Status of registration, re-registration, and accreditation of ethics committees with Central Drugs Standard Control Organization, Department of Health Research, and National Accreditation Board for Hospitals and Healthcare Providers – An evaluation of the extent of ethics oversight in the country

Abstract

Context:

The “New Drugs and Clinical Trials Rules 2019” mandates that Ethics Committees (ECs) register with the Central Drugs Standard Control Organization (CDSCO), while ECs overseeing Postgraduate (PG) theses and academic studies must register with the Department of Health Research (DHR). National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation of ECs is currently optional.

Aim:

To evaluate the current status of EC registration and re-registration with CDSCO, DHR and accreditation of NABH as a metric of ethical oversight.

Subjects and Methods:

Data from January 1, 2019, to September 30, 2022 were collected from the organizational websites and the National Medical Commission (NMC). Registration and re-registration data for ECs were matched against the volume of studies in the Clinical Trials Registry India (CTRI), the number of ECs per state, and state populations. Descriptive and inferential statistics were applied.

Results:

Of the 770 ECs registered with CDSCO, 38.3% were reregistered. Of the 977 DHR-registered ECs, only 17% were re-registered. Among 370 NMC-recognized PG medical institutes, 49.72% had DHR-registered ECs. Only 13% (186/1400) ECs were NABH accredited from the overall data. A total of 14,551 regulatory studies were registered with CTRI. Among the major states (>4% of Indian population), Maharashtra had the highest percentage of CDSCO-registered ECs at 20% and accounted for 14% of regulatory studies, while states such as Bihar and West Bengal had lower percentages of both CDSCO registered ECs and regulatory studies.

Conclusion:

The registration, re-registration status of ECs, and accreditation are not commensurate with the quantum of regulatory and academic studies in the country.

INTRODUCTION

In India, with the increasing quantum of clinical research, empowered Ethics Committees (ECs) play a pivotal role in protecting the rights, safety, and well-being of participants and ensuring high quality research. The “New Drugs and Clinical Trials Rules (NDCT) 2019” states that ECs that oversee regulatory trials must be registered with the registration having a 5-year validity.[1] In addition, it is mandatory for ECs overseeing biomedical and health research (involving human participants) to get registered with the Department of Health Research (DHR).[2] National Accreditation Board for Hospitals and Healthcare Providers (NABH) accredits ECs to ensure the uniform quality standards.

A well-functioning EC would be registered and subsequently re-registered with Central Drugs Standard Control Organization (CDSCO), registered with DHR and possibly accredited by NABH. The authors’ have previously conducted a study[3] which evaluated registration, re-registration, and accreditation of ECs with CDSCO and their NABH accreditation (Timeline January 2013 to February 2018). The study found that only 499/1268 (39.4%) ECs were re-registered with CDSCO and only 7% of these ECs were NABH accredited. Hence, at that time, it was concluded that the registration, re-registration, and accreditation of ECs were not commensurate with the needs of the country.

Against this backdrop, we planned the present study with the primary objective of determining whether this metric had improved in the subsequent years (January 2019 to September 2022). The secondary objectives were to (a) assess whether the number of registered ECs in each state was commensurate with the population of that state and (b) whether ECs in National Medical Commission (NMC) recognized postgraduate (PG) medical institutes that oversee PG theses and/or academic studies were registered (or not) with DHR.

SUBJECTS AND METHODS

Ethics

As the data were available in the public domain, exemption from review for the study was sought and received from the Institutional Ethics Committee (EC/OA-143/2022).

Study procedures

Websites and Search strategy (Time line: January 1, 2019–September 30, 2022).

Websites of the CDSCO, DHR, NABH, Clinical Trial Registry of India (CTRI) and National Medical Commission of India (NMC) were searched and information was collated. In addition, population demographics of states was collated from the Census data (last accessed on September 30, 2022). URLs of websites are listed below:

1. https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/Ethics-Committee/Ethics-Committee-Registration (last accessed on September 30, 2022)[4]

2. https://naitik.gov.in/DHR/app_srv/soam/reports_pc_issued.jsp (last accessed on September 30, 2022)[5]

3. https://www.nabh.co/frmViewAccredited ClinicalTrial.aspx (last accessed on September 30, 2022)[6]

4. http://ctri.nic.in/Clinicaltrials/advsearch.php (last accessed on September 30, 2022)[7]

5. https://www.nmc.org.in/information-desk/college-and-course-search/ (last accessed on September 30, 2022)[8]

6. https://censusindia.gov.in/census.website/data/population-finder (last accessed on September 30, 2022).[9]

Registration, reregistration, and accreditation status

Information on registration and re-registration of ECs with CDSCO was collated. For DHR, there is provisional registration (validity-2 years) and final registration (validity-5 years) and this information was also gathered. Finally, status of NABH accreditation of CDSCO registered ECs (provisional with a validity of 1 year, final accreditation with a validity of 3 years) was collated. Volume of studies was culled from CTRI (January 1, 2019 to September 30, 2022) and matched with the state’s population and the number of ECs in that state.

Outcome measures

We evaluated the number of registered and re-registered ECs, their timelines, population of states, number of regulatory trials in CTRI, number of NMC recognized medical colleges offering a PG degree, and the number of NABH accredited ECs as our key outcome measures. The ratio of the total number of regulatory studies in CTRI in the given timeline to the total number of CDSCO-registered Institutional ECs indicates the burden on Institutional ECs in a given state in the country.

Statistical analysis

Descriptive statistics

Quantitative data (for example, registration timelines of ECs) are presented as median, range and assessed for normality using the Kolmogorov–Smirnov test. The categorical data (for example, the number of NMC recognized medical colleges with DHR registered ECs as a percentage of the total number of NMC recognized medical colleges) are expressed as proportions. We calculated a ratio of the total number of regulatory studies/the total number of institutional ECs in each state with a higher ratio indicating a higher EC workload.

Inferential statistics

We compared: (a) the total number of institutional and independent ECs registered and re-registered, along with their timelines and NABH accreditation status (b) number of registered ECs per state matched with the state’s population and regulatory trials therein (c) number of NMC recognized medical colleges running PG courses matched with the DHR registered ECs in these colleges. The difference between the time to registration/re-registration for all ECs was compared using the Mann–Whitney U-test. We also compared the number of re-registered ECs with the total number of registered ECs using the Chi-square test. These data were also compared with the previous study by Nishandar et al.[3] All analyses were performed at 5% significance using Microsoft Excel (2016).

RESULTS

Number of ethics committees registered, re-registered with Central Drugs Standard Control Organization

Registration

A total of N = 770 ECs were registered with the CDSCO. Of these, n = 687/770 (89%) were Institutional ECs and n = 83/770 (11%) were independent ECs. The median (range) time in days required for initial registration of institutional ECs was 74 (1–1735) while that for independent ECs was 106 (10–933) with the difference being statistically significant (P < 0.0001).

Re-registration

A total of n = 295/770 (38.3%) ECs were reregistered with CDSCO, of which n = 262/295 (89%) were institutional and n = 33/295 (11%) were independent. The median (range) time in days required for re-registration of institutional ECs was 68 (1–1222) days, whereas for that of independent ECs was 108.5 (5–672) days (P < 0.0001) and this difference was statistically significant.

Number of ethics committees registered and re-registered with the Department of Health Research

A total of N = 977 ECs were registered with the DHR, of which n = 699/977 (72%) had received the provisional registration. Of these, 680/699 (97%) were institutional ECs and 19/699 (3%) were independent ECs. The registrations of n = 114/977 (11%) ECs had expired. A total of 109/114 ECs were institutional and the rest independent ECs. A total of n = 164/977 (17%) ECs had received their final registration. The number of Institutional ECs with final registration was 158/164 (96%) while remaining 06/164 (4%) ECs were Independent. Time required for registration of ECs with DHR could not be determined as the dates of submission of applications were unavailable for the analysis.

Number of ethics committees accredited with National Accreditation Board for Hospitals and Healthcare Providers

A total of 304 applications were received by NABH of which 186/304 (61%) ECs were accredited, 116/304 (38.4%) applications were rejected and 2/304 (0.6%) were under review at the point of writing this paper. A total of 186/1400 (13%) ECs registered with CDSCO, were also accredited with NABH. A total of 11/186 (6%) of all the NABH accredited ECs had voluntarily withdrawn their application, 12/186 (6%) accreditations had expired and 2/186 (1%) were terminated by NABH. A total of 7/186 (5%) were provisionally accredited and 28/186 (15%) applications were due for renewal. The NABH database does not allow for comparing Independent and Institutional ECs, and the website does not display timelines for application and accreditation, so this is the overall data available.

State-wise distribution of registered and reregistered ethics committees

Central Drugs Standard Control Organization data

The state of Maharashtra had maximum number of ECs n = 86/770 (12%) registered initially while the states of the Northeast region (Assam, Manipur, Mizoram, Meghalaya, and Tripura) between them had a combined total of 30/770 (4%) ECs registered with CDSCO. Maharashtra had the highest number of ECs n = 66/295 (22%) re-registered, whereas only 19/295 (6%) ECs in the North-eastern states were reregistered. We also used a working definition of a “major state” in the country for the purpose of this study as one with a population exceeding 4% of the country’s population. Details of the major states are given in Table 1 and graphically represented in Figure 1.

Table 1.

Percentage of country’s population in each state versus percentage of central drugs standard control organization registered ethics committees

Major states*	Percentage of total Indian population=n/N×100% (n=1,210,854,977)	Percentage of ECs registered with CDSCO=n/N×100% (n=770)
Uttar Pradesh	16.5	6.43
Maharashtra	9.28	19.74
Bihar	8.59	0.64
West Bengal	7.53	6.23
Tamil Nadu	5.95	9.87
Rajasthan	5.66	3.24
Karnataka	5.04	9.74
Gujarat	4.99	11.6
Andhra Pradesh	4.09	9.35

*Major states with more than 4% of country’s population. ECs=Ethics committees

Figure 1.

Percentage of Indian population in each state versus ethics committees registered with central drugs standard control organization. EC = Ethics committee

Department of Health Research data

Maharashtra had the maximum number of ECs n = 146/977 (15%) registered with DHR while the states of North-east region (Assam, Manipur, Mizoram, Meghalaya, and Tripura) between them had only n = 16/977 (1.64%) ECs registered.

State population versus number of ethics committees registered with either with Central Drugs Standard Control Organization or Department of Health Research

The state of Maharashtra (9.3% of the country’s population) had n = 152/770 (20%) of all ECs registered with CDSCO and n = 146/977 (15%) of ECs registered with the DHR. The state of Uttar Pradesh, (16.5% of the country’s population) had only n = 52/770 (6.5%) ECs registered with CDSCO and n = 54/977 (5.52%) ECs registered with the DHR. Bihar with 8.6% of the country’s population had only n = 5/770 (0.6%) ECs registered with CDSCO and only n = 6/977 (0.6%) registered with the DHR.

Registered regulatory clinical trials versus registered ethics committees within states

A total of 14,551 regulatory studies were registered with CTRI within the timeline (January 2019 to September 2022). Maharashtra accounted the highest number of registered regulatory studies at n = 2048/14,551 (14%). The ratio of total number of regulatory studies to the total number of CDSCO-registered Institutional ECs ranged from 7.8 (Andhra Pradesh) to 43.2 (Delhi) [Table 2].

Table 2.

Comparison of number of regulatory trials versus central drugs standard control organization registered institutional ethics committees as a ratio

States*	Regulatory trials (A)	Institutional ECs (B)	Ratio of A and B	Rank
Maharashtra	2048	137	14.9	7
Karnataka	2022	67	30	4
Delhi	1513	35	43.2	1
Tamil Nadu	1219	65	18.7	5
Gujarat	991	81	12.23	9
Rajasthan	938	25	37.52	2
Uttar Pradesh	855	48	17.8	6
West Bengal	556	38	14.6	8
Andhra Pradesh	456	58	7.8	9
Kerala	438	30	14.6	8
Bihar	182	5	36.4	3

*States with higher volume, more than 180 regulatory studies within the timeline. ECs=Ethics committees

National medical commission recognized medical colleges versus department of health research registered ethics committees

A total of 677 medical colleges offer a medical degree (data as of September 30, 2022) of which n = 370/677 (54.65%) medical colleges in the country were recognized by the NMC for PG courses. Of these, only n = 184/370 (49.72%) had ECs registered with the DHR. In Goa, Meghalaya, Himachal Pradesh, and Chandigarh, all NMC recognized PG medical colleges had DHR registered ECs (n = 1 each for Goa and Meghalaya, n = 2 each for Himachal Pradesh and Chandigarh). In Bihar, none of the 10 NMC recognized medical colleges had a DHR registered EC. Details are given in Table 3 and graphically represented in Figure 2.

Table 3.

Comparison of Department of Health Research registered institutional ethics committees with National Medical Commission recognized postgraduate medical colleges

State*	Number of NMC registered Medical Colleges for PG courses	Number of NMC registered PG Medical Colleges with DHR registered ECs
Karnataka	50	24
Maharashtra	48	26
Tamil Nadu	35	19
Uttar Pradesh	26	16
Kerala	23	10
West Bengal	21	4
Andhra Pradesh	21	6
Delhi	19	9
Gujarat	15	9
Telangana	14	4
Madhya Pradesh	12	8

*States with higher number, more than 10 NMC recognized PG Medical Colleges. DHR=Department of Health Research, PG=Postgraduate, NMC=National Medical Commission, ECs=Ethics Committees

Figure 2.

Comparison of department of health research registered institutional ethics committees with national medical commission recognized medical colleges (postgraduate courses only). NMC = National medical commission, PG = Postgraduate

DISCUSSION

Our study on the registration, reregistration, and accreditation of ECs with the CDSCO, DHR, and NABH highlights the significant concerns regarding ethical oversight in India. Of the 770 ECs registered with the CDSCO, only slightly over half had re-registered. With the DHR, only 17% of the 977 ECs obtained final registration, and from 304 applications to NABH, 61% achieved accreditation. Alarmingly, just 13% of CDSCO-registered ECs also secured NABH accreditation. These indicate potential vulnerabilities in ethical oversight amid increasing academic and regulatory research activities in the country.

While comparing our findings to a previous study by the same authors,[3] we observed an increase in the number of studies registered with the Clinical Trials Registry India (CTRI), from about 738 to 3638 per year. However, the total ECs registered with CDSCO decreased from 1268 to 770. There was a slight, nonsignificant increase in the proportion of Institutional ECs (from 80% to 89%) and a decrease in independent ECs (from 20% to 11%). Reregistration timelines remained largely unchanged, and NABH accreditation rose marginally from 7% to 13%. This discrepancy suggests that while the volume of registered studies is increasing, the ethical oversight mechanisms are not keeping pace, raising concerns about their efficacy.

According to the Chapter IV of the NDCT rules 2019, all ECs overseeing biomedical research must register with the DHR. Given that every medical college in India must manage thesis oversight, we would expect 370 registrations on the DHR site. Instead, we found only 184 of 370 (49.7%) had DHR registration. This suggests significant challenges in the documentation required for DHR registration, hindering compliance with NDCT regulations.

Studies has identified numerous obstacles to effective EC operations: Issues of independence, funding shortages, heavy workloads, limited resources, lack of organizational support, the complexity of studies, and challenges in maintaining experienced membership. These factors likely contribute to the low DHR registration rates.[10] The marginal increase in NABH accreditation (from 7% to 13%) is noteworthy but still inadequate. NABH accreditation is a voluntary process aimed at enhancing the quality and functionality of ECs, which in turn protects research participants. However, this process is lengthy and complex, comprising ten chapters and 49 objective elements. Not all ECs prioritize this accreditation, often due to administrative reluctance and associated costs, reflecting a mindset shift needed among ECs and their institutions.[11]

In addition, there is a significant disparity in the distribution of ECs across the states, raising ethical concerns. Areas with fewer registered ECs may lack adequate oversight, endangering participant rights and safety. States with larger populations, such as Bihar, West Bengal, and Uttar Pradesh, require more ECs to ensure proper ethical oversight, particularly given the growing number of clinical trials. Overburdened Institutional ECs in states such as Delhi and Karnataka face regulatory pressures that further complicate their oversight responsibilities.

This study’s strengths lie in its comprehensive examination of ethical oversight across regulatory and academic contexts, including individual state metrics. However, a notable limitation is the COVID-19 pandemic’s impact on our timeline (January 2019 to September 2022), which may have diverted attention from accreditation efforts. Nonetheless, registration with the CDSCO and DHR should have remained a priority given the substantial volume of studies, and virtual audits during the pandemic should have allowed some degree of oversight.

In summary, the current status of registration, re-registration with CDSCO and DHR, and NABH accreditation of ECs does not align with the volume of research conducted in India. While not all ECs may wish to oversee regulatory studies, they cannot neglect the essential DHR registration requirement. Increased awareness and support are crucial to uplift NABH accreditation and strengthen ethical oversight, particularly in the underserved regions. Addressing these issues is vital to safeguard the rights and welfare of research participants across the country.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.