Ethics committees in India: A study to assess the implementation of registration requirements as per New Drug and Clinical Trial Rules and the scale of standardization

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.

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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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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.