Medical Plastics Data Service Magazine November - December 2020 by Medical Plastics Data Service

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Vol. 28

No. 6

Nov. - Dec. 2020

21 Cover Story

Held In Conjunction With :

Story 21 Cover Galaxy Of Speakers & Panel Experts : Between the eight webinars, about 50 Industry leaders and Experts from India and abroad from various cross section of Medical Devices and allied industries shared their knowledge, experience and vision with more than 800 industry delegates.

23 Webinar Themes and Abstracts of Presentations Story Story 27 Cover 25 Cover IMDI 2020 WEBINAR 07, Dec 17, 2020 : Highlights IMDI 2020 WEBINAR 08, Dec 18, 2020 : Highlights Theme : Medical Device Industry – Standards, Certifications Ans Regulations

Theme : Making Innovation & Indigenization Stick : an IVD Industry Summit

Highlights based on presentations given by Industry Experts & Complied by

Mrs Rama Venugopal

Dr Usha Jain Consultant : Laboratory Medicine, Medical Genetics & Genomic Science, Research Design & Analysis, Scientific Writer

President, Consultants Consortium Of Chennai November-December 2020 D A T A

Highlights based on presentations given by Industry Experts & Complied by

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Vol. 28

No. 6

Nov. - Dec. 2020

Presentations : 30 Select India : Top 5 Global Manufacturing Hub :

Medical Polymeric Materials and Components : Innovations & Developments

Challenges To Overcome

Mr Rajiv Nath

Mr. Kishore Khanna

Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) & Managing Director, Hindustan Syringes and Medical Devices Ltd.

Medical Device Industry India : A Potential Global Manufacturing Hub

Managing Director, Romsons Group of Companies, Agra and Joint Coordinator, Association of Indian Medical Device Industry (AiMed)

Indian MedTech Industry Ecosystem : Facilitating Growth

Dr. Atul Sardana

Mr. Jitesh Shah

Director, Alfa Corpuscles Pvt. Ltd.

Managing Director Suru International Pvt. Ltd.

38 AiMeD & Regulatory Updates • DoP Issues Revised Guidelines For Procurement Of Make In India Medical Devices • Medical Devices Industry Seeks Clarity On PLI Scheme • Centre To Amend MDR-2017 To Include Provision To Allow Import Of Medical Devices Having Lesser Shelf-life • Health Ministry To Remove Requirement Of Audit For Class-A Medical Devices Manufacturing Site By Notified Bodies • Centre To Amend MDR 2017 to Include ASTM In Product Standards To Enhance Competitiveness Of Indigenous Medical Devices

39 Industry News

• Narayana Health And MSMF Team Up With BIRAC To Set Up Advanced Med Tech Innovation Centre • Poly Medicure to Enhance R&D Capabilities To Deliver High Quality Medical Devices • Haryana Set To Become Hub Of Medical Devices As Around 100 Industrial Units Set Up Plants In The State

19 Did You Know ? About Impact Of COVID-19 on “Medical Swabs” : Applications and Markets

www. .com THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTICS/DEVICES TECHNOLOGY AND TRADE 18

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May 2016 to October 2016 • Cover Story : Supplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance (May – June 2016) • Cover Story : Medtech Companies Need Collaboration With External Partners For Innovation And Growth (May – June 2016) • Technology : Innovative Computer-Aided Catheter Reprocessing System (CRS) for Cleaning Catheters Developed By Chandigarh Biomedical Engineer (May – June 2016) • Technology : India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector (May – June 2016) • Global Trends : Medical Adhesives : Fastest growing Segment (May – June 2016) • Did You Know : About Best Practices to Ensure Good Supplier Management (May – June 2016) • Cover Story : Medical Plastics – New Materials & Technologies Help Medical Device Industry (July – August 2016) • Manufacturing : Supply Chain Management–Boon Or Bane For The Medical Device Industry (July – August 2016) • Global Trends : Medical Device Companies Fear Parallel Regulation After Brexit Vote (July – August 2016) • Global Trends : Plastics Remain Material Of Choice In Parenteral Packaging Market (July – August 2016) • Did You Know : About Implants As The Fastest Growing Application For Medical Plastics (July – August 2016) • Technology : INDIA ’S First Medical Technology Zone – AMTZ (September - October 2016)

About Impact Of COVID-19 on “Medical Swabs” : Applications and Markets The sterile swab plays a vital role in the sub-sectors of healthcare industry, such as medical, forensic, sample transport, and environmental testing. In medical sector, sterile swabs are used in various applications, such as applying medicine, collecting the sample, and cleaning a surface where it is hard with bare hands. Moreover, medical sterile swabs are also used for diagnosing, DNA testing, gynecological screening, wound care, and surgeries. The growing incidence of chronic diseases is expected to increase the demand for sterile medical swabs for the collection of samples. A rise in research applications has increased the demand for sterile swab, as swabbing helps collecting unseen microorganisms and facilitates transferring bacterial samples for inoculating bacterial colonies. Thus, the outbreak of pandemic has resulted in increased clinical and diagnostics research applications to understand the physiology of the COVID-19. The introduction of point-of-care (POC) and rapid diagnostic testing (RDT) technologies have increased the demand for sterile medical swabs. Polyester Tipped Swabs Polyester is a synthetic spun fiber made from a polymer. Originally introduced into the realm of medical diagnostics by DuPont under the brand name Dacron®, it is now manufactured by others and no longer carries a brand name. Polyester fiber has been tested and validated for use in specimen collection in microbiology, rapid test diagnostics and PCR analysis. Polyester tipped swabs boast excellent collection and release properties. Foam Tipped Swabs Medical grade polyurethane foam has been found to be an excellent tip material for diagnostics. Foam is produced in a range of porosities in sheet form. Common configuration for use in tipped applicators is 100 ppi (pores per inch). For chemical resistance, polyethylene foam is chosen. (Ref : https://www.theinsightpartners.com/reports/medical-sterile-swabsmarket )

• M a n u f a c t u r i n g : H o w To M e e t Biocompatibility Needs Of Polymeric Medical Components (September - October 2016) • Quality : Quality Management System: Changing Scenario & Challenges In Medical Device Regulations (September - October 2016)

For good ideas and true innovation, you need human interaction, conflict, argument, debate.

• Global Trends : How Plasma Can Aid Catheter Manufacturing (September - October 2016) • Did You Know : About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices (September - October 2016)

Margaret Heffernan

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D.L.PANDYA, B.E.(Chem), M.I.E.

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EDITORIAL ADVISORY BOARD Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon

PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. Jodhpur Char Rasta BRTS Bus Stop, Satellite Road, Ahmedabad-380 015, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: info@medicalplasticsindia.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 • Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

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16th IMDI CONFERENCES ( IMDI 2020 WEBINARS 01-08) IMDI conferences are being organized alongwith Technology Show Exhibitions since 2001. These conferences and technology show webinars are organized with focus on Indian Medical Devices and Plastics Manufacturing sectors thereby promoting “Make-in-India” and now “Atma-Nirbhar” India mission with support and co-operation of leading industry Associations in Medical Devices, Plastics, Pharma as well as Healthcare Services Sectors as well as Government, Regulatory, Research and Academic Organizations. Medical device industry is multidisciplinary. And hence it is important to have collaboration across disciplines and sectors. Through this event, our Mission is to create a platform for Indian Medical Device Industry not only for Knowledge Sharing & Brain storming but also to interact with the stake holders - Materials / Machinery / Technology / Product / Service providers academic & research organizations with an objective to facilitate an environment of healthy growth. Without all the stakeholders as our backbone, this activity would not have continued for consecutive 16 years. We are sincerely grateful to all . In view of current pandemic situation, the event was organized by way of a series of eight webinars divided in two phases - September 2020 and December 2020 and were held in conjunction with virtual trade shows “Medical & Healthcare Expo” organized by Redeecal Communications. The first phase, in September 2020 was supported by leading Industry Associations along with Ministry of Health, Republic of Kenya, Medical Association of Kenya, Critical Care Society of Kenya, as well as Association of Kenya Medical Laboratory Scientific Officers. Objective was to create a platform for co-operation between Medical Device Industry and Healthcare Service organizations from India and various countries in Africa for growth on both the sides, to help companies from India and Africa to face challenges post pandemic and the new normal situations in the coming future For the second phase, in December 2020 , focus was on how India has a potential to become Global Manufacturing Hub for the Medical Device Manufacturing Industry , also to highlight evolving ecosystem with highly integrated and interactive stake holders. I would like to extend our deepest appreciation for two industry associations for their initiatives and support to this event by way of conceptualizing and managing two sessions in this five day event. The consultants consortium of Chennai for session on “Medical Device Industry : Standards, Certifications and Regulations” and Association of Diagnostics Manufacturers of India for the session on, “Making Innovations & Indigenization Stick : An IVD Industry Summit”. We are grateful to both associations and would welcome more industry associations to join us in future. We are happy to mention that , between the eight webinars, about 50 Industry leaders and Experts from India and abroad from various cross section of Medical Devices and allied industries shared their knowledge , experience and vision with more than 800 industry delegates. This issue of magazine highlights a detailed report on the event along with our regular features like Industry & “AiMeD” News, Global Trends, Did You Know, Events etc.

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EVENT REPORT 16

Held In Conjunction With :

September 7 to 9, 2020 December 14 to 18, 2020 Supported By : Association of Diagnostics Manufacturers of India

Medical Disposables Manufacturers’ Association

The All India Plastics Manufacturers’ Association

MSME Chamber of Commerce and Industry of India

Sponsored By :

GLR Laboratories Pvt. Ltd.

Galaxy of Speakers and Panel Experts Webinar 01 : September 7, 2020 Theme : "India : A Reliable Source Of Medical Device Products and Technologies For Africa” Mr Rajiv Nath Dr. Mercy Mwangangi CAS-Healthm Deputy Minister Ministry of Health, Kenya

Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) & Managing Director, Hindustan Syringes and Medical Devices Ltd.

Dr Eric Rutto Kenya National Chamber of Commerce & Industry (KNCCI)

Dr. Elizabeth Gitau CEO, Kenya Medical Association

Mr. Mahesh Desai Chairman, EEPC India

Mr. Ravi Shrivastava CEO Omni Lens Pvt. Ltd.

Webinar 02 : September 8, 2020 Theme : "Safetyand Risk Management For Healthcare Professionals” Dr. J. L. Meena General Manager

H. E. Mr. Willy Bett High Commissioner of Kenya to India

(Hospital Networking & Quality Assurance) Ayushman Bharat - Pradhan Mantri Jan Arogya Yojna

Dr. Karnav A. Patel AIMS Hospital, Apollo Hospital

National Health Authority Mr. V. R. Patel

Mr. Safari K. Kithi

Dy. Chief Environmental Engineer GPCB (Retd.) and CEO at Vir Enviro Management

Chairman, Association of Kenya Medical Laboratory Scientific Officers

Mr. Lawrence Wamiti AKMLSO NEC Member

Webinar 03 : September 9, 2020 Theme : "Technologies, Quality Requirements & Business Opportunities For Medical Textiles, PPEs / Face Masks " Dr. Sundararaman K.S. Managing Director Shiva Texyyarn Ltd.

Dr. Ketan Vadodaria Dr. Karnav A. Patel

Associate Senior Faculty Textile Design Dept. National Institute of Design, Ahmedabad

AIMS Hospital, Apollo Hospital

K. R. Navaneethakrishnan Assistant Director GLR Laboratories Pvt. Ltd.

Webinar 04 : December 14, 2020 Theme : "Medical Device Industry : India - A Potential Global Manufacturing Hub” Mr. Rajiv Nath Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) & Managing Director, Hindustan Syringes and Medical Devices Ltd.

Mr. C. Padmakumar Director, Kerala Lifesciences Industries Parks Pvt. Ltd. & former Chairman and Managing Director, Terumo Penpol .

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Dr. Atul Sardana Director, Alfa Corpuscles Pvt. Ltd.

Mr. Deepak V. Agarkhed AVP, Sakra World Hospital, Bengaluru

EVENT REPORT Webinar 05 : Dec. 15, 2020 Theme : "Medical Polymeric Materials, Components & Processing : Innovations & Developments” Mr. Godwin Suen

Mr. Kishore Khanna

Ms. Marina Lee

Product Expert, Healthcare Industry, AP - Polycarbonate Business Unit, Covestro (Hong Kong) Ltd.

Managing Director, Romsons Group of Companies, Agra and Joint Coordinator, Association of Indian Medical Device Industry (AiMed)

(Q&A Panel member together with Suresh V) - Industrial Marketing, Healthcare Industry, AP - Polycarbonate Business Unit, Covestro (India) Pvt. Ltd.

Dr T S Kumaravel Mr. Chintan Mehta

MD, PhD, DABT, ERT, American Board Certified and UK Registered Toxicologist, Chairman, GLR Laboratories Pvt. Ltd.

Mr Mittal Shah Global Market Manager LLS Health

Asst. Manager (Sales & Business Development), Nu-Vu Conair Pvt. Ltd.

Webinar 06 : Dec. 16, 2020 Theme : "Indian MedTech Industry Ecosystem : Facilitating Growth“ Mr. Ganesh Sabat CEO Sahajanand Medical Technologies Pvt. Ltd.

Dr. Akshay Srivastava

Mr. Shinto Joseph

Mr. Jitesh Shah

Director South East Asia Operations, LDRA

Managing Director Suru International Pvt. Ltd.

Associate Professor, Department of Medical Devices National Institute of Pharmaceutical Education and Research-Ahmedabad (NIPER)

Webinar 07 : Dec. 17, 2020 Theme : "Medical Device Industry Standards, Certifications & Regulations” Dr. Ravikant Sharma Deputy Drug Controller, Central Drugs Standard Control Organization

Mr. Jayanta Roy Chowdhury

Mr Rajiv Nath Mr Anil Jauhri

Scientist-G & DDG, Standardization-Products & Methods, Bureau of Indian Standards

Ex CEO - NABCB

Mr Sathyendra

Dr Sanjeev Kumar Gupta

Founder & CEO Q Mart Global & Member – Consultants Consortium of Chennai

Managing Consultant InTrust Consulting

Managing Director of Hindustan Syringes & Medical Devices Ltd & Forum Coordinator – AIMED

Mrs. Rama Venugopal Executive Director – Value Added Corporate Services P Ltd & President – Consultants Consortium of Chennai

Webinar 08 : Dec. 18, 2020 Theme : “Making Innovation & Indigenization Stick: an IVD Industry Summit”

Managing Director & CEO, Andhra Pradesh MedTech Zone (AMTZ).

Chairman and Managing Director, Transasia Biomedicals Limited.

Mr. Sanjaymon K R

Dr. D.K. Joshi

General Manager, Business Development Agappe Diagnostics Ltd.

IPP, ADMI & Managing Director, Beacon Diagnostics (P) Ltd.

Dr. Ravi Kumar Meruva Founder & CEO, Sensa Core Medical Instrumentation (P) Limited.

Ms. Veena Kohli

Dr. Jitendra Sharma

Mr. Suresh Vazirani

Dr. Rajesh Kumar Patel

Dr. Manoj Chugh

Mr. Sriram Natarajan

Associate Vice President R&D, Transasia BioMedicals Limited.

Founder Director & CEO, Molbio Diagnostics (P) Limited.

Dr. Vishal Warke Director R&D, HiMedia Laboratories (P) Limited.

Director, Premier Medical Corporation (P) Limited.

President, Association of Diagnostics Manufacturers of India (ADMI) & CEO & Founder, Vanguard Diagnostics (P) Limited.

Mr. Abhinav Thakur Secretary, ADMI & Managing Director, Accurex Biomedical (P) Limited.

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www.imdiconferences.com

Indian Medical Devices & Plastics Disposables/Implants Industry 2020

Held In Conjunction With :

Pioneer & The Only Event For Medical Disposables & Implants Industry In India December 14 to 18 2020

Mr. Mittal Shah

SPEAKER ABSTRACTS OF PRESENTATION

Global Market Manager- LLS Health Lubrizol Advanced Materials India Ltd.

THEME - "Medical Device Industry : India - A Potential Global Manufacturing Hub"

Thermoplastic Polyurethane Resin and Components for Safe Medical Devices Lubrizol medical grade polymers are specifically formulated for superior biostability, biocompatibility and processing versatility, and are utilized by global leaders throughout the industry. We offer a full range of thermoplastic polyurethane material solutions such as Pellethane®, Isoplast®, Tecoflex™, Tecothane™, Carbothane™ and Pathway™ polymers as well as polymer customization to meet your performance needs. We provide differentiated design, development and manufacturing services of components, subassemblies and finished devices. Our expertise is aligned with minimally invasive catheters and delivery systems as well as a broad array of silicone-based medical devices; as well as thermoplastic and silicone processing.

Mr. C. Padmakumar Director, Kerala Lifesciences Industries Parks Pvt. Ltd. & former Chairman and Managing Director, Terumo Penpol . Abstract of Keynote address for Medical device industry: India-A Potential Global Manufacturing Hub The medical device industry originated in the US and is even now dominated by American companies. The address looks at the Key success factors for the growth of the medical device industry in the US, and also at Ireland which has grown from zero to a major global medical device manufacturing hub in the last 40 years. The focus is on the medical device cluster as the key element in the growth of the industry. The potential for clusters in India is reviewed with a specific example of the city of Trivandrum in Kerala state. It concludes with recommendations for the Government and a roadmap for industry.

Dr. T S Kumaravel MD, PhD, DABT ERT, American Board Certified and UK Registered Toxicologist, Chairman, GLR Laboratories Pvt. Ltd.

Mr. Deepak V. Agarkhed

Biocompatibility of Polymer Materials

AVP ,Sakra World Hospital, Bengaluru

GLR Laboratories is a leading provider of biocompatibility solutions and testing. The regulatory standard for biocompatibility (ISO10093) is rapidly changing and regulatory agencies are scrutinizing biocompatibility studies in greater details than ever before. The notion of biocompatibility as a box ticking exercise has changed to that of custom designed studies addressing a particular device or device family. There is more emphasis on proper selection of test sub systems, extract preparation, overall safety assessments. In this session, we will critically analyse these recent changes to ISO10993 standards and how they will affect the medical device manufacturers.

Impact On Technology Management With local Manufacturing Of Medical Devices Abstract Of Presentation : This presentation touches on the present medical device industry & its current pitfalls, how is current technology management at the healthcare delivery side. The presentation tries to probe upon the impact of local manufacturing to end customers i.e. patients through the healthcare delivery system.

THEME - “Medical Polymeric Materials, Components & Processing : Innovations & Developments

Mr. Chintan Mehta Asst. Manager (Sales & Business Development) Nu-Vu Conair Pvt. Ltd.

Mr. Godwin Suen Product Expert, Healthcare Industry AP - Polycarbonate Business Unit, Covestro (Hong Kong) Ltd.

Vital Role Of Medline Series Equipment For Cleanroom Condition This presentation is about medLine Auxiliary equipments those are used in manufacturing of medical parts. In this presentation, we briefly talk about major functions of medical part manufacturing like raw material, clean room condition, injection moulding, mould and Auxiliary equipments. We also talk in detail about clean room condition and role of medLine Auxiliary equipments. We also talk about certification work and other compliancy those are very much essential while manufacturing of Auxiliary equipments.

Abstract of the Presentation : Healthcare industry is coping with explosive number of infectious patients this year. This talk from Covestro will introduce high heat medical polycarbonate and chemical resistant material solutions to meet the stringent sterilization needs.

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THEME - Indian MedTech Industry Ecosystem : Facilitating Growth Mr. Shinto Joseph Director – South East Asia Operations, LDRA India Skills Challenges with Medical Device Certification in Indian context

The key emerging trends for medical devices in 2020 include IoMT, Robotics, 3D printed devices, Enhanced Cybersecurity, and Wearable Technology. These trends bring opportunities and challenges such as software obesity where a bug could result in serious safety or cybersecurity issues. In this presentation, Shinto will discuss a standard based certification approach with a focus on risk and quality management followed with a need to build skills at all levels (academia, industry, policy making, regulatory, test & certification).

IMDI 2020 WEBINARS

VIDEO LINKS

WEBINAR – 01 September 7, 2020 India : A Reliable Source of Medical Device Products and Technology For Africa WEBINAR – 02 September 8, 2020 Safety and Risk Management for Healthcare Professionals WEBINAR – 03 September 9, 2020 Technologies, Quality Requirements & Business Opportunities for Medical Textiles, PPEs / Face Masks WEBINAR - 04 December 14, 2020 Medical Device Industry : INDIA - A Potential Global Manufacturing Hub WEBINAR – 05 December 15, 2020 Medical Polymeric Materials, Components & Processing : Innovations & Developments WEBINAR – 06 December 16, 2020 Indian MedTech Industry Ecosystem : Facilitating Growth WEBINAR – 07 December 17, 2020 Medical Device Industry Standards, Certifications & Regulations WEBINAR – 08 December 18, 2020 Making Innovation & Indigenization Stick : an IVD Industry Summit

https://www.youtube.com/watch?v=PgidSAF8CNk https://www.youtube.com/watch?v=p8pRMim2AM8 https://www.youtube.com/watch?v=lLbaXYNSOCA

https://www.youtube.com/watch?v=9DO5OyTz2JY https://www.youtube.com/watch?v=Wkjit8ybsTk

https://www.youtube.com/watch?v=QScII1fbivg https://www.youtube.com/watch?v=QiKB_BrkzT0 https://www.youtube.com/watch?v=UZl2UX5TB7A

Information Resources For Medical Technology Industry And Markets .COM

WWW. AN AUTHENIC PORTAL SITE ON MEDICAL TECHNOLOGY AND MARKETS IN ASIA

WWW. .COM THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTICS/DEVICES TECHNOLOGY AND TRADE A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, DIAGNOSTICS AND PHARMACEUTICAL INDUSTRY

www.imdiconferences.com

Indian Medical Devices & Plastics Disposables Industry Annual Celebration Of Knowledge Sharing, Brain Storming And Networking

CLASSIC COMPUTER SERVICES B-4, Mandir Apts., Opp. Jodhpur Char Rasta BRTS Bus Stop, Satellite Road, Ahmedabad-380 015, INDIA. Ph:+91 79-26740611 Fax: +91 79-26754867 • M. : +91 98254 57563 • E-mail: info@medicalplasticsindia.com • Website : www.medicalplasticsindia.com 24

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Organized In Collaboration With

IMDI 2020 WEBINAR-07 December 17, 2020

Theme : Medical Device Industry – Standards, Certifications And Regulations

Highlights

Highlights based on presentations given by Industry Experts.

Day 4 Webinar was created for Medical Device Industry on Standards, Certifications and Regulations. The Session was scheduled on Dec 17th from 4 – 6 pm and was attended by Med Dev Mrs. Rama Industry players and various stakeholders of the industry. Venugopal Program started off with opening remarks by Dr Usha Jain and Shri D L Pandya, Expo Organisers President, Consultants and thereafter was moderated by Dr Sanjeev Kumar Gupta and Mrs Rama Venugopal from Consortium Of Chennai Consultants Consortium of Chennai, the Conference Organisers.

Compiled by

Key Note Address By

Dr. Ravikant Sharma Deputy Drug Controller, CDSCO

“Towards a World Class Regime” Session started off with a key note speech Dr Ravi Kant Sharma, DDC, CDSCO. Dr Sharma briefed the industry about commitment shown by CDSCO in issuing licenses to the industry even during covid times in about a week’s time to all applicants. CDSCO is committee to work along with the industry to make industry focus on making India Self Reliant in med dev mfrg space. He mentioned that CDSCO currently is regulating only 24 categories of medical devices and all med dev come under Regulation as per the mandate of MoH&FW. Currently , the Regulator has only called for Voluntary Registration of all Med Dev in the country as to understand who is manufacturing what products in the country ! This is purely a voluntary registration process before mandatory licensing kick starts. Industry is currently under transition phase towards a regulatory regime. Dr Sharma has explained that Class A and B devices are given a 12 + 18 months timeline before they come under licensing regime & Class C and D devices are given a 42 months timeline to be ready before mandatory licensing starts. He also clarified that Voluntary Registration doesn’t mean Licensing. He also explained about need to have Licensing audits for Class C & D Categories inspite of having ISO Certificates as this is linked to post market surveillance requirement. He also asked the mfrers to apply for license for products notified in Jan 2020 notification so that they can issue the licenses soon. Rest of the session had series of speakers covering wide range of topics as follows :

Expert Presentation 2

Mr. Jayanta Roy Chowdhury Scientist G & DDG - StandardisationProducts & Methods, Bureau of Indian Standards. "Quality & Safety of Medical Devices & Emerging Focus on Technical Standards" Mr Chowdhury has touched upon the process of standardization of Medical Devices. He mentioned that BIS has created structure

for medical equipments and hospital planning division council which comprises of 20 sectional committees (with 650 experts), 3 sub committees, 2 panels. BIS has so far published 1380 Indian Standards & 465 Standards harmonized with ISO/IEC. He spoke about the Standards National Action Plan which was rolled out by BIS based on the Indian National Strategy for Standardization initiative launched by Govt of India. 1st step towards the Standardization kick started with the HITES List of Commonly procured Medical Devices List from MoH&FW which had a list of 455 items. BIS has published 282 Standards for devices from this list and work in progress for about 81 devices, work yet to start for about 56 high risk devices. Major ongoing standards devt exercise is happening currently for IVD devices, High Risk Devices, Class D Medical Devices, Surgical Instruments, Cold chain equipment, cyber security of connected medical devices, biomedical waste management, telemedicine and telehealth standards. Niti Aayog entrusted BIS with the task of developed standards for Priority Assistive Devices. BIS is taking active part in ISO/IEC International Standardization Work. BIS is inviting any stakeholder to submit proposal for development of Standards and to comment on the draft standards published online. It also proposing creation of Standardization Cells in Industry Associations for better industry collaborations.

Expert Presentation 3

Mr. Anil Jauhri Ex CEO – NABCB. Global Limelight on Authentic Certifications – an outcome of Pandemic Effect Med Dev Industry is regulated across the globe and in India too Med Dev for healthcare is brought under Regulation. Covid 19 has exposed that global markets are also flooded with unauthentic QMS & Product Certificates similar to Indian experience. Market place needs an assurance that these certificates are genuine and reliable. Certification business is voluntary in Indian market and currently there is no regulation of these bodies and no single point of control to monitor their market practices. Anyone can set up a certification body and there is no legal bar too. Certifications are generally voluntary in nature and are driven by market demands, buyers demand etc and not because of regulatory push alone. ISO 13485 is the globally

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recognised Quality Management Systems Std for Med Dev. Indian MDR has mandated compliance to QMS but not mandated ISO 13485 in the Rules. However, during the curent transition phase (towards mandatory regulation), MDR has asked for compliance to ISO 13485 Std as prerequisite for Voluntary Registration process. However its only optional. But for the Certification programs of BIS – ISI Mark or QCI-AIMED driven ICMED Certifications, all other Certifications are done by Pvt Bodies in the market place. So a natural question that arises to our minds is the kind of certificates issued by these private bodies ! These fall under 2 categories – Authentic and Unauthentic Certificates. Mr Jauhri has demonstrated how these certificates look and how to identify both, by following simple steps. Accreditation of Certification Process is the internationally recognised way for improving the market confidence and hence IAF has a strong role to play. Authentic Certificates generally carry IAF logo but not mandatory though ! Mr Jauri raised a question to the Regulator and Industry to clarify too – MDR calls for compliance to QMS spec mentioned in Sch 5 and not mandated ISO 13485. So what will happen to ISO 13485 Certifications when industry gets into Regulation mode. This question needs an answer from the Regulator !

Expert Presentation 4

Shri Rajiv Nath Managing Director, Hindustan Syringes & Medical Devices Ltd & Forum Co-ordinator - AiMeD Indian Certification For Medical Devices : ICMED Certification Mr Rajiv Nath highlighted the need to have smooth and well defined regulatory pathway for the industry to have smooth transition. Well defined and implemented regulatory framework will enable the ease of doing business for the industry too. Industry will attract fresh investments into the sector only if there is a well defined and clear regulatory framework. Lack of well defined regulatory environment is the reason why med dev industry did not attract investments into this segment over the last 10-20 years. Mr Rajiv Nath has recalled how the regulatory framework in the country has evolved since 1989 and how the changes were taking place in regulatory space. He highlighted the need to encourage Make in India and not to discourage investments in this sector and this is possible to have more clarity and well defined regulatory structure. Med Dev Industry has welcomed the Regulations and always is of the opinion that well defined regulatory mechanism will attract investments into this sector. He touched upon the need to separate laws for Drugs , Devices and Cosmetics to bring more clarity while addressing patient safety issues. He touched upon the need to share the work load betn Central Govt, State Govts and the Conformity Assessment bodies to have an effective implementation roadmap. He emphasised upon the need to create laboratory infrastructure in the country to test all med dev in the country. All these have to be on place before the regulations get rolled out. Mr Nath highlighted about the ICMED Certification, an Indian Certification Standard created in alignment with International Standards requirements, 5 years ago by involving multiple stakeholders including MoH&FW. ICMED Certification was designed as a Voluntary Standard and mfrers implementing ICMED Certification meets compliance to MDR 2017 automatically and many more patient safety standards and other elements as well. Mr Nath concluded his speech with a wish list from the industry which includes bringing all mfrers and importers under registration mechanism by CDSCO; compliance to ISO/IS13485 Certification by industry and importers in next 2 years time; to incentivise QCI’S Voluntary ICMED Certification;

Build competence of Auditors, Med Dev officers & Mfrers; create testing infrastructure with more NABL Accredited labs; expedite adaption of ISO Stds as BIS Stds; creating separate law for Medical Devices.

Expert Presentation 5

Dr Sanjeev Kumar Gupta Managing Consultant, InTrust Consulting Indian Medical Device Rules – Transition Period and Industry Preparedness Dr Gupta started off his speech by highlighting the need for med dev industry to prepare for the transition to regulatory regime and why industry should be prepared to spend both time and money on this exercise. He cited how challenging this exercise would be for MSME businesses to meet the QMS & Regulatory Spec but why its inevitable as the mfrers have responsibility to produce both Quality and Safe products. He stressed upon the need for the top mgmt to keep aside good budgets for MDR & QMS implementation as budgeting is also an important exercise for the industry to have an effective roadmap towards implementation. As a Regulatory Planner and Consultant, he has listed out the regulatory compliance roadmap for various segments of industry. He has listed out the key challenges in implementing the regulatory reqts in terms of infrastructure, QMS implementation and upskilling of human resources. He has also listed out the challenges in implementing Sch 4 requirements on MDR which calls for Technical Documentation. He has concluded his speech by sharing some tips to the industry on execution roadmap and do’s and don’t’s suggestions too !

Expert Presentation 6

Mr M G Sathyendra Founder & CEO, Q Mart Global

Global Medical Device Regulations Mr Sathyendra started off his session highlighting why Patient Safety matters and why Regulations in Med Dev space aim at addressing the same. He cited how regulations help to arrest the import of sub standard products into the country , which otherwise may put patients lives to greater risk. He touched upon the various stages of govt regulations that industry is subject too. He touched upon the common framework for regulations .He shared the regulatory systems in GFTF Countries and the role of IMDRF (International Med Dev Regulatory Framework). He discussed about the Med Dev classification and how it differs in global environment. He discussed about key regulatory requirements in key global markets . He also touched upon the role of Standards in the global regulatory regime and finally concluded the session by sharing the list of indispensable standards applicable for med dev industry across the globe.

Conclusion And Vote Of Thanks

Mrs. Rama Venugopal President, Consultants Consortium Of Chennai

Mrs Rama Venugopal, President, Consultants Consortium of Chennai has concluded the session with a vote of thanks by thanking all partners and sponsors for the session. November-December 2020

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Organized In Collaboration With

IMDI 2020 WEBINAR-08 December 18, 2020

Association of Diagnostics Manufacturers of India (ADMI)

Theme : Making Innovation & Indigenization Stick: an IVD Industry Summit Highlights based on presentations given by Industry Experts.

Compiled by

Dr Usha Jain Consultant : Laboratory Medicine, Medical Genetics & Genomic Science, Research Design & Analysis, Scientific Writer

Highlights Since the onset of Covid-19 pandemic, in a short span of time, the world has changed drastically; this pandemic has brought the in -vitro diagnostics (IVD) industry on the forefront for the first time. While Covid-19 has undoubtedly presented enormous challenges, it has, however, created several opportunities for instance, indicating a shift in focus from China to India as the prominent suppliers in IVD reagents and products. In line with this perspective, on the fifth day, a webinar on the theme “Making Innovation & Indigenization Stick: an IVD Industry Summit” was organized. The meeting started with a welcome of all the dignitaries & participants by Mr. D L Pandya Convenor & organizer, IMDI & Ms. Veena Kohli, President, Association of Diagnostics Manufacturers of India (ADMI) & CEO & Founder, Vanguard Diagnostics (P) Ltd. being the moderator, invited the key note speakers, Mr. Suresh Vazirani, Chairman and Managing Director, Transasia Biomedicals Ltd. & Dr. Jitender Sharma, Managing Director & CEO, Andhra Pradesh MedTech Zone (AMTZ).

Key Note Address By

Mr. Suresh Vazirani

Dr. Jitendra Sharma

Chairman and Managing Director, Transasia Biomedicals Limited.

Managing Director & CEO, Andhra Pradesh MedTech Zone (AMTZ).

Envisioning an Atma-Nirbhar IVD Mr. Suresh Vazirani’s key note address entitled “Envisioning on Atma-Nirbhar IVD Industry” highlighted the importance of IVD for every country as diagnostics is the backbone of any healthcare system where 70 – 80% of the treatment decisions depend on outcome of diagnostic tests. Since the onset of the Covid-19 pandemic, IVD has been in real focus. The Govt has to acknowledge the tremendous impact that IVD has made in managing the pandemic in the Indian context, placing India at the lowest mortality rate. Starting from a few RT PCR to 2000 labs doing the Covid-19 diagnostic testing, where 80% of the kits are indigenous. Sharing his 41 years of journey in the IVD industry, when even basic tests kits were being imported. Even today India is importing 70% of its medical devices and less than even 2% is being spent on healthcare. In-spite of that, cost of diagnostics in India is the lowest in the world providing Covid-19 testing for about one US $. It’s unimaginable that in America its 20 US $. The low cost of diagnostic kits is opening a door for the Indian manufactures to export. That’s why the Indian IVD industry is now more quality conscious in the terms of maintaining the global standards product quality. If it remains on the right track, sky is the limit for Indian IVD industry. Becoming Atma-Nirbhar is not a choice but a compulsion for the Indian IVD industry and it needs the support of the Govt of India to achieve its goal of becoming 50% self-reliant during the next five years. He addressed that IVD is the toughest industry to make money but it has a great advantage of great satisfaction by contributing towards the healthcare of your country and its citizens and it’s the greatest satisfaction that no money can give. His words that by doing so we are accumulating Good Karma too boosted the morale of all participants and were well reflected in discussion later with other panelists too.

Another key note speaker Dr. Jitender Sharma, also known as “MEDTECH man of India” addressed to make India AtmaNirbhar, indigenization and Innovation has to go hand in hand. To achieve the same, firstly we need to reverse the flow to diagnostic first, doctor’s consultation next and medicine the last as presently diagnostics being the last causes delayed diagnosis & poor management of health. We can beat this by attaching a micro lab to a pharmacy carrying out some basic diagnostics. When there can be over the counter drugs, there could be over the counter diagnostics too. Secondly, allowing the integration of IVD into modern commodities and thirdly, arresting the free fall in prices in the interest of science and innovations can truly make India Atma-Nirbhar so far as the IVD is concerned.

Panel Discussion Moderator

Ms. Veena Kohli President, Association of Diagnostics Manufacturers of India (ADMI) & CEO & Founder, Vanguard Diagnostics (P) Limited. Thereafter, the panel discussion began involving Mr. Sriram Natarajan, Founder Director & CEO, Molbio Diagnostics (P) Ltd; Dr. Rajesh Kumar Patel, Director, Premier Medical Corporation (P) Ltd.; Dr. Ravi Kumar Meruva, Founder & CEO, Sensa Core Medical Instrumentation (P) Ltd.; Mr. Sanjaymon KR, General Manager- Business Development Agappe Diagnostics; Dr. Vishal Warke, Director R & D, Hi-Media Laboratoies (P) Ltd; Dr. Manoj Chugh, Associate Vice President R&D, Transasia Biomedicals Ltd & Dr. D K Joshi, IPP, ADMI & Managing Director, Beacon Diagnostics (P) Ltd., that goes as follows:

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Mr. Sriram Natarajan

Dr. Rajesh Kumar Patel

Founder Director & CEO, Molbio Diagnostics (P) Limited.

Director, Premier Medical Corporation (P) Limited.

Mr. Sriram threw light on how RT- PCR is a common household buzz word these days since the Covid- 19 has brought about a transformation in the perception of diagnostics for a common man today. He shared his strategies for tremendous success in the innovative sector of molecular biology in India being the main player in this industry for almost 40 years. He shared his mission and vision to take molecular diagnostics to the people in the remotest parts of India. To achieve this, his company had made tireless efforts for almost 20 years by innovating a technology that is truly point of care RT PCR especially for the infectious diseases where RT PCR is quick & the gold standard. Idea of centralized lab. can delay the reporting time & subsequently delay the treatment. Therefore, he envisioned RT PCR at primary health care centres, tier 2 & 3 cities. Due to this vision, today company is serving the nation by being a part of the National TB Control Programme. Taking high end technology to the point of care is going to take them to the remotest areas of the other countries too. He shared his utmost satisfaction on this innovation by saying “Whatever was envisioned is now taking shape”. He was indeed applauded for his tremendous efforts & dedication towards the democratization of molecular testing through setting up of TRUENAT at primary health care centres for various infectious diseases including the Covid-19 in remotest areas of India. In answer to another question on the major difference between RT PCR and the LAMP technology from IVD manufactures’ perspective in context of the pandemic scenario, he highlighted that though both RT PCR & RT LAMP based diagnostics are based on the amplification of DNA. RT PCR requires a thermal cycler and other sophisticated accessories, while LAMP is isothermal where reaction is being carried out in a single tube on a simple thermal block maintaining 60 – 65 degrees. Thus, it requires no sophisticated instrumentation, set up & skilled manpower. He stressed that RT PCR is still the Gold Standard and as it has evolved for over the last 40 years while the LAMP assay has been in limelight for the last 4-5 years. Fundamentally both RT PCR and LAMP are useful in to the IVD industry but we have to keep in mind the end product and the end user.

Dr. Ravi Kumar Meruva

Dr. Rajesh Kumar addressed the challenges and strengths of being an export centric company in IVD. He opined that export to other countries opens up avenues in multiple markets, a larger scale production reduces the manufacturing costs, diversification & reduced risk; compensation of seasonal demands, improvement in the life cycle of the product, enhancement in knowledge due to more R & D to meet the international quality & standards are the other benefits of being in the export segment. He added that the challenges of being in this segment can also not be ignored as being in export, there is financial risk along with delay in payments, requirements for country specific product modifications, large product configurations and the inventory management. He also made the manufactures aware of the importance of WHO prequalification and its procedure.

Mr. Sanjaymon K R General Manager, Business Development Agappe Diagnostics Ltd.

Mr. Sanjaymon shared “Innovation, Quality & Affordability” have been the success mantra of Agappe. To answer the question on systematic steps taken towards indigenisation, he opined that the key step is the industry- industry partnership, Industry- academia partnership and more of localization for accessories and/or spare parts. That will involve more people, more jobs & thereby more employment. This will fulfil our true mission towards “Make in India” or made in India products. On sharing his experience on LAMP and its future in Indian diagnostics, he viewed that there has been innovation in LAMP in the last 5-6 years, this technology reduces the cost of hardware & is faster than RT PCR, nested PCR or CRISPR technology, possibly giving results within 10 min after doing the assay and also the results can be visualised as positive or negative. Further, transportation of reagents at -20ºC in remote areas especially in India is a major challenge. LAMP based reagents could be transported at 2 to 8ºC, even the cartridges of LAMP can be stored at RT. Covid-19 has changed the expectations of molecular based testing, with patients demanding results in an hour or even less, innovation in LAMP by the manufactures & researchers becomes all the more important.

Founder & CEO, Sensa Core Medical Instrumentation (P) Limited.

Dr. Vishal Warke Director R&D, HiMedia Laboratories (P) Limited.

Dr. Ravi Kumar Maruva shared his decision for choosing the less travelled road of IVD industry, focussing on instrumentation rather than on reagents. In his opinion closed systems in biochemistry or haematology secure higher margins as compared to open systems in instrumentation. His company was into the manufacturing of variety of electrodes, functioning for a span of 8-10 years, this makes the heart of a technology so robust. Therefore, it was easier for the company to design a body around the heart designed earlier. Since most of the manufactures are moving towards closed systems, so it was a very judicial decision that has an exponential growth, ahead.

Dr. Vishal Warke, from Hi -Media - a name synonymous with culture media globally, shared how indigenization of technology over more than four decades, has been the success mantra of his company in-spite of all odds, leading it to become one of the top three culture media companies in the world. He addressed the reason behind the presence of a very few players in the culture media industry. Firstly, the segment has a small ticket size as compared to pharmaceuticals and diagnostics. Secondly, most of its resources come from nature e. g. ocean & seaweed because of which there is batch to batch variation and converting them into November-December 2020

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a standard product to get sustainable desired results that too in the absence of any defined technology, is the most challenging aspect of this segment. He also shared how the challenging situation faced by Dr. Warke, Founder & MD of Hi- Media while doing his doctorate due to scarcity of media became an impetus for the growth of Hi-Media company. Though the journey has been tough but the feeling of working for their nation and humanity gives tremendous satisfaction. Since most of the microbiology grade agar comes from cooler climate & oceans of certain type of nature, therefore, the observation of stripping off the natural resources, being one of the reasons for global warming has made company to lead to improvise, switch over to other substitutes and go “Animal Free”. Due to these major changes today Hi-Media is exporting its products to 150 countries across the globe diversifying from microbiology to stem cell, vaccine, therapeutics, plant tissue culture, hydroponics, fermentation media and most recently the rapid test medias, where different bacteria form different colour colonies etc.

Dr. Manoj Chugh

Dr. Joshi threw light on the most awaited & concerned issue of IVD industry by all manufactures i.e. the support Indian IVD would require from the Govt. He stressed that the Indian IVD industry had been focussing mainly on reagents but during the last 3-4 years, device lock systems has restricted this. Every high-tech instrumentation company should tie up with local manufactures and this will boost up Atma-Nirbharta by initiating some provision of high duty by the Govt of India. He also highlighted that most of diagnostic industry in India is MSME, developing an infrastructure and spending huge money on R & D is quite challenging. Under these circumstances the Govt of India rather than providing any subsidy or production linked incentives, should cluster a group of selected companies which could bring technology to India, and Govt negotiates on behalf of those to divide the cost of technology transfer among the interested companies. The reduced in cost would give hope to the manufactures to keep momentum in Indian IVD industry. In-fact this very promising proposal was appreciated by Ms. Veena Kohli and would be discussed by ADMI for further perusal.

Conclusion and Vote of Thanks

Associate Vice President R&D, Transasia Bio-Medicals Limited.

Mr. Abhinav Thakur Secretary, ADMI & Managing Director, Accurex Biomedical (P) Limited.

Dr. Manoj Chugh highlighted on how crucial is the role R & D in making Indian IVD companies successful. He opined that innovation was critical to the growth & progress of all industries across all sectors. Earning out in diagnostics is difficult as there are multiple stakeholders like lab personnel, hospital personnel and now a day’s patients too are well informed about the advancement. Pre- Covid times, Indian firms primarily imported low-cost tests developed elsewhere rather than developing entirely a new technology, competing against each other only. Now is the move from incremental innovation to radical innovation and that is the only mantra to compete with multinational companies which have the additional advantage of financial resources, powerful branding, high note management & marketing skills. Players in IVD industry focussing from volume to value will gain influence & have a competitive edge in the long run. It becomes important for all innovators to acquire significant share not only in the domestic but also in the international market. If we can supply diagnostic tests to International disease control initiative, we are winning. Thus, Dr. Chugh very well-articulated the importance of R & D and innovations that can never be under estimated in any industry including the IVD. He also explained that in recent times there has been a surge seen in industryacademia collaboration that needs to be further sustained in future too. According to him, Innovation with indigenization demands multiple needs e. g. working outside main stream paradigm, large leaps of understanding, a new way of looking at the problem and considerable changes in higher technology are required. To win this, keeping in mind the mantra of “High risk & higher rewards” two systems seamlessly needs to collaborate i.e. generate knowledge through academia and to use or consume it through industry. So that even if there is a global arrest, we do not suffer to procure even the critical raw material. Recently, even the triple helix model where academia, industry & Govt. collaborated through Niti-Ayog has been fruitful.

The panel discussion was concluded with summarising note of the speakers and a vote of Thanks by Mr. Abhinav Thakur, Secretary, ADMI & managing director, Accurex Biomedical (P) Ltd.

Dr. D.K. Joshi IPP, ADMI & Managing Director, Beacon Diagnostics (P) Ltd.

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India: Top5 Global Mfg. Hub..... Challenges To Overcome Mr Rajiv Nath Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) & Managing Director, Hindustan Syringes and Medical Devices Ltd.

AIMED'S MSME PLAN | WADHWANI FOUNDATION Imports & Exports

Wadhwani Advantage Program objectives

Import Summary of 6 Categories Medical Devices 531 2% 1,727 6%

2,292 9%

2,147 8%

1,275 3%

1,533 6%

2,940 7%

Consumables 2,757 7%

4,867 12%

3,735 9%

Disposables Electronics & Equipments Implants

25,853 62%

18,549 69%

Objective 1 Network with potential partners -Scale up and Diversify your business with able support

CHALLENGES CHALLENGE 1 Cash Flow : Many MSME not paid over 6 to 12 months by Public Healthcare Buyers and becoming NPA’s.

FY 2019-20 - Rs. 41,427 Crores

Export Summary of 6 Categories Medical Devices 353 2%

479 3% 312 3%

214 2%

667 4%

270 3%

4,074 41%

Consumables 4,649 29%

3,247 33%

7,085 43%

Disposables Electronics & Equipments

3,028 19%

1,801 18%

Implants IVD Reagent Surgical Instruments

FY 2015-16 - Rs. 9,919 Crores

Objective 3 Access to Top Quality Tools and solutions to business challenges

IVD Reagent Surgical Instruments

FY 2015-16 - Rs. 26,779 Crores

Objective 2 Provide access to industry experts and leaders for mentor ship support

FY 2019-20 - Rs. 16,261 Crores

Atmanirbharta - AiMed's Agenda Objectives Identifying Challenges Needs and solutions sought Working with Consultants & Solution Providers Problem ? Fix It - How? Timeline Case Studies Before & After Covid 150

CHALLENGE 2 Tariff Policy : Competition from lower cost imports due to low duties makes most Projects nonviable. CHALLENGE 3 Competition with low priced Preowned Medical Electronics imports CHALLENGE 4 Tenders seeking Matching of non-remunerative L1 Prices of China which are due to support by Chinese Provincial Govt.s CHALLENGE 5 Tenders seeking US FDA / CE ,Overseas Regulatory Approvals CHALLENGE 6 Discriminatory Regulations that puts licensed Manufacturers at Disadvantage & treats them as Criminal CHALLENGE 7 Unfair Competition where Hospital / Retailer prefer to sell known Brand with higher M.R.P. and higher Margin CHALLENGE 8 Lack of access to accurate Data - what is aggregate market demand ? What is Target Price ? C&F Price ? MRP ?

100

CHALLENGE 9 Unfair Competition with Imports/ unlicensed mfrs not carrying Regulatory Labeling

CHALLENGE 10 Limited access to Plug & Play Facility or Land or Built-up Infrastructure CHALLENGE 11 Unethical Marketing Practices of some MNC’s directly or through their Distributors who lure Doctors / Opinion leaders to endorse their Brands and compensate them with foreign trips for Doctors / their families or Sponsor their Child’s Education or Sponsor their Seminar / Exhibition in return for favors

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CHALLENGE 12 Expensive to participate in Exhibitions / Conferences CHALLENGE 13 Lack of Marketing & Financial muscle of some Domestic Manufacturer to advertise, exhibit, hire Professional Doctors (Trainer - Educators ) for enabling Brand Image & Market creation. CHALLENGE 14 Lack of Indigenous Benchmark Studies by Institutes of Indian Devices to prove competitiveness and cost effectiveness or other benefit CHALLENGE 15 Strong Brand Image / perceived better Quality & Performance of MNC’s entrenched Brands

CHALLENGE 20 Lack of access / interface / knowledge for sourcing technology up-gradation CHALLENGE 21 Hiring sales staff and retaining them once trained Needs How to deal with these challenges? Solution What are the solutions , if any ? Setting Timeline Targets General Steps STEP 1 Working with Consultants & Solution Providers

CHALLENGE 16 Restrictive Trade Practices of Bundling of expensive Consumables as restrictive supplies along with delivered subsidized Capital Equipment

STEP 2 Problem ? Fix It - How?

CHALLENGE 17 Inadequately defined Procurement Technical specification allowing substandard quality to be supplied by Importer / Trader CHALLENGE 18 Importers / Manufacturers claiming to be Manufacturer when actually importing complete Products in their Brand Name and selling as Indian Manufactured Product. CHALLENGE 19 Lack of R&D capabilities of Indian Manufacturers and reliance on outsourcing Technology

STEP 3 Timelines ? Govt. Policy Support Beyond 1 - MII PPO 2 - PLI (did not help MSME) 3 - Medical Devices Parks .............

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Medical Polymeric Materials and Components: Innovations & Developments Shri Kishore Khanna Managing Director, Romsons Group of Companies, Agra and Joint Coordinator, Association of Indian Medical Device Industry (AiMed)

Some Of The Recent Medical Devices, Made By Different Polymeric Materials Plastic Heart : A total artificial heart made by High performance (HPP) polymer which can extend the lives of heart failure patients while they’re waiting for transplant. The plastic heart replaces the original heart(replaces both Ventricles and the four heart valves ) adding years to the lives of loved ones. Plastic Foam: It is a polyurethane plastic which is used to stabilize trauma patients with serious injuries. The foam expands inside the body cavity, applying pressure to the wound and confirming around the injured tissue, greatly slowing blood loss to improve the chances of survival. Painless Plastic Injections: Needle injections can be painful, but easier ways to deliver medications are underway. One currently under development is a tiny patch made of many plastics “microneedles” that dissolve once inserted into the skin, releasing the drug at the same time. Made by cellulose bio polymer. Bacteria Resistant Catheters : Urinary Catheters are used in almost 15–25% of hospitalized patients and those patients often contact Urinary tract infections after the catheters have been inside the body for more than 2~3 days. In order to prevent UTIs antimicrobial coating (non stick polymer coating is done to prevent the bacterial growth.

Liquid Bandages : These are made of various starch and protein bio plastics and solvent such as water or alcohol. When applied to the wound, the solvent evaporates, leaving a thin plastic barrier designed to keep out the dirt and debris and to reduce pain by covering nerve endings. As the wound heals, the plastic of liquid bandage sloughs off with the old skin cells. Central Venous Catheter (CVC): A great innovation of medical science, soft tube put in a vein that leads to your heart. CVC may be placed for urgent hemodialysis and also used for dialysis, an arteriovenous (AV) fistula. Made by HPP Plastic (high performance plastics). Epidural Catheter : The catheter allows access to the epidural space to inject medication such as local anesthetics for relief of pain. Temporary epidural catheters are used for temporary treatment of painful conditions that require pain control made by high performance synthetic polymer. 3D Printing Use For Artificial Plastic Organ : We can 3D print toys, tools, cars, and more. While 3D printed human body parts aren’t quite here yet, they’re closer than you may think. Researchers are working on printing various body parts such as kidneys, skin, bones, cartilage, tissues, blood vessels, and more made from diverse cell types while using plastics to help keep the part’s structure in shape. And today, 3D printed plastic body parts models are used as research and practice for complex, tough surgeries. November-December 2020

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Plastic Heart Stent : Open the heart blockage and dispenses the medication and then dissolves in body, made by poly glycerol bio polymer.

Inflatable Implant – Heart surgeons often face a frustrating problem. Sometimes the sickest patients who need surgery have been so weakened by their conditions that surgery becomes too risky, but a new inflatable device made of poly ether urea urethanes elastomer helps in improving the odds. After the device is implanted doctors can inflate or deflate at as needed to control excess blood flow and relieve pressure on the heart. This technique can give a heart the chance to recover enough to withstand surgery.

• Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

Conclusion: In the end I would like to conclude by saying that Post Covid 19 life is expected to change significantly and polymers are going to be the key in revolutionizing the changes to daily life. The personal protection gears are in high demand for healthcare workers, 3-layer mask and N95 mask are also in huge demand in today’s scenario for general public’s personal protection. We also find Face Shield & Protective Goggles for use in hospitals and industries. All this is going to become a part of our day to day life.

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Medical Device Industry In India : A Potential Global Manufacturing Hub Dr. Atul Sardana Director Alfa Corpuscles Pvt. Ltd. The Indian Healthcare industry is on a high growth trajectory having evolved significantly in the past few decades.

manufacturers producing products in the lower end of the technology value chain

However, healthcare provision remains inequitable and challenges in access to quality and affordable healthcare persist in large parts of our country.

We realise that limited availability of technology and funds not enabling indigenous manufacturing.

The medical devices sector has also grown considerably during this period and plays a critical role at each stage of the healthcare continuum. Although it has been instrumental in improving access and affordability of healthcare services, a number of ecosystem constraints had led to a high dependence on imports for addressing domestic demand. With recent policy changes and the skew in demand and supply dynamics there is a significant opportunity and rationale for manufacturing medical devices in India. The Governments ‘Make in India’ initiative presents a platform for the sector to revisit the operating model, identify key imperatives for growth and explore possibilities for creating a change in the medical devices sector. While the government and value chain participants have undertaken several steps to address the issues of healthcare access, quality and affordability, these have been executed in silos. Globally, medical device companies have focused largely on extending life expectancy and improving quality of care, there is a need to increase affordability for a widespread impact which has been the focus of the Indian Startups and Medical Device Industry. The focus therefore for companies in India is to produce medical devices that are both cost competitive and effective to increase penetration and use. It is in this context that the Make in India initiative becomes significant for the medical devices industry. The global medical devices and technology market was expected to grow to USD 520 billion by 2020 The Indian market is among the top twenty in the world by market size. However, the per capita spend on medical devices in India is the lowest among BRIC countries and it is significantly behind developed economies like the US This current under – penetration of medical devices in India represents a sizeable growth opportunity. The opportunity is significant and recent studies indicate that medical devices are expected to be a USD 25-30 billion industry in India by 2025. The Indian market is currently growing at a CAGR of around 14-15% which is significantly higher than global industry growth of 4-6% . Even today the Indian medical devices industry is small, with a disproportionate reliance on imports with most local

Imports constitute around 75% of the medical devices industry sales in India. A range of factors contribute to this high percentage share of imports 1. An inverted duty structure historically favouring import of finished goods than raw materials /components for medical devices manufacturing 2. Even with MDR, the absence of a concrete dedicated regulatory framework specific to medical devices constraining investments in the market and, lack of a component manufacturing ecosystem and skills base to support domestic manufacturing of medical devices. 3. In addition, global capacities of multinational firms are also boosting imports The Indian medical devices industry comprises four segments – consumables and implants, diagnostic imaging, instruments & appliances and patient aids and, others. In order to bridge the gap existing in medium – high end technology products, an increasing number of multinational companies are establishing and growing their presence in India. Nearly all of the top 40 global medical devices companies today have a presence in the country. The share of multinational firms is around 40% – 50% in consumables and instruments and appliances and, as 80% – 90% in all other sub-segments. Most multinational companies have their production base outside India and import their products for the Indian market. Now, with changing economic and regulatory environment, the medical devices industry is expected to grow significantly, fueled by a range of factors such as: 1. Rising prevalence of chronic diseases resulting in a higher demand for healthcare services 2. Ageing population 3. Increasing income and affordability, resulting in higher demand and utilization of healthcare services: The Government of India has in recent years, implemented several policy measures to address the challenges of medical devices industry. Some of these include: 1. MDR 2017 2. 100% FDI in medical devices under automatic route 3. ‘Make in India’ initiative for promoting indigenous manufacturing 4. The development of a quality standardization framework in India by BIS that is based on international standards and certifies the quality, safety and performance of medical devices November-December 2020

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Availability of advanced and sophisticated medical technology is creating new markets and applications, increasing the dependence of doctors on advanced medical devices, and is leading to rapid obsolescence of existing medical technology thereby creating demand for replacement and up-gradation of products. The increasing penetration of mobile and internet are other important factors contributing to rising awareness and demand. Also the unique Indian ability for frugal engineering innovations has led to the recent development of low cost products that are at par with existing products on quality. The imperatives for the medical devices industry are aligned to the objectives of ‘Make in India’ 1. Availability of Capital and technology investments for setting up manufacturing facilities in India is now available from private and government sector such as TDB in the form of equity and soft loans. 2. India specific innovation to help improve accessibility and affordability of medical devices which is being promoted by BIRAC and ICMR 3. Training and development of human resources for manufacturing, operations and services which is being provided by the Skill Development Council and BCIL 4. Best-in-class infrastructure in compliance with global standards for supporting high-technology industry which is provided in the form of Medical Devices Parks being setup in various states along with common test facilities and single window clearances 5. Support to Indigenous manufacturing in the form of the Public Procurement Policy and Production Linked Incentive Schemes But going further the Challenges across multiple dimensions that are disablers to the growth of indigenous medical devices manufacturing in India need to be addressed. These include aspects around the macroeconomic environment, the medical devices ecosystem and, those specific to the medical devices industry. • Unfavorable duty structure • Low domestic demand for certain product segment(s) • Complexity and lack of transparency in regulation • Absence of comprehensive laws and lax enforcement mechanisms for IP protection • Absence of indigenous ‘quality certification’ authority • Inadequate ecosystem support (suppliers, raw material etc.) for medical device manufacturing • Absence of a structured ‘Innovate in India’ model • Ease of doing business: licensing regime (which includes elapsed time at multiple layers), guidelines on regulatory affairs, layers of bureaucracy (at the center and state level) • Restrictive labour laws • Higher cost of financing To sum it all up demand and supply dynamics provide an unprecedented opportunity for manufacture of medical devices in India as there is Increase in per capita consumption of medical devices and newer market access due to India based innovation which will lead to Shortening of lead-time and better serviciability of products and should serve as a de-risking option for the country in cases of medical emergencies as we face today Capitalizing on these factors, India can move up the technology ladder and focus on manufacturing of even mid and high tech products in the near term As India continues to innovate and develop new technologies,

global demand and potential in the near and medium term will provide India with an opportunity to become a major participant in the global supply chain of medical devices. With success stories from domestic manufacturers, India is steadily developing capabilities in manufacturing medical devices. Indian players have developed expertise in manufacturing products in consumables and implants segment. In the near term, the focus needs to be on manufacturing of mid and high tech products. A key concern for the medical device industry today is that irrespective of the sophistication of technology, all segments and sub-segments of medical devices are being treated uniformly by regulators and other stakeholders in the ecosystem. However, going ahead, as the industry moves towards indigenization, a differential treatment for each segment and subsegment is necessitated. For instance, most products in the high technology segments have a long lead time for development and require large investments. Being low volume products with longer return on investment cycles, such products need to be treated differently, possibly with additional incentives for development and manufacturing. Now as the ecosystem matures to enable indigenous manufacturing of comparable global quality standards, tariffs and barriers need to be used to protect indigenous manufacturing. This would ensure orientation of the industry towards quality, thereby making indigenous manufacturing globally competitive. Also there is urgent need to revise policies to steeply favour made in India Medical Devices.

JIMIT MEDICO SURGICALS PVT. LTD.

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Indian MedTech Industry Ecosystem : Facilitating Growth Mr. Jitesh Shah Managing Director Suru International Pvt. Ltd.

Global Medical Devices Market : • The global medical device market was estimated at USD 228 bn in 2015 (INR 14.82 lakh crores) which has grown tremendously since then • Industry estimates suggest that the global medical device market will grow at a CAGR of 7.8% from 2010 to 2020. • The market is expected to reach USD 332 bn (INR 21.58 lakh crores) by 2021. • The global medical device market is categorized mainly into seven segments as listed below. • Diagnostic imaging • Orthopedic and prosthetic devices • Patient aids • Consumables • Dental products • IV diagnostics • Others • Diagnostics imaging is the largest segment constituting 26% of the medical device market IV Diagnostics 24%

Diagnostics Imaging 26%

54.5 USD Bn

29.

USD

22.

(CATEGORY NAME) (PERCENTAGE)

Dental Products 6%

Bn 13.9 USD n B SD U 68 13.

59.28 USD Bn

34.2

Others 6%

Patient Aids 10%

Consumables 15%

SEGMENT WISE MARKET SHARE OF MEDICAL DEVICES

8.16 8 1.98 0.26 0.57

0.82

3.8

Consumables

0.94

IV Diagnostics 0.12

Country-wise filings were then analysed to have a better understanding of the business interests of different countries in the Indian medical device market and also to evaluate patent applications filed by Indian applicants being a positive indicator of medical device innovation in India. In the last 10 years, around 80% of the patent applications filed in India in the medical device sector were filed by foreign institutes/companies. As per our analysis, patent applications in India by applicants of Indian origin in the medical device sector accounted to only 17% minority share. The Indian medical device sector is highly import dependent with 70%–75% of the demand being met through imports. The finding that about 80% of the patent applications filed in India are by foreign applicants correlates with the Indian medical device sector profile. Most of the foreign companies file patents in India for marketing medical devices in India but they do not have a manufacturing base in India.

USD BN 4

U.K. 3% Japan 4%

1.31

0.27 0.35 0.39 0.63

Orthos and Prosthetics

1.18

Others (Patient Monitor, ECG, Oxygenators etc.

2015

Others 21%

USA 41%

2.47

Dental Products

2020

Germany 5%

Limitation of Medical Device Industry in India : • Not Organized in terms of Manufacturing, very less information currently complied and available in Public domain • Difficulties in understanding International Standards and Indian Regulatory Requirements, lack of professional experience in understanding regulatory requirements • Financing Factory setting up cost – complications in land acquisition

Global patent filing trends in India :

0.75

Diagnostic Imaging

Patient Aids

• Difficulties in getting CE approval and its maintenance specially in the areas of Risk Management, Post Marketing Surveillance and Clinical Evaluation, manpower management, understanding ever changing regulatory requirements • Use of Older Technology in manufacturing and packing • More than 70 to 75 % Import dependent – for components as well as semi assembled products • Lot of unhealthy internal competition between manufacturers leads to manufacturing inferior quality of the products or they are left with not enough margin for plant up gradation / future expansion • Delays from State Govt. in releasing payments for supplies made makes working capital management very difficult for companies engaged specially in supply to state Govt. • Most of the manufacturing is now restricted to low end devices • Use of Old methods in manufacturing compared to Chinese companies with regard to scale and technology • Very limited knowledge of patents and copyrights

India 17%

Europe 9%

Strength and Future Potential : • India is a leader in Pharmaceutical products – India is called “The Pharmacy of the World” and we can do similar wonders in medical device as well November-December 2020

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• Medical device industry now is in the stage where Pharma Industry was in the 1990s • Low cost of production • Inspite of limitations India is world leader in manufacturing several medical devices like Sutures, I V Cannulas etc. • This sector is now under Central Govt. focus for development • Special Medical device Parks are now reality e.g. AP, Gujarat • Availability of skilled Manpower specially for production and Regulatory requirements • Already lot of companies have started manufacturing components in India with continuous improvement in its quality • Several companies have made world class production facilities like HMD – which is supplying syringes to WHO for COVID vaccination programme or POLYMED which is supplying substantial percentage of Infusion devices in Europe or ROMSONS or TERUMO PENPOL OR Sutures India who are leaders in supply of several devices across the world • Govt. of India’s new push for Make in India – which will be a real game changer in a years time Introduction of PLI scheme makes large scale investment in this sector very attractive for MNCs and Local large companies • e.g. Companies like TATA getting into manufacturing Medical devices • Goodwill an Indian product commands compared to a Chinese product for its Quality and Consistency The real challenge would however be in to manufacturing higher value added products like products used in Cardiology, Oncology, Dialysis, making production facilities world class in terms of infrastructure, use of latest technology in manufacturing and assembling, taking regulatory approvals of USA and EU, just like the success story of Pharma products.

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DoP Issues Revised Guidelines For Procurement Of Make In India Medical Devices The Department of Pharmaceuticals (DoP) has issued revised guidelines for implementing the provisions of public procurement (preference to Make in India) Order (PPO)- 2017 DPITT guidelines for procurement of Make in India medical devices. The Department for Promotion of Industry and Internal Trade (DPIIT), pursuant to Rule 153 (iii) of the general financial rules 2017, had issued PPO - 2017 dated June 15, 2017 which was partially modified on May 28, 2018, May 29, 2019 and September

16, 2020. According to Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), “The guidelines on PPO- 2017 are basically to align the PPO of DPITT with earlier guidelines.” http://www.medicalplasticsindia.com/mpds/2020/nov/aimed_re gularoty.htm

Medical Devices Industry Seeks Clarity On PLI Scheme The medical devices industry has sought clarity on the Central government’s claim that medical device sector has been adequately covered under the existing production linked incentive (PLI) scheme unlike pharmaceutical sector for which the Union Cabinet has recently approved new PLI scheme worth Rs. 15,000 crore to boost domestic manufacturing. The Department of Pharmaceuticals (DoP) notified the PLI scheme for the medical device sector through a gazette notification dated July 21, 2020. Total financial outlay for the PLI scheme is Rs. 3,420 crore. The scheme is expected to see investment worth Rs. 5,400 crore, as per government estimates.

Medical device manufacturers had recently urged DoP to consider reducing the threshold investment limit in the range of Rs. 75 to Rs. 90 crore from Rs. 180 crore for domestic manufacturers in the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices. This, according to the Association of Indian Medical Device Industry (AiMeD), will also widen the scope of eligibility to cover COVID-19 utility medical devices. http://www.medicalplasticsindia.com/mpds/2020/nov/aimed_re gularoty.htm

Centre To Amend MDR-2017 To Include Provision To Allow Import Of Medical Devices Having Lesser Shelf-life The Union health ministry will soon amend Medical Device Rules (MDR)-2017 to include the provision for allowing the import of medical devices having lesser shelf-life period but before the date of expiry in exceptional cases based on industry representations. Representations were received from the associations with the request to provide relaxation of residual shelf life requirements

for medical devices and IVDs citing the reason that medical device industry is facing challenges in getting dispatches from overseas manufacturing sites, getting international cargo transportation and clearing the imported devices at port offices due to COVID-19 pandemic across the globe. http://www.medicalplasticsindia.com/mpds/2020/nov/aimed_re gularoty_2.htm

Health Ministry To Remove Requirement Of Audit For Class-A Medical Devices Manufacturing Site By Notified Bodies The Union health ministry may soon remove the requirement of audit for Class-A medical devices manufacturing sites by registered notified bodies based on the recommendation of the Drugs Technical Advisory Board (DTAB). The medical devices division of Central Drugs Standard Control Organisation (CDSCO) has notified 6 bodies to carry out auditing of manufacturing sites as per the provisions of new Medical Device Rules (MDR-2017). The notified bodies registered with

CDSCO are Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, DNV GL, BSI Group India Pvt. Ltd and BSCIC Certifications Pvt Ltd. According to DTAB, it was proposed to remove the requirement of audit of manufacturing site by the registered notified body since Class-A medical devices are least risk prone. http://www.medicalplasticsindia.com/mpds/2020/nov/aimed_re gularoty_3.htm

Centre To Amend MDR 2017 to Include ASTM In Product Standards To Enhance Competitiveness Of Indigenous Medical Devices Centre is planning to amend Medical Device Rules (MDR-2017) to include American Standard Test Method (ASTM) in product standards for medical devices to enhance competitiveness of indigenous medical devices globally. Rule 7 of the MDR -2017 provides product standards for medical

devices. Drugs Technical Advisory Board (DTAB) after detailed deliberation agreed to the proposal and recommended for necessary amendment in the MDR- 2017 in this regard. http://www.medicalplasticsindia.com/mpds/2020/nov/aimed_re gularoty_3.htm November-December 2020

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Industry News Narayana Health And MSMF Team Up With BIRAC To Set Up Advanced Med Tech Innovation Centre The Narayana Health and Mazumdar Shaw Medical Foundation (MSMF) have set up an advanced Med Tech Innovation Centre (MTIC) in collaboration with Biotechnology Industry Research Assistance Council (BIRAC)’s BIONEST. This centre is India's first corporate hospital-based technology business incubator (TBI) for MedTech entrepreneurs working on innovations to address affordability, access and innovation for healthcare challenges. TBI, with a dedicated space of around 8,000 sq ft, will help MedTech entrepreneurs who are looking to address affordability, access and innovation challenges in the healthcare eco-system. It will also augment further the initiatives undertaken by MSMF and Narayana Health towards identifying, mentoring and handholding entrepreneurs and innovators. The space will facilitate close interaction and prototyping facility too for startups. According to Kiran Mazumdar-Shaw, founder, MSMF, “India has the potential to become the next global R&D hub for biomedical devices and health technologies, and the MSMF will help explore this potential. It will provide health tech entrepreneurs a wellequipped incubation space and a collaborative ecosystem. We aim to fill the gap in healthcare innovation to have a single platform for entrepreneurs to co-create and identify clinical

challenges in conjunction with doctors, scientists and technology enthusiasts. The wealth of research and medical data generated at Narayana Health will provide a translational science model, accelerating the lab to market innovative and promising solutions discovered and developed at MSMF”. Dr Devi Prasad Shetty, founder and chairman, Narayana Health said, “Innovation is key to solve the healthcare concerns that we are currently facing. MSMF is here to fill the gap in healthcare innovation by creating a single platform for entrepreneurs to cocreate solutions in conjunction with doctors, scientists and technology enthusiasts. We are hopeful the physical incubator will provide the much needed facilities that startup look for to progress with their innovation. While we have been able to support over 25 startups through our other programs like Clinical Immersion Programme (CIP) and our partnership with VC firms like, Villgro and Axilor. We also have international collaborations too with Japanese and Korean startups through JETRO and GAIN respectively. The physical infrastructure will help us to further strengthen our mission as the infrastructure can support 39 start-ups at any given point of time with the total seating capacity of 82. We are looking at nurturing 10 startups in 2021.” http://pharmabiz.com/NewsDetails.aspx?aid=134168&sid=1

Poly Medicure to Enhance R&D Capabilities To Deliver High Quality Medical Devices Poly Medicure, a leading Indian manufacturer and exporter of medical devices, is planning to invest in newer technologies and is enhancing its R&D capabilities to deliver high quality medical devices at affordable prices. The company is also planning to collaborate and work closely with all stakeholders such as the government, private sector as well as the medical research fraternity to develop new products. "Our business would include releasing new products in the field of renal, respiratory care and diagnostics business. We are also breaking the old boundaries and redefining our model which is clinical focused as even Medtech players need to be more focused on value-based and patient-focused care. To achieve this, we will ensure that user-centered design should begin early and continue throughout device development. The priorities of the clinical users

were identified, as well as a number of factors that would act to the safe and effective adoption of the device," stated Himanshu Baid, managing director, Poly Medicure Ltd. The company will be focusing on the growth prospects in the fastgrowing segments, while maintaining position in the slowgrowing segments. With focus on innovation, safety & quality, the company exports its products to more than 110 countries. The company has 9 ultramodern manufacturing facilities out of which 6 facilities are in India and one each in Italy, Egypt (Joint Venture) and China. Polymed owns more than 215 patents and continues to file new patents for new technologies and devices they are developing with the help of its R&D team. http://pharmabiz.com/NewsDetails.aspx?aid=133137&sid=1

Haryana Set To Become Hub Of Medical Devices As Around 100 Industrial Units Set Up Plants In The State Haryana, the erstwhile popular hub of pharmaceutical formulations in the northern part of the country, is now turning out to be the centre of the medical devices industry to manufacture and sell elite medical diagnostic instruments. Around 100 medical devices industrial units have already established their plants in the state at Karnal. This exponential rise in the number of manufacturing units for medical instruments and equipment is happening at a time when many formulation units are closing down their production facilities and moving out of the business sector due to lack of supportive industrial policies, says P K Gupta, president of the Haryana Pharmaceutical Manufacturers Association (HPMA). He said, among other issues, bureaucracy is the main hurdle for the development of the small scale industry sector in Haryana. “The industry policies of the government most often become

detrimental to the growth of small scale units, or otherwise I would say that bureaucracy is the main hurdle for the growth of the SSI sector. This is not only for the pharma manufacturing industry, but for all the industries. In Haryana, I understand that about 10% of the total units were closed down due to cumbersome regulatory policies and several more units are shrinking now without any growth. The industry cannot survive if there is no business growth as the day-to-day expenses are increasing without limit. In addition to this, the regulatory department is also acting not supportive to the industries.” However, Gupta said, the state government brings out certain attractive projects to retain the existing units and tries to bring more companies to Haryana for a sustainable pharma market. But the implementing agencies do not act properly for the development of the industry. http://pharmabiz.com/NewsDetails.aspx?aid=134315&sid=1

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Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries.

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• • • • • • •

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I.V. Infusion Sets Blood Administration Sets Scalp Vein Set Urine Collection Bags Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.

ISO 9001 – 2015 ISO 13485 – 2012, CE, WHO GMP., MD – 5, MD - 9

• ECG PAPER & ECG ACCESSORIES • ECG PAPER ROLL & Z FOLDING • NASAL CANULA • OXYGEN MASK • NEBULIZER MASK • NEBULIZER COMPRESSOR • MULTI FLOW MASK • VENTURY MASK • HIGH CONCENTRATION MASK • BREATHING FILTER

• • • • • • • • • • • • •

B/PAP & C/PAP MASK COUTRY PENCIL MOUNT CATHETER "T" RECOVERY KIT BREATHING CIRCUIT AMBU BAG BAIN CIRCUIT 3 BALL SPIROMETER PATIENT ID BELT YANKAUR SUCTION SET NEBULIZER CHAMBER GUIDAL AIRWAYS B.P.METER

864/1, Nr. Indian Petrol Pump, Hirapur Char Rasta, Mehemdavad Road, Ahmedabad - 382 435.

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