|Year : 2022 | Volume
| Issue : 3 | Page : 211-218
Present status of department of health research registered ethics committees in india after implementation of new drugs and clinical trials rules 2019
Neeraj Kumar Agrawal1, Uma Gupta2
1 Department of Pharmacology, Government Autonomous Medical College, Ratlam, Madhya Pradesh, India
2 Vice-Chairperson, Institutional Ethics Committee, Department of Pharmacology, Government Autonomous Medical College, Ratlam, Madhya Pradesh, India
|Date of Submission||05-Jun-2021|
|Date of Decision||25-May-2022|
|Date of Acceptance||21-Aug-2022|
|Date of Web Publication||28-Dec-2022|
Dr. Neeraj Kumar Agrawal
Department of Pharmacology, Government Autonomous Medical College, Ratlam - 457 001, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Background: Under the New Drugs and Clinical Trials Rules -2019 that came into force on 14th September 2019, all Ethics Committees (ECs) reviewing biomedical and health research should register with the authority designated by the Central Government of India. Study Objective: We investigated the status of registration of ECs in the Department of Health Research (DHR) to date. Materials and Methods: The data collection was started on 1 April, 2021 and was last updated on 10 April, 2022. The ECs registered with DHR were extracted from NAITIK online portal. The ECs were segregated according to the state and Union territories, medical colleges, dental colleges, and hospital and research institutes. Results: Total of 836 registered ECs were uploaded on the DHR website to date. Out of which, 822 (98.32%) were Institutional and 14 (1.67%) were independent. Among total ECs, 518 (61.96%) were in hospitals and research institutes, 231 (27.63%) in medical colleges, and 73 (8.73%) in dental colleges. 76 (9.09%) got the final certificate after completion of a provisional period of two years. Among 606 medical colleges and 316 dental colleges, 38.11% and 23.10% of colleges had registered ECs respectively. Maharashtra has the highest number with 129 (15.43%) registered ECs whereas Gujarat is number one (53.33%) in terms of percent registered ECs in medical colleges of particular states. Conclusions: Timely registration of ECs should be encouraged by the concerned stakeholders and try to make a robust mechanism for bringing transparency, uniformity, and accountability to the ECs across the states.
Keywords: Ethics committee, Indian Council of Medical Research new drugs and clinical trial 2019, India, registration
|How to cite this article:|
Agrawal NK, Gupta U. Present status of department of health research registered ethics committees in india after implementation of new drugs and clinical trials rules 2019. J Med Evid 2022;3:211-8
|How to cite this URL:|
Agrawal NK, Gupta U. Present status of department of health research registered ethics committees in india after implementation of new drugs and clinical trials rules 2019. J Med Evid [serial online] 2022 [cited 2023 Feb 1];3:211-8. Available from: http://www.journaljme.org/text.asp?2022/3/3/211/365882
| Introduction|| |
Amendments in biomedical and health research (BHR) setups have attained a steep curve in recent times in India. Unity in Diversity which is a key feature of India becomes requisite to do advancement in medicine which can be accomplished by directing quality research. Research is an inevitable part of post-graduate students in the form of a thesis. As far as medical undergraduates are concerned, the Indian Council of Medical Research (ICMR)-Short Term Studentship Programme is running in India to facilitate interest and aptitude for research in the initial stage of the studentship.
While executing research, the Ethics Committee (EC) plays an integral role in safeguarding the dignity, rights, safety as well as well-being of research participants., Ethical paradoxes have been a crucial hardship for researchers for the past two decades when a massive multitude of clinical trials (CTs) were accepted. Hereafter, vast dimensions of unethical research practices were followed which appeared to the public resulting in sequential mending in the previous eight years. In the year 2013, one of the most indispensable regulatory amendments done via Gazette notification G.S.R.72 (E) dated 8 February, 2013 which made all ECs be enrolled with the Central Drugs Standard Control Organization (CDSCO). It brought pellucidity and assured the integrity of ethical review during the procedure of CTs. Further to serve as a guide to answer and confront the challenges and questions put forward by the occurring ethical issues, the updated “ICMR-National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017” (ICMR-NEGBHR 2017) was inaugurated. Subsequently, the Ministry of Health and Family Welfare, Government of India (MOHFW, GOI) informed the “New Drugs and Clinical trials Rules, 2019” (ND and CT 2019) in the Gazette of India vide G.S.R.227 (E) dated 19 March, 2019. This document is aiming to orient ourselves with two vital purposes which are dedicated to ECs. Chapter III committed to those ECs which would be enlisted in CDSCO and they will be regulating CTs, bioavailability and bioequivalence (BA and BE) studies whereas Chapter IV for specific ECs which will be taking care of BHR incorporating human participants and academic CTs in the research institutes/hospitals and will be registered in the Department of Health Research (DHR). Hence, new regulations segregated the ethical governance system for two distinct types of ECs with two authorities for their registration and monitoring.
As per ND and CT-2019 BHR is defined “as a research comprising studies on basic, applied and operational research formulated primarily to escalate the scientific knowledge about diseases and conditions (physical or socio-behavioral), their detection, cause and advancing strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not accommodate clinical trial”. BHR studies are an essential part of any research institute which must be accomplished as per current national and international regulatory protocols.
While conducting BHR, ECs are authorized with the accountability to embark on the ethical review of research proposals before initiation of the study with continuing duty to regularly monitor and rectify the approved research work to assure ethical compliance. These ECs reviewing BHR and academic CTs in the research institutes shall be comprised and are needed to function in compliance with the ICMR-NEGBHR 2017., As per ND and CT 2019, “Academic clinical trial” means a clinical trial of medicine already accepted for a specific claim and commenced by any investigator, academic, or research institution for a new manifestation or fresh route of administration or new dose or new dosage form, where the outcomes of such a trial are planned to be used merely for academic or research purposes and not for seeking approval of the Central Licensing Authority of any country for marketing or commercial purpose. Hence interested investigators now conduct the CTs in their institute without approval from CDSCO.
Chapter IV of ND and CT 2019 came into force on the expiry of 180 days from the date of publication i.e. after 14 September, 2019. Now the ECs shall be expected to enroll with the authority established by the GOI under the DHR, MOHFW through NAITIK online portal with the domain name “https://naitik.gov.in/DHR/Homepage”., The National EC Registry for BHR has been put in place within the DHR to foster the receipt and processing of applications seeking registration. A provisional registration certificate shall stay legal for 2 years and the final registration allotted in Form CT-03 shall persist valid for 5 years from the date of its issue. The DHR website will be showing an expired certificate after completion of 2 years of the provisional period if the final certificate process is not done.
The list of ECs along with the registration number is being regularly updated by the DHR on the NAITIK portal. However, the detailed compilation of progress and structure of registrations of ECs right from the enactment of rules to date is lacking. Hence the present study was planned with two objectives; firstly, to document the progress and pattern of DHR registered ECs in India. Secondly, to document the DHR registered ECs all over India.
| Materials and Methods|| |
Data collection and outcome measures
The data collection was started on 1 April, 2021 and last updated on 10 April, 2022. It was extracted mainly from four major websites. For DHR registered ECs, The data was taken from National EC Registry for BHR (NECRBHR), DHR, Ministry of Health and Family Welfare, Government of India website (https://naitik.gov.in/DHR/Homepage) under the heading of List of provisional/final/expired registered ECs. The time interval revealed on the website was 12 October, 2019 to 10 April, 2022. The ECs were organized according to the different states and union territories of India and distributed according to the type of research institutes. Month-wise registration of ECs was analyzed and organized accordingly. ECs were categorized into Independent and Institutional ECs. Independent ECs are the committees that function from outside institutions and can be used by researchers who have no institutional attachments.
The list of medical colleges, dental colleges, and National Accreditation Board for Hospitals (NABH) accredited hospitals was obtained from the website of National Medical Commission (NMC) (https://www.nmc.org.in), Dental Council of India (DCI) (www.dciindia.org.in), and NABH and Healthcare Providers (www.nabh.co) respectively.,, Medical colleges were separated into NMC approved and NMC permitted colleges. The NMC status of a permitted college remains for five to six years (equivalent to duration of MBBS course) for a new college afterward it becomes approved as per NMC guidelines. The whole data were captured in the Microsoft excel latest version 2019 and descriptive analysis was done.
The descriptive statistics and frequency distribution were used for statistical analysis. Categorical data (number of institutional and independent ECs, whether registered or expired or final certification, the medical and dental colleges of states, number of NMC recognized and permitted medical colleges in a particular state were presented as proportions.
Comparison of (a) number of medical colleges versus number of registered ECs in particular states, (b) number of dental colleges versus number of registered ECs in particular states, and (c) Number of NMC recognized or permitted medical colleges versus number of colleges with registered ECs was done using descriptive statistics.
Ethical approval was obtained from the Institutional EC (IEC) before initiation of the study.
| Results|| |
After the implementation of ND and CT -2019, the first EC was registered on 12 October, 2019 which belongs to Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra.
[Table 1] shows the distribution of DHR registered ECs across India. A total of 836 registered ECs were uploaded on the DHR website till 10 April 2022. Out of which, 822 (98.32%) were Institutional and 14 (1.67%) were independent. Among total ECs, 518 (61.96%) were in hospitals and research institutes, 231 (27.63%) in medical colleges, and 73 (8.73%) in dental colleges. The table is also showing the registered ECs who got the final certificate after completion of a provisional period of 2 years. Among 836 ECs, 76 (9.09%) got final approval certificate whereas 55 ECs registrations have been expired.
|Table 1: State wise distribution of ethics committees registered with the department of health research|
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Maharashtra has highest number with 129 (15.43%) registered ECs followed by Tamil Nadu (n = 111; 13.27%), Karnataka (n = 96; 11.48%) and Delhi (n = 59; 7.05%) as illustrated in [Figure 1].
|Figure 1: State wise distribution of DHR registered ECs in biomedical and health research institutes. ECs: Ethics Committees, DHR: Department of Health Research|
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[Table 1] also depicts the profile of DHR registered ECs in NMC recognized/permitted medical colleges in India. Among 606 medical colleges, only 38.11% (231/606) of medical colleges had registered their ECs. Among 606 medical colleges, 449 (449/554 = 74.09%) were recognized and 157 (157/606 = 25.91%) were permitted. On the NMC website, All India Institute of Medical Sciences (AIIMS) were also included in the list of medical colleges. At present, 15 AIIMS institutes running in India (Delhi, Rishikesh, Jodhpur, Raipur, Bhopal, Bhubaneswar, Patna, Raebareli, Nagpur, Mangalgiri, Gorakhpur, Bibinagar, Bathinda, Kalyani and Deogarh). All had DHR registered ECs except 02 AIIMS (Raebareli, Bibinagar).
[Table 1] also shows the DHR registered ECs in DCI-approved dental colleges in India. Only 23.10% (73/316) dental colleges had registered ECs. The highest number of dental colleges were situated in five states i.e. Karnataka (47), Maharashtra (37), Tamil Nadu (29), Uttar Pradesh (26) and Kerala (26) whereas The highest number of registered ECs belongs to state of Karnataka (14) Maharashtra (12), Tamil Nadu (10), Kerala (6), and Telangana (6).
[Table 2] shows the percent wise distribution of registered ECs in medical colleges of major states and calculated the percent registered ECs in medical colleges of particular states. Gujarat led with the (53.33%) followed by Kerala (51.61%), Telangana (47.05%) and Maharasthra (46.77%).
|Table 2: Percent wise distribution of registered ethics committees in medical colleges of major states|
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As far as the quarterly progression of registration of ECs is concerned, numbers keep on increasing from the first quarter i.e. October- December 2019 to the fifth quarter i.e. October- December 2020. The highest registration (n = 67) was done in October 2020, [Figure 2].
|Figure 2: Quarterly Trend of Registration of ECs in DHR from 12 October, 2019 to 31 March, 2022. ECs: Ethics Committees, DHR: Department of Health Research|
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| Discussion|| |
Best of our knowledge says that this is the first study to illustrate the profile of registered ECs with the DHR in India. As per the gazette notification G.S.R.227 (E) dated 19 March, 2019 that came into force on 14 September., 2019, ECs will be supervising BHR encompassing human participants and academic CTs in the research institutes/Hospitals and will be registered in DHR. The current study revealed that after this notification, in total 836 ECs were enrolled till 10 April, 2022. The shortest number of ECs registered in the quarter April -June 2020. It might be due to the pandemic of COVID 2019. The COVID-19 pandemic badly affected the work output of healthcare professionals and increased their stress level and sad mood. One study conducted in India also showed the depressive symptoms of doctors during the Corona period.,,
We identified that out of the whole 836 registered ECs, more than half were registered in hospitals and research institutes (61.96%). It might be due to the massive abundance of these institutes than medical and dental colleges in India. Moreover, DNB course is also running in these institutes. Results indicate that among 606 medical colleges only 38.11% of colleges had registered their ECs. The reasons could be permission of new medical colleges has been increased in the last few years that they are in the preliminary phase of development and lack proper staff and infrastructure.
There was no regulatory mechanism for doing the BHR and academic CTs before the implementation of ND and CT 2019. The investigators were apprehensive for conducting of academic clinical trials due to complicated procedures and strict regulatory guidelines. The government of India became sensitized and made amendments. There might be a possibility of accepting the suggestion by Das et al. 2019 regarding the distinct registration of another agency like ICMR for particular ECs who should review observational studies and other studies where strict regulations are not mandated. Registering EC with ICMR will promote an institution to enhance the quality of research and deliver transparency in this field. Furthermore, the researchers can do academic CTs without permission from DCGI and can publish their findings. If the results are promising, the investigator can take steps forward to do hardcore CTs.
Maharashtra had the highest number of DHR registered ECs which is quite similar to the study of Das and Singh 2019 in which they studied the registration of EC with CDSCO. As far as the Percent wise distribution of registered ECs in medical colleges is concerned, the range of different states varies from 53.33% (Gujarat) to 10.00% in the state of Bihar. This uneven distributionof registered ECs in various states coherence with the finding of Bhide et al. and Nishander et al., It may generate many issues. Firstly associated with the Quality of research and secondly with post-graduate degrees from different states. NMC is the only designated authority by the GOI for recognition and approval of post-graduation courses but it did not establish guidelines for registration of ECs in medical college to date. There is a vital role of the EC in research work during the post-graduation period where students not only learn the subjects but the research prospects deeply seated within. The degree obtained from medical colleges having unregistered ECs, not only brings up the question mark on the quality of research but the nation-wise uniform system of the medical field.
The startling situation of registered ECs in dental colleges in India must be noted by stakeholders. Though the numbers of DCI-approved dental colleges are 316, only 73 colleges registered their ECs with DHR. This might be due to the less stringent regulation, less number of research activities, or lack of awareness regarding the requirement of registration of ECs. The pattern of registration was not similar across the states. Nine states/UTs had no dental college and Eleven had no DHR registered ECs despite the presence of college. It shows that 16 states/UTs out of 36 are willing to do quality dental research and make the research environment for the budding researchers.
The efforts by the GOI through launch of ICMR 2017 and ND and CT 2019 guideline made streamlined different types of BHR research and interventional trials. , The current description of the status of registration of ECs and distribution by institutions raises several concerns. The low proportion of DHR registered ECs in different research institutes and hospitals need to be addressed and must be analyzed the possible factors. We need to conduct state-wise research to identify such factors and appropriate solutions.
The limitation of our study is extraction of whole information from website of main agencies, which may not be complete or may not be published on internet at actual date and time.
For strengthening the registration process of ECs, we are suggesting five important points. Firstly, the inclusion of DHR registered ECs must be contained by the NMC/DCI in the guideline for recognition of the medical/dental college/DNB institute, especially for post-graduate MD/MS/DNB/MDS and super-specialty courses DM/MCH. NMC must make a clause for mandatory registration of EC at least before beginning the P.G courses or before recognition of the college. Second, one department should be assigned for running EC through NMC/DCI guidelines and the department of pharmacology or community medicine can take a lead in medical college and community dentistry in dental college. Third, the working experience of the EC of faculty should be counted as a research experience and given preference in matters of recruitment and promotions. More faculties would be inquisitive in EC-related work and the integrity of research might enhance. Fourth, there is the almost same process of registration in the CDSCO and DHR with the SUGAM and NAITIK portal respectively., The structure of the committee, SOPs, and required documents are almost the same., It would be simple for the research institute if both these registration processes can be distributed into two steps. The first step will assure the common registration process for both the authorities while the second step will deal with the extra documents required for fulfilling the requirement of individual authority. The more simple process of registration might impact exponentially in the number of registration of ECs and investigators will get the liberty to conduct any type of study in the institutes. Fifth and most importantly, to motivate and foster the regulation and registration of ECs, there should be the establishment of regional and state-wise ICMR or NMC approved nodal centers that may deliver good clinic practice as well as other important regulatory training courses for smooth functioning and regulation of the ECs. It might bring transparency, uniformity and accountability to the ECs across the states. This model may be identical to the medical education training in various medical colleges for a new undergraduate curriculum by NMC in a couple of years or maybe adopted with appropriate modifications.
The quality of medical research is of the utmost need without compromising the right safety and well-being of the human participants. ECs are the ultimate authority to take care of the whole recipe of the research.
| Conclusions|| |
Timely registration of ECs should be encouraged by the concerned stakeholders and try to make a robust mechanism for bringing transparency, uniformity, and accountability to the ECs across the states.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]