Pharmacovigilance is an essential regulatory mandate under Schedule M of the Drugs and Cosmetics Act, 1940. Part 1 of Schedule M sets forth the general requirements for pharmaceutical manufacturing and quality control, establishing the foundation for robust operational standards. Building on these requirements,Part 1, Section 6.11 of revised schedule M specifically mandates that every licensee whether engaged in manufacturing or marketing must establish a comprehensive pharmacovigilance (PV) system. This system is responsible for continuous adverse effect monitoring, systematic data compilation, and the preparation of detailed adverse effect reports. Although the prescribed timeline for implementing these processes has long passed, regulatory authorities are now conducting rigorous Risk-Based Inspections (RBI) to ensure compliance.

In addition, Part 4 of Schedule M further clarifies PV obligations. Section 16.4 requires that any report of an adverse reaction or event be recorded in a separate register and thoroughly investigated to determine whether the reaction is due to a quality issue, if it has been previously reported in the literature, or if it represents a new observation. Regular review of these complaint records is crucial to detect recurring issues that might require special attention or even a recall of marketed products.

Large pharmaceutical companies typically invest in dedicated PV infrastructure complete with specialized teams, advanced IT systems, and ongoing training programs to meet these regulatory demands. In contrast, many small-scale companies struggle to establish an in-house pharmacovigilance department due to the high costs of infrastructure setup, significant operational expenses, and a limited pool of specialized expertise. This often leads to delayed adverse event reporting and increases their exposure to regulatory risks such as product recalls, fines, or even license suspension.

For small companies, a cost-effective alternative is to adopt an outsourced or hybrid PV model. Instead of bearing the full financial burden of developing a complete in-house PV setup, small manufacturers and marketing companies can partner with specialized service providers. By doing so, they can implement continuous adverse effect monitoring, efficient data compilation, and timely adverse effect reporting all in strict compliance with Schedule M without incurring excessive costs. This approach not only ensures regulatory compliance but also reinforces a commitment to patient safety and product quality.