National pharmacovigilance programme: Monitoring drug safety

National pharmacovigilance programme: Monitoring drug safety

The pharmacovigilance programme initiated by Drugs Control Department, Government of India, promises to maintain a close watch over the use of drugs and their effects on people, says Dr Sampada Patvardhan

Pharmacovigilance, a French term referring to identifying side effects of drugs, their treatment, documentation, reportage and regulatory decisions based on them, is a well-established science in the developed world.

India is a country with over one billion population. Each individual in the country has at one time or the other taken a drug. In many instances, a person takes more than one drug, and that too for a fixed period of time. To complicate matters, the people of India utilise various systems of medicine in allopathy, homoeopathy, ayurveda, siddha, etc.

In such a scenario, the pharmacovigilance programme initiated by Drugs Control Department, Government of India, promises to maintain a close watch over the use of drugs and their effects on people. If this monitoring and reviewing process is absent, the pharmacological effects of drugs, their adverse effects, interactions and misuse can play havoc with the health system in this country. A few examples are needed to drive home the point.

In the 1930s, the marketing of elixir of sulphanilamide dissolved in diethylene glycol resulted in the death of over 100 children. In the 1960s, pregnant ladies who ingested thalidomide gave birth to children with deformities. In the last two decades, many drugs have been withdrawn from the market because of serious adverse drug reactions (ADRs). Very recent example of a drug being banned due to severe cardiovascular side effects, in India after its withdrawal by manufacturer is Cox-II inhibitor and anti-inflammatory drug Rofecoxib which has reportedly caused 93,000 heart attacks in users the world.

The National Pharmacovigilance Programme for India, sponsored by the World Health Organization (WHO) and funded by the World Bank, became operational from January 1, 2005. This programme was launched on 23rd Nov 2004 in Delhi. It will be overseen by the National Pharmacovigilance Advisory Committee based at the Central Drugs Standard Control Organization (CDSCO), New Delhi. The Central ministry has announced formation of a National Pharmacovigilance Advisory Committee (NPAC) under the chairmanship of Director General of Health Services in October 2004.

The Drug Controller General of India will function as the member secretary of the Committee. NPAC has been given the sole responsibility of putting in place machinery for monitoring of the pharmacovigilance programme throughout the country.

Two zonal centers, the South-West zonal centre (located at the Department of Clinical Pharmacology, Seth G S Medical College and KEM Hospital, Mumbai) and the North-East zonal centre (located at the Department of Pharmacology, AIIMS, New Delhi), will collate information from all over the country and send it to the Committee as well as to the Uppsala Monitoring centre in Sweden. Three regional centres will report to the Mumbai centre, and two to the New Delhi one. Each regional centre, in turn, will have several peripheral centres reporting to it. Presently, there are 24 peripheral centers.

It is realised by National Pharma-covigilance Advisory Committee that pharmacists would play very important and active role in ADR reporting and monitoring and the participation of community and hospital pharmacists especially is sought by National Pharmacovigilance Program. Mahar-ashtra State Pharmacy Council?s Drug Information Centre has uploaded a simple ADR reporting form on its website: Let us contribute this national cause and elevate the health of our society!

The writer is in-charge, Maharashtra State Pharmacy Council’s Drug Information Centre, Mumbai