Abstract

Abstract Purpose/Aim: Ethics committees (ECs) have gained much importance since the introduction of the New Drugs and Clinical Trials Rules 2019. The committee report authored by Prof. Ranjit Roy Chaudhury suggested the need for accreditation of Institutional ECs. We aimed to enumerate the registered and accredited ECs across different geographical regions in India and to assess the adequacy of EC standard operating procedures (SOPs). Materials and Methods: Our study was conducted between August and October 2022. The registration status of ECs was obtained from the Central Drugs Standard Control Organization (CDSCO) and Department of Health Research (DHR) websites. Information on accreditation status was obtained from the National Accreditation Board for Hospitals and Healthcare Providers (NABH) website. Registration data were categorized region-wise and available SOPs were collected from respective hospital websites and analyzed for adequacy. Results: We found that 1400 ECs in India were registered under CDSCO and 952 under DHR. Maharashtra had the largest number of registered ECs. Puducherry, Delhi, and Daman and Diu had the highest density of ECs. Bihar, Himachal Pradesh, and Jharkhand had the lowest. Only 299 ECs had their composition listed, and 111 had SOPs available on their websites. Most ECs lacked SOPs related to reviewing clinical trial agreements, compensation, and dealing with participant complaints. Conclusion: The advent of the New Drugs and Clinical Trials 2019 has created a definite impetus for increased responsibilities of ECs in India. Yet the registered ECs are not evenly distributed across the country. Moreover, it is disheartening to note that 90% of ECs in the country do not have NABH accreditation. Only a handful of ECs had SOPs posted on their websites.

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