Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems                                       
 

 

Drug Safety News
India's Drugs Control Department within the Ministry of Health & Family Welfare initiated the establishment of a nationwide network to build a comprehensive pharmacovigilance data system in 2004. The National Pharmacovigilance Advisory
of the Director General of Health Services and the Drug Controller General of India (DCGI), who functions as the member secretary of the Committee. Based at the Central Drugs Standard Control Organization, NPAC was assigned the primary responsibility of setting up the system to monitor the pharmacovigilance programme throughout the country. The National Pharmacovigilance Programme for India is sponsored by the World Health Organization (WHO) and is funded by the World Bank.The NPP is 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 programme particularly solicits reports of:
• All adverse events suspected to have been caused by new drugs and ‘drugs of current interest'
  (List to be published by CDSCO from time to time)
• All suspected drug interactions
• Reactions to any other drugs which are suspected of significantly affecting a patient's management, including reactions suspected of causing:
• Death
• Life-threatening (real risk of dying)
• Hospitalisation (initial or prolonged)
• Disability (significant, persistent or permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment or damage.


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