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PvPI identifies 16 India specific signals, 183 drug safety alerts towards patient safety
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Shardul Nautiyal, Mumbai
October 27 , 2025
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The Pharmacovigilance Programme of India (PvPI) under the Indian Pharmacopoeia Commission (IPC) has identified 16 India specific signals. The same has been communicated to the Central Drugs Standard Control Organisation (CDSCO) for timely regulatory interventions towards patient safety.
It has also issued 183 drug safety alerts to all the stakeholders and updated 66 package inserts towards ensuring safe and efficacious drugs.
The IPC, which is also the National Coordination Centre (NCC) of the PvPI, has been working in collaboration with national and international stakeholders, ensuring patient safety by monitoring ADRs.
Pharmacovigilance (PV) is the scientific and regulatory process of detecting, assessing, understanding, and preventing adverse effects of medicines to ensure patient safety and public health.
PvPI communicates drug safety information to patients and healthcare professionals as a public health responsibility. This stable system has enabled us to collect, collate and analyse data scientifically. Thus, evidence-based information collected indigenously is utilized for appropriate regulatory decision by the CDSCO such as changing/updating package-insert, issuing drug alerts, and signals.
Currently 1,120 Adverse Drug Reactions (ADRs) monitoring Centres (AMCs) as part of the PvPI have been playing a crucial role by monitoring and reporting the ADRs encountered by patients throughout the nation. PV has also significantly grown in recent years and its importance in the healthcare system has been recognized worldwide.
PvPI has recorded tremendous growth in recent years, supported by the fact that India stands tall in becoming 7th largest contributor of ADR data in the world to World Health Organisation - Uppsala Monitoring Centre (WHO-UMC) global database, Vigibase, and 3rd largest contributor of ADR in Asia to WHO database, UMC in a short span of 15 years.
The objective of PvPI is to improve patient safety and welfare of Indian population by monitoring drug safety and thereby reducing the risks associated with the use of medicines. PV is based on the sound scientific principles and is an integral part of effective clinical practices. The purpose of the PvPI is to collate data, process and analyse it and use the inferences to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.
PV also complements initial clinical trials by monitoring the real-world use of drugs, identifying rare side effects, evaluating the benefit-risk profile, and mitigating potential harm through measures like updated labelling or risk management plans. Patients, healthcare professionals, and manufacturers all play a role in reporting ADRs, which helps to create a comprehensive understanding of a drug's safety over its entire lifecycle.
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