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Jain Deepika*, Rathore Kamal Singh
BN Institute of Pharmaceutical Sciences,
Udaipur-Raj.313002 INDIA

Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function”. The mission of Pharmacovigilance is to contribute to the protection of public health in the regulation of the safety; quality and efficacy of medicines for human use and to ensure the healthcare professionals and patients have access to information about the safe and effective use of medicine. The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “Any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of the physiological function”.

The discipline of pharmacovigilance has developed considerably since the 1972 WHO technical report, and it remains a dynamic clinical and scientific discipline. It has been essential to meet the challenges of the increasing range and potency of medicines (including vaccines), which carry with them an inevitable and sometimes unpredictable potential for harm. The following is a summary of some of the serious challenges facing pharmacovigilance programmes in the next ten years & the major challenges are:Globalization, Web-based sales and information, Broader safety concerns, Public health versus pharmaceutical industry economic growth , Monitoring of established products, Developing and emerging countries, Attitudes and perceptions to benefit and harm, Outcomes and Impact.


1. Introduction
‘Not all hazards can be known before a drug is marketed’.
- Committee on Safety of Drugs, Annual Report 1969, 1970.

A pharmaceutical product, used in or on human body for the prevention (prophylaxis), mitigation, diagnosis and/or treatment of disease, or for modification of physiological function.

Medicines have led otiovement in the treatment and control of diseases; they also produce adverse effects on the human body from time to time. Many drugs are precisely targeted to the cause and mechanism of a disease, they may also have minor or distressing effects on other parts of the body, or interact negatively with the various systems of a particular individual or with other drugs or substances that they are taking, or, not work well or at all for some, many or all of those who take them. There is no such thing as a safe drug. There are risks in any intrusion into the human body, whether chemical or surgical. Nothing in this field is entirely predictable - except that the interaction between science and the human body may produce surprises1-3.

Benefits: Benefits are commonly expressed as the proven therapeutic good of a product, but should also include the patient’s subjective assessment of its effects

Risk: Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population.

Harm: Harm is the nature and extent of the actual damage that could be caused. It should not be confused with risk.

Effectiveness : Effectiveness is used to express the extent to which a drug works under real world circumstances, i.e., clinical practice (not clinical trials).

Efficacy: Efficacy is used to express the extent to which a drug works under ideal circumstances (i.e. in clinical trials)

Finding the risk of drugs
Pharmaceutical companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available. The manufacturers or their agents usually select a representative sample of patients for whom the drug is designed, at most a few thousand along with a comparable control group. The control group may receive a placebo and/or another drug that is already marketed for the disease. The purpose of clinical trials is to discover:

  • If a drug works and how well
  • If it has any harmful effects, and
  • Its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?

Clinical trials in general, tell us a good deal about how well a drug works and what potential harm of the drug, it may cause. They provide information which should be reliable for larger populations with the same characteristics as the trial group - age, gender, state of health, ethnic origin, and so on.

The variables in a clinical trial are specified and controlled and the results relate only to the population of which the trial group is a representative sample. A clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, there is nothing that could tell you the whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgments about the acceptable balance of benefit and harm4-9.

(Greek), “drug” and vigilare (Latin), “to keep awake or alert, to keep watch.”

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to1,10-14:

  • Identifying new information about hazards associated with medicines
  • Preventing harm to patients

Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function”. Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases15-17.

Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs, such as liver damage, are often undetected because study populations are small. Post marketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs18.

Drug surveillance-WHO
The world health organization (WHO) collects data from 72 countries around the world in an attempt to detect adverse drug reactions (ADRs) signals that are too weak for any individual country to detect. Some of the services provide to the national centers includes-identifying new signals from the information submitted by the national centers, provision of the WHO database, information exchange between national centers and WHO, publications of the newsletters and reports, provision of training and support to the national centers, and annual meeting of the representatives of national centers19.

2. Brief history of Pharmacovigilance in India
Even though pharmacovigilance is still in its infancy, it is not new to India. It was not until 1986 that a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. However, nothing much happened until a decade later when in 1997, India joined the World Health Organization (WHO) Adverse Drug Reaction Monitoring Programmed based in Uppsala, Sweden. Three centers for ADR monitoring were identified, mainly based in teaching hospitals: a National Pharmacovigilance Centre located in the Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi and two WHO special centers in Mumbai (KEM Hospital) and Aligarh (JLN Hospital, Aligarh Muslim University). These centers were to report ADRs to the drug regulatory authority of India. The major role of these centers was to monitor ADRs to medicines marketed in India. However, they hardly functioned as information about the need to report ADRs and about the functions of these monitoring centers were yet to reach the prescribers and there was lack of funding from the government. This attempt was unsuccessful and hence, again from the 1st of January 2005, the WHO sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational5, 20-23.

The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal centre (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal centre (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala Monitoring centre in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 24 peripheral centers24.

Objectives of National Pharmacovigilance Programme
The main objectives of National Pharmacovigilance Programme are as following5

  • To foster the culture of Adverse Event (AE) notification and reporting
  • To establish a viable and broad based ADR monitoring programs in India
  • To create an ADR database for the Indian population
  • To create awareness of ADR monitoring among people
  • To ensure optimum safety of drug products in Indian market.
  • To create infrastructure for ongoing regulatory review of Periodic Safety Updates Regulators (PSURs).



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