A newer dimension to regulation of ethics committees in India

Ila Narang, Ishita Kumari Bharota, S. Raisuddin, Gaurav Kumar Jain, Nidhi Bharal Agarwal
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Abstract

Abstract Clinical research is a pre-requisite part of the drug discovery and development process, with the main aim to ensure the safety and efficacy of any new drug. In today’s date, clinical trials are the backbone for bringing newer and better drugs to market. Although a set of established guidelines are available for governing the conduct of clinical trials in India, the ethics committees of this country are still struggling with basic issues viz, inadequate or no standard operating procedures (SOPs) and non-compliance with the Schedule Y recommendations. The ethics committee being the prime body with the responsibility of regulating clinical research, protecting and safeguarding the rights, safety and well-being of research participants, the institutions, hospitals, and pharmaceutical industries that focus on enhancing their research facilities tend to ignore the various aspects of ethics committees like composition and qualification of members forming the quorum, regular updates of ethics committees to be reported to the central authority, lack of administrative support and communication, inadequate remuneration offered to members serving to ethics committee boards, archival of records and regular auditing of the ethics committee. The central regulatory body of India CDSCO governing the conduct of clinical trial, in October 2012, under the guidance of Drugs Technical Advisory Board, laid down three major amendments in schedule Y. The present article discusses one of the new amendments laid down recently in schedule Y under rule 122 DD which states the requirements and guidelines needed for registration of ethics committees in India.
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印度伦理委员会监管的新层面
临床研究是药物发现和开发过程的先决条件,其主要目的是确保任何新药的安全性和有效性。在今天,临床试验是将更新更好的药物推向市场的支柱。尽管印度有一套既定的指导方针来管理临床试验的进行,但该国的伦理委员会仍在努力解决基本问题,即标准操作程序(SOPs)不充分或没有,以及不遵守附表Y的建议。伦理委员会是负责规范临床研究、保护和维护研究参与者的权利、安全和福祉的主要机构,专注于加强研究设施的机构、医院和制药行业往往忽视伦理委员会的各个方面,如组成和成员资格,构成法定人数,定期向中央报告伦理委员会的最新情况,缺乏行政支持和沟通,为道德委员会委员会成员提供的报酬不足,记录存档和对道德委员会的定期审计。2012年10月,在药品技术咨询委员会的指导下,管理临床试验的印度CDSCO中央监管机构在附表Y中制定了三项主要修正案。本文讨论了最近在附表Y中根据规则122 DD制定的新修正案之一,该规则规定了印度伦理委员会注册所需的要求和指南。
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