Abstract

THE ROLE AND RECENT DEVELOPMENT OF PHARMACOVIGILANCE AS PER CDSCO GUIDELINES IN INDIA COMPARISION WITH CHINA

*Ashok Kumar P., Akshatha S. N., Bhavya V. R., Devika T. S., Hemalatha T. L.

ABSTRACT

Pharmacovigilance (PV) play an important role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators.

Keywords: Pharmacovigilance, Adverse drug reaction, Clinical trials, Pharmacogenomics, Data mining, Indian Pharmacopoeia Commission.