Pharmacovigilance India 2026: Navigating CDSCO Schedule M & Global Compliance

The Indian pharmaceutical sector is undergoing a seismic shift. With the November 2025 mandates regarding QR codes for direct adverse event reporting, the volume of safety data flooding into Manufacturer Marketing Authorization Holders (MAHs) has never been higher.

For Indian pharmaceutical companies, 2026 is not just about manufacturing; it is about Safety Data Integrity. As a leading Pharmacovigilance Service Provider in India, Bosker Medico Services has observed a clear trend: the old methods of manual Excel tracking are no longer compliant with the new Schedule M revised inspection norms.

1. The Regulatory Shift: CDSCO & PvPI Updates

The Pharmacovigilance Programme of India (PvPI) has tightened its grip on data quality. The latest directives require MAHs to not only collect Individual Case Safety Reports (ICSRs) but to demonstrate a robust Quality Management System (QMS).

Traceability is now mandatory. Inspectors are auditing the entire lifecycle of a safety report, ensuring that ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate) are maintained across all computerized databases.

2. Handling the "Volume" Challenge

With patient awareness at an all-time high, spontaneous reporting is surging. However, volume does not equal value. A significant portion of these reports are incomplete or duplicate data noise. At Bosker Medico, we utilize a proprietary Triage Protocol to ensure clients only pay for processing valid ICSRs.

3. Why "Boutique" Expertise Wins

Many pharma companies are moving away from massive BPO-style safety call centers. Why? Because drug safety is a medical science, not a volume game. Our team of specialized Drug Safety Physicians ensures scientific accuracy over simple data entry, focusing on Causality Assessment and deep medical review.