Ethics committees (ECs) are responsible to safeguard the rights, safety and well-being of all trial subjects of reviewed and approved study/trial protocol, as per set international standards within the Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human use1 and Declaration of Helsinki.2 In India, clinical trials (CTs), bioavailability/bioequivalence (BA/BE) study, biomedical and health research are governed by the New Drug and Clinical Trial Rules (NDCT),3,4 2019 vide notification number G.S.R.227(E) dated 19 March 2019.

The ECs related to CTs, BA/BE are registered with the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, India appointed by the Ministry of Health and Family Welfare (MoHFW), Government of India. The registration of an EC for CT, BA/ BE is valid for a period of 5 years from the date of its issue, unless suspended or cancelled by the central licensing authority and is to be renewed every 5 years.

The ECs related to biomedical and health research are registered with the authority designated by the Central Government in the MoHFW, Department of Health Research (DHR) under National Ethics Committee Registry for Biomedical and Health Research (NECRBHR). The provisional registration is granted on receipt of an application which is valid for a period of 2 years. On scrutiny of documents submitted and if satisfied as per requirements, the final registration is granted by the DHR, which is valid for a period of 5 years from the date of its issue, unless suspended or cancelled by the designated authority at the DHR.

The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants by ICMR (2017)5 recommends that ECs should register with the relevant authority as per the regulatory requirements. It also mentions that the certification and accreditation by ECs are voluntary exercises and help in quality assurance and quality improvement to ensure adherence to best practices in protecting the dignity, rights, safety and well-being of study participants. Accreditation is a long-term strategy.6,7 The National Accreditation Board for Hospitals and Healthcare Providers (NABH)8 was set up to establish and operate EC accreditation programmes for the CDSCO registered ECs. The accreditation is valid for a period of 3 years. The EC involved in review and approval of observational studies, registry trials, non-interventional clinical trials/research, biomedical health research are excluded from accreditation.

The NDCT mandates approval from a registered EC for the conduct of CT, BA/BE, biomedical or health research. The list of EC registration and re-registration within the CDSCO (along with the registration and re-registration letter), the list of EC registration with the DHR and accreditation are available in the public domain. We evaluated the status of registered, reregistered and accredited ECs in the country during 2013–2021 to understand the implementation of new requirements on registration of EC as per NDCT 2019 and assess the scale of standardization. We also documented the progress and pattern of registrations and distribution all over India.

METHODS

The EC registered and re-registered from Indian regulatory authority websites—CDSCO,9 DHR10—NAITIK portal (naitik.gov.in) and NABH8 during 2013–2021 were extracted manually. The status of ECs analysed according to the states within the country, type (institution or independent) of EC, year-wise distribution on registration, re-registration and accreditation status to assess the scale of diversity. The data used for this study were obtained from publicly available websites and not linked to any identifiable individual. No explicit individual consent was required. A descriptive analysis was done for the information extracted from different sources using Microsoft Excel.

RESULTS

According to the list of medical colleges approved by the Medical Council of India, dental colleges, hospitals with Diplomate National Board (DNB) courses, hospitals accredited with the NABH, Scientific and Industrial Research Organization (SIRO) recognized by the Department of Science and Industrial Research (DSIR) and Indian Institute of Technology, there are 2414 eligible ECs for oversight of research activities involving human participants. According to the list of ECs registered, 1122 (46%) ECs from these institutions are registered with the CDSCO and 702 (29%) ECs are with the DHR (Table I). The registered and re-registered ECs with the CDSCO, registered ECs with the DHR and accredited ECs across Indian states and Union Territories (UTs) are shown in Table II. Figure 1 shows the trend of registrations and re-registrations of ECs with the CDSCO, during 2013–2021, accreditation of ECs during 2018– 2021 and registration of ECs with the DHR during 2019–2021.

FIG 1. Year-wise ethics committees registered and re-registered with the Central Drugs Standard Control Organization (CDSCO), Department of Health Research (DHR) and accredited ethics committees (EC)

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TABLE I. List of ethics committees (ECs) registered with different agencies

Agency n(%) Healthcare institutions (medical colleges, dental colleges 2414 (%) and hospitals) and medical research institutions Registered with CDSCO 1315 (54) CDSCO—corrected* 1122 (46)   Institutional ECs 973 (87)   Independent ECs 149 (13) Re-registered with CDSCO 1660 Re-registered with CDSCO—corrected* 1416   Institutional ECs 1286 (91)   Independent ECs 130 (9) Registered with DHR 702 (29) Provisional registration (2 years) 675 (97)   Institutional ECs 657 (97)   Independent ECs 18 (3) Final registration (5 years) 27 (3)   Institutional ECs 26 (96)   Independent ECs 1 (4) Accredited with NABH 1 7 9 Accreditation/certification valid 1 2 8 Accreditation/certification expired 1 4 Provisionally accredited 8 Renewal under progress 1 9 Suspended/voluntary withdrawal 1 0

TABLE II. Accredited ethics committees (ECs) across Indian states and Union Territories

State/ Union Territory Registered with CDSCO* Re-registered with CDSCO* Registered with DHR (provisional+final) Accreditation with NABH Andaman and Nicobar Islands 1 0 1 0 Andhra Pradesh 127 121 2 8 4 Assam 1 4 1 3 6 2 Bihar 1 2 7 4 1 Chandigarh 0 2 2 0 Chhattisgarh 2 0 7 0 0 Daman and Diu 1 0 0 0 Delhi 9 4 8 7 5 3 1 2 Goa 9 6 1 0 Gujarat 165 176 4 4 1 4 Haryana 2 0 3 2 1 8 5 Himachal Pradesh 3 4 3 0 Jammu and Kashmir 4 2 3 0 Jharkhand 8 3 5 0 Karnataka 8 4 155 8 5 2 2 Kerala 3 2 8 9 5 0 8 Madhya Pradesh 1 6 2 1 1 3 2 Maharashtra 165 309 114 5 3 Manipur 0 1 2 0 Meghalaya 0 1 1 0 Mizoram 4 0 3 0 Nagaland 0 0 1 0 Odisha 1 6 2 4 8 2 Puducherry 5 1 2 1 1 1 Punjab 1 8 2 6 1 5 5 Rajasthan 4 0 5 1 2 0 6 Sikkim 1 2 1 0 Tamil Nadu 102 115 9 1 2 0 Telangana 4 9 1 5 4 5 6 Tripura 2 0 0 0 Uttar Pradesh 7 2 6 6 3 9 3 Uttarakhand 6 6 5 0 West Bengal 3 1 6 3 2 3 1 3 Total 1122 1416 702 179 Registration and re-registration of EC with CDSCO

About 87% of registered ECs are institutional; the remaining (13%) are independent ECs. Maharashtra and Gujarat lead the list of registered ECs with the CDSCO followed by Andhra Pradesh, Tamil Nadu, Delhi, Karnataka and Kerala.

Registration of EC with DHR

About 97% of registered ECs are institutional and overseeing biomedical and health research (i.e. academic clinical trials). The registration of ECs for biomedical and health research under the DHR as per NDCT rules 2019 started with a low proportion in 2019 (18, 2.5%). The registrations peaked in 2020 (357, 51%) and 2021 (327, 46.6%), despite the impact of Covid-19 lockdowns. This depicts the commitment of ECs for regulatory compliance. Other possible reason could also be the need of initiation of biomedical and health research on Covid-19-related studies, which was the need of hour. Maharashtra (114, 16.2%) leads in registration of EC with the DHR for approving biomedical and health research, followed by Tamil Nadu (91, 12.9%), Karnataka (85, 12.1%) and Andhra Pradesh (73, 10.9%). Several states and UTs (Andaman and Nicobar Island, Chandigarh, Daman and Diu, Himachal Pradesh, Jammu and Kashmir, Jharkhand, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim) had less than 5 registered ECs. There were no registered ECs from Arunachal Pradesh, Lakshadweep, Dadra and Nagar Haveli and Tripura.

Accreditation

Only 16% of registered ECs were accredited with the NABH. The accreditation of ECs with the NABH had an impact in 2020 (35, 20%) and 2021 (35, 20%) compared to 2019 (71, 40%) due to Covid-19-imposed lockdown. The slow accreditation may be due to lack of motivation as it is a voluntary self-improvement process, huge workload, lack of dedicated workforce, etc. Maharashtra (53, 29.6%) leads with the most accredited ECs in the country, followed by Karnataka (22, 12.3%) and Tamil Nadu (20, 11.2%). Half the states/UTs (19 states) did not have even a single accredited EC.

DISCUSSION

This is possibly the first effort to profile ECs registered/reregistered with the CDSCO, ECs registered with the DHR and accreditation with the NABH, as per the NDCT. There is lack of clarity on the target ECs operating as the ECs continue their new registrations annually: 142 new ECs registered in 2021, 166 in 2020, 132 in 2019. The registered institutional ECs does not reflect the total number of ECs that exist in the country. The possible reasons could be that few institutions are unaware of the registration requirements or the EC institutionalized considering the demand of research uptake. The registrations and re-registrations of ECs during 2013–18 lost their validity in 2021, considering that their registrations were valid for 3 years. As of December 2021, a total of 1115 ECs possessed valid registrations, i.e. the registered ECs (440) and re-registered ECs (675) during 2019–21 may possess valid registrations.

The data regarding number of applications under review and rejected are missing in the registration of ECs with the CDSCO while registration with the DHR provides a provisional certificate (validity for 2 years) and final registration (valid for 5 years) after scrutiny of applications. The NABH data provide details on application, accredited list and status such as renewal under progress, suspended, voluntary withdrawal and provisional accreditation. The skewed distribution of ECs among states and concentration in certain states suggests that research is under-represented geographically with limited access for patients to participate in clinical trials—particularly for orphan drugs. One of the limitations of our study is that the data and information published on websites of the concerned agencies were analysed, which may have incomplete or missing data due to lags in posting information on websites.

NDCT 2019 brought clarity for registration of ECs which review biomedical and health research under the DHR. The registration of ECs with the DHR are positively trending in scale, while accreditation with the NABH was stagnant during the Covid-19 years. The possible explanation for low volume of registered ECs undergoing accreditation needs to be explored with evidence for value proposition of accreditation on quality oversight. The current governance model also imposes on the governing bodies of EC registration to conduct inspections to ensure regulatory adherence and harmonized functioning. Alternatively, the NABH accreditation should be stimulated to strengthen and harmonize EC functioning and quality oversight.

Promoting digital EC functioning in the era of technology may ease the monitoring of EC functioning by regulators. The ECs are empowered for patient protection and quality oversight; hence, capability building to scale up the functioning of ECs in the technological era is the need of the hour.