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Pharmacovigilance of Ayurvedic Drugs
Published in Saroya Amritpal Singh, Regulatory and Pharmacological Basis of Ayurvedic Formulations, 2017
The Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safeguard the health of 1.27 billion people of India. Adverse Drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring center (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decisions for the safe use of medicines.
Regulatory and Legislative Policy and Science Considerations in the Era of Patient-Centeredness, Big Data, and Value
Published in Qi Jiang, Weili He, Benefit-Risk Assessment Methods in Medical Product Development, 2017
Tarek A. Hammad, George A. Neyarapally
In July of 2010, India’s national pharmacovigilance program, implemented by the Drug Controller General of India, was reinitiated as the Pharmacovigilance Program of India (PVPI). PVPI will be expanded in the upcoming years and the goal is to establish 350 ADR centers. This will enhance medical product risk assessment in India at the national level. In contrast to the United States and the EU, which changed aspects of their risk management systems in the past 10 years as aforementioned, India does not have specific guidelines pertaining to risk management systems.112 In short, the pharmacovigilance system in India is still developing, although adverse drug reactions are increasingly being reported in India under the auspices of the PVPI.
Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)
Published in Alexandria Journal of Medicine, 2021
Manju Agrawal, Preeti Singh, Usha Joshi
In line with this inkling, the WHO established the Pharmacovigilance program in 1968 for pooling data in ADRs from multiple countries. This program is coordinated at its collaborating center in Uppsala Monitoring Centre (UMC), Sweden, with more than 160 countries participating, including India [11]. Pharmacovigilance Programme of India (PvPI), maintained by the Indian Pharmacopeia Commission (IPC), functions as the National Coordination Centre (NCC) started in 2010 and became a WHO collaborating center in 2017 and is responsible for ensuring the safety of medicines used by the Indian population. India collects about 50,000 domestic ADRs yearly and shares them with the World Health Organization (WHO) Programme for International Drug Monitoring in VigiBase [WHO global database of individual case safety reports (ICSR)] through vigiflow. More than 250 ADR monitoring centers (AMC) are functioning for reporting ADRs in the Indian database. PvPI aims to enhance patient care and safety concerning the use of medicines and provide reliable information by regularly sending drug safety and therapeutic device alerts [12,13]. The AMC at our tertiary hospital contributes ICSRs to the NCC, and in addition, regularly analyzes the ADRs, deals with under-reporting issues, and sensitizes the health care workers to report any suspected ADR to reduce drug-related morbidity and mortality [14].
Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital
Published in Alexandria Journal of Medicine, 2018
Meda Venkatasubbaiah, P. Dwarakanadha Reddy, Suggala V. Satyanarayana
In India, in the year 2010 the Ministry of Health and Family Welfare (MoHFW), launched the nationwide Pharmacovigilance Programme of India (PvPI). Indian Pharmacopoeia Commission (IPC) under the MoHFW has been functioning as the National Coordination Centre (NCC) for PvPI since April 2011, since then rapid progress in reporting of ADRs by the healthcare professionals is seen.11 PvPI stated that during the period of April 2011 to March 2016, a total of 181,656 reports have been received through various reporting modalities.13 Through this data PvPI regularly recommends the drug regulatory authorities and suggests the Healthcare professionals (HCPs) in improving the safe use of drugs.