Live tracking of enforcement status, inspection activity, and resources for pharmaceutical GMP compliance
Central Drugs Standard Control Organisation
Last reviewed: 30 June 2026
Revised Schedule-M is now fully in force — no further extensions
The final MSME compliance deadline of December 31, 2025 has passed. From January 1, 2026, Revised Schedule-M applies to every pharmaceutical manufacturing unit in India, with no further extensions confirmed by CDSCO.
Roughly only 26% of eligible MSMEs had filed upgradation plans by the deadline. State drug controllers are now conducting risk-based inspections and filing monthly compliance reports to CDSCO. Non-compliant units face licence suspension.
Enforcement Status — Live Since January 1, 2026
Compliance deadline has passed. Tracking is now inspection-stage, not countdown-stage.
100%Legally Binding
~26%MSMEs Filed Plans
MonthlyState Inspection Reports
0Further Extensions Granted
Compliance Status
Enforcement Phase Active
The extension window closed on December 31, 2025. All pharmaceutical units, including MSMEs that did not file for extension, are now subject to Revised Schedule-M without exception.
MSMEs with filed upgradation plans26%
WHO-GMP certified units (of ~10,500 total)~19%
Key Dates — Status
SME Extension Application Window
Submitted via ONDLS portal
Closed
Non-SME Full Compliance
Mandatory implementation
Passed
Final MSME Compliance Date
For all pharmaceutical units
Dec 31, 2025
Risk-Based Inspections
CDSCO / state drug controller audits
Ongoing
Industry Impact
Total pharmaceutical units in India: ~10,500
MSME units (turnover < ₹250 crore): ~8,500
~6,300 MSME units at compliance risk
Only ~1,700 MSMEs filed extension/upgrade plans
~2,000 units already hold WHO-GMP certification
Non-compliant units face suspension of manufacturing licence
Compliance Focus Areas
International GMP harmonization (WHO / PIC/S)
Manufacturing premises and HVAC upgrade
Pharmaceutical Quality Systems (PQS)
Equipment and computerised system validation
Personnel qualification standards
Data integrity (ALCOA+) and documentation
Pharmacovigilance / PSUR reporting from launch date
Product recall management
Top Challenge: Capital for Facility Upgrades
Implementation Timeline
December 2023
Revised Schedule-M officially notified by the Health Ministry
Completed
January 1, 2025
Original implementation date came into effect for non-MSME units
Completed
February 11, 2025
G.S.R. 127(E) notification grants MSMEs (turnover under ₹250 crore) a one-year extension, conditional on filing a gap analysis and upgrade plan
Completed
March 2025
CDSCO launched the online extension application system on the ONDLS portal
Completed
May 2025
Deadline for MSMEs to submit extension applications with compliance roadmap via ONDLS — only ~1,700 of ~6,500 eligible units applied
Completed
November 7, 2025
DCGI directive instructs state/UT drug controllers to begin inspections of units that did not apply for extension, with mandatory monthly compliance reporting
Completed
December 31, 2025
Final compliance deadline for MSME pharmaceutical manufacturing units lapses — no further extension granted
Completed
January 1, 2026 – Present
Revised Schedule-M is binding on every pharmaceutical unit in India. Risk-based inspections and monthly state reporting to CDSCO are underway; non-compliant units face licence suspension
Current
January 2026
Ministry of Health and Family Welfare publishes sweeping amendments to the NDCT Rules, 2019, now in effect alongside Schedule-M enforcement
Key Regulatory Changes
1
GMP Harmonization
Full alignment with WHO and PIC/S GMP standards to eliminate duplicative inspections and facilitate international market access.
Global Alignment
2
Facility Standards
Enhanced requirements for manufacturing premises design, maintenance, and environmental controls, including HVAC and water system qualification.
Infrastructure
3
Quality Management
Mandatory implementation of Pharmaceutical Quality Systems (PQS) with enhanced documentation and change control procedures.
Process Control
4
Validation Protocols
Comprehensive validation requirements covering equipment (IQ/OQ/PQ), processes, cleaning, and computerised systems (CSV).
Quality Assurance
5
Personnel Requirements
Stricter qualification standards for all personnel with mandated training programs and competency assessments.
Workforce
6
Data Integrity
ALCOA+ principles for data management with audit trail requirements for all GMP records.
Compliance
7
Pharmacovigilance (PSUR) Update
Periodic Safety Update Reports must now be filed from the actual market launch date rather than approval date, with all dosage forms/indications unified in a single report.
Drug Safety
8
Inspection & Reporting Regime
State and UT drug controllers now submit monthly inspection reports to CDSCO, ensuring non-compliant units cannot remain unaudited.
Note: If you are following the updates on this topic, then keep visiting to this dashboard, we are updating it frequently as any update develops. You can also contact us for paid consultation regarding the implementation of Revised Schedule-M in your existing facility.
