What is the Role of Pharmacovigilance in a Country like India?

Know about the overall role of PV (Pharmacovigilance) in India’s healthcare. Read on to understand its meaning and role in various sectors of the Indian economy.

Pharmacovigilance, or PV, is known to play a vital role in the country’s healthcare system through the stages of monitoring, assessment, as well as the discovery of various interactions taking place between drugs and their overall effects on the human health. Biotechnological and pharmaceutical medicines are designed for curing, preventing, and treating a myriad of diseases out there. However, at the same time, there is no denying the overall adverse effects of the medicines across its lifecycle in the human body, through the stages of drug development like pre-marketing involving the early stages of designing the drug, conducting clinical trials, and ensuring post-marketing auditing. As such, aggregate reporting of pharmacovigilance is required in most cases.

PV or Pharmacovigilance is concerned with the processes of detecting, assessing, understanding, and preventing ADRs (Adverse Drug Reactions) in the patients. Pharmacogenomics and pharmacogenetics are regarded as the inevitable parts of the main clinical trials & research. The variation that is caused in the human genome could turn out to be the cause for variable response to specific drugs as well as how diseases get determined. This turns out to be a vital phase for discovering early drugs to PV. At the same time, professional pharmacovigilance services are also known to be concerned with the mining of spontaneous reports that are submitted to the major national-level surveillance systems.

Introduction to Pharmacovigilance (PV)

PV or Pharmacovigilance was introduced during the time of December 1961. It was introduced through the letter that was written and published in the journal “Lancet” by the influential W. McBride – a famous doctor from Australia who was the first one to come across a possible link between major deformities in fetal development and the drug named “thalidomide” –a major drug that is used during pregnancy.

PV delivered by leading Pharmacovigilance services, is referred to as the process that collects, monitors, researches, assesses, and evaluates information from the leading healthcare providers as well as patients towards analyzing the side effects of certain biological products, medicines, herbals, blood products, traditional as well as complementary drugs, and vaccines. The process of PV through an in-depth aggregate reporting in pharmacovigilance is conducted with a view to identifying new information with regard to the potential hazards that might be associated with certain biological products while preventing harm to the concerned patients from the same.

PV is known to be primarily concerned with ADRs, specific adverse drug responses that might be unintended or noxious, and that might occur at dosages that are normally used for the diagnosis, prophylaxis, and treatment of disease, or for the purpose of modifying specific physiological functions. Continuous monitoring as well as an assessment of drugs and its side effects including outright harmful effects and contraindications that could result in a higher degree of morbidity, tend to be essential towards maximizing the overall benefits and minimizing the risks at the same time.

Educe Solutions is a leading service provider of high-end pharmacovigilance services to the healthcare units as well as patients all around. It ensures clients conform to internationally accepted standards and also comply with local and international regulations.