The Journal of Integrated Health Sciences | Vol III | Issue II |Dec 2015

2 Pages Posted: 23 May 2019

See all articles by Bhagya Sattigeri

Bhagya Sattigeri

Deemed Universities: Symbiosis International Deemed University

SV Desai

Sumandeep Vidyapeeth

Date Written: December 2015


Any medicine or vaccine that are capable of producing a therapeutic effect can also produce unwanted or adverse effects, the severity of which could range from mild to severe which could at times be fatal. The adverse drug reactions affect an individual irrespective of age, gender, economic status, ethnicity etc. It has been considered as a major global concern. The adverse drug reaction may occur with the use of any medicine or vaccine when given to the patient either through prescription, as an Over the Counter (OTC) preparation or as a complementary medicine. These adverse drug reactions have been reported to be the leading cause of morbidity and mortality. They also add to the economic burden in the health care management. It has been obvious with the studies conducted that, the treatment of the adverse drug reactions has been costlier than treating the disease proper.

A rapid and a vast growth in the field of Medicines, with an increasing number of pharmaceuticals has been a difficulty in identifying & controlling the adverse drug reactions to the administered drugs. Limitations with the preclinical toxicity study of the molecules in animals and the limitations of the Phase II Clinical Trial during the development of the new drug molecule add to the difficulty in identifying the adverse drug reactions related to the drug.

Therefore, Pharmacovigilance emerged as an integral part of clinical research, which in principle involves the identification and evaluation of safety signals that arise either from the preclinical data or from the post marketing data. Pharmacovigilance is derived from the Greek word “Pharmakon” meaning “drug” & Latin word “Vigilare” meaning “To keep watch”. Pharmacovigilance is an important Public Health function which aims to reduce the harms related to the administered medicines. It is defined by the WHO as” the science relating to detection, assessment, understanding, and prevention of adverse effects or any other drug related problem”.

In 1932, although 107 deaths caused by sulphanilamide alarmed to enforce the Food, Drug & Cosmetics Act in 1938 to ensure safety to the administered medicines, the adverse drug reactions caused by several other drugs were overlooked for a period of three decades, until the Thalidomide tragedy occurred affecting more than 10000 new born babies with the birth defect Phocomelia (Seal Limbs). It was considered as a milestone, which led to the establishment of International Drug Monitoring Program in 1968 to extend patient safety measures. Initially only 10 countries contributed to this that slowly expanded & led to the establishment of the National Pharmacovigilance Centres.

Suggested Citation

Sattigeri, Bhagya and Desai, SV, Pharmacovigilance (December 2015). The Journal of Integrated Health Sciences | Vol III | Issue II |Dec 2015. Available at SSRN:

Bhagya Sattigeri (Contact Author)

Deemed Universities: Symbiosis International Deemed University ( email )

Post Lavale, Taluka : Mulshi, Pune

SV Desai

Sumandeep Vidyapeeth

At & Po Piparia
Tal: Waghodia
Vadodara, Gujarat 391760

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