Category: Regulations

Industry Update – Second National Essential Diagnostics List – Draft

Posted on by Leave a comment

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

Posted on by Leave a comment

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

Posted on by Leave a comment

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 – India’s Green Steel Taxonomy

Posted on by Leave a comment

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 – FSSAI Notification

Posted on by Leave a comment

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)

Posted on by Leave a comment

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

Posted on by Leave a comment

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

Industry Update – New Government guidelines to prevent greenwashing

Posted on by Leave a comment

New Government Guidelines to prevent Greenwashing

The Government has recently introduced comprehensive guidelines to combat greenwashing, a practice where brands make misleading claims about their environmental benefits. These guidelines, issued by the Central Consumer Protection Authority (CCPA) on October 15, 2024, aim to ensure that environmental claims made by companies are substantiated with credible evidence.

Key Highlights of the Guidelines

  • Substantiation of Claims: Companies must provide scientific evidence to support any environmental claims, particularly those using terms like “clean,” “green,” “eco-friendly,” and “sustainable.
  • Consumer-Friendly Language: The guidelines mandate that companies explain technical terms such as “greenhouse gas emissions” in a way that is easily understandable to consumers. This aims to enhance transparency and prevent confusion
  • Specific Claims: More precise claims, such as “compostable” or “recyclable,” must be supported by credible certifications or reliable scientific evidence. This requirement extends to all manufacturers, service providers, and advertisers involved in promoting these products
  • Disclosure Requirements: Brands must disclose all material information related to their environmental claims in advertisements. This can include using QR codes or URLs for additional information

Rationale Behind the Guidelines

The introduction of these guidelines is part of a broader effort to protect consumer interests and promote sustainable business practices. The government aims to foster a marketplace where environmental claims are both truthful and meaningful, thereby enhancing consumer trust

Prohibition of Misleading Practices: The guidelines explicitly prohibit any deceptive practices that exaggerate or conceal relevant information regarding a product’s environmental impact. Companies found violating these guidelines may face penalties for misleading advertisements and unfair trade practices

The guidelines align with international best practices observed in markets like the US and Europe, reflecting a global trend towards greater accountability in corporate sustainability efforts

Central Consumer Protection Authority (CCPA) seeks to work closely with industry stakeholders, consumer organizations, and regulatory bodies to ensure effective implementation and compliance with the guidelines in the interest of consumers and public.

Click here to read Green Washing Guidelines

source: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/Draft%20Guidline%20with%20approval.pdf

Industry Update – Bioenablers: Biomanufacturing Hubs 

Posted on by Leave a comment

Invitation Proposal for Setting up of Bioenablers: Biomanufacturing Hubs – BIRAC

Department of Biotechnology, Govt of India and  Biotechnology Industry Research Assistance Council (BIRAC) , jointly invite proposals for seeking support to establish Bio-Enabler: Biomanufacturing Hubs

About the Proposal

Enabling Access to Infrastructure and Resources [Bio-foundries] for Bio-manufacturing

Recognizing the potential of Biomanufacturing to power green growth, the Department of Biotechnology (DBT), Govt. of India has undertaken an initiative on Fostering High Performance Biomanufacturing.Against this backdrop, Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the aegis of DBT, invites proposals from Industries/ Academic Institutes/ Incubators etc. to set up biomanufacturing hubs.

The proposals are envisaged in the Public Private Partnership (PPP) mode with financial co-sharing to co-develop integrated infrastructure (bio-foundries) including automation,workflows, processes, scale up facilities and related resources for access by start-ups andresearch communities engaged in biomanufacturing.

Key Features of the Call

Proposed facilities will support process innovation for rapid design and testing of organisms and scale-up engineering to accelerate biomanufacturing processes in the sectoral areas including but not limited to: functional foods and smart proteins, bio-based chemicals and enzymes, precision bio therapeutics, climate change and resilient agriculture, carbon capture and utilization, futuristic marine and space research.

Who can Apply?

The proposals can be submitted by Companies established under the Companies Act 2013/ The Limited Liability Partnership (LLP) incorporated under the Limited Liability Partnership Act,2008/ Academic Research Institutes, Universities, Research Foundation, Medical Colleges and Institutes – both public and private who are valid legal entities such as Trust, Society or established under central or state statute, Recognised Incubators. Applications from academia proposing facilities to be located in institutes premises should mandatorily have an industry collaborator who should operationalize and run the facility.

How to apply?

Proposals for the Scheme is required to be submitted online only. To submit a proposal online, please log on to the BIRAC website (www.birac.nic.in).

 No Hard Copy to be submitted. Proposals submitted online only would be considered.

Last date for Submission of Proposals : 04th November 2024( 5:30 p.m.)

Details of the scheme including eligibility requirements, categories for proposal submission; guidelines for support as grant and loan; agreement templates etc. are available at www.birac.nic.in

𝗟𝗮𝘀𝘁 𝗱𝗮𝘁𝗲 𝗳𝗼𝗿 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻:

The last date for submission of proposals under Bioenablers: Biomanufacturing Hubs is extended till 4th November 2024 (till 5.30 PM). Those who have already submitted the proposal need to revise as per the specific guidelines and revised proposal format

Click here to read Specific Guidelines
Click here to read Implementation Plan

Source: https://www.birac.nic.in/desc_new.php?id=1144

Industry Update – Establishment of the Global Accreditation Cooperation

Posted on by Leave a comment

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

Share