Barna Ganguly

Barna Ganguly

Pramukhswami Medical College

Title: Challenges of pharmacovigilance programme in our set up


Barna Ganguly completed MBBS (1987) from Calcutta University & MD, Pharmacology (1994) from Aligarh Muslim University , Aligarh. She has also done PG Diploma-Bioethics (2012-13) IGNOU, supported by ICMR – NIH (USA). She has got total teaching experience of 21 years (approx). She has got publications at various national and international levels with authorship in chapter of book in CRC publication. She has presented posters and papers at all levels of conference getting scholarships and 12th World Congress with full scholarships from NIH. She is a life member of six associations and reviewer of many journals.


Origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisted of 12 regional centers, each covering a population of 50 million. India is a hub for clinical trials flooded with more than 6,000 licensed drug manufacturers and 60,000 branded formulations. Pharmacovigilance is an important part of clinical research and practice, yet there is an immense need to understand the importance of pharmacovigilance. The Pharmacovigilance Programme of India was launched with an objective to safe guard the health of people of India. While major advancements in this discipline have taken place in West, implementation and compliance still remain as challenge in India. So, it is important to address various challenges of pharmacovigilance. In India, the events are not properly reported due to lack of time, low motivation, ignorance. Lack of continuing medical education on pharmacovigilance and dearth of drug information particularly at the level of primary health centres and private practitioners lead to underreporting of ADR. The practice of self-medication, use of traditional medicines poses other challenges as adverse events in such cases often go unreported. In addition, there are lacunae like lack of communication among healthcare professionals, shortage of trained personnel and inadequate training on pharmacovigilance at undergraduate level. These challenges can be addressed and the mission to safeguard the health is achievable by incorporating changes like making pharmacovigilance reporting mandatory at all levels, introducing pharmacovigilance inspections. Intensive training should be given in all aspects of pharmacovigilance to various stake holders including the patients, efficient system of communication, creating a clinical trial database for SAEs and ADRs for signal detection and access to relevant data for various stakeholders. Thus it can help in proper implementation and compliance of the programme.

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