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  Authors

Muskan R. Shaikh,Nisha K. Bhakare,Kalyani B. Kokane,Parag B. Funde,Ganesh R. Phadtare

  Keywords

Keywords: pharmacovigilance, adverse drug reactions, clinical trials, pharmacogenomics, Indian Pharmacopoeia Commission.

  Abstract


Pharmacovigilance (PV) plays a key role in the healthcare system by assessing, monitoring and detecting drug interactions and adverse drug reactions in humans. Medicines are intended to cure, prevent or treat disease. However, there are also risks, especially adverse drug reactions (ADRs) that can cause serious harm to patients. Therefore, for safe drugs, adverse reactions should be monitored throughout the life cycle of each drug, during drug development (e.g. pre-market, including early stages of drug design, clinical trial phase and post-marketing surveillance). Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding and prevention of adverse effects or any other drug/vaccine related issues. In addition, PV has traditionally been involved in recording spontaneous reports and submitting them to national surveillance systems. An emerging trend in PV is to link pre-market data to human safety information observed in the post-market phase. The PV Systems team captures valuable additional information, building on the scientific data contained in the original report, making it even more informative. This calls for extreme demands for effective regulation of the drug approval process and conscious vigilance against adverse effects before and after approval, especially in India. Adverse events reported through the PV system can benefit the community due to their linguistic and intellectual proximity to the public and public health practitioners, and the reporter can be easily contacted electronically. Thus, PV can help patients stay healthy and manage optimally or ideally, avoiding disease. This review summarizes the objectives and approaches used in PV and provide a critical review of existing PV in India, challenges to overcome and future prospects in the Indian context.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2303795

  Paper ID - 233257

  Author type - Indian Author

  Page Number(s) - g770-g774

  Pubished in - Volume 11 | Issue 3 | March 2023

  DOI (Digital Object Identifier) -    http://doi.one/10.1729/Journal.33653

  No Of Downloads - 102

  Author Country - India, 410507, Talegaon Dabhade, Talegaon Dabhade, 410507, Pharmacy All

  Publisher Name - IJPUBLICATION | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Published Paper PDF : - http://www.ijcrt.org/papers/IJCRT2303795

  Published Paper URL: : - http://ijcrt.org/viewfull.php?&p_id=IJCRT2303795

  Published Paper PDF Downlaod: - download.php?file=IJCRT2303795

  Cite this article

Muskan R. Shaikh,Nisha K. Bhakare,Kalyani B. Kokane,Parag B. Funde,Ganesh R. Phadtare,   "REVIEW ON PHARMACOVIGILANCE IN INDIA", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.11, Issue 3, pp.g770-g774, March 2023, Available at :http://www.ijcrt.org/papers/IJCRT2303795.pdf

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