Mymoona Akhter
Adverse drug reactions (ADRs) are the major cause of morbidity and mortality. Therefore appropriate reporting of ADR becomes important to impact the use of drugs appropriately. Pharmacovigilance program is one such initiative by WHO and governments of the 150 countries that helps in assessment, understanding, and prevention of the adverse effects of drugs. The functions of pharmacovigilance are to detect and study ADRs, measure risk ad effectiveness of drug use, disseminate this information and educate people and health care professionals. In India the pharmacovigilance program was initiated in 1986 with adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India with 12 regional centres for a population of 50 million each, and in 1989, six regional centres were set up in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry and Chandigarh, under the supervision of the drug controller of India. The National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. The IPC-PvPI has now become a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. The National Pharmacovigilance Programme (NPP): The programme had three main objectives: to foster a reporting culture, to involve a large number of HCPs in the system for the dissemination of information, and to be a benchmark for global drug monitoring. The Pharmacovigilance Programme of India (PvPI): As soon as the need for robust pharmacovigilance system was soon realized by the regulatory authorities, the NPP was renamed the Pharmacovigilance Programme of India (PvPI). The programme intended to build trust between the physician and the patient, thereby increasing patient safety and the confidence of people in the health system of the country. The Haemovigilance Programme of India (HvPI): HvPI was launched by the NCC-PvPI with the in year 2012 NIB keeping in view the monitoring of blood quality and blood products in transfusion. The Materiovigilance Programme of India (MvPI): To monitor the adverse events related to use of medical device the MvPI was launched by the Drugs Controller General of India (DCGI) at the IPC in 2015. MvPI program is responsible for monitoring and reporting of adverse events associated with the use of in vitro diagnostics. Till date 250 ADR monitoring centres (AMCs) have been developed and the reporting forms have been made available in ten vernacular languages. “Basic & Regulatory Aspects of Pharmacovigilance” to train young professionals in pharmacovigilance has been developed under the PvPI The National Health Policy 2017, launched by the Ministry of Health and Family Welfare, addresses antimicrobial resistance and pharmacovigilance. National Coordination CentrePvPI has developed an ADR PvPI mobile application for spontaneous ADR reporting, as result ADR reporting has increases significantly. Since these days the use of herbal drugs has grown rapidly and there monitoring becomes an important aspect when it comes to ADR. Most of the herbal drugs are used without prescription and are often considered safe by the consumer. But the fact remain that herbal drugs do cause ADR when taken with modern medicines. Recently, the WHO International Drug Monitoring Program, together with the WHO Collaborating Centre in Sweden, the Uppsala Monitoring Centre (UMC) have widened the scope of Pharmacovigilance to include the herbals and traditional and complementary medicines to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions. But there are number of challenges to face particularly in developing countries like monitoring disease specific adverse drug reaction