Category: Testing Laboratories

CROs Registration

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Launching of registration of Clinical Research Organisation applications through SUGAM Portal

The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024, wherein registration of Clinical Research Organisation (CRO) has been made mandatory with effective from 1st day of April, 2025.

In this regard, the online registration of Clinical Research Organisation (CRO) is now functional on SUGAM portal (www.cdscoonline.gov.in). Applications for registration shall be submitted through SUGAM portal only along with the prescribed checklist of documents for the registration.

Click here to download Notification

Health Ministry notified Rules to register CROs under NDCTR (New Drugs and Clinical Trials Rules), 2019 and amendment to the Rules was introduced in September 2024 notifying the Chapter on CROs with related requirements to the Registration of CROs in the country. These amended rules shall come into force on and from the 1st day of April, 2025.

The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September 19, defines CROs as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organisation having status of legal entity by whatsoever name called, to which the sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study.”

Amendment in NDCTR on CROs stipulates that no clinical research organisation shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licencing Authority (CLA) under these rules.

Newly inducted Chapter VA addresses the following :

  • Registration of Clinical Research Organisation
  • Application for Registration of Clinical Research Organisation
  • Grant of registration to Clinical Research Organisation
  • Validity period and renewal of registration of Clinical Research Organisation
  • Inspection of Clinical Research Organisation registered with Central Licencing Authority.
  • Suspension or cancellation of registration of Clinical Research Organisation

Subsequent to this MoHFW has issued a notification of 4th Feb 2025 launching mandatory registration of CROs and applications for the same through Sugam Portal of CDSCO.

Sharing the notifications issued by MoHfW here for references :

Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024 – New Drugs and Clinical Trials (Amendment) Rules (NDCTAR), 2024.

NDCTAR 2024 Notification

STUDY ON CRO SECTOR IN INDIA CONDUCTED BY DEPARTMENT OF PHARMACEUTICALS MINISTRY OF CHEMICALS & FERTILIZERS GOVERNMENT OF INDIA AUGUST, 2023

Department of Pharmaceuticals has released a report of Clinical Research Organisations in the country in 2023 based on a study conducted.

The Pharmaceutical global contract outsourcing market has been picking up after the covid pandemic. During the years between 2022-30, the global contract research outsourcing market is expected to grow @ CAGR of 7 % and reach USD 90.4 Billion by 2030. Out of this about USD 61.2 Billion will be contributed only by the outsourcing done in the domain of clinical development. The CRO sector in India has been growing @ CAGR of 10.75 % and will reach USD 2.5 Billion by the year Hence, it is imperative to identify the emerging opportunities for the Indian CRO sector beforehand, draft and implement strategies which will help in promoting the Indian CRO business.

Under the PMPDS Scheme, the Department of Pharmaceutical, Government of India took an initiative to conduct an independent study on the CRO sector/ market in India to identify and understand the real issues faced by CROs operating in India and work out a proposed roadmap to resolve those issues and make the necessary policy revisions.

Report has detailed information on :

RESEARCH FRAMEWORK
Business Trends in CRO industry
MARKET DYNAMICS
INDIAN CRO MARKET, BY END USER
INDIA CROs CATEGORIZATION, BY SERVICE TYPE
CROs CATEGORIZATION BY THERAPEUTIC AREA
CROs CATEGORIZATION BY LOCATION
CROs CATEGORIZATION BY SIZE
PROFILES OF SOME PROMISING CROs OPERATING IN INDIA
INSIGHTS & RECOMMENDATION

Click here to download the report

Source https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1Njk=

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 : NABL 112A & NABL 112B

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Industry update : NABL 112A & NABL 112B

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an accreditation body that provides accreditation service to Conformity Assessment Bodies including medical testing laboratories. On December 18,2024, the following documents were issued by NABL.

1 – NABL 112A – Specific Criteria for Accreditation of Medical Laboratories

NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189

NABL documents are updated at regular intervals to keep pace with the latest technical developments and to synchronize with the International Standards.

NABL has released NABL 112A which elaborates the requirements of International Standard ISO 15189:2022 as applicable to Indian setting. The document has been designed to make it user friendly for both NABL assessors and laboratories

This document specifies the criteria for the medical testing laboratories for obtaining NABL accreditation. Medical testing laboratory shall fulfill the requirements of this document in addition to the requirements of the ISO 15189:2022 – “Medical laboratories –Requirements for quality and competence”. This specific criteria document shall be used in conjunction with ISO 15189:2022..

2 – NABL 112 B – Guidance document for Medical Laboratories

NABL has issued 112B Document on 18th December 2024. This document shall provide guidance to medical testing laboratories for the following aspects:

– Operation of sample collection centres / facilities
– Sample format for preparing the scope of accreditation
– Lot verification
– Algorithm for Automated Selection and Reporting of Results
– Sample format for competency assessment
– Examples for the type of sample and their stability for Clinical Biochemistry parameters

Click the buttons given below to read the documents in detail.

NABL 112A Document
NABL 112B – Guidance Document

Source: https://nabl-india.org/




Industry Update – Lab management Program

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Management Development Programme on Laboratory Management By IIHMR University

The Laboratory Management program targets middle to senior professionals in government institutions, private hospitals, and corporate laboratories.

It aims to equip participants with the knowledge and skills needed to manage and lead laboratories effectively while enabling them to pursue higher education.

Recognizing that 80% of patient care depends on diagnostic tests and analyses, the program focuses on developing competent leaders who can ensure laboratory quality, operational efficiency, and regulatory compliance, ultimately enhancing patient care and informed decision-making

Key Objectives of the program :

Leadership and Quality Excellence:
Develop leadership skills while ensuring compliance with international quality standards to enhance laboratory performance and patient care.

Technology and Innovation:
Leverage cutting-edge technologies, including Laboratory Information Systems (LIS) and artificial intelligence (AI), to modernize operations and improve diagnostic accuracy.

Financial and Risk Management:
Build expertise in financial planning and risk management to maintain sustainable and resilient laboratory operations.

Research and Clinical Competency:
Strengthen capabilities in research, clinical trials, and data management, fostering innovation and evidence-based decision-making.

Business Growth and Marketing:
Gain marketing and business development skills to expand laboratory services and succeed in competitive healthcare markets.

Who Should Attend ?

a. Laboratory Managers and Supervisors
b. Pathologists and Laboratory Technicians
c. Quality Assurance and Compliance Officers
d. Biotechnologists and Research
e. Scientists
f. Pharmaceutical and Clinical Trial
g. Professionals
h. Sales and Marketing Professionals in Diagnostics
i. Biomedical Engineers and Technologists
j. Corporate Laboratory Executives
k. Academicians and Trainers in Laboratory

Program Dates & Venue

The programme will start on Monday, March 24, 2025, and will conclude on Wednesday, March 26, 2025.

The programme will be held at IIHMR University, 1, Prabhu Dayal Marg, Sanganer Airport, Jaipur – 302 029.

The University campus provides a learning environment for the participants, who are welcome to use the library and recreational facilities at the campus

Program Fee :

The programme fee for Indian participants is Rs.30,000 plus GST (18% as applicable), and for international participants it is USD 355 plus GST (18% as applicable).

The programme fee covers tuition, background reading material, lodging, and boarding

Certificate of Participation:

A certificate of participation on completion of the programme will be issued by IIHMR University, Jaipur

Program Coordinators:

Kirti Agarwal
Manager-Strategic Planning and Partnership
IIHMR University, Jaipur

Puneet Sethi
COO and Co-Founder
BIO HUBB (A Unit Of Biopreseve Innovations LLP)

Registrations:

Please send your nominations/registrations to the following address

Programme Officer (Training)
IIHMR University
1, Prabhu Dayal Marg, Sanganer Airport,
Jaipur-302029, Rajasthan, India

Phone – +91-141-3924700
Email – training@iihmr.edu.in
Mobile – +91 9358790012

Click here to read the brochure

Source: https://iihmr.edu.in/

Industry Update – Establishment of the Global Accreditation Cooperation

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Establishment of the Global Accreditation Cooperation (GLOBAC)

The establishment of the Global Accreditation Cooperation (GLOBAC) marks a significant shift in the global accreditation landscape, merging the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) into a single entity.

This transition, aimed to be operational by January 2026, follows extensive discussions and agreements among IAF and ILAC members in 2024.

Key Developments

Formation of GLOBAC:

In 2019, IAF and ILAC members decided to create GLOBAC, which will take over their existing roles. The formal incorporation process began in New Zealand in October 2024 after the approval of GLOBAC’s Constitution and General Rules.

Mutual Recognition:

GLOBAC aims to enhance international trade by ensuring mutual recognition of accredited services across borders, thereby removing technical barriers. Until GLOBAC becomes operational, IAF and ILAC will continue their normal operations with existing recognition arrangements remaining valid

Transition Plan

Before Transition Date:

Until the Transition Date, IAF and ILAC will maintain their operations, and existing guidance for regulators will remain applicable. The IAF Multilateral Recognition Arrangement (IAF MLA) and ILAC Mutual Recognition Arrangement (ILAC MRA) will continue to function until GLOBAC takes over

After Transition Date:

Following the Transition Date, GLOBAC will assume all responsibilities of IAF and ILAC. Regulations referencing IAF MLA or ILAC MRA will gradually be updated to reflect GLOBAC’s framework. It is anticipated that the use of IAF MLA and ILAC MRA Marks will cease three years post-transition

Recommendations for Regulators:

Regulators are encouraged to collaborate with IAF and ILAC members to prepare for necessary changes in their documentation as GLOBAC becomes operational. This proactive approach will facilitate a smoother transition to the new accreditation framework

For further inquiries regarding this transition, stakeholders can contact the GLOBAC Executive Committee through its Secretary : secretary@globac.org

Click here to read more

Industry Update – Approval of Bio-Ride scheme by the Cabinet

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Cabinet approves ‘Bio-RIDE’ scheme to support Research and Development in Biotechnology

The Cabinet of India has approved the Bio-RIDE scheme, a significant initiative aimed at enhancing research and development in biotechnology. Here are the detailed points regarding this new scheme:

Overview of the Bio-RIDE Scheme

Continuation and Merger: The Bio-RIDE scheme merges two existing umbrella schemes of the Department of Biotechnology (DBT) into one comprehensive initiative, incorporating a new component focused on Biomanufacturing and Biofoundry.

Financial Outlay: The total proposed budget for the implementation of Bio-RIDE is ₹9,197 crore, covering the period from 2021-22 to 2025-26.

Key Components

The Bio-RIDE scheme consists of three main components:

1. Biotechnology Research and Development (R&D): Focuses on advancing research initiatives in
biotechnology

2. Industrial & Entrepreneurship Development (I&ED): Aims to foster industrial growth and entrepreneurship
within the biotechnology sector

3. Biomanufacturing and Biofoundry: Introduces a new focus on sustainable manufacturing practices in
biotechnology.

Objectives and Goals
Fostering Innovation: The scheme aims to accelerate innovation by providing grants and incentives for cutting-edge research in areas such as synthetic biology, bio-pharmaceuticals, bioenergy, and bioplastics.

Promoting Bio-Entrepreneurship: It seeks to create a supportive ecosystem for startups through seed funding, incubation support, and mentorship.

Enhancing Collaboration: Bio-RIDE will facilitate partnerships between academic institutions, research organizations, and industry to enhance the commercialization of bio-based products.

Sustainable Practices: There is a strong emphasis on promoting environmentally sustainable biomanufacturing practices aligned with India’s green goals.

Extramural Funding Support: The scheme will provide extramural funding to research institutions, universities, and individual researchers across various fields including agriculture, healthcare, bioenergy, and environmental sustainability.

Human Resource Development: It includes initiatives for holistic development of students, young researchers, and scientists in biotechnology to build a skilled workforce capable of leveraging technological advancements.

Alignment with National Goals :
The Bio-RIDE scheme is part of India’s broader vision to establish a circular bioeconomy and contribute to climate change mitigation. It aligns with the “Lifestyle for the Environment (LiFE)” initiative launched by the Prime Minister, promoting environmentally friendly solutions across various sectors.

The DBT’s ongoing efforts aim to position India as a global leader in biotechnology research and innovation, with aspirations of achieving a $300 billion bioeconomy by 2030. The Bio-RIDE scheme is expected to play a crucial role in realizing the vision of “Viksit Bharat 2047,” which focuses on comprehensive national development through advanced biotechnology solutions

Source: https://www.pmindia.gov.in/en/news_updates/cabinet-approves-bio-ride-scheme-to-support-cutting-edge-research-and-development-in-biotechnology/

Smart Hospitals 2024 Conference – Industry Update

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Smart Hospitals Conference 2024 @ Mumbai on
15th March 2024

Smart Hospitals Platform is created to help Business Owners of Small and Midsized Hospitals, Daycare Centers, Clinics etc. LEARN to MANAGE their businesses, in alignment with changing market needs and business scenarios.

Conference this year is designed to create conversations on Growth Opportunities for Healthcare Businesses and Investments the sector is attracting over last few years.

Conference Theme :

Indian Healthcare Services – A Decade Of GROWTH 🡅 Forecast
– SMART GROWTH Enablers

𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗢𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲 :

A Decade Of Growth Forecast For Healthcare

Indian Healthcare Space has been witnessing a strong GROWTH surge over the last 2-3 years, especially in Tier 1 and 2 Cities in the country. Demand for Quality Healthcare is on the rise and this market need is driving heavy flow of Private Equity Investments into the sector over the last 2-3 years.

Industry Reports say in Indian metros total bed density remains largely uncapitalised and for Quality beds there is a demand-supply gap of 20-30 per cent. 

Tier 1 and 2 cities are where a large part of India’s GDP growth is going to happen and they will become a very important growth engine of this healthcare market. Providers of Services prefer to be in the markets where the market needs are not met.

Indian Healthcare Services – 5 Strong Pillars of Growth

Services Growth will be driven by the Convergence of following sub domains providing care delivery through multiple channels :

– Hospitals
– Home Care
– Diagnostics
– Health Insurance
– Digital Health

ENABLERS for GROWTH for each sub domain may vary . SMART Hospitals Conference will have  speakers discussing about the much needed ENABLERS to Drive the Growth.

Opportunity for Healthcare Service Providers across the spectrum from Tier 1,2,3,4 and 5 cities to join the session and Listen to Experts Opinions, Views on the SMART Growth Enablers that will drive the Sectoral Growth over the next decade. 

𝗪𝗵𝗲𝗻 ?

📅 Date: 15th March 2024 – Friday
⏲ Time: 10 00 am – 5 00 pm
🌆 Venue: Bombay Exhibition Centre, Mumbai

𝗪𝗵𝗼 𝗦𝗵𝗼𝘂𝗹𝗱 𝗔𝘁𝘁𝗲𝗻𝗱 ?

Promoters of Hospitals / Other Healthcare Service Organizations (Micro, Small, Medium and Large  Organizations) ,   Medical Professionals / Practitioners ,  Administrators, Management / Operations Teams, Marketing Teams, Managerial Teams, Technology Teams , Startups, Innovators,  HealthTech, MedTech, Digital Health Companies , Investors , Academic Institutions , Innovators, Nursing Professionals, Paramedical Teams, Health Insurers, TPAs, Management Consultants, Finance Professionals and other stakeholders

Download Program Brochure
Download Program Agenda

Conference Entry by prior registration.

Delegate Fee:

INR 1000 (including GST) per Participant. Fee includes Lunch & Hi Tea arrangements

𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 :

𝗦𝘁𝗲𝗽 𝟭 :

Make the payment using the QR code shared below 

𝗦𝘁𝗲𝗽 𝟮 :

Click the ‘Register here” button given below and fill up the delegate registration form. Please mention the payment reference number in the form 

Register here

For detailed information about Expo, Conference , click : https://www.medicalfair-india.com/special-shows-overview

For enquiries related to Conference Partnerships, Stalls booking inside Diagnostics Pavilion , delegate registration enquiries, pls write to :

VermaA@md-india.com / +91-124-4544507
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

For conference delegate registration enquiries, please write to :
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

Source: https://smarthospitals.events/

Clinlab India 2024 Conference – Industry Update

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CLIN LAB INDIA 2024 CONFERENCE @Mumbai on
14th March 2024

MEDICAL FAIR INDIA is India’s leading Trade Fair for the Medical and Healthcare Industry. For the last 28 years, Medical Fair India has been successfully addressing the various needs of Hospitals, Health Centres & Clinics.  With participation from over 20 countries, MEDICAL FAIR INDIA provides an opportunity to position your brand among competitors and further increase your level of visibility. MEDICAL FAIR INDIA acts as a platform where connections are made and business relationships are nurtured.

ClinLab India is the exhibition & conference on the topic of laboratory medicine, Point of Care Testing, molecular diagnostics and clinical chemistry. The show is aimed to promote the recent developments and market trends in the in-vitro diagnostics (IVD) sector and allied areas.

ClinLab India brings together the leaders in the medical laboratory industry designed to create maximum interaction and meeting opportunities where manufacturers, dealers and distributors can promote their brands, meet potential customers and entertain existing clients. 

The year 2024 holds a lot of promise for the Indian IVD industry. Technology is also going to be a critical growth factor. The Indian start-up ecosystem is aggressively targeting the IVD-MedTech segment, and we will see some compelling solutions from them soon

This is the 5th Edition of ClinLab India.

Conference Theme 2024 :
Driving Global Dominance through Innovations :
– IVD Industry’s Role in Economic Growth

𝗪𝗵𝗲𝗻 ?
📅 Date: 14th March 2024 – Thursday
⏲ Time: 10 00 am – 5 00 pm
🌆 Venue: Bombay Exhibition Centre, Mumbai

𝗪𝗵𝗼 𝗦𝗵𝗼𝘂𝗹𝗱 𝗔𝘁𝘁𝗲𝗻𝗱 ?

IVD , Biotech companies – Management & Technical Personnel, Healthcare Services – Management & Technical Teams from Clinical Labs/Hospitals/Blood Banks/CROs/Medical Colleges/Home Healthcare Companies and Other Healthcare Organisations , Startups, Innovators from Biotech space, Other stakeholders, Government Representatives

𝐅𝐨𝐫 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐔𝐩𝐝𝐚𝐭𝐞𝐬, please visit :

https://www.medicalfair-india.com/special-shows-clin-lab-india

Download Clinlab Conference Brochure
Download Clinlab Conference Agenda

Conference Entry by Prior Registration.

Delegate Fee : INR 1100 per participant (including GST). Fee includes Lunch & Hi Tea

𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 :

𝗦𝘁𝗲𝗽 𝟭 :

Make the payment using the QR code shared below

Step 2:
Click the ‘Register here” button given below and fill up the delegate registration form. Please mention the payment reference number in the form 

Register here

For more information about Expo, visit : https://www.medicalfair-india.com

For enquiries related to Conference Partnerships, Stalls booking inside Diagnostics Pavilion , delegate registration enquiries, pls write to :

VermaA@md-india.com / +91-124-4544507
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

For conference delegate registration enquiries, please write to :
Ms Rama Venugopal – info@events.healthcare / +91 9840870532

Source: https://events.healthcare/

Workshop Announcement

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ISO 20658:2023 – Workshop Announcement

Workshop on ISO 20658 – 2023. ISO 20658:2023 is a technical specification (TS) that defines the requirements for the collection, transport, receipt, and handling of samples for medical laboratories

The ISO 20658:2023 is an essential resource for all healthcare professionals and medical institutions

Who Can Attend ?

Laboratory professionals : Pathologists, Microbiologists, Bio chemist, Phlebotomist Customer care managers and Quality managers

Program Details :

Date : April 20, 2024
Venue: 8th Floor Auditorium, Kauvery Hospital, Vadapalani, Chennai
Mode : In Person Training (Interactive sessions with case based learning)
Fee – Rs 2000 per delegate

Click here to Register : https://bit.ly/430kbTO

Click here to make payment : https://bit.ly/49Q4cK7

For more details, please contact Ms.Boomadevi @ 9538616636


Do Register and Join the session

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