The national pharmacovigilance programme, envisaged as part of the World Bank-funded Food and Drugs Capacity Building Programme, is all set to roll with the Central Government working out the final structure of the pharmacovigilance network that is to be in place.
While the new system would have an apex centre at the Central Drugs Standard Control Organisation, Delhi, it would be monitored by a high level technical committee with members drawn from various disciplines of clinical research and practice.
As a first step, the centre has formed the National Pharmacovigilance Advisory Committee (NPAC) 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 National Pharmacovigilance Advisory Committee (NPAC) is to play this role until a formal set up to monitor the entire programme is in place with the Central Drugs Standard Control Organisation.
As per the government plan, 24 peripheral centres, six regional centres and two zonal centres are to be set up 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 would provide training, general support and coordinate the functioning of the regional centres.
Meantime, the NPAC will oversee the performance of these 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 members of the NPAC are DCGI, DG ICMR, Director in-charge of Drugs Division, Dr S K Gupta, HoD Pharmacology, AIIMS, Dr Nilima Kshirsagar, SGS Medical College, Mumbai, Dr Ranjit Roy Chaudhary, NII, New Delhi, Dr C Adithan, Prof Pharmacology, JIPMER, Pondicherry, Dr T D Dogra, AIIMS, Dr Anoop Mishra, AIIMS, Dr A K Agarwal, RML, New Delhi, Dr S D Seth, chair-in Clinical Pharmacology, ICMR, Brijesh Regal, Former WHO Consultant, Dr Y K Gupta, Director, ITRC, Lucknow, Dr M D Gupte, ICMR Institute of Epidemiology, Chennai, Dr Kusum Tiwari, NIPER, Dr Urmila Thatter, HoD Pharmacoliogy, and B L Nair, Medical College Hospital, Mumbai.