Release of Guidance Documents

HELP is a knowledge sharing, networking, and capacity building platform that aims to transform the Indian health sector to green and climate smart health care, and promote environment and public health. It was established through a partnership between Public Health Foundation of India, Centre for Chronic Disease Control and Health Care Without Harm.

On 2nd August 2023, HELP launched the Guidance document on Healthcare Sustainability Committee.

Amidst unprecedented challenges like pandemics and the climate crisis, Health and Environment Leadership Platform( H.E.L.P)hosted by the Centre for Chronic Disease Control(CCDC)   acknowledges the pressing need to prioritize sustainability in healthcare delivery.

Embracing environmental stewardship and social responsibility, H.E.L.P. strongly advocates the establishment of a Healthcare Sustainability Committee.

This committee should focus on key areas such as Energy Efficiency, Waste Management, Water Conservation, Sustainable Food, Improved Transport Strategies, Sustainable Procurement, Pharmaceutical and Chemical Safety, Green Hospital Design, and Sustainable Construction.

By assembling a diverse team of administrators and operational staff, the committee aims to drive eco-friendly initiatives, ultimately enhancing the well-being of people, communities, and the environment we serve.                       

Follow link to access the document : https://greenhospitalsindia.com/healthcare-sustainability-guidance-documents/

Source:https://greenhospitalsindia.com/

Training Program – Announcement

Induction cum Training Program on 13th and 14thJuly 2023 – 2pm to 5 pm – Organised by Indian Pharmacopoea Commission

NCC-MvPI, IPC is organizing 10th Induction-cum-Training Programme from July 13-14, 2023 from 2:00 pm to 5:00 pm via digital/virtual platform to educate/aware Coordinators/Deputy Coordinators of hospitals/clinical establishments those who have submitted the enrolment form under MvPI.

After the completion of the training programme, NCC-MvPI, IPC will provide a time period of 3 months to the hospitals/clinical establishments for actively participating under MvPI.

Based on the active involvement of hospitals/clinical establishments in materiovigilance, NCC-MvPI, IPC will approve the hospitals/clinical establishments as MDMC in forthcoming MvPI partners meeting.

In this connection, all Hospitals / Clinical Establlishments are invited to this training programme in order to strengthen the materiovigilance programme in your organsation. Prior registration is a must.

CME On Pharmacology on 15th July 2023 – Announcement

CME on PHARMACOLOGY – TOPIC : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES on 15th July 2023

Government of Karnataka Shri Atal Bihari Vajpayee Medical College & Research Institute, Bengaluru formerly called Bowring & Lady Curzon Medical College & Research Institute, DEPARTMENT OF PHARMACOLOGY jointly organised with NCC-MvPI, IPC & RTC-MvPI NIMHANS, Bengaluru conducting CME on 15thtJuly 2023

Topic : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES

Mode : Hybrid

Time : 9 am to 4 pm

Fee : Rs. 200

Venue: Lecture Hall 3, SABVMCRI, Bengaluru

Contact : Dr. Nishitha S B @ 9591040864

Who can register: Medical, Dental, Nursing, AHS , Paramedical, Pharmacy, AYUSH, Physiotherapy – faculty/Students, Health Department Officials & Industry Professionals

Registration Link : REGISTRATION FORM (google.com)

For any queries please contact Dr. Nishitha SB: 9591040864 / Dr. Poorvi M: 7259349749
Email: amcsabvmcri@gmail.com

FSSAI Amendment – Information Update

Extension in Enforcement of Food Safety and Standards (Advertising and Claims) Second Amendment 2022

The Food Safety and Standards Authority of India (FSSAI) has announced an extension for the enforcement of the Food Safety and Standards (Advertising and Claims) Second Amendment Regulations, 2022.

The decision is made after considering the representations received from various stakeholders in the industry, requesting additional time to so as to exhaust the existing inventory of old packaging materials.

The FSSAI had initially provided a six-month extension for the enforcement of sub-regulation (7) of regulation 4, allowing businesses to transition smoothly to the new regulations. However, recognizing the ongoing challenges faced by the industry, fresh representations were received requesting a further extension.

After due consideration of the representations received from the industry and also to ensure sustainable practices for food business operations, the FSSAI has decided to extend the date of enforcement of sub-regulation (7) of regulation 4 of the Food Safety and Standards (Advertising and Claims) Second Amendment Regulations, 2022 by a further period of six months from 13thJune 2023.

The FSSAI emphasizes the importance of adhering to the food safety standards and encourages all stakeholders to make the necessary adjustments within the extended timeline.

The extension provides food businesses with an invaluable opportunity to align their practices with the updated advertising and claims regulations. It is expected that this additional time will not only help businesses exhaust their old packaging materials but also enable them to make any necessary adjustments to ensure full compliance with the new standards.

Source: https://www.fssai.gov.in/

Industry Information Update – ESG

ESGpedia registry ensures suppliers hold accredited ISO certifications, helping companies manage global supply chain sustainability

Asia’s leading environmental, social, and governance (‘ESG’) data and technology solutions company, STACS, announced that its platform ESGpedia can help corporates manage supply chain sustainability by ensuring that suppliers hold accredited ISO certifications. The latest progress involves collaboration with International Accreditation Forum’s (‘IAF’) global certificate database IAF CertSearch and Quality Trade.

Global leader in solar innovation and channels, Maxeon Solar Technologies (‘Maxeon’), is onboard as a corporate representative in the live use case, and is making further progress in its supplier sustainability monitoring using ESGpedia.

Maxeon first commenced utilising holistic data and digital solutions on STACS’s ESGpedia to monitor the sustainability performance of suppliers in Maxeon’s end-to-end supply chain last October 2022.

In the latest development, ESGpedia platform enables Maxeon to ensure that suppliers within its supply chain meet Maxeon’s corporate sustainability requirements of being ISO-compliant.

A company’s supply chain accounts for majority of its scope 3 emissions. With rising regulatory, consumer, and investor scrutiny, companies like Maxeon have implemented corporate sustainability measures to manage its supply chain sustainability and decarbonise – and this is where monitoring comes in place to ensure the success of these initiatives.

Lindsey Wiedmann, Chief Legal & Sustainability Officer at Maxeon, said: “As part of our company’s purpose of Powering Positive Change™, Maxeon screens suppliers carefully and requires them to be ISO-certified. The goal of our partnership with ESGpedia by STACS is to achieve a one-stop holistic view of all relevant ISO certificates of current suppliers in one portfolio on a single data registry.”

In the latest collaboration, ESGpedia connects directly with IAF CertSearch, powered by Quality Trade, to retrieve valid accredited ISO certificates. Validity of certificates is dependent on numerous factors such as expiry or any updates in the company’s sustainability commitment.

Established by the IAF, IAF CertSearch is a global database of 900,000+ verified and accredited ISO Certificates obtained from various accreditation and certification bodies. ESGpedia then harmonises the ISO certificates data into standardized company ESG profiles, and organises Maxeon’s current suppliers’ ESG profiles into a single portfolio for ease of verification and monitoring by Maxeon. Based on various factors, Maxeon is also able to gain full transparency of which suppliers across their entire supply chain hold valid accredited certifications and be alerted when there is a change to the status of any certification, helping Maxeon manage supply chain risk.  

Sharon Yuen, Chief Commercial Officer at STACS, said: “With ESGpedia, we support corporates’ net zero journey and help them manage their supply chain sustainability and scope 3 emissions, to stay ahead of regulations, future-proof, and strengthen their competitive edge. A digital solution is especially key for companies like Maxeon with more complex supply chains and regional suppliers. We are therefore delighted to be collaborating with International Accreditation Forum and Quality Trade, and furthering our partnership with corporates like Maxeon through ESGpedia, to help them ensure the overall green-ness of their supply chains.”

Emanuele Riva, Chair at International Accreditation Forum, said: “The IAF CertSearch database helps businesses, asset owners and regulators know exactly which organisations in their supply chains, portfolios and networks hold valid accredited certifications.”

Rajesh Maheshwari, IAF Database Management Committee Chair, said “There has never been a more important time to know your suppliers, customers, and investees meet international standards, particularly in the area of ESG. The database quells fears of greenwashing as it records and provides transparency of the validity of certifications.”

Nigel Johnston, Chief Executive Officer at Quality Trade, said: “Businesses, asset owners and regulators require swift and reliable exchange of information to operate in today’s digital environment. We look forward to working with STACS to ensure valid accredited certification information can be aggregated and easily accessed on ESGpedia, helping organisation such as Maxeon to achieve their sustainability goals.”

Earlier this year in May (23 May 2023), the latest ESGpedia platform version was launched at its one-year milestone since its deployment in May 2022, with greater data coverage, solutions and analytics, and the ESCAP Sustainable Business Network (‘ESBN’) Asia-Pacific Green Deal for Businesses digital assessment.

Available at no cost on ESGpedia, the digitalised and simplified self-assessment tool is designed to lower the barriers to entry for corporates and SMEs to kickstart their sustainability journey through a form of an easy and guided program towards sustainability, and to report metrics that are aligned with stakeholders’ needs for consistent, comparable, and shareable data.

This helps suppliers who have yet embarked on sustainability or any certifications to start easily with a simplified and guided program, to attain their ESBN Asia-Pacific Green Deal badge to showcase their sustainability commitment to corporates like Maxeon.

For further information, please contact:

STACS (www.stacs.io)
Grace Lim, Senior Marketing Manager
Email: grace.lim@stacs.io

Source: https://stacs.io/esgpedia-registry-ensures-suppliers-hold-accredited-iso-certifications-helping-companies-manage-global-supply-chain-sustainability/

Carbon Credit Trading Scheme, 2023

Carbon Credit Trading Scheme, 2023

The Ministry of Power notified the Carbon Credit Trading Scheme, 2023 whereby the governance of Indian Carbon Market and direct oversight of its functioning will be done by the National Steering Committee for Indian Carbon Market

1. The National Steering Committee shall recommend to Bureau the following functions:

  1. for the formulation and finalisation of procedures for institutionalizing the Indian carbon market;
  2. for the formulation and finalisation of the rules and regulations for the functions of Indian carbon market;
  3. for the formulation of specific greenhouse gases emission targets for the obligated entities;
  4. for the formulation and finalisation of guidelines regarding trading of carbon credit certificates outside India;
  5.  to issue carbon credit certificate;
  6. for the development of the process or conditions for crediting period or renewal or expiry of carbon credit certificate;
  7. to monitor the functions of Indian carbon market;
  8.  to constitute any Committee or Working group as required in connection with Indian carbon market; and
  9. any other functions assigned to it by the Central Government.

2. The Chairperson shall call the meeting at least once in a quarter of every year.

The bureau, in its role as administrator, will carry out the following tasks:

 (a) to identify sectors and potential for reduction of greenhouse gases emissions in such sectors and recommend to the Ministry of Power to include such sectors in Indian carbon market;

(b) to develop trajectory and targets for the entities under compliance mechanism;

(c) to issue the carbon credits certificate based on the recommendation of the National Steering Committee for Indian carbon market and subsequent approval of the Central Government;

(d) to develop market stability mechanism for carbon credits;

(e) to develop the procedure for accreditation and functions of accredited carbon verification agency;

(f) to accredit the agencies in accordance with the approved procedure for accredited carbon verification agency;

(g) to determine, the fees and charges payable by the registered entities with the approval of Central Government, for the purposes of meeting the cost and expense towards the implementation of this Scheme;

(h) to develop the process or conditions for crediting period or renewal or expiry of carbon credit certificates;

(i) to develop data submission formats, forms for effective functioning of Indian carbon market;

(j) to undertake capacity building activities for the stakeholders;

(k) to develop and maintain the information technology infrastructure including the user guidance platform required for Indian carbon market;

(l) to maintain secure database with all security protocols as approved by the Central Government;

(m) to constitute any Committee or working group as recommended by the National Steering Committee for Indian carbon market; and

(n) any other functions assigned to it by the Central Government.

The Central Electricity Regulatory Commission as a regulator to Indian Carbon Market shall perform the following functions:

(a) to regulate matters relating to trading of carbon credit certificates;

(b) to safeguard interest of both sellers and buyers;

(c) to regulate frequency of carbon credit certificates trading; and

(d) to provide market oversight and take necessary preventive and corrective actions to prevent fraud or mistrust

The Bureau shall constitute, one or more Technical Committees for different areas as required under compliance mechanism for the purposes of this Scheme

The Bureau with prior approval of the Central Government shall determine the procedure including eligibility criteria for accreditation of any agency to function as accredited carbon verification agency based on the recommendation of the National Steering Committee for Indian carbon market

The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau;

The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau

The National Steering Committee for Indian carbon market and other authorities shall develop the detailed procedure for operationalising the Indian carbon market, in accordance with this Scheme. The detailed procedure shall contain the following, namely: –

  • criteria for issuance of carbon credit certificates;
  • validity of carbon credit certificates;
  • floor and forbearance price of carbon credit certificates;
  • requirement, format and timeline for submissions;
  • monitoring, reporting and verification; and
  • any other related and incidental matters.

The Bureau may, from time to time, issue such directions and orders to the registered entities, with the approval of the Central Government, as considered appropriate for the implementation of this Scheme.

NABL Document Review Checklist

NABL Document Review Checklist as per ISO 15189:2022 Standard

National Accreditation Board for Testing and Calibration Laboratories (NABL) has released Document Review Checklist (NABL 220D) based on ISO 15189:2022 Standard

All NABL Lead assessor is required to review the information provided by the laboratory in line with NABL policies relevant to applicant medical testing laboratories and provide their remarks / comments on the overall completeness of the information on the application forms and the management system document in conformance with the requirements of ISO 15189: 2022 standard.

Lead assessor is required to submit the Document Review Report (DRR) directly to NABL within 10 days along with duly filled Form-74 ‘Declaration of Impartiality and Confidentiality’.

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

Notification given by FSSAI

FSSAI issued a Directions to all FSSAI Notified laboratories for Organic Testing

The Food Safety and Standards Authority of India has given a Direction to all FSSAI Notified Laboratories for Organic Testing under section 43(1) and 43(2) of FSS Act 2006.

All the FSSAI Notified laboratories are directed for the following:

a. To review their current capabilities and take the necessary steps to enhance the infrastructure and scope of the testing for organic products.

b. To make an application to APEDA for recognition of the laboratory for testing organic products.

c. To apply to National Referral Laboratory of APEDA for participation in proficiency testing as a pre-requisite to qualify for pre-export testing of organic products.

Source: https://www.fssai.gov.in/

BSI Launch Event: Antimicrobial Resistance (AMR) certification

BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)

According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled

BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.

  • Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing 
  • Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
  • Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust

Who should attend?

  • Pharmaceutical manufacturers
  • Regulators
  • Government policy makers
  • Trade associations
  • Contract manufacturers
  • Hospital / healthcare systems sustainability procurement

News Letter

Materiovigilance Program of India (MvPI) News Letter

Indian Pharmacopoeia Commission has released its News Letter – Materiovigilance Program of India Volume 5 – Issue 1 recently.

Sharing the same for information