Abstract

RECENT ADVANCEMENT IN REGULATORY GUIDELINES FOR CLINICAL TRIALS IN USA AND INDIA

Vijay Kumar*, Meenu Bist, Ashir and Pawandeep Kaur

Abstract

Clinical trials (CTs) are conducted to discover new methods of interventions that are better than the existing ones. They are conducted as per the guidelines suggested by the drug regulatory authority of the country where they are being conducted. In United State (U.S.), CTs are regulated by U.S. Food and Drug Administration (USFDA) as per 21 Code of Federal Regulations (CFR) Part 312 and 812 of Federal Food, Drug, and Cosmetic Act. On the other hand In India; CTs are regulated by Central Drugs Standard Control Organisation (CDSCO) in consultation with Indian Council of Medical Research (ICMR) as per the schedule Y of the Drug and Cosmetics Rules, 1945 and Ethical Guidelines for Biomedical Research on Human subjects. To initiate trials in USA, an Investigational New Drug Application (INDA) has to be submitted by the company to USFDA regulatory body. But In India applicant has to be submit, Form 44 along with other documents mentioned in Form 44 checklist. Approval time for INDA in USA is 30days, but in India this will take approximately 16-18 weeks. In USA, the INDA should be submitted in USFDA recommended format or common technical document (CTD) format, whereas, CTD format is still not enforced in India for INDA. In this review article, CTs regulations in India and USA were discussed on the basis of different parameters such as CTs Application Format, Approval Time, Compensation, and Other regulations. The success rate of CTs in USA is higher, which may be due to well-trained investigators, fast regulatory approval process and volunteer participation by the subjects. In contrast, there is decline in CTs in India because of violation of ethical guidelines and regulations are not being adopted strictly. Hence, by this review, we intend to present a comprehensive view of overall transition and modernization of the drug discovery process and its impacts on the scientific community.

Keywords: Clinical Trails, CDSCO, USFDA, CTD.