Abstract

COMPARATIVE ANALYSIS OF REGULATIONS AND REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN A MODEL COUNTRY FROM ASIA, AMERICA AND MIDEAST

Bhagyashri M. Sutar* and I. D. Gonjari

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Abstract

Clinical trials (CTs) are research studies that investigate whether a medical strategy, treatment, or devices is safe and effective for humans. These researches may also reveal which medical treatments are most effective for specific disorders or groups of people. Clinical trials are designed to conduct research, thus they follow strict scientific guidelines. These guidelines protect patients while also helping in the production of reliable study results. Clinical trials are carried out in compliance with the regulatory guidelines set forward by the drug regulatory authority in the country in which they are to be carried out. In India, CTs are regulated by Central Drugs Standard Control Organization (CDSCO) (Schedule Y of the Drug and Cosmetics Rules, 1945) and Indian Council on Medical Research (ICMR) (Ethical guidelines for Biomedical Research on Human subjects) respectively. In USA they are regulated by USFDA as per their 21 Code of federal regulations part 312(CFR) of federal food and Drug cosmetic act. In Saudi Arabia CTs are regulated by Saudi Food and Drug Authority. This review paper contains Comparative Analysis of Regulations and Requirements to conduct clinical trials in a model country from Asia, America and Mideast, viz, India, USA and Saudi Arabia respectively, in order to determine safety and efficacy of pharmaceutical products like drug, biologic and medical device and to confirm the clinical trials studies follows strict scientific standards.

Keywords: Clinical trials, CDSCO, USFDA, SFDA, Regulatory framework.