The National Pharmacaovigilance Advisory Committee has called for the first national level meeting of experts and medical practitioners on November 16 to put in place the national pharmacovigilance network as envisaged under the national pharmacovigilance programme planned by the central government. The World Bank through its Food and Drugs Capacity Building Programme supports this project.
The meeting would seek the willingness of the medical practitioners from various hospitals to set up peripheral pharmacovigilance centers in their institutions. The government is planning 24 peripheral centres, six regional centres and two zonal centres for recording adverse events (AE), collate and scrutinise the data and carry out casualty analysis of the reported AEs. In addition to this, the zonal centres are to provide training, general support and coordinate the functioning of the regional centres.
According to sources, the medical experts had already expressed their interest in a meeting that was held in Mumbai some time back. The forthcoming meeting would chalk out concrete plans for the monitoring of ADRs in the country.
The meeting of NPAC has acquired more significance in the wake of its very first decision to recommend withdrawal of roficoxib formulations from the country. According to experts, one of the first jobs of NPAC would be develop a system of ADR monitoring and withdrawal of drugs. "Instead of the highly emotive reaction to the press reports on the dangers behind roficoxib formulations there should be a proper system based on scientific merits to declare a drug harmful or not. The NPAC should try to develop such a system" they opined.
The NPAC is functioning under the chairmanship of the Director General of Health Services. The Drugs Controller General of India (DCGI) is the member secretary of the committee. The committee has been given the responsibility of overseeing the entire programme and offer technical guidance.
The NPAC is to oversee the performance of the regional, peripheral centres and recommend possible regulatory measures based on data received from various centres. NPAC will also periodically evaluate their protocol compliance levels to ensure that the data received is homogenous and can be scientifically pooled for informed regulatory decisions. The publication of the ADR monitoring data will also be the responsibility of the NPAC. The committee has also been empowered to seek expert help in various areas as and when required.
The availability of viable ADR data is expected to contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost effective) use. It is aimed at improving patient care and safety in relation to use of medicines and all medical and paramedical interventions and enhancing public health/safety in relation to use of medicines. Further, it is expected to promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
The experts from office of the DCGI, ICMR, AIIMS, SGS Medical College, Mumbai, NII, New Delhi, JIPMER, Pondicherry, RML, New Delhi, ITRC, Lucknow, NIPER, etc constitute the advisory committee.