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WHO(World Health Organization) defines ” Pharmacovigilance is the Science and activities relating to the detection, Assessment, understanding and prevention of Adverse Drug Reactions(ADRs) or any other possible drug related problems.”

Goal: To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the population.

Evolution of Pharmacovigilance:

    • 1934-1960: (Period of drug Explosion): 
    • USA —-> Diethylene Glycol —-> Mistakenly used to solubilize Sulphanilamide —–>107 Died.

      • 1956:(The Thalidomide Disaster): Thalidomide launched in market.
      • 1959-61:Reports of foetal abnormalities (maximum in Germany).
      • 1962: USA revised law requiring to prove safety and efficacy before issuing marketing authorisation.
      • 1963: British committee on safety of drug monitoring.
      • 1964: UK started “yellow cards” system.
      • 1964-1965: National ADR reporting system, UK, Australia, Newzealand, Canada, West Germany, Sweden.
      • 1978: WHO center moved from Geneva to Uppsala.

      Note: Thalidomide was prescribed to pregnant women to treat morning sickness.

      Pharmacovigilance In India:

        • 1986: ADR monitoring system proposed for India(12 regional centers).
        • 1997: India joined WHO-ADR monitoring program (3 centers: AIIMS, KEM, JLN)
        • 2004-08: National Pharmacovigilance program (2 Zonal, 5 regional, 24 peripheral centers).
        • 2010: Pharmacovigilance program of India was launched on July 2010.

        Pharmacovigilance program of India(PVPI) has been for developed for assuring drug safety to the Indian population. Central Drugs Standard Control Organisation(CDSCO) & Directorate General of Health Services(DGHS) under the guidance of Ministry of Health & Family Welfare, Government of India.

        Indian Pharmacopia Commision(IPC), Ghaziabad, U.P.has initiated a notion wide Pharmacovigilance program for protecting the health of the patients by assuring drug safety.

        The Pharmacovigilance programe of India(PVPI) is coordinated by the Indian Pharmacopia Commision, Ghaziabad as a National Coordinating Center(NCC).

        Chairman: Drugs Controller General India(DCGI), New Delhi.

        Who os responsible for Pharmacovigilance?

        1. Physician/Dentist

        2. Pharmacists

        3. Nurses & Paramedics

        4. Academia

        5. Pharmaceutical Industry.