Post-Marketing Surveillance in India: Challenges and Solutions

Post-Marketing Surveillance (PMS) plays a crucial role in ensuring the safety of medicines once they are used by the general population. Since clinical trials involve limited participants, not all rare or long-term adverse reactions are identified before approval. With India’s large, diverse patient population, continuous monitoring becomes essential to identify real-world safety concerns. The Pharmacovigilance Programme of India (PvPI), established in 2010, leads the national ADR reporting efforts. However, inconsistent reporting practices, limited awareness, and uneven healthcare systems still reduce the overall impact of PMS across the country.

At Dhanvanthari Clinical Research Solutions, we recognise PMS as an essential pillar of public health protection. Post-marketing monitoring helps:

·       Detect previously unreported adverse drug reactions

·       Assess effectiveness in real-world clinical settings

·       Support regulatory decisions such as label updates or drug withdrawal

·       Enhance patient safety by enabling timely action

·       Build trust between patients, healthcare providers, and the healthcare system

Effective PMS ensures that medicines remain safe throughout their lifecycle, beyond the initial stages of approval.

Current PMS Framework in India

India’s post-marketing surveillance operates through multiple structured components, including:

·       PvPI, which collects and analyses ADR data across the country

·       ADR reporting platforms, such as forms, helplines, and mobile applications

·       CDSCO, acting as the national regulatory authority

·       Risk Management Plans (RMPs) for newly approved drugs

Even with this framework, varying adoption levels across states and institutions affect nationwide PMS outcomes.

Key Challenges in India’s PMS System:

1.     Under-Reporting of ADRs:

Most healthcare institutions rely on voluntary ADR reporting. Due to time constraints, limited awareness, and lack of motivation, many adverse reactions remain unreported.

2.     Inadequate Training and Awareness:

Pharmacovigilance is still not fully integrated into medical and pharmacy education. Many practitioners are unfamiliar with ADR identification and reporting processes.

3.     Limited Patient Involvement:

Patients often do not recognise side effects or may not be aware of their ability to report them independently, reducing the depth of available safety data.

Solutions to Strengthen PMS in India:

At Dhanvanthari Clinical Research Solutions, we support strategic improvements to enhance PMS efficiency:

1.     Making ADR Reporting Mandatory:

Hospitals, clinical research centres, and pharmacies should adopt compulsory ADR reporting to ensure consistent data capture.

2.     Strengthening Training and Capacity Building:

Introducing pharmacovigilance in academic curricula, conducting training programs, workshops, and providing continuous education can improve reporting culture.

3.     Leveraging Technology:

Integrating ADR alert systems into Electronic Health Records (EHRs), enhancing the usability of PvPI apps, and adopting real-world evidence platforms can modernise surveillance systems.

4.     Increasing Patient Awareness:

Multilingual reporting forms, awareness campaigns, and pharmacy-driven counselling can encourage patients to actively report ADRs.

Conclusion:

Post-Marketing Surveillance is essential for ensuring the long-term safety and effectiveness of medicines in India. Although progress has been made, gaps remain in reporting, training, and patient awareness. By improving digital integration, strengthening education, and fostering collaboration between healthcare professionals, patients, and regulatory bodies, India can significantly improve its PMS system.

At Dhanvanthari Clinical Research Solutions, we are committed to supporting robust pharmacovigilance practices and contributing to a safer, more transparent healthcare environment. A strong PMS system not only protects patients but also enhances clinical decision-making and reinforces trust in medical products.