New Delhi, Sep 21: The Union Health Ministry has approved a new Biovigilance Programme of India aimed at strengthening monitoring of adverse events associated with organ and tissue transplantation and widening the country’s patient safety framework.
Union Minister of State for Health and Family Welfare Anupriya Patel announced the initiative on Monday while launching the 7th National Formulary of India 2026. The programme will be led by the Indian Pharmacopoeia Commission (IPC) and will focus on monitoring and reporting adverse events linked to transplantation.
The announcement came during the 6th National Pharmacovigilance Week, being observed from September 17 to 23 with an emphasis on the rational use of medicines and safer healthcare practices.
The government said the expanded monitoring system is intended to strengthen the country’s ability to identify, document and respond to medicine-related safety concerns. The initiative adds a specific focus on adverse events connected with organ and tissue transplantation, an area requiring close monitoring because of the complexity of treatment and the range of medicines used before and after transplantation.
Patel said medicine safety should involve healthcare professionals, institutions and patients, stressing the importance of reporting suspected adverse events. The Health Ministry also highlighted India’s growing contribution to the World Health Organization’s patient-safety database.
According to the ministry, India has moved from 123rd position to eighth globally in terms of contributions to the WHO patient-safety database. Around 1,150 adverse drug reaction reporting centres are currently operating across the country, with plans to extend the reporting network further into the primary healthcare system.
The expansion is expected to improve the flow of safety information from healthcare facilities to the national monitoring system. Greater reporting can help authorities identify patterns associated with medicines and support action when safety concerns emerge.
The government’s emphasis on pharmacovigilance comes as India continues to expand access to medicines and healthcare services. With a larger number of patients receiving treatment through hospitals, specialist centres and primary healthcare facilities, systematic monitoring of adverse reactions remains an important component of healthcare delivery.
The new National Formulary of India was also launched as part of the government’s effort to promote appropriate prescribing and rational medicine use. A national formulary provides healthcare professionals with information intended to support the safe and effective use of medicines.
The latest initiatives also place greater emphasis on making patient safety a routine part of healthcare rather than limiting it to specialist institutions. The proposed expansion of adverse drug reaction reporting to primary healthcare facilities could provide a broader picture of medicine-related events occurring outside major hospitals.
The government has said the reporting system depends on participation from healthcare workers and institutions. Each reported event can contribute to the identification of previously unrecognised safety signals and help strengthen the evidence available to regulators and medical professionals.
The focus on transplantation related safety is particularly significant because patients undergoing organ or tissue transplantation generally require complex and prolonged medical care. Monitoring adverse events can help healthcare systems better understand potential risks associated with treatment and improve follow up.
The Health Ministry’s announcement comes during a week dedicated to pharmacovigilance, providing an opportunity to highlight the role of responsible medicine use and timely reporting.
The government is also seeking to build a stronger patient-safety culture across different levels of the healthcare system. By increasing the number of reporting centres and connecting more facilities to the national network, authorities aim to make safety reporting more accessible.
The measures announced on Monday therefore combine three areas: updated national guidance on medicines, expanded monitoring of adverse events and a dedicated system for transplantation related safety concerns.
The Health Ministry said the broader objective is to strengthen India’s patient safety net and ensure that information about adverse events reaches the appropriate monitoring mechanisms.
As the country continues to develop its healthcare infrastructure, the expansion of pharmacovigilance is expected to remain an important part of efforts to promote safer treatment and more informed medicine use.