Industry Information update

Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters

The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.

A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits

Holding the certificate can also help exporters in availing benefits with respect to customs and excise.

These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.

The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.

source: https://economictimes.indiatimes.com/news/economy/foreign-trade/commerce-ministry-authorises-epcmd-to-issue-registration-cum-membership-certificates-for-exporters/articleshow/101386747.cms

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.

New Drugs and Clinical Trial Rules (2023)

New Drugs and Clinical Trial Rules (2023) 

New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.

Need for new regulations:

  • Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
  • The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.

Key-highlights of the Amendment:

  • The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
  • These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies

Technologies suggested as alternatives:      

To avoid animal use for clinical trials, technologies can be used effectively which includes;

  • Technologies developed using human cells or stem cells: These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
  • ‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, to mimic blood flow inside the body.
    • These systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.
  • USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
    • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.

OPPI Excellence Innovation Awards

OPPI Excellence in Innovation Award for Healthcare Start-up of the year 2023 – APPLY NOW

The Organisation of Pharmaceutical Producers of India (OPPI) established in 1965, represents the research-based global pharmaceutical companies in India. lt has been an integral part of the healthcare journey of the country. We remain committed to supporting the nation’s healthcare objectives and collaborating with all stakeholders to find sustainable solutions to realize the collective vision of Health for All.

Last year, OPPI had introduced a new award as “OPPI Excellence in Innovation Award for Healthcare Start-up of the year” and had received an encouraging response from many start-up organisations.

OPPI wishes to continue applauding the efforts of entrepreneurs with its Excellence in Innovation Award for Healthcare Start-up. This award will recognise the innovative mind-set and digital, social focus to increase the healthcare outreach programs and amplify the access to healthcare products, services, and life-saving medicines.

 The awards will come with the following gratification:

  • A grant in aid of INR 1,00,000/-
  • Citation on media release, OPPI website & social media handles
  • Mentorship from and exposure to OPPI member companies

Nominations/submissions are invited from new and established start-ups.

For further details on the awards including criteria and registration, please click here:  http://innovationawards.indiaoppi.com/

Applicants are requested to follow instructions on the webpage. A Help Document is available to facilitate the process.

In case of any query on awards, please write to Asawari Sathaye, Director Communications and Patient Advocacy, OPPI on her email id  asawari.sathaye@indiaoppi.com

For any technical query related to awards portal / application form, please feel free to connect on the following email id Clara Rodricks clara.rodricks@indiaoppi.com / Mobile: +91 9619080644

The last date for receiving completed applications is 30th June 2023.

ESG metrics of IT services companies

ESG metrics of IT services companies turn crucial in winning deals

For IT services companies, ESG (environmental, social, and corporate governance) metrics are becoming a crucial component in winning deals as clients are considering sustainability a top priority and are keen to work with partners who are on the same page.

“Sustainability is becoming an important part of the client’s evaluation. There is a tremendous focus across the world on sustainability, and it is becoming one of the top five business priorities. Organisations cannot become sustainable in isolation unless they have a complete ecosystem, including their partners, who are also sustainable. It is also becoming increasingly relevant for endusers,” said D D Mishra, senior director analyst, Gartner.

In a recent Gartner survey, more than half the end-users indicated that sustainability is a “must-have criterion” in the selection of service providers. End-users are also willing to pay extra to providers who can prove their strong sustainability commitment

Source: https://www.business-standard.com/

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

EGA 2023 – Application Now Open

Envirocare Green Awards 2023

Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment. 

EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care. 

The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.

The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.  

The application for this award is online and is open for across the globe under the following categories:

1. Individual / s

2. Private Ltd / LLP / MSME

3. Public Sector / Large Corporates

4. Non Government Organisation NGO / Cooperatives

5. Government Organisation / Municipal

6. Academia

7. Others

To apply please click here for online Google Form:https://forms.gle/ZfWBjSR8PA6W5Bqe7

The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA

Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in

For regular updates on EGA 2023 , visit  https://lnkd.in/eDiKu3R

Best Practices in Social Sector

NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023”

NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023” in collaboration with the United Nations Development Programme.

To commemorate 75 years of India’s independence and highlight and laud the efforts of Union Ministries and State Governments, this compendium includes 75 case studies cutting across 14 key social sectors. The case studies have been sourced from all States/ Union Territories and 30 Ministries and Departments of the Government of India.

The seventy-five best practices highlight models which are innovative, sustainable, replicable and impactful. The aim of this exercise has been to synthesise lessons for the future to expand, enhance and improve life at the grassroots level. Due care was taken to ensure that the cases identified are spread over diverse themes, including education, health and nutrition, e-governance and digitization, agriculture, women’s empowerment, sports, and financial inclusion, among others.

Source: https://niti.gov.in/node/3568

Certification Schemes from AMTZ 

Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme 

Program on Healthcare Textiles Processing Facility Certification Scheme  

The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again.   

Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme    This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis.

This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider.  

These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).


Date: 27th May 2023

Time: 3:00 pm to 6:00pm IST

Mode – Virtual Mode / Webinar

Announcement – AMR Quest 2023

AMR Quest 2023-The Call for Applications is now open! Apply by 15th June 2023

The Centre for Cellular and Molecular Platforms(C-CAMP) is excited to announce C-CAMP AMR Quest 2023 and invites applications from innovators and start-ups working in the domain of Antimicrobial Resistance.
 
C-CAMP AMR Quest is one of its kind events to attract, identify, reward, and foster the innovators who are working towards the development of solutions to tackle AMR and present opportunities for funding and commercialization. The ideas can be from any domain of AMR like Non-traditional therapeutics, Preventatives, Diagnostics, and Direct Acting Small Molecules.  
 
The exciting rewards associated are (*conditions apply):

  1. Acceptance into the 3-month C-CAMP AMR Accelerator Program 2023. In this, an opportunity will be provided to develop the solution further with mentorship in the domains of science, business, regulatory, patent law, fundraising, etc
  2. Acceptance into one week C-CAMP AMR Innovators School 2023.
  3. Participation in any one of the following International Conferences/Programs, with all costs covered: 
    • The 8th AMR Conference Novel Antimicrobials & AMR Diagnostics cocci and Staphylococcal Infections. Congress Center Basel, Switzerland on 6-7 March 2024.
    • The 34th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2024, Barcelona, Catalonia, ES on 27 – 30 April 2024
  4. Mentorship for seeking funding opportunity through CARB-X funding round.
  5. Spotlight in C-CAMP’s social media platforms.
  6. Opportunity to attend appropriate C-CAMP workshops & events.

C-CAMP AMR Quest 2023 is open to Individuals (Including researchers, scientists, post-doctoral fellows, academicians, students, and individual innovators), startups, SMEs, and Large Companies.

Link to apply: https://forms.gle/z46DZi7bbxzpgSZJ9

Last date to apply: 15th June 2023

For further queries write to us at amr@ccamp.res.in

Source: https://www.ccamp.res.in/amr-quest?utm_source=sendinblue&utm_campaign=AMA-AMR%20Quest%202023_copy&utm_medium=email