India has more than half a million qualified Doctors and15,000 hospitals having a 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 the 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 “.

The specific aims of the Pharmacovigilance Programme are to:


The module will enable aspirants to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations, and consequences of adverse drug effects (ADEs), the manner in which these are detected and monitored, and the related historic and legal frameworks introduce aspirants to fundamental statistical, economic and epidemiological concepts and methods introduce aspirants to important pharmacoepidemiological concepts and methods and to enable them to apply these methods to drug issues equip participants with skills to facilitate further learning in these areas will provide an introduction to epidemiology, statistics, Pharmacoepidemiology and health economics. It will also cover the historical and legal background to pharmacovigilance and pharmacoepidemiology, and pharmacological basis of ADEs, addressing ADE issues at individual and population levels, and the application of pharmacoepidemiological principles and methods to practical drug issues.

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