The National Pharmacovigilance programme, as envisaged under the World Bank (WB) Assisted Capacity Building Project on Food Safety and Quality Control of Drugs, is to be completely functional by June 2005. The WB has cleared the "Terms of Reference" of the programme few days ago, thereby paving way for the setting up of the programme, it is learnt.
According to Ashwini Kumar, Drugs Controller General of India (DCGI), the entire mechanism for the programme would turn functional within a month. The programme envisages setting up of 24 Peripheral centres for recording Adverse Events (AE), 6 Regional Centres to collate and scrutinize the data received from the Peripheral Centres and 2 Zonal Centres for causality analysis of the reported AE's and to provide training, general support and coordinate the functioning of the Regional Centres. "We have already identified and trained the doctors who are to be part of the network. With the WB nod, we are in a position to start off officially," DCGI informed.
The pharmacovigilance programme was launched by the union minister for health in November last year. As a first step, a National Pharmacovigilance Advisory Committee (NPAC) under the chairmanship of Director General of Health Services was notified soon. The Committee has already made two major recommendations to stop continued marketing of COX-2 inhibitor rofecoxib and valdecoxib in the country. While the government has notified a ban on rofecoxib formulations, the announcement to ban valdecoxib is expected any time. In the absence of locally generated data, the NPAC decisions on these two occasions were based on adverse drug reaction (ADR) data generated outside the country. With the peripheral centres turning fully functional by June end, NPAC can now depend upon India data to study the risk-benefit profile of drugs in future.
The NPAC will now oversee the performance of various Zonal, Regional and Peripheral Pharmacovigilance centres as well as recommended possible regulatory measures based on data received from various centres. NPAC will also oversee data collection and assessment, interpretation of data as well as publication of ADR monitoring data. The Committee 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. Wherever necessary, NPAC will also seek the opinion of experts in various specializations.
The specific aims of the proposed pharmacovigilance programme are 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, improve patient care and safety in relation to use of medicines and all medical and paramedical interventions, improve public health and safety in relation to use of medicines and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.