Saturday, August 6, 2011


Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.


There are differences among countries (and even regions within countries) in the occurrence of ADRs and other drug-related problems. This may be due to differences in diseases and prescribing practices, genetics, diet, traditions of the people, drug manufacturing processes used which influence pharmaceutical quality and composition, drug distribution and use including indications, dose and availability.

The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products.

The Specific Aims of Pharmacovigilance are to
  • improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
  • improve public health and safety in relation to the use of medicines.
  • contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
  • promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
History of National Pharmacovigilance program

India's Drugs Control Department within the Ministry of Health & Family Welfare initiated the establishment of a nationwide network to build a comprehensive pharmacovigilance data system in 2004. The National Pharmacovigilance Advisory of the Director General of Health Services and the Drug Controller General of India (DCGI), who functions as the member secretary of the Committee. Based at the Central Drugs Standard Control Organization, NPAC was assigned the primary responsibility of setting up the system to monitor the pharmacovigilance programme throughout the country. The National Pharmacovigilance Programme for India is sponsored by the World Health Organization (WHO) and is funded by the World Bank.The NPP is based on the recommendations made in the WHO document titled "Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre".

What to report

The programme particularly solicits reports of:
  • All adverse events suspected to have been caused by new drugs and ‘drugs of current interest' (List to be published by CDSCO from time to time)
  • All suspected drug interactions
  • Reactions to any other drugs which are suspected of significantly affecting a patient's management, including reactions suspected of causing:
  • Death
  • Life-threatening (real risk of dying)
  • Hospitalisation (initial or prolonged)
  • Disability (significant, persistent or permanent)
  • Congenital anomaly
  • Required intervention to prevent permanent impairment or damage.
Purpose importance scientific aims of Pharmacovigilance

Recently, its concerns have been widened to include
  •  herbals
  • traditional and complementary medicines
  • blood products
  • biologicals
  • medical devices
  • vaccines

1 comment:

  1. The importances of minimizing the adverse effect of drugs are interpreted in the pharmacovigilance course and this course has been interestingly chosen by many graduates.