Guidance from ICMR for ECs during COVID-19 outbreak
On May 6, 2020 the Indian Council of Medical Research (ICMR) released the National Guidelines for Ethics Committees reviewing Biomedical and Health Research during COVID-19 Pandemic.
Other research during COVID-19 outbreak
The Central Drugs Standard Control Organization (CDSCO) has issued a circular on the conduct of clinical trials during the COVID-19 outbreak. Please click on the following link to access the circular: CDSCO Circular
COVID-19
In the wake of COVID-19 outbreak globally, government agencies in India and others (globally) have set out guidance for researchers. Following is a list of important links which may help researchers access relevant information and publications:
Please note the WHO has requested that the WHO official acronym for the Coronavirus disease (COVID-19) is to be entered in the title field of the trial registration dataset. This will facilitate finding and extracting all clinical trials related to COVID-19, from the public databases.
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Guidance for research applications to support COVID-19 R&D in India |
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S. No. |
Agency |
Link |
| 1. | Central Drugs Standard Control Organization (CDSCO) | Notice regarding the regulatory pathway for R&D for in-vitro diagnostic kits for the diagnosis of COVID-19. |
| 2. | Central Drugs Standard Control Organization (CDSCO) | Notice regarding the regulatory pathway for R&D of drug or vaccine for prevention or treatment of COVID-19. |
| 3. | Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India | Rapid response regulatory framework for COVID-19, to deal with applications for development of vaccines, diagnostics, prophylactics and therapeutics
The document details on the timeline laid down by DBT in consultation with the Drug Controller General of India (DCGI), to fast track the regulatory approval process of applications for development of vaccines, diagnostics, prophylactics and therapeutics for COVID-19. |
Important links from global agencies:
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Guidance for managing existing clinical trials during COVID-19 |
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| S. No. | Agency |
Link |
| 1. | Medicines and Healthcare products Regulatory Agency (MHRA) (UK Government) | Managing clinical trials during Coronavirus (COVID-19) |
| 2. | MHRA | Guidance for Good Laboratory Practice (GLP) facilities in relation to Coronavirus (COVID-19) |
| 3. | MHRA | Medical devices clinical investigations during the Coronavirus (COVID-19) outbreak
(advice for investigators and sponsors of ongoing clinical investigations and new applications) |
| 4. | European Medicines Agency (EMA) | Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic |
| 5. | U.S. Food and Drug Administration (FDA) | Guidance on conduct of clinical trials of medical products during COVID-19 pandemic
This document contains guidance for the industry, investigators, and Institutional Review Boards (Institutional Ethics Committees). |
| 6. | World Health Organization (WHO) | Coronavirus disease (COVID-19) technical guidance: Maintaining essential health services and systems |
| 7. | NHS Health Research Authority | COVID-19: Guidance for sponsors, sites and researchers (v2.2, 26 March 2020)
This link contains guidance for both, new studies relating to COVID-19 and amendments to existing studies to address COVID-19 elements. |
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Guidance for research applications to support COVID-19 R&D |
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S. No. |
Agency |
Link |
| 1. | World Health Organization (WHO) | Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D |
| 2. | MHRA | How to place a Coronavirus (COVID-19) test kit on the market
(what manufacturers need to know) |
| 3. | MHRA | Clinical trial applications for Coronavirus (COVID-19) |
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Calls for proposals by Indian agencies |
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S. No. |
Agency |
Link |
| 1. | Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) | DBT and BIRAC have announced a COVID-19 Research Consortium, and seek Request for Proposals, with a focus on diagnostics, vaccines, novel therapeutics, repurposing of drugs or any other intervention for control of COVID-19. |
| 2. | Technology Development Board (TDB), Department of Science and Technology (DST) | TDB invites technology proposals for fighting COVID 19 |
| 3. | Technology Development Board (TDB), Department of Science and Technology (DST) | Innovative Israeli companies with solutions for COVID-19 |
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Calls for proposals |
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| S. No. | Agency |
Link |
| 1. | World Health Organization (WHO) | WHO R&D Blueprint novel Coronavirus – Outline of designs for experimental vaccines and therapeutics |
| 2. | World Health Organization (WHO) | Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO (date issued: 28 February 2020). |
New Drugs and Clinical Trial Rules, 2019
On 19th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019 [G.S.R. 227(E)]. These rules will be effective from the date of publication (the only exception being Chapter IV – Ethics Committee for Biomedical and Health Research). Chapter IV of these rules will come into force 180 days after the date of publication, i.e., 19th September 2019.
These rules describe the requirements and guidelines to obtain a permission to import or manufacture new drugs for sale or to undertake a clinical trial / bioavailability / bioequivalence study, in India. With the introduction of these rules, Part XA and Schedule Y of the Drugs and Cosmetic Act and Rules, are no longer applicable. However, New Drugs for veterinary use will continue to be regulated as per Part XA. The New Drugs and Clinical Trial Rules, 2019 can be accessed via the Central Drugs Standard Control Organization website.
Medical Devices Rules, 2017
On 31st January 2017, the Ministry of Health and Family Welfare (MoHFW) released the Medical Devices Rules, 2017 [G.S.R. 78(E)]. These rules have been effected since the 1st of January 2018.
The Medical Devices Rules, 2017 are applicable to:
Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii);
Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
The Medical Devices Rules, 2017 can be accessed via the Central Drugs Standard Control Organization website.