Tag: Regulations

Industry Update – DPDP Rules 2025 – Draft

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Digital Personal Data Protection Rules, 2025- DRAFT

The Ministry of Electronics and Information Technology (MeitY) has released the draft ‘Digital Personal Data Protection Rules,2025’.

The draft rules along with a explanatory note of the rules in plain and simple language to facilitate ease of understanding are available on Ministry’s website at www.meity.gov.in/data-protection-framework.

The feedback/comments on the draft rules in a rule wise manner may be submitted by 18th February 2025 on MyGov portal at the link : https://innovateindia.mygov.in/dpdp-rules-2025/

Click here for DPDP Rules 2025 – Draft
Click here for Explanatory Note

Source: https://www.meity.gov.in/writereaddata/files/259889.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 – 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 – 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

Industry Update – Bioenablers: Biomanufacturing Hubs 

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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

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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 Updates – MCA Notification Amendment Order – MSME

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Specified Companies (Furnishing of information about payment to micro and small enterprise suppliers) Amendment Order, 2024 – MINISTRY OF CORPORATE AFFAIRS Notification

On July 15, 2024, the Ministry of Corporate Affairs issued an amendment to the Specified Companies (Furnishing of information about payment to micro and small enterprise suppliers) Order, 2019, namely Specified Companies (Furnishing of information about payment to micro and small enterprise suppliers) Amendment Order, 2024

Objectives

The amendment aims to improve transparency and accountability in corporate payments to micro and small enterprises, ensuring they receive timely payments essential for their operations and growth. This initiative helps protect the interests of smaller suppliers within the business landscape.

Summary of the Amendment

Title: Specified Companies (Furnishing of information about payment to micro and small enterprise suppliers) Amendment Order, 2024.

Effective Date: The amendment takes effect immediately upon publication in the Official Gazette.

Reporting Criteria: Only specified companies with payments pending to micro or small enterprises for more than 45 days from the acceptance date of goods or services must report this information using MSME Form-1.

Form Update: The existing MSME Form-1 has been replaced with a new form to better capture details about overdue payments.

Click here to read the Notification

Source: https://www.mca.gov.in/bin/ebook/dms/getdocument?doc=NDU5OTY2Mjky&docCategory=Notifications&type=open

Industry Update – MeDevIS (Medical Devices Information System) introduced by WHO

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MeDevIS platform announced to boost access to Medical Technologies and Devices

World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System), the first global open access clearing house for information on medical devices. It is designed to support governments, regulators and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing and treatment of diseases and health conditions.

Here are the key insights from the news release about the MeDevIS platform from WHO :

Purpose and Scope: MeDevIS (Medical Devices Information System) is an online platform launched by WHO to provide global open access to information on medical devices. It aims to assist governments, regulators, and users in decision-making regarding the selection, procurement, and use of medical devices across various health conditions.

Coverage: The platform includes information on 2,301 types of medical devices used for a wide range of health issues, including reproductive health, noncommunicable diseases (e.g., cancer, cardiovascular diseases), infectious diseases (e.g., COVID-19), and more.

Complexity and Challenges: The increasing number and complexity of medical technologies make it challenging for healthcare practitioners and patients to navigate. MeDevIS aims to simplify access to reliable international information on medical devices, especially beneficial in resource-limited settings.

Functions and Features: Users can access detailed information about medical devices, including their types, suitable healthcare settings (e.g., community or specialized hospitals), scope of use, required infrastructure, and more. This replaces the need for separate searches across multiple publications with inconsistent naming conventions.

Nomenclature: MeDevIS incorporates two international naming systems for medical devices – the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN). These systems facilitate registration, procurement, regulatory approval, inventory management, and pricing of medical devices globally.

Impact and Benefits: The platform is expected to aid national policy-makers in developing procurement lists and contribute to universal health coverage goals. It can also support health insurance and reimbursement policies, benefiting patients globally.

Future Developments: WHO plans to continually improve MeDevIS by engaging stakeholders and expanding its coverage with additional medical technologies, including those needed in pandemic and emergency settings.

Overall, MeDevIS represents a significant initiative by WHO to enhance access to crucial medical technologies and devices worldwide, streamlining information dissemination and improving healthcare delivery.

Source:https://www.who.int/news/item/08-07-2024-medevis-platform-announced-to-boost-access-to-medical-technologies-and-devices

Industry Update – Amendments to Tamil Nadu Shops and Establishments Rules, 1948

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AMENDMENTS TO THE TAMIL NADU SHOPS AND ESTABLISHMENTS RULES, 1948

Labour Welfare and Skill Development Department of Tamil Nadu has issued the Amendments to The Tamil Nadu Shops and Establishments Rules 1948 on July 2, 2024

Latest Amendments :

(1) after rule 2, the following rule shall be inserted, namely:-

“2A. Application for registration of establishment.-

(1) Every application for registration of an establishment shall be made in Form-Y to the Inspector of the area in which the establishment is located.
(2) Every application under sub-rule (1), shall be made online together with a fee of Rs.100/- (Rupees one hundred only) through the designated web portal of the Labour Department.

2B. Issue of registration certificate for establishment.-

(1) The Inspector shall issue registration certificate online in Form-Z within twenty four hours from
the time of making of the application under rule 2A.
(2) A Register of establishments shall be maintained by the Inspector in Form-ZA.

2C. Intimation of existing establishments.–

The employer of every establishment in existence on the date of commencement of the Tamil Nadu Shops and Establishments (Amendment) Act, 2018 shall furnish online, through the designated web portal of the Labour Department, details of the establishment in Form ZB to the Inspector of the area in which the establishment is located.

2D. Amendment of Registration Certificate.-

(1) The application for amendment of a registration certificate shall be made online, through the designated web portal of the Labour Department.
(2) The Inspector shall issue a fresh registration certificate online in Form-Z within twenty four hours from the
time of making of the application under sub-rule (1).

Other Amendments:

(2) after rule 6, the following rule shall be inserted, namely:-

6A – Amendment on First Aid Facilities
(1) In every establishment, First-aid box shall be provided at the rate of not less than one box for every one hundred and fifty persons or part thereof ordinarily employed and shall be maintained so as to be readily accessible during all working hours.
(2) The first-aid box shall be distinctively marked with a red cross on a white background and shall contain basic first aid related materials for treating small injuries.
(3) Adequate arrangements shall be made for immediate recoupment of the equipment when necessary”;

(3) in rule 18 (Penalty for non compliance of Rules), for the expression “which may extend to fifty rupees”, the expression “which may extend to two thousand rupees” shall be substituted;

(4) The following Forms shall be added, in addition to Form X
– Form Y ( Application for Registration)
– Form Z (Registration Certificate)
– Form ZA (Register of Shops & Establishments)
– Form ZB (Intimation by existing Establishments)

click here to read the Notification

Source: https://www.tn.gov.in/go_view/dept/18

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