India currently has the largest pharmacovigilance programme in the world, and it is time to integrate pharmacovigilance with technology and other innovative fields, said experts during the inaugural function of the 5th National Pharmacovigilance Week organised by the Indian Pharmacopoeia Commission (IPC).
The event is being observed throughout the country from September 17 to 23, 2025, for enhancing the outreach of PvPI and sensitization of stakeholders for reporting adverse events due to drugs, medical devices, blood & blood-related products, etc.
Delivering his keynote address as the chief guest of the inaugural session, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, who was the secretary-cum-director of IPC, said, “We have been successful in bringing IPC and IP at the highest agenda of this country.”
“What is needed is the smart integration of technology and innovative approaches to drive differential thinking”.
“Initiation of National Pharmacovigilance Week in the journey of pharmacovigilance in the country has changed its course. With the number of reporting, we ranked among the top contributors globally in reporting adverse events,” he averred.
Renowned pharmacologist Prof. Y K Gupta, said, “Pharmacovigilance is an upcoming field with immense potential, especially for young pharma graduates. The time has come to explore its synergies with pharmacoeconomics, pharmacogenomics, statistics, and AI/ML.”
What began at AIIMS in 2010 with just a few AMCs has now expanded into a nationwide network of more than 1,000 AMCs. This could not have been possible without the steadfast support of clinical departments, patients, NGOs, and healthcare professionals, he said.
Highlighting India’s leadership, he said, “India today has the largest pharmacovigilance programme in the world, with each medical college now mandated to establish an ADR Monitoring Centre.”
He also acknowledged the unique challenges for India and said, “As our country has a large population and vast genetic diversity. Public awareness about side effects must be strengthened, and it is vital that physicians and pharmacists not only understand but also report ADRs.”
Dr. Nilima Kshirsagar, former chair – ICMR & VC, MUHS, Government of India, expressed her appreciation for the impact of the event, and said that the foundations for pharmacovigilance in India were laid as early as the 1990s with the establishment of the WHO Special Centre for Pharmacovigilance in GSMC, KEM Hospital, Mumbai.
Commenting on the growth of PvPI, she said, “I am happy to note that we have now reached about 100 ADR reports per million population. This achievement reflects our collective mission and vision, supported by the recognition of India’s national regulatory system in respect of re-benchmarking for vaccines by WHO at Maturity Level 3.”
ADRs observed following the use of drugs such as bedaquiline and miltefosine were carefully assessed by PvPI, and committees which led to updated package inserts and WHO statements on risk minimization measures after causality analysis, she added.
The introduction of PvPI’s IVRS system in multiple languages marks a new era of accessibility, empowering patients and healthcare providers alike to report ADRs more effectively, she averred.
Dr. V Kalaiselvan, secretary-cum-scientific director, IPC, outlined the activities planned during the 5th NPW, including an international webinar on Strengthening Signal Detection and Risk Management Framework. He also emphasized the sensitization of stakeholders across the country, extending it to the Panchayat level and rural areas, launch of the IVRS initiative, pharmacovigilance awards, and special outreach activities.
He further highlighted that, in line with the Government of India’s Swasth Nari, Sashakt Parivar Abhiyaan, IPC has also set up stalls at both IPC and Bharat Mandapam, the latter of which was inaugurated by Dr. Nilima Kshirsagar.
Dr. Raghuvanshi conferred the PvPI – Patient Safety Excellence Award to the ADR Monitoring Centre (AMC) at Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi, for its contributions in preventing ADRs, and the PvPI – Patient Connect Award to Delli Kumar T. from Vikruthamala, Chittoor District, Andhra Pradesh, for actively reporting Medical Device Adverse Events to MvPI.
A short film of PvPI, Pharmacovigilance Comic in different vernacular languages, and QR code for online reporting of ADRs through ADRMS were release.
The National Pharmacovigilance Week (NPW) is aligned with World Patient Safety Day and highlighted the importance of cultivating a culture of patient safety in the country. With the theme “Your Safety, Just a Click Away: Report to PvPI”, the 5th NPW aimed at sensitization of healthcare professionals, regulators, researchers, and other stakeholders to report Adverse Drug Reactions (ADRs) to PvPI. For this, PvPI has also developed digital platforms.
The inaugural session concluded with a vote of thanks by Dr. Jai Prakash, Senior Principal Scientific Officer & Officer-in-Charge PvPI – IPC.
The scientific programme featured deliberations by experts, including WHO’s perspective on strengthening India’s pharmacovigilance system by Dr. Madhur Gupta, insights on ADR reporting frameworks by Prof. Mira Desai, discussions on materiovigilance by Prof. Pravesh Mehra, and regulatory perspectives by CDSCO representatives. The panel discussion, moderated by Prof. Y K Gupta, brought together experts from academia, regulatory agencies, marketing authorization holders, and PvPI to explore multi-stakeholder approaches for strengthening ADR reporting systems in India.
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