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A Retrospect on Clinical Trials and Current Status of Schedule Y in India
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| Author:
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RAGHAV MISHRA
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| Abstract:
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A clinical trial is a human volunteer research study to respond to certain health issues. The best and easiest way to find treatments that work on patients and improve wellbeing is through carefully planned clinical studies. The safety of the drug, its therapeutic benefits in patients and quantities must be assured by pharmaceutical, biological and medical devices manufacturers. To assess the safety and efficacy of the treatment, preclinical testing progresses before clinical trials. Schedule Y of the Drugs and Cosmetic Act, laid out the legal requirements and standards for import and production of new drugs for sale or to undertake clinical trials. This review is necessary to prior reviews and plans to review the work in regards to clinical trials and presenting current status of Schedule Y in India including procedure and prerequisites for conducting clinical trials complying with the amendment in Schedule Y.
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| Keyword:
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Clinical Trial, Phases, Schedule Y, Amendment.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.020
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| Download:
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Request For Article
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