Register Ethics Committees on Bio-Medical and Health Research involving human participants with DHR: NMC directs Medical Colleges, PG Institutes
New Delhi: All the medical colleges/ postgraduate institutes have been directed by the National Medical Commission (NMC) to get their Ethics Committees related to Bio-Medical and Health Research involving human participants to register with the Department of Health Research (DHR) immediately.
The Apex medical commission has issued this direction while referring to the New Drug and Medicine Trial Rules, 2019 notified on 19.03.2019. Writing to the medical colleges and postgraduate medical institutes under the NMC, the Commission mentioned, "Department of Health Research has informed that in accordance with the New Drug and Medicine Trial Rules 2019, which were notified on 19th.03.2019, all the Ethics Committees related to all Medical and Health Research involving human participants are required to be registered with the Departments of Health Research to facilitate processing of application and registration. A copy of Secretary, DHR & DGICMR, D.O. No. U-11022/01/2020-HR, Dated: 7th.06.2023 is enclosed."
"All Medical Colleges/Post Graduate Institutes are directed to get their Ethics Committees related to Bio Medical and Health Research involving human participants to register with DHR immediately. This issues with the approval of Chairman NMC," added the letter issued by NMC Director Ashok Kumar.
This comes after the Secretary of DHR, under the Union Health Ministry, wrote to the NMC Chairman and on June 7, 2023 and mentioned, "As you may be aware, the 'New Drugs and Clinical Trials Rules, 2019' was notified in the Gazette of India vide G.S.R.227 (E) dated 19.03.2019 wherein, Chapter IV of this rules mandates that, all ethics committees related to biomedical and health research involving human participants shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research(DHR)."
DHR mentioned how the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) was set up at Department of Health Research in 2019 to facilitate processing of such applications, seeking registration of ethics committees for biomedical and health research involving human participants.
"With effect from 15.09.2019, it is a mandatory requirement under law for those ethics committees conducting or intending to conduct biomedical and health research, involving human participants, to get registered with the designated authority in the DHR. In this regard, a communication No.U.11024/01/2018-HR(Part-2)/8015255 dated 12thSeptember, 2019 (copy enclosed) was also sent to all the stakeholders," the letter by DHR mentioned.
Asking NMC to direct the medical colleges to register with DHR, the letter further added, "In the light of the above. I would seek your personal indulgence to issue appropriate instructions to medical colleges / Post graduate research institutions to get their ethics Committees registered with DHR."
Along with the letter, DHR also provided a state-wise list of institutes registered with NMC, whose ethics committees are not yet registered with DHR. The list includes 174 such institutes across the country. Among these, 17 medical colleges are from Andhra Pradesh, 2 from Assam, 9 from Bihar, 1 from Chandigarh, 4 from Chattisgarh, 8 from Delhi, 7 from Gujarat, 4 from Haryana, 3 from Himachal Pradesh, 2 from Jammu and Kashmir, 3 from Jharkhand, 13 from Karnataka, 14 from Kerala, 4 from Madhya Pradesh, 12 from Maharashtra, 2 from Orissa, 1 from Punjab, 4 from Rajasthan, 20 from Tamil Nadu, 10 from Telangana, 1 from Uttarakhand, 15 from Uttar Pradesh, and 18 from West Bengal.
After the implementation of New Drugs and Clinical Trials Rules 2019, DHR had issued another notification on September 12, 2019 informing that any institute conducting biomedical and health research, required to have an Ethics Committee to review and oversee the conduct of research.
In the notification dated 12.09.2019, DHR had mentioned, "It is informed that. in exercise of the powers conferred by the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, has notified the New Drugs and Clinical Trials Rules, 2019', on 19.03.2019, in the Gazette of India (Extraordinary) - Part-11, Section 3, Sub-section (i), vide G.S.R.227 (E.) dated 19.03.2019. The above Rules, except Chapter-IV thereof, have come into force from the date of their publication in the Official Gazette, i.e., w.e.f. 19.03.2019. The Chapter IV of the aforesaid Rules, relating to Ethics Committees for Biomedical and Health Research. involving human participants, shall come into force on expiry of 180 days from the date of publication of the above Rules, i.e., after 14.09.2019."
"The Chapter IV of the above Rules provides that any institution or organization, etc., which intends to conduct biomedical and health research, shall be required to have an Ethics Committee to review and oversee the conduct of such research, as detailed in the 'National Ethical Guidelines for. Biomedical and Health Research Involving Human Participants', specified by the Indian Council of Medical Research (ICMR). These guidelines may be seen at the website of the Department of Health Research -https://dhr.gov.in ---- under 'Important Links' with the heading 'National Ethical Guidelines for Biomedical and Health Research Involving Human Participants — `download'," DHR had added.
In that notification, DHR had also referred to sub-rule (1) of rule 17 of these Rules and mentioned, "The sub-rule (1) of rule 17 of these Rules provides that such an Ethics Committee- to be constituted in accordance with the said guidelines - shall register itself with the authority to be designated for the purpose by the Department of Health Research (DHR) in the Ministry of Health and Family Welfare. In this regard. an authority has already been designated by the DHR for registration of Ethics Committees for biomedical and health research involving human participants, vide this Department's Office Order No.U-11024/01/2018-FIR (Part)/8006615 dated 12.09.2019. Also, a set-up, with the nomenclature `National Ethics Committee Registry for Biomedical and Health Research' (NECRBHR), has been put in place within the Department of Health Research, vide this Department's ID Note No. U-I1024/0112018-HR (Part)/80066I5 dated 12.09.2019 to facilitate receipt and processing of applications seeking registration, and to assist the authority, thus designated, in the discharge of its duties."
"The entire process of receipt and processing of the applications, seeking registration of ethics committees for biomedical and health research involving human participants, shall be carried out in the DHR online only. For this purpose, a portal has been developed, to facilitate the task, with the domain name "naitik.gov.in". entities/institutions/medical collegesiresearchers/stakeholders, etc. - whether in public or private and, who are conducting or intending to conduct biomedical and health research involving human participants, are requested to submit proposals for registration of Ethics Committees on the above portal. It may be noted that now, it is a mandatory requirement with effect from 15.09.2019, for getting all ethics committees for biomedical and health research, involving human participants, registered with the designated authority in the DHR," the 2019 notification had mentioned.
State wise list of institutes registered with NMC, whose ethics committees are not yet registered with DHR:
| STvo | Name and Address of Medical College / Medical Institution | State |
| 1 | 5 V Medical College, Tirupati | Andhra Pradesh |
| 2 | Guntur Medical College, Guntur | |
| 3 | Government Medical College. Kadapa | |
| 4 | Government Medical College. Ananthapurarn | |
| 5 | Gayathn Vidya Panshad Institute of Health Care & Medical Technology, Visakhapatnam | |
| 6 | Government Medical College, Ongole (Previously known as Rajiv Gandhi Institute of Medical Sciences, Ongole.) | |
| 7 | NRI Medical College. Guntur | |
| 8 | Rajiv Gandhi Institute of Medical Sciences. Snkakulam | |
| 9 | P E S Institute Of Medical Sciences and Research, Kuppam | |
| 10 | SVIMS - Sri Padmavathi Medical College for Women, Alipin Road, Tirupati | |
| 11 | Fathima Mat. of Medical Sciences.Kadapa | |
| 12 | Katun Medical College. Guntur | |
| 13 | NR1 Institute of Medical Sciences, Visakhapatnam | |
| 14 | Konaseema Institute of Medical Sciences & Research Foundation, Amalapuram | |
| 15 | Dr P.S.I. Medical College . Chinoutpalli | |
| 16 | Maharajah Institute of Medical Sciences. Vizianagaram | |
| 17 | Santhiram Medical College. Nandyal | |
| 18 | Assam Medial College, Dibrugarh | Assam |
| 19 | Fakhruddin Ali Ahmed Medical College. Barpeta, Assam | |
| 20 | Patna Medical College. Patna | Bihar |
| 21 | Mata Gujn Memorial Medical College. Kishanganj | |
| 22 | Nalanda Medical College, Patna | |
| 23 | Government Medical College. Bettiah | |
| 24 | Katihar Medical College, Katihar | |
| 25 | Jawaharlal Nehru Medical College, Bhagalpur | |
| 26 | All India Institute of Medical Sciences, Patna | |
| 27 | Bhagwan Mahavir Institute of Medical Sciences, Pawapun (Formely known as Vardhman Institute of Medical Sciences, Pawapuri) | |
| 28 | Anugrah Narayan Magadh Medical College. Gaya | |
| 29 | Government Medical College. Chandigarh | Chandigarh |
| 30 | Pt. J N M Medical College. Raipur | Chattisgarh |
| 31 | Government Medical College (Bharat Rama Shri Atal Bihar' Van:ire Memorial Med Col ), Rajnandgaon | |
| 32 | Raipur Institute of Medical Sciences (RIMS). Raipur | |
| 33 | Rajmata Shriman Devendra kumari Singhdeo Government Medical College, Surguja ( C G ) | |
| 34 | Kasturba Hospital. New Delhi | Delhi |
| 35 | University College of Medical Sciences & GTB Hospital. New Delhi | |
| 36 | VP Chest Institute of Medical Sciences. Delhi | |
| 37 | Institute of Human Behaviour and Allied Sciences, Delhi | |
| 38 | G.B. Pant Institute of Postgraduate Medical Education and Research, New Delhi | |
| 39 | National Institute of Health and Family Welfare, New Delhi | |
| 40 | Central Health Education Bureau. New Delhi | |
| 41 | Institute of Nuclear Medicine & Allied Sciences, New Delhi |
| 42 | Pramukhswami Medical College, Karmsad | Gujarat |
| 43 | Smt. G.R. Doshi and Smt K.M. Mehta Institute of Kidney Diseases and Research Centre, Dr. H.L. Trivedi Institute of Transplantation | |
| 44 | Smt. NH L.Municipal Medical College, Ahmedabad | |
| 45 | Pandit Deendayal Upadhyay Medical College. Rajkot | |
| 46 | Surat Municipal Institute of Medical Education & Research, Surat | |
| 47 | SBKS Medical instt. & Research Centre, Vadodra | |
| 48 | Narendra Modi Medical College, Ahmedabad (Formely known as Ahmedabad Muncipal Coporation Medical Edu Trust Medical ('ollege) | |
| 49 | Al Fatah School of Medical Sciences & Research Centre. Fandabad | Haryana |
| 50 | Maharishi Markandeshwar Institute Of Medical Sciences & Research, Mullana, Ambala | |
| 51 | Faculty of Medicine and Health Sciences, Gurgaon (Formarly SGGST Medical College & R Centre,Gurgaon) | |
| 52 | Command Hospital,Chandimandir | |
| 53 | Government Medical College. Nahan, Sirmour H.P. | Himachal Pradesh |
| 54 | Shn Lal Ilahadur Shasta Government Medical College, Mandl, HP | |
| 55 | Maharishi Markandeshwar Medical College & Hospital, Solan | |
| 56 | Sher-I-Kashmir Instt. Of Medical Sciences, Srinagar | Jammu and Kashmir |
| 57 | Acharya Shri Chander College of Medical Sciences, Jammu | |
| 58 | M G M Medical College, Jamshedpur | Jharkhand |
| 59 | Central Institute of Psychiatry, Ranchi | |
| 60 | Ranchi Instt Of Neuro-Psycluatry and Allied Sciences,Kanke,Ranchi | |
| 61 | Jawaharlal Nehru Medical College, Belgaum | Karnataka |
| 62 | Shri B M Paul Medical College, Hospital & Research Centre, VijayapuralBitapur | |
| 63 | Command Hospital Air Force. Bangalore | |
| 64 | Bangalore Medical College and Research Institute, Bangalore | |
| 65 | JJM Medical College, Davangere | |
| 66 | Institute of Aerospace Medicine Indian Air Force, Bangaluru | |
| 67 | Raichur Institute of Medical Sciences,Raichur | |
| 68 | Indira Gandhi Institute of Child Health. Bangalore | |
| 69 | Basaveswara Medical College and Hospital, Chitradurga | |
| 70 | Akash Institute of Medical Sciences & Research Centre. Devanhalli, Bangalore, Karnataka | |
| 71 | Gadag Institute of Medical Sciences, Mallasamudra, Mulgund Road, Gadag | |
| 72 | lIclagavi Institute of Medical Sciences, Belagavi | |
| 73 | S S Institute of Medical Sciences& Research Centre, Davangere | |
| 74 | Medical College, Thiruvananthapuram | Kerala |
| 75 | Government Medical College. Koahikode, Calicut | |
| 76 | Dr Moopen s Medical College, Wayanad, Kerala | |
| 77 | Govt Medical College,Panyaram. Kannur (Prey Known as Academy of Medical Sciences) | |
| 78 | Mount Zion Medical College, Chayalode, Ezhamkulam Moor. Pathanamthitta | |
| 79 | Government Medical College. Manien. Malapuram Dist | |
| 80 | Sree Naravana Insn. of Medical Sciences, Chalakka.Emakulam | |
| 81 | Travancore Medical College. Kollam | |
| 82 | T D Medical College, Alleppey (Allappuzha) | |
| 83 | Malankara Orthodox Syrian Church Medical College, Kolenchery | |
| 84 | Ateezia !not of Medical Science.Ntecyannoor,Kollam | |
| 85 | Government Medical College. Parippally, Kollam | |
| 86 | Dr Somervel Memorial CSI Hospital & Medical College, Karakonam, Thiruvananthapuram | |
| 87 | M E S Medical College , Perintalmanna Malappuram Distt.Kerala |
| 88 | Netaji Subhash Chandra Bose Medical College, Jabalpur | Madhya Pradesh |
| 89 | Gandhi Medical College, Bhopal | |
| 90 | Shyarn Shah Medical College, Rewa | |
| 91 | Gwalior Mansik Arogyashala, Madhya Pradesh | |
| 92 | Lokmanya Tilak Municipal Medical College, Sion, Mumbai | Maharashtra |
| 93 | Grant Medical College, Mumbai | |
| 94 | Rural Medical College, Loni | |
| 95 | Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha | |
| 96 | Dr Vaishampayan Memorial Medical College, Solapur | |
| 97 | Mahatma Gandhi Missions Medical College. Aurangabad | |
| 98 | College of Physicians and Surgeons. Mumbai | |
| 99 | Dr. Shankarrao Chav-an Govt Medical College, Nanded | |
| 100 | Institute of Navel Medicine, INI IS. Aswini | |
| 101 | Bhabha Atomic Research Centre,Mumbai | |
| 102 | Dr. Vithalrao Vikhe Patil Foundations Medical College & Hospital. Ahmednagar | |
| 103 | Sanjeevan Medical Foundation ENT Post Graduate Training Irish., Mira) | |
| 104 | Hi-Tech Medical College & Hospital, Rourkela | Orissa |
| 105 | Hi-Tech Medical College & Hospital, Bhubaneswar | |
| 106 | Netaji Subhas National Instt. Of Sports Medicine. Patiala | Punjab |
| 107 | Ananta Institute of Medical Sciences & Research Centre, Rajsarnand | Rajasthan |
| 108 | Sardar Patel Medical College, Bikaner | |
| 109 | RN T Medical College, Udaipur | |
| 110 | Pacific Medical College & Hospital, BM() Ka BedIa, Udaipur | |
| 111. | Government Medical College, Omandurar | Tamil Nadu |
| 112 | Government Erode Medical College & Hospital, Perundurai (Formerly IRT Perundurai Medical College) | |
| 113 | Shn Sathya Sal Medical College and Research Institute, Kancheepuram | |
| 114 | Coimbatore Medical College. Coimhatore | |
| 115 | Chenualpattu Medical College, Chengalpanu | |
| 116 | Regional centre for Cancer Research and treatment,Adyar.Chennai | |
| 117 | The Tamilnadu Dr. MGR Medical University,Chermai | |
| 118 | K A P Viswanathan Government Medical College, Trichy | |
| 119 | Chettinad Hospital & Research Institute. Kanchipuram | |
| 120 | Thoothukudi Medical College, Thoothukudi | |
| 121 | Institute of Opthalmology Joseph Eye Hospital, Tiruchirapalli | |
| 122 | Sri Muthukumaran Medical CoIlege,Chennai | |
| 123 | Saveetha Medical College and Hospital, Kanchipuram | |
| 124 | Government Vellore Medical College, Vellore | |
| 125 | Government 'Fh truvannamalai Medical College, Thiruvannamalai | |
| 126 | ACS Medical College and Hospital, Chennai | |
| 127 | Madha Medical College and llospital, Thandalam. Chennai | |
| 128 | Government Medical College & ESIC Hospital, Coimbatore, Tamil Nadu | |
| 129 | Government Dharmapuri Medical College, Dharrnapuri | |
| 130 | Annapoorna Medical College & Hospital. Salem |
| 131 | Kakatiya Medical College, Warangal | Telengana |
| 132 | Dr VRK Worsens Medical College. Aziznagar | |
| 133 | Rajiv Gandhi Institute of Medical Sciences, adilabad | |
| 134 | Mahavir Institute of Medical Sciences. Vikarabad, Telengana | |
| 135 | Surabhi Institute of Medical Sciences, Siddipet, Telangana | |
| 136 | Maheshwara Medical College. Chitkul, Patancheru, l'vledak | |
| 137 | Bhaskar Medical College, Yenkapally | |
| 138 | Deccan College of Medical Sciences, Hyderabad | |
| 139 | Shadan Institute of Medical Sciences,Research Centre and Teaching Hospital, Peerancheru | |
| 140 | Prathima Institute Of Medical Sciences. Karimnagar | |
| 141 | Himalayan Institute of Medical Sciences, Behradun | Uttarakhand |
| 142 | Maharani Laxmi Bat Medical College, Jhansi | Uttar Pradesh |
| 143 | Muzaffarnagar Medical College, Muzaffarnagar | |
| 144 | Regional Matt. of Opthalmology Previously Known asNehru insttof Opthalmo, S kaput- | |
| 145 | Uttar Pradesh University of Medical Sciences, (Prey. UP Rural lnst.of Med.Sc&R) Etawah | |
| 146 | Government Medical College & Super facility hospital, Azamgarh | |
| 147 | Government Allopathic Medical College, Banda. UP | |
| 148 | Shaikh-UL-Hind Maulana Mahmood Hasan Medical College. Saharanpur | |
| 149 | Hind Institute of Medical Sciences , •arabanki | |
| 150 | Varun Arjun Medical College. Banthra. Shahjahanpur | |
| 151 | Venkateshwara institute of Medical Sciences, Ciajraula | |
| 152 | G.S. Medical College & Hospital, Hama-, UP | |
| 153 | Ra shree Medical Research Institute, Bareilly | |
| 154 | Krishna Mohan Medical College & hospital, Mathura | |
| 155 | Rajkiya Medical College Jalaun, Orai, Uttar Pradesh | |
| 156 | Institute of Mental health and Hospital. Agra | |
| 157 | Bankura Sammilani Medical College, Bankura | West Bengal |
| 158 | Midnapore Medical College, Midnapore | |
| 159 | institute of Postgraduate Medical Education & Research, Kolkata | |
| 160 | WARE institute of Medical Sciences & Research, Haldia, Purba Midanpore | |
| 161 | Govt Medical College, Kolkata | |
| 162 | Nilratan Sircar Medical College. Kolkata | |
| 163 | North Bengal Medical College, Darjeeling | |
| 164 | University College of Medicine, Kolkata | |
| 165 | College of Medicine and Sagore Data Hospital, Kolkata | |
| 166 | Murshidabad Medical College & Hospitals. Murshidabad | |
| 167 | Employees State Insurance Corporation Medical College, Joka. Kolkata | |
| 168 | IQ-City Medical College. Burdwan | |
| 169 | Shri Ramkrishna institute of Medical Sciences & Sanaka Iiospitals. Durgapur | |
| 170 | Jagannath Gupta Institute of Medical Sciences & Hospital, Kolkata | |
| 171 | Malda Medical College & Hospital, Malda | |
| 172 | KPC Medical College,Jadavpur.Kolkata | |
| 173 | Dr. B C Roy Post Graduate institute of Paediatric Sciences,Kolkata | |
| 174 | Command hospital, Kolkata |
To view the notice, click on the link below –
https://medicaldialogues.in/pdf_upload/department-of-health-research-211762.pdf
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