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Home Explore Medical Plastics Data Service January - February 2016

Medical Plastics Data Service January - February 2016

Published by Medical Plastics Data Service, 2021-04-26 04:49:28

Description: The Only Indian Portal Site On The Medical Plastics/Devices Technology And Trade www.medicalplasticsindia.com

Keywords: medical plastics news, medical device news, medical plastics magazine, medical device magazine, magazine, medical plastics data service, medical tubing, medical grade plastics, medical packaging, sterilization services, I.V. component, medical equipments, clean room supplies, catheters, medical design, implants, medical devices, biomedical technology, regulatory affairs, medical technology, injection molding, medical component, surgical products, plastics, medical plastic applications, machines for medical devices, pharmaceuticals, india, gujarat, ahmedabad

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EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITORS FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) The Theme of this annual conference is,” Indian Medical Device Ms. Bishuna Singh, B.E. (Biomedical Eng.) Industry: Integrating Market, Technology, Innovation and Ecosystem” EDITORIAL ADVISORY BOARD As per Ms Karin Ezbiansky Pavese, vice president of Innovation & Dr. TARANG PATEL Sustainability at the New York Academy of Sciences,”… a system M.B.B.S., M.Ch. (ONCO) truly poised to innovate is one in which the barriers between organizations Cancer & Reconstructive Surgeon and individuals are broken down, where collaboration happens across disciplines and sectors, and where a diverse, democratized culture supports Mr. C. BALAGOPAL risk taking, tolerates failure, and celebrates success. The regions and Director - Enter Technologies Pvt. Ltd. institutions that embrace their importance can gain the competitive Chairman - Mobilexion Technologies Pvt. Ltd. advantage.” Trivandrum While the much acclaimed new national program by Hon. Prime Minister of India, Shri Narendra Modi, is designed, among various other objectives, to foster Innovation, Dr. DILIP H. RAIKER enhance Skill Development, protect Intellectual Property and build Best-in-class Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Manufacturing Infrastructure, there is no better time to brain-storm on how to Former Chief Manager(P), CIPET - Chennai accelerate the process for “Make In India” for the Indian Medical Device Industry. ING LOUIS C. SUHUURMAN However, we are proud to say that this annual event being organized since 2001 Formerly Sales Director has the sole objective of promoting “Make-In-India” mission focused on Medical COLPITT B.V., Holland Disposables and Implants sub-sectors of Indian Medical Device Industry. Pioneer and The only Event of its type focused on promoting manufacturing industry in Dr. A.V. RAMANI India. It is being organized consistently year after year since 2001 with close Group Sr. Vice President (R&D), The TTK Group involvement and support of the Leading Industry Associations both in Medical Devices , Pharmaceuticals and Plastics sectors, Government including Regulatory Agencies, Dr. C.S.B. NAIR Research and Academic Institutes as well as large number of Raw Materials, Director (R&D), Peninsula Polymers Ltd Equipments and Expert Service Providers. Dr. BHARAT GADHAVI From the last year, it has expanded reach to the healthcare professionals through a CEO, Medisurge Hospitals parallel event focusing on, “Safety and Risk Management For Healthcare Professionals”. Healthcare Professionals including Doctors, Nursing Staff as well Mr. A.S. ATHALYE as Technicians face a wide range of occupational injuries and hazards. This Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai conference is being organised to create awareness and devise preventive strategies to minimize these risks. International & Indian Experts from the Industry and leading Dr. SUJOY K. GUHA hospitals will share their knowledge and experience on this critical issue of importance B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. to Healthcare Professionals. IIT, Kharagpur We acknowledge and highly appreciate the kind support from almost 50 Industry Experts not only from all parts of the countries but also from foreign countries Dr. G.S. BHUVANESHWAR including USA, Europe, China , Singapore etc for sparing their valuable time and Director - Innovation & Edn, efforts and sharing their techno-commercial knowledge & vision with about 500 or Trivitron Healthcare Pvt. Ltd., Chennai and more delegates over these two days, about 35 companies for taking active Jt. Co-ordinator - Regulation, AIMED, India. participation in the Technology Show Exhibition, all leading Industry Associations for their kind support, sponsoring and advertising companies for their generous Dr. J. V. Tyagi support in making this event successful. Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] 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-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Jan.-Feb. 2016 21

Programme Schedule 13th National Conference And Technology Exhibition On Indian Medical Devices & Plastic Disposables/ Implants Industry 2016 Feb 12-13, 2016, J. B. Auditorium, Ahmedabad Management Association, Ahmedabad Tentative Programme Schedule Theme: “Indian Medical Device Industry: Integrating Market, Technology, Innovation and Ecosystem” Day -1 : February 12, 2016 Time 9.00 am to 6.00 pm 09:00-09:30 Registration and Welcome Drinks 09:30-11:35 Inaugural Session • Address by Mr. B. Sarkar – Executive Director, Engineering Export Promotion Council (EEPC) India. • Address by Shri H.G. Koshia – Commissioner, Food & Drug Control Administration (FDCA) Gujarat State. • Address by Dr. Kiran Kalia – Director, NIPER Ahmedabad, C/O B.V Patel PERD Centre, Ahmedabad, on the subject Changing Medical Device Industry Scenario in Gujarat. • Address by Mr. Rajiv Nath – Forum Coordinator, Association of Indian Medical Devices Industry (AIMED) & Joint Managing Director, Hindustan Syringes & Medical Devices Limited, New Delhi. • Key Note Address: “Indian Medical Device Industry: Integrating Market, Technology, Innovation and Ecosystem” Dr. Jitendar Sharma - Head, HTD – Health Technology Division, National Health Systems Resource Centre – NHSRC, Ministry of Health & Family Welfare, Govt. of India. • Inauguration and Inaugural Address By Dr. S. Eswara Reddy -- Joint Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare -- Government of India. • Conclusion and Vote of Thanks: Dr. G. D. Agarwal: CMD, G Surgiwear Limited, Shahjahanpur, U.P & Jt. Coordinator, AIMED (Implants), 11:30 -12:00 Comfort Tea & Visit To Technology Display Show 2016 12:00- 13:00 Session I : Panel Discussion Theme of Panel Discussion: “Indian Medical Device Industry: Integrating Market, Technology, Innovation and Ecosystem”. Moderator: Dr. Jitendar Sharma: Head, HTD – Health Technology Division, National Health Systems Resource Centre–NHSRC, Ministry of Health & Family Welfare, Govt. of India, New Delhi. Presentation by Dr. G. D. Agarwal: CMD, G Surgiwear Limited Shahjahanpur, U.P. & Jt. Coordinator, AIMED (Implants), on, “Innovation” only way forward to survive & grow. 1. Mr. Rajiv Nath: Forum Coordinator ,Association of Indian Medical Device Industry (AIMED) & Joint Managing Director , Hindustan Syringes & Medical Devices LTD., New Delhi. 2. Mr. B. Sarkar: Executive Director, Engineering Export Promotion Council (EEPC) India. 3. Dr. Pallavi Kulkarni: Technical Manager, Lubrizol Advanced Materials India Pvt. Ltd. USA. 4. Mr. Ganesh Sabat: CEO, Sahajanand Medical Technologies Pvt. Ltd., Surat. 5. Mr. Anand Srinivasan: Head-Polycorbonate (ISC), Covestro (India) Pvt. Ltd., Maharashtra. 6. Mr. Balram Sankaran: CEO, SCTIMST- TIMED, Trivandrum. 7. Mr. D.K. Sharma: CEO, Sharma Pharmaceutical Pvt. Ltd., Vadodara. 8. Dr. T. S. Kumaravel: Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai. 13:00- 14:00 LUNCH & Visit To Technology Display Show 2016 14:00- 15:40 Session II: Theme: Building Competitiveness Through Innovation in Materials, Machineries & Processes. Session Chairman: Mr. Narasinh K. Balgi: Director, Ferromatik Milacron India Limited, Mumbai. • “Thermoplastics Polyurethanes: Enabling Innovative Competitive Technologies through Advanced Materials” by Dr. Pallavi Kulkarni, Lubrizol Advanced Materials India Pvt. Ltd. USA. • “Process oriented approach for building safer and secure medical devices” by Mr. Shinto Joseph: Director, LDRA Technology Pvt. Ltd. Bangalore. • “Improving Quality, Efficiency and Compliance with Paperless Manufacturing (Manufacturing Execution Systems)” by Mr. Mekala Rao: Founder & President, Atachi Systems Private Limited, Hyderabad. • “How to fulfill biocompatibility in today’s rapidly changing regulatory and scientific scenario?” by Dr. T. S. Kumaravel: Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai. • “Novel Styrenic Block Copolymers and Polyisoprene Rubber for Medical Devices.” by Dr. Manasi Nath: Technical Application Engineer, Kraton Polymers International Ltd. Mumbai. • “Coloration & Modification of Medical Plastics – Managing Risk & New Opportunities.” by Mr. Derrick Chan: Head of Regional Segment Healthcare Polymer Solutions, Asia Pacific, Clariant (Singapore) Pte. Ltd. 16:00- 16:20 Comfort Tea & Visit To Technology Display Show 2016 16:20- 17:00 Session III: Panel Discussion On: “Make-In-India”- Challenges in Successful Implementation. Moderator: Mr. Rajiv Nath: Forum Coordinator, Association of Indian Medical Devices Industry (AIMED) & Joint Managing Director, Hindustan Syringes & Medical Devices Limited, New Delhi. 22 Jan.-Feb. 2016

Programme Schedule Brief Introduction by Dr. Prashant Jha: Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India, Followed by Panel Discussion. Panel Experts: 1. Mr. J. P. Dutta: CEO, Lancer Medical Technology Ltd., Ahmedabad. 2. Mr. Ravi Srivastava: CEO, Omni Lens Pvt. Ltd., Ahmedabad. 3. Dr. Atul Sardana: Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi. 4. Mr. Vipul Sheth: Managing Director, Matrix Meditec Pvt. Ltd., Ahmedabad. 5. Mr. Sanjay Shah: Owner Promoter, Unikal Consultants, Ahmedabad. 6. Mr. Dhiren Mehta: MD, Surgimedik Healthcare India Pvt. Ltd, Mumbai. 7. Dr. Inder Jain: Managing Director, Airways Surgical Pvt. Ltd., Ahmedabad. 17:00- 18:00 Meeting Of “Association for Indian Medical Device Industry (AIMED)” Members. Coordinator: Mr. Rajiv Nath: Forum Coordinator, Association of Indian Medical Devices Industry (AIMED) & Joint Managing Director, Hindustan Syringes & Medical Devices Limited, New Delhi. TECHNOLOGY DISPLAY SHOW 2016 EXHIBITION An Exhibition Displaying Materials, Adhesives, New Technologies, Manufacturing / Testing Equipments, Packaging / Sterilization Equipments And Supplies For Medical Device Industry Participants interested in Biocompatibility training by GLR Laboratories on February 13 may please submit the attached form at the reception before 4:00 p.m. on 12th February, 2016. Day -2 : February 13, 2016 Track I : Time: 10:00 AM to 4:00 PM 10:00-10:30 Registration and Welcome Drink Session Theme: Emerging Technology Trends in MedTech Industry - 1 Session Chairman: Mr. Atul Kanuga: President, IPI & Environmental Committee Chairmain, Plastindia Foundation. 10:30– 13:00 Session I : • “Indian Medical Device Contract Manufacturing: Trends & Opportunities”, by Mr. Manoj Bhardwaj: Managing Director, SMC Ltd., Bangalore. • “Blood is not ketchup! Biocompatible Plastics for Medical Devices” by Mr. Sanjay Chotalia: Manager – Technical Sales & Marketing, Covestro (India) Private Limited, Thane, Maharashtra. • “Opportunities in Medical Textiles Industries” by Dr. Ketan Kumar Vadodaria: Head, Medical Textiles, Coimbatore. • “What Are Investors Looking For In The MedTech Sector” by Dr. Atul Sardana: Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi. • \"Bio-medical Applications of Plasma Technology\" by Dr. Nirav Jamnapara: Scientist, Facilitation Center for Industrial Plasma Technologies, Institute for Plasma Research, Gandhinagar, Gujarat. • “Styrenics solution for Infusion system, Fluid delivery, Respiratory & Drug device” by Mr. Partha Mohapatra: Lead Healthcare (India) & Technical Support, Styrolution ABS (India) Ltd, India 13:00 – 14:00 LUNCH & Visit To Technology Display Show 2016 Session Theme: Emerging Technology Trends in MedTech Industry - 2 Session Chairman: Dr. Hemant Desai: Vice President – Operations, Makcur Laboratories, Ahmedabad. 14:00 – 16:00 Session II : • “Importance of Packaging Material & Sealing; Sterility Monitoring, Preserving & Validation of Sterilization Process” by Mr. Tim Galekop: TiGaMed Consulting, Belgium. • “EU Clinical Explanation Reports (CER) and Literature Review for Medical Devices”, By Dr. Ashok Thakkar: Head, Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi. & Mr. Siddharth Jain: CEO and Chief Regulatory Advisor, Symbiorph Clinical Trialogy, Ahmedabad. • “Voluntary Certification Scheme for Medical Device Industries”, By Dr. Jaishree Kasliwal: Quality Council Of India (QCI). Panel Discussion On: Redesigning the Manufacturing Process to Meet Quality Standards. • Moderator: Mr. Manoj Bhardwaj: Managing Director, SMC Ltd., Bangalore. Panel Experts: • Dr. T. S. Kumaravel: Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai. • Dr. S.S. Murugan: Managing Director, GLR Laboratories Pvt. Ltd., Chennai. • Mr. Jayavanth Kamath: Founder & Principal Consultant, Caliber Assurance Services, Bangalore. • Mr. Ashish Bhutada: CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore • Mr. Deepak Dave: Vice President, Medical Surgical and Healthcare Industries Trade Association, Ashutosh Export International, Mumbai. Jan.-Feb. 2016 23

Programme Schedule Track II : 10:00 AM to 01:00 PM Biocompatibility (ISO 10993) Training, February 13, 2016 at Ahmedabad, India Workshop On Classification, Grouping And Biocompatibility of Medical Devices. Workshop on Biocompatibility - ISO 10993. Will include various Lectures on Classification, Grouping and Biocompatibility, Testing of Medical Devices as well as hands on Training. End of the day with Conclusion and issue of Certificates. Session Co-ordinator: Mr. Sanjay Shah, Managing Director, Unikal Consultants, Ahmedabad. Faculty: Dr. S. S. Murugan, PhD, Managing Director, and Experts from GLR Laboratories Pvt Ltd, Chennai. The Biocompatibility Workshop will be conducted by GLR Laboratories Pvt .Ltd., Chennai is conducting a one day for the benefit of medical devices manufacturers. Biocompatibility testing (ISO10993) is not just a box ticking exercise, but a crucial part of the risk management process (ISO 14971) and ensures the safety of medical devices. Biological Evaluation of Medical Devices is often not well understood and typically falls upon QA Manager to comply with its requirements. This hands-on training course will help participants understand biocompatibility requirements for their medical devices and develop approaches to go about testing their products. It should be noted that not all testing are required to determine the biological safety of medical devices. Depending on the nature of the materials and combina- tions, a literature review and report may be the only justification required to save cost and time on performing unnecessary testing. This course will help you decide if testing is appropriate, and help with researching to generate data for justifications to support a biologically safe device. Attendance certificate will be provided at the end of the training. Who should attend 1. QA managers in medical device manufacturers 3. Senior management 2. Regulatory affair personnel 4. Design engineers Course outcome 1. Good understanding of ISO 10993 4. When to perform the test, and when not to test 2. Understanding of required Biocompatibility tests 5. How to interpret and understand results 3. How to plan and undertake a biological evaluation of a medical device For conference venue on day-2, please check at the reception desk for room nos. for each track on February 12, 2016 at the time of registration. 10:00-11:30 Track III : Student Programme FOCUS: CAREER OPPORTUNITIES FOR BIOMEDICAL ENGINEERS • Entrepreneurial Opportunities in Medical Devices by Dr. Prashant Jha: Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India. • Career Opportunities for Medical Device Software Development by Mr. Shinto Joseph: Director, LDRA Technology Pvt. Ltd. Bangalore. • Career Opportunities in Medical Device Start- up Companies by Mr. Ashish Bhutada: CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore. 12:00-04:00 Sahajanand Laser Technology - SUSHRUTA Innovation Award (SIA): Paper Presentation Competition The Sahajanand Laser Technology - SUSHRUTA Innovation Award (SIA) will be held, to recognize and appreciate students with innovative ideas and concepts having wider applicability to the society for development of Medical Technology products. A jury compromising of experts in the medical device industry and medical professionals will analyze/examine the idea for scientific merit, innovation and commercialization potential. Visit To Technology Display Show Exhibition Technical Poster Display Opportunity For Students Announcement of Winners 13:45-16:15 Valedictory Address Track IV : Safety & Risk Management For Healthcare Professionals Moderator & Session Chairman: Dr. Rajesh C. Shah: President, Gujarat Chapter, Associations of Surgeons of India, Consultant Surgeon, A- Prof. Surgery & Medicolegal Expert, Sheth V. S. General Hospital & Smt. N. H. L. Muni. Medical College, Ahmedabad. • Mr. Tim Galekop: TiGaMed Consulting, Belgium. • Mr. Sumit Marwah: CEO & Director, Dispoline India Private Limited, Dispoline Healthcare Private Limited i2i Consulting, Deccan Crest, Management Consultant & Entrepreneur. • Dr. J. L. Meena: State Quality Assurance Medical Officer, Commissioner of Health, Govt. of Gujarat, Gandhinagar. • Dr. Mahesh Patel: Quality & Patient Safety Officer, Apollo Hospitals International Limited, Ahmedabad • Safe Point India on Injection Safety & Infection Safety by Expert Speaker of Safe Point India. 24 Jan.-Feb. 2016

Invited Speakers & Panel Experts Day -1 : February 12, 2016 Dr. S. Eswara Reddy Dr. Jitendar Kumar Sharma Joint Drugs Controller (India), Head- Healthcare Technology Division & Central Drugs Standard Director- WHO CC for Priority Medical Devices & Health Technology Policy, Control Organisation (CDSCO), National Health Systems Resource Centre, Ministry of Health & Family Welfare Ministry of Health & Family Welfare, Govt. of India Government of India, New Delhi. New Delhi. Mr. H.G. Koshia Dr. Kiran Kalia Mr. B. Sarkar Mr. Rajiv Nath Commissioner, Director, Executive Director, Forum Coordinator, Food & Drug Control NIPER EEPC-INDIA, Association of Indian Administration C/O B.V Patel New Delhi. Medical Device Industry (Gujarat State), PERD Centre, (AIMED), New Delhi, & Gandhinagar. Ahmedabad. Joint Managing Director Hindustan Syringes & Medical Devices Ltd. Dr. G. D. Agarwal Mr. Ganesh Sabat Dr. T. S. Kumaravel Mr. Anand CMD, CEO, Founder Chairman, Srinivasan G Surgiwear Sahajanand Medical GLR Laboratories Head-Poly- Limited Technologies Pvt. Ltd., Pvt. Ltd., carbonates (ISC) Shahjahanpur, U.P. Surat. Chennai. Covestro (India) & Jt. Coordinator- Pvt. Ltd., AIMED (Implants) Mr. D.K. Sharma Mr. Narasinh K. Maharashtra. CEO, Balgi Mr. Balram Sharma Director, Dr. Inder Jain Sankaran Pharmaceutical Pvt. Ferromatik Milacron Airways Surgical CEO, Ltd., India Limited, Pvt. Ltd., SCTIMST- Vadodara Mumbai Mumbai. TIMED, Trivandrum. Dr. Pallavi Kulkarni Mr. Shinto Mr. Mekala Rao Dr. S.S. Murugan Technical Manager, Joseph Founder & (UK and EU Registered Lubrizol Advanced Director, President, Toxicologist), Materials Pvt. Ltd., LDRA Technology Atachi Systems Managing Director, USA. Pvt. Ltd., Pvt. Ltd., GLR Laboratories Bangalore. Hyderabad. Pvt. Ltd., Dr. Manasi Nath Chennai Technical Application Mr. Derrick Chan Engineer, Head-Regional Segment, Dr. Prashant Jha Kraton Polymers Healthcare Polymer Solutions, Fellowship Director, International Ltd., Asia Pacific, School Of BioDesign, Mumbai. Clariant (Singapore) Pte. Ltd. All India Institute Of Medical Sciences, Delhi. Mr. J. P. Dutta Mr. Ravi Dr. Atul Sardana Mr. Vipul Sheth CEO, Shrivastava Director, Managing Lancer Medical CEO, Alfa Corpuscles Director , Technology Ltd., Omni Lens Pvt. Ltd., Pvt. Ltd., Matrix Meditec Ahmedabad. Ahmedabad. New Delhi. Pvt. Ltd., Ahmedabad. Mr. Sanjay Shah Mr. Dhiren Mehta Owner, Promoter, Managing Director, Unikal Consultants, Surgimedik Ahmedabad. Healthcare India Pvt. Ltd., Mumbai. Jan.-Feb. 2016 25

Invited Speakers & Panel Experts Day -2 : February 13, 2016 Mr. Manoj Mr. Sanjay Chotalia Dr.Ketan Kumar Dr. Nirav Bhardwaj Manager – Technical Jamnapara Managing Director, Sales & Marketing, Vadodaria Scientist, SMC Ltd., Covestro (India) Pvt. Institute for Plasma Bangalore. Ltd., Maharashtra. Head -Medical Research, Textiles, Gandhinagar, Mr. Tim Galekop The South India Textile Gujarat. TiGaMed Research Association Consulting, (SITRA), Belgium. Coimbatore. Mr. T. S. Dr. Ashok Mr. Siddharth Jain Dr. Jaishree Kasliwal Kumaravel Thakkar CEO and Chief Quality Council of India Founder Head, Clinical Regulatory Advisor, (QCI) Chairman, Research, Symbiorph Clinical GLR Laboratories Meril Life Sciences Trialogy, Pvt. Ltd., Pvt. Ltd., Ahmedabad. Chennai. Vapi. Mr. Ashish Mr. S. S. Murugan Mr. Sanjay Shah Mr. Jayavanth Bhutada Managing Director, Owner, Promoter, Kamath CEO & Managing GLR Laboratories Unikal Consultants, Founder & Principal Director, Pvt. Ltd., Ahmedabad. Consultant, Health Mantra Chennai. Caliber Assurance India Pvt. Ltd., Services, Bangalore. Bangalore. Mr. Sumit Marwah Dr. Mahesh Patel CEO & Director, Quality Manager, Dispoline Healthcare Private Limited, Apollo Hospitals, I2i Consulting, Ahmedabad Deccan Crest, India Management Consultant & Entrepreneur. Dr. Rajesh C. Shah Mr. Deepak Dave Dr. J.L. Meena President, Gujarat Chapter, Vice President, State Quality Assurance Associations of Surgeons of India, Medical Surgical and Medical Officer, Consultant Surgeon, Healthcare Industries Commissioner of Health, A- Prof. Surgery & Medico legal Expert, Trade Association, Govt. of Gujarat. Sheth V. S. General Hospital & Ashutosh Export Gandhinagar. Smt. N. H. L. Muni. Medical College, International, Mumbai. Ahmedabad. Mr. Partha Mohapatra Dr. Hemant Desai (Lead Healthcare Mr. Atul Kanuga Vice President– (India) & Technical President- IPI & Operations, Support, Styrolution Environmental Committee Makcur Laboratories, ABS (India) Ltd, Chairmain, Ahmedabad. India) Plastindia Foundation. Invited Speakers & Panel Experts : Presentation Abstracts Mr. T.S. Kumaravel, Biocompatibility testing provided confidence to the manufacturer, (Founder Chairman, regulators and the patients that the device is safe for the intended GLR Laboratories Pvt. Ltd., use. Chennai) “How to fulfill biocompatibility in today’s rapidly changing General guidance for biocompatibility testing is provided by regulatory and scientific scenario?” ISO10993, Part 1. The other parts of ISO 10993, Parts 2-20 give guidance on how to perform these tests. There are also other It is the management responsibility to assure the safety of medical guidance that are device specific. These device specific guidance devices that they placed in the market. One of the safety are issued by ISO, regulatory bodies and sometimes scientific requirements is to fulfill the biocompatibility of the medical device. committees can issue recommendations. 26 Jan.-Feb. 2016

Invited Speakers & Panel Experts : Presentation Abstracts Biocompatibility testing and guidance came into use in mid 1990s, biocompatibility experts to review the files submitted to them for when ISO started developing guidelines. Initially the regulators CE marking or 510K/PMA. and notified bodies looked at biocompatibility as a mere box ticking exercise. At that time, certificate that biocompatibility was fulfilled Under these circumstances, it is important for the manufacturers was considered sufficient. With further developments and revisions to understand these changing requirements and prepare their in ISO standards, and further experiences in biocompatibility biocompatibility files accordingly. There is also more emphasis on testing over the last 10 years, the expectation from biocompatibility literature review and risk management approached to fulfil testing has massively increased. The regulators and the notified biocompatibility requirement, without the need for unnecessary bodies have started looking at the biocompatibility reports in greater animal testing. details for scientific and regulatory fulfilments. They are employing In this talk, I will briefly introduce you to these changing regulatory Dr. Manasi Nath, requirements in biocompatibility testing. (Technical Application Engineer, Kraton Polymers International Ltd. (Kraton®ERS SEBS) in transparent medical applications. Due to their cleanness, softness, good processability and excellent Mumbai) compatibility with polypropylene, Kraton ERS SEBS polymers have been widely used, as a toughness modifier for polypropylene, in “Novel Styrenic Block Copolymers and Polyisoprene transparent medical application such as IV bag films, medical tubing Rubber for Medical Devices.” and consumer goods application such as containers, etc. Cariflex®Polyisoprene Products are designed to replace natural Styrenic Block Copolymers (SBCs) and polyisoprene rubber are rubber for producing medical products ranging from surgical gloves suitable for a variety of applications. This paper describes Kraton® and tube connectors to IV bag and medical stoppers, balloon polymers, especially Kraton Enhanced Rubber Segment SEBS catheters, needle shields, dental dams and cohesive bandages. Dr. Pallavi Kulkarni cade with an evolving regulatory landscape. Device design engi- (Technical Manager neers are constantly looking to create the next-generation device Lubrizol Life Sciences, with advanced polymers and materials that offer an edge over Lubrizol Advanced Materials, USA) existing materials. The versatility and tailor ability of thermoplastic polyurethanes has become an essential tool in the design Thermoplastics Polyurethanes: Enabling Innovative engineer’s toolbox. TPUs have successfully replaced PVC for cer- Competitive Technologies through Advanced Materials. tain device applications where regulations prohibit the use of plas- ticizers. In some other instances, TPUs are being used instead of Thermoplastic Polyurethanes (TPUs) are a class of polymers with silicones in next generation devices, thereby providing a competi- unique physicochemical properties. They are inherently strong like tive edge in the marketplace. thermoplastics yet flexible like elastomers, making them the most Lubrizol’s medical grade TPU offer a wide range of chemistries to versatile class of polymers. TPUs are composed of soft and hard choose from depending on the application. Ease of process ability building blocks and the phase segregated morphology of these is key for efficient manufacturing, Lubrizol’s TPUs can be processed building blocks imparts physical properties that cover the entire by standard methods such as extrusion, injection molding, and range of polymers from soft, flexible elastomers to rigid engineered solvent casting. With the addition of Vesta, Lubrizol has gained polymers and everything in between. Additionally, the soft and additional capabilities more towards device manufacturing and hard blocks can be chemically chosen such that they are assembly. Lubrizol is no longer just a resin supplier; it is a biocompatible and biostable, suitable for medical applications. complete Device Solution provider. Medical Device industry has grown exponentially in the last de- challenges time-to-market goals and threatens to explode devel- Mr. Shinto Joseph opment costs. Along with Safety, now Security is also a serious (Director, concern for all and without global safety certifications, today our LDRA Technology Pvt. Ltd., innovations cannot reach global markets. We would discuss in- ternational safety standards like IEC 62304 and secure software Bangalore.) development approaches that could help in accelerating your go to market strategy, while keeping the costs under check. Process oriented approach for building safer and secure medical devices meeting performance and regulatory standards to fulfil the increasingly stringent demands of these global markets. Materials For medical device developers, increased government scrutiny that can help minimize the risks and costs of non-compliance in a and new international standards create a compliance burden that product’s development and lifecycle are vital to this process. Clariant’s package of dedicated service and expertise, product Mr. Derrick Chan reliability and innovative material performance gives the industry (Head, Regional Segment Healthcare Polymer Solutions, the confidence it needs to address risk potential. Asia Pacific, Clariant (Singapore) Pte. Ltd.) 27 “Coloration & Modification of Medical Plastics – Managing Risk & New Opportunities.” Designers and manufacturers of medical devices and pharmaceutical packaging invest significant time and money in Jan.-Feb. 2016

Invited Speakers & Panel Experts : Presentation Abstracts Mr. Sanjay Chotalia challenge today. Let us make durable medical devices to support Manager – Technical Sales & Marketing, the billions. Covestro High Performance Polycarbonate is a proven Covestro (India) Private Limited, choice with 50 years of Makrolon in the global medical market. We Maharashtra. enhance design freedom by weight reduction, heat resistance, toughness & transparency. “Blood is not ketchup! Biocompatible Plastics for Medical Devices” • Replace paper on the manufacturing floors with Manufacturing Execution Systems Individual medical care with increased life expectancy, is a • Continuously improve the product quality with reduced CAPA (Corrective and Preventative Actions) Mr. Mekala Rao • Simplify compliance with global regulatory GMPs and 21 CFR (Founder & President, Part 11 Atachi Systems Pvt. Ltd., • Generate instantly Electronic Device (eDHR) and/ Batch History Hyderabad) Records (eBHR) and Retain them throughout the life cycle of the product Improving Quality, Efficiency and Compliance with Paperless • Improve your bottom line with Manufacturing Operations Manufacturing (Manufacturing Execution Systems) Challenges have been constantly increasing for Medical Device Management coupled with Supplier Quality and Post Market Manufacturers to produce a high quality product with regulatory Surveillance from FDA compliance. Global demand has been putting high pressure on • Reduce your Validation time and Time-to-Market for New the manufacturers to release the new products in short time. Products Regulatory authorities have been releasing and enforcing the stringent regulations for the processes, validations, documentation tubes, DPI inhalers, Airways, nebulizer housing,face masks & res- and record retention requirements. piratory filters. Edical grade styrencis Products are designed to replace PVC & PC for producing medical devices products infu- Mr. Partha Mohapatra sion systems & respiratory device applications. This presentation (Lead Healthcare (India) describes specially opaque & transparent medical grade polymers & Technical Support, in infusion system (Fluid delivery) and respiratory (drug delivery) Styrolution ABS (India) Ltd, device. Our bio-compatible styrenic products have good process- India) ing, high impact strength, surface quality, dimensional stability, high gloss appearance, high stiffness, scratch resistance, resistance to Styrenics solution for Infusion system, Fluid delivery, fluctuating temperature & excellent resistance to chemicals. The Respiratory & Drug device regulatory compliance of our Styrenics are, USP Class VI, ISO- 10993, DMF registration, EUP, JP, Regulation (EU) No.10/2011 Styrenic polymers ( Novodur ® HD ABS, Luran ® HD SAN, NAS statement and FDA (US) statement. ®SMMA, Styrolux ®SBC, Styroflex ®SBC, Zylar ®MBS & Terlux ® MABS) are suitable for medical device application with regula- up. Safety critical industries like Medical devices creates a value tory compliances. These styrenic products have been long used added engineering skills based career opportunity for students. for major medical device applications, such as Infusion set con- Even though a safety critical product development involves nectors, adaptors, Stop cock, Valves, Drip Chamber, Infusion requirement analysis, design, development, testing & certification, the last two consumes more time and money. This forces global Mr. Shinto Joseph players to outsource testing to countries like India. But lack of skills (Director, in international safety & security standards in India, becomes a LDRA Technology Pvt. Ltd., major bottleneck for students getting into this area. This paper Bangalore.) would discuss career opportunities as well as how students and faculties can be prepared to grab these opportunities. Career Opportunities for Medical Device Software Development Changing global economic cycles have created a lot of disturbance in global supply chain as well as in job market. This forces students to look at career alternatives, as conventional IT opportunities dries Dr. Mahesh Patel • Integrating Employee & Patient Safety (Quality Manager, • Healthcare Stress Management Apollo Hospitals, Ahmedabad • Managing SUD’s in Hospital India) • Critical Care Equipment Cleaning Protocol • Patient Medical Device Management Safety And Risk Management For Healthcare Professionals • Management of NSI / Blood or Body Fluid Exposure & Significant In this talk, I will briefly introduce you to the following topics which of Vaccination can be very useful for healthcare professionals in daily routine • Hospital Cleaning or Sterilization Protocol practices. • Hospital Acquired Infection 28 Jan.-Feb. 2016

Invited Speakers & Panel Experts : Profile Dr. S. Eswara Reddy • President of All India Syringes & Needles Mfg. • Visiting professor at School of Health Sciences, (Joint Drugs Controller (India), Association. (AISNMA) Purdue University, USA in 2006-07 Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare • Forum Coordinator of Association of Indian Medical • Awarded 8th “International Prestigious Sardar Patel Government of India, New Delhi) Device Industry (AIMED) Award” for Excellence in Women Empowerment. Dr. S. Eswara Reddy is the Deputy Drugs Controller Of • Jt. Coordinator of Indian Medical Device Regulatory • Awarded the “President Guide award” by His India, Central Drugs Standard Control Organisation, Review Group (IMDRRG) Excellence President of India Shri V.V. Giri Ministry of Health & Family Welfare, Govt. of India. He holds a Masters Degree in Pharmacy and Ph.D. and • Jt. Coordinator of UDAIMED • Received grants for 16 major research projects from has rich experience in manufacturing of pharmaceuti- • A Member of International Association of Safe University Grants Commission (UGC), Department cals, academic and in Regulations. of Biotechnology of Ministry of Science and Injection Technology (IASIT) and served on the Board. Technology (DBT), Govt. of India, Gujarat State He started his career as a Drugs Inspector in CDSCO, • Member of “International Safe Healthcare and HIV Biotechnology Mission (GSBTM) Gandhi Nagar, West Zone, Mumbai in 1998 and has good experience Ministry of Earth Sciences (MoES), New Delhi and in GMP, GCP and GLP audits and promoted as an /AIDS Working Group”. Defense Research and Development Organization Assistant Drugs Controller of India in 2009. • Member of “India Coalition on Injection Safety” (DRDO), New Delhi. • Member of Think Tank Pharma Forum He participated in many national and international semi- Life member of various academic and professional nars / workshops / meetings on various areas of Drugs An active Member of expert committee and Task Force bodies like Indian Science Congress; Society of regulations and undergone training from USFDA, KFDA, for Medical Devices Regulation in India. Biological Chemists, India; Society of Toxicology – India; South Korea and WHO, Geneva. He is regularly invited Indian Association of Micronutrients, New Delhi; and to make presentations at various seminars and work- *********************************************************************** Organization of Women Scientists in Developing World shops. He also published articles in various journals. Dr. Jitendar Kumar Sharma (OWSD), Italy. (Head- Healthcare Technology Division & *********************************************************************** Director- WHO CC for Priority Medical Devices & Health *M**r*.**B**.**S**a*r**k*a**r***************************************************** Shri H.G. Koshia Technology Policy, (Executive Director, EEPC India) (Commissioner, National Health Systems Resource Centre, Food & Drugs Control Administration, Gujarat) Ministry of Health & Family Welfare, Govt. of India Shri B. Sarkar had joined EEPC India in 2001, as Joint New Delhi.) Director (Finance & Accounts) in the Head Office of Dr. H.G. Koshia is currently Commissioner, Food & EEPC India in Kolkata. Being a professionally qualified Drugs Control Administration, Gujarat and his key Re- Dr. Jitendar Kumar Sharma is Head of Healthcare Chartered Accountant and having prior audit experience sponsibilities are Enforcement of “Drugs & Cosmetic Technology Division and Director of WHO Collaborating in various audit firms, Shri Sarkar’s advent to EEPC Act, 1940 and Rules” & Enforcement of “Food Safety & Centre for Priority Medical Devices & Health Technology India as above was quite justifiable. Standard Act, 2006” and rules, in Gujarat State. Policy, at National Health Systems Resource Center, the technical support institution under Ministry of Health & In his professional journey, in EEPC India, Shri He is actively representing nine national and state level Family Welfare, Government of India. He is also Adviser Sarkar was first elevated to the post of Director (Budget committees. He is Chairman of the very important (Health & Medical Technology) to the Hon’ble Chief & Finance) in 2004 and posted to one of the premier committee “Track & Trace”, for preparation of Minister, Govt. of Andhra Pradesh. He earlier served offices of EEPC India in Mumbai for solving various guidelines to prevent of menace of spurious drugs. at Sri Sathya Sai Institute of Higher Medical administrative problems as well as looking after the Sciences, later as consultant to World Bank and then as large section of members of EEPC India in Western He has played a pivotal role in transformation of pharma Consultant to the World Health Organization, Region. He has wide experience in handling and medical devices sectors in Gujarat to emerge as a Geneva. He is Clinical Faculty at University of Adelaide, various policy issues and important high level favorable investment destination with proactive & Australia and program director for Health Technology administrative tasks. He proved himself to be very pragmatic approaches. He was instrumental in the Assessment (HTA) fellowships in India. He has been capable and, subsequently, he was elevated to the implementation of e-governance in FDCA and is an adviser at Health Technology Innovation Centre, IIT position of Addl. Executive Director & Secretary of EEPC winner of one state level and three national level awards. Madras and serves as faculty for National Accreditation India in 2007. With the passage of time, it was an Board for Hospitals (NABH) in India for Medical Devices. important milestone in his career, as it marked the *********************************************************************** He has contributed through several research papers, beginning of 13 years of professional excellence that Mr. Rajiv Nath seven books on health technologies & assessments, six eventually led him to crown the highest Executive Post (Jt. Managing Director, compendiums on technical specifications for medical as the Executive Director of EEPC w.e.f. 1st December, Hindustan Syringes & Medical Devices Ltd. technologies and has been contributor to several reports 2012. He is also concurrently holding the post of the Forum Coordinator on health technologies by International agencies Secretary of the Council. Shri Sarkar has been Association of Indian Medical Device Industry (AIMED)) including WHO. He is a key coordinator of several health instrumental in organising various promotional events technology programs in India and a faculty for courses in India and abroad. He has widely traveled to countries Mr. Rajiv Nath is Jt. Managing Director of Hindustan on health technology policy & assessment in several like Brazil, Venezuela, Turkey, Germany, South Africa, Syringes & Medical Devices Ltd. which is having a countries. Egypt, Thailand, Bangladesh, Thailand, Czech Republic turnover of over 500 Crores & Trustee – Safe Point India etc. EEPC India still has the highest membership and – a CSR Initiative of HMD (Hindustan Syringes & *********************************************************************** is a highest foreign exchange earner of the country that Medical Devices Ltd.). He is President of All India Prof. Kiran Kalia possibly a Council can boast of. Syringes & Needles Mfg. Association. (AISNMA) & as (Director, well as the Founder and Forum Coordinator – National Institute of Pharmaceutical Education and Shri Sarkar is a true music lover and is fond of reading Association of Indian Medical Device Industry (AIMED) Research (NIPER), Ahmedabad, Gujarat, India various books. He also loves traveling. All these habits with over 350 Members nationwide whereby Medical Professor in Biochemistry,Sardar Patel University, perhaps keep him going in spite of all the constraints Device Manufacturers all types of technologies have VallabhVidyanagar, Gujarat, India) and rigors that his present position demands. been attracted nationwide on one Platform. • Ph.D. degree from Industrial Toxicology Research *********************************************************************** As Forum Coordinator of AIMED, Mr. Nath has taken Centre, Lucknow, India’s most prestigious CSIR Mr. Narasinh K. Balgi many initiatives of establishing a Collaborative Research Institute in 1986 (Director, Framework with various Dept. of the Govt. and Media Ferromatik Milacron India Limited, Mumbai) to bring to their attention issues troubling the industry • 34 years of research and 29 years of teaching and attract investments into India in his quest to make experience N.K. Balgi is Director on Board of Ferromatik Milacron India as the Preferred Manufacturing Destination and India Pvt. Ltd (FMIPL). He holds Bachelor degree in the leading Supplier of Medical Device Worldwide. • 67 publications in various national and international Engineering. peer review journals Position held : He has been serving the Plastics Industry for the last • Jt.Managing Director of Hindustan Syringes & Medical • 75 presentations at various national and international 42 years and has wide-spread experience in Quality symposiums and conferences and 3 chapters in book Assurance, Manufacturing Systems, Technology Devices Ltd. (HMD) published by International Publishers. 29 Jan.-Feb. 2016 • Delivered plenary lectures / Lead lectures at various international conferences in last ten years at Malaysia, Singapore, Czech Republic, France, China and USA.

Invited Speakers & Panel Experts : Profile Management and has exposure to Sales & Marketing, of innovative manufacturing of orthopedic implants. He Product Development. Alfa Corpuscles is backed by the Finance, Human Resource Development & traveled across the globe in search of business and Technology Development Board, DST, DBT, ICMR and Organizational Development. learned dynamics of international business. GVFL. Mr. Sharma has to his credits the vast experience of He has three national patents for his invention of the Klockner Windsor India and Larsen & Toubro - Plastics more than 25 years of working in the field of Orthope- “Laparoscopic Access Trocar”, “Safety Syringe” and Machinery Division, before taking over leadership dic Implants. Mr. Sharma’s visionary approach to serv- “Oral Vaccine Reconstitution & Delivery Device” and position at Ferromatik Milacron India. Under his ing his clients has enabled him to anticipate and meet one PCT filed for his invention of the “Safety Syringe”. leadership the company has attained leadership position the changing imperatives of the marketplace. His efforts on the safety syringe have been in the Indian market and has spread its presence over As an entrepreneur, Mr. Sharma embodies the creativ- acknowledged by the “Wellcome Trust, UK” and the 46 countries. He is recipient of “The James A.D.Geier ity and innovation that keeps his company ahead in the invention has been awarded the Silver Prize at the Seoul Leadership Award” - an award instituted by Milacron in competition, along with the reliability and trust that International Invention Fair 2012. the name of their outstanding leader - in the year 2008. clients and employees value. He has prepared “SHARMA ORTHOPEDIC” for continual growth by *********************************************************************** Industry Representations: developing its distinctive business model, client Mr. J. P. Dutta • Fellow Member of Indian Plastics Institute [IPI] relationships and depth of staffing expertise. (CEO, • Member of Society of Plastics Engineers. Lancer Medical Technology Ltd., Ahmedabad) • Member of Regional Advisory Committee of IGTR. *********************************************************************** • Member of Regional Advisory Committee of C.I.P.E.T. Mr. J. P. Dutta is presently working as CEO, with Lancer • Immediate Past Chairman of Governing Council, Mr. Balram Sankaran Medical Technology Ltd. since June 2011. He looks af- (CEO, ter the overall goal setting, future technology develop- Indian Plastics Institute SCTIMST- TIMED, Trivandrum) ment, Image building and making the operation profit- • Convener and Founding Director of Plastics able. The company has one of the best facilities Mr. Balram Sankaran is Chief Executive Officer of amongst the Indian Medical Device manufacturers. The Machinery Manufacturers Assn. SCTIMST-TIMED, a national technology business company works closely with physicians and engineers • Member of Governing Council of Capital Goods Skill incubator dedicated to promote start-ups and to understand the need of the type of products to entrepreneurship in medical devices and biomaterials develop which should meet patient’s requirement. The Council (CGSC) promoted by Sree Chitra Tirunal Institute for Medical goal is to Improve the quality of life for patients at an Sciences & Technology (SCTIMST), Trivandrum with affordable cost. D***r*.*P**r**a*s**h**a*n**t**J**h**a************************************************ support of DST, Govt of India & KSIDC. He is also (Fellowship Director, Scientist-G at SCTIMST and has over 20 years of *********************************************************************** School of International BioDesign experience in the area of technology transfer and Mr. Ashish Bhutada All India Institute of Medical Sciences, Delhi) commercialisation of medical devices. His interests (CEO & Managing Director, include Medical Devices Testing &Regulation, Health Mantra India Pvt. Ltd., Bangalore) Dr. Prashant Jha is a physician-engineer with over a Intellectual Property Rights and technology Incubation. decade of trans-disciplinary experience in patient care, He is a member of the working group of Materio- Outstanding performance in every role year after year, training physicians, innovating medical technologies, vigilance programme of India. He has received experience in leading large cross-functional teams for training med-tech leaders and creating an ecosystem fellowships for training in Japan, USA and UK and is a critical projects, along with practical experience in for innovating medical devices and technologies in post graduate in Engineering. following areas gives him the confidence for taking up Australia, India, Japan and USA. bigger leadership challenges: *D**r*.*A**t*u**l**S**a**r*d**a*n**a***(*M**B**B***S**,*M***S**,**F*I*A**G***E**S**)***************** He serves as the Fellowship Director of Medical (Chairman, Building a new business from scratch, Campus recruit- Technology Innovation Program at AIIMS Delhi, where Alfa Corpuscles Pvt. Ltd., New Delhi.) ment, sales team building, marketing management, he trains physicians, engineers, designers & product management, new product launch, sales entrepreneurs in the art & science of innovating & Dr. Atul Sardana is a minimal access surgeon with a programs, leading cross-functional teams, market commercializing healthcare innovations. He also serves knack for applying technology to conventional surgical research, pricing strategy, competitive response, a visiting faculty in several Medical, Engineering & principals which benefits patients. Dr. Atul Sardana has branding analysis, financial analysis, nationwide sales Business Schools in India as well as in Japan, UK, been working in the health care sector since 1990 force training (US based), increasing sales rep Australia & USA. starting as a social worker in one of Delhi’s large productivity, coaching, motivating, engineering projects, government hospital. He is currently a Senior Consultant field sales, account management, retention strategies, Dr. Jha is the co-founder and editor of BMJ Innovations, Surgeon at Sir Ganga Ram Hospital and Apollo Spectra accounting management, finance, effective negotiating, world’s first general medical journal on innovations in Hospital at New Delhi. He has over 30 national and customer service, efficiency improvement projects, healthcare. He also serves as an advisor to various international clinical publication and presentations and change management, six sigma green belt. NGOs, Medical Device Corporations and MedTech is an honorary member of the World Association of StartUps. laparoscopic Surgeons, and a member of the Indian *********************************************************************** Association of Gastrointestinal and Endoscopic Dr. T. S.Kumaravel *********************************************************************** Surgeons. (Founder Chairman, Mr. D. K. Sharma GLR Laboratories Pvt. Ltd., Chennai) (CEO, He was awarded the fellowship of Indian Association of Sharma Pharmaceutical Pvt. Ltd., Vadodara) Gastrointestinal and Endoscopic Surgeons in 2007. He Dr. T. S.Kumaravel is the Founding Chairman of GLR was actively involved in training of surgeons in the field Laboratories Pvt Ltd. Dr. Kumaravel is American Board “SHARMA ORTHOPEDIC\" - RICHEST SHOULD of Advanced Solid Organ Laparoscopic Surgery, Endo certified and UK/Eurotox Registered Toxicologist with PREFER AND ANYONE CAN AFFORD” stapling Principles and Techniques, and Laparoscopic more than 20 years experience in industry as well as in Hernia Surgery at Ethicon Institute of Surgical academia. He is a leading expert in Biological Safety Mr. Dayanand Sharma, the CEO of “SHARMA PHAR- Education, New Delhi and is a faculty for the conduct of Assessments, Biocompatibility studies and developing MACEUTICAL PVT LTD” is at the helm of the company’s the fellowship of Indian Association of Gastrointestinal strategies for testing medical devices. He obtained his operations. His enterprising skills and experience in the and Endoscopic Surgeons. He is also an active member Bachelor's degree in Medicine and Surgery from Stanley industry continue to play a pivotal role in the company’s of AIMED (All India Medical Device Manufactures Medical College, Doctoral degree in Pharmacology/ growth. He has played an active role in acquiring Association). He is a certified internal auditor of quality Toxicology from University of Madras and finally ob- “SHARMA ORTHOPEDIC” the reputation of a leading management systems for medical device manufacturing tained PhD in Genetic Toxicology/Cancer Genetics from brand in orthopedic implants and making the strong as per ISO 13485:2003 from TUV SUD. MGR Medical University, Chennai. He then carried out presence across India and emerging as a fast growing toxicology research at Hiroshima University, Japan; brand across the Globe. He served as the head of Technical operations at National Institutes of Health, USA and Princess Marga- He started his career with grass root working including Biosurge Technologies, Mumbai and later was the ret Hospital, Canada. Subsequently, he has worked with working long hours on manually operated conventional founder chairman at Alfa Corpuscles Private Limited world leading contract research companies such as machines and assembly of the orthopedic implants. where he currently serves at the Head for R & D and Covance Laboratories and Huntingdon Life Sciences, While the evolving technology he came up with new where he worked with various international medical concerns, redefined goals, advanced technology, inno- vative materials. He bought all kind of technical Jan.-Feb. 2016 changes, process up-gradations and mastered the art 30

Invited Speakers & Panel Experts : Profile devices clients. He has extensive experience in Coimbatore. He is in the field of textiles for more than 9 Tim is attending the INDA, EDANA and SBA (Sterile Biocompatibility studies, advising clients on their years and has worked in manufacturing, R&D labs, Barrier Association as a board member) meetings. Tim requirements to comply with national and international Quality Assurance, Technical Services, Teaching, led EDANA’s Task Force infection prevention guidelines. Additionally, he has experience of manag- Consultancy etc. conference – “ IN CONTROL” in the role of Chairman. ing regulatory submissions for FDA and EU. He has authored several confidential reports, 40 peer-reviewed This has given him a vast exposure to various Tim now consults with some of the most respected publications and has 50+ conference papers to his techniques in short staple fibre spinning, weaving, companies worldwide. name. garment making, melt spinning as well as advanced electro-spinning in various parts of the country and *********************************************************************** *********************************************************************** abroad. Mr. Sumit Marwah CEO & Director, Mr. Sanjay Y Shah He has obtained his Masters and Bachelors in Textile Dispoline Healthcare Private Limited, (Owner Promoter, Engineering from M.S. University of Vadodara, Gujarat. I2i Consulting, Unikal Consultants, Ahmedabad) He did his Doctorate in Textiles in Nanotechnology & Deccan Crest, Smart Fibres from Herriot-Watt University, United Management Consultant & Entrepreneur. Mr. Sanjay Shah has experienced regulatory Kingdom. consultants for In the field of Single Use Medical Devices And Infection 1. Medical Devices of various classification and He has presented papers in national / international Prevention for the past 17 years, as a Manufacturer, seminars & Conferences. He has also published national Consultant & Trainer. applications. Devices including cardiac (drug device and international journal papers. He is also invited for combination products), ophthalmic, orthopedics, lecturers in conferences / seminars. Committed to Medical Education Programmes and have IUDs, pain management devices, surgical & taken programmes at various International Conferences, transfusion devices etc. *********************************************************************** Forums and Hospitals across the globe. Special focus Compliance for international registrations in Mr. Siddharth Jain on Education through Creative Learning Programmes. European and Latin American countries and device (CEO and Chief Regulatory Advisor, These are done uner the aegis of THE INPREV certifications like CE marking, US FDA registrations Symbiorph Clinical Trialogy, Ahmedabad) FOUNDATION. (510k), China CFDA. Regulatory Compliance advisor for medical device Siddharth Jain is CEO and Chief Regulatory Advisor of Interests in OT, CSSD and Sterilization with specific plants in India, USA, European countries, Middle Symbiorph Clinical Trialogy. He is based in Ahmedabad reference to Infection Prevention. Eastern countries and Indian CDSCO. and has extensive experience in Medical Device Clinical 2. Consulting in Drug Master File (DMF) for US-FDA Evaluation Report Preparation, Post Market Clinical Pioneered Customised Pre Sterile OT / Procedure Kits for active pharmaceutical ingredients (API) and 510k Follow-up (PMCF), Risk Management, CE Certification in India, and developed a low cost model of Design, US FDA CDRH regulatory submissions. and Global Product Registration in Latin America, GCC, Manufacturing and Distribution for the same. 3. Projects related to international technology transfers MENA, South East Asia and US FDA. He has total 04 and setting up new plants for medical devices like years of experience in Medical Device Regulatory Affair Active Member of various Medical Device - industry and Drug Eluting stents, Ophthalmic Implants (IOL), Compliance and currently advising many Orthopaedic regulatory bodies, with a vision to form a Comprehensive Orthopedic implants, IUDs etc. Implant Manufacturers, Disposable Manufacture and Medical Device Regulation for India and assist the Laparoscopic Instrument & Equipment Manufacturer medical device industry to produce products with He has wide experience in consulting for Quality across India. He has done Post Graduate in adequate and appropriate controls and systems for Management System implementation & audits as per Microbiology from the B.R Doshi School of Bioscience, ensuring patient and staff safety. ISO 9001 & EN ISO 3485. Sardar Patel University, Vallabh Vidyanagar and further did Post Graduate Diploma in Clinical Research from *********************************************************************** Expert team in auditing degree of company’s Xcellon Institute, a sister concern company of Claris Mr. Manoj Bhardwaj compliance to the standards and regulations: ISO 9001, Pharmaceuticals affiliate to Ganpath University. He has (Managing Director, ISO 13485, Quality System Regulations & c-GMP. also published his research paper on Naphthalene SMC Medical Manufacturing, Degradation by Bacteria Consortium (DV-AL) developed Bangalore) Consulting and auditing for c-GMP of Medical Device from Alang-Sosiya Ship breakage yard, Gujarat in & API Plants. Science Direct Journal. Manoj Bhardwaj is the Managing Director of SMC Medical Manufacturing headquartered at Bangalore, Consult in registering R&D Centres of Pharma, API, *********************************************************************** India. Chemicals and Medical Device companies. Mr. Tim Galekop (TiGaMed Consulting, SMC Medical Manufacturing is a fully owned subsidiary Unikal Consultants is an Indian representative of Obelis, Belgium) of SMC Ltd headquartered in Somerset, Wisconsin US. S. a. Brussels based European Authorized Rep. The core competencies of SMC Ltd spans across company. Mr. Tim is regarded as a Global Expert in the field of medical device design, tool design and build, molding, Infection Prevention and Sterilization In his last role Tim manufacture and assembly of medical devices as well *********************************************************************** was Responsible for Global Technical Support and as industrial automation and robotics. Mr. Derrick Chan Regulatory affairs and has been working in the medical (Head, Regional Segment Healthcare Polymer field for more than 30 years. Manoj is a polymer engineer with over three decades Solutions, Asia Pacific, Clariant (Singapore) Pte. Ltd.) experience in Manufacturing, Consulting and IT sectors. He is a member of the Dutch Norm group from the day Manoj has hands on experience in compounding of Mr. Derrick Chan earned his Master of Science in of foundation in 1980 and has participated in the German polymers, alloys and blends as well as downstream Polymer Technology from Loughborough University in DIN, and the French AFNOR. polymer processing operations like extrusion, injection the United Kingdom. Since joining Clariant in 2010, he molding, welding, machining, printing, decoration, etc. has held various technical and marketing positions in Since 1988 he is convener of TC 102 WG 4 Packaging He also has experience in manufacture of extrusion and the company’s Master batches business unit. Mr. Chan Materials, Tim is as well a participant in ISO TC 198 injection molding machines, product design, mold design is currently the Asia Pacfic Regional Segment Head for WG 7 Medical Packaging and CEN TC 205 WG 14 and mold making. the business unit’s Healthcare Polymer Solutions Surgical drapes and gowns. segment. Besides polymer science, Manoj’s background includes Over the years he has visited many hospitals globally business strategy consulting, business process *********************************************************************** and spoke on numerous international conferences. consulting, supply chain and logistics, new product Dr. Ketankumar Vadodaria During his stay in India he has spoken in various introduction, lean manufacturing, program management (Head, conventions and visited several hospitals and surgeons as well as IT/ ITeS consulting, infrastructure and Medical Textiles- The South India Textile Research in Delhi, Chennai, Bangalore, Kolkata, Hyderabad and services. Association (SITRA), Coimbatore) Mumbai among other cities. *********************************************************************** Dr. Ketankumar Vadodaria is heading Centre of Tim is committed as well to several medical education Mr. Dhiren Mehta Excellence – Medical Textiles Division at The South programs and has published several publications. (Managing Director, India Textile Research Association (SITRA), Surgimedik Healthcare India Pvt. Ltd. Mumbai & Surat) Jan.-Feb. 2016 31

Invited Speakers & Panel Experts : Profile Mr. Dhiren Mehta is a B.Chem Engineering with 27 years symposia as an invited speaker. He has been previously employed, with increasing in Medical Device industry. responsibilities by medical device manufacturers and *M**r*.**S**a**n**j*a*y***C**h**o**ta**l*i*a******************************************** services, such as Wipro Technologies, GE Healthcare Currently he is the Managing Director of Surgimedik (Manager – Technical Sales & Marketing, and L&T Medicals. Healthcare India Pvt Ltd (Mumbai & Surat.) Covestro (India) Private Limited) He has worked in Medical Devices such as Patient *********************************************************************** Sanjay Chotalia is MBA in Marketing, Bachelors in Monitoring Devices, Ultrasound / CT scanners, Drug Dr. Pallavi Kulkarni Polymer Engineering from Pune university and Diploma delivery systems, Implantable pacemakers, leads, (Technical Manager Lubrizol Life Sciences, in Plastics Engineering from Mumbai university. defibrillators, Mobile c-arms, endoscopes, energy based Lubrizol Advanced Materials, USA) devices, Home monitoring devices etc. He has total 8 years of experience in Technical Sales Dr. Pallavi Kulkarni is Technical Manager at Lubrizol and Application Development of Engineering Plastics He has handled over 100 projects for Medical Devices Advanced Materials Life Sciences division. Her area of like Polycarbonate, Nylons, PBT, Polyacetal etc. Manufacturers, Pharmaceutical, CRO and IVD expertise is in developing thermoplastic polyurethanes manufacturers. for medical applications. He has been working with Covestro India Pvt. Ltd., for more than 3 years as Manager – Technical Sales & *********************************************************************** Pallavi obtained her PhD in Chemical Engineering from Marketing for west India region, Handling Polycarbonate University of Toledo, Ohio, USA followed by a 2 year resin with the Major focus on Medical & Electrical Dr. Nirav Jamnapara post-doctoral fellowship at University of Massachusetts, segments. (Scientist, USA. Over the past decade she has gained knowledge Institute of Plasma Research, Gandhinagar) and experience in polymer chemistry, processing and *********************************************************************** structure-property relationship. She is the author on Mr. Shinto Joseph Dr. Nirav is a metallurgist with over 15 years of several research articles as well as inventor on several (Director, experience. He is a doctorate from IIT Bombay and patents. LDRA, Bangalore) presently working at the Institute for Plasma Research, Gandhinagar. He is taking care of the technology Pallavi has contributed to the commercialization of Mr. Shinto Joseph is Operations and Sales Director at transfer portfolio of the Institute for Plasma Research. several products at Lubrizol, and is a subject matter LDRA Technology Pvt. Ltd, Bangalore. He holds a He works exhaustively on expanding novel applications expert in thermoplastic polyurethanes and their B.Tech from Kerala University and MBA from Christ of plasma technology for diversified applications such applications specifically for medical devices. As a senior University, Bangalore. With over 18 years of experience as space, environment, defense, power sector etc. scientist, her role is to develop novel polyurethanes for in supporting and implementing embedded software Though his core expertise is in high temperature un-met market needs and to explore new areas of lifecycle solutions, Shinto has built a solid reputation at materials and coatings for extreme environments such application for existing polymers. She is also actively the forefront of embedded systems working with cross as fusion reactors, one of his key areas of interest is involved in Lubrizol’s regulatory efforts in manufacturing border delivery teams, technology partners and industry the development of plasma technologies specific to excipient GMP grade materials and preparing DMF files. regulators within the defence, aerospace, nuclear, rail biomedical applications and water. He has over 11 The medical device market in India is growing with an and automotive sectors. Today he concentrates on publications and 1 patent to his credit. He is the evolving regulatory landscape, requiring component creating a healthy ecosystem in the embedded, mission secretary of Gujarat Chapter and board member of India manufacturing using engineered polymers versus and safety critical domains in India. National Council of ASM International, USA - the globally commodity plastics. Pallavi is working extensively with renowned materials information society. He is the Indian medical devices manufacturers and assisting *********************************************************************** corporate member of Institution of Engineers (India) and them in introducing complex technology to manufacture a certified Chartered Engineer. specialized medical devices. She is helping customers Mr. Mekala Rao adopt TPU based manufacturing and critical (Founder & President, *********************************************************************** components sourcing through Vesta Inc. Atachi Systems, Hyderabad) Dr. J. L. Meena (State Quality Assurance Medical Officer, *********************************************************************** Mekala Rao is the Founder and President of Atachi Department of Health & Family welfare, Dr. Manasi Nath Systems. Mekala has more than 20 years of expertise Govt of Gujarat, India) (Technical Application Engineer, in designing and deploying the shop floor systems for Kraton Polymers International Ltd. Mumbai) the world’s leading medical devices and diagnostics Dr.Jitu Lal Meena is the State Quality Assurance Medi- companies in US, Canada and Europe. Mekala’s cal Officer, Department of Health and Family Welfare, Dr. Manasi Nath is currently working as Technical expertise comes from streamlining the manufacturing Government of Gujarat and monitors the whole Quality Application Engineer– with Kraton Polymer International operations by reducing the wastage on the floor, product Improvement Programme (NABH / NABL / 5 S / Kaizen Limited, India. In her present role, she is actively recalls and ensuring the FDA compliance for the medical / IPHS/ Family friendly / BMW / Radiation safety / Fire involved in Application & Product Development with key devices and diagnostics and Pharmaceuticals. Atachi safety / Mahatma Gandhi Swachhta Mission / National focus on new Business Opportunities for Kraton has an innovative MES software NGIMES (Next Quality Standards etc.) in the Department of Health & Polymer. Generation Manufacturing Execution System) that is Family Welfare, Government of Gujarat. built on the cloud using the latest In-Memory computing Dr. Manasi Nath is M. Tech and Ph. D in Polymer technologies that brings traceability, compliance, faster Dr. Meena has wide-ranging exposure (e.g. from bot- Technology from renowned University of Chemical NPI (new product introduction), with IT simplification and tom level Primary Health Centre, India to world Top level Technology (U.I.C.T.), Mumbai. She had varied cost-effectiveness to the manufacturing floors. Johns Hopkins University, USA). He is working in experience of Research & Development to Techno- Quality Healthcare service science 2002 in the public commercial Activities. Her research interests are in *********************************************************************** healthcare sector, Government of Gujarat. Specialty Polymer, Polymer Modification, Polymer processing and Polymers in Healthcare sector. She has Mr. Jayavanth Kamath Dr. Meena led to prepare the Quality Standards in Re- a diverse Techno- Commercial experience in the field (Founder & Principal Consultant productive and Child Health programme (RCH) and of Polymers. Caliber Assurance Services, Bangalore) National Accreditation Standards (NABH) for Primary Healthcare Centre / Community Health Care Centre. Prior to the current portfolio, she worked as a Senior Mr. Jayavanth Kamath (Jay), Sr. Principal Consultant, He is also led to awareness of the Quality Healthcare Technical Manager – Application Development with Fine Medical Devices Practice, currently provides service (NABH / NABL) in the public health sector in Organics, Mumbai for four years. She also worked as a Engineering, R&D, Quality and Regulatory compliance India. project co-coordinator of an innovative highly reputed consultative services to global medical device World Bank Project at IRMRA through National manufacturers, and also has an accomplished record Dr. Meena is winner of several prestigious awards and Agricultural Innovation Project of Govt. of India for few with more than 24 years of experience with Class I/II/III recognitions. During his leadershipnumbers of the years. medical devices, In Vitro diagnostics, and Government facilities are accredited as per NABH / pharmaceuticals in the areas of Systems Engineering, NABL and make a history in India. Under his leader- Earlier, she worked as a Research Scientist with Quality Assurance, Regulatory Affairs and Compliance. ship Government of Gujarat is also the winner of “Baerlocher” Research Centre, Mumbai. He currently runs Caliber Assurance Services several prestigious awards for Provide Quality (CALIBER), a consulting firm focused on R&D, Healthcare Service. She has presented papers in various International Engineering, Quality, and Regulatory Assurance Services. He is an MBBS, PGQM & AHO, NABH Assessor, 32 Jan.-Feb. 2016

Invited Speakers & Panel Experts : Profile Member of NABH Accreditation Committee – Quality tional client audits. He was also a member of CPCSEA He has travelled widely in about 90 countries across Council of India & Member of the Quality Assurance guidelines committee, which over sees the animal U.S., Latin America, Europe, Africa, Middle East, UAE, Expert Group, Ministry of Health & Family Welfare - experimentation in India. Korea, China and many other Asian countries. Government of India. *********************************************************************** *M**r*.**V**i*p**u*l**S**h**e**t*h************************************************** *********************************************************************** (Managing Director, Mr. Anand Srinivasan Matrix Med Tec Pvt. Ltd., Ahmedabad) Dr. Mahesh Patel (Head-Polycarbonates ISC (Indian sub-continent), (Quality Manager, Covestro (India) Pvt. Ltd., Maharashtra) Vipul Sheth is Managing Director of Matrix Meditec (P) Apollo Hospitals, Ahmedabad India) Ltd – the company engaged in manufacturing and ex- Anand Srinivasan is the Head of Polycarbonates ISC porting of orthopaedic implants and instruments. He is Dr. Mahesh is Quality & Patient Safety Officer at Apollo (Indian sub-continent). A Chemical engineer by training, also heading company named Life Sight Surgicals (P) Hospitals International Limited, Ahmedabad, a pioneer Anand joined Bayer Corporation at Pittsburgh post his Ltd - a company engaged in manufacturing and trading and one of the largest healthcare groups in Asia. He is Master’s Degree from Penn State University, USA in of Ophthalmic Instruments and intra ocular lenses. He associated with Apollo Hospitals Group for more than 7 1998. He started off as a process engineer, and moved has significant contribution in bringing and educating years, where he is playing a leadership role in designing on to project engineering. phaco emulsification technique in India. and instituting systems that promotes patient safety. He is a key member of various Operational & Quality The next opportunity was at the Baytown Texas He is a distinguished personality in the field of medical Steering committees and is actively involved in (Covestro) site, where he was the Air Compliance lead. devices & instrumentation having experience of more implementing Quality Improvement & Patient Safety In 2009 he decided to move back to India and took up than 20 years. He has been representing CARL ZEISS, Initiatives. He has worked extensively on setup quality the commission of a new molecule, as plant manager at Germany for more than a decade. He has also attended management system including indicator monitoring. the Agro plant in Ankleshwar, Bayer CropScience. numerous workshops / seminars organized by SYNTHS, ZEISS in Davos, Switzerland, USA Germany. Dr. Mahesh Patel has a medical background and After production, Anand headed the Supply Chain Mr Sheth is a science graduate and his company Ma- management credentials from Apollo Institute of Center for Covestro India (formerly Bayer trix Meditec is actively involved in bringing new / unique Hospitals Administration, Hyderabad. He is also serving MaterialScience). He was instrumental in establishing technologies in the field of orthopaedic implants and as a Visiting Faculty & External Examiner at Dept. of the nicer globe initiative, where chemical companies instruments. Hospital Management, Hemchandracharya North have come together for a common vision, to address Gujarat University (HNGU), Patan since year 2009. transportation distribution safety in India. *********************************************************************** Mr. Sanjeev Rajput Dr. Mahesh has presented many papers pertaining to He has actively lead initiatives at the Texas Chemical (Founder, his field, delivered talks on Quality Improvement and Council and now participates at the Indian Chemical Balaji Concepts, Vadodara) Patient Safety and has many publications too. Council. Mr. Sanjay Rajput is Founder of Balaji Concepts, His special interest includes Lean Management, Anand recently took over the position of heading the Vadodara, and Partner in Excel Balaji Sterilization Con- Process & System Innovations through IT, Hospital Polycarbonates business for the Indian sub-continent. cepts, Manufacturer of Industrial & Hospital size ETO Operations, Accreditation, Quality Management He lives in Thane with his wife and 2 little kids, and is a Sterilizers, ETO Scrubbers and ETO Sterilization Systems, and Healthcare Quality Training. musician, artist, and a fitness fan. services Provider, Ahmedabad. *********************************************************************** *********************************************************************** Mr. Sanjeev Rajput is having experience of more than Dr. Ashok Thakkar Mr. Ganesh Sabat 10 years in the field of ETO Sterilization. He is an ex- (Head – Clinical Research, (CEO, pert in ETO Sterilization process and technology. He Meril Life Sciences Pvt. Ltd., Vapi) Sahajanand Medical Technologies Pvt. Ltd., Surat) also has experience in design and manufacture of mod- ern sophisticated fully automatic ETO Sterilizers. He is • Education: M.Pharm, MBA, PhD Mr. Sabat has got more than 15 years of global experi- a solution provider and consultant in ETO sterilization • Experience: 9 years in Drugs/Devices trials plus 2 ence of working in USA and India. He has got more than systems and process. His interests in modern engineer- 5 years of experience in medical device industry. Cur- ing, continuous research and consumer feedback years in Sales and Marketing rently Mr. Sabat is working as the CEO of SMT Pvt. Ltd. helped him to develop and upgrade various new and • Working experience with CDSCO, New Delhi as a He has successfully expanded SMT presence in India innovative tech additions to his products. as well as in 40 countries across the world. Under his Medical Device Consultant leadership, SMT is developing as a global leader in *********************************************************************** • Experience in Projects Handled: More than 100 cardiovascular market. Mr. Partha Mohapatra • Publications: More than 100 (Lead Healthcare (India) & Technical Support, Mr. Sabat has completed his MBA from Washington Styrolution ABS (India) Ltd, India) Core Competences in University in Saint Louis. He also holds a degree from • Clinical Research • Medical Writing ICSI, India and has completed his graduation in science Mr. Partha Mohapatra is working as Lead Healthcare • Preparation of Clinical Evaluation Report with Physics (Hons). As a young and dynamic profes- (India) & Technical Support with Styrolution ABS • Preparation of Literature Search Report sional, he wants to strongly position Indian medical (India) Ltd , India. • Medical Device • Interventional Cardiology device industry in the global field. In his present role, he is actively involved in Applica- *********************************************************************** *********************************************************************** tion & Product Development along with Technical sup- Dr. S. S. Murugan Mr. Ravi Shrivastava port, with major key focus on new business opportuni- (Managing Director, (CEO, ties for styrene’s in medical device industry . GLR Laboratories Pvt. Ltd., Omni Lens Pvt. Ltd., Ahmedabad) UK and EU Registered Toxicologist, Chennai) Mr. Partha Mohapatra is Post graduate in Plastic tech- Ravi Srivastava has about 27 years in handling sales nology from CIPET, Hyderabad & M.B.A (Marketing) Dr. Murugan is a UK and EU Registered Toxicologist and marketing functions in domestic and international from I.G.N.O.U (New Delhi) with 18 years’ of experi- with more than 20 years experience in industry. Dr. business. He has worked with well-established global ence in plastics processing & raw material industry . Murugan obtained his Bachelors, Masters as well as western multinational companies and start up compa- He has expertise in processing of engineering plastic Doctoral degree in Toxicology from University of nies of repute from India. & actively engages in business development/ market- Madras and MGR Medical University. He has worked ing of styrene’s products for healthcare industry, also with major contract research organizations (CRO) in He is currently designated as CEO with major responsi- involve in new projects developments with other OEMs/ India - Head of Genetic Toxicology at IIBAT, Toxicology bilities of Global Business development in Omni Lens Industry along with T1 & T2 supplier. Provides techni- and Quality Assurance Manager at SGS and Scientific (P) Ltd., manufacturing wide range of CE certified oph- cal support to customer from initial stage to project com- Director at RCC India. He has extensive operational and thalmic medical devices and other pharmaceutical prod- mercialization stage & also diverse technical sales quality assurance experiences. He has been instrumen- ucts meeting International standard. His Key responsi- marketing experience in the field of MEDICAL GRADES tal in obtained GLP certification and has turned around bilities include strategic planning, identification of emerg- STYRENCIS POLYMERS. the business at 2 Indian CROs. He has successfully ing market areas, new product development besides faced several GLP, ISO17025 and FDA audits. strengthening the present business in International mar- 33 Additionally, he has faced several national and interna- kets like U.S., Latin America, Europe, Japan, China, Korea etc. besides strengthening existing business. Jan.-Feb. 2016

Venue : Ahmedabad Management Association, Atira Campus, Ahmedabad-380 015. Schedule : February 12 & 13 9.00 am. to 6.00 pm. An Exhibition Displaying Manufacturing Equipments, Medical Components / Sub-assemblies, Polymeric / Other Raw Materials Packaging, Printing & Sterilization Supplies, Adhesives, Clean Room Supplies Laboratory Equipments & Supplies, Services For : Manufacturing, Quality Testing, Quality Certification, Technology, Marketing etc. Industry Associations, Publications & Information Providers For Medical Devices & Plastics Disposables/Implants And Diagnostic Industry Concurrently held with National Confrence on Indian Medical Devices & Plastics Disposables/Implants Industry 2016 No. Company Name Products / Services Website 1 FDCA, Gujarat Implementing various acts and rules related to drugs, cosmetics, medical www.fdca.guj.nic.in devices, food and safety, cigarette and other tobacco products. 2 Pradeep Surgipack, India Manufacturing medical grade sterilization packaging products. www.pradeepsurgipack.com 3 Medical Textiles- SITRA, Centre of Excellence for Medical Textiles, promoted by Ministry of Textiles, www.sitra.org.in India Government of India. 4 Et Elastomer Technik GmbH, Medical Moulded Parts For OEM's From Liquid Silicone Using The Highest www.elastomer-technik.com Germany Medical-Grade Materials. 5 Maider Medical Industry Sterile Medical Automation Equipment for : I.V. sets & Syringe automatic www.maiderchina.com Equipment Co., Ltd., China assembly equipment, Dialyzer / Blood series auto assembly equipment etc. 6 Lubrizol Advanced Materials Specialty Materials To Deliver Application Specific Solutions To Medical www.lubrizol.com India Pvt. Ltd. Device, Pharmaceutical, Healthcare & Food Industries. 7 Shriram Axiall Pvt. Ltd., India PVC Compounds in India with world class manufacturing facility. www.shrirampolytech.com 8 SAI-TREAT, India Water treatment and commercial water purification systems. www.saitreat.com 9 Federal (I) Trading Company, Plastic Testing Equipments. www.fitcoindia.com India 10 LDRA Technology Pvt. Ltd., India Testing Tools for IEC 62304/FDA Compliance Training & Consulting. www.ldra.com 11 Excel Formulations, India State-of-the-art ETO formulation and bottling facility www.excelformulations.com 12 Atachi Systems Private Limited, Seamless, cloud-based Manufacturing Execution System that reduces www.atachisystems.com India dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility. 13 Covestro (I) Private Limited, Polycarbonates for medical technology’s essential devices and next genera- www.covestro.com India tion life- saving technology. 14 Rup’s India Medical Device Packaging Pouches, Products for Infection Control Steriliza- www.rupscare.com tion Monitoring & Patient Documentation. 15 Aakar Packart, Manufacturer of creative packaging materials and Equipments used in www.aakarpackart.com India Industrial, Consumer, Engineering and Pharma / Medical Device Products using advanced technology. 16 Shiv Enterprise, India House of packaging machinery since last 15 years, provide 100% service. 17 Bhavya Polymers, India Silicone Medical Grade Tubings For Healthcare & Pharmaceutical Application www.bhavyapolymers.com 18 Operon Strategist, India Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification www.operonstrategist.com in the fields of Medical Devices, 19 Pall India Pvt. Ltd. Micro porous Materials And Devices With Robust Performance Characteristics www.pall.com And Documented Quality Compliance. 34 Jan.-Feb. 2016

Exhibitor’s Profile No. Company Name Products / Services Website 20 Apar Industries Ltd., India Electron Beam Sterilization Services. www.apar.com 21 Interplex India Pvt. Ltd., India High tensile PET Straps, Co-extruded Multilayer PET Sheets, Thermoformed www.interplexindia.com containers from PET and other plastics, Cellulose Acetate compounds for specialized injection molding applications. 22 Technic Automation, India Air Leak Tester For Rigid Surgical Devices, Pneumatic / Hydraulic Automation. www.technicautomation.in 23 Guru Polymer, India Silicone rubber products for the most precious and complex applications for www.gurupolymer.com the food, Pharma, Medical and Heavy Engineering sectors, also products in Viton, EPDM, Neoprene, Hypalon, SBR. 24 Sputnikpipes (Kisan Pipes & Medical Tubes and Hoses for different Application like Catheter Mount, www.sputnikpipes.com Profiles Pvt. Ltd., India) Respiratory Tubes, Surgical Tubes etc. 25 Multivac Laraon India Pvt. Ltd., Packaging solutions: thermoformers and , tray sealers, vacuum chamber www.multivac.com Gurgaon, India machines, conveyor belt machines, etc. 26 Ami Polymers Pvt. Ltd., Thane, Platinum Cured Silicone Tube, Custom molded parts for medical Indus-tries, www.amipolymer.com India Silicone Tube for Catheter and IV set, Silicone Rubber sheets etc. 27 VascuTech Medical, USA Manufacturing vascular access devices including catheters, dialators, www.vascutechmedical.com introducers, trocars, tunnelers and needles. 28 Medical Manufacturing Asia, The 3rd Manufacturing Processes for Medical Technology Exhibition and www.medicalmanufacturing- India Conference, 31 Aug - 2 Sep 2016, Singapore. asia.com 29 Medical Plastics Data Services, A Techno-Economic News Magazine For Medical Plastics And Pharmaceutical www.medicalplasticsindia.com India Industry. 30 Medi Source Asia, India Web Portal For Medical Technology And Markets In Asia www.medisourceasia.com 31 National Hub for Healthcare To carry out R & D on healthcare instruments as required by indigenous Instrumentation Development industry and vice versa, DST- funded. (NHHID), Anna University – Chennai, India 32 U.V Patel College of Engineering, Institute offering courses on Biomedical Engineering. Mehsana, India Jan.-Feb. 2016 35

Exhibitor’s Profile Food and Drugs Control Administration (FDCA), Gujarat sterilization packaging products which are used to pack medical devices which are to be sterilized. Pradeep Surgipack is an ISO www.fdca.guj.nic.in 9001:2008 & ISO 13485:2003 Certified Manufacturing Company and its products are certified to EN Standards for Medical Devices. Food and Drugs Control Administration (FDCA), Gujarat plays Pradeep Surgipack’s range of products includes, MedicalGrade Peel- important role in enforcement of “Drugs and Cosmetics Act 1940 Open Pouches and Reels which are compatible with Steam, EtO, & Rules” and enforcement of : “Food Safety and Standard Act, Gamma & Plasma Sterilization processes. The pouches and reels are 2006” and Rules in Gujarat State. It plays pivotal in Pharma and made of a variety of substrates like, Uncoated Kraft Papers, Coated medical devices sectors in Gujarat to make the state a favorable Papers, Reinforced Papers, Grid Lacquered Papers, and Tyvek etc investment destination towards inclusive development and which are sealed on to variety of Laminated Films of Poly growth. It has played a vital role in the implementation of e- Propylene, Polyester and Polyethylene. governance in FDCA and is winner of one state level and three national level awards. Contact Details: Mr. Pradeep Rao Lubrizol LifeSciences Pradeep Surgipack 3-A , Sarakki Industrial Estate, J.P. Nagar 3rd Phase, www.lubrizol.com Bannerghatta Road, Bangalore - 560076. P: 080 – 26586254 M: 9880723272 Specialty Materials To Deliver Application Specific Solutions To E: [email protected] Medical Device, Pharmaceutical, Healthcare & Food Industries. Lubrizol LifeSciences is a healthcare product solution partner for ET Elastomer Technik GmbH medical and pharmaceutical manufacturers who need product development support and drug eluting device solutions. www.elastomer-technik.com Exceptional healthcare products with proven performance begin with the polymer technology of Lubrizol LifeSciences medical Medical Moulded Parts For OEM's From Liquid Silicone Using The device solutions. Lubrizol works with you to create functional Highest Medical-Grade Materials. polymer solutions for various medical applications. Key product brands Pellethane® TPE, Tecoflex™ TPU, Tecothane™ TPU, Isoplast® ET Elastomer Technik GmbH was founded 1992 in Lauffen am Neckar ETPU and Carbothane™ TPU. / South Germany. Now with Vesta and Particle Sciences - LifeSciences is the only healthcare product solution partner offering comprehensive The company started injection moulding of joints and gaskets. In polymer, formulation and manufacturing capabilities that provide 1994 ET had its first big success in producing a breathing bag out of polymer customization, complex drug formulation and contract Liquid Silicone Rubber. From there on ET Elastomer Technik was manufacturing solutions. known in the market and worked close to the medical and automo- Lubrizol LifeSciences has significantly expanded our capabilities tive industry, where silicone could push the boundary of other through new products, state-of-the-art facilities, acquisitions and Elastomers. alliances. With this unique combination, Lubrizol LifeSciences delivers comprehensive medical solutions, including to the drug- In 1996 the production capacities of the plant in Lauffen am Neckar eluting device product market. where too small and ET found a bigger production site in Ellhofen / Contact Details: Germany. In this new Factory, ET also begins the facilities for the Mr. Mittal Shah - Head Strategy and Business Development manufacturing of long term implants. One of their first projects was Lubrizol Advanced Materials India Pvt. Ltd. a larynges implant for people who suffered from ‘Mustard Gas’ at- Application & Business Center, 6th & 7th Floor, Jaswanti Landmark, tacks during the gulf war. Since then ET started a wide range of Mehra Industrial Estate, LBS Marg, Vikhroli (W), Mumbai - 400079 different implants. P: +91 22 6602 7800 M: 9167702682. Fax: +91 22 25778486 [email protected] In 2004 ET decided to start a second plant in Hammelburg/Germany. Here they brought in a new idea of production: each industry has its Pradeep Surgipack, Bangalore, India own production facility. A clean room class 8 as well as a tool shop was installed in 2006 and 2 years later they established the ISO 13485. www.pradeepsurgipack.com In 2010, ET Elastomer Technik GmbH have started their production Manufacturing Medical Grade Sterilization Packaging Products. facility at Gandhinagar, Gujarat under the name of “ET Elastomer Pradeep Surgipack is in the business of manufacturing medical grade Technik India Private Limited. 36 Now ET Elastomer TechnikGmBH has everything to meet the de- mands of its customers ET Elastomer Technik GmbH is specialised in manufacturing silicone medical products using the highest medical-grade materials, meeting US FDA requirements with quick development and turnaround. Products include a wide range of O-Rings and moulded shapes for short- and long-term implantation. Complete product assembly services are offered with on-site clean room and tool shop. • ET provides custom-made silicone products and solutions for a wide range of industrial applications and consumer needs • Serving globally active customers from various industries, including medical engineering, automotive, and electronics, we have become a trusted partner of choice for the timely and Jan.-Feb. 2016

Exhibitor’s Profile reliable development of high-end items • Clear Injection Moulding - Oxygen Mask, Drip Chamber, Connec • ET provides custom-made silicone products and solutions for a tors wide range of industrial applications and consumer needs • Rigid Injection/Blow Moulding - Connectors, Small Bottles, Five • Serving globally active customers from various industries, includ Gallon Bottles, Suction Handle, Veterinary Tubes ing medical engineering, automotive, and electronics, we have Contact details: become a trusted partner of choice for the timely and reliable Shriram Axiall (Formerly Shriram PolyTech) development of high-end items. 2nd Floor, Plot No. 52, Sector 32, Institutional Area, Contact Details: Gurgaon – 122 003, Haryana, India. ET Elastomer Technik GmbH Phone +91 124 4632100 Abtsäckerstraße 16, 74248 Ellhofen, [email protected] Tel.: +49 (0)9732/ 78865 – 12, Fax:+49 (0)9732/ 78865 - 18 [email protected] SAI-TREAT ET Elastomer Technik India Private Limited B 183-184 GIDC Electronic Estate, www.saitreat.com Sector 25 Gandhinagar- 382024 Ph: +91 79 23287624, M: +91 97277 63274 Water treatment and commercial water purification systems. [email protected] SAI-TREAT is a leading manufacturer and wholesale distributor of water treatment and commercial water purification systems since Maider Medical Industry Equipment Co., Ltd. 1989. Since the last 26 years, We have offered a wide range of pre-engineered as well as custom engineered solutions for all www.maiderchina.com water purification needs of the customers. We offer a wide range of products ranging from domestic water Sterile Medical Automation Equipment purifiers to advanced waste water treatment plants. Maider is a national leading hi-tech enterprise in the field of Contact Details: automation, engaged in developing and manufacturing of sterile Ninad Sankhe medical automation equipment, to provide optimum automation Anandi Specialities & Services Pvt. Ltd. solutions for customers. Our main products are I.V. set automatic 175, V-Mall, 1st Floor, W. E. Highway, assembly equipment, Syringes automatic assembly equipment, Near Sai Dham, Thakur Complex, Kandivali (E), Dailyser automatic assembly equipment, Blood series automatic Mumbai - 400 101. (INDIA). assembly equipment and etc. Tel.: +91 22 4297 4397. Fax.: +91 22 2854 2480 Contact Details: [email protected] Qiyu Chen No. 3 Tianyou Load, Bingang Industry City, Yuhuan County, LDRA Zhejiang Province, P. R.China.- 317608 P: 86-576-87498999, F: 86-576-87110008, www.ldra.com M: 86-18057668205 E: [email protected] Testing Tools for IEC 62304/FDA Compliance Training & Consulting Shriram Axiall For more than forty years, LDRA has developed and driven the market for software that automates code analysis and software www.shriramaxiall.com testing for safety-, mission-, security- and business-critical markets. Working with clients to achieve early error identification and full Medical Grade PVC Compounds in India with world class compliance with industry standards, LDRA traces requirements manufacturing facility. through static and dynamic analysis to unit testing and verification In 2014, DCM Shriram Ltd., had entered into a 50/50 Joint Venture for a wide variety of hardware and software platforms. Agreement for its Polymer Compounding business with Axiall Boasting a worldwide presence, LDRA is headquartered in the United Corporation, a North American manufacturer of Chloro-Vinyl, Kingdom with subsidiaries in the United States and India coupled Aromatics and Building Products. Shriram Axiall is now one of the with an extensive distributor network. largest organized players for PVC compounds in India and has been Contact Details: present in the medical segment for more than 45 years. LDRA Technology Pvt. Ltd Shriram Axiall manufactures Engineered Vinyl Compounds which #2989/l B, 3rd Floor, 12th Main, HAL II Stage, finds applications across multiple medical devices. All compounds Bangalore -560 008. Ph: +91 80 4080 8707. Fax: +91 80 4204 3186 are safe to use (phthalate free) and comply with global standards Email: [email protected] (Ideal for Exports). The medical grades adhere to Indian standards as well as biological tests prescribed under USPXXI. The compounds Federal India are manufactured in state of the art class 100,000 facility conform- ing to GMP requirements. Shriram Axiall supplies India's leading www.fitcoindia.com OEM's for disposable medical devices. Some of the key products by Shriram Axiall are : Plastic Testing Equipments • Clear Extrusion - USP Class 6 Material for Tubes, Flexible tubes 37 for IV sets, Catheter Tubing, Cardio Vascular Tubes Jan.-Feb. 2016

Exhibitor’s Profile Federal India Trading Company represents reputed Testing Equip- to deploy, cost efficient and highly scalable, it’s never been easier ments manufacturers from USA, UK and Europe. We are in this to measure real return on your MES investment. business for over 45 years. The company was founded in 2007 to streamline the IT services that We not only supply products but provide installation, training on enable discrete manufacturing companies to improve efficiencies operation of the equipment, calibration and complete after sales and grow profits. services. Over the years we have worked closely with the world’s foremost We represent Dynisco, USA, Systech, UK, Testometric, UK, Carver, medical device and diagnostics, electronics and other discrete manu- USA, Wabash, USA, KOPP, Germany. We offer Melt Flow Index facturing companies to evaluate MES vendors, oversee MES ERP Tester, Capillary Rheometer, systems integrations, manage leading MES vendor implementations Universal Testing Machine, MFI Tester, Tensile Tester, Gaspace and provide IT support to ensure that our clients benefited from Analyzer, WVTR Tester, OTR Tester, Friction Tester, Sealing Tester, highly productive shop floor systems. Headspace Analyzer, After more than a decade of manufacturing industry expertise across COF Tester, Hot and Cold Tack Tester, etc. discrete verticals we developed NGIMES to help manufacturing Contact Detail: companies gain a competitive edge in rapidly changing industries, Mr. Mehul P.Javeri by reducing risk, optimizing response time and keeping costs low. Federal India Trading Company, Our mission is to support customer success. No.49/50, Jainnagar, Sukhipura Road, Paldi, Contact Details: Ahmedabad 380007 Atachi Software Systems P: 079-26620059, 26607020, F:079-26640002 Pvt. Ltd. Module No: 201, NSIC EMDBP, Kamala Nagar, E-mail: [email protected] Hyderabad – 500 062 [email protected] Excel Formulations Shanker - Mobile: 9966589917, Desk: 040-42603666 [email protected] www.excelformulations.com Covestro (India) Private Limited State-of-the-art ETO formulation and bottling facility. Established in 2007, Excel Formulations is amongst India’s leading www.covestro.com manufacturers of ETO Gas mixtures. Company is ISO 9001 and D&B certified. They are manufacturing various types ETO gas mixtures in Polycarbonates for medical technology’s essential devices and next cylinders as well as Disposable E.O Cartridges. The company estab- generation life- saving technology. lished a state-of-the-art ETO formulation and bottling facility at Polycarbonates from Covestro are responsible for some of the Sanand, Gujarat and supplies various combinations of Ethylene modern medical technology’s essential devices and the develop- Oxide with Carbon Dioxide in different sized cylinders. ment of next generation life- saving technology. In products rang- The plant that manufactures mixtures of ethylene oxide and ing from insulin pens and pumps, inhalers, renal care and blood carbon dioxide is manned by skilled team with a strong quality management to heart defibrillators, intravenous access components orientation. This ensures strict adherence to safety, health and and surgical instruments used to assist patients, polycarbonate is environment standards at the plant. This in turn ensures that the there and so is Covestro. products manufactured are reliable and are of the highest quality, With 2014 sales of EUR 11.8 billion, Covestro is among the world’s all in keeping with our commitment towards excellent customer largest polymer companies. Business activities are focused on the service. manufacture of high-tech polymer materials and the development Contact Details: of innovative solutions for products used in many areas of daily life. Mr. Dipesh Patel - Partner The main segments served are the automotive, electrical and 401, Sanidhya- A, Opp. Anandnagar Shopping Center, electronics, construction and sports and leisure industries. Covestro, Prahladnagar 100ft. Road, Satellite, Ahmedabad-380015 formerly Bayer MaterialScience, has 30 production sites worldwide Ph: +91-79-40067245, +91-9228008275 and employees approximately 15,700 people (calculated as full-time E: [email protected] equivalents) at the end of September 2015. Contact Details: Atachi Systems Pvt. Ltd. Suresh V-Market Development Manager Covestro (India) Private Limited www.atachisystems.com Bayer House, Central Avenue, Hiranandani Estate, Ghodbunder Road Seamless, cloud-based Manufacturing Execution System that Thane (West) – 400607, Maharashtra reduces dependencies on infrastructure, lowers maintenance costs, 025866161; [email protected] and improves access to real-time visibility. Atachi Systems provides discrete manufacturing companies with a Medical Textiles- SITRA seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, www.sitra.org.in and improves access to real-time visibility of shop-floor operations for engineers and managers at all levels. Jan.-Feb. 2016 Our new MES solution, NGIMES-in-the-cloud, does just that. Quick 38

Exhibitor’s Profile Centre of Excellence for Medical Textiles, promoted by Ministry of Application. Textiles, Government of India. Bhavya Polymers is a dynamic specialist manufacturer of silicone products since 1995, located at Dediyasan GIDC Mehsana (Gujarat) The South India Textile Research Association (SITRA) is a premier with 700 sq. m manufacturing facility, The company has been National level autonomous organization for Research, Consultancy serving customers for over 18 years. and Human Resources Development in the field of Textiles. SITRA is Bhavya Polymers takes quality very seriously. The company attained the designated Centre of Excellence for Medical Textiles, promoted ISO 9001 : 2008 certification and have progressively moved into by Ministry of Textiles, Government of India. As a Centre of the supply of high tech industries. The company makes silicone Excellence for Meditech, SITRA has addressed itself to a number of rubber products that are even as small as 0.2 mm. They use a multi-varied activities such as: process that is as much an Art, as it is a Science. It is this that has given them a competitive edge over other silicone rubber players in • Testing and Evaluation (Physics, Microbiology, Bio-Technology, the field. Analytical Chemistry) Business philosophy is simple: Aim is to provide high quality products, efficiently and at very competitive prices. • Standard Formulation (BIS, International bodies) Contact Details: • Incubation Services Bhavya polymers • Detailed Project Reports (DPRs) C-1/137, GIDC, phase-II, Dediyasan, Mehsana-384002. • Pilot Scale Production (Medical/Technical Textile Products such P: 02762-224114. E: [email protected] as Face Mask, Sanitary Napkin & many more) Pall Corporation • Training and Seminar • Technical Consultancy www.pall.com • Testing Instrument / Product Machine – Technology Micro porous Materials And Devices With Robust Performance Development Characteristics And Documented Quality Compliance. • Prototype Development / Contract Research Pall Corporation offers a comprehensive portfolio of microporous • Information Resources materials and devices with robust performance characteristics and documented quality compliance, making it easy for you to find the Contact Details: best medical filtration components to satisfy your product applica- Mr. Thiruppathi Shanmugam tion requirements. Combining extensive membrane manufacturing Medical Textiles, SITRA, 13/37, Avinashi Road, Coimbatore-641014 capabilities with advanced medical engineering and design exper- P: 09790225424 tise, Pall can create unique and reliable solutions for your specific [email protected] application needs. Our adherence to internationally recognized quality and six sigma principles assure consistent lot-to-lot Multivac Laraon India Pvt. Ltd performance and compliance with global industry standards. Contact details: www.multivac.com Rajnish Singh - +91 9971587733 [email protected] - Marketing Packaging solutions: thermoformers and , tray sealers, vacuum [email protected] chamber machines, conveyor belt machines, etc. Operon Strategist, Pune MULTIVAC is one of the world’s leading suppliers of packaging so- lutions: global market leader in thermoformers and manufacturer www.operonstrategist.com of an extensive range of traysealers, vacuum chamber machines, conveyor belt machines, labelers, quality control systems and auto- Turnkey Projects, Regulatory, Quality Assurance, Validation and mation solutions, as well as turn-key packaging lines. MULTIVAC has Certification in the fields of Medical Devices. pooled its packaging, product and application expertise in both its Operon Strategist is one of the renowned consultancy companies Systems division and its in-house Application Center, in order to be for designing of the layouts, Designing of the classified area able to offer top-class packaging technology. criteria, Validation and implementation. For medical device indus- try. they have many Medical device projects going on under their The MULTIVAC Group employs more than 4600 people worldwide credential with the value for money effectiveness. The company has with around 1600 employees based at its headquarters in large number of satisfied customer base with the repeat order Wolfertschwenden, Germany. With over 70 subsidiaries the com- guarantee. They have highly technical and experienced staff to pany has a presence on every continent. Over 1000 advisors and handle all levels and sizes of the projects. service technicians worldwide use their expertise and experience Contact Details: in the service of customers and ensure the maximum availability of Anil Chaudhari all installed MULTIVAC machines. Operon Strategist 7,\"A\" Tower, First Floor Sagar Complex, Kasarwadi, Pune411 034, Contact Details: P: +91(020)4678055 M: 9823283428 RITESH DHINGRA - MANAGING DIRECTOR E: [email protected], [email protected] Plot No. 137, Sector 5 , IMT Manesar, Gurgaon – 122050. India. Telephone No.: 0091 124 4610000. 39 Fax No.: 0091 124 4610051 Email.: [email protected] Bhavya Polymers, Mehsana, Gujarat www.bhavyapolymers.com Silicone Medical Grade Tubings For Healthcare & Pharmaceutical Jan.-Feb. 2016

Exhibitor’s Profile Aakar Packart, Vadodara in its new cable manufacturing plant in South Gujarat. This Plant is certified by BARC, AERB, FDA and its quality systems accredited to www.aakarpackart.com ISO 9001:2008. Electron Beam radiation is a form of ionizing energy. The beam, a concentrated, highly charged stream of electrons, is Manufacturer of creative packaging materials and Equipments used generated by the acceleration and conversion of electricity. It ster- in Industrial, Consumer, Engineering and Pharma / Medical Device ilizes medical devices and other Pharma products in seconds instead Products using advanced technology. of hours or days compared with other technologies. Such very short • Printing Matter For Exhibition Directory Sterilization cycles allow manufacturers to apply “just in time” manu- • Big Bubble Air Cushion System, facturing techniques. More than 92% of all disposable medical prod- • Buffer Air Cushion Machine, Void Filling ucts are compatible with E-beam sterilization treatments. The ex- • Pe/Hd Disposable Gloves Making Machine tremely rapid treatment times of electron beam sterilization greatly • Multi Seal Irrigation Flexible Pipe Sealing Machine/Surgical reduce effects on materials this is especially noticeable with prod- ucts made of non-woven and polypropylenes. High energy electrons Packing Rolls offer good depth penetration for the sterilization of medical devices • Innovative Integrated Packing Solution in their final shipping boxes. • Plastic Corrugated Reusable Corru Crates/Boxes/Record Keeping Contact Details: Khata No. 1932, Survey No. 82/2, P & 88, 861/1 & 862/1 & 863/1, Boxes. Multi-Utility Boxes. Display Rack/Danglors. Agri Tray And Manakpore Road, Khatalwada, Cushion Packaging ,Blister Forming Tal: Umbergaon, Dist. Valsad (Gujarat) Pin 396120 Winner Of Indiastar 1990,2002,2008,2012,2015 Worldstar 1990, Corporate Office: 12/13, Jyoti Wire House, Placticon Award 2003. Shah Industrial Estate, Off Veera Desai Road, Contact Details: Andheri West, Mumbai 400 053; Aakar Packart Ph: 022 26740001/2/3; M: +91-7506265220; 2nd Fl, BEI Compound Behind Amar Ice Factory, Vadodara 390024 [email protected] 02652773018 9376226980 [email protected] Technic Automation Sputnikpipes (Kisan Pipes & Profiles Pvt. Ltd.) www.technicautomation.in www.sputnikpipes.com Medical Tubes and Hoses for different Application like Catheter Air Leak Tester For Rigid Surgical Devices & Pneumatic / Hydraulic Mount, Respiratory Tubes, Surgical Tubes etc. Automation. KISAN PIPES & PROFILES PVT. LTD. is a Group Company of SATEL- LITE PLASTIC INDUSTRIES devoted to the Production and Manufac- We the Technic Automation would like to introduce ourselves as a turing of Corrugated Plastic Pipes from almost all kinds of Thermo- leading organization in the field of Pneumatic / Hydraulic Automa- plastic Raw Materials like PP, COPP, HDPE, LDPE, LLDPE, EVA, PVC, tion across Globe for providing cost effective solutions for all your POLYAMIDE, TPR, TPE and a combination of the above including ideas. We are successfully exploring & serving in many leading Flame Retardant and LSHF. grades. industries since 1992 under the guidance and support of With a complete State of Art Automatic Production Lines from ITIB Mr. Bhupendra Khatri, Pioneer of Technic Automation. We do work Italy since 1994 and use of Modern Manufacturing facilities has re- on our prime motto of Customer Satisfaction & perhaps this is the sulted in a renowned Brand “SPUTNIK” which is synonymous to main reason of our survival in this cut throat era of competition. quality and workmanship. With regular exports to Middle East, Sri Lanka, Australia, New Zealand, Africa and Italy we ensure timely Our vision is “to be globally recognized as an Automation Engineer delivery, packing as per International standard and adherence to for any kind of Industrial Automation requirement to produce mass functional requirements of the customers. quantity with improved quality”. Contact details : Kisan Pipes & Profiles Pvt Ltd, The company is certified by ISO 9001:2008 for Quality Management 2 A2, Court Chambers, 35, New Marine Lines, Mumbai – 400 020. & NSIC-D&B-SMERA for Performance & Credit Rating. The company Phones: 022-22006477, 66346816 has production house in Ahmedabad with well-equipped work shop [email protected] and has work force of efficient engineers. Apar Industries Ltd. (Unit: Uniflex Cables) Our summarize scope of work includes Pneumatic Automation, Hydraulic Automation, Sales & Service Of Pneumatic Products, www.apar.com Pneumatic Consultation & Training, Pneumatic Training Kit, Air Leak Testing Equipment, Hydro Leak Testing Equipment & Test Systems Electron Beam Sterilization Services. For – Temperature, Pressure, Flow, Noise, Vibration, Power etc. Apar Industries Ltd now offers Electron Beam Sterilization Services Contact Details: 40 Technic Automation, 1st Floor, Shah Chamber, Nr. Nidihi Co. Op. Bank, CTM Cross Road, CTM, Ahmedabad. +91 79 25855821, +91 93270 06790. [email protected] Jan.-Feb. 2016

Exhibitor’s Profile Ami Polymer Pvt. Ltd. • Shrink Wrapping m/c. • Continuous Bag Sealers m/c. www.amipolymer.com • Semi Auto box-strapping m/c. • Continuous Induction Capper Sealer. Platinum Cured Silicone Tube, Custom molded parts for medical • Continuous Carton(BOPP TAPE) Sealer m/c. Indus-tries, Silicone Tube for Catheter and IV set, Silicone Rubber sheets etc. Benefits Offered: Time saving, Man power saving, Good Packing Image, Shape your products, No Maintenance, Light weight & • USFDA-DMF Accredited Platinum Cured Silicone Tubing’s. Reliable. • Medical Grade Silicone Suction Tubing’s. • Platinum Cured Silicone Braided Hoses. Contact Details: • Medical-Grade Silicone & Viton Products. Mr. Yatin Patel Shiv Enterprise All Types of Medical-Food-Pharma Grade Silicone & Viton Rubber 14 & 39, Arihant Estate, B/h, Sabari Hotel, Products manufactured under clean-room of Class 10000, Dept. of Nr. Odhav Ring - Road Circle, Odhav, Ahmedabad. USFDA has assigned us DMF# 26201 for Silicone tubes. We have tech- M: 9879015456. [email protected] nology of Permanent Laser marking products/tubing also available for identification purpose. We also make customized products. Guru Polymer Contact Details: www.gurupolymer.com Mr. Darshan Gandhi - Asst. Manager Marketing Ami Polymer Pvt. Ltd. Silicone rubber products for the most precious and complex appli- 303, Mahesh Industrial Estate, Opp. Silver Park, cations for the food, Pharma, Medical and Heavy Engineering Mira Bhayander Road, Mira Road (E), Dist. Thane, sectors, also products in Viton, EPDM, Neoprene, Hypalon, SBR. Mumbai - 401104. Maharashtra. Tel: +91 22 28555 107/631/914. M: +91 86910 13939 Guru Polymer has started its operation in 2008. [email protected]; [email protected]; [email protected] To manufacture a large range of Silicone rubber products for the most precious and complex applications for the food, Pharma, Medi- Interplex India Pvt. Ltd. cal and Heavy Engineering sectors in India and also for the overseas customers. The company enjoys a high reputation among the www.interplexindia.com major pharmaceuticals giants in India. Coupled with the experience in R & D and armoured with management capabilities. High tensile PET Straps, Co-extruded Multilayer PET Sheets, Thermoformed containers from PET and other plastics, Cellulose Besides the Silicone rubber products, the company also manufac- Acetate compounds for specialized injection molding applications. tures a large range of products in Viton, EPDM, Neoprene, Hypalon, also in SBR. The Company enjoys in Customer Satisfaction and swift Interplex is a pioneering multi-product company focused on serv- development, Speedy delivery, Supreme quality, and also very ing markets requiring specialized plastics products for demanding competitive rates. applications. Interplex product range includes PET Straps, Co-ex- truded Multilayer PET Sheets for the packaging sector, Contact Details: Thermoformed packaging from PET and other plastics, Cellulose Bhavesh Chauhan Acetate compounds for specialized injection moulding applications. C-1-64, G.I.D.C, Phase-II, Mehsana (North.Gujarat-384002) Interplex has a modern plant near Vadodara with dedicated Tel: 02762-224584, Mob:- 9978304978 production lines incorporating state of the art processing Email Id: [email protected], equipments from Europe and the USA. [email protected] Contact Details: National Hub for Healthcare Instrumentation 314/1, Village Baska, Development (NHHID), Taluka Halol – 389350. Anna University –Chennai. District Panchmahals, GUJARAT. INDIA. Tel.: 0091 265 2353444 / 2310750 Products to be displayed at the exhibition: Fax : 091 265 3057712 • Antibiogram Device Email : [email protected] • CMCdaq • Leptospirosis Kit Shiv Enterprise • Synthetic milk tester • Milk protein Estimator House of packaging machinery since last 15 years, provide 100% service. Service: • Calibration Suppliers of Packaging Machineries for Pharmaceuticals & Medical Devices Industries, Hospitals and many more Industries. National Hub for Healthcare Instrumentation Development (NHHID) Wide range of machines including: was started in the year 2011 with an initial 5 - year grant of 12.4 Crores. It is a DST - funded (under Technology Development Programme) Jan.-Feb. 2016 national facility in Anna University, Chennai, in collaboration with reputed national institutes and R&D organizations. The NHHID is a platform for integration of Scientists, Engineers, Technologists, Industrialists, Businessmen and Clinicians to promote 41

Exhibitor’s Profile and accelerate the development of healthcare instrumentation in- technology, service solutions and materials tailored for the medtech digenously. It aids in the transfer of basic research ideas from re- industries, as well as connect you to influential decision makers and search institutions to private biomedical companies and vice versa. trade visitors from the region. It will mainly carry out R & D on healthcare instruments as required by indigenous industry and healthcare needs. The Calibration Rups Center one of the prominent activities of NHHID is being established. 1. We develop commercially and clinically important healthcare www.rupscare.com prototype devices. Medical Device Packaging Pouches, Products for Infection 2. Undertake R&D services & product validation. Control Sterilization Monitoring & Patient Documentation. 3. Calibration & Testing of critical care medical devices and A proprietorship firm established in the year 1994 is engaged in certification. manufacture of Sterilization Packaging for Hospital, Pharmaceuti- 4. Training of manpower. cal manufacturing companies and Medical Device Manufacturing 5. Help getting funds from DST for the prospective productization. companies. The products are mandated for use under all Interna- tional Standards and play one of most important role in combat- Medical Plastics Data Services, Ahmedabad, India ing and preventing infection. www.medicalplasticsindia.com Besides the firm also manufactures monitoring devices for effec- tive sterilization to ensure that no micro-organisms are let out to Periodicity : Once every two months. cause infection. Additionally, the firm manufactures Patient Docu- Publisher : Classic Computer Services. mentation system to keep tab on effective sterilization; use of ster- Target Audience : All who are involved or interested in Medical ilized device on patient and in case of need recall all records for it. Plastics user industries ranging from Pharmaceutical Industries, Medical Plastic Devices/ Equipments Manufacturers /Marketing The firm is certified to all International Certificates including CE Companies, Hospitals, Doctors, Medical & Pharmacy Colleges, and follows GMP. Research Institutes. Editorial Content : Applications, Book Review, Company Profiles, Contact Details: Country Profiles, Design, Discovery, Eminent Institutions, Eminent Rups Packaging Industry Personalities, Events, Global Opportunities and Trends, Health A 196, Sector – 83, Noida – 201 305 (U.P.) update, Import - Export News, Industry News, Manufacturing, Tel: +91 120 4044500 – 506, Fax: +91 120 4044502 Markets, Materials, Product Profiles, Products & Processes, E-mail: [email protected], Regulatory Affairs, sterilization, Quality, Technology [email protected], [email protected] Advertising Opportunities : • Suppliers of Machineries/Equipments/Raw Materials/Services to Mascot Medical Plastics Processors. Specialty Silicone Tubing For Medical Devices Fabrication And • Vendors to Medical Devices/Equipments Manufactures Supplying Lubrication Raw Materials / Clean Room Equipments / Assemblies / Sub- With more than 100 years of experience in Asia, Connell Bros. Co. Assemblies / Components / Technology etc. (CBC), with its headquarters in the US, is well accepted as a reli- • Medical Equipments/Devices Manufacturers/Suppliers and able and trustworthy partner by customers as well as suppliers. Marketing Companies. • Technical/Management Consultants for Plastic and Medical Established in 1999, Connell-India is part of the Asia Pacific region Devices Industries. distribution network, consisting of 38 offices and 34 warehouses Contact Details: in 17 different countries, CBC, a business unit of USD 3.2 billion D L Pandya - Editor & CEO (Sales) Wilbur Ellis Co., is a new age, high-commitment distribu- Classic Computer Services tion partner that more than meets the growing needs of the B-4, Mandir Apartments, Opp. P & T Colony, Jodhpur Char Rasta, industry. Ahmedabad – 380 015, India. P : +91 79-26740611, F : +91 79-26754867 E : [email protected] / [email protected] Mascot PC & HC Division of Connell India with its vast experience in providing specialty products & services to the Pharmaceutical, Medical Manufacturing Asia 2016 Biotech & Medical devices industries, understands the importance of use of superior quality products in formulations and processes. Medical Manufacturing Asia 2016 : Medical Manufacturing Asia, The 3rd Manufacturing Processes for Medical Technology Exhibition and We are complete solution providers offering specialty silicones for Conference, 31 Aug - 2 Sep 2016, Singapore.: Your Strategic Platform Medical devices fabrication and lubrication, wound care and scar for Medical Technology Solutions care applications, silicones for topical/ dermatological formula- The third edition of Medical Manufacturing Asia returns as the tions, Silicone tubings for Pharmaceutical & Biotech processing and region's leading specialist trade fair for Asia's medtech and medical silicone Anti-foams (Simethicones for Pharmaceutical and Biotech manufacturing processes sectors. Co-located with Medical Fair Asia processing). 2016 - the No. 1 medical and healthcare exhibition in Southeast Asia, the synergistic trade fairs will showcase a comprehensive range of We represent Dow corning for the mentioned applications. 42 Contact Details: Mr. Abhishek Shukla 317, Shah & Nahar Industrial Premises, Off. Dr. E. Moses Road, Worli, Mumbai - 400018. M: 9619470670. [email protected] [email protected] Jan.-Feb. 2016

ADDENDUM Venue : Ahmedabad Management Association, Atira Campus, Ahmedabad-380 015. Schedule : February 12 & 13 9.00 am. to 6.00 pm. An Exhibition Displaying Manufacturing Equipments, Medical Components / Sub-assemblies, Polymeric / Other Raw Materials Packaging, Printing & Sterilization Supplies, Adhesives, Clean Room Supplies Laboratory Equipments & Supplies, Services For : Manufacturing, Quality Testing, Quality Certification, Technology, Marketing etc. Industry Associations, Publications & Information Providers For Medical Devices & Plastics Disposables/Implants And Diagnostic Industry Concurrently held with National Confrence on Indian Medical Devices & Plastics Disposables/Implants Industry 2016 Accuprec Research Labs Pvt. Ltd. After Kothari Cross road, Post: Santej, Ta: Kalol, Dist: Gandhinagar-382721 www.accuprec.com (M) +91-9429571239/9099616769 E-mail: [email protected] Provide Quality Solutions For Testing Services Required For Phar- maceuticals, Medical Device, Chemicals, Photochemicals, Herbals VascuTech Medical And Food Industries. AccuPrec® has been founded in August 2012 with an objective to www.vascutechmedical.com provide quality solutions for various testing services required for pharmaceuticals, Medical device, chemicals, photochemicals, herb- Vascular Access Devices Including Catheters, Dilators, Introducers, als and food industries. Trocars, Tunnelers And Needles. AccuPrec® is fully conscious of its role in quality control and quality VascuTech Medical is a medical device manufacturing company that assessment and therefore created facilities (with surveillance sys- develops class I, class II and class III devices for the world’s leading tem and auditable data system) as per standard requirements of medical device OEM customers. Our main focus is on vascular ISO and GLP and compliance to USFDA and CDSCO. access devices including catheters, dilators, introducers, trocars, AccuPrec® is approved by FDCA (License No. GTL/37/31) and certi- tunnelers and needles. fied by ISO 9001:2008 and GLP certification. NABL applied VascuTech Medical, LLC has evolved from a consulting firm serving Mission: To provide quality testing services with accuracy and preci- major customers such as C.R. Bard, to a contract manufacturer of sion to offer its clients a seamless experience in ensuring quality of FDA and ISO 13485 registered medical device manufacturer serving their products. We aim at becoming the “Ultimate Solution” for our OEMs and healthcare providers in interventional radiology, clients. interventional cardiology, pain management and urology. Vision: To become the most-preferred quality testing service pro- Contact Details: vider for its clients with its services making the clients feel Accuprec PO Box 1051, Oaks, PA 19456 98 Highland Avenue, as their “Extended Enterprise”. Building A, Oaks, PA 19456, Phone: 484-956-0437 Motto: Uncompromised quality and prompt service. [email protected] Contact Details: Dr. Rina H. Gokani Jan.-Feb. 2016 Director & Chief Scientific Officer, Accuprec Research Labs Pvt. Ltd., Shed no.9, Shree Raghuvir Industrial Estate, 34

Supporting Association Mr. Rajiv Nath Most of the unit members hold approved Drug Manufacturing License, GMP, ISO & CE certifications with product barcodes. Forum Coordinator, Our main objective is to contribute to the development and growth of the inter-disciplinary areas of Medical Devices Industries in all Association of Indian aspects and specialties. Association of Indian Medical Device Main Activities of the Association: Industry (AIMED) • Organizing Meetings, Seminars, Symposia, Exhibitions & Medical Device Industry Demonstrations (AIMED) • Conducting Training Programs for Skill Development, Manage- AI-MED is an Umbrella Association of Indian Manufacturers of ment & Marketing Medical Devices covering all types of Medical Devices including • Training Man Power [Technical, Non-Technical] consumables, disposables, equipments of diagnostics represent- • Exchange information between the Members regarding ing the interest of over 700 Manufacturers of Medical Devices to changing Government policies & regulations cover issues and address the manufacturer’s problem. • Representation of the issues with Government Authorities like The aim behind forming AI-MED is allow the Government to ac- FDA, Excise, VAT cess a single point of contact and provide various services to the • Assistance and Guidance to the Members for quality manufacturers like Advocacy on policy issues, Information ser- vices, Regulations for medical devices, Education and Training, certifications like ISO, CE, and GMP. services, Testing Assistance and guidance for Quality Certifica- tion (ISO, CE, GMP), Lobbying for funding for R&D from the Gov- Society for Biomaterials and Artificial ernment, encourage innovations from member units, Improve Organs – India (SBAOI) clinician and patient access to the modern, innovative and reli- able medical device technologies through organizing Meeting, INDIA is one of the fastest growing health care markets in the Seminars, Symposia, Exhibitions and Demonstrations and also, world. The current estimate of health care device market is about $1billion with a projected growth rate of 18%. Realizing this huge to promote global harmonization of Indian device industry. potential, Indian industry as well as academician has started show- ing keen interest in biomaterials and medical devices research. AI-MED will ensure convergence at a one common platform, when As a result, establishments like National Laboratories, Indian In- needed, for ensuring overall growth of Indian Medical Devices stitutes of Technology and other leading Universities have started Industry and further address the needs of all members of the research as well as teaching programs. Many of the establish- Medical Device Industry irrespective of their affiliation or their ments work in close association with the industry also. As an company size. It will also help in wider dissemination of informa- outcome of this, apart from the ongoing research activities, indig- tion to each player of the industry. AI-MED would be horizontally enously developed implants and devices like artificial heart valve, divided into common groupings like – Legal Issues, Tax Issues, hydrocephalus shunt, blood oxygenator etc. are also available in Export Related Issues, Medical Device Regulatory Issues com- the Indian market. mon to all vertical groups of different families of product lines In order to develop coherence among the scientists and engi- with Zonal Representations. neers working in this field, way back in 1986 Dr. Chandra P. Sharma along with his colleagues founded the society, Society AI-MED has initiated the formation of the IMDRRG (Indian Medi- for Biomaterials and Artificial Organs - India. cal Device Regulatory Review Group) This is an open informal forum – broad based consisting of Regulators, the Regulated National Biomedical Engineering Industry, the conformity assessment quality system auditing bod- Society (NBES) ies like SGS/TUV/Intertek/UL/DNV/BSI, Testing Facilities and other Stake Holders – Consultants/Doctors/Nurses/Patients to Founded in 1978, the National Bio-Medical Engineering Society review proposed regulations on ongoing basis and ensure that is carrying out various activities for the development, growth and these are aligned to the GHTF (Global Harmonization Task Force) popularity in the interdisciplinary areas of Medicine, Engineering Guidelines - AI-MED wishes to collaborate with the Govern- and Bio-Medical Engineering. These include efforts to improve ment. Currently we have over 400 individuals and organization education technical information, organising meetings, work-shops, representatives receiving e-mails with opportunity to use this fo- seminars etc. rum for informal and candid e-mail exchange as well as pass on The Society has created a very effective platform for bringing information to members of their organizations. professionals from Medicine, Engineering academics and indus- try together. Mr. M. M. Saiyed President Aims & Objectives : • To contribute to development, growth & popularity of the inter- MEDICAL DISPOSABLE MANUFACTURERS' disciplinary area of Bio-Medical Engineering in all aspects and ASSOCIATION (MDMA) specialty in India • To review & strive to improve education in this field at all levels We are an Association of Medical Disposable Manufacturers • To undertake, promote, encourage or sponsor studies and popularly known as MDMA [Medical Disposable Manufacturers;' research projects in the field of Bio-Medical Engineering with Association] in Gujarat. We have more than 40 members. The the ultimate aim of making high quality medical care available Medical Disposable Manufacturing Industry is in existence for the last more than 30 years and many of our units are major 43 suppliers of Disposable Medical Devices like Intravenous Infu- sion Sets [I.V. Sets], Blood Transfusion Sets [B.T. Sets] to the local regions, export markets and central government for tender supply. Jan.-Feb. 2016

Supporting Association industry friendly, prompt & still known for taking strict action against law breakers. to lowest echelon of society with the help of modern engineer- ing technology Testing Laboratories: • To establish research centers pertaining to Bio-Medical Food & Drug Laboratory (FDL), Vadodara is the first NABL ac- Engineering. credited Government laboratory in the country. In addition to FDL, Vadoadara, FDCA has two other Regional Food Laboratories for Shri H.G. Koshia testing of food samples, one at Rajkot and one at Bhuj. FDCA is Commissioner also setting up one more state of art Food & Drug Laboratories in the state. Food & Drug Control Administration, Gujarat Training: Training of FDCA officers of both cadres, Drug & Food, has been Food & Drugs Control Administration, a regular practice. It includes induction training of newly appointed Govt. Of Gujarat (FDCA) officers and in service training as well. The objective of training is to sharpen their knowledge not only to maintain performance of Drugs Control Administration (DCA), Gujarat came into existence FDCA but also to achieve newer landmarks. on 1st May 1960 after separation of Gujarat State from Greater Bombay State and Mr. B.V. Patel became the first director of DCA, e-Governance: Gujarat. FDCA, Gujarat makes optimum use of information technology for achieving excellence in performance. DCA, Gujarat was entrusted implementation of Drugs & Cosmet- ics Act – 1940 & Rules 1945 and Drugs Magic Remedies (Objec- FDCA, Gujarat is the first State to initiate online software for sales tionable Advertisement) Act – 1954. Mr. B.V. Patel played a vital & manufacturing licenses. role in establishing well defined administrative structure, policies and procedures of DCA, Gujarat. He seeded the present culture After successful implementation of Sales Licensing Software since of this department - industry friendly, prompt & strict action against 1st January 2007 and with proven sustainability of the software, law breakers. He also took initiative to establish state of art Drug Drugs Controller General India (DCGI), Government of India Laboratory equipped with latest equipments at Vadodara. praised and recommended this software to all State Drugs Controllers at several occasions. Dr. M. A. Patel was followed by SHRI A. G. Shah, Shri G. R. Bhagat, Dr. S. P. Adeshara, Mona Khandhar, (I.A.S.), DR. S. Murlikrishna, Association Of Diagnostics ( I.A.S. ) & Dr. H. G. Koshia as Commissioners of FDCA, Gujarat. Manufacturers Of India (ADMI) Since, 22nd January 2009 Dr. H. G. Koshia is Commissioner, FDCA, Gujarat. ADMI is a non-profit making company, incorporated in the year of 2002 with its registered office in the State of Gujarat. With effect from 5th August 2011, PFA and seven other acts The management of the business affairs and control of the com- related to food have been repealed by “The Food Safety and pany are rested with the Managing Committee, which is elected Standards Act, 2006” (FSSA). based on the tenets as enshrined in the constitution of ADMI. The office bearers are elected every three years. Dr. H.G. Koshia, Commissioner, Food & Drugs Control Adminis- tration, Gujarat His Key Responsibilities are Enforcement of Medical Surgical and Healthcare Industry “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Trade Association (MSAHITA) Safety & Standard Act, 2006” and rules, in Gujarat State. He is actively representing nine national and state level commit- The aim of MSAHITA is “OUR STRENGTH IS ALWAYS IN tees. He is Chairman of the very important committee “Track & HELPING OTHERS BY UNITING, IT CAN MAKE A DIFFER- Trace”, for preparation of guidelines to prevent of menace of ENCE.” spurious drugs. Every Trade has a collective community for the betterment and Dr. Koshia regularly interact with officials of US FDA, Health showcase of Strength, Unity and uniform trade policy governed Canada, MHRA, DCGI, technocrats, academicians, IDMA, Chem- by the association for the well being of its members. Our trade ists & Druggists Association etc. to ensure a consultative lacked the effective way of voicing our concern and grievances approach towards inclusive development and growth. at all levels, weather it was amongst us or being targeted as soft and most sullied business organization. He has played a pivotal role in transformation of pharma sector in Gujarat to emerge as a favorable investment destination with The treatment given to the patients are at par with the interna- proactive & pragmatic approaches. tional level, as the cost is much less and the patients care is equally good here in the private sector. We provide better and He has played a vital role in the implementation of e-governance cheaper healthcare products, services and expenses to the indi- in FDCA and is winner of one state level and three national level viduals. It is here that our trade plays a very important role. The awards. relentless efforts for up gradation by our trade there is a constant urge to grow along with the international standards. FDCA implementing various Acts and rules related to Drugs, Cosmetics, Medical Devices, Food & Safety, Cigarettes & other There is tremendous scope and wide variety of product range, tobacco products etc. always a place for every new comer who has been accommo- dated. It has therefore become the need of the hour for the well Medical Device Industry In Gujarat: being and the prestige of our trade at large to get the recognition Gujarat State has the largest number of licensed Medical Devices Companies which are nurtured by Gujarat FDCA Dept. Jan.-Feb. 2016 with an exemplar nary approach and has been receiving recog- nition in the country. The present culture of this department is 44

Supporting Association and reorganization to get our identities as of well groomed and Plastics Industry respected traders amongst other trade as well. The pharmaceu- • Spreading awareness on responsible use of Plastics amongst tical industry is a classic example. The health sector being one of the most vital sector and even accepted by the government. society under program- Plastics and Ecology, conducted individually or associating with other institutes. Gujarat State Plastic Manufacturers’ • Spreading awareness of use of Plastics in agriculture for effic Association (GSPMA) ient use of water and protecting the crop and subsequent agricultural produce, associating with other institutes- Established in 1970, the Gujarat State Plastic Manufacturers’ Plasticulture program of Plastindia Foundation Association (GSPMA) is one of the leading plastic manufactur- • Encouraging and recognizing innovations in Industry and ers associations in the country, representing Plastic Industry at Academia, associating with other associations. - Plasticon State as well as Central level. At present, total membership Awards of Plastindia Foundation. strength of the Association stands at around 2500. GSPMA is • Providing expert guidance on matters of technology to Industry also one of the founder members of the PLASTINDIA FOUNDA- and individuals under AAP (Anything About Plastics) program TION, an apex body engaged in the research & development in of IPI. the Plastic Industry throughout the country and dedicated to national progress through plastics. All India Plastics Manufacturers’ GSPMA is working for the cause of Plastic Industry since last Association (AIPMA) more than four decades. GSPMA has been engaged in the promotion of image of Gujarat based units in the country and has Products / Services: The All India Plastics Manufacturers’ Asso- been functioning as a major link between the Industry & the ciation (AIPMA) established in 1945 is the oldest and largest apex Government. body to promote development and growth of Indian Plastics In- GSPMA also participates in the national/ international plastics dustry. Spectrum of membership include all categories of plas- exhibition from time to time. GSPMA had organized national level tics industry spread over 175 cities and towns nationwide. Over plastics exhibitions PLEXPO in the year 1979, 1995,2004, 2007 44 National and Regional Plastic Associations all over India are & 2010. These events are considered to be the landmark in the affiliated to AIPMA. AIPMA is one of the founder promoters of history of GSPMA PLEXPO’79 was the fist-ever plastics & Plastindia Foundation established in 1987 with an objective of packaging exhibition show held in India. jointly promote interests of Indian Plastics Industry globally, and Nodal Agent for Arabplast Exhibition held in Dubai. AIPMA was Indian Plastics Institute (IPI) Indian partner for PlastPack Africa Exhibition in Kenya/South Af- rica. AIPMA has representations in various Bodies / Commit- Indian Plastics Institute (IPI) is the national Association of tees of Government of India for promotion of Plastics and Petro- Plastics professionals from industry, academics and students chemical industries. Business delegations to Chinaplas, K, established to pursue following objectives: Koplas, Taipei Plas, NPE, etc. are organised regularly. The 10th • Advance & develop the art, science, technology & engineering Plastivision India -2017 from 19-23 January, 2017 at Mumbai and 3rd Plastivision Arabia 2016 from 10-13 January, 2016 at Sharjah, of plastics for the benefit of its members & the public … UAE are announced. • Form & organize a strong professional body of those connected Indian Drug Manufacturers’ or concerned with plastics… Association (IDMA) • Institute, supervise, advise upon & advance the standard & Indian Drug Manufacturers’ Association “Gujarat State Board” is methods of education & training at all the levels in the fields of a state level Association, represents 200 units from the State of plastics… Gujarat. It was established in the year 1979, under the Chair- • Project plastics… as ‘eco friendly material’ manship of Shri I. A. Modi, Cadila Pharmaceutical Ltd. • Project the vital contribution of plastics in various fields of Ahmedabad. economy… • Disseminate for public awareness all relevant information about As a State level Association, it has been active in resolving gen- plastics … to remove myths & misconceptions…educate eral issues pertaining to Pharma industries. Association is hav- public … the beneficial role plastics play in improving overall ing a closed rapport with the Central & State Government, simi- quality of life. larly, Association maintains closed cordial relations with various Indian Plastics Institute was registered as Society (under Society financial institutions of the state. Association is actively studying Act 1860- Regn. No.333 dated 17.4.1985)in Mumbai and as a the problems like Finance, Power, Pollution, Sales Tax and un- Public Trust in May 1985, as a successor to Plastics & Rubber healthy interference in laws and Rules. Association hold semi- Institute, London (Indian Section) which had started its educa- nars, workshops and interactive Sessions to educate members, tional activities in India in 1963. Due to the implementation of Schedule-M, lot of works have been IPI has 11 Chapters and 5 Sub-Chapters spread all over India done to educate the members of the units. with more than 3,500 members in different categories. Main activities of IPI fall in following categories: Over & above, Association carries out following activities. Spot • Education, Training and Manpower Development for the Guides, Development Programmes, Central Excise Problems, Workshop and Seminar on Sale Tax & Income Tax. Association Jan.-Feb. 2016 always believes in representing right cases of the Pharma Industries. Its motto is service to the Pharma Units. 45

Supporting Association place where people from all parts of the industry can come to- gether around important issues & technologies. Engineering ExportPromotion Council (EEPC India) It has never been more important to be a member of your pro- fessional society than now, in the current climate of change and EEPC India is the premier trade and investment promotion volatility in the plastics industry. Now, more than ever, the infor- organization in India, sponsored by the Ministry of Commerce & mation you access and the personal networks you create can Industry, Government of India and caters to the Indian engineer- and will directly impact your future and your career. ing sector. As an advisory body it actively contributes to the policies of Government of India and acts as an interface between Active membership in SPE – keeps you current, keeps you the engineering industry and the Government. informed, and keeps you connected. Set up in 1955, EEPC India now has a membership base of over 13,000 out of whom 60% are SMEs. For more details visit www.speindia.org Keeping ‘Engineering the Future’ as the motto, EEPC India serves as the reference point for the Indian engineering industry and the Orthopedic Implant international business community in its efforts towards establish- Manufacturers Association ing India as a major engineering hub in the future. EEPC India is (OIMA) also working aggressively on the promotion of the Indian Medical Device & Pharma Machinery sector. • An Association of FDCA Approved Manufacturers of Orhopedic Year 2015 holds a special significance for EEPC India as it marks Implants And Instruments. the 60 years of its establishment. Hon’ble President of India, Mr. Pranab Mukherji graced the Diamond Jubilee celebrations of • To Develop The Orthopedic Fraternity For The Well-Being Of EEPC India as “Chief Guest”. Department of Posts has released Mankind. a Commemorative Stamp to mark the 60 years of EEPC establishment. • To Promote Good Practices In Manufacturing And Services Of Orthopedic Implants. The Society Of Plastics Engineers (SPE) • Standardization Of Product Processing Service Approved Indian FDA. • Following All The Necessary Regulatory Norms. • Encouraging Research And Development Through Clinical Analysis. • Increase Awareness of FDCA To All. The Society Of Plastics Engineers (SPE) founded in 1942, the MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS premier source of peer-reviewed technical information for plas- tics professionals. SPE India has been in existence for over 25 • I.V. Infusion Sets years, and has effectively functioned as an extension of the • Blood Administration Sets parent body to fulfill its objective of serving the Indian Plastics • Scalp Vein Set Industry. • Urine Collection Bags • Ryles / Feeding Tubes The organization is divided into five parts: • Catheters and Tubes Local and Geographical Sections, Technical Divisions, Staff, • Surgical Gloves. Volunteer Leadership, Student Organizations. There are also groups which are under formation, such as Sections in Forma- Contact : tion (SPE Sections) or Special Interest Groups (SPE Divisions.) Mr. Bhavin Shah It has been holding numerous technical seminars and interna- tional conference to facilitate the transfer of knowledge across MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS various industry segments. 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi SPE India constituted of some of the top individuals from the Mill, Narol - Isanpur Highway, Narol, plastics industry who volunteer their time, resources and efforts towards furthering the cause of the India Plastics Industry. SPE Ahmedbad-382405. (India) Phone : (O) 079- is the only place where people from all parts of the industry can 25733318 (R) 079-25430211 (M) +91-9825018952 come together around important issues & technologies. Email : [email protected], SPE’s contribution to the plastics industry has made a signifi- [email protected] cant difference to the technologies & innovations the industry enjoys today. Today, the industry is more interdependent than Website : www.mescosurgical.com ever, and professional networks have taken on global dimen- sions. Such networks are almost impossible to develop and Jan.-Feb. 2016 maintain in our fast-paced industry. Participation in SPE is a key success factor to thrive in today’s business environment. The objective of the SPE is to promote the scientific and engi- neering knowledge relating to plastics. SPE helps people and companies in the plastics industry succeed, by spreading knowl- edge, strengthening skills & promoting plastics. SPE is the only 46

Industry News Import Duty On Medical Devices Raised The customs department has raised import duty on medical in the basic customs duty rate on certain medical devices devices used for surgical, dental and veterinary use from the together, with the imposition of SAD, accompanied by a reduc- current five per cent to 7.5 per cent (increase of 2.5 percentage tion in the customs rates on the raw materials and parts required points) to help companies manufacture these products in India to manufacture such devices, signifies the government's itself. The move would help Make in India programme in these commitment to encourage manufacturers in India.\" items. These changes are expected to provide impetus to the domestic The step came over a month ahead of the Budget 2016-17, medical devices sector, support Make in India campaign of the expected to be tabled in Parliament on February 29. government and generate employment, the finance ministry's statement said. Besides, the government imposed special additional duty on these items of four per cent by withdrawing exemptions, a state- The concessional basic customs duty will continue for equip- ment by the finance ministry. ment in hospitals run by central or state governments or regis- tered societies, rehabilitation aid and other goods for disabled. Also, basic customs duty will be reduced to 2.5 per cent on raw materials, parts and accessories of these items. (Ref: http://www.business-standard.com) M S Mani, senior director, Deloitte in India, said, •\"The increase DBT Collaborates With AIIMS And IITs For Medical Device Technology The Department of Biotechnology (DBT) has collaborated with instruments, orthopaedic and ophthalmic devices. Syringes, All Indian Institute of Medical Sciences (AIIMS) and leading needles, catheters, scanning devices and bandages are increas- research institutes like Indian Institutes of Technology (IITs) in ingly being manufactured and marketed in the country. “Realising the country to develop the medical devices technology in the the growing importance of healthcare, the Department of country under the ‘Make in India’ initiative taken up the Prime Biotechnology is promoting the medical devices sector through Minister of India. various programmes for affordable products relevant to societal and public health,” said Vijay Raghavan, Secretary of DBT. “Our aim is to make India self reliant in the medical devices sec- tor. As our healthcare sector is vast and require high quality “India has complete value chain right from product innovation to medical devices for advanced medical care, we are calling up commercialization to support and facilitate entrepreneurs. on the medical technology innovators to collaborate and develop Currently about 40 medical devices and diagnostics have been affordable and need based technologies for the common man,” invented in India and have even received US FDA clearances.” opined Dr Harsh Vardhan, Minister for Science and Technology and Earth Sciences. The DBT has collaborated with AIIMS and IITs for development of in-vitro diagnostics tools, implants, and other medical devices. Medical technology industry in India is 4th largest in Asia and is valued at $6.3 billion in the year 2013. At present the industry is According to Dr. Balram Bhargava, the DBT along with premier witnessing 10-12 per cent growth per year. With medical devices research institutions are aiming at global promotion, affordable industry growing at this pace, industry experts are expecting that need driven, health innovation (GANDHI). So far the Biotechnol- the government will do a humongous spending of $250-350 ogy Industry Research Assistance Council (BIRAC) has trained every year for innovation, research and new development in the 110 innovators and developed 34 medical devices and has country. obtained 51 provisional patients. Currently the Indian medical device market consists of medical (Ref: http://www.pharmabiz.com) AP Showcases Exclusive Medical Device Park At Arab Health Expo In its effort to attract global investments in medical device manu- will be complemented with our State led incentives to help make facturing faculties, Andhra Pradesh is showcasing AP and India become a medical devices hub in the world,\" an exclusive project in this sector. Satyanrayana said. \"There is a congenial environment prevailing in Andhra includ- \"We are pleased to be associated with the country’s first medical ing best industrial policy, 24x7 power supply and 10 lac acres of device park. Arab Health Exhibition is a great platform to launch land dedicated to industrial purposes,\" said Andhra Pradesh’s this project. It will assure global attention and interest and will go Health Commissioner KV Satyanarayana. a long way in making this unique project a huge success,\" said Rajiv Nath, Forum Coordinator, Association of Indian Medical Gopinath MG, Director of AP Medical Infrastructure Corporation, Device Manufacturers (AIMED). said that Andhra being the biggest market for medical devices and having large number of medical colleges and super spe- Over 4000 pharma and medical device companies besides are cialty hospitals is on its way to become the biggest medical hub taking part in the Dubai exhibition. in Asia. Andhra government has earmarked 200 acres near Vishakhapatnam to build country’s first and among the world’s \"To achieve this objective we have planned dedicated infrastruc- most advanced medical device manufacturing park. ture for medical device manufacturing faculties,\" he said. In a global first for any manufacturing park, this park will have a \"The recent Central Government announcement of withdrawal dedicated research, development and incubation centre to of duty concession on import of medical devices and the ensure that country becomes a global leader in chosen niche concession duty on raw materials is very timely for success of medical device verticals. our project. (Ref: http://indiatoday.intoday.in) \"This along with the National Medical Devices Policy on anvil Jan.-Feb. 2016 47

Product Gallery Qosina Adds over 90 Compression Fittings to their New Berman Airways from Qosina Large Line of Connectors Qosina is pleased to announce the addition of a new Qosina is pleased to announce the addition of over 90 compression line of Berman Airways (#50114 - #50121), in stock fittings in various sizes and configurations. Individually packaged in a and ready for immediate delivery. These components cleanroom, they are available for tubing OD connections in 1/8, 1/4, 3/ are color-coded which provides instant identification 8, 1/2,3/4 and 1 inch sizes. Configurations include straight, elbow, and of sizes; light pink (40 mm), blue (50 mm), black (60 T, with or without NPT threads. Accessories are also available, including mm), white (70 mm), green (80 mm), yellow (90 mm), ferrules, nuts and plugs. These compression fittings are made of High dark pink (100 mm), and orange (110 mm).An LDPE, Purity PFA, PVDF, PTFE and ETFE. Sterilization methods that could BPA-Free ergonomic design offers a smooth finish per- be used include ETO, Steam, E-beam and Gamma. mitting easy insertion, and part #50121 is equipped with holes through the center of the body that allow for These compression fittings offer PFA purity combined with a robust additional air passage. Berman airways assure a ven- compression style fitting, and are ideal for gas, pneumatic and fluid tilated channel and permit access of a suction tube, connections in applications that require an alternative to a barb or bond even if the airway shifts or partially closes.Qosina of- connection. Once tubing has been cut to the desired length, the simple fers a variety of respiratory components in addition to design allows for ease of installation and requires no tools. They also thousands of single-use components. withstand temperatures up to 212Ú F (100Ú C). Qosina also offers FEP (Pharmafluor®) tubing to fit your project needs. Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and Qosina is a worldwide supplier of thousands of stock OEM disposable pharmaceutical industries including connectors, luers, components to the medical and pharmaceutical industries including bag clamps, adapters, clips, valves, needle hubs, stop- ports, connectors, luers, clamps, adapters, clips, valves, needle hubs, cocks, hemostasis valves, tuohy borst adapters, sanitary flanges, stopcocks, hemostasis valves, tuohy borst adapters, swabs, and spikes. Qosina operates an ISO 9001 swabs, spikes and syringes. Qosina operates an ISO 9001 and ISO and ISO 14001 registered facility. 14001 registered facility. Visit us at www.qosina.com to see our latest products. Visit us at www.qosina.com to see our latest products. Custom sourcing Custom sourcing services are available through our services are available through our knowledge specialists using Qosina’s extensive network. extensive resources. Contact : Ryan Edwards, Qosina, 2002-Q Orville Contact: Maria Stazzone,Qosina, 2002-Q Orville Drive North, Drive North, Ronkonkoma, NY 11779, Phone +1 Ronkonkoma, NY 11779 Phone +1 (631) 242-3000, Fax +1 (631) (631) 242-3000, Fax +1 (631) 242-3230, Email: 242-3230, Email: [email protected] [email protected] Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 48 Jan.-Feb. 2016

Surgical Industry GMP ISO - 9001-2008 For Certified Company SALE S. Nath & Co. In Excellence in Quality Hyderabad, R. R. District, Manufacturer & Exporter of Telangana. Surgical Disposable Products since 1980 An ISO 9001:2008, 13485:2012 IDEAL® & GMP Certified Company • Infusion Set Contact through: • Blood Administration Set • Urine Collection Bag [email protected] • Urine Specimen Container • Umblical Cord Clamp Jan.-Feb. 2016 Address S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 49


Medical Plastics Data Service

Medical Plastics Data Service January - February 2016
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