Tamil Nadu Global Investors Meet 2024

Tamil Nadu, with its robust educational system and a strong focus on Science, Technology, Engineering, and Mathematics (STEM), is rapidly emerging as a leader in the Global Capability Centres (GCC) landscape. The state’s journey from skill arbitrage to leadership arbitrage in this domain is a testament to its growing prowess and the trust it has garnered globally.

GCCs, which have been a part of India’s business ecosystem for decades, are witnessing a significant surge in Tamil Nadu. Renowned companies like Cognizant Technology Solutions (CTS), Genpact, and Flipkart are notable examples of businesses that have thrived in this space. Moreover, the state is becoming a hub for startups in the GCC sector, further diversifying and strengthening its position.

As of 2015, India was expected to host over 2025 GCCs, highlighting the sector’s rapid growth. Tamil Nadu, in particular, has been pivotal in this expansion, offering a market potential that ranges from $35 billion to $60 billion. The state’s ability to create a large number of GCC leaders, estimated between 5,000 to 25,000, is also noteworthy. This growth is attributed to the shifting of markets from the West to India, leveraging the country’s strong STEM education.

One of the key strengths of Tamil Nadu in the GCC arena is the close gap between engineering and end-users. Product managers in the state work closely with customers, unlike in the past, where GCCs focused only on building certain parts. This proximity enables the development of trusted relationships and a deeper understanding of end-user needs.

Talent acquisition and retention are other areas where Tamil Nadu excels. The state’s educational institutions, startups, and industries collaborate closely, creating a robust ecosystem that supports the growth and development of GCCs. This synergy is critical in understanding and adapting to consumption patterns in the fast-growing digital economy.

Despite these strengths, GCCs in Tamil Nadu have faced challenges. Initially, driving business transformation and achieving cost efficiencies were significant hurdles. However, these have been largely overcome, and today the focus is on co-innovation, joint IPs, and skill development in collaboration with the government and academia. Cultural gaps and trust-building, once significant challenges, are now areas where best practices have been established.

Opportunities abound in Tamil Nadu, especially in engineering R&D. Cities like Chennai and Coimbatore are recognized for their skilled talent, particularly in Tier 2 cities like Coimbatore. The state offers a comprehensive product portfolio, facilitated by the proximity of engineers, product managers, architects, and customers.

Tamil Nadu is also home to various GCCs from major players in diverse sectors, each contributing uniquely to the ecosystem. For example, Optimum Health focuses on simplifying and scaling healthcare innovation, while Reynold Nissan GCC leverages core automotive technology for local and global markets. Standard Chartered Bank and UPS have also established significant GCC presences in Chennai, tapping into the diverse talent pool and collaborative ecosystem.

In summary, Tamil Nadu’s strengths in education, innovation, and a collaborative ecosystem make it an ideal location for GCCs. The state’s ability to adapt to changing global needs, coupled with its focus on co-innovation and talent development, positions it as a leader in the GCC landscape. With continued investment and growth, Tamil Nadu is set to play an increasingly vital role in the global GCC sector.

Click the link below to watch the TNGIM2024 Day 1 & Day 2 sessions: https://www.tngim2024.com/live-event-listing

Source: https://tngim2024.com/

Electronic Export Documents

The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.

Starting January 2, 2024, certificates like CFG, COE, and NCR will be electronically issued as downloadable PDFs via CECATS.

Recipients have 45 days to access and print the document.

Verification can be done through the FDA’s FECV system using a QR code, and certificates remain valid for 2 years.

Electronically issued documents include:

  • Certificate to Foreign Government (CFG);
  • Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
  • Non-Clinical Research Use Only Certificate (NCR);
  • Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
  • Export Permit Letter

Any queries regarding electronic export documents for medical devices, please email to Exportcert@cdrh.fda.gov.

Source: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry

Fostering R&D and innovation in pharma and medtech sector

The pharmaceuticals and MedTech sectors in India play a pivotal role in both economic growth and public health. These industries are vital for India’s self-reliance and for meeting global demands

In order to encourage R&D in pharmaceuticals and medical technologies, and create an ecosystem for innovation in this segment, the central government has recently launched two complementary initiatives, namely, the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector, and the scheme on Promotion of Research and Innovation in Pharmaceuticals and Medical Device (PRIP).

National Policy on R&D and Innovation in the Pharma Med-Tech Sector in India’ :

The objective of the scheme is to transform the Indian Pharma MedTech sector from cost-based to innovation-based growth. The policy serves as a blueprint to drive discovery and development of new drugs, vaccines, diagnostics and devices.

It encourages collaboration and aims to elevate India’s status as a global hub for cutting-edge healthcare solutions by creating a conducive ecosystem for innovation through stronger infrastructure, cross-sectoral research, enhanced public and private investments, and a streamlined regulatory framework.

Promotion of Research and Innovation in Pharmaceuticals and Medical Device (PRIP)

The PRIP scheme will provide Rs 5,000 crore over 5 years to support research and development in India’s Pharma-MedTech sector. It will create seven centres of excellence at NIPERs and fund projects in priority areas, helping established companies, expediting research projects, and aiding startups. The goal is to encourage innovation, collaboration, and growth in the sector.

The scheme has two components :

  • Component A: Focuses on improving research infrastructure by establishing seven centres of excellence (CoEs) at National Institutes of Pharmaceutical Education and Research (NIPERs). These CoEs will cover various areas such as drug discovery, medical devices, novel drug delivery systems, with an investment of Rs 700 crore.
  • Component B: Aims to fund projects in six priority areas with a budget of Rs 4,250 crore. This includes:

    • Support for established pharma companies collaborating with academic institutions.
    • Funding for 30 research projects at advanced stages (TRL 5 to TRL 9) to speed up their commercialization.
    • Support for about 125 projects to help startups and small to medium-sized enterprises in the early stages of product development (up to TRL 4).

The success of these initiatives hinges on collective efforts from government, industry, academia, and researchers, marking a decisive decade for India’s pharmaceutical and med-tech innovation.

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

MedTech Mitra

Union Minister, Health & Family Welfare, Dr. @mansukhmandviya inaugurates “MedTech Mitra,” a groundbreaking initiative by ICMR and CDSCO, supported by NITI Aayog.

This turning point marks a landmark for India’s healthcare landscape, enabling affordable healthcare solutions for all citizens.

ICMR & CDSCO in collaboration with NITI Aayog have launched #MedTechMitra, a game-changer for India’s healthcare. Fostering innovation & strategic support for medical device and diagnostic development. It will strengthen ecosystem, with affordable solutions for all.

MedTech Mitra streamlines MedTech R&D with preclinical & clinical support, collaboration initiatives, & funding opportunities. It is a primary step towards building a robust, self-reliant ecosystem for affordable & accessible healthcare in India.

Source:https://medtechmitra.icmr.org.in/

News Letter from IPC

News Letter from IPC on Materiovigilance Program is shared below for information.

Since Medical Devices are brought under Full Regulations in the country, one of the mandatory Regulatory Requirement is Market Surveillance by Regulator .

Read the news letter shared below for more information

World Standards Day 2023

Oct 14th is Celebrated World over as World Standards Day.🎊

CCC(Consultants Consortium of Chennai) and MSCC(Management Systems Consultants Consortium) are organising a webinar on Oct 14th 2023 from 4 pm–5 pm.🗓️

WSD Theme this year : Shared Vision for a better World – Incorporating SDG 3

SDG 3 is all about Good Health and Wellbeing 👩🏻‍⚕️

In alignment with Global Theme,we have scheduled a webinar on the following topic:

Healthcare Quality Assurance – Standards ✅

ISO has released a Healthcare QMS Std – ISO 7101, for the first time globally.🏥
Pharma Sector is witnessing Global MS Standards in Pharma Manufacturing as well💊
Medical Devices Sector is racing towards implementing MDQMS 🩺

Session on Healthcare Quality Assurance is designed to Educate Healthcare Sector – be it Services or Products , and various other stakeholders, about various Healthcare Quality Assurance Standards which are introduced globally to improve the Healthcare Quality Focus across the globe.

Healthcare Services can’t offer Assurance on its Quality when its Supply Chain, Value Chain Quality is not in alignment with its Quality Assurance Framework.

Time to LEARN, UNLEARN and RELEARN 🧑‍🎓

Prog Info :

Date : Oct 14, 2023
Time : 4 pm – 5 pm
Meeting Mode : Zoom Meeting
Fee – No Fee. Free for all 🆓

Registration Link :https://us02web.zoom.us/meeting/register/tZwsd-uhrD8rHdXTn3awk0eCxcSxAzqqSg20

Prior registration is a must. All registered delegates will receive direct mail from ZOOM, CCC Secretariat and also a SMS.

For Prog info, updates, visit – https://ccc-consultants.org/world-standards-day-2023/

For queries , pls mail :

CCC – contact@ccc-consultants.org
MSCC – info@msccglobal.com

INTERNAL AUDITOR TRAINING PROGRAM

IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System

COURSE OUTCOMES:

a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·  
d. Understanding how to meet regulatory requirements leading to increased patient safety

Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student

Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in

Program Details: https://www.ibsc-amtz.in/coursedetails/30

Last Date for Registration: 7th October 2023

For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in

Regulatory Awareness & Experiential Learning Workshop

Indian Council of Medical Research (ICMR)is conducting a Regulatory Awareness & Experiential Learning Workshop for Medical Device/Diagnostic Innovators/Start-ups in India jointly with Central Drugs Standard Control Organisation (CDSCO) on 12th Oct 2023 at ICMR Hqrs, New Delhi.

Date of the Workshop – 12th October 2023
Time – 10 am to 5 pm
Venue – Conference Hall, ICMR Hqrs, New Delhi
Mode of workshop – Hybrid mode

Last Date for Registration – 30th September 2023

Registration Link – https://docs.google.com/forms/d/e/1FAIpQLSeQZCq00-CnvqpG-tUZRHF43fc3gthxkGvVSl-3KP9FrmKyqw/viewform

HOSPEX Healthcare Expo 2023

The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.

2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi,  Kerala.

HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.

Expo cum Conference Theme this year is on :

Future of Healthcare – Device | Digital | Diagnostics

Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.

HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry. 

HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.

For more information about Expo, visit – https://hospex.in/

All Conference details are available at – https://hospex.in/hospex-2023-conference/

Contact :

T S Soumya, Hospex
+91 9080078447
Email – reach@hospex.in

The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.

SMART Hospitals Conference

Date : Sep 16, 2023

Time : 10 00 am to 6 00 pm

Fee : Rs 500 per delegate

SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.

Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.

Conference Outline :

  • SMART Medical Technologies help Practitioners to improve service standards
  • SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
  • Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
  • Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
  • Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
  • SMART Prescription for Prescribers – EHR Solution
  • SMART Technologies to enable Small Hospitals – Technology Session 
  • SMART HealthTech Ecosystem
  • Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
  • Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
  • Smart Healthy Aging Tech Solutions

Target Audience :

Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc

Venue: Zamra Convention Centre, Kochi, Kerala 

Date : September 15, 2023

Time : 2 30 pm – 5 30 pm

Fee – Rs 250 + GST 

Target Audience :

Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings 

Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .

Workshop shall cover following items that Hospitals Procure with special reference to:

– Biomedical Equipments

– Consumables and Disposables

– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose

Program Objective :

Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)

Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :

  • Understanding Medical Device Regulations- Laws of the Land
  • Medical Device Regulations – Role of Bureau of Indian Standards
  • Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
  • Claims of Voluntary Certifications – How Authentic these claims are ?
  • Materiovigilance Program of India – Regulatory Requirement
  • Post Market Surveillance of Medical Devices
  • Biomedical Engineers Skill Certification Program, Scheme Details, Benefits 

Contact Details :

For more information about Conference, visit – https://hospex.in/hospex-2023-conference/

For more information about Expo, visit – https://hospex.in/

For support in registration, reach out to :

Ms Soumya – 9080078447 

Email – reach@hospex.in

Industry information update – Medical devices

DoP releases strategy document to fine tune & implement National Medical Devices Policy

In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.

It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.

The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.

As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.

“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”

Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products

Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.

Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.

Source:https://pharmaceuticals.gov.in/policy/strategy-document-national-medical-devices-policy-2023

Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=160035&sid=1