Updated: Dec 19, 2022
Knowing What Pharmacovigilance is?
According to WHO Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. But to make it simple, etymologically Pharmacovigilance is to keep a watch on drugs (Pharmakon= Drug, Vigilare= to keep a watch).
History and Development of Pharmacovigilance:
Before diving deep into any topic, it is necessary to understand its history and Development. Let’s know why there was need to develop Pharmacovigilance as an important branch in Health care systems. The following figure describes the milestones that led to evolution of Pharmacovigilance activities.
The above events highlighted the need for a structured system to vigil the safe and effective use of health products.
Aim and Objectives of Pharmacovigilance:
As the definition and the etymology suggests the main objective of Pharmacovigilance is to reduce drug related harm, safety of drugs for patients and to promote rational use of medicines. Pharmacovigilance deals with adverse drug reactions, including lack of efficacy, medication errors, off-label use, acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of health products, and adverse interactions of medicines with chemicals and other drugs etc.
To whom will Pharmacovigilance Benefit?
1. Medical staff
2. Paramedical staff
4. Pharmaceutical company
5. Patients and their relatives
How the Aim and Objectives are met?
By following activities, the aim and objectives of Pharmacovigilance can be satisfied.
Ø Post Marketing surveillance can be carried out by following methods:
1. ADR form filling by doctors or other health professionals.
2. Voluntary Reporting.
3. Prescription event monitoring.
4. Computerized record linkage.
5. Cohort case studies.
6. Anecdotal Case Studies.
Ø Dissemination of ADR data:
1. Drug Alerts.
2. Medical letters.
3. Advisory send to Physicians by regulatory agencies.
Ø Changes in Labeling:
1. Statuary Warning.
Ø Causality Assessment:
1. Relationship With time of drug administration.
2. Previous knowledge about drug.
3.. Dechallenge and Rechallenge.
Ultimately, Pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and Pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance. It is always wise to learn from our history and mistakes and Pharmacovigilance is the outcome of the same. This branch of science has unlimited significance which can do wonders in the health care system.
Pharmacovigilance in India
Pharmaceutical Industry in India is valued at around 90,000 crore and is growing at a rate of 12-14% per annum. India is now being recognized as the ‘Global Pharmacy of Generic Drugs’ and also provides quality generic drugs at affordable price. India is also emerging as a hub of Global clinical trials and of Drug development and discovery.
In short period of time more & more new drugs are being introduced into the country which include New Chemical Entities (NCE), high tech Pharma products, vaccines as well as new dosage forms, new routes of drug administrations and new therapeutic claims of existing drugs.
Almost every chemical entity has side effects, and such rapid induction of NCEs and high tech Pharma products in the market throw up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base.
There are considerable social and economic consequences of ADRs there is a need to engage health-care professionals, in a well-structured programme to build synergies for monitoring ADRs. The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems. The Central Drugs Standard Control Organisation established the program in July 2010 with All India Institute of Medical Sciences, New Delhi as the National Coordination Centre, which later shifted to Indian Pharmacopoeia Commission in Ghaziabad on 15 April 2011.
History and Development of Pharmacovigilance in India
Many developed countries set up their Pharmacovigilance programs following the Thalidomide scandal in the 1960s. India set up its program in the 1980s. This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the Indian Pharmacopoeia Commission.
As of 2018 there were 250 centers around India capable of responding to reports of serious adverse reactions. One of the challenges of the organization is training doctors and hospitals to report adverse drug reactions when patients have them. The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic. The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.
One of the successes of the program was detecting adverse effects of people in India using carbamazepine. While this drug is safer among people native to the Europe, people of South Asia have different genetics and are more likely to experience problems when using it. Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.
Pharmacovigilance Program of India (PvPI)
The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi has launched the nation-wide Pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programme is coordinated by the Department of Pharmacology at AIIMS as a National Coordinating Centre (NCC). The center will operate under the supervision of a Steering Committee which consists of a Chairman, five Ex-officio members and a member secretary.
Goals and Objectives of PvPI
Goal: To ensure that the benefit of use of medicine outweighs the risks and thus safeguard the health of the Indian population.
1. To monitor Adverse Drug Reactions (ADRs) in Indian population.
2. To create awareness amongst health care professionals about the importance of ADR reporting in India.
3. To monitor benefit-risk profile of medicines.
4. Generate independent, evidence based recommendations on the safety of medicines.
5. Support the CDSCO for formulating safety related regulatory decisions for medicines.
6. Communicate findings with all key stakeholders.
7. Create a national Centre of excellence at par with global drug safety monitoring standards.
Governance Structure of PvPI
Following image describes the governance structure of PvPI
Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC)
WHO-UMC work with and/or provide technical support to more than 94 countries worldwide. The long term objective of the PvPI is to establish a ‘Centre of Excellence’ for Pharmacovigilance in India. To achieve this objective, the PvPI National Coordinating Centre will collaborate with the WHO - UMC Collaborating Centre based in Sweden.
Training of the staff at the PvPI national coordinating Centre at AIIMS, the ADR Monitoring centers in medical colleges across the country
Usage of UMC’s Vigiflow software (for medicines) and Paniflow (for vaccines) at no cost to PvPI.
Access to Vigibase, which contains worldwide medicines safety data
Access to early information about potential safety hazards of medicines (worldwide data)
Technical collaboration for Pharmacovigilance Programme of India
Technical collaboration for a regular publication that will be issued by the PvPI National Coordinating Centre for distribution to the ADR Monitoring centers and other stakeholders.
CDSCO Headquarters has held several meetings with UMC over the past few years to discuss the potential role and approach for technical collaboration.
The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research. Understanding the quality of India's Pharmacovigilance programme is key to international researchers conducting trials in India.
The program collaborates both in India and internationally with the World Health Organization on projects for safe medication. As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.
While the United States and Europe have Pharmacovigilance systems which are developed well in some ways, the Indian programme has more and specialized expertise to apply for the unique circumstances of India. The Pharmaceutical industry in India produces more drugs than any other national industry. Because of the large amount of drugs and the many countries which import them, the Indian program monitors in some ways more than anywhere else.