Category: Industry Update

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

Industry update : NABH GUIDEBOOK FOR CLIMATE ACTION AND SUSTAINABILITY IN HEALTHCARE

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NABH GUIDEBOOK FOR CLIMATE ACTION AND SUSTAINABILITY IN HEALTHCARE

National Accreditation Board for Hospitals and Healthcare Providers (NABH) has been developing quality healthcare standards . NABH standards have always focused on creating an ecosystem for quality and safety of the services delivered in the healthcare organizations.

As a step towards addressing the biggest challenge of 21st century i.e. climate change and sustainability, NABH has developed a simple checklist to guide NABH accredited and certified healthcare organizations to achieve climate change adaption, resilience and sustainability.

This cohesive document includes essential of concept of sustainability in healthcare, guidance for implementation and strategic framework. To motivate healthcare organizations, industry best practices are also showcased in the document.

This document along with a self-assessment checklist is available for free download in NABH website http://www.nabh.co/

Click here to read the guidebook with a self assessment checklist

Source: http://www.nabh.co/

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 – ADVANCING TECHNOLOGY & INNOVATION IN INDIAN MEDICAL DEVICES AND ALLIED SECTORS

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ADVANCING TECHNOLOGY & INNOVATION IN INDIAN MEDICAL DEVICES AND ALLIED SECTORS

The Indian medical devices market has been identified as a sunrise sector by the Government of India, with its valuation anticipated to reach USD 50 Billion by 2030 Ernst & Young India; 26 Nov., 2024.

Notwithstanding the enormous growth potential of Indian medical device sector, its global market share is still fairly low with most of the domestic manufacturing focused on consumable and disposables, i.e. the lower end of technology value chain.

Realizing this, Government has identified medical devices sector as a priority area for the flagship ‘Make in India’ program and is committed to strengthen the manufacturing ecosystem through its ambitious initiatives

Technology and Development Board (TDB) has also, over the years, supported development and commercialization of socially and technologically relevant medical devices. In order to strengthen country’s priority sectors, TDB is launching the current ‘Call for proposal’ to supplement existing policy initiatives to bridge the current medium to high technology gap in Indian medical devices industry..

Technology Development Board invites proposals from Indian industrial concerns operating in medical devices and allied sectors to apply for funding support for product development/ manufacturing/scale-up; technology adaptation for new product development; medical device supply chain components; chemical and raw materials for diagnostics and kits; and product commercialization

Objectives of the Call for Proposal

I. Identify and act in areas requiring strategic interventions and develop socially relevant technologies by increasing access and universality to affordable and quality medical and healthcare devices.

II. Encourage production of competitive consumer products thereby reducing import dependence by supporting manufacturing and commercialization of medium to high technology medical devices.

III. Invest in core technological strengths to enable Indian industry to stand-up to the competitive pressure and   accelerate country’s share of high-end, complex medical devices in global market.

Scope and focus areas

  • Diagnostics and Imaging devices: Including Radiology (both ionizing & non-ionizing radiation products); Nuclear Imaging Devices; Anesthetics & Cardio-Respiratory medical devices including catheters of cardio respiratory category; Renal Care medical devices; Artificial Intelligence based devices for detecting and monitoring lifestyle and other diseases.
  • Therapeutic and Prosthetics: Including cancer care/Radiotherapy devices; All Implants including prosthetic limbs/organs, implantable hearing aids/ear prosthesis; ophthalmic prosthetics (artificial eyeballs/cornea, eye socket replacements); voice prosthesis etc.
  • Regenerative therapy devices: Including cell therapies, immunomodulation therapies and tissue engineering (laboratory grown organs and tissues) related devices.
  • Medical equipment (others): All medical devices as classified under low risk (Class A) to high risk (Class D) categories in the Medical Devices Rules, 2017 and as detailed by Central Drugs Standard Control Organization on their website.

Eligibility Criteria:

  • Any Company incorporated under the Companies Act, 1956/the Companies Act, 2013.
  • A company intending to commercialize the technology.
  • The eligibility criteria and financial support shall be as per the TDB guidelines. Please refer to the website for more details: https://tdb.gov.in/project-funding-guidelinesfaqs 

Modes of Funding:

  • Loan @ 5% Simple Annual Interest

How to Apply:

All applications have to be submitted through online portal of TDB. The detailed information and the format for submission of the proposal may be downloaded from the official website: https://tdb.gov.in/

For queries and further details contact:

Dr. Richa Panwar
Sr. Project Coordinator
Technology Development Board
https:/tdb.gov.in/
Email: richa.panwar@tdb.gov.in

Starting date of call for Proposal: December 16, 2024

Last date to apply : 16th February 2025

Source: https://tdb.gov.in/

Industry Update – FICCI TANCARE 2025

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FICCI TANCARE 2025

15th Edition of FICCI TANCARE 2025 is scheduled on Saturday, 4th January 2025

Join healthcare leaders, innovators, and change-makers at FICCI TANCARE 2025 to explore cutting-edge developments and solutions in healthcare delivery.

Program Details are given below.

Theme: “Thinking for Tomorrow, Today: Embracing Changes in Healthcare”

Date: Saturday 4th January 2025

📍 Venue: Radisson Blu, Coimbatore

⏰ Time: 2 PM onwards

Program Objectives:

✅ Cutting-edge insights on healthcare innovations
✅ Networking with top industry leaders
✅ Panels by thought leaders
✅ Visionary discussions on healthcare excellence

Registration Link:
🔗 Register Now: https://lnkd.in/gju_9Yjr

Industry Associate Partners and Sponsors are welcome to connect to
sudharsan.ramu@ficci.com/ +91-9003052624

Click here for Detailed program agenda

List of Eminent Speakers to the program are given below

Industry Update – India’s Green Steel Taxonomy

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India’s Green Steel Taxonomy

On December 12, 2024, India marked a significant milestone in its journey toward decarbonizing the steel sector by unveiling the Taxonomy of Green Steel.

The Taxonomy of Green Steel is a pioneering effort by India, as it is the first nation to establish a formal definition of “green steel,” amid a global lack of consensus on the concept

Green Steel is defined based on its CO2 equivalent emission intensity, specifically for steel produced with emissions less than 2.2 tonnes of CO2 equivalent per tonne of finished steel (tfs). The greenness percentage is determined by how much lower a plant’s emissions are compared to this threshold.

Key features of the taxonomy include:

Rating System

  • Steel is rated based on its emission intensity:
  • Five-star green-rated steel: Emission intensity less than 1.6 t-CO2e/tfs.
  • Four-star green-rated steel: Emission intensity between 1.6 and 2.0 t-CO2e/tfs.
  • Three-star green-rated steel: Emission intensity between 2.0 and 2.2 t-CO2e/tfs.
  • Steel with emissions above 2.2 t-CO2e/tfs is not eligible for any green rating.

Review and Scope

  • The thresholds for star ratings will be reviewed every three years.
  • The emissions considered include Scope 1, Scope 2, and limited Scope 3, which encompasses various processes related to steel production but excludes upstream mining and downstream transportation emissions.

Certification Process

  • The National Institute of Secondary Steel Technology (NISST) is designated as the nodal agency responsible for measuring, reporting, and verifying emissions, as well as issuing greenness certificates and star ratings.
  • A registration fee of ₹10,000 will be charged per steel plant, with an additional certification fee of ₹1,000 for every 500 tonnes of finished steel certified.

Technical Explanation

  • The notification includes a technical appendix that explains how to calculate the greenness percentage based on actual emission intensity compared to the defined threshold.

This framework aims to promote sustainable practices in the steel industry by encouraging lower carbon emissions and providing a clear certification process for producers.

This initiative underscores India’s commitment to reducing emissions in its steel industry as part of its broader climate goals, aligning with the net-zero emission intensity target by 2070.

Click here to read the Notification

Source: https://pib.gov.in/PressReleasePage.aspx?PRID=2083839

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 – FSSAI Notification

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FSSAI classifies packaged drinking water as ‘High Risk Food Category’

FSSAI classifies packaged drinking water as ‘High Risk Food Category’. Food products that come under the ‘High Risk’ category are subjected to mandatory risk-based inspections

The Food Safety and Standards Authority of India (FSSAI) has decided to treat the packaged drinking and mineral water segment as a “High Risk Food Category” and subject to mandatory inspection and third-party audit norms.

From the recent FSSAI order, here are the specific points related to non-alcoholic soft beverages, packaged drinking water, and associated inspections:

1. Omission of BIS Certification:

Clauses related to mandatory BIS Certification for certain food products (including packaged drinking water) have been omitted. This indicates a regulatory shift, potentially delegating certification responsibility or modifying compliance requirements.

2. Inspection of Manufacturers:

The order outlines changes regarding the inspection process for manufacturers:
Specific details about the nature and scope of inspections may no longer reference previously mandatory BIS protocols.

Manufacturers might need to adhere to updated FSSAI guidelines for inspections and compliance.

3. Inspection Frequency:

Frequency of inspections for manufacturers of packaged drinking water and non-alcoholic beverages may have been updated:

It suggests a move towards a risk-based inspection framework, where high-risk categories could face more frequent inspections.

Lower-risk categories or compliant manufacturers might experience reduced inspection frequency to streamline oversight.

4. Other Relevant Amendments:

The general regulatory focus appears to be on reducing redundancy (e.g., removing duplicate certification processes like BIS) while strengthening direct oversight under FSSAI.

Packaged drinking water manufacturers must adhere strictly to the FSSAI’s revised standards for production and packaging.


In summary, the amendments simplify compliance by removing some previous certifications (like BIS), focusing on direct FSSAI oversight, and potentially altering inspection frequency to be risk-oriented.

This aligns with FSSAI’s goal of improving efficiency in regulating high-risk categories like packaged drinking water and non-alcoholic beverages.

FSSAI has recently removed the necessity for FBOs to obtain AGMARK, BIS/ISI Certifications for their Food Products and FSSAI Licensing norms will redefine the Certification, Inspection norms that are needed for FBOs.

Click here to read the Notification

Source : FSSAI Advisory dated Nov 29th 2024

Industry update – ISO launches ISO ESG Implementation Principles (IWA 48)

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ISO launches ISO ESG Implementation Principles (IWA 48)

The International Organization for Standardization (ISO) has launched the ISO ESG Implementation Principles, providing guidance to enhance the integration, performance, measurement, and reporting of environmental, social, and governance (ESG) practices.

The ISO ESG Implementation Principles (IWA 48) provide a high-level framework to help organizations integrate Environmental, Social, and Governance (ESG) practices into their operations. This guidance supports consistent, comparable, and reliable ESG management, measurement, and reporting aligned with existing global frameworks. By serving as a universal reference model, it promotes global interoperability and fosters a culture of sustainable business practices.

Key objectives of the principles include:

  • Supporting transparent and effective ESG management.
  • Improving measurement and reporting under existing frameworks for consistency, comparability, and reliability.
  • Aligning with global standards to ensure interoperability and clear communication of sustainability efforts.
  • Helping organizations integrate ESG requirements, establish KPIs, and assess their ESG maturity.

The principles were collaboratively developed with input from over 1,900 experts and national standards bodies such as the British Standards Institution (BSI) and Standards Council of Canada (SCC) and the Brazilian Association of Technical Standards (ABNT), The principles address all aspects of ESG, including climate action, social inclusion, and governance, offering a holistic approach. They also outline measurable KPIs to assess organizational maturity and align with frameworks such as IFRS/ISSB S1 and S2 and the EU’s ESRS standards. While not a standalone reporting framework, the document complements existing standards, enabling organizations to enhance their ESG performance and contribute to a resilient, responsible global business ecosystem

Click here to read the IWA 48 framework

Soruce: https://www.esgtoday.com/iso-launches-principles-for-esg-performance-and-reporting/
https://www.iso.org/standard/89240.html

Industry Update – Guidelines for Coaching Sector

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Guidelines for “Prevention of Misleading Advertisement in Coaching Sector” , 2024

The Central Consumer Protection Authority (CCPA) has introduced the Guidelines for Prevention of Misleading Advertisement in Coaching Sector, 2024, aimed at safeguarding students and the public from deceptive practices in the coaching industry.

These guidelines prohibit false claims about course offerings, success rates, or guarantees of results.

The guidelines will apply to every person engaged in coaching, meaning not just the coaching centers, but also any endorsers or public figures promoting their services through advertisements

Key provisions of the Guidelines include:

  • Transparency: Accurate representation of services, truthful use of student testimonials (only with post-success consent), and clear disclaimers in advertisements.
  • Accountability: Endorsers of coaching services must ensure the truthfulness of claims they promote.
  • Fair Practices: Ban on creating false urgency or unfair contracts and mandatory disclosures of fees, ranks, and course details in advertisements.
  • Grievance Redressal: Partnership with the National Consumer Helpline for student complaints.
  • Enforcement: Violations will be penalized under the Consumer Protection Act, 2019.

These guidelines are a crucial step in preventing the exploitation of students and ensuring that they are not misled by false promises or compelled into unfair contracts benefiting both consumers and the broader educational ecosystem.

These guidelines will be in addition to any existing regulations, enhancing the overall regulatory framework governing advertisements in the coaching sector

Click here to read the Guidelines

Source: https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2073013

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