With an aim to enhance the capacity for pharmacovigilance studies, a workshop for pharmacovigilance was conducted by National Institute for Research in Reproductive Health (NIRRH) ICMR, Mumbai. It was coordinated by Dr Acchelal Pasi and Sagar S Bachhav with the help of Manish Mahajan and under the guidance of Dr SD Kholkute, Director, NIRRH and Dr NA Kshirsagar, National Chair (Clinical Pharmacology), ICMR. The programme consisted of two contact sessions and one project work. Out of 44 applicants, 20 were selected on the basis of their prior experience and need for capacity building in their region.
The first contact session was inaugurated by Dr VM Katoch, Secretary DHR and DG ICMR. Lectures and hands on work were delivered. Dr Shanthi Pal (WHO, Geneva) delivered lectures on basics, as well as advanced topics including international issues. Participants practiced assessment of adverse reactions, using vigiflow which was provided online courtesy WHO, Uppsala monitoring centres WHO.
The participants presented their research project to experts Dr YK Gupta, Dr RD Lele and others and refined the protocol based on valuable suggestions from the experts. All participants were asked to work in group to develop multi-centric projects.
Participants worked on projects to evaluate knowledge, attitude and practices of physicians and paediatrician to report ADRS and AEFIs respectively, metabolic risks associated with antipsychotic drugs: A cross sectional study, adverse drug reaction profile of anti snake venom in a rural tertiary care teaching hospital and comparison of Indian and non Indian published literature reporting adverse drug reaction of new drugs marketed in India and under safety scrutiny by US FDA and EMA. The second contact session had lectures on data management and statistical analysis, qualitative research, manuscript development, good clinical practices, ethics in descriptive and observational studies and pharmacovigilance programme in India. Lectures were delivered by Dr Nandini Kumar, Dr RR Shinde, Dr YK Gupta, Dr Nithya Gogtay, Dr Shahina Begum. Participants presented interim analysis data of above mentioned ongoing projects. All the presentations were refined in the light of guidance and comments received from Dr Ashok Vaidya and Dr Robin Ferner, Consultant physician and clinical pharmacologist, Birmingham (UK). It is expected that the training and research project will help develop pharmacovigilance capacity in various parts of the country, enhance safety of medicines and contribute to regulatory decision.
EP News Bureau – Mumbai
