07th November 2025

 

The Central Drugs Standard Control Organisation (CDSCO) has issued a directive to all State Licensing Authorities (SLAs) to conduct inspections of pharmaceutical manufacturing firms in accordance with the Revised Schedule M requirements.

As per the notice dated 07.11.2025, the Drugs Controller General of India (DCGI) has instructed SLAs to initiate inspections based on the Revised Schedule M, notified vide G.S.R. 922(E) dated 28.12.2023, which comes into effect from 01.01.2026.

However, this effective date of 01.01.2026 applies only to those manufacturers who had applied for an extension under G.S.R. 127(E) dated 11.02.2025.

For all manufacturers who have not applied for such an extension, inspections in line with the Revised Schedule M are to be initiated immediately.

It is noteworthy that despite repeated advisories and directives from CDSCO and SLAs, it is estimated that only 10–12% of manufacturing firms applied for an extension. Consequently, the remaining firms will now be subject to immediate and comprehensive inspections under the revised requirements.

CDSCO has also directed all SLAs to submit monthly reports containing details of:

  • Inspections conducted and observations made, and
  • Actions taken pursuant to such inspections.

This directive signifies a strong regulatory push toward ensuring uniform compliance with the Revised Schedule M, emphasizing Good Manufacturing Practices (GMP) and quality assurance across all categories of pharmaceutical manufacturing units in India.

For complete details, kindly refer to the official CDSCO circular.

 

💼 How Vaayath Consulting Services Pvt. Ltd. Can Support You

At Vaayath Consulting Services Pvt. Ltd., we specialize in guiding pharmaceutical manufacturers toward full compliance with the Revised Schedule M through our end-to-end technical and regulatory services, including:

✅ GAP Assessment & Compliance Roadmap
Evaluate current systems and define a clear path to compliance.

🏗️ GMP Layout Designing
Facility design and modification support to meet GMP and regulatory standards.

🏭 Greenfield & Brownfield Project Handling
Turnkey consulting for setting up or upgrading manufacturing facilities in line with regulatory expectations.

🧪 Quality System Implementation & Auditing
Internal audits, third-party GMP audits, and vendor qualification audits to ensure robust compliance.

📚 Training & Capacity Building
Customized training programs for QA, QC, Production, and Engineering teams on Revised Schedule M compliance.

💊 Pharmacovigilance & Regulatory Support
Implementation of post-marketing surveillance systems and dossier preparation assistance.

 

For more details, Contact us at info@vaayath.com