The origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. However, nothing much happened until a decade later when in 1997, India joined the WHO Adverse Drug Reaction Monitoring Program me based in Uppsala, Sweden. This attempt was unsuccessful and hence, from 1January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational.
The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal center (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal center (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala monitoring center in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 26 peripheral centers. The program has three broad objectives: the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the system in information dissemination and the long-term objective is for the program to be a benchmark for global drug monitoring.
Given this background on pharmacovigilance in India to date, things have definitely changed for the better but at a very slow pace. The Regulatory Authority for India should be commended for introducing and implementing the Schedule Y and for reporting of all serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARS) from clinical trials. However, there is a need of spontaneous adverse event reporting from post-marketed medicines to the zonal centers and in turn to the National Pharmacovigilance Centers to the WHO Uppsala Monitoring Center, which at the moment is woefully lacking. Therefore, in these circumstances, the questions that arise are whether the strategy should be changed and if so, how?
The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal center (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal center (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala monitoring center in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 26 peripheral centers. The program has three broad objectives: the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the system in information dissemination and the long-term objective is for the program to be a benchmark for global drug monitoring.
Given this background on pharmacovigilance in India to date, things have definitely changed for the better but at a very slow pace. The Regulatory Authority for India should be commended for introducing and implementing the Schedule Y and for reporting of all serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARS) from clinical trials. However, there is a need of spontaneous adverse event reporting from post-marketed medicines to the zonal centers and in turn to the National Pharmacovigilance Centers to the WHO Uppsala Monitoring Center, which at the moment is woefully lacking. Therefore, in these circumstances, the questions that arise are whether the strategy should be changed and if so, how?
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