The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.
The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public.
THE WORLD HEALTH ORGANIZATION:
In the 1960s, the World Health Organization (WHO) established the global ADR monitoring program, the WHO Collaborating Centre for International Drug Monitoring. This program aimed to collect and analyze ADR reports from around the world to identify potential safety concerns and improve the safety of drugs.
As National Regulatory Authority, CDSCO has the responsibility to conduct the Pharmacovigilance Programme of India (PVPI). For the said purpose, National Coordination Centre (NCC) at IPC has been established to conduct pharmacovigilance under Pharmacovigilance Programme of India.
THE GOVERNMENT OF INDIA LUNCHED NATIONAL PV:
The Pharmacovigilance Programme of India (PvPI) was started by the Government of India on 14th July 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country for safe-guarding Public Health.
The three main types of post-marketing Pharmacovigilance are:
- Drug safety surveillance
- Drug abuse and adverse effects monitoring.
- Safety monitoring of new products.
Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safeguard the health of people of India. Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also works in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs database. NCC-PvPI monitors ADRs among Indian population and helps the regulatory authority of India (Central Drugs Standard Control Organization, CDSCO) in taking decisions for safe use of medicines. The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. Since there exist considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management – there is a need to engage healthcare professionals and the public at large, in a well structured program to build synergies for monitoring adverse drug reactions in the country The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public.
The broadened patient safety scope of pharmacovigilance includes the detection of medicines of substandard quality as well as prescribing, dispensing and administration errors. Counterfeiting, antimicrobial resistance, and the need for real time surveillance in mass vaccinations are other pharmacovigilance challenges which need to be addressed. The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines. The ultimate safety decisions on medicines may need considerations of comparative benefit/risk evaluations between products for similar indications.
Article written by Yashwanth katika B. Pharmacy Sankar reddy institute of pharmaceutical sciences.
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