ICMR releases guidelines for operational mechanisms for establishing COVID-19 Biorepositories
In the backdrop of the COVID-19 pandemic, while it is of paramount importance to provide early diagnosis and treatment to all infected individuals, it is also critical to promote research and development for larger public health benefit. For development and validation of new diagnostics, therapeutics, or vaccines, access to different kinds of clinical samples from infected patients is an essential requirement. NITI Aayog has recently issued guidelines for sharing of biospecimens and data for research related to COVID-19. This document, released by ICMR on 23rd July 2020, in tandem lays down the brief processes and operational mechanisms for establishing COVID-19 biorepositories in the country. Currently, there is no structured mechanism for collecting and storing these valuable clinical samples. In view of this, it is important to create designated biorepositories for collecting, storing, and maintaining clinical samples (Oropharyngeal/Nasopharyngeal swabs, Bronchoalveolar lavage, Sputum, Blood, Urine and Stool) of COVID-19 patients. Such samples will be used to develop validated diagnostics, therapeutics, vaccines etc. Additionally, the samples will be a valuable resource for research & development-related activities to understand the early predictors of disease severity, immunopathogenesis of the disease, etc.
DGHS releases advisory for Gated Residential Complexes with regards to COVID-19
Resident Welfare Associations functioning in gated complexes can play an active role in creating awareness about the COVID-19 disease, simple preventive measures that need to be followed, encourage early reporting and inform community about myths and stigma often encountered by patients, healthcare or other frontline workers. Accordingly, Directorate General of Health Services (DGHS) of Ministry of Health & Family Welfare (MoHFW) issued guidelines for Gated Residential Complexes with regards to COVID-19. This document outlines the preventive and response measures to be observed to minimize and contain the spread of COVID-19 in gated complexes. The purpose of this document is to advice and guide RWAs/residential societies in prevention and control of COVID-19 transmission in gated residential complexes. Persons above 65 years of age, persons with comorbidities, pregnant women and children below the age of 10 years should be encouraged to stay at home only and keep contact with visitors/ guests to a minimum.
DGHS releases guidelines for Gated Residential Complexes desirous of setting up small COVID care facility
The community living in gated complexes may like to create small COVID Care Facility within the residential complex managed either by the RWAs/Residential Societies or in collaboration with an NGO. This may be more acceptable to the residents and will help reduce the burden on existing facilities for managing suspect/pre-symptomatic/asymptomatic/very mild cases of COVID-19. Directorate General of Health Services (DGHS) of Ministry of Health & Family Welfare (MoHFW) issued guidelines for Gated Residential Complexes Desirous of Setting up Small COVID Care Facility by Resident Welfare Associations/Residential Societies/NonGovernmental Organizations (NGOs). This guidance document has been prepared to help RWAs/Residential Societies/ NGOs desirous of establishing a small COVID Care Facility, a community-based isolation facility, with their own resources.
AIIMS New Delhi’s “e-ICU” video consultation programme gains traction
In order to strengthen the Government of India’s efforts to reduce COVID-19 mortality, AIIMS New Delhi has started a video-consultation programme with ICU doctors across the country called e-ICU on 8th July, 2020. The programme aims at holding case-management discussions among doctors who are at the frontline in treating COVID-19 patients in hospitals and COVID-19 facilities around the country. Physicians who manage COVID-19 patients including those in the ICUs can raise queries, present their experience and share knowledge with other physicians and experts from AIIMS, New Delhi on this video platform. The primary objective of these discussions is to reduce mortality from COVID-19 by learning from shared experience and strengthening best practices among hospitals with 1000 beds including isolation beds, oxygen-supported and ICU beds. Four sessions have been held till date covering 43 institutions [Mumbai (10), Goa (3), Delhi (3), Gujarat (3), Telangana (2), Assam (5), Karnataka (1), Bihar (1), Andhra Pradesh (1), Kerala (1), and Tamil Nadu (13)]. Each of these sessions conducted through Video Conference span over 1.5 to 2 hours. The discussions have covered the entire range of issues related to management of COVID-19 patients. Some of the important issues that have been stressed upon are the need for rational use of ‘Investigational Therapies’ like Remdesevir, convalescent plasma and Tocilizumab. The treating teams have discussed the current indications and possible harm due to their indiscriminate use and the need to limit social media pressure-based prescriptions. The use of proning, high flow oxygen, non-invasive ventilation and ventilator settings for advanced disease have also been a common discussion point. The role of various testing strategies in diagnosing COVID-19 has also been an important topic of shared learning. Issues such as the need for repeat testing, admission and discharge criteria, management of post-discharge symptoms, and return to work have been addressed. Some of the other common concerns have been the methods of communication with patients, screening of healthcare workers, managing new-onset diabetes, uncommon presentations such as stroke, diarrhoea and myocardial infarction etc. The team from AIIMS, New Delhi was able to act as a bridge for new knowledge from one group to the other at each VC, apart from advising from its own experience and the extensive literature reviews done by the domain experts. 10 The “e-ICU’ video consultation programme in the coming weeks would cover ICU doctors from smaller healthcare facilities (i.e., those having 500 beds or more) across the country.
List of IgG ELISA/CLIA kits for COVID-19 validated by ICMR identified validation centre
Serosurveys are performed to understand the proportion of population exposed to infection including asymptomatic individuals. Depending upon the level of seroprevalence of infection, matching public health interventions can be implemented for prevention and control of the disease. Survey in high risk or vulnerable populations (healthcare workers, frontline workers, immunocompromised individuals, individuals in containment zones etc.) helps to know who has been infected in the past and has now recovered. List of IgG ELISA/CLIA kits for COVID-19 are
1. Zydus Cadila Healthcare Ltd., Ahmedabad (Gujarat), India: COVID Kavach IgG ELISA;
2. Euroimmun US Inc., USA: Euroimmun Anti-SARS-COV-2 IgG ELISA;
3. Calbiotech Inc., USA: Erbalisa COVID-19 IgG ELISA;
4. YHLO iFlash, China: SARS-CoV-2 IgG CLIA;
5. Karwa Enterprises Pvt. Ltd, Delhi, India: KAVACH Karwa SARS-COV 2 IgG ELISA;
6. Voxtur Bio Ltd., (Mumbai), India: VOXEL Anti-SARS COV-2 IgG Antibody detection kit COVID KAVACH
ICMR has transferred COVID Kavach IgG ELISA technology to below mentioned pharma companies: Zydus Cadila Healthcare Ltd; Meril Diagnostics Pvt. Ltd; Voxtur Bio Ltd.; Trivitron Healthcare Pvt. Ltd; J. Mitra & Co. Pvt Ltd; Karwa Enterprises Pvt Ltd; and Avecon Healthcare Pvt Ltd.
Advisory on district-wise login credentials for rapid antigen testing for COVID-19
ICMR has invited researchers/entrepreneurs to come up with testing kits, which are accurate and useful. Efforts are being made to validate such kits and make multiple options available for use. With the use of antigen tests, more and more tests are being carried out. It is absolutely necessary that all such testing data is uploaded on the ICMR database and all positive cases are brought to the attention of district/municipal authorities for isolation/quarantine/treatment, as the case may be. It is expected that to 11 provide safe healthcare services, all Government hospitals/labs as well as all private NABH/ NABL hospitals/labs may initiate antigen testing and also apply for obtaining login credentials for data entry into the ICMR portal. ICMR has been receiving multiple requests from various public sector units, small private/ government facilities, temples, etc. for initiating this testing. In an effort to facilitate and further liberalize testing, ICMR has generated five common login credentials for each district of your State/UT, which may be shared with all Government and private facilities selected for antigen testing. A nodal person from respective State/UT can also be nominated who could contact the ICMR team for obtaining login credentials.
AIIMS Delhi starts tele-consultation guidance to State doctors on COVID-19 clinical management
Tele-consultation is a critical component of the clinical intervention protocol for COVID-19. To strengthen Government of India’s efforts to reduce COVID mortality, a specialist team of doctors from AIIMS, New Delhi shall provide guidance on effective clinical management of COVID-19 patients in the ICUs of different State hospitals through tele/video consultation. They will handhold the States in clinical management of COVID-19 patients to reduce the case fatality rate. These tele-consultation sessions for providing timely and expert guidance to the doctors in the States shall be conducted twice every week, on Tuesdays and Fridays. 17 This tele-consultation exercise has been initiated with 10 hospitals which shall be extended to another 61 hospitals that have the bed capacity ranging from 500-1000 on twice-a-week basis. A calendar of these expert-led tele-consultation sessions has been drawn up to cover the States till 31st July. Total of 17 such States shall be covered (Delhi, Gujarat, Telangana, Kerala, Andhra Pradesh, Karnataka, Bihar, West Bengal, Tamil Nadu, Haryana, Odisha, Rajasthan, Uttar Pradesh, Madhya Pradesh, Punjab, Jharkhand and Maharashtra). Up to two doctors handling ICU patients from each hospital along with the Director General of health Services (DGHS) of the concerned State will participate in the VC interaction.
MoHFW comes up with an online registration framework portal, for getting OPD appointments, lab reports and blood availability
Since physical and social distancing have become the new normal after the outbreak of COVID-19 pandemic, Ministry of Health & Family Welfare (MoHFW) has come up with an online registration framework portal for getting OPD appointments, lab reports and blood availability. For the patient, the first visit to hospital, registration and appointment with the doctor have been made simpler. All one needs to do is to verify using Aadhaar number, select hospital and department, select date of appointment and receive SMS for the appointment. Online Registration System (ORS) is a framework to link various hospitals across the country for Aadhaar-based online registration and appointment system, where counter-based OPD registration and appointment system through Hospital Management Information System (HMIS) has been digitalized. Total number of hospitals for which appointment can be taken through web along with their departments for which online appointment can be taken can be seen in reports. Detail reports showing information about new and old patients taking appointment through this portal can be seen. Hospitals can come on board in using this platform and provide their appointment slots for online booking by patients. The system facilitates the hospitals to easily manage their registration and appointment process and monitor the flow of patients.
Dr Harsh Vardhan chairs 18th meeting of Group of Ministers (GOM) on COVID-19
The 18th meeting of the high-level Group of Ministers (GoM) on COVID-19 was held on 9th July 2020, under the chairpersonship of Dr Harsh Vardhan, Union Minister of Health & Family Welfare by a video-conference. He was joined by Dr S. Jaishankar, Union Foreign Minister; Shri Hardeep S. Puri, Union Minister of Civil Aviation; Sh. Ashwini Kumar Choubey, Minister of State, Health & Family Welfare; and Sh. Mansukh Mandaviya, Minister of State, Chemical and Fertilizers, & Shipping. Dr Vinod Paul, Member (Health), Niti Aayog joined the meeting through video conference as well. At the outset, the GoM was briefed on the current status of COVID-19 in India. The global comparison between the five most affected countries clearly depicted that India has one of the lowest cases per million (538) and deaths per million (15) compared the global average of 1453 and 68.7, respectively. Within the country, eight states (Maharashtra, Tamil Nadu, Delhi, Karnataka,Telangana,Andhra Pradesh,Uttar Pradesh and Gujarat) contribute to around 90% of the active caseload and 49 districts account for 80% of active caseload, as of today. Moreover, six states (Maharashtra, Delhi, Gujarat, Tamil Nadu, Uttar Pradesh and West Bengal) account for 86% of total deaths, and 32 districts account for 80% deaths.The GoM was briefed that special efforts were made in the regions showing higher Case Fatality Rate. Dr Harsh Vardhan stated that “as we move forward, our focus shall be on the management of COVID-19 through strict containment measures and surveillance; utilizing full testing capacity; focus on monitoring of co-morbid and elderly population; predicting emerging hotspots leveraging digital tools such as Aarogya Setu; ensuring seamless patient admission processes; focus on infrastructure preparedness (critical care beds, oxygen, ventilators and logistics).” He pointed out that “along with States/UTs, our aim is to reduce and keep the Case Fatality Rate low by early identification and effective clinical management.”
ICMR fast-tracks the development of vaccine against COVID-19 pandemic
An inactivated COVID-19 vaccine candidate has been developed by Bharat Biotech International Ltd (BBIL) in collaboration with ICMR – National institute of Virology (NIV), Pune. After intense characterization and review of all data from BBIL, ICMR is supporting the clinical development as the vaccine candidate appears to be promising. Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trial. ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel. ICMR is committed to treat the safety and interest of people of India as a topmost priority.
Contact Info: firstname.lastname@example.org
MoHFW releases revised guidelines for home isolation of very mild/pre-symptomatic/asymptomatic COVID-19 patients
Ministry of Health and Family Welfare (MoHFW) issued revised guidelines for home isolation of very mild/pre-symptomatic/asymptomatic COVID-19 cases on 2nd July 2020. The guidelines are in supersession to the guidelines issued on the subject on 10thMay, 2020. As per the guidelines, the patients should be clinically assigned as very mild/mild, moderate or severe, and accordingly admitted to (i) COVID Care Centre, (ii) Dedicated COVID Health Centre or (iii) Dedicated COVID Hospital, respectively. In view of the large number of asymptomatic cases being detected, the current guidelines have been extended to asymptomatic positive cases also besides very mild and pre-symptomatic cases.
Clinical Management Protocol for COVID-19 patients released by MoHFW
Ministry of Health and Family Welfare (MoHFW) has released Clinical Management Protocol for COVID-19 patients on 3rd July 2020. This document contains all information related to COVID-19 pandemic, like disease epidemiology, case definition, risk factors, infection prevention, control practices, laboratory diagnosis, investigational therapies, prevention of complications, etc.
ICMR-NIRRH provides information related to pregnant women with SARS-CoV-2 exposure
ICMR - National Institute for Research in Reproductive Health (NIRRH) provided flowchart for pregnant women with SARS-CoV-2 exposure who has travelled to an affected country within the previous 14 days and have a close contact with a confirmed case of COVID-19 (i.e. less than 1 metre and for more than 15 minutes, living together, and direct contact with body fluids).
IJMR brings forth the second edition of special issue on COVID-19
Indian Journal of Medical Research (IJMR), a publication of ICMR, is a peer-reviewed online journal with monthly print-on-demand compilation of issues. The COVID-19 pandemic has created opportunities to build an improved response mechanism for future pandemics. Concerted, well-funded, comprehensive, planned, and all encompassing activities should facilitate building sustained institutional capacity to provide a swift and effective nationwide response to disease outbreaks. This could be done through access to appropriate technologies and improved logistics for efficient supply chains. These will also promote developing multi-sectoral stakeholder consortia 55 at national and state levels to coordinate actions and launch a comprehensive whole-of-thesociety response to emerging infections. Overall and long-term target should be to encourage and ensure convergence of all stakeholders for human health, animal health and environment to collaborate in implementing the One Health approach and protecting human life, reduce misery and avoid damage to the national economy. These are doable actions. The national will and determination are vital to mitigate the severe impact of pandemics, such as COVID-19 in India. India’s COVID-19 Containment Strategy has been aligned with WHO’s Strategic Preparedness and Response Plan for COVID-19. During the ongoing pandemic, India could successfully and rapidly scale-up several important interventions.
ICMR invites Expression of Interest for validation of rapid antigen detection assays for COVID-19
ICMR invites applications for validation of rapid antigen detection tests for COVID-19 from all manufacturers who have developed rapid antigen-based detection assays for Coronavirus wherein all manufacturers who have developed antigen-based assays have been invited for validation. The gold standard RT-PCR diagnostic test for COVID-19 has limitations in terms of widespread availability. In view of this, there is urgent requirement of reliable and convenient rapid pointof-care antigen detection assays with high sensitivity and specificity. Such assays could be used as potential diagnostic tests in all possible public and private healthcare settings and made available for mass testing.
Contact Info: email@example.com
MoHFW releases fourth version of Clinical Management Protocol for COVID-19
On 27 June 2020 Ministry of Health and Family Welfare (MoHFW) has released revised version (version-4) of Clinical Management Protocol for COVID-19. This document contains all information related to COVID-19 pandemic, like disease epidemiology, case definition, risk factors, infection prevention and control practices, laboratory diagnosis, investigational therapies, prevention of complications, etc. In this guideline, the MoHFW said that Dexamethasone can be given to severe COVID-19 patients as an alternative to another steroid, Methylprednisolone, which was included in the protocol earlier. Dexamethasone is a type of corticosteroid that has long been used for its antiinflammatory and immunosuppressant properties.
ICMR releases guidelines for storage of respiratory specimens collected for COVID-19 diagnosis by RT PCR platforms in Government laboratories
In the ongoing laboratory testing for COVID-19 diagnosis by molecular diagnostic methods, clinical specimens or a subset of the clinical specimens may need to be retained for various purposes such as performing additional tests, for quality control purposes, or for use as control materials to assess newer diagnostic tests. In addition, a laboratory may need to store specimens for projects aimed at studying genomic epidemiology of the SARS CoV-2 virus across regions and over time. Considering all these requirements, ICMR, on 25th June 2020, has released the specific guidelines for the storage of respiratory specimens in government laboratories.
ICMR releases fresh additional strategies for COVID-19 diagnostic testing
Since test, track and treat is the only way to prevent spread of infection and save lives, it is imperative that testing should be made widely available to all symptomatic individuals in every part of the country and contact tracing mechanisms for containment of infection are further strengthened. On 23rd June 2020 ICMR released advises all concerned public and private authorities and institutions to take required steps to scale-up testing for COVID-19 by deploying combination of various tests as advised in the advisory.
ICMR issues revised guidelines for positive sample storage by ICMR-approved private labs doing COVID-19 testing
ICMR issues revised guidelines for positive sample storage by ICMR-approved private labs that are doing COVID-19 testing by Real-time RT-PCR/CB-NAAT/TrueNat. According to the new guidelines, all labs will send 10 random positive and 5 random negative samples per month to QC labs. All testing labs will liaise with the recommended QC labs and will ensure regular participation in QC activity. All testing labs will ensure storage of samples at -800 C (or at least at -200 C) and will ensure regular monthly transfer to QC labs.
ICMR invites Expression of Interest (EOI) for transfer of technology for development of equine anti-serum against SARS-CoV-2
ICMR, the apex body of medical research in India, invites Expression of Interest (EOI) through email from experienced Indian agencies for undertaking transfer of technology for development of equine anti-serum against SARS-CoV-2. The EOI Document containing the details of qualification criteria, submission details, brief objective and scope of work and evaluation criteria etc. are available at ICMR website.
Last Date of Submission: 26th June 2020
Updated Advisory for managing healthcare workers working in COVID and Non-COVID areas of the hospital
The healthcare personnel working in hospitals are at increased risk of acquiring the COVID-19 disease, if there is a breach in the personal protection while managing patients. The healthcare workforce is a valuable and scarce resource. Large number of COVID-19-affected health personnel getting isolated for treatment and their close contacts undergoing quarantine affects the health and the hospital service delivery. Ministry of Health & Family Welfare (MoHFW) has released the updated advisory for managing healthcare workers working in COVID and Non-COVID areas of the hospital. The purpose of the document is to provide guidance on preventive measures, isolation and quarantine of healthcare functionaries.
Ministry of Health releases revised version of clinical management protocol for COVID-19
Ministry of Health & Family Welfare (MoHFW), on 13th June 2020, released revised version of clinical management protocol for COVID-19. The protocol deliberates upon detailed clinical features, case definitions, risk factors, and management of mild, moderate and severe cases.
Advisory on use of Rapid Antigen Detection Test for COVID-19
ICMR recommends the use of Standard Q COVID-19 Ag detection assay as a point-of-care diagnostic assay for testing. There are no reliable antigen detection tests available worldwide, which could be used as rapid point-of-care tests for quick detection of COVID-19 positive patients. Such tests would help in proper implementation of the Government strategy to test, track and treat. Such tests will also help in allaying the anxiety and fear of healthcare workers and aid in better clinical management of the patients. In view of this, an independent two-site evaluation of the only available or standalone antigen detection assay: Standard Q COVID-19 Ag detection kit, was conducted with an aim to evaluate its sensitivity, specificity and feasibility of use as a point-of-care test for early detection of SARS-CoV-2. Standard Q COVID-19 Ag detection kit is a rapid chromatographic immunoassay for qualitative detection of specific antigens to SARS-CoV-2 which has been developed by SD Biosensor, a South Korea-based company, having its manufacturing unit in Manesar, Gurugram.
Pregnant women with SARS-CoV-2 exposure
ICMR - National Institute for Research in Reproductive Health (NIRRH) provided flowchart for pregnant women with SARS-CoV-2 exposure who has travelled to an affected country within the previous 14 days and have a close contact with a confirmed case of COVID-19 (i.e., less than 1 metre and for more than 15 minutes, living together, direct contact with body fluids).
Commerce and Industry Minister interacted with the captains of the Pharmaceutical industry and Office-bearers of the Pharma Associations
The Commerce and Industry Minister Shri Piyush Goyal interacted with the captains of the Pharmaceutical industry and Office-bearers of the Pharma Associations through Video Conference. Shri Goyal lauded the pharma industry for making India proud by rising to the occasion during the COVID-19 crisis. India has been recognized as the ‘Pharmacy of the World’, as over 120 countries received some essential medicines during the last two months, including 40 of them getting them in the form of grant, free of cost. During the crisis, the officials of DGFT, MEA, Health and DoP worked round the clock to ensure that the export consignments are delivered at the earliest. The whole world appreciated India’s gesture, and this has swelled India’s goodwill and reputation.
India became self-reliant in COVID-19 testing capacity
On 18 May India reached a landmark in its fight against COVID-19 by performing 100,000 tests in one day. Starting from less than 100 tests per day just two months ago, a 1000 fold increase in just 60 days was made possible by dedicated teams from research institutions, medical colleges, testing laboratories, ministries, airlines and postal services working together. The remarkable story of how India became fully self-reliant in its testing capabilities, despite starting from scratch just a few months ago, is one about the steely resolve of multiple agencies, working together round-the-clock to save lives. Faced with an unprecedented challenge, both in terms of technicalities and scale, Indian scientists had to innovate extensively, health workers had to train and learn on the job, administrators had to coordinate multiple actions round-the-clock amid the challenges of nationwide lockdown, and civil and defence aviation personnel had to fly at the shortest of notices. With the pandemic soaring, there were severe constraints for procuring COVID-19 diagnostic material. Empowered groups set up by the Government of India, cutting across ministries, were tasked with the objective of increasing procurement and ensuring regular supplies. Indian missions and embassies abroad helped identify global suppliers in a highly competitive seller’s market. The scale-up of testing laboratories started with a network of 106 ICMR-funded Viral Research and Diagnostic Laboratories, (VRDLs), which already had the capacity to conduct testing for viruses similar to SARS-CoV-2. Subsequently, the testing was initiated in partnership with laboratories in DST, DBT, ICAR, CSIR, DRDO, MHRD, medical colleges and private laboratories. Private laboratories that had approval from the National Accreditation Board for Testing and Calibration Laboratories (NABL) were accepted. With its testing capabilities now matching the most advanced countries in the world, Indian institutions have risen to the occasion in an emergency situation. In the days ahead their contributions will be required even more as India continues to grapple with the clear and present danger still posed by COVID-19.
Contact info: Dr Rajni Kant; firstname.lastname@example.org; Dr Nivedita Gupta; email@example.com
ICMR validates completely indigenous diagnostic platform for COVID-19 diagnosis
As the COVID-19 pandemic is expanding, there is a global shortfall of diagnostic supplies. It is critical for countries to strengthen indigenous production of diagnostic material to ensure uninterrupted availability. A total of 11 RT-PCR-based indigenous assays were validated and recommended for COVID-19 testing. In April 2020, the indigenous manufacturer developed TrueNat assay for screening of SARSCoV-2, causing COVID-19. ICMR undertook successful validation of the E gene screening assay, following which TrueNat-based testing has been initiated by the states for SARS-CoV-2 detection. From April 2020 till date, more than 1.3 lakh screening tests have been conducted by states. However, the rate-limiting step has been the lack of TrueNat confirmatory assay. All the TrueNat positive samples had to be confirmed by RT-PCR-based tests either located in the same or different laboratory. Recently, the indigenous manufacturer has also developed an RdRp gene-based confirmatory assay of TrueNat which has been successfully validated again by ICMR and has been found to have high sensitivity and specificity. Both the validations have been stringently conducted by DHR/ICMR Virus Research & Diagnostic Laboratory (VRDL) at Bangalore Medical College & Research Institute, Bengaluru. ICMR has now recommended the TrueNat COVID-19 test as a two-step test: step one, i.e., E gene screening assay for all COVID-19 suspect samples to be followed by step two for the RdRp-based confirmatory test in all E gene positives.
Contact info: Dr Rajni Kant; firstname.lastname@example.org
ICMR advises States to conduct sero-survey to measure coronavirus exposure in the population using IgG ELISA Test
ICMR has advised the States to conduct sero-survey to measure coronavirus exposure in the population using IgG ELISA test. In an attempt to decide the future course of action against the pandemic, ICMR has communicated a detailed plan to all the states to measure coronavirus exposure in general population as well as in high risk populations. The numbers and frequency in different groups to be tested has been entrusted with states depending upon the requirement and situation in that particular area. There is continuous demand for various types of diagnostic tests by countries all across the globe. Real-time, i.e., RT-PCR test is considered gold standard frontline test for clinical diagnosis of SARS-CoV-2, causing COVID-19. The test is useful only when performed in the acute stage of infection (less than 7 days). For several viral infections, antibody tests are useful for disease detection after 5–7 days of illness. Understanding related to antibody tests for COVID-19 is evolving and several tests are being developed globally. IgG antibodies generally start appearing after two weeks of onset of infection, once the individual has recovered after infection and last for several months. Therefore, the IgG test is not useful for detecting acute infection but for indicating episode of SARS-CoV-2 infection in the past. However, detection of IgG antibodies is useful in the following situations:
i) Sero-surveys help to understand the proportion of population exposed to SARS-CoV-2 infection including asymptomatic individuals. Depending upon the level of sero-prevalence of infection, appropriate public health interventions can be planned and implemented for prevention and control of the disease. Periodic sero-surveys are useful to guide the policy makers.
ii) Survey in high risk or vulnerable populations (healthcare workers, frontline workers, immune-compromised individuals, individuals in containment zones, etc.) to know who has been infected in the past and has now recovered. The sero-survey would be conducted using an IgG ELISA kit. Scientists at ICMR-National Institute of Virology, Pune have developed and validated an indigenous IgG ELISA test for antibody detection for SARS-CoV-2. The test has undergone intense validation in three stages and has been found to have high sensitivity and specificity. To fast-track production and increase availability of the IgG ELISA test, ICMR has transferred this technology to many pharma companies viz. Zydus Cadila, J Mitra & Company, Meril Diagnostics, Voxtur Bio, Trivitron Healthcare, Karwah Enterprises, Avecon Healthcare, etc. The technology has been transferred to various entities without exclusivity clause and therefore can be further shared with others as per demand and capability. IgG ELISA tests from other USFDA/CE-IVD/indigenous sources such as Abott, Roche etc. are also available.
Contact info: Dr Rajni Kant; email@example.com
ICMR invites Expression of Interest (EOI) providing Personal Accident Insurance Cover with COVID-19 Extension
ICMR has invited proposals from eligible parties who are interested in providing Personal Accident Insurance cover with COVID-19 Extension, indicating the conditions and extent of coverage, date of commencement and expiry of coverage, and conditions thereof, including the premium and other costs, as per rules.
Submit expression of interest to Email: firstname.lastname@example.org
Last date and time of submission of offer: 03rd June, 2020; 13:00 Hrs
Contact info: Dr R. Lakshminarayanan
ICMR releases revised advisory on the use of Hydroxychloroquine as prophylaxis for SARS-CoV-2 infection
ICMR released revised advisory on the use of Hydroxychloroquine (HCQ) as prophylaxis for SARS-CoV-2 infection. The Joint Monitoring Group under the Chairmanship of DGHS and representatives from AIIMS, ICMR, NCDC, NDMA, WHO and experts drawn from Central Government hospitals reviewed the prophylactic use of HCQ in the context of expanding it to healthcare and other frontline workers deployed in non-COVID and COVID areas, respectively. This advisory supersedes the earlier related advisory dated 23rd March 2020. It has been reiterated in the advisory that the intake of HCQ should not instil a sense of false security.
Establishment of a Network of COVID-19 Biorepositories in India
In the backdrop of the COVID-19 pandemic, while it is of paramount importance to provide early diagnosis and treatment to all infected individuals, it is also critical to promote research and development for larger public health benefit. For development and validation of new diagnostics, therapeutics or vaccines, access to different kinds of clinical samples from infected patients is an essential requirement. NITI Aayog has recently issued guidelines for sharing of bio-specimens and data for research related to COVID-19. This document in tandem lays down the brief processes and operational mechanisms for establishing COVID19 biorepositories in the country
ICMR releases guidance notes for evaluation of novel applications for COVID-19
ICMR has issued the guidance notes for evaluation of novel applications for COVID-19. Since the inception of the COVID-19 pandemic, ICMR has received over 190 requests for evaluation of molecules/AYUSH regimens/products/technologies/ diagnostic kits, etc. In view of ICMR’s involvement in diagnosis, research, surveillance, clinical trials and validation of diagnostic kits for COVID-19, ICMR has partnered with various Science Departments like Department of Science & Technology (DST), Department of Biotechnology (DBT) and Council of Scientific & Industrial Research (CSIR) for evaluating the antiviral properties of investigational products/repurposed drugs/devices/technologies, etc.
Dr Harsh Vardhan dedicates COBAS 6800 testing machine to the nation
Union Minister of Health & Family Welfare and Science & Technology, and Earth Sciences, Dr Harsh Vardhan, visited the National Centre for Disease Control (NCDC) and dedicated the COBAS 6800 testing machine to the nation. This is the first such automated diagnostic machine that has been procured by the Government for testing of COVID-19 cases and is installed at NCDC, New Delhi. COBAS 6800 is a sophisticated machine enabled with robotics that minimizes the chance of contamination as well as the risk of infection to the healthcare workers since it can be operated remotely with limited human intervention. COBAS 6800 can also detect other pathogens like Viral Hepatitis B & C, HIV, MTb (both rifampicin and isoniazide resistance), Papilloma, CMV, Chlamydia, Neiserreia, etc.
ICMR releases list of state-wise mentor institutes for COVID-19 diagnostics
ICMR has identified and released a list of mentor institutes along with their allocated states. These mentor institutes have been identified for various states and are mandated to review the requests for approving any new laboratory for COVID testing.
India forges ahead towards developing ‘fully indigenous’ COVID-19 vaccine as ICMR partners with Bharat Biotech
The ICMR announced a tie-up with the Bharat Biotech International Limited (BBIL) for the development of a fully indigenous vaccine for Covid-19. According to the ICMR, the virus strain has been isolated at the National Institute of Virology (NIV) laboratory in Pune and will be used to develop the vaccine. The strain has been successfully transferred from NIV to BBIL and work on vaccine development has been initiated.
NIV Pune develops COVID Kavach Elisa for COVID-19 testing
ICMR-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test ‘COVID KAVACH ELISA’ for antibody detection for COVID-19. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, the test will have the advantage of testing 90 samples together in a single batch run within 2.5 hours. The enzyme-linked immunosorbent assay (ELISA) can detect and measure IgG antibodies in blood samples.
ICMR initiates PLACID Trial and releases list of approved institutions
Indian Council of Medical Research (ICMR) has initiated a multicentre clinical trial (PLACID Trial) titled ‘A Phase II, OpenLabel, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease.’ The PLACID trial protocol has been registered with the Clinical Trial Registry of India (CTRI). The study has also received approval from the COVID-19 National Ethics Committee (CoNEC). The generic protocol for this study has been approved by the DCGI, CDSCO. The sample size of the study is 452. Once 400 patients are enrolled, no more sites will be added. The clinical trial liability insurance has been bought centrally by ICMR.
ICMR releases National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic
ICMR has released National Guidelines for Ethics Committees Constituted for Reviewing Biomedical and Health Research during COVID-19 Pandemic. The instructions are developed 24 by its bioethics unit NCDIR, Bengaluru, under the guidance of COVID-19 National Ethics committees (CoNEC). The document highlights the critical and facilitatory role that the ethics committees need to play in supporting the ethical conduct of research in India.
ICMR releases Guidelines for appropriate recording of COVID19-associated deaths
ICMR has released guidelines for appropriate recording of COVID-19-associated deaths. The cause of death (COD) is defined as “all those diseases, morbid conditions or abnormalities, injuries which either resulted in or contributed to death and the circumstances of the accident or violence which produced any such injuries.” The Guideline entails the detailed description of how to record COVID19-related deaths.
ICMR releases standard guidelines for medico-legal autopsy in COVID-19-related deaths
A brief guidance document has been drafted and released by Indian the ICMR in consultation with various stakeholders in healthcare who are following the outbreak of COVID-19 pandemic. The objective of this document includes providing the standard operating procedure for medico-legal autopsy as well as following standard biosafety precautions.
IJMR publishes a special issue on COVID-19
Indian Journal of Medical Research (IJMR), a publication of ICMR, is a peer-reviewed online journal with monthly print-on-demand compilation of issues published. The COVID-19 pandemic has created opportunities to build an improved response mechanism for future pandemics. Concerted, well-funded, comprehensive, planned, and all-encompassing activities should facilitate building sustained institutional capacity to provide a swift and effective nationwide response to disease outbreaks. This could be done through access to appropriate technologies and improved logistics for efficient supply chains. These will also promote developing multisectoral stakeholder consortia at national and state levels to coordinate actions and launch a comprehensive whole-of-the-society response to emerging infections. Overall and long-term target should be to encourage and ensure convergence of all stakeholders for human health, animal health and environment to collaborate in implementing the One Health approach and protecting human life, reduce misery and avoid damage to the national economy. These are doable actions. The national will and determination are vital to mitigate the severe impact of pandemics, such as COVID-19 in India.
ICMR releases Guidelines for liver transplantation amid COVID-19 infection
Indian Council of Medical Research (ICMR) has issued the guidelines to address the issues specific for liver transplantation considering the impacts of the outbreak of COVID-19 Pandemic. These guidelines have been prepared by Liver Transplant Society of India (LTSI). The guidelines include various aspects of COVID-19 diagnostics during, pre and post liver transplant.
ICMR appeals to the general public not to consume and spit smokeless tobacco in public areas
In view of the increasing danger of COVID-19 pandemic, Indian Council of Medical Research (ICMR) appeals to the general public to refrain from consuming the smokeless tobacco products and spitting in public places. Chewing Smokeless Tobacco products (like Gutkha, Paan masala with tobacco, Paan and other chewing tobacco products) and areca nut (supari) increases the production of saliva followed by a very strong urge to spit. Spitting in public places could increase the spread of the COVID-19 virus.
Call for proposals (CFP) for Translational Immunology Approaches to COVID-19
Indian Council of Medical Research (ICMR) invites full proposals (in ICMR Ad-hoc Project format) to fast-track the funding opportunities for Translational Immunology and Cellular Therapeutics approach targeting COVID-19 pandemic. All scientific institutions and laboratories are eligible to apply for this CFP. The supported projects are expected to start in June 2020 and should complete latest by the end of May 2022. Last date for project submission: 01 May 2020
Contact info: Dr Geeta Jotwani; email@example.com
Clinical trial of convalescent plasma in COVID-19 Patients
Clinical trial for convalescent plasma therapy is submitted by Indian Council of Medical Research (ICMR) on April 13, 2020 to Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator body. CDSCO, on 17 April 2020, has approved the proposal of Indian Council for Medical Research (ICMR) for conducting clinical trial of convalescent plasma in Covid-19 patients, as per the protocol developed by the ICMR.
Strategy for COVID-19 testing for pregnant women in India
As per ICMR Strategy for COVID-19, asymptomatic pregnant women should be tested in the health facilities where they are expected to deliver and all arrangements should be made to collect and transfer samples to testing facilities.
National labs identified for COVID-19 testing to remain open all 7 days a week
A decision has been made by Department of Health Research (DHR) that all the notified national laboratories for COVID-19 testing, including Viral Research & Diagnostic Laboratories (VRDLs) and other labs, spread across the country shall remain open all the 7 days a week.The document contains the list of all the laboratories spread across the country.
Measures undertaken to ensure safety of health workers drafted for COVID-19 services
Doctors and health professionals are at the forefront in the fight against COVID-19. Their efforts and spirit is being widely acclaimed at all levels. The skills and spirit of service among these professional place them in a unique position to save people from this disease. It is of utmost importance that adequate measures have been taken for ensuring their safety. Several measures are taken to ensure safety of healthcare professionals. These are annexed with the attachment (website link).
Onboarding of States/Union Territories’ COVID-19 warriors to iGoT (Integrated Government Online Training) courses on DIKSHA Platform on COVID-19 pandemic
Integrated Government Online Training (iGOT) has launched a programme to train all the COVID-19 warriors of India. The learning portal has National coverage, free access to all, 24X7 content availability from any location, any device and above all has relevant content developed by the Government of India which is updated regularly as the situation unfolds.The iGOT COVID version is being hosted on Ministry of Human Resource Development’s DIKSHA platform.
Contact info: firstname.lastname@example.org
Performance evaluation of commercial kits for detection of SARS-CoV-2 RNA by Real-Time PCR
Till 20 April 2020, 33 real-time PCR kits have been validated at various ICMR validation centres. Out of these, 15 kits have been found to be suitable for diagnostics purposes.The link provides the details of the kits, along with their batch number and manufacturer details.
Revised COVID-19 testing strategy for India
The National Task Force at ICMR has carefully reviewed the data evolving from different countries on the use of various diagnostic kits. Based on available evidences, the testing strategy for COVID-19 has been revised further, effective from 17 April 2020.
ICMR study finds two kinds of Coronaviruses in Indian bat species
A study by the Indian Council of Medical Research (ICMR) has found the presence of coronaviruses in bat species from Kerala, Himachal Pradesh, Puducherry and Tamil Nadu. Amid the ongoing pandemic, there have been studies and theories that the coronavirus pandemic which spread from Wuhan in China had originated from bats.
Advisory for use of Cartridge-based Nucleic Acid Amplification Test (CBNAAT) using Cepheid Xpert Xpress SARS-CoV-2
ICMR releases advisory for use of Cartridge- based Nucleic Acid Amplification Test (CBNAAT) using Cepheid Xpert Xpress SARS-CoV2, effective from 19 April 2020.
Additional guidelines for TrueNat testing for COVID-19
ICMR releases additional guidelines, in addition to existing guidelines, for testing of COVID-19 by TrueNat testing technology. This includes the bio-safety precautions for sample collection and transportation.These additional guidelines are effective from 19 April 2020.
Consolidated information for Regional Depots for Storage and transportation of COVID KITS
The daily COVID-19 testing capacity at various laboratories in the country is being increased and is expected to reach to 1 lakh tests per day by May 31 2020. To meet the increased requirement of testing material with an increasing number of tests, the current model of inventory stocking and distribution is being scaled up significantly. Accordingly, a total of 16 regional depots are being set up and are modelled into self-contained units by strengthening human resources, other resources and infrastructure. Besides 16 regional depots depots at NIMR, New Delhi and NIV, Pune would also function as central depots.
Modification in medicine list in Telemedicine Practice Guidelines
The Indian Government has made a modification in the medicine list of its earlier published Telemedicine Practice Guidelines (Telemedicine Guidelines) on March 25, 2020.
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Advisory against spraying of disinfectant on people for COVID-19 management
Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division) has issued advisory to examine the merit of using disinfectants as a spray over the human body to disinfect them from COVID-19.
Updated containment plan for large outbreaks of COVID-19
The risk assessment, guidelines, and containment measures are being reviewed regularly, and preventive measures are being identified and implemented by Ministry of Health and Family Welfare (MoHFW), Government of India.
Advisory for effective management & availability of safe drinking water during lockdown due to COVID-19
COVID-19 has taken pandemic proportions in many countries and in view of the seriousness of the matter, Government of India and State Governments have taken several pre-emptive measures to contain this disease in the country. Frequent washing of hands with frothing soaps is recognized as most efficient and effective measure in the listed preventive measures for controlling the spread of the virus. Thus, there is an urgent need to ensure that safe potable water is available to all citizens particularly in the rural areas where facility of medical sanitizers may not be available.
Revised guidelines on the use of TruenatTM beta CoV
ICMR has validated TruenatTM beta CoV diagnostic test on TruelabTM workstation and has recommended it as a screening test. All positive samples need to be reconfirmed by a separate confirmatory assay for SARSCoV-2. ICMR released detailed and revised guidelines to perform the diagnostic test.
Guidance note for enabling delivery of essential health services during the COVID-19 outbreak
The COVID-19 outbreak has placed unprecedented demands on our health system. Focusing on COVID-19-related activities and continuing to provide essential services, it is important not only to maintain people’s trust in the health system to deliver essential health services but also to minimise any increase in morbidity and mortality from other health conditions.This note is released by ICMR that is intended to guide states to deliver essential health services for the duration of the COVID-19 outbreak. It elucidates a set of basic principles categorized by health systems elements and provides guidance on the essential services with details annexed. Essential services for all areas include reproductive, maternal, newborn and child health, prevention and management of communicable diseases, treatment for chronic diseases to avoid complications, and addressing emergencies.
List of antibody (IgM, IgG)-based rapid tests
ICMR released a document that enlists 16 antibody-based rapid diagnostic tests that have been validated at National Institute of Virology, Pune. The validation was performed on different parameters, like sensitivity, specificity, repeatability and reproducibility, and found to be satisfactory
Advisory on feasibility of using pooled samples for molecular testing of COVID-19
An advisory has been issued by Indian Council of Medical Research (ICMR), the apex body of medical research in India, to increase the capacity of the laboratories for screening increased numbers of samples using molecular testing for COVID-19 for the purpose of surveillance.
Newborns may get Covid-19 transmission from mothers: ICMR issues guidelines
According to the Indian Council of Medical Research (ICMR), there is a possibility of transmission of coronavirus from a pregnant mother to a newborn baby. However, the proportion of pregnancies affected and the significance to the newborns is yet to be determined.
Remdesivir can be used to treat COVID-19: ICMR
Indian Council of Medical Research (ICMR) might have been used remdesivir drug for the treatment of COVID-19 if it can be manufactured by the domestic companies. Remdisiver was an experimental drug that was made by Gilead Sciences.
ICMR seeks participation for trial of plasma therapy for Covid-19 treatment
The primary objective of the treatment will be to assess the safety and efficacy of convalescent plasma in treating Covid-19 patients. Plasma from a cured patient is assumed to have antibodies against the virus and this can then be used to cure another patient.
Call for Letter of Intent for Participation in A Phase II, Open Label, Randomized Controlled Study to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19-associated Complications
ICMR is inviting a letter of intent from institutions with the equipment and infrastructure available to participate in a clinical trial to study the safety and efficacy of convalescent plasma in COVID19 patients, subsequent to necessary approvals and clearances.
Call for Letter of Intent for Participation in Therapeutic Plasma Exchange in COVID-19: Protocol for a Multi-centre, Phase II, Open Label, Randomized Controlled Study
ICMR is inviting a letter of intent from institutions with the equipment and infrastructure available to participate SCIENCE & TECHNOLOGY EFFORTS ON COVID-19 by The Indian Council of Medical Research (ICMR), and The Ministry of Health & Family Welfare (MoHFW) in a clinical trial to study the safety and efficacy of therapeutic plasma exchange in COVID-19 patients, subsequent to necessary approvals and clearances.
Applications invited from Government & Private Medical Colleges for setting up COVID-19 testing facility
ICMR invites applications from all Government and Private Medical Colleges for establishing a COVID-19 testing facility. All Medical Colleges with following infrastructure and expertise may apply.
Integrated Govt. Online Training (iGOT) courses on DIKSHA platform on COVID-19 pandemic
Ministry of Personnel, Public Grievances & Pensions, D/O Personnel & Training launched separate courses on the DIKSHA platform on COVID-19 pandemic.
COVID-19 - Sample collection guidelines
This document gives information on sample collection, packing and transport to laboratory for COVID-19 testing. The scope of the document to be used by hospitals involved in collecting samples for COVID-19 diagnosis.
Standard Operating Procedure for Specimen Collection, Packaging and Transport Guidelines for 2019 Novel Coronavirus (2019-nCoV)
The document contains the detailed information, procedure, and dos & don'ts of Specimen Collection, Packaging and Transport Guidelines for 2019 novel Coronavirus (2019-nCoV).
COVID-19 Testing Laboratories Location Map
The website is a visual representation of Diagnostic Laboratories doing testing across the country for presence of 2019-nCoV. The website has also detailed information for each laboratory across the country.
ICMR Rapid Response Team for COVID-19
The document contains emails and direct contact numbers related to COVID-19 management at Apex level.
Guidelines for Waste disposal
The document contains the detailed information related to handling, treatment and disposal of biological as well as non biological waste disposal during diagnosis, quarantine, isolation period and treatment of COVID-19 Patients.
Guidelines for Quarantine facilities
The documents entails the specific requisites for establishing quarantine facilities. This includes evaluation of proposed sites to all the checklist for establishing the centres.
Advisory & strategy for use of rapid antibody based blood test for COVID-19
The document contains advisory to start rapid antibody based blood test for COVID-19.
Containment Plan for Large Outbreaks of Novel Coronavirus Disease 2019
The document contains detailed information of containment Plan for Large Outbreaks of COVID-19.
Advisory on use of Homemade Protective Cover for Face & Mouth
The document contains detailed information on use of Homemade Protective Cover for Face & Mouth.
AarogyaSetu App is an initiative for staying informed and alert against COVID19. The App aims to develop a digital Bridge to fight against COVID-19.