Medical Plastics Data Service Magazine January - February 2016

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

ASSOCIATE EDITORS Mr. Rahil Engineer, B.E. (Biomedical Eng.) Ms. Bishuna Singh, B.E. (Biomedical Eng.)

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.)

Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India.

Dr. J. V. Tyagi 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: mpds00@vsnl.com Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-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

Editor’s Desk

From the

The Theme of this annual conference is,” Indian Medical Device Industry: Integrating Market, Technology, Innovation and Ecosystem” As per Ms Karin Ezbiansky Pavese, vice president of Innovation & Sustainability at the New York Academy of Sciences,”… a system truly poised to innovate is one in which the barriers between organizations and individuals are broken down, where collaboration happens across disciplines and sectors, and where a diverse, democratized culture supports risk taking, tolerates failure, and celebrates success. The regions and institutions that embrace their importance can gain the competitive advantage.”

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, enhance Skill Development, protect Intellectual Property and build Best-in-class Manufacturing Infrastructure, there is no better time to brain-storm on how to accelerate the process for “Make In India” for the Indian Medical Device Industry.

However, we are proud to say that this annual event being organized since 2001 has the sole objective of promoting “Make-In-India” mission focused on Medical Disposables and Implants sub-sectors of Indian Medical Device Industry. Pioneer and The only Event of its type focused on promoting manufacturing industry in India. It is being organized consistently year after year since 2001 with close involvement and support of the Leading Industry Associations both in Medical Devices , Pharmaceuticals and Plastics sectors, Government including Regulatory Agencies, Research and Academic Institutes as well as large number of Raw Materials, Equipments and Expert Service Providers.

From the last year, it has expanded reach to the healthcare professionals through a parallel event focusing on, “Safety and Risk Management For Healthcare Professionals”. Healthcare Professionals including Doctors, Nursing Staff as well as Technicians face a wide range of occupational injuries and hazards. This conference is being organised to create awareness and devise preventive strategies to minimize these risks. International & Indian Experts from the Industry and leading hospitals will share their knowledge and experience on this critical issue of importance to Healthcare Professionals.

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 including USA, Europe, China , Singapore etc for sparing their valuable time and efforts and sharing their techno-commercial knowledge & vision with about 500 or more delegates over these two days, about 35 companies for taking active participation in the Technology Show Exhibition, all leading Industry Associations for their kind support, sponsoring and advertising companies for their generous support in making this event successful.

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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.

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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

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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 combinations, 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 2. Regulatory affair personnel

3. Senior management 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

12:00-04:00

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.

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.

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Jan.-Feb. 2016

Invited Speakers & Panel Experts Day -1 : February 12, 2016 Dr. S. Eswara Reddy Joint Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare Government of India, New Delhi.

Mr. Rajiv Nath Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi, & Joint Managing Director Hindustan Syringes & Medical Devices Ltd.

Dr. Kiran Kalia Director, NIPER C/O B.V Patel PERD Centre, Ahmedabad.

Mr. H.G. Koshia Commissioner, Food & Drug Control Administration (Gujarat State), Gandhinagar.

Mr. B. Sarkar Executive Director, EEPC-INDIA, New Delhi.

Dr. G. D. Agarwal CMD, G Surgiwear Limited Shahjahanpur, U.P. & Jt. CoordinatorAIMED (Implants)

Mr. Ganesh Sabat CEO, Sahajanand Medical Technologies Pvt. Ltd., Surat.

Dr. T. S. Kumaravel Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai.

Mr. Anand Srinivasan Head-Polycarbonates (ISC) Covestro (India) Pvt. Ltd., Maharashtra.

Mr. Balram Sankaran CEO, SCTIMSTTIMED, Trivandrum.

Mr. D.K. Sharma CEO, Sharma Pharmaceutical Pvt. Ltd., Vadodara

Mr. Narasinh K. Balgi Director, Ferromatik Milacron India Limited, Mumbai

Dr. Inder Jain Airways Surgical Pvt. Ltd., Mumbai.

Dr. Pallavi Kulkarni Technical Manager, Lubrizol Advanced Materials Pvt. Ltd., USA.

Dr. Manasi Nath Technical Application Engineer, Kraton Polymers International Ltd., Mumbai.

Mr. J. P. Dutta CEO, Lancer Medical Technology Ltd., Ahmedabad.

Mr. Sanjay Shah Owner, Promoter, Unikal Consultants, Ahmedabad.

Jan.-Feb. 2016

Dr. Jitendar Kumar Sharma Head- Healthcare Technology Division & Director- WHO CC for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Govt. of India New Delhi.

Mr. Shinto Joseph Director, LDRA Technology Pvt. Ltd., Bangalore.

Mr. Mekala Rao Founder & President, Atachi Systems Pvt. Ltd., Hyderabad.

Mr. Derrick Chan Head-Regional Segment, Healthcare Polymer Solutions, Asia Pacific, Clariant (Singapore) Pte. Ltd.

Mr. Ravi Shrivastava CEO, Omni Lens Pvt. Ltd., Ahmedabad.

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

Dr. S.S. Murugan (UK and EU Registered Toxicologist), Managing Director, GLR Laboratories Pvt. Ltd., Chennai Dr. Prashant Jha Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, Delhi.

Mr. Vipul Sheth Managing Director , Matrix Meditec Pvt. Ltd., Ahmedabad.

Mr. Dhiren Mehta Managing Director, Surgimedik Healthcare India Pvt. Ltd., Mumbai.

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Invited Speakers & Panel Experts Day -2 : February 13, 2016 Mr. Manoj Bhardwaj Managing Director, SMC Ltd., Bangalore.

Mr. Sanjay Chotalia Manager – Technical Sales & Marketing, Covestro (India) Pvt. Ltd., Maharashtra.

Mr. Tim Galekop TiGaMed Consulting, Belgium.

Dr. Ashok Thakkar Head, Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi.

Mr. Siddharth Jain CEO and Chief Regulatory Advisor, Symbiorph Clinical Trialogy, Ahmedabad.

Mr. T. S. Kumaravel Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai.

Mr. S. S. Murugan Managing Director, GLR Laboratories Pvt. Ltd., Chennai.

Mr. Sanjay Shah Owner, Promoter, Unikal Consultants, Ahmedabad.

Mr. Ashish Bhutada CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore.

Mr. Sumit Marwah CEO & Director, Dispoline Healthcare Private Limited, I2i Consulting, Deccan Crest, Management Consultant & Entrepreneur.

Mr. Deepak Dave Vice President, Medical Surgical and Healthcare Industries Trade Association, Ashutosh Export International, Mumbai.

Dr. Rajesh C. Shah President, Gujarat Chapter, Associations of Surgeons of India, Consultant Surgeon, A- Prof. Surgery & Medico legal Expert, Sheth V. S. General Hospital & Smt. N. H. L. Muni. Medical College, Ahmedabad.

Mr. Atul Kanuga President- IPI & Environmental Committee Chairmain, Plastindia Foundation.

Dr.Ketan Kumar Vadodaria Head -Medical Textiles, The South India Textile Research Association (SITRA), Coimbatore.

Dr. Hemant Desai Vice President– Operations, Makcur Laboratories, Ahmedabad.

Dr. Nirav Jamnapara Scientist, Institute for Plasma Research, Gandhinagar, Gujarat.

Dr. Jaishree Kasliwal Quality Council of India (QCI)

Mr. Jayavanth Kamath Founder & Principal Consultant, Caliber Assurance Services, Bangalore.

Dr. Mahesh Patel Quality Manager, Apollo Hospitals, Ahmedabad India

Dr. J.L. Meena State Quality Assurance Medical Officer, Commissioner of Health, Govt. of Gujarat.

Gandhinagar.

Mr. Partha Mohapatra (Lead Healthcare (India) & Technical Support, Styrolution ABS (India) Ltd, India)

Invited Speakers & Panel Experts : Presentation Abstracts Mr. T.S. Kumaravel, (Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai) “How to fulfill biocompatibility in today’s rapidly changing regulatory and scientific scenario?”

It is the management responsibility to assure the safety of medical devices that they placed in the market. One of the safety requirements is to fulfill the biocompatibility of the medical device.

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Biocompatibility testing provided confidence to the manufacturer, regulators and the patients that the device is safe for the intended use.

General guidance for biocompatibility testing is provided by ISO10993, Part 1. The other parts of ISO 10993, Parts 2-20 give guidance on how to perform these tests. There are also other guidance that are device specific. These device specific guidance are issued by ISO, regulatory bodies and sometimes scientific committees can issue recommendations.

Jan.-Feb. 2016

Invited Speakers & Panel Experts : Presentation Abstracts Biocompatibility testing and guidance came into use in mid 1990s, when ISO started developing guidelines. Initially the regulators and notified bodies looked at biocompatibility as a mere box ticking exercise. At that time, certificate that biocompatibility was fulfilled was considered sufficient. With further developments and revisions in ISO standards, and further experiences in biocompatibility testing over the last 10 years, the expectation from biocompatibility testing has massively increased. The regulators and the notified bodies have started looking at the biocompatibility reports in greater details for scientific and regulatory fulfilments. They are employing Dr. Manasi Nath, (Technical Application Engineer, Kraton Polymers International Ltd. Mumbai) “Novel Styrenic Block Copolymers and Polyisoprene Rubber for Medical Devices.”

Styrenic Block Copolymers (SBCs) and polyisoprene rubber are suitable for a variety of applications. This paper describes Kraton® polymers, especially Kraton Enhanced Rubber Segment SEBS Dr. Pallavi Kulkarni (Technical Manager Lubrizol Life Sciences, Lubrizol Advanced Materials, USA) Thermoplastics Polyurethanes: Enabling Innovative Competitive Technologies through Advanced Materials.

Thermoplastic Polyurethanes (TPUs) are a class of polymers with unique physicochemical properties. They are inherently strong like thermoplastics yet flexible like elastomers, making them the most versatile class of polymers. TPUs are composed of soft and hard building blocks and the phase segregated morphology of these building blocks imparts physical properties that cover the entire range of polymers from soft, flexible elastomers to rigid engineered polymers and everything in between. Additionally, the soft and hard blocks can be chemically chosen such that they are biocompatible and biostable, suitable for medical applications.

Medical Device industry has grown exponentially in the last deMr. Shinto Joseph (Director, LDRA Technology Pvt. Ltd., Bangalore.)

Process oriented approach for building safer and secure medical devices For medical device developers, increased government scrutiny and new international standards create a compliance burden that Mr. Derrick Chan (Head, Regional Segment Healthcare Polymer Solutions, Asia Pacific, Clariant (Singapore) Pte. Ltd.) “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

biocompatibility experts to review the files submitted to them for CE marking or 510K/PMA. Under these circumstances, it is important for the manufacturers to understand these changing requirements and prepare their biocompatibility files accordingly. There is also more emphasis on literature review and risk management approached to fulfil biocompatibility requirement, without the need for unnecessary animal testing.

In this talk, I will briefly introduce you to these changing regulatory requirements in biocompatibility testing.

(Kraton®ERS SEBS) in transparent medical applications. Due to their cleanness, softness, good processability and excellent compatibility with polypropylene, Kraton ERS SEBS polymers have been widely used, as a toughness modifier for polypropylene, in transparent medical application such as IV bag films, medical tubing and consumer goods application such as containers, etc.

Cariflex®Polyisoprene Products are designed to replace natural rubber for producing medical products ranging from surgical gloves and tube connectors to IV bag and medical stoppers, balloon catheters, needle shields, dental dams and cohesive bandages. cade with an evolving regulatory landscape. Device design engineers are constantly looking to create the next-generation device with advanced polymers and materials that offer an edge over existing materials. The versatility and tailor ability of thermoplastic polyurethanes has become an essential tool in the design engineer’s toolbox. TPUs have successfully replaced PVC for certain device applications where regulations prohibit the use of plasticizers. In some other instances, TPUs are being used instead of silicones in next generation devices, thereby providing a competitive edge in the marketplace.

Lubrizol’s medical grade TPU offer a wide range of chemistries to choose from depending on the application. Ease of process ability is key for efficient manufacturing, Lubrizol’s TPUs can be processed by standard methods such as extrusion, injection molding, and solvent casting. With the addition of Vesta, Lubrizol has gained additional capabilities more towards device manufacturing and assembly. Lubrizol is no longer just a resin supplier; it is a complete Device Solution provider.

challenges time-to-market goals and threatens to explode development costs. Along with Safety, now Security is also a serious concern for all and without global safety certifications, today our innovations cannot reach global markets. We would discuss international safety standards like IEC 62304 and secure software development approaches that could help in accelerating your go to market strategy, while keeping the costs under check.

meeting performance and regulatory standards to fulfil the increasingly stringent demands of these global markets. Materials that can help minimize the risks and costs of non-compliance in a product’s development and lifecycle are vital to this process.

Clariant’s package of dedicated service and expertise, product reliability and innovative material performance gives the industry the confidence it needs to address risk potential.

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Invited Speakers & Panel Experts : Presentation Abstracts Mr. Sanjay Chotalia Manager – Technical Sales & Marketing, Covestro (India) Private Limited, Maharashtra.

“Blood is not ketchup!

Biocompatible Plastics for Medical Devices” Individual medical care with increased life expectancy, is a Mr. Mekala Rao (Founder & President, Atachi Systems Pvt. Ltd., Hyderabad) Improving Quality, Efficiency and Compliance with Paperless Manufacturing (Manufacturing Execution Systems) Challenges have been constantly increasing for Medical Device Manufacturers to produce a high quality product with regulatory compliance. Global demand has been putting high pressure on the manufacturers to release the new products in short time.

Regulatory authorities have been releasing and enforcing the stringent regulations for the processes, validations, documentation and record retention requirements.

Mr. Partha Mohapatra (Lead Healthcare (India) & Technical Support, Styrolution ABS (India) Ltd, India) Styrenics solution for Infusion system, Fluid delivery, Respiratory & Drug device Styrenic polymers ( Novodur ® HD ABS, Luran ® HD SAN, NAS ®SMMA, Styrolux ®SBC, Styroflex ®SBC, Zylar ®MBS & Terlux ® MABS) are suitable for medical device application with regulatory compliances. These styrenic products have been long used for major medical device applications, such as Infusion set connectors, adaptors, Stop cock, Valves, Drip Chamber, Infusion Mr. Shinto Joseph (Director, LDRA Technology Pvt. Ltd., Bangalore.)

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 (Quality Manager, Apollo Hospitals, Ahmedabad India) Safety And Risk Management For Healthcare Professionals In this talk, I will briefly introduce you to the following topics which can be very useful for healthcare professionals in daily routine practices.

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challenge today. Let us make durable medical devices to support the billions. Covestro High Performance Polycarbonate is a proven choice with 50 years of Makrolon in the global medical market. We enhance design freedom by weight reduction, heat resistance, toughness & transparency.

• Replace paper on the manufacturing floors with Manufacturing Execution Systems • Continuously improve the product quality with reduced CAPA (Corrective and Preventative Actions) • Simplify compliance with global regulatory GMPs and 21 CFR Part 11 • Generate instantly Electronic Device (eDHR) and/ Batch History Records (eBHR) and Retain them throughout the life cycle of the product • Improve your bottom line with Manufacturing Operations Management coupled with Supplier Quality and Post Market Surveillance from FDA • Reduce your Validation time and Time-to-Market for New Products

tubes, DPI inhalers, Airways, nebulizer housing,face masks & respiratory filters. Edical grade styrencis Products are designed to replace PVC & PC for producing medical devices products infusion systems & respiratory device applications. This presentation describes specially opaque & transparent medical grade polymers in infusion system (Fluid delivery) and respiratory (drug delivery) device. Our bio-compatible styrenic products have good processing, high impact strength, surface quality, dimensional stability, high gloss appearance, high stiffness, scratch resistance, resistance to fluctuating temperature & excellent resistance to chemicals. The regulatory compliance of our Styrenics are, USP Class VI, ISO10993, DMF registration, EUP, JP, Regulation (EU) No.10/2011 statement and FDA (US) statement. up. Safety critical industries like Medical devices creates a value added engineering skills based career opportunity for students.

Even though a safety critical product development involves requirement analysis, design, development, testing & certification, the last two consumes more time and money. This forces global players to outsource testing to countries like India. But lack of skills in international safety & security standards in India, becomes a major bottleneck for students getting into this area. This paper would discuss career opportunities as well as how students and faculties can be prepared to grab these opportunities.

• • • • • •

Integrating Employee & Patient Safety Healthcare Stress Management Managing SUD’s in Hospital Critical Care Equipment Cleaning Protocol Patient Medical Device Management Management of NSI / Blood or Body Fluid Exposure & Significant of Vaccination • Hospital Cleaning or Sterilization Protocol • Hospital Acquired Infection Jan.-Feb. 2016

Invited Speakers & Panel Experts : Profile Dr. S. Eswara Reddy (Joint Drugs Controller (India), Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare Government of India, New Delhi) Dr. S. Eswara Reddy is the Deputy Drugs Controller Of India, Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare, Govt. of India. He holds a Masters Degree in Pharmacy and Ph.D. and has rich experience in manufacturing of pharmaceuticals, academic and in Regulations.

He started his career as a Drugs Inspector in CDSCO, West Zone, Mumbai in 1998 and has good experience in GMP, GCP and GLP audits and promoted as an Assistant Drugs Controller of India in 2009.

He participated in many national and international seminars / workshops / meetings on various areas of Drugs regulations and undergone training from USFDA, KFDA, South Korea and WHO, Geneva. He is regularly invited to make presentations at various seminars and workshops. He also published articles in various journals. *********************************************************************** Shri H.G. Koshia (Commissioner, Food & Drugs Control Administration, Gujarat) Dr. H.G. Koshia is currently Commissioner, Food & Drugs Control Administration, Gujarat and his key Responsibilities are Enforcement of “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Safety & Standard Act, 2006” and rules, in Gujarat State.

He is actively representing nine national and state level committees. He is Chairman of the very important committee “Track & Trace”, for preparation of guidelines to prevent of menace of spurious drugs.

He has played a pivotal role in transformation of pharma and medical devices sectors in Gujarat to emerge as a favorable investment destination with proactive & pragmatic approaches. He was instrumental in the implementation of e-governance in FDCA and is winner of one state level and three national level awards. *********************************************************************** Mr. Rajiv Nath (Jt. Managing Director, Hindustan Syringes & Medical Devices Ltd. Forum Coordinator Association of Indian Medical Device Industry (AIMED)) Mr. Rajiv Nath is Jt. Managing Director of Hindustan Syringes & Medical Devices Ltd. which is having a turnover of over 500 Crores & Trustee – Safe Point India – a CSR Initiative of HMD (Hindustan Syringes & Medical Devices Ltd.). He is President of All India Syringes & Needles Mfg. Association. (AISNMA) & as well as the Founder and Forum Coordinator – Association of Indian Medical Device Industry (AIMED) with over 350 Members nationwide whereby Medical Device Manufacturers all types of technologies have been attracted nationwide on one Platform.

As Forum Coordinator of AIMED, Mr. Nath has taken many initiatives of establishing a Collaborative Framework with various Dept. of the Govt. and Media to bring to their attention issues troubling the industry and attract investments into India in his quest to make India as the Preferred Manufacturing Destination and the leading Supplier of Medical Device Worldwide.

Position held : • Jt.Managing Director of Hindustan Syringes & Medical Devices Ltd. (HMD)

Jan.-Feb. 2016

• President of All India Syringes & Needles Mfg. Association. (AISNMA) • Forum Coordinator of Association of Indian Medical Device Industry (AIMED) • Jt. Coordinator of Indian Medical Device Regulatory Review Group (IMDRRG) • Jt. Coordinator of UDAIMED • A Member of International Association of Safe Injection Technology (IASIT) and served on the Board.

• Member of “International Safe Healthcare and HIV /AIDS Working Group”.

• Member of “India Coalition on Injection Safety” • Member of Think Tank Pharma Forum An active Member of expert committee and Task Force for Medical Devices Regulation in India. *********************************************************************** Dr. Jitendar Kumar Sharma (Head- Healthcare Technology Division & Director- WHO CC for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Govt. of India New Delhi.)

Dr. Jitendar Kumar Sharma is Head of Healthcare Technology Division and Director of WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, at National Health Systems Resource Center, the technical support institution under Ministry of Health & Family Welfare, Government of India. He is also Adviser (Health & Medical Technology) to the Hon’ble Chief Minister, Govt. of Andhra Pradesh. He earlier served at Sri Sathya Sai Institute of Higher Medical Sciences, later as consultant to World Bank and then as Consultant to the World Health Organization, Geneva. He is Clinical Faculty at University of Adelaide, Australia and program director for Health Technology Assessment (HTA) fellowships in India. He has been an adviser at Health Technology Innovation Centre, IIT Madras and serves as faculty for National Accreditation Board for Hospitals (NABH) in India for Medical Devices.

He has contributed through several research papers, seven books on health technologies & assessments, six compendiums on technical specifications for medical technologies and has been contributor to several reports on health technologies by International agencies including WHO. He is a key coordinator of several health technology programs in India and a faculty for courses on health technology policy & assessment in several countries. *********************************************************************** Prof. Kiran Kalia (Director, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, Gujarat, India Professor in Biochemistry,Sardar Patel University, VallabhVidyanagar, Gujarat, India) • Ph.D. degree from Industrial Toxicology Research Centre, Lucknow, India’s most prestigious CSIR Research Institute in 1986 • 34 years of research and 29 years of teaching experience • 67 publications in various national and international peer review journals • 75 presentations at various national and international symposiums and conferences and 3 chapters in book published by International Publishers.

• Delivered plenary lectures / Lead lectures at various international conferences in last ten years at Malaysia, Singapore, Czech Republic, France, China and USA.

• Visiting professor at School of Health Sciences, Purdue University, USA in 2006-07 • Awarded 8th “International Prestigious Sardar Patel Award” for Excellence in Women Empowerment.

• Awarded the “President Guide award” by His Excellence President of India Shri V.V. Giri • Received grants for 16 major research projects from University Grants Commission (UGC), Department of Biotechnology of Ministry of Science and Technology (DBT), Govt. of India, Gujarat State Biotechnology Mission (GSBTM) Gandhi Nagar, Ministry of Earth Sciences (MoES), New Delhi and Defense Research and Development Organization (DRDO), New Delhi.

Life member of various academic and professional bodies like Indian Science Congress; Society of Biological Chemists, India; Society of Toxicology – India; Indian Association of Micronutrients, New Delhi; and Organization of Women Scientists in Developing World (OWSD), Italy. *********************************************************************** Mr. B. Sarkar (Executive Director, EEPC India) Shri B. Sarkar had joined EEPC India in 2001, as Joint Director (Finance & Accounts) in the Head Office of EEPC India in Kolkata. Being a professionally qualified Chartered Accountant and having prior audit experience in various audit firms, Shri Sarkar’s advent to EEPC India as above was quite justifiable.

In his professional journey, in EEPC India, Shri Sarkar was first elevated to the post of Director (Budget & Finance) in 2004 and posted to one of the premier offices of EEPC India in Mumbai for solving various administrative problems as well as looking after the large section of members of EEPC India in Western Region. He has wide experience in handling various policy issues and important high level administrative tasks. He proved himself to be very capable and, subsequently, he was elevated to the position of Addl. Executive Director & Secretary of EEPC India in 2007. With the passage of time, it was an important milestone in his career, as it marked the beginning of 13 years of professional excellence that eventually led him to crown the highest Executive Post as the Executive Director of EEPC w.e.f. 1st December, 2012. He is also concurrently holding the post of the Secretary of the Council. Shri Sarkar has been instrumental in organising various promotional events in India and abroad. He has widely traveled to countries like Brazil, Venezuela, Turkey, Germany, South Africa, Egypt, Thailand, Bangladesh, Thailand, Czech Republic etc. EEPC India still has the highest membership and is a highest foreign exchange earner of the country that possibly a Council can boast of.

Shri Sarkar is a true music lover and is fond of reading various books. He also loves traveling. All these habits perhaps keep him going in spite of all the constraints and rigors that his present position demands. *********************************************************************** Mr. Narasinh K. Balgi (Director, Ferromatik Milacron India Limited, Mumbai) N.K. Balgi is Director on Board of Ferromatik Milacron India Pvt. Ltd (FMIPL). He holds Bachelor degree in Engineering.

He has been serving the Plastics Industry for the last 42 years and has wide-spread experience in Quality Assurance, Manufacturing Systems, Technology

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Invited Speakers & Panel Experts : Profile Management and has exposure to Sales & Marketing, Finance, Human Resource Development & Organizational Development.

Klockner Windsor India and Larsen & Toubro - Plastics Machinery Division, before taking over leadership position at Ferromatik Milacron India. Under his leadership the company has attained leadership position in the Indian market and has spread its presence over 46 countries. He is recipient of “The James A.D.Geier Leadership Award” - an award instituted by Milacron in the name of their outstanding leader - in the year 2008.

Industry Representations: • Fellow Member of Indian Plastics Institute [IPI] • Member of Society of Plastics Engineers.

• Member of Regional Advisory Committee of IGTR. • Member of Regional Advisory Committee of C.I.P.E.T. • Immediate Past Chairman of Governing Council, Indian Plastics Institute • Convener and Founding Director of Plastics Machinery Manufacturers Assn.

• Member of Governing Council of Capital Goods Skill Council (CGSC) *********************************************************************** Dr. Prashant Jha (Fellowship Director, School of International BioDesign All India Institute of Medical Sciences, Delhi) Dr. Prashant Jha is a physician-engineer with over a decade of trans-disciplinary experience in patient care, training physicians, innovating medical technologies, training med-tech leaders and creating an ecosystem for innovating medical devices and technologies in Australia, India, Japan and USA. He serves as the Fellowship Director of Medical Technology Innovation Program at AIIMS Delhi, where he trains physicians, engineers, designers & entrepreneurs in the art & science of innovating & commercializing healthcare innovations. He also serves a visiting faculty in several Medical, Engineering & Business Schools in India as well as in Japan, UK, Australia & USA. Dr. Jha is the co-founder and editor of BMJ Innovations, world’s first general medical journal on innovations in healthcare. He also serves as an advisor to various NGOs, Medical Device Corporations and MedTech StartUps. *********************************************************************** Mr. D. K. Sharma (CEO, Sharma Pharmaceutical Pvt. Ltd., Vadodara) “SHARMA ORTHOPEDIC" - RICHEST SHOULD PREFER AND ANYONE CAN AFFORD” Mr. Dayanand Sharma, the CEO of “SHARMA PHARMACEUTICAL PVT LTD” is at the helm of the company’s operations. His enterprising skills and experience in the industry continue to play a pivotal role in the company’s growth. He has played an active role in acquiring “SHARMA ORTHOPEDIC” the reputation of a leading brand in orthopedic implants and making the strong presence across India and emerging as a fast growing brand across the Globe.

He started his career with grass root working including working long hours on manually operated conventional machines and assembly of the orthopedic implants.

While the evolving technology he came up with new concerns, redefined goals, advanced technology, innovative materials. He bought all kind of technical changes, process up-gradations and mastered the art

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of innovative manufacturing of orthopedic implants. He traveled across the globe in search of business and learned dynamics of international business.

Mr. Sharma has to his credits the vast experience of more than 25 years of working in the field of Orthopedic Implants. Mr. Sharma’s visionary approach to serving his clients has enabled him to anticipate and meet the changing imperatives of the marketplace.

As an entrepreneur, Mr. Sharma embodies the creativity and innovation that keeps his company ahead in the competition, along with the reliability and trust that clients and employees value. He has prepared “SHARMA ORTHOPEDIC” for continual growth by developing its distinctive business model, client relationships and depth of staffing expertise. *********************************************************************** Mr. Balram Sankaran (CEO, SCTIMST- TIMED, Trivandrum) Mr. Balram Sankaran is Chief Executive Officer of SCTIMST-TIMED, a national technology business incubator dedicated to promote start-ups and entrepreneurship in medical devices and biomaterials promoted by Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Trivandrum with support of DST, Govt of India & KSIDC. He is also Scientist-G at SCTIMST and has over 20 years of experience in the area of technology transfer and commercialisation of medical devices. His interests include Medical Devices Testing &Regulation, Intellectual Property Rights and technology Incubation.

He is a member of the working group of Materiovigilance programme of India. He has received fellowships for training in Japan, USA and UK and is a post graduate in Engineering.

Dr. Atul Sardana (MBBS, MS, FIAGES) *********************************************************************** (Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi.)

Dr. Atul Sardana is a minimal access surgeon with a knack for applying technology to conventional surgical principals which benefits patients. Dr. Atul Sardana has been working in the health care sector since 1990 starting as a social worker in one of Delhi’s large government hospital. He is currently a Senior Consultant Surgeon at Sir Ganga Ram Hospital and Apollo Spectra Hospital at New Delhi. He has over 30 national and international clinical publication and presentations and is an honorary member of the World Association of laparoscopic Surgeons, and a member of the Indian Association of Gastrointestinal and Endoscopic Surgeons.

He was awarded the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons in 2007. He was actively involved in training of surgeons in the field of Advanced Solid Organ Laparoscopic Surgery, Endo stapling Principles and Techniques, and Laparoscopic Hernia Surgery at Ethicon Institute of Surgical Education, New Delhi and is a faculty for the conduct of the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons. He is also an active member of AIMED (All India Medical Device Manufactures Association). He is a certified internal auditor of quality management systems for medical device manufacturing as per ISO 13485:2003 from TUV SUD. He served as the head of Technical operations at Biosurge Technologies, Mumbai and later was the founder chairman at Alfa Corpuscles Private Limited where he currently serves at the Head for R & D and

Product Development. Alfa Corpuscles is backed by the Technology Development Board, DST, DBT, ICMR and GVFL. He has three national patents for his invention of the “Laparoscopic Access Trocar”, “Safety Syringe” and “Oral Vaccine Reconstitution & Delivery Device” and one PCT filed for his invention of the “Safety Syringe”.

His efforts on the safety syringe have been acknowledged by the “Wellcome Trust, UK” and the invention has been awarded the Silver Prize at the Seoul International Invention Fair 2012. *********************************************************************** Mr. J. P. Dutta (CEO, Lancer Medical Technology Ltd., Ahmedabad) Mr. J. P. Dutta is presently working as CEO, with Lancer Medical Technology Ltd. since June 2011. He looks after the overall goal setting, future technology development, Image building and making the operation profitable. The company has one of the best facilities amongst the Indian Medical Device manufacturers. The company works closely with physicians and engineers to understand the need of the type of products to develop which should meet patient’s requirement. The goal is to Improve the quality of life for patients at an affordable cost. *********************************************************************** Mr. Ashish Bhutada (CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore) Outstanding performance in every role year after year, experience in leading large cross-functional teams for critical projects, along with practical experience in following areas gives him the confidence for taking up bigger leadership challenges: Building a new business from scratch, Campus recruitment, sales team building, marketing management, product management, new product launch, sales programs, leading cross-functional teams, market research, pricing strategy, competitive response, branding analysis, financial analysis, nationwide sales force training (US based), increasing sales rep productivity, coaching, motivating, engineering projects, field sales, account management, retention strategies, accounting management, finance, effective negotiating, customer service, efficiency improvement projects, change management, six sigma green belt. *********************************************************************** Dr. T. S.Kumaravel (Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai) Dr. T. S.Kumaravel is the Founding Chairman of GLR Laboratories Pvt Ltd. Dr. Kumaravel is American Board certified and UK/Eurotox Registered Toxicologist with more than 20 years experience in industry as well as in academia. He is a leading expert in Biological Safety Assessments, Biocompatibility studies and developing strategies for testing medical devices. He obtained his Bachelor's degree in Medicine and Surgery from Stanley Medical College, Doctoral degree in Pharmacology/ Toxicology from University of Madras and finally obtained PhD in Genetic Toxicology/Cancer Genetics from MGR Medical University, Chennai. He then carried out toxicology research at Hiroshima University, Japan; National Institutes of Health, USA and Princess Margaret Hospital, Canada. Subsequently, he has worked with world leading contract research companies such as Covance Laboratories and Huntingdon Life Sciences, where he worked with various international medical

Jan.-Feb. 2016

Invited Speakers & Panel Experts : Profile devices clients. He has extensive experience in Biocompatibility studies, advising clients on their requirements to comply with national and international guidelines. Additionally, he has experience of managing regulatory submissions for FDA and EU. He has authored several confidential reports, 40 peer-reviewed publications and has 50+ conference papers to his name. *********************************************************************** Mr. Sanjay Y Shah (Owner Promoter, Unikal Consultants, Ahmedabad) Mr. Sanjay Shah has experienced regulatory consultants for 1. Medical Devices of various classification and applications. Devices including cardiac (drug device combination products), ophthalmic, orthopedics, IUDs, pain management devices, surgical & transfusion devices etc.

Compliance for international registrations in European and Latin American countries and device certifications like CE marking, US FDA registrations (510k), China CFDA. Regulatory Compliance advisor for medical device plants in India, USA, European countries, Middle Eastern countries and Indian CDSCO. 2. Consulting in Drug Master File (DMF) for US-FDA for active pharmaceutical ingredients (API) and 510k US FDA CDRH regulatory submissions.

3. Projects related to international technology transfers and setting up new plants for medical devices like Drug Eluting stents, Ophthalmic Implants (IOL), Orthopedic implants, IUDs etc.

He has wide experience in consulting for Quality Management System implementation & audits as per ISO 9001 & EN ISO 3485.

Expert team in auditing degree of company’s compliance to the standards and regulations: ISO 9001, ISO 13485, Quality System Regulations & c-GMP. Consulting and auditing for c-GMP of Medical Device & API Plants.

Consult in registering R&D Centres of Pharma, API, Chemicals and Medical Device companies.

Unikal Consultants is an Indian representative of Obelis, S. a. Brussels based European Authorized Rep. company. *********************************************************************** Mr. Derrick Chan (Head, Regional Segment Healthcare Polymer Solutions, Asia Pacific, Clariant (Singapore) Pte. Ltd.) Mr. Derrick Chan earned his Master of Science in Polymer Technology from Loughborough University in the United Kingdom. Since joining Clariant in 2010, he has held various technical and marketing positions in the company’s Master batches business unit. Mr. Chan is currently the Asia Pacfic Regional Segment Head for the business unit’s Healthcare Polymer Solutions segment. *********************************************************************** Dr. Ketankumar Vadodaria (Head, Medical Textiles- The South India Textile Research Association (SITRA), Coimbatore) Dr. Ketankumar Vadodaria is heading Centre of Excellence – Medical Textiles Division at The South India Textile Research Association (SITRA),

Jan.-Feb. 2016

Coimbatore. He is in the field of textiles for more than 9 years and has worked in manufacturing, R&D labs, Quality Assurance, Technical Services, Teaching, Consultancy etc.

Tim is attending the INDA, EDANA and SBA (Sterile Barrier Association as a board member) meetings. Tim led EDANA’s Task Force infection prevention conference – “ IN CONTROL” in the role of Chairman.

This has given him a vast exposure to various techniques in short staple fibre spinning, weaving, garment making, melt spinning as well as advanced electro-spinning in various parts of the country and abroad.

Tim now consults with some of the most respected companies worldwide.

He has obtained his Masters and Bachelors in Textile Engineering from M.S. University of Vadodara, Gujarat.

He did his Doctorate in Textiles in Nanotechnology & Smart Fibres from Herriot-Watt University, United Kingdom.

He has presented papers in national / international seminars & Conferences. He has also published national and international journal papers. He is also invited for lecturers in conferences / seminars. *********************************************************************** Mr. Siddharth Jain (CEO and Chief Regulatory Advisor, Symbiorph Clinical Trialogy, Ahmedabad) Siddharth Jain is CEO and Chief Regulatory Advisor of Symbiorph Clinical Trialogy. He is based in Ahmedabad and has extensive experience in Medical Device Clinical Evaluation Report Preparation, Post Market Clinical Follow-up (PMCF), Risk Management, CE Certification and Global Product Registration in Latin America, GCC, MENA, South East Asia and US FDA. He has total 04 years of experience in Medical Device Regulatory Affair Compliance and currently advising many Orthopaedic Implant Manufacturers, Disposable Manufacture and Laparoscopic Instrument & Equipment Manufacturer across India. He has done Post Graduate in Microbiology from the B.R Doshi School of Bioscience, Sardar Patel University, Vallabh Vidyanagar and further did Post Graduate Diploma in Clinical Research from Xcellon Institute, a sister concern company of Claris Pharmaceuticals affiliate to Ganpath University. He has also published his research paper on Naphthalene Degradation by Bacteria Consortium (DV-AL) developed from Alang-Sosiya Ship breakage yard, Gujarat in Science Direct Journal. *********************************************************************** Mr. Tim Galekop (TiGaMed Consulting, Belgium) Mr. Tim is regarded as a Global Expert in the field of Infection Prevention and Sterilization In his last role Tim was Responsible for Global Technical Support and Regulatory affairs and has been working in the medical field for more than 30 years.

He is a member of the Dutch Norm group from the day of foundation in 1980 and has participated in the German DIN, and the French AFNOR. Since 1988 he is convener of TC 102 WG 4 Packaging Materials, Tim is as well a participant in ISO TC 198 WG 7 Medical Packaging and CEN TC 205 WG 14 Surgical drapes and gowns.

Over the years he has visited many hospitals globally and spoke on numerous international conferences.

During his stay in India he has spoken in various conventions and visited several hospitals and surgeons in Delhi, Chennai, Bangalore, Kolkata, Hyderabad and Mumbai among other cities.

Tim is committed as well to several medical education programs and has published several publications.

*********************************************************************** Mr. Sumit Marwah CEO & Director, Dispoline Healthcare Private Limited, I2i Consulting, Deccan Crest, Management Consultant & Entrepreneur.

In the field of Single Use Medical Devices And Infection Prevention for the past 17 years, as a Manufacturer, Consultant & Trainer.

Committed to Medical Education Programmes and have taken programmes at various International Conferences, Forums and Hospitals across the globe. Special focus on Education through Creative Learning Programmes.

These are done uner the aegis of THE INPREV FOUNDATION. Interests in OT, CSSD and Sterilization with specific reference to Infection Prevention.

Pioneered Customised Pre Sterile OT / Procedure Kits in India, and developed a low cost model of Design, Manufacturing and Distribution for the same.

Active Member of various Medical Device - industry and regulatory bodies, with a vision to form a Comprehensive Medical Device Regulation for India and assist the medical device industry to produce products with adequate and appropriate controls and systems for ensuring patient and staff safety. *********************************************************************** Mr. Manoj Bhardwaj (Managing Director, SMC Medical Manufacturing, Bangalore) Manoj Bhardwaj is the Managing Director of SMC Medical Manufacturing headquartered at Bangalore, India.

SMC Medical Manufacturing is a fully owned subsidiary of SMC Ltd headquartered in Somerset, Wisconsin US. The core competencies of SMC Ltd spans across medical device design, tool design and build, molding, manufacture and assembly of medical devices as well as industrial automation and robotics.

Manoj is a polymer engineer with over three decades experience in Manufacturing, Consulting and IT sectors.

Manoj has hands on experience in compounding of polymers, alloys and blends as well as downstream polymer processing operations like extrusion, injection molding, welding, machining, printing, decoration, etc.

He also has experience in manufacture of extrusion and injection molding machines, product design, mold design and mold making.

Besides polymer science, Manoj’s background includes business strategy consulting, business process consulting, supply chain and logistics, new product introduction, lean manufacturing, program management as well as IT/ ITeS consulting, infrastructure and services. *********************************************************************** Mr. Dhiren Mehta (Managing Director, Surgimedik Healthcare India Pvt. Ltd. Mumbai & Surat)

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Invited Speakers & Panel Experts : Profile Mr. Dhiren Mehta is a B.Chem Engineering with 27 years in Medical Device industry.

Currently he is the Managing Director of Surgimedik Healthcare India Pvt Ltd (Mumbai & Surat.) *********************************************************************** Dr. Pallavi Kulkarni (Technical Manager Lubrizol Life Sciences, Lubrizol Advanced Materials, USA) Dr. Pallavi Kulkarni is Technical Manager at Lubrizol Advanced Materials Life Sciences division. Her area of expertise is in developing thermoplastic polyurethanes for medical applications.

Pallavi obtained her PhD in Chemical Engineering from University of Toledo, Ohio, USA followed by a 2 year post-doctoral fellowship at University of Massachusetts, USA. Over the past decade she has gained knowledge and experience in polymer chemistry, processing and structure-property relationship. She is the author on several research articles as well as inventor on several patents.

Pallavi has contributed to the commercialization of several products at Lubrizol, and is a subject matter expert in thermoplastic polyurethanes and their applications specifically for medical devices. As a senior scientist, her role is to develop novel polyurethanes for un-met market needs and to explore new areas of application for existing polymers. She is also actively involved in Lubrizol’s regulatory efforts in manufacturing excipient GMP grade materials and preparing DMF files.

The medical device market in India is growing with an evolving regulatory landscape, requiring component manufacturing using engineered polymers versus commodity plastics. Pallavi is working extensively with Indian medical devices manufacturers and assisting them in introducing complex technology to manufacture specialized medical devices. She is helping customers adopt TPU based manufacturing and critical components sourcing through Vesta Inc. *********************************************************************** Dr. Manasi Nath (Technical Application Engineer, Kraton Polymers International Ltd. Mumbai) Dr. Manasi Nath is currently working as Technical Application Engineer– with Kraton Polymer International Limited, India. In her present role, she is actively involved in Application & Product Development with key focus on new Business Opportunities for Kraton Polymer.

Dr. Manasi Nath is M. Tech and Ph. D in Polymer Technology from renowned University of Chemical Technology (U.I.C.T.), Mumbai. She had varied experience of Research & Development to Technocommercial Activities. Her research interests are in Specialty Polymer, Polymer Modification, Polymer processing and Polymers in Healthcare sector. She has a diverse Techno- Commercial experience in the field of Polymers.

Prior to the current portfolio, she worked as a Senior Technical Manager – Application Development with Fine Organics, Mumbai for four years. She also worked as a project co-coordinator of an innovative highly reputed World Bank Project at IRMRA through National Agricultural Innovation Project of Govt. of India for few years.

Earlier, she worked as a Research Scientist with “Baerlocher” Research Centre, Mumbai.

She has presented papers in various International

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symposia as an invited speaker. *********************************************************************** Mr. Sanjay Chotalia (Manager – Technical Sales & Marketing, Covestro (India) Private Limited) Sanjay Chotalia is MBA in Marketing, Bachelors in Polymer Engineering from Pune university and Diploma in Plastics Engineering from Mumbai university.

He has total 8 years of experience in Technical Sales and Application Development of Engineering Plastics like Polycarbonate, Nylons, PBT, Polyacetal etc.

He has been working with Covestro India Pvt. Ltd., for more than 3 years as Manager – Technical Sales & Marketing for west India region, Handling Polycarbonate resin with the Major focus on Medical & Electrical segments. *********************************************************************** Mr. Shinto Joseph (Director, LDRA, Bangalore) Mr. Shinto Joseph is Operations and Sales Director at LDRA Technology Pvt. Ltd, Bangalore. He holds a B.Tech from Kerala University and MBA from Christ University, Bangalore. With over 18 years of experience in supporting and implementing embedded software lifecycle solutions, Shinto has built a solid reputation at the forefront of embedded systems working with cross border delivery teams, technology partners and industry regulators within the defence, aerospace, nuclear, rail and automotive sectors. Today he concentrates on creating a healthy ecosystem in the embedded, mission and safety critical domains in India. *********************************************************************** Mr. Mekala Rao (Founder & President, Atachi Systems, Hyderabad) Mekala Rao is the Founder and President of Atachi Systems. Mekala has more than 20 years of expertise in designing and deploying the shop floor systems for the world’s leading medical devices and diagnostics companies in US, Canada and Europe. Mekala’s expertise comes from streamlining the manufacturing operations by reducing the wastage on the floor, product recalls and ensuring the FDA compliance for the medical devices and diagnostics and Pharmaceuticals. Atachi has an innovative MES software NGIMES (Next Generation Manufacturing Execution System) that is built on the cloud using the latest In-Memory computing technologies that brings traceability, compliance, faster NPI (new product introduction), with IT simplification and cost-effectiveness to the manufacturing floors. *********************************************************************** Mr. Jayavanth Kamath (Founder & Principal Consultant Caliber Assurance Services, Bangalore) Mr. Jayavanth Kamath (Jay), Sr. Principal Consultant, Medical Devices Practice, currently provides Engineering, R&D, Quality and Regulatory compliance consultative services to global medical device manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Systems Engineering, Quality Assurance, Regulatory Affairs and Compliance.

He currently runs Caliber Assurance Services (CALIBER), a consulting firm focused on R&D, Engineering, Quality, and Regulatory Assurance Services.

He has been previously employed, with increasing responsibilities by medical device manufacturers and services, such as Wipro Technologies, GE Healthcare and L&T Medicals.

He has worked in Medical Devices such as Patient Monitoring Devices, Ultrasound / CT scanners, Drug delivery systems, Implantable pacemakers, leads, defibrillators, Mobile c-arms, endoscopes, energy based devices, Home monitoring devices etc.

He has handled over 100 projects for Medical Devices Manufacturers, Pharmaceutical, CRO and IVD manufacturers. *********************************************************************** Dr. Nirav Jamnapara (Scientist, Institute of Plasma Research, Gandhinagar) Dr. Nirav is a metallurgist with over 15 years of experience. He is a doctorate from IIT Bombay and presently working at the Institute for Plasma Research, Gandhinagar. He is taking care of the technology transfer portfolio of the Institute for Plasma Research.

He works exhaustively on expanding novel applications of plasma technology for diversified applications such as space, environment, defense, power sector etc.

Though his core expertise is in high temperature materials and coatings for extreme environments such as fusion reactors, one of his key areas of interest is the development of plasma technologies specific to biomedical applications and water. He has over 11 publications and 1 patent to his credit. He is the secretary of Gujarat Chapter and board member of India National Council of ASM International, USA - the globally renowned materials information society. He is the corporate member of Institution of Engineers (India) and a certified Chartered Engineer. *********************************************************************** Dr. J. L. Meena (State Quality Assurance Medical Officer, Department of Health & Family welfare, Govt of Gujarat, India) Dr.Jitu Lal Meena is the State Quality Assurance Medical Officer, Department of Health and Family Welfare, Government of Gujarat and monitors the whole Quality Improvement Programme (NABH / NABL / 5 S / Kaizen / IPHS/ Family friendly / BMW / Radiation safety / Fire safety / Mahatma Gandhi Swachhta Mission / National Quality Standards etc.) in the Department of Health & Family Welfare, Government of Gujarat.

Dr. Meena has wide-ranging exposure (e.g. from bottom level Primary Health Centre, India to world Top level Johns Hopkins University, USA). He is working in Quality Healthcare service science 2002 in the public healthcare sector, Government of Gujarat.

Dr. Meena led to prepare the Quality Standards in Reproductive and Child Health programme (RCH) and National Accreditation Standards (NABH) for Primary Healthcare Centre / Community Health Care Centre.

He is also led to awareness of the Quality Healthcare service (NABH / NABL) in the public health sector in India.

Dr. Meena is winner of several prestigious awards and recognitions. During his leadershipnumbers of the Government facilities are accredited as per NABH / NABL and make a history in India. Under his leadership Government of Gujarat is also the winner of several prestigious awards for Provide Quality Healthcare Service.

He is an MBBS, PGQM & AHO, NABH Assessor,

Jan.-Feb. 2016

Invited Speakers & Panel Experts : Profile Member of NABH Accreditation Committee – Quality Council of India & Member of the Quality Assurance Expert Group, Ministry of Health & Family Welfare Government of India. *********************************************************************** Dr. Mahesh Patel (Quality Manager, Apollo Hospitals, Ahmedabad India) Dr. Mahesh is Quality & Patient Safety Officer at Apollo Hospitals International Limited, Ahmedabad, a pioneer and one of the largest healthcare groups in Asia. He is associated with Apollo Hospitals Group for more than 7 years, where he is playing a leadership role in designing and instituting systems that promotes patient safety. He is a key member of various Operational & Quality Steering committees and is actively involved in implementing Quality Improvement & Patient Safety Initiatives. He has worked extensively on setup quality management system including indicator monitoring.

Dr. Mahesh Patel has a medical background and management credentials from Apollo Institute of Hospitals Administration, Hyderabad. He is also serving as a Visiting Faculty & External Examiner at Dept. of Hospital Management, Hemchandracharya North Gujarat University (HNGU), Patan since year 2009.

Dr. Mahesh has presented many papers pertaining to his field, delivered talks on Quality Improvement and Patient Safety and has many publications too.

His special interest includes Lean Management, Process & System Innovations through IT, Hospital Operations, Accreditation, Quality Management Systems, and Healthcare Quality Training. *********************************************************************** Dr. Ashok Thakkar (Head – Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi) • Education: M.Pharm, MBA, PhD • Experience: 9 years in Drugs/Devices trials plus 2 years in Sales and Marketing • Working experience with CDSCO, New Delhi as a Medical Device Consultant • Experience in Projects Handled: More than 100 • Publications: More than 100 Core Competences in • Clinical Research • Medical Writing • Preparation of Clinical Evaluation Report • Preparation of Literature Search Report • Medical Device • Interventional Cardiology *********************************************************************** Dr. S. S. Murugan (Managing Director, GLR Laboratories Pvt. Ltd., UK and EU Registered Toxicologist, Chennai) Dr. Murugan is a UK and EU Registered Toxicologist with more than 20 years experience in industry. Dr. Murugan obtained his Bachelors, Masters as well as Doctoral degree in Toxicology from University of Madras and MGR Medical University. He has worked with major contract research organizations (CRO) in India - Head of Genetic Toxicology at IIBAT, Toxicology and Quality Assurance Manager at SGS and Scientific Director at RCC India. He has extensive operational and quality assurance experiences. He has been instrumental in obtained GLP certification and has turned around the business at 2 Indian CROs. He has successfully faced several GLP, ISO17025 and FDA audits.

Additionally, he has faced several national and interna-

Jan.-Feb. 2016

tional client audits. He was also a member of CPCSEA guidelines committee, which over sees the animal experimentation in India.

He has travelled widely in about 90 countries across U.S., Latin America, Europe, Africa, Middle East, UAE, Korea, China and many other Asian countries.

*********************************************************************** Mr. Anand Srinivasan (Head-Polycarbonates ISC (Indian sub-continent), Covestro (India) Pvt. Ltd., Maharashtra)

*********************************************************************** Mr. Vipul Sheth (Managing Director, Matrix Med Tec Pvt. Ltd., Ahmedabad)

Anand Srinivasan is the Head of Polycarbonates ISC (Indian sub-continent). A Chemical engineer by training, Anand joined Bayer Corporation at Pittsburgh post his Master’s Degree from Penn State University, USA in 1998. He started off as a process engineer, and moved on to project engineering.

The next opportunity was at the Baytown Texas (Covestro) site, where he was the Air Compliance lead.

In 2009 he decided to move back to India and took up the commission of a new molecule, as plant manager at the Agro plant in Ankleshwar, Bayer CropScience.

After production, Anand headed the Supply Chain Center for Covestro India (formerly Bayer MaterialScience). He was instrumental in establishing the nicer globe initiative, where chemical companies have come together for a common vision, to address transportation distribution safety in India.

He has actively lead initiatives at the Texas Chemical Council and now participates at the Indian Chemical Council.

Anand recently took over the position of heading the Polycarbonates business for the Indian sub-continent.

He lives in Thane with his wife and 2 little kids, and is a musician, artist, and a fitness fan. *********************************************************************** Mr. Ganesh Sabat (CEO, Sahajanand Medical Technologies Pvt. Ltd., Surat) Mr. Sabat has got more than 15 years of global experience of working in USA and India. He has got more than 5 years of experience in medical device industry. Currently Mr. Sabat is working as the CEO of SMT Pvt. Ltd. He has successfully expanded SMT presence in India as well as in 40 countries across the world. Under his leadership, SMT is developing as a global leader in cardiovascular market.

Mr. Sabat has completed his MBA from Washington University in Saint Louis. He also holds a degree from ICSI, India and has completed his graduation in science with Physics (Hons). As a young and dynamic professional, he wants to strongly position Indian medical device industry in the global field. *********************************************************************** Mr. Ravi Shrivastava (CEO, Omni Lens Pvt. Ltd., Ahmedabad) Ravi Srivastava has about 27 years in handling sales and marketing functions in domestic and international business. He has worked with well-established global western multinational companies and start up companies of repute from India.

He is currently designated as CEO with major responsibilities of Global Business development in Omni Lens (P) Ltd., manufacturing wide range of CE certified ophthalmic medical devices and other pharmaceutical products meeting International standard. His Key responsibilities include strategic planning, identification of emerging market areas, new product development besides strengthening the present business in International markets like U.S., Latin America, Europe, Japan, China, Korea etc. besides strengthening existing business.

Vipul Sheth is Managing Director of Matrix Meditec (P) Ltd – the company engaged in manufacturing and exporting of orthopaedic implants and instruments. He is also heading company named Life Sight Surgicals (P) Ltd - a company engaged in manufacturing and trading of Ophthalmic Instruments and intra ocular lenses. He has significant contribution in bringing and educating phaco emulsification technique in India.

He is a distinguished personality in the field of medical devices & instrumentation having experience of more than 20 years. He has been representing CARL ZEISS, Germany for more than a decade. He has also attended numerous workshops / seminars organized by SYNTHS, ZEISS in Davos, Switzerland, USA Germany.

Mr Sheth is a science graduate and his company Matrix Meditec is actively involved in bringing new / unique technologies in the field of orthopaedic implants and instruments. *********************************************************************** Mr. Sanjeev Rajput (Founder, Balaji Concepts, Vadodara) Mr. Sanjay Rajput is Founder of Balaji Concepts, Vadodara, and Partner in Excel Balaji Sterilization Concepts, Manufacturer of Industrial & Hospital size ETO Sterilizers, ETO Scrubbers and ETO Sterilization services Provider, Ahmedabad.

Mr. Sanjeev Rajput is having experience of more than 10 years in the field of ETO Sterilization. He is an expert in ETO Sterilization process and technology. He also has experience in design and manufacture of modern sophisticated fully automatic ETO Sterilizers. He is a solution provider and consultant in ETO sterilization systems and process. His interests in modern engineering, continuous research and consumer feedback helped him to develop and upgrade various new and innovative tech additions to his products. *********************************************************************** Mr. Partha Mohapatra (Lead Healthcare (India) & Technical Support, Styrolution ABS (India) Ltd, India) Mr. Partha Mohapatra is working as Lead Healthcare (India) & Technical Support with Styrolution ABS (India) Ltd , India.

In his present role, he is actively involved in Application & Product Development along with Technical support, with major key focus on new business opportunities for styrene’s in medical device industry .

Mr. Partha Mohapatra is Post graduate in Plastic technology from CIPET, Hyderabad & M.B.A (Marketing) from I.G.N.O.U (New Delhi) with 18 years’ of experience in plastics processing & raw material industry .

He has expertise in processing of engineering plastic & actively engages in business development/ marketing of styrene’s products for healthcare industry, also involve in new projects developments with other OEMs/ Industry along with T1 & T2 supplier. Provides technical support to customer from initial stage to project commercialization stage & also diverse technical sales marketing experience in the field of MEDICAL GRADES STYRENCIS POLYMERS.

33

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 devices, food and safety, cigarette and other tobacco products.

www.fdca.guj.nic.in

2

Pradeep Surgipack, India

Manufacturing medical grade sterilization packaging products.

www.pradeepsurgipack.com

3

Medical Textiles- SITRA, India

Centre of Excellence for Medical Textiles, promoted by Ministry of Textiles, Government of India.

www.sitra.org.in

4

Et Elastomer Technik GmbH, Germany

Medical Moulded Parts For OEM's From Liquid Silicone Using The Highest Medical-Grade Materials.

www.elastomer-technik.com

5

Maider Medical Industry Equipment Co., Ltd., China

Sterile Medical Automation Equipment for : I.V. sets & Syringe automatic assembly equipment, Dialyzer / Blood series auto assembly equipment etc.

www.maiderchina.com

6

Lubrizol Advanced Materials India Pvt. Ltd.

Specialty Materials To Deliver Application Specific Solutions To Medical Device, Pharmaceutical, Healthcare & Food Industries.

www.lubrizol.com

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, India

Plastic Testing Equipments.

www.fitcoindia.com

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, India

Seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility.

www.atachisystems.com

13

Covestro (I) Private Limited, India

Polycarbonates for medical technology’s essential devices and next generation life- saving technology.

www.covestro.com

14

Rup’s India

Medical Device Packaging Pouches, Products for Infection Control Sterilization Monitoring & Patient Documentation.

www.rupscare.com

15

Aakar Packart, India

Manufacturer of creative packaging materials and Equipments used in Industrial, Consumer, Engineering and Pharma / Medical Device Products using advanced technology.

www.aakarpackart.com

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 in the fields of Medical Devices,

www.operonstrategist.com

19

Pall India Pvt. Ltd.

Micro porous Materials And Devices With Robust Performance Characteristics And Documented Quality Compliance.

www.pall.com

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 containers from PET and other plastics, Cellulose Acetate compounds for specialized injection molding applications.

www.interplexindia.com

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 the food, Pharma, Medical and Heavy Engineering sectors, also products in Viton, EPDM, Neoprene, Hypalon, SBR.

www.gurupolymer.com

24

Sputnikpipes (Kisan Pipes & Profiles Pvt. Ltd., India)

Medical Tubes and Hoses for different Application like Catheter Mount, Respiratory Tubes, Surgical Tubes etc.

www.sputnikpipes.com

25

Multivac Laraon India Pvt. Ltd., Gurgaon, India

Packaging solutions: thermoformers and , tray sealers, vacuum chamber machines, conveyor belt machines, etc.

www.multivac.com

26

Ami Polymers Pvt. Ltd., Thane, India

Platinum Cured Silicone Tube, Custom molded parts for medical Indus-tries, Silicone Tube for Catheter and IV set, Silicone Rubber sheets etc.

www.amipolymer.com

27

VascuTech Medical, USA

Manufacturing vascular access devices including catheters, dialators, introducers, trocars, tunnelers and needles.

www.vascutechmedical.com

28

Medical Manufacturing Asia, India

The 3rd Manufacturing Processes for Medical Technology Exhibition and Conference, 31 Aug - 2 Sep 2016, Singapore.

www.medicalmanufacturingasia.com

29

Medical Plastics Data Services, India

A Techno-Economic News Magazine For Medical Plastics And Pharmaceutical Industry.

www.medicalplasticsindia.com

30

Medi Source Asia, India

Web Portal For Medical Technology And Markets In Asia

www.medisourceasia.com

31

National Hub for Healthcare Instrumentation Development (NHHID), Anna University – Chennai, India

To carry out R & D on healthcare instruments as required by indigenous industry and vice versa, DST- funded.

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 www.fdca.guj.nic.in

Food and Drugs Control Administration (FDCA), Gujarat plays important role in enforcement of “Drugs and Cosmetics Act 1940 & Rules” and enforcement of : “Food Safety and Standard Act, 2006” and Rules in Gujarat State. It plays pivotal in Pharma and medical devices sectors in Gujarat to make the state a favorable investment destination towards inclusive development and growth. It has played a vital role in the implementation of egovernance in FDCA and is winner of one state level and three national level awards.

Lubrizol LifeSciences

sterilization packaging products which are used to pack medical devices which are to be sterilized. Pradeep Surgipack is an ISO 9001:2008 & ISO 13485:2003 Certified Manufacturing Company and its products are certified to EN Standards for Medical Devices.

Pradeep Surgipack’s range of products includes, Medical Grade PeelOpen Pouches and Reels which are compatible with Steam, EtO, Gamma & Plasma Sterilization processes. The pouches and reels are made of a variety of substrates like, Uncoated Kraft Papers, Coated Papers, Reinforced Papers, Grid Lacquered Papers, and Tyvek etc which are sealed on to variety of Laminated F ilms of Poly Propylene, Polyester and Polyethylene.

Contact Details: Mr. Pradeep Rao Pradeep Surgipack 3-A , Sarakki Industrial Estate, J.P. Nagar 3rd Phase, Bannerghatta Road, Bangalore - 560076. P: 080 – 26586254 M: 9880723272 E: pradeep.surgipack@gmail.com

ET Elastomer Technik GmbH www.lubrizol.com www.elastomer-technik.com Specialty Materials To Deliver Application Specific Solutions To Medical Device, Pharmaceutical, Healthcare & Food Industries.

Lubrizol LifeSciences is a healthcare product solution partner for medical and pharmaceutical manufacturers who need product development support and drug eluting device solutions.

Exceptional healthcare products with proven performance begin with the polymer technology of Lubrizol LifeSciences medical device solutions. Lubrizol works with you to create functional polymer solutions for various medical applications. Key product brands Pellethane® TPE, Tecoflex™ TPU, Tecothane™ TPU, Isoplast® ETPU and Carbothane™ TPU. Now with Vesta and Particle Sciences - LifeSciences is the only healthcare product solution partner offering comprehensive polymer, formulation and manufacturing capabilities that provide polymer customization, complex drug formulation and contract manufacturing solutions.

Lubrizol LifeSciences has significantly expanded our capabilities through new products, state-of-the-art facilities, acquisitions and alliances. With this unique combination, Lubrizol LifeSciences delivers comprehensive medical solutions, including to the drugeluting device product market.

Contact Details: Mr. Mittal Shah - Head Strategy and Business Development Lubrizol Advanced Materials India Pvt. Ltd. Application & Business Center, 6th & 7th Floor, Jaswanti Landmark, Mehra Industrial Estate, LBS Marg, Vikhroli (W), Mumbai - 400079 P: +91 22 6602 7800 M: 9167702682. Fax: +91 22 25778486 Mittal.Shah@Lubrizol.com

Pradeep Surgipack, Bangalore, India www.pradeepsurgipack.com

Manufacturing Medical Grade Sterilization Packaging Products.

Pradeep Surgipack is in the business of manufacturing medical grade

36

Medical Moulded Parts For OEM's From Liquid Silicone Using The Highest Medical-Grade Materials.

ET Elastomer Technik GmbH was founded 1992 in Lauffen am Neckar / South Germany.

The company started injection moulding of joints and gaskets. In 1994 ET had its first big success in producing a breathing bag out of Liquid Silicone Rubber. From there on ET Elastomer Technik was known in the market and worked close to the medical and automotive industry, where silicone could push the boundary of other Elastomers.

In 1996 the production capacities of the plant in Lauffen am Neckar where too small and ET found a bigger production site in Ellhofen / Germany. In this new Factory, ET also begins the facilities for the manufacturing of long term implants. One of their first projects was a larynges implant for people who suffered from ‘Mustard Gas’ attacks during the gulf war. Since then ET started a wide range of different implants.

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 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.

In 2010, ET Elastomer Technik GmbH have started their production facility at Gandhinagar, Gujarat under the name of “ET Elastomer Technik India Private Limited.

Now ET Elastomer TechnikGmBH has everything to meet the demands 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 • 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, includ ing medical engineering, automotive, and electronics, we have become a trusted partner of choice for the timely and reliable development of high-end items.

Contact Details: ET Elastomer Technik GmbH Abtsäckerstraße 16, 74248 Ellhofen, Tel.: +49 (0)9732/ 78865 – 12, Fax:+49 (0)9732/ 78865 - 18 info@elastomer-technik.com ET Elastomer Technik India Private Limited B 183-184 GIDC Electronic Estate, Sector 25 Gandhinagar- 382024 Ph: +91 79 23287624, M: +91 97277 63274 info@elastomer-technik.in

Maider Medical Industry Equipment Co., Ltd. www.maiderchina.com Sterile Medical Automation Equipment Maider is a national leading hi-tech enterprise in the field of automation, engaged in developing and manufacturing of sterile medical automation equipment, to provide optimum automation solutions for customers. Our main products are I.V. set automatic assembly equipment, Syringes automatic assembly equipment, Dailyser automatic assembly equipment, Blood series automatic assembly equipment and etc.

Contact Details: Qiyu Chen No. 3 Tianyou Load, Bingang Industry City, Yuhuan County, Zhejiang Province, P. R.China.- 317608 P: 86-576-87498999, F: 86-576-87110008, M: 86-18057668205 E: sales@maiderchina.com

Shriram Axiall www.shriramaxiall.com Medical Grade PVC Compounds in India with world class manufacturing facility.

In 2014, DCM Shriram Ltd., had entered into a 50/50 Joint Venture Agreement for its Polymer Compounding business with Axiall Corporation, a North American manufacturer of Chloro-Vinyl, Aromatics and Building Products. Shriram Axiall is now one of the largest organized players for PVC compounds in India and has been present in the medical segment for more than 45 years.

Shriram Axiall manufactures Engineered Vinyl Compounds which finds applications across multiple medical devices. All compounds are safe to use (phthalate free) and comply with global standards (Ideal for Exports). The medical grades adhere to Indian standards as well as biological tests prescribed under USPXXI. The compounds are manufactured in state of the art class 100,000 facility conforming to GMP requirements. Shriram Axiall supplies India's leading OEM's for disposable medical devices.

Some of the key products by Shriram Axiall are : • Clear Extrusion - USP Class 6 Material for Tubes, Flexible tubes for IV sets, Catheter Tubing, Cardio Vascular Tubes Jan.-Feb. 2016

• Clear Injection Moulding - Oxygen Mask, Drip Chamber, Connec tors • Rigid Injection/Blow Moulding - Connectors, Small Bottles, Five Gallon Bottles, Suction Handle, Veterinary Tubes Contact details: Shriram Axiall (Formerly Shriram PolyTech) 2nd Floor, Plot No. 52, Sector 32, Institutional Area, Gurgaon – 122 003, Haryana, India.

Phone +91 124 4632100 info@shriramaxiall.com

SAI-TREAT www.saitreat.com Water treatment and commercial water purification systems.

SAI-TREAT is a leading manufacturer and wholesale distributor of water treatment and commercial water purification systems since 1989. Since the last 26 years, We have offered a wide range of pre-engineered as well as custom engineered solutions for all water purification needs of the customers.

We offer a wide range of products ranging from domestic water purifiers to advanced waste water treatment plants.

Contact Details: Ninad Sankhe Anandi Specialities & Services Pvt. Ltd. 175, V-Mall, 1st Floor, W. E. Highway, Near Sai Dham, Thakur Complex, Kandivali (E), Mumbai - 400 101. (INDIA).

Tel.: +91 22 4297 4397. Fax.: +91 22 2854 2480 sales@saitreat.com

LDRA www.ldra.com Testing Tools for IEC 62304/FDA Compliance Training & Consulting For more than forty years, LDRA has developed and driven the market for software that automates code analysis and software testing for safety-, mission-, security- and business-critical markets.

Working with clients to achieve early error identification and full compliance with industry standards, LDRA traces requirements through static and dynamic analysis to unit testing and verification for a wide variety of hardware and software platforms.

Boasting a worldwide presence, LDRA is headquartered in the United Kingdom with subsidiaries in the United States and India coupled with an extensive distributor network.

Contact Details: LDRA Technology Pvt. Ltd #2989/l B, 3rd Floor, 12th Main, HAL II Stage, Bangalore -560 008. Ph: +91 80 4080 8707. Fax: +91 80 4204 3186 Email: india@ldra.com

Federal India www.fitcoindia.com

Plastic Testing Equipments

37

Exhibitor’s Profile Federal India Trading Company represents reputed Testing Equipments manufacturers from USA, UK and Europe. We are in this business for over 45 years.

We not only supply products but provide installation, training on operation of the equipment, calibration and complete after sales services.

We represent Dynisco, USA, Systech, UK, Testometric, UK, Carver, USA, Wabash, USA, KOPP, Germany. We offer Melt Flow Index Tester, Capillary Rheometer, Universal Testing Machine, MFI Tester, Tensile Tester, Gaspace Analyzer, WVTR Tester, OTR Tester, Friction Tester, Sealing Tester, Headspace Analyzer, COF Tester, Hot and Cold Tack Tester, etc.

Contact Detail: Mr. Mehul P.Javeri Federal India Trading Company, No.49/50, Jainnagar, Sukhipura Road, Paldi, Ahmedabad 380007 P: 079-26620059, 26607020, F:079-26640002 E-mail: mehul.javeri@fitcoindia.com

Excel Formulations www.excelformulations.com State-of-the-art ETO formulation and bottling facility.

Established in 2007, Excel Formulations is amongst India’s leading manufacturers of ETO Gas mixtures. Company is ISO 9001 and D&B certified. They are manufacturing various types ETO gas mixtures in cylinders as well as Disposable E.O Cartridges. The company established a state-of-the-art ETO formulation and bottling facility at Sanand, Gujarat and supplies various combinations of Ethylene Oxide with Carbon Dioxide in different sized cylinders.

The plant that manufactures mixtures of ethylene oxide and carbon dioxide is manned by skilled team with a strong quality orientation. This ensures strict adherence to safety, health and environment standards at the plant. This in turn ensures that the products manufactured are reliable and are of the highest quality, all in keeping with our commitment towards excellent customer service.

Contact Details: Mr. Dipesh Patel - Partner 401, Sanidhya- A, Opp. Anandnagar Shopping Center, Prahladnagar 100ft. Road, Satellite, Ahmedabad-380015 Ph: +91-79-40067245, +91-9228008275 E: info@excelformulations.com

Atachi Systems Pvt. Ltd. www.atachisystems.com Seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility.

Atachi Systems provides discrete manufacturing companies with a seamless, cloud-based Manufacturing Execution System that reduces dependencies on infrastructure, lowers maintenance costs, and improves access to real-time visibility of shop-floor operations for engineers and managers at all levels.

Our new MES solution, NGIMES-in-the-cloud, does just that. Quick

38

to deploy, cost efficient and highly scalable, it’s never been easier to measure real return on your MES investment.

The company was founded in 2007 to streamline the IT services that enable discrete manufacturing companies to improve efficiencies and grow profits.

Over the years we have worked closely with the world’s foremost medical device and diagnostics, electronics and other discrete manufacturing companies to evaluate MES vendors, oversee MES ERP systems integrations, manage leading MES vendor implementations and provide IT support to ensure that our clients benefited from highly productive shop floor systems.

After more than a decade of manufacturing industry expertise across discrete verticals we developed NGIMES to help manufacturing companies gain a competitive edge in rapidly changing industries, by reducing risk, optimizing response time and keeping costs low.

Our mission is to support customer success.

Contact Details: Atachi Software Systems Pvt. Ltd. Module No: 201, NSIC EMDBP, Kamala Nagar, Hyderabad – 500 062 info@atachisystems.com Shanker - Mobile: 9966589917, Desk: 040-42603666 shanker@atachisystems.com

Covestro (India) Private Limited www.covestro.com

Polycarbonates for medical technology’s essential devices and next generation life- saving technology.

Polycarbonates from Covestro are responsible for some of the modern medical technology’s essential devices and the development of next generation life- saving technology. In products ranging from insulin pens and pumps, inhalers, renal care and blood management to heart defibrillators, intravenous access components and surgical instruments used to assist patients, polycarbonate is there and so is Covestro.

With 2014 sales of EUR 11.8 billion, Covestro is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life.

The main segments served are the automotive, electrical and electronics, construction and sports and leisure industries. Covestro, formerly Bayer MaterialScience, has 30 production sites worldwide and employees approximately 15,700 people (calculated as full-time equivalents) at the end of September 2015.

Contact Details: Suresh V-Market Development Manager Covestro (India) Private Limited Bayer House, Central Avenue, Hiranandani Estate, Ghodbunder Road Thane (West) – 400607, Maharashtra 025866161; suresh.v@covestro.com

Medical Textiles- SITRA www.sitra.org.in

Jan.-Feb. 2016

Exhibitor’s Profile Centre of Excellence for Medical Textiles, promoted by Ministry of Textiles, Government of India.

The South India Textile Research Association (SITRA) is a premier National level autonomous organization for Research, Consultancy and Human Resources Development in the field of Textiles. SITRA is the designated Centre of Excellence for Medical Textiles, promoted

by Ministry of Textiles, Government of India. As a Centre of Excellence for Meditech, SITRA has addressed itself to a number of multi-varied activities such as: • Testing and Evaluation (Physics, Microbiology, Bio-Technology, Analytical Chemistry) • Standard Formulation (BIS, International bodies) • Incubation Services • Detailed Project Reports (DPRs) • Pilot Scale Production (Medical/Technical Textile Products such as Face Mask, Sanitary Napkin & many more) • Training and Seminar • Technical Consultancy • Testing Instrument / Product Machine – Technology Development • Prototype Development / Contract Research • Information Resources Contact Details: Mr. Thiruppathi Shanmugam Medical Textiles, SITRA, 13/37, Avinashi Road, Coimbatore-641014 P: 09790225424 tps13518@gmail.com

Multivac Laraon India Pvt. Ltd www.multivac.com Packaging solutions: thermoformers and , tray sealers, vacuum chamber machines, conveyor belt machines, etc.

MULTIVAC is one of the world’s leading suppliers of packaging solutions: global market leader in thermoformers and manufacturer of an extensive range of traysealers, vacuum chamber machines, conveyor belt machines, labelers, quality control systems and automation solutions, as well as turn-key packaging lines. MULTIVAC has pooled its packaging, product and application expertise in both its Systems division and its in-house Application Center, in order to be able to offer top-class packaging technology.

The MULTIVAC Group employs more than 4600 people worldwide with around 1600 employees based at its headquarters in Wolfertschwenden, Germany. With over 70 subsidiaries the company has a presence on every continent. Over 1000 advisors and service technicians worldwide use their expertise and experience in the service of customers and ensure the maximum availability of all installed MULTIVAC machines.

Contact Details: RITESH DHINGRA - MANAGING DIRECTOR Plot No. 137, Sector 5 , IMT Manesar, Gurgaon – 122050. India. Telephone No.: 0091 124 4610000.

Fax No.: 0091 124 4610051 Email.: info@multivac.co.in

Bhavya Polymers, Mehsana, Gujarat www.bhavyapolymers.com Silicone Medical Grade Tubings For Healthcare & Pharmaceutical Jan.-Feb. 2016

Application.

Bhavya Polymers is a dynamic specialist manufacturer of silicone products since 1995, located at Dediyasan GIDC Mehsana (Gujarat) with 700 sq. m manufacturing facility, The company has been serving customers for over 18 years.

Bhavya Polymers takes quality very seriously. The company attained ISO 9001 : 2008 certification and have progressively moved into the supply of high tech industries. The company makes silicone rubber products that are even as small as 0.2 mm. They use a 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 the field.

Business philosophy is simple: Aim is to provide high quality products, efficiently and at very competitive prices.

Contact Details: Bhavya polymers C-1/137, GIDC, phase-II, Dediyasan, Mehsana-384002.

P: 02762-224114. E: bhavyapolymers@yahoo.co.in

Pall Corporation www.pall.com Micro porous Materials And Devices With Robust Performance Characteristics And Documented Quality Compliance.

Pall Corporation offers a comprehensive portfolio of microporous materials and devices with robust performance characteristics and documented quality compliance, making it easy for you to find the best medical filtration components to satisfy your product application requirements. Combining extensive membrane manufacturing capabilities with advanced medical engineering and design expertise, Pall can create unique and reliable solutions for your specific application needs. Our adherence to internationally recognized quality and six sigma principles assure consistent lot-to-lot performance and compliance with global industry standards.

Contact details: Rajnish Singh - +91 9971587733 rajnish_singh@pall.com - Marketing pallindiamarketing@pall.com

Operon Strategist, Pune www.operonstrategist.com Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification in the fields of Medical Devices.

Operon Strategist is one of the renowned consultancy companies for designing of the layouts, Designing of the classified area criteria, Validation and implementation. For medical device industry. they have many Medical device projects going on under their credential with the value for money effectiveness. The company has large number of satisfied customer base with the repeat order guarantee. They have highly technical and experienced staff to handle all levels and sizes of the projects.

Contact Details: Anil Chaudhari Operon Strategist 7,"A" Tower, First Floor Sagar Complex, Kasarwadi, Pune411 034, P: +91(020)4678055 M: 9823283428 E: info@operonstrategist.com, anil@operonstrategist.com

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Exhibitor’s Profile Aakar Packart, Vadodara www.aakarpackart.com Manufacturer of creative packaging materials and Equipments used in Industrial, Consumer, Engineering and Pharma / Medical Device Products using advanced technology.

• Printing Matter For Exhibition Directory • Big Bubble Air Cushion System, • Buffer Air Cushion Machine, Void Filling • Pe/Hd Disposable Gloves Making Machine • Multi Seal Irrigation Flexible Pipe Sealing Machine/Surgical Packing Rolls • Innovative Integrated Packing Solution • Plastic Corrugated Reusable Corru Crates/Boxes/Record Keeping Boxes. Multi-Utility Boxes. Display Rack/Danglors. Agri Tray And Cushion Packaging ,Blister Forming Winner Of Indiastar 1990,2002,2008,2012,2015 Worldstar 1990, Placticon Award 2003.

Contact Details: Aakar Packart 2nd Fl, BEI Compound Behind Amar Ice Factory, Vadodara 390024 02652773018 9376226980 aakarpackart@rediffmail.com

in its new cable manufacturing plant in South Gujarat. This Plant is certified by BARC, AERB, FDA and its quality systems accredited to ISO 9001:2008. Electron Beam radiation is a form of ionizing energy.

The beam, a concentrated, highly charged stream of electrons, is generated by the acceleration and conversion of electricity. It sterilizes medical devices and other Pharma products in seconds instead of hours or days compared with other technologies. Such very short Sterilization cycles allow manufacturers to apply “just in time” manufacturing techniques. More than 92% of all disposable medical products are compatible with E-beam sterilization treatments. The extremely rapid treatment times of electron beam sterilization greatly reduce effects on materials this is especially noticeable with products made of non-woven and polypropylenes. High energy electrons offer good depth penetration for the sterilization of medical devices in their final shipping boxes.

Contact Details: Khata No. 1932, Survey No. 82/2, P & 88, 861/1 & 862/1 & 863/1, Manakpore Road, Khatalwada, Tal: Umbergaon, Dist. Valsad (Gujarat) Pin 396120 Corporate Office: 12/13, Jyoti Wire House, Shah Industrial Estate, Off Veera Desai Road, Andheri West, Mumbai 400 053; Ph: 022 26740001/2/3; M: +91-7506265220; info.cable@apar.com

Technic Automation

Sputnikpipes (Kisan Pipes & Profiles Pvt. Ltd.) www.sputnikpipes.com Medical Tubes and Hoses for different Application like Catheter Mount, Respiratory Tubes, Surgical Tubes etc.

KISAN PIPES & PROFILES PVT. LTD. is a Group Company of SATELLITE PLASTIC INDUSTRIES devoted to the Production and Manufacturing of Corrugated Plastic Pipes from almost all kinds of Thermoplastic Raw Materials like PP, COPP, HDPE, LDPE, LLDPE, EVA, PVC, POLYAMIDE, TPR, TPE and a combination of the above including Flame Retardant and LSHF. grades.

With a complete State of Art Automatic Production Lines from ITIB Italy since 1994 and use of Modern Manufacturing facilities has resulted in a renowned Brand “SPUTNIK” which is synonymous to quality and workmanship. With regular exports to Middle East, Sri Lanka, Australia, New Zealand, Africa and Italy we ensure timely delivery, packing as per International standard and adherence to functional requirements of the customers.

Contact details : Kisan Pipes & Profiles Pvt Ltd, 2 A2, Court Chambers, 35, New Marine Lines, Mumbai – 400 020.

Phones: 022-22006477, 66346816 Sputnikpipes@Yahoo.Co.In

Apar Industries Ltd. (Unit: Uniflex Cables) www.apar.com Electron Beam Sterilization Services.

Apar Industries Ltd now offers Electron Beam Sterilization Services

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www.technicautomation.in

Air Leak Tester For Rigid Surgical Devices & Pneumatic / Hydraulic Automation.

We the Technic Automation would like to introduce ourselves as a leading organization in the field of Pneumatic / Hydraulic Automation across Globe for providing cost effective solutions for all your ideas. We are successfully exploring & serving in many leading industries since 1992 under the guidance and support of Mr. Bhupendra Khatri, Pioneer of Technic Automation. We do work on our prime motto of Customer Satisfaction & perhaps this is the main reason of our survival in this cut throat era of competition.

Our vision is “to be globally recognized as an Automation Engineer for any kind of Industrial Automation requirement to produce mass quantity with improved quality”.

The company is certified by ISO 9001:2008 for Quality Management & NSIC-D&B-SMERA for Performance & Credit Rating. The company has production house in Ahmedabad with well-equipped work shop and has work force of efficient engineers.

Our summarize scope of work includes Pneumatic Automation, Hydraulic Automation, Sales & Service Of Pneumatic Products, Pneumatic Consultation & Training, Pneumatic Training Kit, Air Leak Testing Equipment, Hydro Leak Testing Equipment & Test Systems For – Temperature, Pressure, Flow, Noise, Vibration, Power etc.

Contact Details: Technic Automation, 1st Floor, Shah Chamber, Nr. Nidihi Co. Op. Bank, CTM Cross Road, CTM, Ahmedabad. +91 79 25855821, +91 93270 06790. care@technicautomation.in Jan.-Feb. 2016

Exhibitor’s Profile Ami Polymer Pvt. Ltd. www.amipolymer.com

Platinum Cured Silicone Tube, Custom molded parts for medical Indus-tries, Silicone Tube for Catheter and IV set, Silicone Rubber sheets etc.

• USFDA-DMF Accredited Platinum Cured Silicone Tubing’s.

• Medical Grade Silicone Suction Tubing’s.

• Platinum Cured Silicone Braided Hoses.

• Medical-Grade Silicone & Viton Products.

All Types of Medical-Food-Pharma Grade Silicone & Viton Rubber Products manufactured under clean-room of Class 10000, Dept. of USFDA has assigned us DMF# 26201 for Silicone tubes. We have technology of Permanent Laser marking products/tubing also available for identification purpose. We also make customized products.

Contact Details: Mr. Darshan Gandhi - Asst. Manager Marketing Ami Polymer Pvt. Ltd. 303, Mahesh Industrial Estate, Opp. Silver Park, Mira Bhayander Road, Mira Road (E), Dist. Thane, Mumbai - 401104. Maharashtra. Tel: +91 22 28555 107/631/914.

M: +91 86910 13939 darshang1987@gmail.com; alpesh@amipolymer.com; abg.gandhi@gmail.com

Interplex India Pvt. Ltd. www.interplexindia.com High tensile PET Straps, Co-extruded Multilayer PET Sheets, Thermoformed containers from PET and other plastics, Cellulose Acetate compounds for specialized injection molding applications.

Interplex is a pioneering multi-product company focused on serving markets requiring specialized plastics products for demanding applications. Interplex product range includes PET Straps, Co-extruded Multilayer PET Sheets for the packaging sector, Thermoformed packaging from PET and other plastics, Cellulose Acetate compounds for specialized injection moulding applications.

Interplex has a modern plant near Vadodara with dedicated production lines incorporating state of the art processing equipments from Europe and the USA. Contact Details: 314/1, Village Baska, Taluka Halol – 389350.

District Panchmahals, GUJARAT. INDIA. Tel.: 0091 265 2353444 / 2310750 Fax : 091 265 3057712 Email : info@interplexindia.com

Shiv Enterprise

House of packaging machinery since last 15 years, provide 100% service.

Suppliers of Packaging Machineries for Pharmaceuticals & Medical Devices Industries, Hospitals and many more Industries.

Wide range of machines including: Jan.-Feb. 2016

• Shrink Wrapping m/c.

• Continuous Bag Sealers m/c.

• Semi Auto box-strapping m/c.

• Continuous Induction Capper Sealer.

• Continuous Carton(BOPP TAPE) Sealer m/c.

Benefits Offered: Time saving, Man power saving, Good Packing Image, Shape your products, No Maintenance, Light weight & Reliable.

Contact Details: Mr. Yatin Patel Shiv Enterprise 14 & 39, Arihant Estate, B/h, Sabari Hotel, Nr. Odhav Ring - Road Circle, Odhav, Ahmedabad.

M: 9879015456. se_pack@yahoo.co.in

Guru Polymer www.gurupolymer.com Silicone rubber products for the most precious and complex applications for the food, Pharma, Medical and Heavy Engineering sectors, also products in Viton, EPDM, Neoprene, Hypalon, SBR. Guru Polymer has started its operation in 2008.

To manufacture a large range of Silicone rubber products for the most precious and complex applications for the food, Pharma, Medical and Heavy Engineering sectors in India and also for the overseas customers. The company enjoys a high reputation among the major pharmaceuticals giants in India. Coupled with the experience in R & D and armoured with management capabilities.

Besides the Silicone rubber products, the company also manufactures a large range of products in Viton, EPDM, Neoprene, Hypalon, also in SBR. The Company enjoys in Customer Satisfaction and swift development, Speedy delivery, Supreme quality, and also very competitive rates.

Contact Details: Bhavesh Chauhan C-1-64, G.I.D.C, Phase-II, Mehsana (North.Gujarat-384002) Tel: 02762-224584, Mob:- 9978304978 Email Id: gurupolymer010@gmail.com, maheshpatel6791@gmail.com

National Hub for Healthcare Instrumentation Development (NHHID), Anna University –Chennai.

Products to be displayed at the exhibition: • Antibiogram Device • CMCdaq • Leptospirosis Kit • Synthetic milk tester • Milk protein Estimator Service: • Calibration National Hub for Healthcare Instrumentation Development (NHHID) 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) 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

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Exhibitor’s Profile and accelerate the development of healthcare instrumentation indigenously. It aids in the transfer of basic research ideas from research institutions to private biomedical companies and vice versa.

It will mainly carry out R & D on healthcare instruments as required by indigenous industry and healthcare needs. The Calibration Center one of the prominent activities of NHHID is being established.

1. We develop commercially and clinically important healthcare prototype devices.

2. Undertake R&D services & product validation.

3. Calibration & Testing of critical care medical devices and certification.

4. Training of manpower.

5. Help getting funds from DST for the prospective productization.

Medical Plastics Data Services, Ahmedabad, India www.medicalplasticsindia.com Periodicity : Once every two months.

Publisher : Classic Computer Services.

Target Audience : All who are involved or interested in Medical Plastics user industries ranging from Pharmaceutical Industries, Medical Plastic Devices/ Equipments Manufacturers /Marketing Companies, Hospitals, Doctors, Medical & Pharmacy Colleges, Research Institutes.

Editorial Content : Applications, Book Review, Company Profiles, Country Profiles, Design, Discovery, Eminent Institutions, Eminent Personalities, Events, Global Opportunities and Trends, Health update, Import - Export News, Industry News, Manufacturing, Markets, Materials, Product Profiles, Products & Processes, Regulatory Affairs, sterilization, Quality, Technology Advertising Opportunities : • Suppliers of Machineries/Equipments/Raw Materials/Services to Medical Plastics Processors.

• Vendors to Medical Devices/Equipments Manufactures Supplying Raw Materials / Clean Room Equipments / Assemblies / SubAssemblies / Components / Technology etc.

• Medical Equipments/Devices Manufacturers/Suppliers and Marketing Companies.

• Technical/Management Consultants for Plastic and Medical Devices Industries.

Contact Details: D L Pandya - Editor & CEO Classic Computer Services B-4, Mandir Apartments, Opp. P & T Colony, Jodhpur Char Rasta, Ahmedabad – 380 015, India. P : +91 79-26740611, F : +91 79-26754867 E : mpds00@vsnl.com / dlpandya@gmail.com

Medical Manufacturing Asia 2016

Medical Manufacturing Asia 2016 : Medical Manufacturing Asia, The 3rd Manufacturing Processes for Medical Technology Exhibition and Conference, 31 Aug - 2 Sep 2016, Singapore.: Your Strategic Platform for Medical Technology Solutions The third edition of Medical Manufacturing Asia returns as the region's leading specialist trade fair for Asia's medtech and medical manufacturing processes sectors. Co-located with Medical Fair Asia 2016 - the No. 1 medical and healthcare exhibition in Southeast Asia, the synergistic trade fairs will showcase a comprehensive range of

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technology, service solutions and materials tailored for the medtech industries, as well as connect you to influential decision makers and trade visitors from the region.

Rups www.rupscare.com

Medical Device Packaging Pouches, Products for Infection Control Sterilization Monitoring & Patient Documentation.

A proprietorship firm established in the year 1994 is engaged in manufacture of Sterilization Packaging for Hospital, Pharmaceutical manufacturing companies and Medical Device Manufacturing companies. The products are mandated for use under all International Standards and play one of most important role in combating and preventing infection.

Besides the firm also manufactures monitoring devices for effective sterilization to ensure that no micro-organisms are let out to cause infection. Additionally, the firm manufactures Patient Documentation system to keep tab on effective sterilization; use of sterilized device on patient and in case of need recall all records for it.

The firm is certified to all International Certificates including CE and follows GMP. Contact Details: Rups Packaging Industry A 196, Sector – 83, Noida – 201 305 (U.P.) Tel: +91 120 4044500 – 506, Fax: +91 120 4044502 E-mail: rups.a196@rupscare.com, office_rups@rupscare.com, rups@rupscare.com

Mascot Specialty Silicone Tubing For Medical Devices Fabrication And Lubrication With more than 100 years of experience in Asia, Connell Bros. Co. (CBC), with its headquarters in the US, is well accepted as a reliable and trustworthy partner by customers as well as suppliers.

Established in 1999, Connell-India is part of the Asia Pacific region distribution network, consisting of 38 offices and 34 warehouses in 17 different countries, CBC, a business unit of USD 3.2 billion (Sales) Wilbur Ellis Co., is a new age, high-commitment distribution partner that more than meets the growing needs of the industry.

Mascot PC & HC Division of Connell India with its vast experience in providing specialty products & services to the Pharmaceutical, Biotech & Medical devices industries, understands the importance of use of superior quality products in formulations and processes.

We are complete solution providers offering specialty silicones for Medical devices fabrication and lubrication, wound care and scar care applications, silicones for topical/ dermatological formulations, Silicone tubings for Pharmaceutical & Biotech processing and silicone Anti-foams (Simethicones for Pharmaceutical and Biotech processing).

We represent Dow corning for the mentioned applications.

Contact Details: Mr. Abhishek Shukla 317, Shah & Nahar Industrial Premises, Off. Dr. E. Moses Road, Worli, Mumbai - 400018.

M: 9619470670. abhishek.shukla@wecocbc.com javed.shaikh@wecocbc.com 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. www.accuprec.com

After Kothari Cross road, Post: Santej, Ta: Kalol, Dist: Gandhinagar-382721 (M) +91-9429571239/9099616769 E-mail: rina.gokani@accuprec.com

VascuTech Medical Provide Quality Solutions For Testing Services Required For Pharmaceuticals, Medical Device, Chemicals, Photochemicals, Herbals And Food Industries.

AccuPrec® has been founded in August 2012 with an objective to provide quality solutions for various testing services required for pharmaceuticals, Medical device, chemicals, photochemicals, herbals and food industries.

AccuPrec® is fully conscious of its role in quality control and quality assessment and therefore created facilities (with surveillance system and auditable data system) as per standard requirements of ISO and GLP and compliance to USFDA and CDSCO. AccuPrec® is approved by FDCA (License No. GTL/37/31) and certif ied by ISO 9001:2008 and GLP certification. NABL applied Mission: To provide quality testing services with accuracy and precision to offer its clients a seamless experience in ensuring quality of their products. We aim at becoming the “Ultimate Solution” for our clients.

Vision: To become the most-preferred quality testing service provider for its clients with its services making the clients feel Accuprec as their “Extended Enterprise”.

Motto: Uncompromised quality and prompt service.

Contact Details: Dr. Rina H. Gokani Director & Chief Scientific Officer, Accuprec Research Labs Pvt. Ltd., Shed no.9, Shree Raghuvir Industrial Estate,

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www.vascutechmedical.com Vascular Access Devices Including Catheters, Dilators, Introducers, Trocars, Tunnelers And Needles.

VascuTech Medical is a medical device manufacturing company that develops class I, class II and class III devices for the world’s leading medical device OEM customers. Our main focus is on vascular access devices including catheters, dilators, introducers, trocars, tunnelers and needles.

VascuTech Medical, LLC has evolved from a consulting firm serving major customers such as C.R. Bard, to a contract manufacturer of FDA and ISO 13485 registered medical device manufacturer serving OEMs and healthcare providers in interventional radiology, interventional cardiology, pain management and urology.

Contact Details: PO Box 1051, Oaks, PA 19456 98 Highland Avenue, Building A, Oaks, PA 19456, Phone: 484-956-0437 Mikebasta@vascutechmedical.com

Jan.-Feb. 2016

Supporting Association Mr. Rajiv Nath Forum Coordinator, Association of Indian Medical Device Association of Indian Industry (AIMED)

Medical Device Industry (AIMED)

AI-MED is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including consumables, disposables, equipments of diagnostics representing the interest of over 700 Manufacturers of Medical Devices to cover issues and address the manufacturer’s problem.

The aim behind forming AI-MED is allow the Government to access a single point of contact and provide various services to the manufacturers like Advocacy on policy issues, Information services, Regulations for medical devices, Education and Training, services, Testing Assistance and guidance for Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the Government, encourage innovations from member units, Improve clinician and patient access to the modern, innovative and reliable medical device technologies through organizing Meeting, Seminars, Symposia, Exhibitions and Demonstrations and also, to promote global harmonization of Indian device industry.

AI-MED will ensure convergence at a one common platform, when needed, for ensuring overall growth of Indian Medical Devices Industry and further address the needs of all members of the Medical Device Industry irrespective of their affiliation or their company size. It will also help in wider dissemination of information to each player of the industry. AI-MED would be horizontally divided into common groupings like – Legal Issues, Tax Issues, Export Related Issues, Medical Device Regulatory Issues common to all vertical groups of different families of product lines with Zonal Representations.

AI-MED has initiated the formation of the IMDRRG (Indian Medical Device Regulatory Review Group) This is an open informal forum – broad based consisting of Regulators, the Regulated Industry, the conformity assessment quality system auditing bodies like SGS/TUV/Intertek/UL/DNV/BSI, Testing Facilities and other Stake Holders – Consultants/Doctors/Nurses/Patients to review proposed regulations on ongoing basis and ensure that these are aligned to the GHTF (Global Harmonization Task Force) Guidelines - AI-MED wishes to collaborate with the Government. Currently we have over 400 individuals and organization representatives receiving e-mails with opportunity to use this forum for informal and candid e-mail exchange as well as pass on information to members of their organizations.

Mr. M. M. Saiyed President

MEDICAL DISPOSABLE MANUFACTURERS' ASSOCIATION (MDMA) We are an Association of Medical Disposable Manufacturers popularly known as MDMA [Medical Disposable Manufacturers;' Association] in Gujarat. We have more than 40 members. The Medical Disposable Manufacturing Industry is in existence for the last more than 30 years and many of our units are major suppliers of Disposable Medical Devices like Intravenous Infusion 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

Most of the unit members hold approved Drug Manufacturing License, GMP, ISO & CE certifications with product barcodes.

Our main objective is to contribute to the development and growth of the inter-disciplinary areas of Medical Devices Industries in all aspects and specialties.

Main Activities of the Association: • Organizing Meetings, Seminars, Symposia, Exhibitions & Demonstrations • Conducting Training Programs for Skill Development, Management & Marketing • Training Man Power [Technical, Non-Technical] • Exchange information between the Members regarding changing Government policies & regulations • Representation of the issues with Government Authorities like FDA, Excise, VAT • Assistance and Guidance to the Members for quality certifications like ISO, CE, and GMP.

Society for Biomaterials and Artificial Organs – India (SBAOI) INDIA is one of the fastest growing health care markets in the world. The current estimate of health care device market is about $1billion with a projected growth rate of 18%. Realizing this huge potential, Indian industry as well as academician has started showing keen interest in biomaterials and medical devices research.

As a result, establishments like National Laboratories, Indian Institutes of Technology and other leading Universities have started research as well as teaching programs. Many of the establishments work in close association with the industry also. As an outcome of this, apart from the ongoing research activities, indigenously developed implants and devices like artificial heart valve, hydrocephalus shunt, blood oxygenator etc. are also available in the Indian market.

In order to develop coherence among the scientists and engineers working in this field, way back in 1986 Dr. Chandra P. Sharma along with his colleagues founded the society, Society for Biomaterials and Artificial Organs - India.

National Biomedical Engineering Society (NBES) Founded in 1978, the National Bio-Medical Engineering Society is carrying out various activities for the development, growth and popularity in the interdisciplinary areas of Medicine, Engineering and Bio-Medical Engineering. These include efforts to improve education technical information, organising meetings, work-shops, seminars etc.

The Society has created a very effective platform for bringing professionals from Medicine, Engineering academics and industry together.

Aims & Objectives : • To contribute to development, growth & popularity of the interdisciplinary area of Bio-Medical Engineering in all aspects and specialty in India • To review & strive to improve education in this field at all levels • To undertake, promote, encourage or sponsor studies and research projects in the field of Bio-Medical Engineering with the ultimate aim of making high quality medical care available

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Supporting Association to lowest echelon of society with the help of modern engineering technology • To establish research centers pertaining to Bio-Medical Engineering.

Shri H.G. Koshia Commissioner Food & Drug Control Administration, Gujarat

Food & Drugs Control Administration, Govt. Of Gujarat (FDCA) Drugs Control Administration (DCA), Gujarat came into existence on 1st May 1960 after separation of Gujarat State from Greater Bombay State and Mr. B.V. Patel became the first director of DCA, Gujarat.

DCA, Gujarat was entrusted implementation of Drugs & Cosmetics Act – 1940 & Rules 1945 and Drugs Magic Remedies (Objectionable Advertisement) Act – 1954. Mr. B.V. Patel played a vital role in establishing well defined administrative structure, policies and procedures of DCA, Gujarat. He seeded the present culture of this department - industry friendly, prompt & strict action against law breakers. He also took initiative to establish state of art Drug Laboratory equipped with latest equipments at Vadodara.

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, ( I.A.S. ) & Dr. H. G. Koshia as Commissioners of FDCA, Gujarat.

Since, 22nd January 2009 Dr. H. G. Koshia is Commissioner, FDCA, Gujarat.

With effect from 5th August 2011, PFA and seven other acts related to food have been repealed by “The Food Safety and Standards Act, 2006” (FSSA).

Dr. H.G. Koshia, Commissioner, Food & Drugs Control Administration, Gujarat His Key Responsibilities are Enforcement of “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Safety & Standard Act, 2006” and rules, in Gujarat State.

He is actively representing nine national and state level committees. He is Chairman of the very important committee “Track & Trace”, for preparation of guidelines to prevent of menace of spurious drugs.

Dr. Koshia regularly interact with officials of US FDA, Health Canada, MHRA, DCGI, technocrats, academicians, IDMA, Chemists & Druggists Association etc. to ensure a consultative approach towards inclusive development and growth.

He has played a pivotal role in transformation of pharma sector in Gujarat to emerge as a favorable investment destination with proactive & pragmatic approaches.

He has played a vital role in the implementation of e-governance in FDCA and is winner of one state level and three national level awards.

FDCA implementing various Acts and rules related to Drugs, Cosmetics, Medical Devices, Food & Safety, Cigarettes & other tobacco products etc.

Medical Device Industry In Gujarat: Gujarat State has the largest number of licensed Medical Devices Companies which are nurtured by Gujarat FDCA Dept. with an exemplar nary approach and has been receiving recognition in the country. The present culture of this department is

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industry friendly, prompt & still known for taking strict action against law breakers.

Testing Laboratories: Food & Drug Laboratory (FDL), Vadodara is the first NABL accredited Government laboratory in the country. In addition to FDL, Vadoadara, FDCA has two other Regional Food Laboratories for testing of food samples, one at Rajkot and one at Bhuj. FDCA is also setting up one more state of art Food & Drug Laboratories in the state.

Training: Training of FDCA officers of both cadres, Drug & Food, has been a regular practice. It includes induction training of newly appointed officers and in service training as well. The objective of training is to sharpen their knowledge not only to maintain performance of FDCA but also to achieve newer landmarks. e-Governance: FDCA, Gujarat makes optimum use of information technology for achieving excellence in performance.

FDCA, Gujarat is the first State to initiate online software for sales & manufacturing licenses.

After successful implementation of Sales Licensing Software since 1st January 2007 and with proven sustainability of the software, Drugs Controller General India (DCGI), Government of India praised and recommended this software to all State Drugs Controllers at several occasions.

Association Of Diagnostics Manufacturers Of India (ADMI) ADMI is a non-profit making company, incorporated in the year of 2002 with its registered office in the State of Gujarat.

The management of the business affairs and control of the company are rested with the Managing Committee, which is elected based on the tenets as enshrined in the constitution of ADMI. The office bearers are elected every three years.

Medical Surgical and Healthcare Industry Trade Association (MSAHITA) The aim of MSAHITA is “OUR STRENGTH IS ALWAYS IN HELPING OTHERS BY UNITING, IT CAN MAKE A DIFFERENCE.” Every Trade has a collective community for the betterment and showcase of Strength, Unity and uniform trade policy governed by the association for the well being of its members. Our trade lacked the effective way of voicing our concern and grievances at all levels, weather it was amongst us or being targeted as soft and most sullied business organization.

The treatment given to the patients are at par with the international level, as the cost is much less and the patients care is equally good here in the private sector. We provide better and cheaper healthcare products, services and expenses to the individuals. It is here that our trade plays a very important role. The relentless efforts for up gradation by our trade there is a constant urge to grow along with the international standards.

There is tremendous scope and wide variety of product range, always a place for every new comer who has been accommodated. It has therefore become the need of the hour for the well being and the prestige of our trade at large to get the recognition Jan.-Feb. 2016

Supporting Association and reorganization to get our identities as of well groomed and respected traders amongst other trade as well. The pharmaceutical industry is a classic example. The health sector being one of the most vital sector and even accepted by the government.

Gujarat State Plastic Manufacturers’ Association (GSPMA) Established in 1970, the Gujarat State Plastic Manufacturers’ Association (GSPMA) is one of the leading plastic manufacturers associations in the country, representing Plastic Industry at State as well as Central level. At present, total membership strength of the Association stands at around 2500. GSPMA is also one of the founder members of the PLASTINDIA FOUNDATION, an apex body engaged in the research & development in the Plastic Industry throughout the country and dedicated to national progress through plastics.

GSPMA is working for the cause of Plastic Industry since last more than four decades. GSPMA has been engaged in the promotion of image of Gujarat based units in the country and has been functioning as a major link between the Industry & the Government.

GSPMA also participates in the national/ international plastics exhibition from time to time. GSPMA had organized national level plastics exhibitions PLEXPO in the year 1979, 1995,2004, 2007 & 2010. These events are considered to be the landmark in the history of GSPMA PLEXPO’79 was the fist-ever plastics & packaging exhibition show held in India.

Indian Plastics Institute (IPI) Indian Plastics Institute (IPI) is the national Association of Plastics professionals from industry, academics and students established to pursue following objectives: • Advance & develop the art, science, technology & engineering of plastics for the benefit of its members & the public …

• Form & organize a strong professional body of those connected or concerned with plastics…

• Institute, supervise, advise upon & advance the standard & methods of education & training at all the levels in the fields of plastics…

• Project plastics… as ‘eco friendly material’ • Project the vital contribution of plastics in various fields of economy…

• Disseminate for public awareness all relevant information about plastics … to remove myths & misconceptions…educate public … the beneficial role plastics play in improving overall quality of life.

Indian Plastics Institute was registered as Society (under Society Act 1860- Regn. No.333 dated 17.4.1985)in Mumbai and as a Public Trust in May 1985, as a successor to Plastics & Rubber Institute, London (Indian Section) which had started its educational activities in India in 1963.

IPI has 11 Chapters and 5 Sub-Chapters spread all over India with more than 3,500 members in different categories.

Main activities of IPI fall in following categories: • Education, Training and Manpower Development for the Jan.-Feb. 2016

Plastics Industry • Spreading awareness on responsible use of Plastics amongst society under program- Plastics and Ecology, conducted individually or associating with other institutes.

• Spreading awareness of use of Plastics in agriculture for effic ient use of water and protecting the crop and subsequent agricultural produce, associating with other institutesPlasticulture program of Plastindia Foundation • Encouraging and recognizing innovations in Industry and Academia, associating with other associations. - Plasticon Awards of Plastindia Foundation.

• Providing expert guidance on matters of technology to Industry and individuals under AAP (Anything About Plastics) program of IPI.

All India Plastics Manufacturers’ Association (AIPMA) Products / Services: The All India Plastics Manufacturers’ Association (AIPMA) established in 1945 is the oldest and largest apex body to promote development and growth of Indian Plastics Industry. Spectrum of membership include all categories of plastics industry spread over 175 cities and towns nationwide. Over 44 National and Regional Plastic Associations all over India are affiliated to AIPMA. AIPMA is one of the founder promoters of Plastindia Foundation established in 1987 with an objective of jointly promote interests of Indian Plastics Industry globally, and Nodal Agent for Arabplast Exhibition held in Dubai. AIPMA was Indian partner for PlastPack Africa Exhibition in Kenya/South Africa. AIPMA has representations in various Bodies / Committees of Government of India for promotion of Plastics and Petrochemical industries. Business delegations to Chinaplas, K, Koplas, Taipei Plas, NPE, etc. are organised regularly. The 10th Plastivision India -2017 from 19-23 January, 2017 at Mumbai and 3rd Plastivision Arabia 2016 from 10-13 January, 2016 at Sharjah, UAE are announced.

Indian Drug Manufacturers’ Association (IDMA) Indian Drug Manufacturers’ Association “Gujarat State Board” is a state level Association, represents 200 units from the State of Gujarat. It was established in the year 1979, under the Chairmanship of Shri I. A. Modi, Cadila Pharmaceutical Ltd. Ahmedabad.

As a State level Association, it has been active in resolving general issues pertaining to Pharma industries. Association is having a closed rapport with the Central & State Government, similarly, Association maintains closed cordial relations with various financial institutions of the state. Association is actively studying the problems like Finance, Power, Pollution, Sales Tax and unhealthy interference in laws and Rules. Association hold seminars, workshops and interactive Sessions to educate members, Due to the implementation of Schedule-M, lot of works have been done to educate the members of the units.

Over & above, Association carries out following activities. Spot Guides, Development Programmes, Central Excise Problems, Workshop and Seminar on Sale Tax & Income Tax. Association always believes in representing right cases of the Pharma Industries. Its motto is service to the Pharma Units.

45

Supporting Association Engineering ExportPromotion Council (EEPC India) EEPC India is the premier trade and investment promotion organization in India, sponsored by the Ministry of Commerce & Industry, Government of India and caters to the Indian engineering sector. As an advisory body it actively contributes to the policies of Government of India and acts as an interface between the engineering industry and the Government.

Set up in 1955, EEPC India now has a membership base of over 13,000 out of whom 60% are SMEs. Keeping ‘Engineering the Future’ as the motto, EEPC India serves as the reference point for the Indian engineering industry and the international business community in its efforts towards establishing India as a major engineering hub in the future. EEPC India is also working aggressively on the promotion of the Indian Medical Device & Pharma Machinery sector.

Year 2015 holds a special significance for EEPC India as it marks the 60 years of its establishment. Hon’ble President of India, Mr. Pranab Mukherji graced the Diamond Jubilee celebrations of EEPC India as “Chief Guest”. Department of Posts has released a Commemorative Stamp to mark the 60 years of EEPC establishment.

The Society Of Plastics Engineers (SPE)

The Society Of Plastics Engineers (SPE) founded in 1942, the premier source of peer-reviewed technical information for plastics professionals. SPE India has been in existence for over 25 years, and has effectively functioned as an extension of the parent body to fulfill its objective of serving the Indian Plastics Industry.

The organization is divided into five parts: Local and Geographical Sections, Technical Divisions, Staff, Volunteer Leadership, Student Organizations. There are also groups which are under formation, such as Sections in Formation (SPE Sections) or Special Interest Groups (SPE Divisions.)

It has been holding numerous technical seminars and international conference to facilitate the transfer of knowledge across various industry segments.

SPE India constituted of some of the top individuals from the plastics industry who volunteer their time, resources and efforts towards furthering the cause of the India Plastics Industry. SPE is the only place where people from all parts of the industry can come together around important issues & technologies.

SPE’s contribution to the plastics industry has made a significant difference to the technologies & innovations the industry enjoys today. Today, the industry is more interdependent than ever, and professional networks have taken on global dimensions. Such networks are almost impossible to develop and 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 engineering knowledge relating to plastics. SPE helps people and companies in the plastics industry succeed, by spreading knowledge, strengthening skills & promoting plastics. SPE is the only

46

place where people from all parts of the industry can come together around important issues & technologies.

It has never been more important to be a member of your professional society than now, in the current climate of change and volatility in the plastics industry. Now, more than ever, the information you access and the personal networks you create can and will directly impact your future and your career.

Active membership in SPE – keeps you current, keeps you informed, and keeps you connected.

For more details visit www.speindia.org

Orthopedic Implant Manufacturers Association (OIMA) • An Association of FDCA Approved Manufacturers of Orhopedic Implants And Instruments.

• To Develop The Orthopedic Fraternity For The Well-Being Of Mankind.

• To Promote Good Practices In Manufacturing And Services Of Orthopedic Implants.

• 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.

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

•

I.V. Infusion Sets

•

Blood Administration Sets

•

Scalp Vein Set

•

Urine Collection Bags

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com

Jan.-Feb. 2016

Industry News Import Duty On Medical Devices Raised The customs department has raised import duty on medical devices used for surgical, dental and veterinary use from the current five per cent to 7.5 per cent (increase of 2.5 percentage points) to help companies manufacture these products in India itself. The move would help Make in India programme in these items.

The step came over a month ahead of the Budget 2016-17, expected to be tabled in Parliament on February 29.

Besides, the government imposed special additional duty on these items of four per cent by withdrawing exemptions, a statement by the finance ministry.

Also, basic customs duty will be reduced to 2.5 per cent on raw materials, parts and accessories of these items.

M S Mani, senior director, Deloitte in India, said, •"The increase

in the basic customs duty rate on certain medical devices together, with the imposition of SAD, accompanied by a reduction in the customs rates on the raw materials and parts required to manufacture such devices, signifies the government's commitment to encourage manufacturers in India."

These changes are expected to provide impetus to the domestic medical devices sector, support Make in India campaign of the government and generate employment, the finance ministry's statement said.

The concessional basic customs duty will continue for equipment in hospitals run by central or state governments or registered societies, rehabilitation aid and other goods for disabled.

(Ref: http://www.business-standard.com)

DBT Collaborates With AIIMS And IITs For Medical Device Technology The Department of Biotechnology (DBT) has collaborated with All Indian Institute of Medical Sciences (AIIMS) and leading research institutes like Indian Institutes of Technology (IITs) in the country to develop the medical devices technology in the country under the ‘Make in India’ initiative taken up the Prime Minister of India.

“Our aim is to make India self reliant in the medical devices sector. As our healthcare sector is vast and require high quality medical devices for advanced medical care, we are calling up on the medical technology innovators to collaborate and develop affordable and need based technologies for the common man,” opined Dr Harsh Vardhan, Minister for Science and Technology and Earth Sciences.

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 witnessing 10-12 per cent growth per year. With medical devices industry growing at this pace, industry experts are expecting that the government will do a humongous spending of $250-350 every year for innovation, research and new development in the country.

Currently the Indian medical device market consists of medical

instruments, orthopaedic and ophthalmic devices. Syringes, needles, catheters, scanning devices and bandages are increasingly being manufactured and marketed in the country. “Realising the growing importance of healthcare, the Department of Biotechnology is promoting the medical devices sector through various programmes for affordable products relevant to societal and public health,” said Vijay Raghavan, Secretary of DBT. “India has complete value chain right from product innovation to commercialization to support and facilitate entrepreneurs.

Currently about 40 medical devices and diagnostics have been invented in India and have even received US FDA clearances.”

The DBT has collaborated with AIIMS and IITs for development of in-vitro diagnostics tools, implants, and other medical devices.

According to Dr. Balram Bhargava, the DBT along with premier research institutions are aiming at global promotion, affordable need driven, health innovation (GANDHI). So far the Biotechnology Industry Research Assistance Council (BIRAC) has trained 110 innovators and developed 34 medical devices and has obtained 51 provisional patients.

(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 manufacturing faculties, Andhra Pradesh is showcasing an exclusive project in this sector.

"There is a congenial environment prevailing in Andhra including best industrial policy, 24x7 power supply and 10 lac acres of land dedicated to industrial purposes," said Andhra Pradesh’s Health Commissioner KV Satyanarayana.

Gopinath MG, Director of AP Medical Infrastructure Corporation, said that Andhra being the biggest market for medical devices and having large number of medical colleges and super specialty hospitals is on its way to become the biggest medical hub in Asia.

"To achieve this objective we have planned dedicated infrastructure for medical device manufacturing faculties," he said.

"The recent Central Government announcement of withdrawal of duty concession on import of medical devices and the concession duty on raw materials is very timely for success of our project.

"This along with the National Medical Devices Policy on anvil Jan.-Feb. 2016

will be complemented with our State led incentives to help make AP and India become a medical devices hub in the world," Satyanrayana said.

"We are pleased to be associated with the country’s first medical device park. Arab Health Exhibition is a great platform to launch this project. It will assure global attention and interest and will go a long way in making this unique project a huge success," said Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Manufacturers (AIMED).

Over 4000 pharma and medical device companies besides are taking part in the Dubai exhibition.

Andhra government has earmarked 200 acres near Vishakhapatnam to build country’s first and among the world’s most advanced medical device manufacturing park.

In a global first for any manufacturing park, this park will have a dedicated research, development and incubation centre to ensure that country becomes a global leader in chosen niche medical device verticals.

(Ref: http://indiatoday.intoday.in)

47

Product Gallery Qosina Adds over 90 Compression Fittings to their Large Line of Connectors Qosina is pleased to announce the addition of over 90 compression fittings in various sizes and configurations. Individually packaged in a cleanroom, they are available for tubing OD connections in 1/8, 1/4, 3/ 8, 1/2,3/4 and 1 inch sizes. Configurations include straight, elbow, and T, with or without NPT threads. Accessories are also available, including ferrules, nuts and plugs. These compression fittings are made of High Purity PFA, PVDF, PTFE and ETFE. Sterilization methods that could be used include ETO, Steam, E-beam and Gamma.

These compression fittings offer PFA purity combined with a robust compression style fitting, and are ideal for gas, pneumatic and fluid connections in applications that require an alternative to a barb or bond connection. Once tubing has been cut to the desired length, the simple design allows for ease of installation and requires no tools. They also 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 pharmaceutical industries including bag ports, connectors, luers, clamps, adapters, clips, valves, needle hubs, sanitary flanges, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes and syringes. Qosina operates an ISO 9001 and ISO 14001 registered facility.

Visit us at www.qosina.com to see our latest products. Custom sourcing services are available through our knowledge specialists using Qosina’s extensive resources.

Contact: Maria Stazzone,Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone +1 (631) 242-3000, Fax +1 (631) 242-3230, Email: mstazzone@qosina.com

New Berman Airways from Qosina Qosina is pleased to announce the addition of a new line of Berman Airways (#50114 - #50121), in stock and ready for immediate delivery. These components are color-coded which provides instant identification of sizes; light pink (40 mm), blue (50 mm), black (60 mm), white (70 mm), green (80 mm), yellow (90 mm), dark pink (100 mm), and orange (110 mm).An LDPE, BPA-Free ergonomic design offers a smooth finish permitting easy insertion, and part #50121 is equipped with holes through the center of the body that allow for additional air passage. Berman airways assure a ventilated channel and permit access of a suction tube, even if the airway shifts or partially closes.Qosina offers a variety of respiratory components in addition to thousands of single-use components.

Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohy borst adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility.

Visit us at www.qosina.com to see our latest products.

Custom sourcing services are available through our extensive network.

Contact : Ryan Edwards, Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779, Phone +1 (631) 242-3000, Fax +1 (631) 242-3230, Email: redwards@qosina.com

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 : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630.

Ta.: Kathlal, Dist. Kheda, Gujarat.

Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964

48

Corresponding Address: HINDUSTAN SURGICAL Hasmukhbhai B. Patel 23, Manav Mandir Bungalows, Taxshilla Colony, Old Aradhana School Circle, B/h Ramannagar, Sukhipura, Maninagar, Ahmedabad - 380008 Email : info@hindustansurgical.com

Jan.-Feb. 2016

GMP ISO - 9001-2008 Certified Company

Surgical Industry For

SALE In Hyderabad, R. R. District, Telangana.

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

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

An ISO 9001:2008, 13485:2012 & GMP Certified Company Address

Contact through:

surgicalindustrysale@gmail.com Jan.-Feb. 2016

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India.

Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

49

AN ISO 13485-2012 CE certified Company

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concetration Mask • Breating Filter

• • • • • • • • • • •

Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankaur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Heathcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026.

M. : +91 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 7874006597/7600020901

Events Calender • Plexpo India 2016 7th International Plastic, Packaging, Printing, Converting & Rubber Industries Exhibition Date : 07th-11th January, 2016.

Venue : Exhiition Centre, Near Town Hall, Gandhinagar.

• 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016.

Date: 12-13 February, 2016 Venue: Ahmedabad Management Association, A’bad.

• Plastivision Arabia 2016 Region’s Leading Plastics Event Date: 22-25 February, 2016 Venue: Expo Center, Sharjah.

• Medical Fair India 2016 22st International Exhibition and Conference Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Mumbai.

• Medicall 2016 15th Edition Date: 22-24 July, 2016 And Venue: Chennai.

• Medical Manufacturing Asia 3rd Manufacturing Processes for Medical Technology Exhibition and Conference Date : 31st August - 2nd September 2016.

Venue : Singapore

50

Jan.-Feb. 2016

November 2014 to December 2015 Column

Content

Column

November- December 2015 Cover Story

• Global Medical Disposables Industry Scenario and the Role of Plastics • Most Widely Used Medical Disposable Products Global Trends • The Eleven Most Implanted Medical Devices In America • Fecal Incontinence Device Book Review • Medical Devices: Regulations, Standards and Practices • UHMWPE Biomaterials Handbook • The Medical Device R&D Handbook, • The Effect of Sterilization on Plastics and Elastomers • Advanced Polymers in Medicine Did You Know • About Failure of Endotracheal Tubes September-October 2015

Cover Story

• • • •

Manufacturing • Global Trends • • Product Gallery • • Did You Know •

Medical Tubing And Extrusion Technology Tubes and Catheters Sizing Medical Tubing : Materials and Applications MPDS Supplier Bulletin : Medical Tubing And Extrusion Technology Make In India : From Slogan To Policy Implementation Safety Considerations Related To Misconnections Between Medical Devices Modern Medical Tubing for Medical Device Downgauging New Winged Female Luer Lock To Barb Connectors Breakable Male Luer Lock Connector About Hospital Errors on Medical Tubing Killing Patients July-August 2015

Cover Story

• Indian Medical Device Industry : Government Initiatives For Regulations, Safety &Competitiveness - Department Of Pharmaceutical To Study Factors Affecting Competitiveness Of Indian Medical Devices In Domestic Market - Government to Soon Remove Duty Anomalies in Medical Devices Sector - Ministry Of Health Launches Materiovigilance Programme To Monitor Safety Of Medical Devices Technology - AdvaMed Demands Passage Of D&C Amendment Bill To Delineate Medical Devices From Drugs • Cold Plasma Treatment For Biomedical Applications • Plasma Treatment Improve Adhesion To Polymers Global Trends • Impact Of New European Regulations On Outsourcing Of Medical Devices Did You Know • Balancing Product Development Effectiveness with Regulatory Compliance May-June 2015

Cover Story

Jan.-Feb. 2016

• Medical Device Manufacturing : Components Bonding and Joining Techniques

Content

Mfg. Policy

• National Medical Device Authority (NMDA)Recommended By Task Force To Strengthen “Make In India” Drive Global Trends • Medical Disposables Market Worth $245 Billion By 2018 Product Gallery• New Kynar Connectors Did You Know • About Welding of Thin Polymeric Films For Medical Applications March- April 2015 Cover Story

• Promotion Of Domestic Production Of High End Medical Devices • The Medical Devices Sector In India : Task Force Recommendations · • “Medical Plastics Data Service” Thanks And Welcomes Mr. C. Balagopal To The Editorial Advisory Board Market • Drug Device Combination Products : Market Review And Future Trends Global Trends • Global Biomaterials Market For Implantable Devices Driven By Polymers Did You Know • About Challenges Of Using Combination Products January- February 2015 Cover Story

• Manufacturing Medical Devices In India : Many Opportunities - Mr. Himanshu Baid, Managing Director, Poly Medicure Ltd. • How Do We Balance Between Compliance, Quality And Innovation?

- Mr. C. Padmakumar, Chairman & Managing Director, Terumo Penpol Limited Global Trends • Understanding Barriers to Medical Device Quality • China : Medical Technology Potentials Are Enormous Product Gallery• New Sanitary Flanges With Barbs Did You Know • About Trends In Medical Device Adverse Events November -December 2014 Cover Story

• 12th National Conference & Exhibition on “Indian Medical Devices & Plastics Disposables/ Implants Industry 2015” Technology • Exhibitors Offering Material, Display Exhibition Adhesives, New Technologies, Manufacturing/Testing Equipments.

• Packaging/Sterilization Equipments And Services For Medical Devices, Implants & Diagnostics Industry.

• Presentations • Speakers’ Profiles • Exhibitors’ Profile • Advertisers Profile....etc.

Book Review • Regulatory Affairs for Biomaterials and Medical Devices • Polymeric Biomaterials : 2 Volume Set

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List & Profile Of Advertisers Company Name

Products / Services

Accuprec Research Labs Pvt. Ltd., A’bad.

Airways Surgical Pvt. Ltd., Ahmedabad Alpha Medicare and Devices Ltd., A;bad.

Alpha Therapatics Pvt. Ltd., Ahmedabad Ambica Medicare Engineering, A’bad.

Amigo Surgi Care Pvt. Ltd., Gandhinagar Angiplast Pvt. Ltd., Ahmedabad Apar Industries, Mumbai Apex Medical Devices, Ahmedabad Basil Polymers, Ahmedabad Beacon Plastics, Ahmedabad

Bio Compatibility Services for Medical Devices Surgical Products Surgical Disposable Products Surgical Disposable Products Sterilization Equipment Surgical Disposable Products Medical Disposable Products & Components Electron Beam Sterilization Services Medical Disposable Devices & Surgical Products PVC Compounds Disposable Needle, Disposable Needle IV Set, Regulator IV Set, IV Set Chamber Bhagwati Medicare Devices, Manufacturer & Exporter of Medical Disposable Devices Ahmedabad & Surgical Products Bhavya Polymers, Mehsana Silicon rubber products manufactures: tubes, extruded section, sleevings, cords, strips, molded parts BRY-AIR (ASIA) PVT. LTD. Plastic Auxiliary Equipments CEpartner4U, The Netherlands General consultancy, authorized representative, Quality system Classic Enterprises, Hyderabad Disposable, Surgical Disposable & Surgical Instruments COVESTRO, Thane(W) High Performance Material Manufacturers, Component for Coating Adhesive & Elastomer for Healthcare Industry Eewa Engineering Co P. Ltd, Ahmedabad Packing Machine, Sealing Machine, Welding Machine etc.

Excel Formulations, Ahmedaad ETO gas / ETO gas mixtures GLR Laboratories Pvt. Ltd., Chennai Nonclinical safety testing of pharmaceuticals, chemicals, medical devices and other products Gurukrupa Consultants, Mumbai Technical Consultants in Plastics, Medical Grade PVC & Extrusions.

Hindustan Surgical, Ahmedabad Manufacturers and Suppliers of Medical Disposables & Surgical Products I Kare Polyalloys, Nani Daman Soft Transparent PVC Compounds, General Compounds, various Rigid PVC Compounds, CPVC compound Etc. Ignisol Mediplas Corporation, Mumbai Medical Surgical and Healthcare Products Jain Rubbers Pvt. Ltd., Tamilnadu Rubber Products For Disposables And Rubber Stoppers For Pharmaceutical Packaging Jimit Medico Surgicals, Ahmedabad Medical Disposables products Kavya Packaging, Ahmedabad Manufacturers of flexible packaging pouchs and rolls and aluminium foil for pharma industries KLJ Polymers and Chemicals Ltd., Polymer compounds like PVC, XLPE, PP, TPR, TPE, EVA, New Delhi EPR, ZHFR, Master Batches etc Lakshmi Designers, Bangalore Medical disposable products and Infrastructure Life-O-Line Technologist Respiratory Disposale and Medical Surgical Devices Maider Medical Industry Equipment Co., Sterile Medical Automation Equipment Ltd., China MEDICALL, Chennai Medical company conference Mesco Surgical, Ahmedabad Medical Disposable Products Messe Düsseldorf Asia Pte. Ltd., Leading Specialist Trade Fair for Asia’s Medtech and Singapore Medical Manufacturing Processes Sector Messe Düsseldorf India Pvt. Ltd., Medical Technology & Conf.

New Delhi Morrisons Lifecare Pvt. Ltd., Chennai Surgical Disposable & Medical Devices National Healthcare, Ahmedabad

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Medical Disposables products

Website

Page No.

www.accuprec.com www.airwayssurgical.com www.alphamedicare.com www.atplworld.com www.ambicamedicareengg.com www.amigo-india.com www.angipalst.com www.apar.com www.apexmedicaldevices.com www.basilpolymers.com

10 56 57 74 69 59 54 75 59 58 54

www.medicaredevices.com

50

www.bhavyapolymers.com

35

www.bryairsystems.com www.cepartner4u.eu

68 72

www.covestro.com

49 1

www.eewaengineering.com www.excelformulations.com www.glrlabs.com

66 11 77 48

www.hindustansurgical.com

48

www.i-kare.in

70

www.ignisol.net www.jainrubbers.com

76 72

www.jimitsurgicals.com

60 59

www.kljindia.com

7

www.Ldmoulds.com/medical www.maiderchina.com

12 50 2

www.medicall.in www.mescosurgical.com www.medmanufacturing-asia.com

17 46 65

www.md-india.com;

18

www.morrisonslifecare.com www.medicalfair-india.com www.nationalhealthcare.in

60 60 Jan.-Feb. 2016

List & Profile Of Advertisers Company Name

Products / Services

Website

Neejtech India, Ahmedabad

High precision medical device molds, all electric injection molding machines, automation systems etc.

Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification for Medical Devices, Pharmaceuticals, etc.

Packaging Machinery Critical Medical Components and Devices Medical Grade Paper-Poly Pouches PTFE, FEP Tubing; Gaskets for Disposble syringes in Butyl and silicone rubbers; S.S. Needles / Cannula Medical Grade PVC Compound, Extruded Medical Grade Tubings Stock components such as lipid resistant stopcocks, luers, ports, caps, tuohy borst adapters, USP Class VI tubing, spikes, instrument and many more Ethylene Oxide Mixture Gas For Sterilization Medical Grade PVC Tubing, Silicon Tubing, noDOP Tubing, Connectors Surgical Disposable Products Injection Moulded Medical Components

www.neejtech.com

9

www.operonstrategist.com

49

www.polyzen.com www.pradeepsurgipack.com www.pragatiplastics.com

60 6 55 67

www.pvclplastics.com

73

www.qosina.com

78

www.RAUMEDIC.com

10 16

Operon, Pune

Pack-Equip, Ahmedabad Polyzen , U.S.A. Pradeep Surgipack, Bangalore Pragati Plastics Pvt. Ltd., New Delhi PVC Coloring Compounding & Processing Qosina, U.S.A

R R Patel Gases (P) Ltd., Ahmedabad RAUMEDIC, Pune S.Nath & Company, Ahmedabad Sanidhya Enterprice, Ahmedabad ScanTube, Thailand Shin Yan Sheno Precision Industrial Co., Ltd., Taiwan Shriram Axiall Pvt. Ltd., Haryana SMC Medical Manufacturing Pvt. Ltd., Karnataka

Sterimed Surgicals India Pvt. Ltd., New Delhi Styrolution ABS (INDIA), New Delhi

Surgi Pack India Pvt. Ltd., Mumbai

Technic Automation, Ahmedabad Trade Contacts. New Delhi Twist Engineering, Ahmedabad Unikal Consultant, Ahmedabad

VERIPACK, Mumbai Virtue Certifications Pvt. Ltd., Vadodara Welset Plast Extrusions Pvt. Ltd., Mumbai Yuhuan Shengjiu Mould Co., Ltd., China

Nov.-Dec. 2014

Fluoropolymer tubing for the medical device market with more than 30 years of experience.

Molds of Medical Parts and components Plasticized & Unplasticized clear Extrusion, Soft & rigid clear Injection & Blow Moulding, Radiopaque Compound SMC can design, develop prototypes, build tools, manufacture components, assemble and package your finished device while managing the entire supplychain along the way Steripore Non Woven Microporous tape, Cuff & Plain Endotracheal Tube, Customized Gynecological & Other Kits, Medical Disposables Leading, global styrenics supplier with a focus on styrene monomer, polystyrene, ABS (acrylonitrile butadiene styrene) Standard and styrenic specialties.

Medical products manufacturers for Surgical Peelable & Tearable Puches, Lids & Reels for sterilized Medical Disposables & Devices.

Custom air leakage testing machine for medical devices like urine bags , I.V. sets etc.

An International monthly magazine for hospital, medical, healthcare and related trades Plastic Extrusion Machineries Leading consulting organization providing an integrated services with focus on project technology: Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit Documentation, Training and c-GMP A world leader in Thermoforming Machines Quality Certification Service Medical Grade PVC Compounds Molds for Medical Instrument

Page No.

www.snathco.com www.medisourceasia.com/ productgallery/sanidhya.htm www.scantube.com

49 57

www.medical-part.com.tw

5

www.shriramaxiall.com

15

www.smcltd.com

71

www.sterimedgroup.com

8

www.styrolution.com

64

www.surgipackindia.com

56

www.technicautomation.in

76

www.webptc.com

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www.twistplasticmachinery.com www.unikalindia.com

63 58

www.veripackindia.com

4 59 14 3

www.welset.com www.yhsjmould.com

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Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests.

Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc...

The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing.

– Supply of Components for Medical Devices.

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India.

Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

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: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India.

Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

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High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount Jan.-Feb. 2016

®

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests.

ISO 13485 : 2003 • Exporting our products to almost more than 23 countries.

Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com

0434

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •

Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components

Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com Jan.-Feb. 2016

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BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance.

BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc.

• DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.

BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014.

Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com 58

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

Jan.-Feb. 2016

VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are entrusted with the responsibility to manage in India on behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Accredited.

We are involved on the certification activities in the following areas : • ISO 9001:2008 - QMS • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing • CE Marking • GMP We have collaboration with European Notified Body for CE Marking & SA 8000 certifications.

We have assisted over 6500 clients all over the country, as an expansion plan we also require well qualified personnel’s in various districts to conduct the audits and provide after sale services, for Business Associates kindly apply for your location with complete details. Business Plan preferred.

For further details OR clarification pleases contact :

Virtue Certification Systems Pvt. Ltd. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Sama Road, Vadodara – 390008. Gujarat.

Ph. : 91-265 – 2794158 / 98250 43523 Email: shankarbkm@gmail.com OR virtueinternationals@gmail.com

GMP. & ISO 9001 – 2000 Certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products:

Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch E. O. Indicator Pouches Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699

Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com Jan.-Feb. 2016

I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE VOLUME SETS ETC.

Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.)

(DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India 59

National Healthcare An ISO 9001 : 2008 Company

Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Injection Moulded Medical Components and Extended Tubes :

PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in

ISO : 13485 : 2012

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 60

Jan.-Feb. 2016