An adverse drug reaction clinic: Breathing fresh life into the pharmacovigilance programme

After the launch of National Pharmacovigilance Programme in 2004[1], the Government of India came out with a revised programme called “Pharmacovigilance Programme of India (PvPI)” in 2010,[2] to streamline the drug safety monitoring in India. PvPI has come out with five phases in the span of 5 years, from the initiation phase in 2010-2011 to the excellence phase in 2014-2015.[2] Irony is that the hospitals and medical colleges are not still aware of this programme. Even in the teaching curriculum for both under graduates and post graduates, pharmacovigilance is a part of their syllabus, but not much attention is paid to teach this subject. This leads to a sense of ignorance among the young budding doctors, as they do not realize the importance of pharmacovigilance.[3] Most of the young doctors and medical students have neither seen the adverse drug reaction (ADR) form issued by the Central Drugs Standard Control Organization(CDSCO) nor they are aware of the procedure to report an ADR.[4] Most of the hospitals are understaffed with an abysmal ratio of doctors to the population in India, and they are striving to clear their out patient departments(OPDs) in time while trying to maintain an utmost clientele satisfaction.[5] There are hardly any hospitals and institutions which have taken this programme seriously, and have made an organised system for data collection, data maintenance, and data reporting. This scenario does not augur well for the country especially when India has become a major centre for clinical trials.[5] A step has been made in this direction with the establishment of a pharmacovigilance cell becoming mandatory for all medical colleges and hospitals in India.[6] However, this may not be adequate and until all health care providing institutes play an active part in the pharmacovigilance, it may not be fully successful.