Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities.

Soon India will launch a fully developed system to monitor adverse drug reactions. The national requirement for this project encompasses 12 regional centres; district hospitals and primary health centres will be affiliated to these. Patient investigation and referrals will be manned by completely trained medical and paramedical personnel. The system is expected to become operational by 1987. Peculiar problems arise in the scientific research of adverse drug related events in India: illiteracy, the strong influence of traditional medicine, over-the-counter drug availability, inadequate numbers of trained personnel, shifting doctor-patient relations and costs. There is an opportunity for rigorous prospective epidemiological investigation in India, since the great majority of the population depends on governmental health support. Detailed drug-related events, timing of exposure and withdrawal can be accurately monitored. Various influential 'non-drug' factors relevant to the drug reaction must be considered in the assessment of any adverse drug reaction.