India is a country with a population of 1.6 billion. It has 18 official languages and 35 States and Union
Territories. It is the fourth largest producer of pharmaceuticals in the world. It is therefore an enormous challenge to establish and maintain a credible adverse drug reaction monitoring programme in the country. However, the central drugs regulatory authority - Central Drugs Standard Control Organization (CDSCO) - has done just that.
The national Pharmacovigilance Programme was launched in November 2004. The Programme aims to foster a culture of adverse drug event reporting in its first year of operation and subsequently aims to:
• generate broad-based adverse drug reactions (ADR) data on the Indian population and share this information globally through the WHO Programme for International Drug Monitoring;
• ensure optimum safety of medicinal products in the Indian market;
• provide technical expertise for evaluating adverse events (AE) reports from clinical trials in India.
Although India started participating in the WHO Programme for International Drug Monitoring in 1998, it was not until 3 years later that CDSCO started to hold discussions with the various players - health professionals, pharmacists, the pharmaceutical industry, clinical research organizations and academics from related fields - in order to plan a nation-wide pharmacovigilance programme. These discussions eventually culminated in the protocol for pharmacovigilance in India.
The national pharmacovigilance programme consists of:
• two zonal centres situated in Mumbai and New Delhi;
• five regional centres situated in Kolkata, Mumbai, Nagpur, New Delhi and Pondicherry;
• a yet to be defined number of peripheral centres.
It is envisaged that the peripheral centres will collect their data and send them on to the regional centre which in turn will submit the data to the zonal centre where it will be consolidated, analysed and forwarded to the national Pharmacovigilance Advisory Committee which makes appropriate recommendations to CDSCO for regulatory interventions. The information collected at the regional centres and the zonal centres will also be submitted to the WHO global database.
The first training course involving most of the zonal, regional and peripheral centres was held in Mumbai in January 2005. There were 28 participants in total who varied from community pharmacists in small peripheral centres to clinical pharmacologists in large teaching hospitals. The course was organized by Dr Urmila Thatte and her staff from the Nair Medical Hospital, Mumbai. It was funded by WHO/SEARO. The course material was adapted from the course provided by the WHO Collaborating Centre for International Drug Monitoring in Uppsala. Mr Sten Olsson from Uppsala was the main facilitator with assistance from Dr Mary Couper, WHO. Other facilitators were from India making presentations ranging from drug development to traditional medicine and to ethical issues for the programme to consider. Dr Kris Weerasuriya, Regional Adviser (PSM, SEARO) made a presentation at the course in which he indicated that WHO/SEARO would continue to support the programme provided that results were tangible in the form of a significant number of reports being sent to the global database in Uppsala by June.
The enthusiasm and dedication that was evident throughout the course needs to be sustained in order for this ambitious programme to be effective. This can only succeed if all the centres work effectively together.