भारतीय भेषज संहिता आयोग
Indian Pharmacopoeia Commission Observes 5th National Pharmacovigilance Week to Promote Responsible Reporting of Adverse Drug Reactions
The Indian Pharmacopoeia Commission (IPC), functioning as the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI), successfully organized the inaugural ceremony of the 5th National Pharmacovigilance Week (NPW) on 17th September 2025 at Bharat Mandapam Convention Centre, New Delhi. This event 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 ceremony commenced with lamp-lighting, followed by welcome remarks from Dr. V. Kalaiselvan, Secretary-cum-Scientific Director, IPC. In his address, he 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, Former Chair – ICMR & VC, MUHS, Govt. of India.
Prof. Y. K. Gupta, reflected on the journey of PvPI since its inception, saying, “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 underscored the importance of pharmacovigilance, remarking, “Pharmacovigilance ensures continuous risk-benefit assessment of medicines.” 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.”
Adding a lighter note, Prof. Gupta explained pharmacovigilance using a line from a popular Hindi song, “Ye kya hua, kaise hua, kab hua, kyun hua,” to underline its importance. Looking ahead, he emphasized opportunities for the next generation, noting, “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.” 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, expressed her appreciation for the impact of the event, and she said, “It is truly phenomenal to witness the participation of about 600 delegates.” During the event, she mentioned 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.
She further highlighted the remarkable growth of PvPI, stating, “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 rebenchmarking for vaccines by WHO at Maturity Level 3.”
Sharing specific success stories, Dr. Kshirsagar said, “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 also lauded the technological strides of the programme, adding, “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 very much appreciated the toll-free number, which has a pharmacovigilance-trained person interface.
The Chief Guest, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, delivered the keynote address, highlighting the growing role of pharmacovigilance in safeguarding patient health. He remarked, “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.” Underlining India’s achievements, he further added, “We have been successful in bringing IPC and IP at the highest agenda of this country.” He also emphasized the importance of innovation and forward thinking, stating, “What is needed is the smart integration of technology and innovative approaches to drive differential thinking.”
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 Sh. 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 released.
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.
On the initiative of NCC-PvPI, the 5th NPW is being observed throughout the country from 17th–23rd September 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. IPC expresses its deepest gratitude for the invaluable contributions of all PvPI experts in strengthening the culture of patient safety in the nation. The overall support of the Ministry of Health and Family Welfare, Govt. of India to PvPI is gratefully acknowledged.
