For Indian sites and global MA holders sourcing from India, Schedule M isn’t just a legal checklist; it’s the baseline that determines whether Indian-made product can credibly support global supply chains and SRA-grade expectations.

“Schedule M is where Indian law meets global GMP reality. If your plant only just passes Schedule M today, it will struggle under WHO, EMA or FDA tomorrow.”

1) What Schedule M Actually Is

Schedule M is an annex to the Indian Drugs and Cosmetics Rules that sets out GMP requirements and facility standards for the manufacture of pharmaceutical products. It describes general requirements (Part I) and specific requirements for different dosage forms and activities (e.g. sterile products, oral solids, liquids, topicals, inhalers, APIs). Compliance with Schedule M is a licence condition for Indian manufacturers: without it, they cannot legally manufacture drugs for the domestic market, and they are unlikely to be trusted for export. Practically, Schedule M is the baseline benchmark State Drug Controllers and CDSCO use during GMP inspections and licence renewals.

2) CDSCO, State Regulators and the Enforcement Model

India’s regulatory system splits responsibilities between CDSCO at the central level and State Drug Controllers at the state/UT level. Schedule M provides the legal requirements; enforcement happens through inspections, sampling and testing, and licence actions (approval, renewal, suspension, cancellation). Historically, enforcement quality has been variable across states. Recent moves toward risk-based inspection, national coordination and revised Schedule M guidelines aim to tighten and harmonise enforcement so that GMP expectations are consistent irrespective of geography or company size.

3) Structure of Schedule M – General and Specific Requirements

Schedule M is structured into general GMP requirements and product-specific chapters. General requirements cover premises design, surroundings, personnel, sanitation, storage, documentation, self-inspection, quality control and site master files. Specific parts add extra requirements for sterile products, oral solids, liquids, topicals, metered-dose inhalers and APIs, among others. For example, sterile chapters specify air classification, cleanroom behaviour and environmental monitoring, while API sections focus on containment and segregation for beta-lactams, steroids and cytotoxics. Manufacturers must comply with both the general and the relevant specific sections for the products they make.

4) Revised Schedule M – Why It Changed and What It Adds

India has been under increasing pressure—from domestic stakeholders and global partners—to raise GMP standards across its highly fragmented manufacturing base. Revised Schedule M incorporates more explicit requirements for pharmaceutical quality systems, risk management, validation, training and self-inspection, and it seeks closer alignment with WHO GMP and PIC/S PE009. Key additions include formalised PQR/APR, structured QRM, enhanced expectations for process validation, and increased attention to computerised systems and data integrity. The goal is to narrow the gap between “Schedule M compliant” and “global GMP ready.”

5) Pharmaceutical Quality System (PQS) Under Schedule M

Revised Schedule M explicitly recognises the need for a structured Pharmaceutical Quality System similar to ICH Q10 concepts. That means documented processes for change control, deviations, CAPA, management review, supplier management and continual improvement. It expects quality to be built into processes and culture, not bolted on at QC release. For Indian manufacturers, this often means formalising practices that were previously ad-hoc and ensuring that QA has sufficient authority, resources and independence to challenge production and commercial pressures when needed.

6) Premises, HVAC and Utilities – Design for Compliance, Not Retrofits

Schedule M spends significant space on the design and maintenance of buildings, HVAC, water systems and other utilities. Requirements include suitable layout to prevent mix-ups and cross-contamination, appropriate room finishes, environmental controls for critical operations, and validated water systems. For sterile and high-risk products, expectations are closer than ever to WHO GMP and EU Annex 1: clear zoning, pressure differentials, air filtration and documented qualification. In practice, compliance is easiest when facilities are designed with these principles in mind; retrofitting non-compliant legacy buildings can be much more expensive than building correctly from the start.

7) Validation and Qualification – From Implied to Explicit

Earlier versions of Schedule M implied validation; revised text makes it explicit. Manufacturers must qualify equipment, utilities and facilities and validate processes, cleaning procedures, sterilisation steps and analytical methods. Documentation must be sufficient to demonstrate that processes are capable, robust and under ongoing control. That aligns Schedule M with global expectations around protocol-based qualification, process performance qualification (PPQ) and lifecycle validation. For many plants, this means upgrading from one-time “validation projects” to ongoing CPV and integrated validation planning across changes and technology transfers.

8) Documentation, GDP and Data Integrity Expectations

Schedule M has always emphasised documentation; revisions sharpen that focus in line with modern data integrity thinking. Manufacturers must maintain contemporaneous, legible, complete and traceable records for manufacturing, packaging, testing and distribution. Good Documentation Practices (GDP) are not optional niceties—they are how firms demonstrate control to inspectors. For computerised systems, expectations align with CSV and ALCOA+ principles: validated systems, controlled access, meaningful audit trails and governance of hybrids and spreadsheets.

9) Risk-Based Inspection and Self-Inspection

Indian regulators have explicitly embraced risk-based inspection models, supported by guidance for risk-based inspection planning. Schedule M complements this by requiring robust self-inspection and internal audit programmes. Sites are expected to identify and correct their own weaknesses proactively—not wait for CDSCO or State inspectors to point them out. For global customers and NRAs, evidence of effective self-inspection and CAPA is often as reassuring as the outcome of any single regulatory visit. Weak or cosmetic self-inspection is a frequent underlying root cause of recurring findings in India and elsewhere.

10) Computerised Systems – MES, LIMS and Electronic Records

Revised Schedule M explicitly calls out computerised storage systems and electronic records as part of the GMP environment. That encompasses MES/eBMR, LIMS, inventory systems and local tools. The implication is clear: manufacturers must validate these systems, manage access and roles, review audit trails and treat system design as part of GMP, not as a pure IT exercise. For Indian manufacturers supplying SRAs, aligning Schedule M compliance with global expectations for electronic records is a critical integration point.

11) Product Quality Review (PQR) and Annual Reporting

Schedule M now explicitly expects periodic review of product quality and process performance, similar to EU and WHO requirements. PQR should consolidate data on batches, deviations, complaints, OOS/OOT results, stability, changes and returns, and propose improvements or confirm ongoing suitability. For companies serving multiple markets, Schedule M PQRs can be harmonised with EU-style PQR/APR processes to avoid duplication. What matters is that reviews are analytical and action-oriented, not just compilations of numbers created “for the file.”

12) Training, Competence and Quality Culture

Schedule M requires manufacturers to have adequately trained personnel with clearly defined responsibilities. Revisions reinforce the need for structured training programmes, competency assessments and role-based expectations. In practice, this moves Indian GMP closer to the global emphasis on quality culture: operators who understand why controls exist, supervisors who reinforce good behaviours, and managers who lead by example in deviation reporting and decision-making. Training that is merely attendance-based will not satisfy inspectors who can see gaps on the shop floor or in batch documentation.

13) Impact on MSMEs and the Wider Indian Industry

Many Indian manufacturers are micro, small or medium enterprises (MSMEs). Revised Schedule M sets the same GMP principles for all, but regulators have recognised the cost and complexity for smaller firms by providing phased implementation timelines and targeted support schemes. Nonetheless, the direction of travel is clear: plants that cannot meet upgraded expectations face licence actions and shrinking market access. Strategically, MSMEs may need to rationalise portfolios, invest in facilities and systems, partner with larger organisations, or pivot to contract manufacturing models under stronger central QA oversight.

14) How Global MA Holders Should View Schedule M

For non-Indian companies sourcing APIs or FDFs from India, Schedule M compliance is necessary but not sufficient. It should be treated as a baseline to be supplemented by supplier audits, quality agreements, additional controls and, where relevant, alignment with WHO, EMA, FDA or other SRA expectations. When sites demonstrate strong Schedule M compliance and mature PQS practices, they become more attractive long-term partners. When they barely meet local GMP, global sponsors should expect higher oversight costs, more variability and more regulatory risk.

15) Implementation Roadmap – Moving from “Paper Compliance” to Real Control

Many sites already “comply on paper” with Schedule M but struggle with consistent execution. A realistic roadmap starts with a gap analysis against revised requirements, focusing on QMS maturity, validation, utilities, documentation, data integrity and computerised systems. Next come prioritised remediation projects—facility upgrades, process revalidation, MES/LIMS improvements, training and cultural interventions. Finally, sites should embed monitoring (KPIs, PQR, CPV, internal audits) so that improvement continues after the next inspection. The more Schedule M becomes part of everyday decision-making rather than a once-a-year licence ritual, the less painful each regulatory tightening will feel.

16) FAQ

Q1. Is Schedule M equivalent to EU GMP or PIC/S GMP?
Revised Schedule M has moved closer to WHO and PIC/S-style GMP, especially around PQS, validation and risk management. However, exact equivalence depends on implementation and enforcement. Global firms should still assess Indian sites against EU/PIC/S expectations when needed.

Q2. Does Schedule M apply only to finished product manufacturers?
No. Schedule M also includes specific requirements for active pharmaceutical ingredient (bulk drug) manufacturing, alongside dosage-form-specific chapters. API manufacturers must comply with relevant sections as a condition of their licences.

Q3. Do computerised systems really fall under Schedule M?
Yes. Revised Schedule M explicitly calls out computerised storage and records, which brings MES, LIMS, inventory and other GxP systems into scope for validation, access control and data integrity expectations, consistent with global CSV principles.

Q4. How often will regulators inspect for Schedule M compliance?
Inspection frequency is risk-based and depends on product types, compliance history and other factors. However, revised guidance and circulars emphasise more proactive and harmonised enforcement, especially for non-compliant or high-risk units.

Q5. What is a practical first step for a plant upgrading to revised Schedule M?
Conduct a structured gap assessment against revised Schedule M, prioritise remediation around PQS, validation, utilities and documentation, and build a realistic, resourced implementation plan. Use that plan to drive capital, IT and training decisions rather than treating GMP upgrades as one-off patch jobs.

Related Reading
• Core GMP & QMS: GMP / cGMP | QMS | 21 CFR 211 | PIC/S PE009
• Validation & Risk: Process Validation | Cleaning Validation | CPV | QRM
• Systems & Data: CSV | MES | LIMS | Data Integrity
• Monitoring & Improvement: PQR/APR | Deviation / NC | RCA | CAPA