CDSCO Revised Schedule-M Compliance Dashboard

Important Regulatory Update

SME pharmaceutical companies (turnover < ₹250 crore) can apply for compliance extension until December 31, 2025.

Application deadline: May 10, 2025 via ONDLS portal. Non-SME companies must be fully compliant by August 1, 2025.

Final Compliance Deadline Countdown

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Compliance Status

Extension Period Active

SME pharmaceutical companies (turnover < ₹250 crore) can apply for extension until December 31, 2025.

Industry Implementation Progress 78%

SME Compliance Rate 42%

Critical Deadlines

SME Extension Application

Submission via ONDLS portal

May 10, 2025

Non-SME Compliance

Full implementation required

Aug 1, 2025

Final Compliance Date

For all pharmaceutical units

Dec 31, 2025

First Audit Cycle

CDSCO facility inspections

Jan 15, 2026

Industry Impact

Total pharmaceutical units in India: ~10,500

SME companies eligible for extension: ~8,200 (78%)

2,300 units at risk

Estimated compliance cost: ₹15-50 lakhs per unit
Average implementation timeline: 6-9 months
Training requirements: 85% of workforce

Compliance Focus Areas

International GMP harmonization
Manufacturing premises upgrade
Quality management systems
Equipment validation protocols
Personnel qualification standards
Documentation and record keeping
Validation and qualification processes
Product recalls management

Top Challenge: Facility Upgrades

Implementation Timeline

December 2023

Revised Schedule-M officially notified by Health Ministry

Completed

January 1, 2025

Original implementation date came into effect

Completed

January 6, 2025

Union Health Ministry notified revised rules with extension provisions

Completed

March 2025

CDSCO launched online extension application system (ONDLS)

Completed

May 10, 2025

Deadline for SME companies to submit extension applications via ONDLS portal

Current

August 1, 2025

Mandatory compliance date for non-SME pharmaceutical companies

December 31, 2025

Final compliance deadline for all pharmaceutical manufacturing units

January 15, 2026

Commencement of first audit cycle by CDSCO inspection teams

Key Regulatory Changes

GMP Harmonization

Full alignment with WHO and PIC/S GMP standards to eliminate duplicative inspections and facilitate international market access.

Global Alignment

Facility Standards

Enhanced requirements for manufacturing premises design, maintenance, and environmental controls including HVAC validation.

Infrastructure

Quality Management

Mandatory implementation of Pharmaceutical Quality Systems (PQS) with enhanced documentation and change control procedures.

Process Control

Validation Protocols

Comprehensive validation requirements covering equipment, processes, cleaning, and computerized systems.

Quality Assurance

Personnel Requirements

Stricter qualification standards for all personnel with mandated training programs and competency assessments.

Workforce

Data Integrity

New ALCOA+ principles for data management with audit trail requirements for all GMP records.

Compliance

Compliance Resources

Official Guidelines

Complete Schedule-M documentation and regulatory text

Download

ONDLS Portal

Online portal for extension applications and compliance submissions

Access Portal

Compliance Checklist

Step-by-step verification for facility and process requirements

Download

SME Application Guide

Detailed documentation requirements and submission process

View Guide

Training Webinars

Recorded CDSCO workshops and implementation tutorials

Watch Now

Support Center

Regulatory experts available for compliance queries

Contact

Central Drugs Standard Control Organization (CDSCO) – Directorate General of Health Services

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.