Good Pharmacovigilance Practices growing scenario in India

May, 2016

Pharmacovigilance programme started in India with the formation of a National Pharmacovigilance Advisory Committee in 2004 under the chairmanship of the then Director General of Health Services with the intention of building a comprehensive ADR data bank for drugs marketed in the country. The progress of the countrywide collection of ADR data has been rather slow in the initial years of the programme with inadequate number of monitoring centres. However, after Indian Pharmacopoeia Commission took over as the National Coordination Centre for the programme in 2010 the ADR data collection improved somewhat better. For collection and compilation of reliable ADR data across the country there needs to be a network of medical colleges or hospitals. IPC now claims to have 179 adverse drug reaction monitoring centres (AMCs) in different parts of the country and it plans to take the number to 200 by end of this year. IPC also received over 100 applications expressing intent to associate with it for ADR reporting. Such responses from stakeholders indicate that the programme seems to have well received by all the stakeholders considering the huge number of new drugs and irrational combinations in the domestic market. Many of these products are not free from ADRs as the routine three phase clinical trials do not always guarantee safety of a new drug as human trials usually cover only a few thousands of volunteers.

Currently the ADR data is largely collected from medical colleges and hospitals in the country with no cooperation from the pharmaceutical companies. To build up a comprehensive data base of ADRs, support of pharmaceutical companies is crucial as they are expected to conduct post marketing surveillance of their new drugs. The decision of IPC, in this context, to prepare a Good Pharmacovigilance Practices guidance document to help pharmaceutical companies to comply with reporting of all the ADRs is laudable. The guidance document is expected to be drafted in consultation with the stakeholders in a simplified format. This move can provide the industry with best practices in pharmacovigilance which may ultimately help them in preventing ADRs. Apart from involving pharmaceutical companies, participation of patient community and doctors running own clinics is also necessary to widen the scope of PvPI and strengthen the evidence based information. Currently ADR data is not sourced from these two key groups. IPC needs to seriously ponder how that kind of a data can be collected from all over the country in the years to come.Ipc