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Need to transition from awareness-driven reporting to performance-oriented PV framework: Dr Kalaiselvan

Shardul Nautiyal, Mumbai
Saturday, March 14, 2026, 08:00 Hrs  [IST]

There is a need to transition from awareness-driven reporting to a performance-oriented pharmacovigilance (PV) framework with measurable outcomes, said Dr V Kalaiselvan, secretary-cum-scientific director, the Indian Pharmacopoeia Commission (IPC) at the 1st Annual Meeting of Regional Centres participating in the Pharmacovigilance Programme of India (PvPI) and the Materiovigilance Programme of India (MvPI).

The IPC in collaboration with the Andhra Pradesh MedTech Zone (AMTZ) organised a two-day National Meet on Strengthening Pharmacovigilance and Materiovigilance in India recently at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam.  

During the event, the ADR PvPI 2.0 Mobile Application was launched to facilitate ease of reporting, strengthen real-time data capture, and improve stakeholder engagement in adverse drug reaction monitoring across the country.

Technical sessions were conducted to review progress under PvPI and MvPI and to deliberate on key challenges including underreporting of adverse drug reactions, documentation gaps, and the need for strengthening medical device safety oversight. Discussions also focused on enhancing the performance of ADR Monitoring Centres (AMCs), and Medical Device Monitoring Centres (MDMCs) and promoting a culture of systematic reporting in healthcare institutions.

The second day of the meet was devoted to structured working group deliberations under the theme “Empowering India’s Pharmacovigilance and Materiovigilance: From Awareness to Action.” Along with the technical sessions, the working groups examined strategies to address underreporting, develop standardised frameworks for documentation and analysis of preventable adverse events, and expand pharmacovigilance and materiovigilance outreach beyond district-level healthcare facilities.

The recommendations emerging from the deliberations emphasised capacity building, standardisation of reporting practices, improved inter-institutional coordination, and integration of technology-enabled monitoring mechanisms to strengthen patient safety.

The first-time ever national meet was organised to strengthen India’s drug and medical device safety systems and enhance coordination among regulators, healthcare institutions, AMCs, and MDMCs. Senior officials from regulatory authorities, leading medical institutions, and representatives from the WHO Country Office for India participated in the deliberations.

The inaugural session was presided over by Dr V Kalaiselvan. Senior leadership from leading AIIMS institutions, including Prof. Y K Gupta, Prof. Ashok Puranik, along with Dr Jitendra Sharma, managing director and founder CEO, AMTZ, and Dr Kavita Kachroo, CEO, Kalam Institute of Health Technology (KIHT), participated in the inaugural session and highlighted the importance of institutional collaboration in strengthening pharmacovigilance and materiovigilance systems across the country.

The meet concluded with a reaffirmation of IPC’s commitment to further strengthening India’s pharmacovigilance and materiovigilance ecosystem through coordinated and evidence-based interventions.

 

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