In India, the cost of consumption of medicine is estimated to be 60% i.e approx. 1.3% of GDP on health care. Therefore, it is essential to ensure the safe use of medicine which matches the needs. Several studies have reported misconception and misuse of drugs at prescriber, dispenser and consumer level which needs to be addressed. Continuous reporting on patient safety and irrational use of drugs should be done in a structured manner. In India reporting of adverse drug reactions (ADRs) was scattered before the introduction of Pharmacovigilance Programme of India (PvPI) in 2010 by the Ministry of Health & Family Welfare (MoH& FW), Government of India (GOI).

The pharmacovigilance reporting system includes collect, collate and analyze Adverse Drug Reactions (ADRs), through National Coordination Centre (NCC) established at different hospitals, research centres, under Indian Pharmacopoeia Commission (IPC). NCC-PvPI also started working in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden contributing to the global ADRs database.

The data examined by NCC-PvPI will be recommended to the Central Drugs Standard Control Organization (CDSCO), regulator for interventions for developing the awareness program on risk communication.

Since last seven years, one hundred and seventy-nine ADR monitoring centres (AMCs) are established and the authorities are making it mandatory to establish AMCs in all public and private sectors. The Indian Individual Case Safety Reports (ICSRs) are being documented from 2006. The growth of ICSRs reporting has increased from 11633 to 149,000 in 2015 which comprises 3% of WHO global database. Since Pharmacovigilance is an important area of reporting we have combined the investigations which are restricted to consumption profile of medicines. The pilot studies for antihypertensive, hypoglycaemic and cholesterol-lowering medicines have demonstrated nontherapeutic compliance, muscle related ADRs along with vitamin D deficiency.

In addition, reporting of ADRs from specialized centres viz., National Tuberculosis Programme (RNTCP), National Aids Control Organization (ART), Immunization (AEFI) is also linked to ADR reporting under NCC-PvPI. In the recent past, a load of lifestyle disorder led to use of herbal/drug-food/herbals/traditional preparations caused by nonvalidated claims. Therefore, the Nutravigilance Centre has been established under NCC-PvPI at ICMR-National Institute of Nutrition, Hyderabad.