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Table of Contents
Year : 2015  |  Volume : 3  |  Issue : 2  |  Page : 1-2


1 Profesor & HOD, Department of Pharmacology, SBKS MI & RC, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat, India
2 Professor, Department of Pharmacology, SBKS MI & RC, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat, India

Date of Web Publication24-Aug-2018

Correspondence Address:
B M Sattigeri
Profesor & HOD, Department of Pharmacology, SBKS MI & RC, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2347-6486.239789

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How to cite this article:
Sattigeri B M, Desai S V. Pharmacovigilance. J Integr Health Sci 2015;3:1-2

How to cite this URL:
Sattigeri B M, Desai S V. Pharmacovigilance. J Integr Health Sci [serial online] 2015 [cited 2022 Dec 4];3:1-2. Available from: https://www.jihs.in/text.asp?2015/3/2/1/239789

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.

In India the centre was established in 2005 which was then in 2010 renamed as the Pharmacovigilance Program of India (PvPI) which, works in collaboration with the Global adverse drug reaction monitoring centre i.e. the Uppsala Monitoring Centre (WHO-UMC), Sweden. Thus, PvPI involves a systematic collection of the adverse drug reaction data and provides valuable information to the drug regulation authorities to take necessary action in order to promote patient safety & contributes to the global data base of adverse drug reactions.

Under the PvPI, there are about more than 190 Adverse Drug Reactions Monitoring Centres (AMC). All these centres function with the aim of improving patient care, ensuring patient safety, improve public health through ensured safe use of medicines, help in assessment of benefit, harm effectiveness & risk of medicines, promote understanding, education, and training on Pharmacovigilance.

Pharmacovigilance in Sumandeep Vidyapeeth:

It is mandatory for every medical college in India to have a Pharmacovigilance committee, as per regulations of Medical Council of India, 2010. Therefore, Pharmacovigilance committee of SBKS Medical Institute and Research Centre was established in 2011 with the goal, to generate awareness about the need of identifying and reporting of Adverse Drug Reactions (ADR), amongst all sections of health care providers (doctors, consultants, nurses, pharmacists, postgraduates and undergraduate students, service providers etc) of the SBKS MI & RC and attached Dhiraj Hospital. Also to pick up and identify ADR occurring in patients admitted to Dhiraj Hospital and reports the same to the appropriate authorities.

Further, the committee monitors the occurrence of the adverse drug reactions in the patients attending OPD and in those admitted in the wards, to optimize safe, rational and effective use of medicines, provide safety related information to the health care providers and the stakeholders, regularly conduct the sensitisation programs so as to create awareness among all the health care professionals on the importance of reporting the suspected adverse drug reactions & facilitates research in the field of Pharmacovigilance.

The institute aims to establish an adverse drug reaction monitoring centre has applied for the same and is in process. This is with an idea to contribute & support the national program and in turn benefit the mankind.

With the efforts made by every health care professional, attitudinal and cultural changes of reporting the adverse drug reactions as an integral part of the clinical activities of the doctors would in long run definitely prove to benefit the mankind.


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