Category: Manufacturing Sector

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 Update – World Health Innovation Forum 2024

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World Health Innovation Forum 2024 @ Vizag

Kalam Institute of Health Technology (KIHT), Vizag is organising the 2nd edition of World Health Innovation Forum 2024 at Vizag from December 12th to 14th 2024.

Key Highlights of the Program

a. To Explore Innovation in Healthcare.
b. To Create Public Private Partnerships Platform.
c. To Support Policy-Making in Healthcare
d. To Impact Global Health.

To explore the transformative learning, unparalleled networking opportunities and collaborative initiatives please click the link https://www.whif.kiht.in/registration/ and register for the program.

For additional details on the program, please contact:
Email : whif@kiht.in
Phone: +91 8341622261

Click here for Program Agenda

Source: https://www.whif.kiht.in/

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 – 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

Industry update

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Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) as Certification Body for ICMED 9000 and ICMED 13485

Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) is awarded provisional approval from the Quality Council of India (QCI) to function as a certification body for the ICMED 9000 (ISO 9001 requirements plus additional requirements specified under the scheme) and ICMED 13485 (ISO 13485 requirements plus additional requirements specified under the scheme) certification schemes.

This accreditation will enable IPC-MvPI to assess the quality management systems of medical device industries, ultimately enhancing the quality of medical devices and ensuring consumer protection

To know more, please visit https://ipc.gov.in/news-highlights/1296-indian-pharmacopoeia-commission-%E2%80%93-materiovigilance-programme-of-india-ipc-mvpi-as-certification-body-for-icmed-9000-and-icmed-13485.html

Source: https://www.ipc.gov.in/icmed-certification.html

DRAFT AMENDMENTS TO THE CCI REGULATIONS, 2009

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DRAFT AMENDMENTS TO THE COMPETITION COMMISSION OF INDIA (GENERAL) REGULATIONS, 2009

CCI (Competition Commission of India) is amending its Regulations and the notification was released on June 6th 2024. Public Consultation is open and comments are invited from the public.

Consultation on draft ‘The Competition Commission of India (General) Regulations, 2009’ Back ground Note for the proposed amendment and proposed draft amendments are posted in the CCI’s portal. Sharing the links below for the same.


Background Note – https://cci.gov.in/images/stakeholderstopicsconsultations/en/background-note1717612208.pdf

Draft amendments – https://cci.gov.in/images/stakeholderstopicsconsultations/en/draft-amendments-to-the-cci-general-regulations-20091717612278.pdf

The stakeholders can submit written comments on the draft amendments to the Competition Commission of India (General) Regulations, 2009, within 30 (thirty) days from 06.06.2024 to 08.07.2024.

The stakeholders can submit their comments at the link shared below: https://cci.gov.in/stakeholders-consultations/30

source : https://cci.gov.in/stakeholders-topics-consultations

CDSCO mandates online safety reporting

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CDSCO mandates online safety reporting for Medical Devices

Following pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) has mandated that manufacturers of medical devices and in-vitro devices submit their safety reports online.

The Drugs Controller General of India, has issued the directive on 19th March 2024 for online submission of Period Safety Update Reports for Medical Devices and in-vitro devices, aimed at improving post-market surveillance data evaluation

Effective 1 April 2024, the option to submit applications offline in hard copy or any other method will no longer be available

A PSUR is a vital pharmacovigilance document that assesses the risk-benefit balance of a drug product after its authorization, providing a comprehensive analysis based on all available information, including new data.
This report determines whether additional studies are necessary or if modifications are needed

This is part of efforts to overhaul India’s drug regulation framework and enhance safety transparency.

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Latest-Circulars/
https://www.livemint.com/

Launch of Indian Foundation for Quality Management

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Launch of Indian Foundation for Quality Management

A consortium of seven leading Indian companies have launched the Indian Foundation for Quality Management (IFQM), a Section 8 not-for-profit Company. IFQM is a unique institute dedicated to fostering a culture of quality and innovation within Indian businesses.

The initiative spearheaded by India Inc. viz. Tata Sons, TVS Motor Company, Sun Pharma, Motherson Group, Bharat Forge, Boeing India, and Biocon aims to propel the “Make in India” brand on the global stage.

IFQM will endeavour to equip business leaders with the latest knowledge and tools in quality management, connecting them to renowned global experts for personalized guidance, and facilitating knowledge sharing and collaboration among industry leaders. IFQM will provide support to organisations with specialized quality counsellors  and bridge the gap between industry and academia to ensure access to cutting-edge research and insights.

IFQM’s governing council members besides Venu Srinivasan, N Chandrasekaran, and Dilip Shanghvi will include Kiran Mazumdar Shaw, Baba Kalyani. T.V. Narendran, Vivek Chaand Sehgal, Salil Gupte and K.N. Radhakrishnan.

These founding members will be actively involved in IFQM’s governance ensuring its programs are tailored to the specific needs of Indian businesses. IFQM is designed to provide senior leadership in India with targeted counselling, training, coaching, and expert guidance.

The one-of-its-kind industry-led initiative will help improve the product and service quality and reliability of Indian businesses equipping them to compete more effectively on the global stage and build supply chain resilience. The aim is to reinforce the “Made in India” brand in international markets, thereby stimulating trade expansion.

Enhanced competitiveness will lead to economic growth and overall prosperity for the people of India.

Source: https://www.autocarpro.in/news/import-dependency-for-natural-gas-consumption-expected-at-around-45-by-fy26-careedge-ratings-119688

“SANJEEVANI”- HEALTHCARE AND WELLNESS EXPO

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“SANJEEVANI”- HEALTHCARE AND WELLNESS EXPO – Organised by Services Export Promotion Council (SEPC)

SEPC with the support of the Ministry of Commerce has been taking the steps to expand the horizon of healthcare services to attract medical value tourists from across the world, the global landscape of MVT being so dynamic in nature has thrown up new challenges. The competitive environment has completely taken a new dimension. Many countries have emerged as strong competitors to India in terms of cost advantage and India needs to reorient its positioning in the global market. Having the largest pool of doctors in the world, world class hospitals, post treatment care centres, wellness centres for post and preventive healthcare measures and all related infrastructure, India is well poised to aptly position itself as a destination for “Responsible and Credible Healthcare.”

In order to give impetus to this new initiative of repositioning, Services Export Promotion Council, with the support of Ministry of Commerce and Industry, Government of India, is organizing SANJEEVANI (India Heals) – An International Event on Medical Tourism from 28th March 2024 to 30th March 2024 at Chennai Trade Centre, Nandambakkam, Tamil Nadu.   Two editions of India Heals were organized to showcase the competence, affordability and advantage India offered in the healthcare services sector.  The renaming of India Heals as SANJEEVANI, the life infusing herb, adds a significant dimension of trust and care for life in our repositioning of India as a destination for healthcare.

The upcoming “Sanjeevani 2024” aims to establish a platform fostering enduring partnerships among countries, particularly in the identified champion and focus Healthcare Service Sector. The exhibition anticipates the participation of over 100 Indian companies from the Medical Tourism and healthcare service sector, with over 5000 domestic visitors expected to attend. The event will showcase diverse segments including:

  • Hospitals/Medical centre
  • MVT Facilitators
  • Health Tech Companies
  • Medical Devices
  • Wellness & Ayurvedic centre
  • Medical Insurance Companies
  • Hair Transplant Clinics and Cosmetic Surgeries Hospitals
  • Medical Insurance Companies

Program Details:

Date : 28th March 2024 to 30th March 2024
Locatin : Chennai Trade Centre, Nandambakkam, Tamil Nadu.  

“Sanjeevani” is designed to foster business opportunities through focused B2B Sessions, distinguishing itself with innovative formats and value additions. With the invaluable support from Indian Missions abroad, the event anticipates the participation of over 150 Foreign Delegates worldwide.

For more information you can visit: https://www.servicesepc.org/sanjeevani/

To reserve space under the “Sanjeevani 2024”, please register here

Register here

To read sponsorship brochure and program brochure, click here:

Sponsorship Brochure
Program Brochure

For more query regarding stall sell you can reach the following :

Mr. Mayank Sharma, E-mail Id– mayank.Sharma@servicesepc.org / Mobile – 8349417890

Mr. Desh Raj, E-mail:Id – desh.raj@servicesepc.org  / Mobile – 8010215260

Mr. Dalip Chopra, E-mail Id – dalipchopra65@gmail.com / Mobile – 9873548997

Mr. Mohit Arora, E-mail Id – mohit.arora@servicesepc.org  / Mobile – 7827517525

Source : https://www.servicesepc.org/

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