The regulatory landscape for Indian pharmaceutical manufacturers has officially shifted. On June 3, 2026, the Central Drugs Standard Control Organization (CDSCO) issued a critical circular regarding File No. PSUR-11/13/2024-eoffice (Comp. No. 17367). The Drugs Controller General of India (DCGI), this notice mandates the immediate establishment and maintenance of an effective Pharmacovigilance (PV) System.
Enforced under the statutory requirements of Para 6.11 of Schedule M of the Drugs & Cosmetics Act 1940 (and rules thereunder) alongside the NDCT Rules 2019, the notice leaves no room for ambiguity: every licensee must have an active system to collect, process, and forward Adverse Drug Reaction (ADR) reports to licensing authorities.
Furthermore, compliance is no longer a distant goal. The CDSCO has made it clear that State Licensing Authorities (SLA), UT administrations, and central officers will actively verify these PV systems during routine inspections and ongoing regulatory audits.
For pharmaceutical CEOs, Directors, and Quality Assurance (QA) Heads, the directive is plain: implement a compliant, bulletproof PV infrastructure immediately, or face severe regulatory penalties during your next facility inspection.
Key Takeaway
Every pharmaceutical license holder must establish, maintain and demonstrate an effective Pharmacovigilance System that satisfies Para 6.11 of Schedule M and NDCT Rules 2019 during regulatory inspections.
The Core Challenge: Transitioning from Reactive to Proactive Compliance
For many companies, capturing safety data has historically been a fragmented, manual process. However, Schedule M compliance demands a tightly unified, auditable lifecycle for handling post-marketing data.
Adhering to this lifecycle via manual, paper-heavy tracking creates immense corporate risk. Human data entry errors, lost communication strings, lack of secure audit trails, and missed submission timelines can compromise patient safety and trigger non-compliance findings from the CDSCO.
To build a sustainable architecture that protects your licenses, you need an integrated blend of expert compliance consulting and regulatory software engineered precisely for the life sciences sector.
Architecting Your PV Framework with Glaers & Aizilus Technologies
At Aizilus Technologies, we specialize in transforming intricate operational and regulatory burdens into scalable competitive advantages.
Through Glaers, our dedicated life sciences division, we provide an affordable, end-to-end ecosystem that addresses the CDSCO mandate from both an operational and digital perspective.
1. Affordable GxP & Pharmacovigilance Consulting
Deploying software without clean standard operating procedures (SOPs) is a recipe for failure.
Our seasoned compliance experts act as an extension of your QA team to build the foundational framework required by the DCGI notice.
- SOP Design & Gap Analysis: We align your internal adverse event workflows with Schedule M and NDCT Rules 2019 requirements.
- PSMF & Inspection Readiness: We assist in drafting and maintaining your Pharmacovigilance System Master File (PSMF), preparing your leadership and personnel for unannounced SLA/CDSCO inspections.
- Safety Signal Monitoring: Establish standardized protocols to evaluate risk-benefit profiles accurately before files leave your facility.
2. Proprietary, Cloud-Native Safety Software Built for Submissions
To securely handle the data pipeline mandated by Para 6.11, Glaers offers a custom-built, cloud-native software platform engineered exclusively for regulatory reporting and submissions.
- Strict Validation Standards: Our platform is fully validated under GAMP 5 manufacturing and supply chain software paradigms, inherently embedding US FDA 21 CFR Part 11 and WHO-GMP data integrity rules right down to the database level.
- Intelligent Automation: Transition away from spreadsheet trackers. Our modular architecture streamlines multi-channel adverse event intake, automates duplicate checking, and routes urgent cases dynamically to ensure you never miss a regulatory submission deadline.
- Secure Cloud Tenancy: Rest assured that your highly confidential post-marketing data remains locked down. Built with a robust infrastructure framework, our remote, secure, multi-user environment ensures data isolation, ironclad access logs, and absolute protection against local system data breaches.
Action Plan for Life Sciences Executives
Organizations should take immediate steps to align their pharmacovigilance processes with the latest CDSCO Schedule M requirements.
01
Conduct an Immediate Internal Audit
Evaluate how your company currently captures, processes, and logs spontaneous adverse reactions from retail networks, medical representatives, hospitals, and other reporting channels.
02
Transition Away from Localized / Paper Logging
Implement a unified safety database to ensure complete data transparency, chronological audit logs, version control, and regulatory traceability.
03
Train Personnel for Inspector Visits
Ensure regulatory and plant teams can clearly demonstrate to CDSCO and State Licensing Authority inspectors how every incoming ADR is triaged, evaluated, documented, and forwarded to the government.
Secure Your Regulatory Standing
The CDSCO's June 2026 circular signals a highly structured, digitally transparent era for Indian pharmaceutical manufacturers.
Partnering with a specialized solution provider like Glaers / Aizilus Technologies ensures your organization avoids generalist mistakes, secures global-grade data integrity, and scales manufacturing operations with absolute confidence.
Ready to Align Your Facility?
Ready to align your facility with the new Schedule M PV mandate? Discover our GxP validation suites and cloud safety database solutions at glaers.com.
Regulatory Reference
File No. PSUR-11/13/2024-eoffice (Comp. No. 17367), Directorate General of Health Services, Central Drugs Standard Control Organization, dated 03 JUN 2026.