Tag: ICMR

Industry Update – Guidance Document

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GUIDANCE DOCUMENT – VALIDATION OF RAPID DIAGNOSTICS FOR PATHOGEN IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST)

Indian Council of Medical Research (ICMR) in coordination with Central Drugs Standard Control Organisation (CDSCO) has published a Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST)

This document provides guidance for innovators and testing laboratories on validating diagnostics for pathogen identification and antimicrobial susceptibility testing.

It outlines a systematic framework to evaluate diagnostic performance, focusing on precision, accuracy, reproducibility, and the ability to detect target pathogens or their genetic materials (e.g., DNA, RNA, toxins, or antigens).

It also includes methods for antimicrobial susceptibility testing and prepares developers for the validation process by detailing evidence requirements and regulatory approval pathways.

Prepared by the AMR Coordination Unit of ICMR, this third draft incorporates expert feedback and inputs from the Central Drugs Standard Control Organization (CDSCO).

The document is designed to evolve with advancements in technology and methodologies, ensuring reliable diagnostics for clinical decision-making.

Click here to Download the Guidance Document

Source: https://www.icmr.gov.in/icmrobject/uploads/Guidelines/1736941384_guidancedocument_amrdiagnostics_revised.pdf

Industry Update – Standard IVD Evalution protocols

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Standard IVD Evaluation Protocols –
Drafted by ICMR and CDSCO

Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly issued the Draft Standard IVD Evaluation Protocols

The document outlines the need for standardized evaluation protocols for IVDs as mandated by the Medical Devices Rules 2017. These protocols are essential to ensure the quality and performance of diagnostic kits used in India

Several specific performance evaluation protocols have been drafted, including those for:

a. Chikungunya IgM ELISA
b. Dengue NS1 RDT and ELISA
c. Zika virus real-time PCR , among others

The document includes detailed guidelines for evaluating various IVDs, emphasizing:

i. Study design and ethical considerations
ii.Requirements for evaluation sites and laboratory standards
iii.Procedures for conducting diagnostic accuracy studies
iv.Acceptance criteria for sensitivity and specificity of tests.

This initiative by ICMR and CDSCO aims to enhance the reliability of diagnostic testing in India through structured evaluation processes, ensuring that manufacturers adhere to high standards of quality in their products. Stakeholder engagement is critical to refining these protocols before their final adoption.

Stakeholders are invited to provide comments on these protocols until February 15, 2025.

Comments should be submitted via email before 15th February 2025, at ivdevaluation@gmail.com as per the specified format given in the notification

Click here to read IVD protocols

Source: https://www.icmr.gov.in/icmrobject/uploads/WhatsNew/1735801120_advt_ivd_document.pdf

Industry Update – Second National Essential Diagnostics List – Draft

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Second National Essential Diagnostics List – Draft

Draft of Second edition of “National Essential Diagnostics List” for public comment is released by Indian Council of Medical Research (ICMR), New Delhi

Public comments are invited on or before 15/1/2025 via email to mail id icmr.nedl2@gmail.com

Appreciating the urgent need to improve the availability of quality diagnostics at all levels of healthcare facilities in the country, Indian Council of Medical Research has drafted the second edition of National Essential Diagnostics List (NEDL).

The list has been drafted in consultations with all the relevant stakeholders for all levels of health care.

The comments/views on the draft may be forwarded via email at icmr.nedl2@gmail.com on or before 15/l/2025

Click here to read Draft document

Source: https://www.icmr.gov.in/icmrobject/uploads/Static/1735745135_draftsecondeditionnedl.pdf

MedTech Mitra

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Launch of MedTech Mitra Portal

Union Minister, Health & Family Welfare, Dr. @mansukhmandviya inaugurates “MedTech Mitra,” a groundbreaking initiative by ICMR and CDSCO, supported by NITI Aayog.

This turning point marks a landmark for India’s healthcare landscape, enabling affordable healthcare solutions for all citizens.

ICMR & CDSCO in collaboration with NITI Aayog have launched #MedTechMitra, a game-changer for India’s healthcare. Fostering innovation & strategic support for medical device and diagnostic development. It will strengthen ecosystem, with affordable solutions for all.

MedTech Mitra streamlines MedTech R&D with preclinical & clinical support, collaboration initiatives, & funding opportunities. It is a primary step towards building a robust, self-reliant ecosystem for affordable & accessible healthcare in India.

Source:https://medtechmitra.icmr.org.in/

Biomedical Research Course

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Biomedical Research Course by ICMR-National Institute of Epidemiology

The National Medical Commission (NMC) has mandated a uniform research methodology course called ‘Basic Course in Biomedical Research’ in order to improve the research skills of Indian medical postgraduates (PG) and teachers in medical institutions.

The course will be offered in online mode by ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai and will explain the fundamental concepts of research methodology in health. It will be delivered through video lectures and reading materials. The students will be awarded with a certificate based on their evaluation of the lecture wise assignments and a final proctored exam.

The enrollment for the course is open throughout the year. There is no deadline for enrolment into the course or for submission of assignments

The participants can learn on their own pace and schedule. They will be eligible for exam registration once they secure the cut off scores in assignments. The students are required to score at least 50 per cent in every assignment for 23 lectures. The candidates can then register for the proctored exam for the upcoming schedule. 

The exam registration link for the next available date will be provided as the participant successfully secures a minimum score of 50 per cent in every assignment for 23 lectures.

To register for examination, the participant will have to fill-up an online form and pay the examination fees of ₹ 1,000 online. The city-wise list of examination centres will be made available at the time of registration. 

The next exam date for the course is set for February 25, 2024

The course will be available on the websites of SWAYAM (https://swayam.gov.in) and ICMRNIE (https://nie.gov.in/icmr_sph/BCBR.html).

Enrollment into BCBR will be open throughout the year and the participants can access the course according to their individual schedule.

Click here to read more

Source: https://www.nmc.org.in/

Regulatory Awareness & Experiential Learning Workshop

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Regulatory Awareness & Experiential Learning Workshop for Medical Device / Diagnostic Innovators / Start-ups in India

Indian Council of Medical Research (ICMR)is conducting a Regulatory Awareness & Experiential Learning Workshop for Medical Device/Diagnostic Innovators/Start-ups in India jointly with Central Drugs Standard Control Organisation (CDSCO) on 12th Oct 2023 at ICMR Hqrs, New Delhi.

Date of the Workshop – 12th October 2023
Time – 10 am to 5 pm
Venue – Conference Hall, ICMR Hqrs, New Delhi
Mode of workshop – Hybrid mode

Last Date for Registration – 30th September 2023

Registration Link – https://docs.google.com/forms/d/e/1FAIpQLSeQZCq00-CnvqpG-tUZRHF43fc3gthxkGvVSl-3KP9FrmKyqw/viewform

Ethical Guidelines for the Application of AI

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Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare by the ICMR

Artificial Intelligence (AI) and Machine Learning (ML) are certainly the game-changer in the space of healthcare. A wide variety of exciting and future-looking applications of AI/ML techniques and platforms are available now. Identification of disease, screening, making diagnosis, medical imaging, intelligent health operations management, personalized medicine to digital surveillance for public health, outbreak prediction, and drug discovery are only some of the emerging uses of AI/ML.

However, AI as data-driven technology has many potential ethical challenges which include algorithmic transparency and explainability, clarity on liability, accountability and oversight, bias and discrimination

The Indian Council of Medical Research (ICMR) has come up with the country’s first Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare to provide an ethical framework for the development of AI-based tools which will benefit all stakeholders. These guidelines apply to AI based tools created for all biomedical and health research and applications involving human participants and/or their biological data.

The purpose of the Guideline is to provide an ethics framework which can assist in the development, deployment, and adoption of AI-based solutions for biomedical research and healthcare delivery. The guidelines are intended for all stakeholders involved in research on artificial intelligence in healthcare, including creators, developers, technicians, researchers, clinicians, ethics committees, institutions, sponsors, and funding organizations.

The document includes separate sections addressing ethical principles for AI in health, guiding principles for stakeholders, ethics review process, governance of AI use for healthcare and research, and informed consent process involving human participants and their data. The guideline has been formulated after extensive discussions with subject experts, researchers and ethicists

Click here to read Ethical Guidelines

Source:https://main.icmr.nic.in/content/ethical-guidelines-application-artificial-intelligence-biomedical-research-and-healthcare

Notification – UGC asks higher education institutions to get registered on BioRRAP

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Biological Research Regulatory Approval Portal (BioRRAP)

The integrated portal – Biological Research Regulatory Approval Portal (BioRRAP)-has been initiated by the Government of India (GOI) to provide regulatory information to researchers and to facilitate approvals.

The University Grants Commission (UGC) has asked higher educational institutions and their affiliated colleges/institutions to get registered on Biological Research Regulatory Approval Portal (BioRRAP).

According to UGC, it is one-of-a-kind digital gateway intended to make science and scientific research more accessible as well as make it easier to create businesses. The information on international research projects as approved by all line Ministries/Departments of GOI is expected to be integrated with BioRRAP (with unique BioRRAP ID for each proposal).

With regard to Research Projects by entities falling under the category of Central/State Government, the relevant approvals will be dealt with by the concerned Ministry of the Government of India. State Governments have been requested to forward all such proposals to the concerned line Ministry of Government of India

In respect of Non-Government Organizations, the Health Ministry’s Screening Committee, operated by DHR/ICMR, that has been reconstituted by the Ministry of Health and Family Welfare will review the research projects involving international collaboration/funding in health research including studies in humans, animals, plants & environment.

UGC advised the higher educational institutions to follow the above provisions strictly and get registered on the portal

Click here to read Notification

Source:https://odishatv.in/news/education/ugc-asks-higher-education-institutions-to-get-registered-on-biorrap-193363

ICMR Survey

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ICMR Survey on Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program

Request for Participation In ICMR’s Landscape Study For Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program of Medical Device and Diagnostics Mission Secretariat, ICMR

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation,
coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.

ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical
research on the one hand and to the need of finding practical solutions to the health problems of the country,
on the other.

The Indian Medical device market is currently valued at USD 11.2 billion and is experiencing a growth rate
of 15% CAGR as against growth rates observed by developed countries of about 4% CAGR. India is
dependent on imports for its medical device needs with 80% of medical devices being imported. In view of
the huge import, dependency and long technology development cycle of medical devices, there is an urgent
need for providing holistic support across the medical device development and commercialisation cycle
including R&D, scale-up, validation, regulatory compliance, market access etc.

To cater to the above challenges, ICMR has established Medical Device and Diagnostics Mission Secretariat
(MDMS) with a vision to support and catalyze research, development and indigenous manufacturing of cost effective medical devices to strengthen health care sector in India and reduce import dependency through a Mission mode consortia approach. ICMR-MDMS aims to conduct a multipronged landscape study inviting medical professionals working at both Government and Private Institutes to provide their opinion on the medical device and diagnostic products as they are the Key Opinion Leaders and the end users of the
products.

The objectives of the study are:

(i) To identify various medical devices/sub-sectors/verticals based on unmet healthcare needs and
contribute to import dependency in the Country with inherent potential for societal impact.
(ii) To strategize, categorize, prioritize, and plan devices/sub-sectors/verticals for extending funding
support in a phased manner initially focussing on low end devices, which can deliver volumes and then
graduating to high end devices as the program progresses, for accelerating unmet need driven devices
and diagnostics product development for wide societal impact.
Medical professionals in both Government and private medical colleges/ institution are requested to fill the
virtual survey form. The form can be accessed through the link given below. A guidance document is also
enclosed for your kind perusal for assisting in filling up the form.

Link for the Medical Device form : http://103.25.130.160/icmr-survey/
Link for Invitro Diagnostic Devices Form: http://103.25.130.160/icmr-survey/niform.php

Date of Submission:
Start Date: 3rd Feb’ 2022 Time: 09:00 AM
End Date: 25th Feb’20202 Time: 05:00 PM

In case of any query you may contact the following officials:
Medical Device and Diagnostics Mission Secretariat (MDMS)
Indian Council of Medical Research
Ansari Nagar, New Delhi- 110029
Email: suchita.markan@icmr.gov.in,
icmrmdmsoffice@gmail.com,
div.itr.icmr@gmail.com
Telephone No.: +91-11-26588895 Ext-337

Source : https://main.icmr.nic.in/sites/default/files/whats_new/Landscape_participation_request_03022022_1.pdf

Indian Clinical Trial & Education Network (INTENT)

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EoI Announcement from ICMR

Expression of Interest (EOI) for Participation in “Indian Clinical Trial & Education Network (INTENT)”.

The Indian Council of Medical Research (ICMR) under the Department of Health Research
(DHR), Ministry of Health & Family Welfare, Government of India, is the apex biomedical
research body in the country for formulation, co-ordination, and promotion of medical research.
The overall goal of ICMR-DHR is to generate evidence to inform policy, program and practices
pertaining to health care in India.

Clinical Studies, Trials and Projection Unit (CSTPU), Indian Council of Medical Research (ICMR),
Department of Health Research (DHR) proposes to launch the Indian Clinical Trial & Education
Network (INTENT), which will serve as a pan-India network of institutes with proven excellence
in clinical research. The network, thus established, will conduct large scale, multi-centric clinical
trials in a timely and well-regulated manner.

Why clinical trial network ?
INTENT envisages to provide evidence-based, cost effective, scientifically sound, and culturally appropriate solutions to diseases and health issues of national and/or regional importance. It will provide a single platform to conduct a range of randomized clinical trials (RCT), that will enable harmonization of trial methods, pooling of results and timely completion of the projects, along with an inclusive representation of the diverse Indian communities. Additionally, this network will be at the forefront for capacity building of a pool of health researchers across the country. The trainees will acquire requisite skills to plan and conduct RCTs and to analyse and disseminate the results that could inform policy and practice.

Structure of INTENT
INTENT will work on a hub and spoke model with a co-ordinating centre located at ICMR-DHR. Hubs will be distributed over the six regions of the country (North, South, East, West, Central and North-east) and will function as nodal point for RCTs in that region. These Advanced Centres for Clinical Trials (ACCT) will include Institutes/Medical Colleges/Hospitals of repute with rich experience and expertise related to RCTs. They will have functional linkages with Multidisciplinary Research Unit (MRU) and/or Model Rural Health Research Unit (MRHRU) under the aegis of ICMR-DHR in the region.

Each regional hub, thus identified, will act as the mentoring body for a region, with the responsibilities of supportive supervision and troubleshooting as required. They will have an inclusive expansion plan so that the newly identified potential partnering agency/institutes/organizations are inducted in the regional network. The identified MRU/MRHRU will act as a Regional Clinical Trial Unit (RCTU), responsible for daily functioning and monitoring of the trials. Each regional hub will select their study sites (spokes) as per the research question to be answered. Funding for human resource, as well as for the mentoring activities at each of these hubs will be provided by ICMR-DHR (Figure 1). The number of regional hubs will be scaled up in a phased manner. Disease-oriented domain specific networks within INTENT will be recognised according to the
domain expertise and subject specific clinical requirements.

Who can apply for Advanced Centre for Clinical Trial?
Govt. Medical Colleges/Institutes
Private Medical Colleges/Institutes
Hospitals with experience of conducting RCTs
ICMR Institutes .

Investigators motivated to lead the regional hubs can apply with institutional approval.

Criteria for selection
Investigator
a. Endorsed by the Head of the Institute/College
b. Experience of initiating/participating in multi-centric RCT
c. Good quality publications on RCTs
d. Subject specialization
e. Preferably a multi-disciplinary team of investigators to be involved, with at least 2 of the team members being mid-level faculty (associate or additional professor, or equivalent experience)

Institute
a. Community outreach programme
b. Access to potential trial participants, both in-patient and outpatients
c. History of collaboration with other institutes/medical colleges/community-based organizations
d. Catchment area catering to various geographical and population groups
e. Presence of requisite infrastructure and space

Trials to be conducted via INTENT
Research priorities of INTENT will reflect the national and/or health priorities of urgent and important nature. Among others, the areas which will be covered by INTENT are reproductive, maternal, neonatal, child and adolescent health (RMNCHA), communicable and noncommunicable diseases, nutrition, mental health, environmental health, health system research, healthcare financing, digital health, occupational health, vulnerable people’s health and oral health.

The clinical trials to be conducted by INTENT partners can be grouped as short, intermediate, and long-term projects. To begin with, the focus of the network will be on short-term projects, where questions relevant to national health needs can be answered within 1-2 years. The projects will be primarily funded by ICMR.

Interested parties should fill the Google form at the following link:
https://docs.google.com/forms/d/e/1FAIpQLSf6yt0HbP0vfJswup8q8nHRt5b1omYX8iQNWt
GEN8aSd3VjaA/viewform?usp=sf_link

The last date of receiving application: 25th October 2021

For further information, please contact:

Dr. Aparna Mukherjee
Scientist E
Clinical Studies Trials & Projection Unit
Epidemiology and Communicable Diseases Division
Indian Council of Medical Research
Email: intent.icmr@gmail.com
Mob: +919968408999

Source : https://main.icmr.nic.in/sites/default/files/upload_documents/EoI_INTENT_v1.pdf

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