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National Pharmacovigilance Programme

India has more than half a million qualified Doctors and15,000 hospitals having bed strength of 6,24,000.  It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important Clinical trial hub in the world. Many new drugs are being introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs.
            Clearly aware of the enormity of task the Central Drugs Standard Control Organization (CDSCO) has initiated a well structured and highly participative National Pharmacovigilance Programme. It is largely based on the recommendations made in the WHO document titled “Safety Monitoring of Medicinal Products – Guidelines for Setting up and Running a Pharmacovigilance Centre”.
            The National Pharmacovigilance Programme was officially inaugurated by the Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New Delhi.
            The specific aims of the 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.
·       promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.   
            The Programme aims to foster the culture of ADR notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC.
Under the program 26 peripheral centers, 5 Regional Centers and 2 Zonal Centers were established. The Peripheral centers will record the Adverse Events (AE) and send to the Regional Centers. They in turn collate and scrutinize the data received from the Peripheral Centers and submit to the Zonal Centers. The Zonal Centers will analyze the data and submit consolidated information to the National Pharmacovigilance Centre. The Zonal Centre will also provide training, general support and coordinate the functioning of the Regional Centers.
The National Pharmacovigilance Advisory Committee (NPAC) oversee the performance of various Zonal, Regional and Peripheral Pharmacovigilance centers as well as recommend possible regulatory measures based on the data received from various centers. It also oversees data collection and assessment, interpretation of data as well as publication of ADR monitoring data. The Committee also periodically evaluates their protocol compliance levels to ensure that the data received is homogenous and can be scientifically pooled for informed regulatory decisions. Wherever necessary, NPAC also seeks the opinion of experts in various specializations.  
For further information please contact:
The National Pharmacovigilance Centre
Office of Drugs Controller General of India,
Central Drugs Standard Control Organization,
Room No. 347-A,
D.G.H.S., Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi 110 011.
Tel: (11) 23018806 Fax: (11) 23012648
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