Medical Plastics Data Service Magazine January - February 2017 by Medical Plastics Data Service

Table of

Vol. 25

No. 1

Jan.-Feb. 2017

Contents 24

Cover Story

Cover Story : Event Highlights 14th National Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/ Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. Conference Theme : “Manufacturing Medical Devices in India : Growth Opportunities” Highlights : Workshops : Panel Discussions: 1. Technology Driven Transactions : Skill 1. “Regulatory Issues: Current Status and Strategies” Development Workshop For Business Owners 2. “Innovate In India” 2. Biocompatibility Training : Updated Information, 3. “Indian Medical Device Industry : Moving Up Value Clarifications and Recent Advancements Chain” Student Program : Session Themes : 1. Participation in Technological Conference. 1. Developments in Materials & Processes to Facilitate 2. Introduction to Career Opportunities in the Growth. Medical Technology Industry. 2. Drug / Device Combination Products & Implants : 3. Opportunity for poster Presentation in the Definition & Technological Challenges, Market Overview. Technology Show Exhibition. 3. Drug / Device Combination Products & Implants : 4. Paper and Poster Presentation Competitions for Regulatory Challenges & Requirements, Clinical Trial Students evaluated by Industry Experts. Requirements, Innovations and New Developments. AMTZ Investor’s Meet 4. Medical Plastics : Materials, Processes & Markets AiMeD Members Meet An Exhibition Displaying Manufacturing Equipments, Medical Components / Subassemblies, 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 & Plastic Disposables Implants And Diagnostic Industry

Roadmap for Indian Medical Device Industry Shri Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) And Jt. Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad. “AiMeD has submitted a defined roadmap and task list with Department of Industrial Policy & Promotion (DIPP) and Department of Personnel (DOP) to enable ‘Make in India’”

49 Indian Medical Device Industry to Develop Into A Global Manufacturing Hub Shri Kishore Khanna, Managing Director, Romsons Group of Industries, Agra. “Indian medical device industry is consolidating with the introduction of several steps initiated by the Indian government to broaden the medical device manufacturing base and to enhance exports from India”

49 Quality

Advanced Process Validation For Medical Device Manufacturers Speakers’ Introduction, Presentation Abstracts, Exhibitors’ Profile

49 20

Industry News • AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components • Biotechnology Policy for Gujarat. Jan.-Feb. 2017

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

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. Vinny Sastri President, Winovia LLC, U.S.A. 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. 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-54 •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. 2017

Editor’s Desk

From the

“MEDICAL PLASTICS DATA SERVICE” : NOW IN THE 25TH YEAR OF PUBLICATION. In first editorial of our first issue of magazine before about 24 years, I had mentioned that, “Medical Plastics Products (Now Devices) manufacturing Industry in India today is witnessing a transformation from an unorganized, uncontrolled industry to a controlled and organized industry”. Initial phase of introduction of Device Legislation was just started. Now at the beginning of our 25th year of publication, we are in the growth acceleration phase. Our journey of Successful and Consistent 24 years’ service to the Indian Industry has been possible because of generous support from our readers, advertisers and valuable contributions of articles by Industry Leaders and Professionals. We are extremely grateful to all for the kind support and co-operation. As rightly mentioned by Mr Kishore Khanna, Managing Director, Romsons Group of Industries, in his vision statement reproduced in this issue, “Indian Medical Device Industry shall develop into a global manufacturing hub. “Mr. Kishore Khanna has very precisely enumerated the enablers and opportunities to support his strong confidence in the Indian Industry. Roadmap For Indian Medical Device Industry. Despite of many achievements, there are still many challenges faced by Indian Industry. In an “Roadmap for Indian Medical Device Industry” covered in this issue, Mr. Rajiv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD) has given a very detailed analysis of the achievements in the Healthcare Sector, Challenges faced by Indian Industry as well as how the Government can facilitate to make India a Global Hub for Medical Device Manufacturing. “Innovate-in India” – India’s Opportunity To Leapfrog Beyond Manufacturing Dr. G. D. Agrawal, Chairman & Managing Director, G. Surgiswear Limited, has explained how utilizing brains of India can lead to leapfrog beyond manufacturing into “Innovate-in India” 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastic Disposables / Implants Indsurty 2017. Being organized year after year since 2001 with a sole objective of promoting “Makein-India” mission and close involvement and support of Leading Industry Associations in Medical Devices, Plastics and Pharma Sectors, a well as Government , Regulatory, Research and Academic Organizations. Also actively supported and participated by large number of Raw Materials, Equipments and Service Providers, it has truly become The Annual Celebration Of Knowledge Sharing, Brain Storming and Networking.

Programme Schedule 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastic Disposables/ Implants Industry 2017 March 17-18, 2017, J. B. Auditorium, Ahmedabad Management Association, Ahmedabad Tentative Programme Schedule Theme: “Manufacturing Medical Devices in India: Growth Opportunities”

Day -1 : March 17, 2017 Time 9.00 am to 6.00 pm 08:30-09.30

Registration And Welcome Drinks

09:30-11.35

Inaugural Session : Guests of Honor : *Shri Rajneesh Tingal : Jt. Secretary, Department of Pharmaceuticals, New Delhi. Dr. Eswara Reddy: Joint Drugs Controller General (India), Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare, Government Of India, New Delhi. Dr. Jitendar Kumar Sharma : CEO, AMTZ and Adviser for Health, Hon. Chief minister, Andra Pradesh Dr. H G Koshia : Commissioner, FDCA, Gujarat State Food & Drugs Control Admin., Gandhinagar. Dr. Arvind Kukrety : Deputy Drugs Controller, Central Drugs Standard Control Organisation Zonal Office, Ahmedabad. Special Address : Shri Rajiv Nath : Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) And Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad. Conclusion and Vote of Thanks : Shri Kishore Khanna : Managing Director, Romsons Group of Industries, Agra.

11:30-13:30

Panel Discussions - I & II Panel Discussion – I, Theme : Regulatory Issues: Current Status and Strategies Moderator : Dr. Jitendar Kumar Sharma : Director & CEO, Andhra Pradesh MedTech Zone (AMTZ) Panel Experts : • Shri Rajiv Nath : Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) and Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad • Dr. Eswara Reddy : Jt. Drug Controller, Central Drugs Standard Control Organisation, New Delhi • Mr. K. L. Sharma : Jt. Secretary Ministry of Health & Family welfare Govt. of India, New Delhi. • Dr. G. S. Bhuveneshwar : Consultant Medical Devices and Former Head Biotechnology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum. • UL India, Bangalore. • Ms. Sashi Rekha : Director, National Accreditation Board for Certification Bodies (NABCB), New Delhi. • Mr. Ravi Shrivastava : CEO, Omni Lens Pvt. Ltd., Ahmedabad. • Mr. V. K. Sharma : Director, Sharma Pharmaceutical Pvt. Ltd., Vadodara. Panel Discussion – II, Theme : “Innovate In India” Moderator : G. S. Bhuveneshwar : Consultant Medical Devices and Former Head Biotechnology Wing, Sree Chitra Tirunal Institute. For Medical Sciences & Technology, Trivandrum. Panel Experts : • Dr. G.D. Agarwal : Chairman & Managing Director, G Surgiwear Limited, Shahjahanpur. • Dr. Kiran Kalia : Director, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad • Dr. A.S. Rao : President, Indian Innovators Association, Hyderabad. • Mr. Anand Srinivasan : Head of Polycarbonates ISC (Indian sub-continent), Covestro (India) Pvt. Ltd, Mumbai • Dr. Prashant Jha : Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India • Mr. Dhiren Mehta : Managing Director, Surgimedik Healthcare India Pvt. Ltd., Mumbai. • Mr. Manoj Bhardwaj : Managing Director, SMC Medical Manufacturing Pvt. Ltd., Bangalore. • Lubrizol Lifescience, Mumbai. • Mr. Sarabjot Singh : Director, Sterimed Surgical India Pvt. Ltd., New Delhi

14:00-15:45

Session - II : Theme : Developments in Materials & Processes To Facilitate Growth (Part - I) Session Chairman : Shri Kishore Khanna : Managing Director, Romsons Group of Industries, Agra • “Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets” By Ms. Elena Draganoiu : Manager, Lubrizol Lifesciences, Mumbai. • “Arise & Enhance: Biocompatible Polycarbonates for Medical Devices” By Mr. Sanjay Chotalia : Manager, Technical Sales & Marketing And Medical Segment Expert Covestro (India) Pvt. Ltd, Mumbai • “Medical regulatory compliance Styrenics solution provided by INEOS Styrolution” By Mr. Partha Mohapatra : Lead Healthcare & Technical Support, INEOS Styrolution India Limited, New Delhi. • “Validation Needs for Packages of Medical Devices” By UL India, Bangalore • “Polymer Compounds & Masterbatches - Helping You Deliver Safe Treatments Globally” By Mr.Umang Shah : National Sales Manager, Clariant Chemicals (India) Ltd., Mumbai.

16:05-17:20

Session III: Andhra Pradesh MedTech Zone (AMTZ) Investor’s Meet Jan.-Feb. 2017

Programme Schedule 17:20-18:15

Meeting Of “Association for Indian Medical Device Industry (AIMED)” Members. Coordinator : Shri Rajiv Nath : Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) and Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad.

Day -2 : March 18, 2017 Track I : Time: 10:00 AM to 17:30 PM 08:00-09:30

Registration and Welcome Drink

09:30-11:30

Session - I : Interactive Workshop On “Technology Driven Transactions “with Focus On Medical Devices, Pharmaceuticals & Healthcare Sector Investments. An Intensive Skill Development Workshop For Business Owners. To be conducted By : Dr Milind Antani, Nishith Desai Associates , Mumbai Background : When one negotiates a license of technology, they need to know what royalty rate and other financial terms they should seek (as a licensor) or pay (as a licensee) and the Allied Clauses in the Legal Agreement whether a Technical Collaboration or a Joint Venture. This intense skills development workshop will show how to make that determination. It will show the methodologies one should employ, and those that one should not. It will show the sources of information that one need to make that determination, and it will teach the skills that one need to hone to be able to reliably make that determination

12:00-13:30

Session II : Drug / Device Combination Products & Implants : Critical Issues-I Overview : Introduction, definition & technological challenges , Market overview, Panel Discussion Session Chairman : Mr. Ganesh Sabat : CEO, Sahajanand Medical Technologies Pvt. Ltd., Surat Expert Speakers : • “Developing Drug / Device Combination Products : Concept to Commissioning” By Dr. Atul Sardana : Director, Alfa Corpuscles Pvt. Ltd., New Delhi. • “Regulatory Update on Medical Devices Including Drug / Device Combination Products, Implants etc.” By Mr. N.R. Saiyad : Senior Drug Inspector, FDCA, Gujarat. • “Drug / Device Combination Products : Introduction And Market Overview” By Mr. Sanjay Shah : Managing Director, Unikal Consultants, Ahmedabad. • “Additive Manufacturing Enables Novel Approaches to Optimize Medical Devices : Growth Opportunities for 3D Printing in Healthcare” By Ms. Swarna Sundar : Senior Consultant & Program Manager Healthcare, Frost & Sullivan, Mumbai. Panel Discussion, Theme : Indian Medical Device Industry : Moving Up Value Chain. • Mr. Ravi Shankar Srivastava : Chairman & Managing Director, Invent Bio-Med Pvt. Ltd., Mumbai. • Mr. Ravi Shrivastava : CEO, Omni Lens Pvt. Ltd., Ahmedabad. • Mr. S. Sridharan : Managing Director, Eucare Pharmaceuticals Pvt. Ltd., Chennai. • Dr. Hemant Desai : Vice President, Operations, Makcur Laboratories Ltd., Ahmedabad • Dr. Inder Jain : Managing Director, Airways Surgical Pvt. Ltd., Ahmedabad. • Mr. Vipul Sheth : Managing Director, Matrix Meditec Pvt. Ltd., Ahmedabad.

14:30-17:30

Session III : Drug / Device Combination Products & Implants : Critical Issues-II Overview : Regulatory challenges & requirements, Clinical Trial Requirements, Innovations and new developments, Panel Discussion Session Chairman : Dr. G. S. Bhuveneshwar : Consultant Medical Devices and Former Head Biotechnology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum. Expert Speakers : • “Plasma Jet : A novel device for bio-medical applications” By Dr. Subroto Mukherjee : Associate Dean, Facilitation Centre for Industrial Plasma Technologies, Gandhinagar. • “Medical Device Standards Development : Challenges” By Mr. Prakash Bachani : Scientist E & Head (MHD), Bureau of India Standard, New Delhi. • “Biofilms – An Emerging Challenge for Catheter Manufacturers for preventing Infections” By Dr. Chirag Patel : Assistant Professor, Microbiology, Shree Krishna Hospital, Karamsad. • “Converting Performance Polymers Into Implants / Devices” By Mr. Hiten Bheda, Managing Director, Vinit Performance Polymers Pvt Ltd., Mumbai. • “Global Product Registration For Medical Devices” By Mr. Siddharth Jain : CEO and Chief Regulatory Advisor, Symbiorph Clinical Trialogy, Ahmedabad. • Business Development Opportunities in Medical Textiles” By Dr. Ketan Kumar Vadodaria : Principal Research Investigator, The South India Textile Research Association, Tamil Nadu.

Jan.-Feb. 2017

Invited Speakers Programme Schedule & Panel Experts Track II : 9:30 AM to 13:00 PM (Includes Tea / Refreshment Break) Session I : Workshop on Biocompatibility Training, March 18, 2017 at Ahmedabad, India Workshop On Biocompatibility : Updated Information, Clarifications and Recent Advancements : Biocompatibility training will deliver the updated information, clarifications and recent advancements on ISO 10993 and FDA guidance updates for compliant biocompatibility strategies by incorporating several new considerations, including the use of risk-based approaches. This training program also provides an unique opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines including in determining the relevant biocompatibility endpoints for an evaluation (test selection (if needed); considerations for use of animal testing vs. in vitro testing; sample preparation of nanoscale, bio absorbable, and in situ polymerized materials; evaluation of color additives); general biocompatibility testing considerations, including test article preparation; specific considerations for the following testing specially for devices utilizing nanotechnology. An opportunity on hands-on workshop will provide real time case studies on medical devices which will provide an understanding of presenting for submission. Participants will walk away with the knowledge of planning and in enduring potential obstacles in biological evaluation of medical devices. Attendance certificate will be provided at the end of the training. To be Conducted By : Dr J. S. I. Rajkumar, PhD Dr B. Rajan, PhD K. R. Navaneethakrishnan, M.Sc (PhD) Toxicologist Toxicologist Assistant Director GLR Laboratories Pvt. Ltd., Chennai GLR Laboratories Pvt. Ltd., Chennai GLR Laboratories Pvt. Ltd., Chennai Note : Interested participants please fill in the attached form and pass it on to the reception desk (before 4:00 p.m. on March 17, 2017) as soon as possible to enable GLR Laboratories Pvt. Ltd. to Arrange Training Materials and Certificate. Track III : 14:00 PM to 16:30 PM 14:00-17:30

Theme : Medical Plastics : Materials, Processes & Markets Session Chairman : Shri N.K. Balgi : Director, Ferromatik Milacron India Pvt. Ltd., Ahmedabad Expert Speakers / Panel Experts : • “Computer Aided Mold Design and Manufacturing” By Mr. Ketan Panchal : Production Manager, Indo German Tool Room, Ahmedabad. • “Injection Moulding Requirements for Medical Plastic Components” By Mr. Saumil Mistry : EngineeringSales Project Engineer, Ferromatik Milacron India Pvt. Ltd., Ahmedabad. • “Medical Polymers : Applications” By Expert from Central Institute of Plastics Engineering & Technology (CIPET), Ahmedabad. • “Key differentiators for Plastics in Medical - Pharma Segment & Future GROWTH Prospects” By Mr.Umang Shah : National Sales Manager, Clariant Chemicals (India) Ltd., Mumbai. • “Medical Component Product Design & Development” By Mr. Parthiv Desai : Director, Sitech, Vadodara. • “Role of Thermoplastics Polyurethane in Medical Device Industry” By Mr. Sachin Jadhav : Assistant Manager, Lubrizol Lifescience, Mumbai Track IV : Student Programme

10:00-11:15

FOCUS : Career Opportunity. Session Coordinator : Dr. Deepak Dave : Former President, Medical Surgical And Healthcare Industries Trade Asso. & Ashutosh Export International, Mumbai. Expert Speakers / Panel Experts : • Special Address By : Dr. A.S. Rao : President, Indian Innovators Association, Hyderabad. • “Business Opportunity in Innovative Medical Device” By Mr. Devendra Patel : Director, Medisoft Telemedicine Pvt. Ltd., Ahmedabad • Dr. Prashant Jha : Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India • “Role of Biomedical Engineers in Hospital” By Er. U. Karthik Premkumar : Manager- Biomedical Engineer, Apollo Hospitals International Ltd., Ahmedabad Judges Panel : • Prof. H.T. Kashipara, Former Head, Biomedical Department, U.V. Patel College of Engineering, Kherva • Mr. Deepak Dave : Former President, Medical Surgical And Healthcare Industries Trade Asso. & Ashutosh Export International, Mumbai. • Dr. Alok Ray : Head, Center for Biomedical Eng., IIT & All India Institute Of Medical Sciences, New Delhi. • Dr. Prashant Jha : Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India • Prof. H. A. Patel : Head, Department of Biomedical Engineering, U. V. Patel College of Engineering, Kherva. • Dr. A.S. Rao : President, Indian Innovators Association, Hyderabad.

11:30-13:30

SUSHRUTA Innovation Award (SIA) : Paper Presentation Competition

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. 14:30-16:00

Address by Guest of Honor : Dr. G. P. Vadodaria : Principal, L.D. College of Engineering, Ahmedabad Judge’s Comments and Declarations of Winners Jan.-Feb. 2017

www.imdiconferences.com 14th National Conference And Technology Exhibition On

Indian Medical Devices & Plastics Disposables/Implants Industry 2017

Pioneer & The Only Event For Medical Disposables & Implants Industry In India Invited Speakers & Panel Experts Day -1 : March 17, 2017 Dr. S. Eswara Reddy Joint Drugs Controller General (India), Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare Government of India, New Delhi.

Dr. Jitendar Kumar Sharma Director & CEO Andhra Pradesh MedTech Zone, Andhra Pradesh

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

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

Shri Kishore Khanna Managing Director, Romsons Group of Industries, Agra.

Dr. Arvind Kukrety Deputy Drugs Controller, Central Drugs Standard Control Organisation Zonal Office, Ahmedabad.

Dr. G. S. Bhuvaneshwar Consultant Medical Devices and Former Head Biotechnology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum.

Jan.-Feb. 2017

Ms. Sashi Rekha Director, National Accreditation Board for Certification Bodies (NABCB), New Delhi.

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

Mr. V. K. Sharma Director, Sharma Pharmaceutical Pvt. Ltd., Vadodara.

Dr. G.D. Agarwal Chairman & Managing Director, G Surgiwear Ltd, Shahjahanpur

Dr. Kiran Kalia Director, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad

Dr. A. S. Rao President, Indian Innovators Association, Hyderabad.

Dr. Prashant Jha Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India

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

Mr. Manoj Bhardwaj Managing Director, SMC Medical Manufacturing Pvt. Ltd., Bangalore

Mr. Sarabjot Singh Director, Sterimed Surgical India Pvt. Ltd., New Delhi

Ms. Elena Draganoiu Global Technology Manager Lubrizol LifeSciences, Mumbai

Mr. Sanjay Chotalia Manager – Technical Sales & Marketing And Medical Segment Expert Covestro (India) Pvt. Ltd, Mumbai

Mr. Partha Mohapatra Lead Healthcare & Technical Support, INEOS Styrolution India Limited, New Delhi.

Mr. Umang Shah National Sales Manager, Clariant Chemicals (India) Ltd., Mumbai

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

Invited Speakers & Panel Experts Day -2 : March 18, 2017 Mr. Ganesh Sabat CEO, Sahajanand Medical Technologies Pvt. Ltd., Surat

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

Mr. N.R. Saiyad Senior Drug Inspector, FDCA, Gujarat.

Mr. Sanjay Shah Managing Director, Unikal Consultants, Ahmedabad.

Ms. Swarna Sundar Senior Consultant & Program Manager Healthcare, Frost & Sullivan, Mumbai.

Mr. Ravi Shankar Srivastava Chairman & MD, Invent Bio-Med Pvt. Ltd., Mumbai.

Mr. S. Sridharan Managing Director, Eucare Pharmaceuticals Pvt. Ltd., Chennai.

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

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

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

Dr. Subroto Mukherjee

Mr. Prakash Bachani Scientist E & Head (MHD), Bureau of India Standard, New Delhi.

Dr. Chirag Patel Assistant Professor, Microbiology, Shree Krishna Hospital, Karamsad.

Mr. Hiten Bheda Managing Director, Vinit Performance Polymers Pvt Ltd., Mumbai.

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

Dr. Ketan Kumar Vadodaria

K. R.

Dr. J. S. I. Rajkumar, PhD Director/Scientist toxicology GLR Laboratories Pvt. Ltd., Chennai

Dr. B. Rajan Director/ Toxicology Scientist GLR Laboratories Pvt. Ltd, Chennai

Shri N.K. Balgi Director, Ferromatik Milacron India Pvt. Ltd., Ahmedabad

Mr. Ketan Panchal Production Manager, Indo German Tool Room, Ahmedabad.

Mr. Saumil Mistry Engineer – Sales Project Engineering Ferromatik Milacron India Pvt. Ltd.

Mr. Parthiv Desai Director, Sitech, Vadodara.

Mr. Sachin Jadhav Lubrizol Lifescience, Mumbai

Dr. G.P. Vadodaria, PhD. (IITD) Principal L.D. College of Engineering, Ahmedabad

Mr. Deepak Dave Former President,

Mr. Devendra Patel Director, Medisoft Telemedicine Pvt. Ltd., Ahmedabad.

Er. U. Karthik Premkumar

Prof. H.T. Kashipara

Dr. Alok Ray Head, Center for Biomedical Eng., IIT & All India Institute Of Medical Sciences, New Delhi.

Navaneethakrishnan

M.Sc (PhD) Assistant Director GLR Laboratories Pvt. Ltd., Chennai

Former Head, Biomedical Department, U.V. Patel College of Engineering, Kherva

Medical Surgical And Healthcare Industries Trade Asso. & Ashutosh Export International, Mumbai.

Associate Dean, Facilitation Centre for Industrial Plasma Technologies, Gandhinagar.

Principal Research Investigator, The South India Textile Research Association, Tamil Nadu.

ManagerBiomedical Engineer, Apollo Hospitals International Ltd., Ahmedabad

Prof. H. A. Patel Head, Department of Biomedical Engineering, U. V. Patel College of Engineering, Kherva.

Jan.-Feb. 2017

Invited Speakers & Panel Experts : Presentation Abstracts Dr. G D Agrawal Chairman & Managing Director G. Surgiwear Limited, Shahjahanpur

Road map for Utilising Brains of India for Medical device innovation, Development Indian brain is best in the world. Unfortunately brain power is not directed to right direction. To utilise this power one needs to

disseminate information about the inventions made and capabilities. Communication between three pillars Inventor, user & manufacturer required. Inventors should approach the world with businessman attitude.

Mr. Sanjay Chotalia Manager – Technical Sales & Marketing And Medical Segment Expert, Covestro (India) Private Limited, Mumbai Arise & Enhance : Biocompatible Polycarbonates for Medical Devices Capture the growth of medical device market when the infrastructure & awareness at its best. Enhance your brand by using high quality biocompatible Polycarbonate which are proven globally for more than 50 years.

Covestro High Performance Polycarbonate is a proven choice in the global medical market. We enhance design freedom by weight reduction, heat resistance, toughness & transparency

Ms. Elena Draganoiu Global Technology Manager Lubrizol LifeSciences Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets Compatibility between medications and intravascular (IV) administration sets is important for assuring predictable delivery of the drug dose, safety and efficacy. Potential interactions include sorption, permeation of the drug into the administration set, leaching of the set material components into the drug solution. The use of thermoplastic polyurethanes (TPU) for IV sets has seen

a recent increase. A comprehensive evaluation of the in vitro compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties, indicated that TPU sets did not affect the pH, impurity and particulates of the drug products tested, being similar or better to compared to TPE and PVC IV sets.

Dr. Subroto Mukherjee Associate Dean Facilitation Centre for Industrial Plasma Technologies, Gandhinagar. PLASMAJET - A NOVEL DEVICE FOR BIOMEDICAL APPLICATIONS Plasma the fourth state of matter after solid, liquid and gas, comprises of ions, electrons, unionized gas atoms/molecules. Depending on the nature of plasma generation either the plasma will have low heat content but high in chemical reactivity (commonly known as cold plasma and used for surface modification) or will have high heat content (commonly known as hot plasma and used for bulk material modification, waste disposal). At FCIPT division of IPR, work on both cold and hot plasmas is being undertaken for various applications for societal benefit. Plasmajet is a device, which produces a cold plasma at atmospheric pressure and is extremely useful for biomedical applications.

An atmospheric pressure plasmajet is developed with argon and oxygen as plasma forming gases, and then it is directed to the patient’s skin having fungal infection (Tinea Cruris). The initial results indicate that patients are getting cured in 3 to 4 sittings where each sitting ~ 15 minutes. Further studies on the mechanism of fungal infection with plasma and micro-biological tests are going on. This work is done in collaboration with IIEST, Howrah and IPGMER, Kolkata. Now plasmajet is planned to be put on some cancer cells to test its performance in collaboration in BSG-BARC. The talk will highlight development of the plasmajet at FCIPT and also mention some other technologies which may benefit the biomedical community.

Mr. Partha Mohapatra Lead- Healthcare, ( India ) & Technical Support INEOS Styrolution India Limited Medical regulatory compliance Styrenics solution provided by INEOS Styrolution “INEOS Styrolution offers Medical Industry with “Healthcare Jan.-Feb. 2017

Service Package”. There are two main pillars. First, our Medical Grade Styrenics comply with Bio-compatibility, such as ISO 10993 and USP Class VI. Second, we do not intentionally change product

Invited Speakers & Panel Experts : Presentation Abstracts formulation and guarantee customers NOC (Notification of Change) up to 3 years. These our Healthcare Packages have been highly appreciated by many Medical Device customers where strict regulatory compliance is required.” The medical regulatory compliance of Styrenics products offered by INEOS STYROLUTION are Novodur ® HD ABS, Novodur HD GF ABS

G3, Luran ® HD SAN, NAS ®SMMA, Styrolux ®SBC, Zylar ®MBS & Terlux ® MABS, which is meant for various medical device applications like Connectors, Adaptors, IV set, Stop Cock, Valves, Drip Chamber, DPI Inhalers, Airways, Nebulizer Housing, Face Masks & Respiratory Filters etc.

Dr. Milind Antani Nishith Desai Associates, Mumbai

Workshop On “Technology Driven Transactions “with Focus On Medical Devices Pharmaceuticals & Healthcare Sector Investments. When one negotiates a license of technology, they need to know what royalty rate and other financial terms they should seek (as a licensor) or pay (as a licensee) and the Allied Clauses in the Legal Agreement whether a Technical Collaboration or a Joint Venture. This intense skills development workshop will show how to make

that determination. It will show the methodologies one should employ, and those that one should not. It will show the sources of information that one need to make that determination and it will teach the skills that one need to hone to be able to reliably make that determination.

Mr. Hiten Bheda Managing Director Vinit Performance Polymers Pvt Ltd., Mumbai Converting Performance Polymers Into Implants / Devices Engineering and high performance plastics have been used in life sciences as materials of construction for Medical Devices, Instruments, Sizing Specimens and Handling Equipments. These materials are available as stock shape like Rods, Plates and Blocks which can be converted into desired form using numerical Machining Techniques.

As per required Designs, Selection, Criteria is Driven by Material Attributes that include Mechanical, Thermal, Electrical, Electrical, Tribological, Bio-Compatibility, etc. and Compliance to Regulatory Requirements, Presentation in Context of Current Scenario and way Forward gives glimpse on the subject

K. R. Navaneethakrishnan, M.Sc (PhD) Assistant Director Dr J. S. I. Rajkumar, PhD Toxicologist Dr B. Rajan, PhD Toxicologist GLR Laboratories Pvt. Ltd., Chennai. Workshop On Biocompatibility : Updated Information, Clarifications and Recent Advancements Biocompatibility training will deliver the updated information, clarifications and recent advancements on ISO 10993 and FDA guidance updates for compliant biocompatibility strategies by incorporating several new considerations, including the use of riskbased approaches. This training program also provides an unique opportunity to understand the policies, laboratory practices, and

challenges faced in broader disciplines including in determining the relevant biocompatibility endpoints for an evaluation (test selection (if needed); considerations for use of animal testing vs. in vitro testing; sample preparation of nanoscale, bio absorbable, and in situ polymerized materials; evaluation of color additives); general biocompatibility testing considerations, including test article preparation; specific considerations for the following testing specially for devices utilizing nanotechnology.

UL India, Banglore

Validation Needs For Packages Of Medical Devices. According to the World Health Organization (WHO), healthcareassociated infections (HAIs) are the mostfrequent adverse event in the delivery of healthcare services worldwide, affecting hundreds of millions of patients each year. Ensuring the sterility of medical devices is an important tactic in the overall effort to reduce the rate of infections in hospitals and other healthcare settings. Effective packaging and packaging materials are essential to help

preserve the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental exposure, or be compromised through normal handling encountered during storage and transportation. As a result, rigorous testing of packaging systems used with medical devices is mandatory in most major jurisdictions around the world. Regulators in the EU, the U.S. and other major healthcare markets have implemented strict requirements for packaging systems and Jan.-Feb. 2017

Invited Speakers & Panel Experts : Presentation Abstracts packaging materials used to preserve the sterility of medical devices, protect their functionality and retain their biological safety. In the EU, medical device directives and regulations mandate that medical device packaging materials and systems conform with the requirements of the ISO 11607 series of standards, Packaging for terminally sterilized medical devices. And in the U.S., the FDA accepts evidence of compliance with ISO 11607 in support of 510(k) applications for the approval and registration of medical devices. In this UL presentation, we’ll discuss the requirements and

validation testing methods applicable to packaging systems and/ or materials used in conjunction with sterile medical devices. Beginning with a review of the importance of packaging validation for medical devices, the presentation then presents a summary of ISO 11607, the standard for packaging materials used for sterilized medical devices, and provides details on validation testing as prescribed in the standard. The presentation concludes with some recommendations for manufacturers on the selection and evaluation of suitable packaging and packaging materials for medical devices.

Mr. Umang Shah National Sales Manager Clariant Chemicals (India) Ltd., Ahmedabad

POLYMER COMPOUNDS & MASTERBATCHES - HELPING YOU DELIVER SAFE TREATMENTS GLOBALLY • Key differentiators for Medical Masterbatch compared to conventional MB. • Regulatory requirements • Medical & Pharma MB overview for Drug Delivery, Invasive, Diagnostics and Pharma Packaging

• Various Innovative solutions of Masterbatch and compounds from CLARIANT. • Various Applications • CLARIANT’s overview and focus for the Medical & Pharma Segment.

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

Global Product Registration-Medical Device Despite the significant presence of domestic players in the industry, the Indian medical devices market is still largely dependent on imports. However, ‘Local innovation’ by MNCs as well as domestic players is expected to drive indigenous manufacturing and lead to rapid growth of exports. Export of medical devices have grown at a rate of around 12% over the past five years, reaching a value of USD 1.2 billion in 2014. This indicates strong performance of the domestic manufacturing industry although limited in size. The Consumables and implants segment accounts for more than 40% of exports from India with USA being the leading destination of export of

medical devices. In the recent years, MNCs and domestic players have designed and developed India specific medical devices in their R&D centers located in India. These products have been designed to suit the needs of the developed market – in terms of product specifications and pricing. Interestingly, these products have also created demand in other developing markets outside India. Challenges across multiple dimensions that were disablers to the export of indigenous medical devices need to be addressed. These include poor knowledge for country specific regulatory requirement, poor regulatory documentation and providing the Marketing Authorization to single distributors are some specific road blocker for Indian medical device export industries.

Dr. Chirag Patel Assistant Professor, Microbiology Shree Krishna Hospital, Karamsad Biofilms in Indwelling medical devices The Indwelling medical devices are used frequently in patients typically critical patients in multiple ways for multiple purpose and those devices along with aiding the treatment, also sometimes becomes biggest source of infection and becomes challenge for the therapeutic world to be treated. The present work and knowledge about the indwelling device associated infection with the focus on biofilms are the key emerging issue to be primarily

Jan.-Feb. 2017

addressed by device manufacturing industry. The development of newer preventive technology in device manufacturing industry will need an eyesight to be developed in the manufacturers. In the emerging world of antimicrobial resistance in potentially infectious healthcare associated pathogens, to prevent them to harm further in patients and control this challenge before it becomes threat to mankind, its indeed research done from manufacturers are of great future value.

Roadmap for Indian Medical Device Industry Rajiv Nath Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi, Joint Managing Director, Hindustan Syringes & Medical Devices Ltd. Key Initiatives Set By in Motion AiMed AiMeD has created a dialogue with various government departments and ministries to highlight the issues faced by the medical device industry and prepare a strategic roadmap to address India’s import dependency in medical devices to reverse it to make India one of the top five medical devices manufacturing hubs in the world. We have submitted a defined roadmap and task list with Department of Industrial Policy & Promotion (DIPP) and Department of Personnel (DOP) to enable ‘Make in India’. With Ministry of Health and Family Welfare (MoH & FW) we have requested for regulations to address patient safety while creating trust for India-made devices but not of traditional. License Raj-type relying on inspection by government inspectors but by unbundling of regulations and ensuring maximum governance with minimal government and ease of doing business by utilising third party certification bodies. Some of the other key initiatives include Department of Revenue and Tariff Commission a review of the inverted duty structure that was making imports cheaper than manufacturing, with Department of Commerce and Engineering Export Promotion Council (EEPC) a focus is on creating brand India and a coordinated overseas marketing plan to unleash our export potential. Achievements in the HealthCare Sector More than AiMED’s list let me share the government’s Progress Report (some of them triggered by aforemen tioned initiatives) which includes : i) Request to government to address Inverted Duty Structure and nominal Tariff Protection : - Revise Basic Duty on Import of Medical Devices to 10% Basic, as earlier (now 7.5% done on January 19, 2016 for 78 items, 21 pending - Government to revise special additional duty on medical devices to 4% as earlier to enable business viability (Done on Jan 19th 2016 for 78 items, rest 21 to be covered) - Government reduced duty on imported Raw Material to 2.5% on Jan 19, 2016 for above 78 items. ii) For enabling consumer protection our proposed tax-based disincentive are pending. However, steps are being taken by Department of Consumer Affairs to ensure all medical devices carry an MRP whether they are an OTC product or not and NPPA is bringing Stents under price control. iii) QCI introduced ICMED 13485 Quality Certification System as a pre-cursor to medical device regulations for enabling confidence in quality of Indian products (Done on 15th March 2016) and have held a series of workshops in Delhi, Mumbai, Chennai, Pune, Ahmedabad, and Bangalore with financial support from Department of Commerce on capacity building of Manufacturers for building QMS - Quality 30

Jan.-Feb. 2017

Management Systems capability development for getting CE and ICMED Certification. On our request to create a Separate Rule Book for Devices, the Mo-H&FW responded favourably and subsequently on 19 October, 2016 the initial draft of the separate rules to regulate medical devices was shared with the stakeholders and uploaded on website for public comments. Comments have been collected and collated and the draft updated and rules are in process of notification. Also in response to our request for a Separate Law from Drugs & Cosmetics Act, a draft Medical Device Bill has, meanwhile, been prepared by MOH&FW and is going internal review within the Ministry, thereafter Stakeholders will be invited for consultations and thereafter we expect this to be uploaded on the website for public comments before being presented to the parliament by ministry. iv) On our request to government to review and pull back its Auto Approval Brownfield FDI Policy - it’s ok to retain this for 100% Green Field Projects for manufacturing, not trading - for ensuring choice of Indian brands to Indian consumers , RBI has initiated investigation on the 100% FDI policy for potential misuse and its impact. About Challenges Faced By Indian Medical Devices Industry The Indian medical device industry is facing the challenge of having to compete with imports with deep pocketed MNC importers and pseudo manufacturers in a very adverse eco system that is encouraging imports-based trading instead of manufacturing so that even existing Indian manufacturers are shifting to imports as that is more convenient and more profitable than to produce in India. From being a manufacturing-led economy, India is becoming a trading and services- led economy in the past decade. Manufacturing was brought back into focus by the honourable Prime Minister with his slogan and vision of Make in India and starting point is to make illegal – pseudo manufacturers by clearly defining it as falsely and purportedly claiming to being an Indian manufacturers without actual manufacturing it in India – manufacturing site and country of origin needs to be clearly labeled to ensure transparency and tracking and the site where there is a value addition of over 40% and there’s a change of sub-heading of classification indicating transformation of an output from more than one input so at least it’s an assembly of components.

How Can Government Facilitate to Make India a Global Hub For Medical Equipment Manufacturers. Most of the policy decisions taken in the past have been based on White Papers published at the behest of MNCs who are ruling the roost in CII and FICCI – (importers with overseas manufacturing facilities) who are comfortable to access the large unregulated Indian market with minimal tariff barriers and while they make right sounding noises they have been opposing most of the five corrective strategic actions suggested by AiMeD that could strengthen Make in India or help make Indian manufacturers more competitive and thereby increase their market share, such as: Tariff Correction, with the plea that it affects affordability and accessibility to poor patients. Our contention is being to make manufacturing viable and profitable as before and reverse ongoing trend of manufacturers becoming importers / traders. Later domestic competition will bring down prices. Regulations, (Short Term Correction of Amending Rules , Schedule MIII, Guidelines, etc.) with the plea that it would lead to further confusion and affects accessibility and better to wait till a law is passed. Our contention being to use the available short term solutions of administrative circulars and of executive orders rather than delay till availability of lengthy legislative process. Mandatory MRP & Price Capping – With the plea that it will scare away investment. Our contention being that affordability and competition is getting skewed - not lower ex-factory price but higher retail price wins and consumers are suffering from artificial inflation and domestic manufacturers suffer from loss of market share unless they match ever increasing MRP and trade margin. ICMED – Self Certification and Self Regulation, with the plea that it creates a parallel mechanism with CDSCO so better to have only one control and are afraid it could be used as a non-tariff barrier in due course. Our contention being it provides credibility to Indian products and low cost access to local certification rather than getting expensive overseas certification for CE / ISO 13485 etc. and respect for Indian brand, a law to regulate all devices may not be there for a few years and a law can permit voluntary certification. Preferential Market Access – With the plea that it restricts access to quality products in the absence of regulations. Our contention is it will boost domestic manufacturing and also stop usage of USFDA compliance as a mandatory qualifying criteria in many tenders. Why should Indian manufacturers be denied access to our own Indian market unless they comply with a foreign country regulatory approval of CE / USFDA ? It’s unfair. Use ICMED! (Based On a Recent Interview Published in “eHealth”)

Jan.-Feb. 2017

Indian Medical Device Industry to Develop Into A Global Manufacturing Hub Kishore Narain Khanna, Managing Director, Romsons Group of Industries Indian medical device industry has come a long way from its humble beginnings to the current status where in gradually Indian manufacturer have extensively used their talent & experience into various manufacturing entitiesfrom disposable medical devices, implants, electro-surgical devices, endoscopes, patient aids to instruments & equipment, etc. Of late the Indian medical device industry is consolidating with the introduction of several steps initiated by the Indian government to broaden the medical device manufacturing base and to enhance exports from India. The latest encouraging support from the Indian regulator, has been bestowed through delinking of the medical devices from the pharmaceuticals, which has resulted in the elevation of confidence of the medical device industry. To dwell & explore on the subject of prominent growth opportunities& enablers available to the Indian medical device manufacturer; well these can be enumerated as below,

• • •

•

• •

• Continued support from the Indian medical device regulator for provision of globally harmonized regulatory framework. • Continued support from government to encourage ease of doing business under the Make in India initiative. Making the process of issue of Free Sale Certificate easier. Inclusion of more Medical Device entities into the notified item list. Surge in the medical device consumption & demand owing to high ageing population, increased healthcare awareness, increased lifestyle related disorders, increase in the health spent through medical insurance coverage, etc. Increase in the infrastructure by provision of skilled manpower, through medical devices cluster and similarly for development of medical device testing & biocompatibility evaluation. Initiation of dedicated Medical Device Park, like in AP that will spur domestic production of medical devices and help reduce import dependency and as well creating avenue for export & increase employment and generate wealth and enable flourish and ecosystem for high end medical device manufacturing. Introduction of innovative product entities through dedicated R & D grants and angel funding and incubation centres. Increase in the healthcare infrastructure in the form of corporate hospitals and in number of beds, leading to hospital capacity enhancement and additional increase in the capability enhancement of healthcare workforce, to sustain steady up surge in patient numbers and also increase in medical tourism.

Hence, I would like to conclude that it is my strong belief that Indian Medical Device Industry shall develop into a global manufacturing hub.

Jan.-Feb. 2017

Industry News Landmark Public-Private Partnership MoU Inked AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components • This landmark public-private partnership will help India become the top 5 global hub for medical device manufacturing - Rajiv Nath, Forum Coordinator, AiMeD • We are delighted to join hands with AiMeD to bring in investment to the medical devices sector in India and convert India into a global medical devices manufacturing hub - Deepak Bagla, Managing Director, Invest India New Delhi, 15th Feb, 2017 : In a landmark public-private collaboration aimed at making India a global manufacturing hub of medical devices, the Association of Indian Medical Device Industry (AiMeD) and Invest India today signed a MoU which will promote and facilitate ‘Ease of Doing Business, Promote Manufacturing and provide Hand Holding Services while aiming to transform India into a Global Medical Devices Manufacturing Hub in keeping with ‘Make in India’ mission. AiMeD is the leading voice of domestic medical device manufacturers while Invest India is the official investment promotion and facilitation agency of the Government of India, mandated to facilitate investments into India.The MoU was signed by Mr Rajiv Nath, Forum Coordinator, AiMeD on behalf of the industry body and Mr Deepak Bagla, Managing Director, Invest India.

This landmark public-private partnership will help India become the top 5 global hub for medical device manufacturing,” said an elated Mr Rajiv Nath, Forum Coordinator, AiMeD. “We know the roadblocks that need to be addressed for both Indian and Overseas Investors and will focus on getting collaborations and joint ventures with midsized Indian companies with midsized overseas manufacturers and OEM relationships with large overseas companies. This MoU will create basis for implementing a coordinated cooperation in achieving the manufacturing objectives as was recently done for Indian Cellular Industry. I have a vision of India being amongst Top 5 Manufacturing Hubs of Medical Devices and this MoU will help realize it by giving a big strategic push to manufacturing and innovation in Indian medical device industry while promoting Ease of Doing Business in India,” Mr Nath added. Mr Deepak Bagla, Managing Director, Invest India said “We look forward to work with AiMeD to bring in investment to the medical devices sector in India and convert India into a global Medical Devices Manufacturing Hub.” According to credible estimates, India imports over Rs 30,000 crores of medical devices, which is nearly 70% of our requirement. In addition, there is an equally huge export potential to the tune of Rs 50,000 Crore!

Significant Points and Objectives of the MoU : i. AiMeD to provide support to Invest India to enhance domain knowledge in medical devices and components sector and jointly aim to build capacity and capability in a d v a n c e d manufacturing technologies and negotiating skills for technology tie ups. ii. Invest India to support and supplement AiMeD’s efforts to achieve the broader vision to establish India the Global Manufacturing HUB for medical devices and components. iii. AiMeD and Invest India will jointly work with various Central Government and State G o v e r n m e n t Departments & Agencies to establish appropriate policies and regulatory framework to promote manufacturing of medical devices and components on a day to day basis. iv. AiMeD and Invest India will reach out to all Tier 1, Tier 2 and Tier 3 companies in major medical devices destinations like Taiwan, Japan, South Korea, Italy, Israel, Germany, USA etc with the objective of technology sourcing and manufacturing JVs for India. v. AiMeD and Invest India will jointly host international road shows including conferences, seminars, exhibitions to promote manufacturing in India and to apprise potential investors of the policies, investment and manufacturing opportunities available in India related to medical device and component sector.

Medical device sector is being seen as the next big thing after IT and Defence and India has the potential to emerge as a major exporter on the lines of pharma products. Government of India has now added medical devices as one of the flagship sector to catapult its ambitious ‘Make in India’ mission. The MoU between AiMeD and Invest India is in tune with realizing these national

“We are honoured and delighted to join forces with Invest India to work as their knowledge partners on practical strategies to realize Make in India.

For more information please contact : Rituparna Madhukalya, Mob: 08826639144, Email: rituparna@fourthestateindia.com

Jan.-Feb. 2017

objectives. About AiMeD: AIMED is an u m b r e l l a association of I n d i a n manufacturers of medical devices covering all types of medical devices including consumables, disposables, equipments, Implants, instruments and diagnostics. AIMED has a primary membership of over 350 manufacturers and additionally of over 150 associate members representing the interest of over 800 manufacturers of medical devices to address the manufacturer’s problems. To know more about AIMED, please visit www.aimedindia.com About Invest India: Invest India is the official Investment Promotion and Facilitation Agency of the Government of India, mandated to facilitate investments into India. Invest India has a team of domain and functional experts who provide sector-and state-specific inputs, and hand-holding support to investors through the entire investment cycle, from pre-investment decision-making to after-care.

Quality Advanced Process Validation For Medical Device Manufacturers Background : Due to the complexity of many medical devices, routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of the device or its components. With a focus on in-depth process validation methods and statistical rigor, this four-day advanced session will explain the intent and importance of process validation with respect to the regulations and standards, emphasizing the connectivity between design controls, risk management and statistical techniques. The training will also provide participants the fundamental knowledge and tools to establish and implement effective process validation lifecycle systems. Hands-on, interactive exercises will highlight and reinforce the principles learned. Objectives : • Understand the intent and purpose of regulations as it applies to process validation and production controls • Know how design controls and risk management feed into process validation • Learn the fundamentals of Test Method Validation and Measurement Systems Analysis • Learn to identify which processes to verify and which process to validate • Be able to develop a Master Validation Plan • Learn to calculate basic quality metrics and determine sample sizes • Learn to use statistical methods like design of experiments (DOE) to determine critical process and raw material parameters • Learn the principles of Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) using protocols and reports • Understand the basics of risk management and developing a Process Failure Mode and Effects Analysis (PFMEA) • Identify key outputs from process validation • Learn to formulate methods for process monitoring and control • Understand the concepts of statistical process control (SPC) and statistical quality control (SQC) • Understand how to maintain the validated state and the criteria for revalidation

Test Method Validation Background : Test methods are one of the most critical elements in the design, development, manufacture and release of products. They provide the objective evidence for the safety and effectiveness of devices. It is thus imperative that device manufacturers ensure their test methods used in the determination of safety and effectiveness for their product are suitable, capable and reliable for their intended use. Inadequate test method validation can have severe regulatory and business consequences. In the past few years, regulatory bodies have added additional focus on test method suitability and reliability in their audits and inspections. This two-day session will explain the intent and importance of test method validation with respect to the regulations and standards. The training will also provide participants the fundamental knowledge and tools to establish and implement effective test method validation procedures and processes. Hands-on, interactive exercises will be used to highlight the principles learned. Objectives : • Understand the intent and purpose of regulations as it applies to test methods across the product lifecycle • Learn the basic principles of Test Method Validation to determine suitability and capability of the test method for its intended use • Understand the requirements for the qualification of test equipment • Understand requirements for calibration • Understand how to conduct a gauge repeatability and reproducibility (Gauge R&R) for variable data and attribute data • Learn the principles of method transfer • Lear how to develop and complete test method protocols and reports • Understand the validation life-cycle and changes to test methods The Links For the Above Two Training Programs : • Advanced Process Validation Training, May 16-19, 2017, Chicago IL http://winovia.com/advanced-process-validation/ • Test Method Validation Training, July 18-19, 2017, Chicago, IL http://winovia.com/test-method-validation/

Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles Dr. S. Eswara Reddy (Joint Drugs Controller General (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. *********************************************************************** Dr. Jitendar Kumar Sharma Director & CEO Andhra Pradesh MedTech Zone, Andhra Pradesh Known in media circles as the “Med Tech Man” Dr. Jitendar Sharma is the Director & CEO of Andhra Pradesh MedTech Zone which is Asia’s first medical devices manufacturing city. He is the Adviser for Health to the Hon’ble Chief Minister, Govt. of Andhra Pradesh and a Fellow at Joanna Briggs Institute of Evidence Based Medicine at University of Adelaide, Australia besides the program Director for Health Technology Assessment (HTA) fellowships in India. Earlier he established the Healthcare Technology Division and was the Founder Director of WHO Collaborating Centre for Medical Devices at NHSRC under Ministry of Health & Family Welfare, Government of India. His past experience includes that at Sri Sathya Sai Medical Institutions- one of India’s largest non-for profit healthcare organizations, as consultant to World Bank, as Consultant to the World Health Organization, Geneva and advisor to Health Technology Innovation Centre at Indian Institute of Technology (IIT). He has contributed through several research papers, seven books on health technologies & assessments, six compendiums on technical specifications for medical technologies and a number of WHO reports on health technologies. He has been a key designer and coordinator for several technology intensive health programs in India such as the national biomedical equipment maintenance program, the national diagnostics program and national dialysis program besides creating the National Materiovigilance Program for adverse event tracking due to medical devices, program for setting up of medical devices testing laboratories and the program for medical technology innovations uptake in public health system. He teaches courses on health policy & health technology in several countries, including India. *********************************************************************** Dr. 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.

Jan.-Feb. 2017

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. *********************************************************************** Shri Rajiv Nath (Jt. Managing Director, Hindustan Syringes & Medical Devices Ltd., Faridabad 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) • 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. *********************************************************************** Shri Kishore Khanna Managing Director Romsons Group of Industries, Agra Qualifications: B.Sc., LL.B., MBA (OMP) Current Professional Activities: Managing Director, Overlooking the complete management of the Romsons Group of Industries. Experience & work responsibilities: Rich experience of 50 years in the medical device industry and more than 25 years in serving the community. Mr. Kishore Narain Khanna is a distinguished entrepreneur with an undying spirit to excel in his chosen field of disposable medical devices. Mr Khanna

is responsible for the brand “ROMSONS”. His indomitable stance for research and development has led to the nurturing of the brand “Romsons”, which is today an eminent player in the healthcare sector, serving millions of patients in the country &worldwide. His contribution to the medical fraternity has been recently recognised at ASICON for undertaking the Mission “Make in India”. He has also been honoured by the Government of Uttar Pradesh with the “Udyog Ratan Award” for Quality Management Practices in Business. He had also been bestowed with Presidential Award for Innovative Achievement in Medical Devices. In the early 70s, at the age of 20 he was the youngest member to join the family business of disposable medical devices and started his career manually operating moulding & extruder machines, working on assembly& packing lines. At the age of 30, he took over the business and brought all kinds of technical advancements, process upgradation and mustered all the mechanisms to arrive at state-of-the-art manufacturing. Today Romsons has to its credit 10 design patents with the backing of the dedicated stateof-the-art R & D unit approved by the Department of Science & Technology. He has travelled across the globe in search of business and learned the dynamics of international business. As a result today Romsons is one of the pre-eminent brands in the disposable medical devices field. Romsons is a name to reckon with medical disposable devices in over 90 countries, where the company exports. Mr. Khanna is also an important stakeholder in the Indian Medical Device Industry. He is the co-founder and co-ordinator of AIMED, which is the most influential association in the Indian Medical Device Industry. Mr. Khanna is also an active member and integral part of the management committee of National Chamber of Commerce and Industry, Agra. Mr. Khanna possesses a strong commitment towards social responsibility and runs a Romsons Charitable Society which is focused on serving the needy. He is also the Vice President of Agra Charitable Eye Centre. *********************************************************************** Dr. G.S. Bhuvaneshwar Consultant, Medical Devices – Design, development, testing and quality mgmt., Adjunct Prof., Dept. of Engineering Design, IIT, Madras He graduated with a B.Tech (Electronics) in 1972 and M.S. (Bioengineering) from IIT Madras. He later obtained a PhD in Biomedical Technology from SCTIMST in 1994. He has been honored with several awards, notably the Distinguished Alumnus Award of IIT Madras in 1999, Materials Society of India Medal lecture and NRDC awards for meritorious inventions. In May 2016 he was elected “Fellow, Biomaterials Science & Engineering (FBSE)” by the International Union of Societies of BSE at the World Biomaterials Congress held in Montreal, Canada. From Sep 2012 to Dec 2015, he was Director of Innovation at Trivitron Healthcare Pvt, LTd., Chennai – a leading company of Indian origin with a major focus in In vitro Diagnostics. Previously, he retired as Head of the Biomedical Technology Wing of Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Trivandrum in 2012 after a long distinguished career spanning 36 years. His long career has covered the very important aspect of medical device testing / validation with active

Invited Speakers & Panel Experts : Profiles involvement in the development of test systems for heart valves, blood oxygenators, vascular grafts, hydrocephalus shunt systems, with many of them having computer based data acquisition and control. In 2008, he lead a small team in the institute, which drafted a Bill for the Medical devices regulation at the behest of the Government of India. During his 4 decade long career, he has worked closely with clinicians and surgeons and been closely involved in clinical trials, animal studies and clinical ethics. He has to his credit 9 patents, 5 book chapters and 33 research publications. *********************************************************************** Ms. Sashi Rekha Director, National Accreditation Board for Certification Bodies (NABCB), New Delhi Ms. Sashi Rekha has a graduation in Food Technology from the University of Agricultural Sciences, Hebbal, Bangalore and a post-graduation in Food Technology from CFTRI, Mysore. She has worked with Cadburys India Ltd. for two years looking after production and quality control of ice cream in franchisee ice cream factories. She then joined the Bureau of Indian Standards (National Standards Body) and has worked with them at Hyderabad, Bangalore, Chennai and Delhi in Product Certification, Management Systems Certification, Laboratory as well as Standards formulation activities for over 21 years. She joined National Accreditation Board for Certification Bodies as Director (Operations) on 01 April, 2015 and has been handling Inspection bodies and Certification bodies Accreditation programmes. *********************************************************************** Mr. Ravi Shrivastava (CEO, Omni Lens Pvt. Ltd., Ahmedabad) Mr. 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. 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. V. K. Sharma, DIRECTOR (GLOBAL TRADE) Sharma Pharmaceutical Pvt. Ltd., Vadodara. Mr. Vivekanand Sharma is a Director of Sharma Pharmaceutical Pvt. Ltd. He got an Engineering (Mechanical) degree from Parul University, Vadodara. Mr. V. K. Sharma has started his career in 2006 as a Design Engineer and through his vision and keen interest in product design; he was also much interested in Production as well as Strategic Planning. Within 2 years of time, he has started to build a business relation

in International Market. Due to his extensive knowledge and experience in Restructuring Operations, International Marketing, International Business Relations, Collaborations and Joint Ventures, he has been appointed as Director (Global Trade) in 2011. He traveled across the globe in search of business and learned dynamics of international business. His visionary approach to serving his clients has enabled him to anticipate and meet the changing imperatives of the marketplace. He has played a very 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 has prepared “SHARMA ORTHOPEDIC” for continual growth by developing its distinctive business model, client relationships and depth of staffing expertise. *********************************************************************** Dr. G D Agrawal Chairman & Managing Director G. Surgiwear Limited, Shahjahanpur Dr. Agrawal is a science graduate and has done MBBS and Masters in general surgery from King George Medical College, Lucknow. His Interest and Specialization lies in Creating New Medical Devices. His Developments & creations include Hydrocephalous Shunt System; Penile Prosthesis, Peritoneo-venous shunt, Combined disposable drape, Hydroxyapatite bone substitute; First aid products for Army: Rakshika, Universal emergency splint and many more; Glaucoma Shunt and Glaucoma device; Cranial Flap closing systems of many types; Buzywoman one boil food products & Many Many more He has published research articals in international journals. He has received 20 National awards and has to his credit 3 International Patents and has applied for 50-60 Patents. *********************************************************************** Dr. Kiran Kalia Director - National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad Dr. Kiran Kalia is presently serving as the Director of National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad at Gandhinagar. She graduated in Biochemistry and received her PhD degree in 1984 from Industrial Toxicology Research Centre (ITRC), Lucknow. She was an awardee of prestigious DBT overseas research associateship and was the visiting Professor at School of Health Sciences, Purdue University, USA in 2006-07.Her current areas of interest/ expertise include several aspects of diabetic nephropathy, metal toxicity and presently interested in proteomic and genomic biomarkers. She is the task force member of many national level committees of decision making under Govt. of India. She is also one of the core members of policy making in Department of Pharmaceutics, Govt. of India. She is a INSA visiting fellow and the Fellow of Gujarat Science Academy. She is reviewer of various National and International Journals and recipient of numerous Awards and scholarships including 8th “International Prestigious Sardar Patel Award” for Excellence in Women Empowerment. She was awarded with the “President Guide award” by His Excellence The President of India

Shri V.V. Giri. She is member of many professional societies 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. She has delivered 75 presentations and guest lectures at various national and international platforms that includes plenary / lead lectures. She has 3 chapters in book published by international publishers. She is actively involved in teaching masters, doctoral students and specializes in exploring biochemical aspect of diabetes. She has 35 years of research and 31 years of teaching experience with 71 publications in various national and international peer-reviewed journals. She has guided 22 Ph.Ds, over 50 M.Sc. dissertation students.Currently,7 students are working under her for their doctoral degree. She has received several extramural research grants from different funding agencies and has completed 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. *********************************************************************** Dr. A.S. Rao President-Indian Innovators Association, Hyderabad Dr. Aynampudi Subbarao (Dr. A.S.Rao) is an innovation consultant with a rich perspective gained from working in industry, government and academia. He was in industry during license raj period marketing products which are imitations, made with foreign collaboration and with CSIR technology. Worked for two decades in DSIR, Government of India, went thru the technology absorption phase with TAAS, new product development with PATSER and creativity with TePP. As a part time academic, regularly contributed articles and authored books -Management of Technology Change published in 1994 was the first book on MOT in India. Full time mentor to innovators, his current passion is connecting innovators to the market. Formally associated with IIT Hyderabad and devotes maximum time to the NGO – Indian Innovators Association. Organised India’s first International Innovation Fair in 2016 in Bangalore and now working on 2017 fair coming up at Visakhapatnam. *********************************************************************** Mr. Anand Srinivasan Head of Polycarbonates ISC (Indian sub-continent) Covestro (India) Private Limited, Mumbai Mr. Anand Srinivasan is the Head of Polycarbonates ISC (Indian sub-continent). A Chemical engineer by training, he 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.

Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles He has actively lead initiatives at the Texas Chemical Council and now participates at the Indian Chemical Council. He recently took over the position of heading the Polycarbonates business for the Indian sub-continent. Apart from being technically skilled, he is a musician, artist, and a fitness fan. *********************************************************************** Dr. Prashant Jha Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, New Delhi Dr. Prashant Jha is a physician, engineer, entrepreneur and a medical editor. He teaches at AIIMS & IIT Delhi where he directs a post-graduate Fellowship program in medical device innovations and entrepreneurship. He also serves as an adjunct professor of Healthcare Innovations at various medical, engineering and business universities in Japan, Australia and Europe. Dr. Jha has invented over a dozen medical devices in domains of gastroenterology, women’s health, ENT, paediatrics and Intensive care medicine. He is a serial entrepreneur and has set up enterprises in healthcare, education and internet technologies over last 15 years. He is the founder & editor of BMJ Innovations, world’s first general medical innovations journal and also serves as the Senior Editor for The BMJ in South Asia. *********************************************************************** Mr. Dhiren Mehta Managing Director Surgimedik Healthcare India Pvt. Ltd., Mumbai He has completed his Graduation in Chemical Engineering from UDCT, Mumbai and has done Marketing Management & Management Studies from JBIMS, Mumbai. He has extensive professional experience in developing products and business in the areas of Medical Devices. He is Managing Director of Surgimedik Healthcare India Pvt Ltd, Mumbai. He has Professional Experience as Managing Director, CEO, President & Product Manager in various national and international companies like Medi Surg GmbH, Germany; Allwin Medical Devices, USA; DVM International, India; Bard, USA. *********************************************************************** Mr. Manoj Bhardwaj Managing Director SMC Medical Manufacturing Pvt. Ltd., Bangalore Mr. 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. He is a polymer engineer with over three decades experience in Manufacturing, Consulting and IT sectors. He 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, his background includes

Jan.-Feb. 2017

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. Sarabjot Singh Director - Sterimed Surgical India Pvt. Ltd., New Delhi Mr. Singh is an entrepreneur and Founding Member of Sterimed Group of Industries. He has done Diploma in Polymer Technology from Indian Plastic Institute (IPI). He has over 30 years of experience in the field of manufacturing of Disposable Medical Products and 17 years of experience in the field of manufacturing of Industrial and Medical Adhesive Tapes. Mr. Sarabjot Singh is also experienced in the field of manufacturing of Hotmelt Adhesives and manufacturing of Nonwoven bags. *********************************************************************** Ms. Elena Draganoiu Global Technology Manager Lubrizol LifeSciences, Mumbai Ms. Elena Draganoiu, Ph.D. is global technology manager in Lubrizol LifeSciences, where she is responsible for leading technical programs in the area of pharmaceutical ingredients. She holds a Ph.D. in Pharmaceutics from the University of Cincinnati and has extensive experience in pharmaceutical formulation. Her work at Lubrizol has been focused on acrylic acid and thermoplastic polyurethane technology platforms for pharmaceutical and medical solutions. *********************************************************************** Mr. Sanjay Chotalia Manager – Technical Sales & Marketing And Medical Segment Expert - Covestro (India) Private Limited, Mumbai Mr. Sanjay Chotalia is working with Covestro for more than 4 years as Manager – Technical Sales & Marketing for west India region for Polycarbonate resin & Medical segment expert. He has completed MBA in Marketing, Bachelors in Polymer Engineering from Pune university and Diploma in Plastics Engineering from Mumbai university. He has 9 years of experience in Technical Sales and Application Developments of Engineering Plastics like Polycarbonate, Nylon6, PBT, Polyacetal. He also has rich experience in Handling Electrical & Electronics, Medical, Consumer and Industrial segments with very good exposure to west India region and customer base. *********************************************************************** Mr. Partha Mohapatra Lead- Healthcare, (India) & Technical Support INEOS Styrolution India Limited, New Delhi Mr. Partha Mohapatra is working as Lead Healthcare (India) & Technical Support with INEOS Styrolution India Limited. In his present role, he is actively involved in Application & Product Development along with Technical support, with key focus on new business opportunities for styrene in medical device industry. Mr. Mohapatra is Post graduate in Plastic technology from CIPET, Hyderabad and has an M.B.A (Marketing) from I.G.N.O.U ( Delhi ) with 19 years’ experience in plastics processing & raw material industry . He has expertise in processing of engineering plastic & is

actively engaged in business development/ marketing of styrene’s products for healthcare industry. He is involved in new projects developments with pharmaceutical packaging & medical disposable device industry. He provides technical/development support to customer from initial stage to project commercialization stage. He possesses diverse technical sales marketing experience in the field of medical grade styrenic polymers. *********************************************************************** Mr. Umang Shah National Sales Manager Clariant Chemicals (India) Ltd., Mumbai Mr. Umang Shah is working with CLARIANT Chemicals India Ltd. CLARIANT is one of the world’s leading Specialty chemical companies. He is a National Sales Manager – Masterbatches & Compounds for Medical & Pharma Segment since Dec, 2015 and based at head quarter in Navi Mumbai. Earlier, he has worked with SABIC Innovative Plastics & GE Plastics India for more than 22 years. He has rich & multi-functional experience and handled various key responsibilities as a Key Accounts Manager – Sales & Marketing, Application Development Specialist, Technical Services Manager at Mumbai. Engineering Plastics Compounding at Vadodara Plant, Application Development Centre at Gurgaon and GE’s Global R&D center at Bangalore. *********************************************************************** 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. *********************************************************************** Dr. Atul Sardana Director - Alfa Corpuscles Pvt. Ltd., New Delhi Dr. Atul Sardana (MBBS, MS, FIAGES) 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 has over 30 national and international clinical publication and presentations and is a honorary member of the World Association of laparoscopic Surgeons, and a member of the Indian Association of Gastrointestinal and Endoscopic Surgeons and the BIS Technical Committee on Surgical Instruments. 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

Invited Speakers & Panel Experts : Profiles 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 as the Head for R & D and Product Development. Alfa Corpuscles has been supported by the Technology Development Board, DBT, ICMR and GSBTM. 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. He also has the distinction of being honoured twice by display of his innovative technologies during the exhibition on “Innovations in Medical Science and Biotechnology at the Rashtrarapati Bhawan. *********************************************************************** Mr. Naimuddin R. Saiyed Sr. Drug Inspector, FDCA, Gujarat Mr. Naimuddin R. Saiyed is Sr.Drugs Inspector, FDCA, Gujarat. He has done B. PHARM – LMCP, LL.B from Guj Uni., and Diploma in Management from IGNOU. He has 8 years of mfg. experience (tablet,svp) and very good regulatory experience. He has worked for 8 years as Drugs Inspector in Sales Segment Regulation. As Sr.Drugs Inspector, since last 6 years, he has been looking after regulating Blood Bank, Blood Storage and mfg. of Medical Devices. He has attended various workshops on Medical Device Regulations at PERD, Ahmedabad; at Gandhinagar Head Office and GFSU by CDSCO. *********************************************************************** Mr. Sanjay Shah Managing Director-Unikal Consultants, Ahmedabad

validations, process validation for sterilization and stability studies and Plant design to comply with international requirements. He has worked on various stages of regulatory submissions including biocompatibility, pre-clinical & clinical studies. He has been a Consultant for UNIDO cluster program for QMS & CE marking of Medical Devices and Bio Pruner Mentor with EDI & MSME Cluster. He has widely travelled in USA, Canada, Europe, China, UAE for consultations / Audits / executing projects; attending conferences and technical presentations. He has been a Speaker at various WHO-GMP WORKSHOPS - NEW DELHI/HYDERABAD and also served as member of first Core group of DCGI (Indian FDA) for Medical Device Regulations revision. *********************************************************************** Ms. Swarna Sundar Senior Consultant - Healthcare Frost & Sullivan, Mumbai She graduated from University of Madras, Chennai and has done Masters in Applied Science from Dalhousie University, Canada. She has Functional Expertise of 11+ years of market research & analysis and applying customized research and analytical solutions in diverse healthcare domains on a global scale. She has Particular expertise in Competitive intelligence, Acquisition due diligence, and Value proposition; Market assessment, modeling and trend forecasting; New product development and launch strategies; Develop market entry and expansion strategies. She has experience in broad range of sectors, including Advanced Medical Technologies; surgical and patient monitor technologies; Emerging Medical Technologies / Next-generation Healthcare; In-vitro Diagnostics; Consumer healthcare and general healthcare system trends market. She has worked with prominent companies in medical devices and technologies market, like GE Healthcare, Phillips Healthcare, Siemens Medical, Medtronic, Johnson & Johnson, among others.

Mr. Sanjay Shah is founder promoter of Unikal Consultants.

She has Published her work (s) on Diagnosis of Carpal Tunnel Syndrome in peer-reviewed journals and presented at international conferences.

He is an experienced Quality Management System Consultant, knowledgeable in ISO 9001 & ISO 3485 system. He has experience in training related to QMS; c-GMP & WHO GMP.

*********************************************************************** Mr. Ravi Shankar Srivastava Chairman & MD Invent Bio-Med Pvt. Ltd., Mumbai

He has done MS by research from University Department of Chemical Technology, Bombay University and BS (Chemistry & Physics) from Bombay University.

Mr. Ravi Shankar Srivastava is Chairman & MD of Invent Bio-Med Pvt. Ltd., Mumbai.

He has presented papers and talks on various aspects of Coronary Stents including Drug Eluting Stents and on Regulatory Aspects of Medical Devices. He has experience in Quality System Audits & Consultancy for CE Certification for all Class of Sterile/ Non-sterile Medical Devices. He also has experience in US FDA 510 k CDRH regulatory submissions for Medical Devices & PMA. He has more than 10 years experience in projects related to international technology transfers and setting up new plants for medical devices like Coronary stents, Drug Eluting stents, Ophthalmic Implants (IOL), Orthopaedic implants, IUDs etc. He has designed & executed DQ, IQ, OQ, PQ

Company manufacture of Cardiovascular Device specially diagnostic Angiography and Angioplasty material including coronary stent, Drug coated stent and Working on New Innovation of vascular devices like Retrieval device, Perfusion catheter, Distal protection device, Thrombolytic catheter, Bioabsorbable stent etc. They have Indian FDA approvals and will also receive CE certificate very shortly. They have dedicated infrastructure and research development facility and and trained staff. *********************************************************************** Mr. Vipul Sheth (Managing Director, Matrix Meditec Pvt. Ltd., Ahmedabad) Mr. 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. *********************************************************************** Dr. Subroto Mukherjee Associate Dean - Facilitation Centre for Industrial Plasma Technologies, Gandhinagar. Dr S Mukherjee is Head – FCIPT Division, and Associate Dean – Academics of Institute for Plasma Research. He has 115 peer reviewed journal papers, 13 patents, guided 13 PhD scholars, and has contributed towards transferring FCIPT’s knowhow in industrial plasma applications for benefit of society. He is the 1st recipient of “BUTI Foundation Award” for outstanding contribution in plasma sciences and is a fellow of the Alexander von Humboldt foundation. He received the VASVIK-2016 award in the field of “Materials and Metallurgical Science and Technology” and was elected Fellow of Gujarat Science Academy in 2016. His areas of research are industrial plasma applications, plasma applications in biology and developing plasma technologies for societal benefit.

Mr. Srivastava is B.sc (Hons) Diploma in Business development, certificate on Biotechnology from SIS Institute, Government of India. He has also done MBA (Marketing) and completed OMP4 one year post graduate management program from SPJIM, Mumbai.

*********************************************************************** Mr. Prakash Bachani Scientist E & Head (MHD) Bureau of India Standard, New Delhi

He has worked in multinational pharmaceutical company at senior level. He has also worked in Pfizer (Schneider) medical device company of Switzerland, & took training in Australia, Singapore, Paris, Toulouse.

Mr Prakash Bachani is MIE (Electrical Engg.) GOLD MEDALIST, Institution of Engineers, India. He is presently posted as Scientist E & Head (MUBO-1), Mumbai in Bureau of Indian Standards, for Certification Marks Deptt. In Mumbai at national level.

He has participated & attended many international cardiology and interventional therapeutics programs and trainings. He has also attended national workshop on medical device regulations. He started trading company initially at Mumbai. Then he expanded to manufacturing, under the name of Invent Bio-Med Pvt. Ltd., at Surat. An ISO 9001 – 2008

He has 32 years experience in Bureau of Indian Standards. At the Technical level, he has overseen the following activities:1. Product Certification, 2. System Certification (QMS), 3. Hallmarking of Gold and Silver, 4. Standards Formulation (Electrotechnical), 5. Laboratory Management.

Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles In conformity assessment of the products in electrotechnical area, includes cables; conductors; energy meters; electrical accessories like switch, plugs and sockets, MCBs; electrical appliances like geysers, fans, motors, pumps, ballasts; GLS Sodium and compact fluorescent lamps; luminaries etc. He has participated and presented several papers relating to Standardization, Certification in the field of Electrical Engg. at various seminars organized in the country. He has also participated in the meetings of IEC for Rotating Machinery in China, Power Capacitors in Russia and Transformers in Japan. *********************************************************************** Dr. Chirag Patel Assistant Professor, Microbiology Shree Krishna Hospital, Karamsad He is practising since 10 years as Infection preventionist, Clinical Microbiologist, academician and guide for MBBS and MD students in medical college. He has published 6 international and national level research papers and has 7 international and national level papers under acceptance. He has completed 9 Research projects and is currently working on 8 other projects. His Primary areas of interest are: Indwelling medical device associated infections, Multi-drug resistant organism in healthcare associated infections, Microbial diversity in Blood stream infection and Respiratory tract infections. *********************************************************************** Mr. Hiten Bheda Managing Director Vinit Performance Polymers Pvt Ltd., Mumbai Mr. Hiten Bheda , a Chemical Engineer by training has been associated with plastics since the beginning of his career. He pursued a BS degree in Chemical Engineering from the University of Tennessee, Department of Chemical and Polymer Engineering, Knoxville, USA where his interest in Polymer processing was nurtured. He did his Masters in Chemical engineering from the University of Connecticut. During those years he was fortunate to learn about polymer processing and train under some of the renowned professors of Rheology. He was associated in conversion of Engineering Plastics and have worked on Casting of Polyamides, Polyurethanes as well as extrusion of EP and High Performance Polymers. He has closely worked with many OEM’s and Govt institutions for successful application of these products involving extensive design and testing of materials for qualification. Currently he is Managing Director of Vinit Performance Polymers Pvt Ltd., engaged in conversion and CNC machining of engineering plastics and high performance plastics under POLYMAT brand. The company pioneered extrusion of high temp materials like PEEK in India. He has served the trade in the capacity of Hon Secretary AIPMA, Hon editor of Plastic News, and currently is Vice President West Zone AIPMA. He has represented AIPMA for Govt advocacy on fiscal matters like budget and GST. Active member of SPE, he is keen to further cause of plastic processing through knowledge enhancement. He is member of Tau Beta Pi, a honorary engineering fraternity based in the USA.

Jan.-Feb. 2017

He spends his free time to support social causes through family trust providing medical help and vocational training in suburb of Mumbai, is associated with education trust BNKCT as Managing Trustee. *********************************************************************** Mr. Siddharth Jain CEO and Chief Regulatory Advisor Symbiorph Clinical Trialogy, Ahmedabad Mr. 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. *********************************************************************** 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), 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. 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. 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. *********************************************************************** Dr. J. S. I. Rajkumar, PhD Director/Scientist toxicology Glr Laboratories Pvt. Ltd., Chennai Dr. J. S. I. Rajkumar, PhD., Doctorate in Zoology from Madras University, working as Study Director/Scientist toxicology at GLR Laboratories Private limited, Chennai. Have published more than 55 scientific papers both in peer reviewed national and international journals. Presented and published more than 45 scientific articles in international conferences and proceedings. Written 3 books and 5 book chapters. Hold prestigious memberships in world renowned societies, ACS,

SEATC, BNHS, etc. Serving as Editor, Editorial board member and reviewer for many peer reviewed international journals. Attended more than 20 workshops, International and national conferences training programmes. Actively involved as committee member for international conferences worldwide.Apart from this specialization, Worked as Research fellow in Integrated Coastal Marine Area Management, Chennai for marine toxicology project for creating critical limits for heavy metal pollution and also worked as Research Associate for climate change project. *********************************************************************** Dr. B. Rajan Director/Toxicology Scientist GLR Laboratories Pvt. Ltd, Chennai Dr. B. Rajan,Study Director/Toxicology Scientist, GLR Laboratories Pvt. Ltd., has a PhD in Biochemistry, from University of Madras, India. He has been working in the field of nanoscience, nanotoxicity and nanotherapeutics for over 6 years. He was a recipient of various prestigious fellowships from government of India like fellowship in sciences for meritorious students Basic Scientific Research (BSR) scheme of the University Grant Commission (UGC), New Delhi and Senior research fellowship (SRF) of Indian Council of Medical Research (ICMR), New Delhi. He has quite a few peer-reviewed literatures in reputed international journals and he has also presented his research work in various international conferences. Currently he is involved in the biocompatibility testing of medical devices. *********************************************************************** Mr. Narasinh K. Balgi Director - Ferromatik Milacron India Limited, Ahmedabad Mr. 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 46 years and has wide-spread experience in Quality Assurance, Manufacturing Systems, Technology Management and has exposure to Sales & Marketing, Finance, Human Resource Development & Organizational Development. He has worked with : 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 it’s 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] since 2009. - Member of Society of Plastics Engineers. - Member of Governing Council of Indo- German Tool -rooms. - Member of Regional Advisory Committee of C.I.P.E.T. - Imm. Past Chairman of Governing Council, Indian Plastics Institute - Convener and Founding Director of Plastics Machinery Manufacturers Assn. *********************************************************************** Mr. Ketan Panchal Production Manager Indo German Tool Room, Ahmedabad

Invited Speakers & Panel Experts : Profiles Mr. Ketan Panchal has done Diploma in plastic engineering and B.tech in mechanical engineering. He is presently working as Head of Production at Indo German Tool Room - Ahmedabad

College, Ahmedabad. He completed his master’s degree in the year 2000 from L D College of Engineering and PhD in the field of water resources management from IIT Delhi in July 2008.

He has 26 years of experience in the field of tool and die making. He has previously worked with Milton Plastics- Halol; Elemex Industries – Baroda; Karnavati Plastomach – Ahmedabad and now with Indo German Tool Room since 1993.

During his research work he published 05 research papers in peer reviewed journals (ASCE (Irrigation and drainage), ICE (Proceedings of Water resources management) and Journal of Hydrology (Elsevier)), 20 papers in proceedings of international conference which includes paper presentation at EWRI conference at Bangkok & International Conference on Information Technology in Construction” INCITE at Tsinghua University, Beijing and 13 paper in proceedings of national conference. Also, he had been to National University of Singapore on 4th January,2011 to present research paper under IPWE-2011. He is also a life member of various international organizations such a s international association of hydrologists (IAH), international association of engineers (IAE), Institute of Engineers (IE), Indian Association of Hydrologists, ICE (UK) and Indian Association of Hydrologists. He has supervised more than 30 thesis at masters level and two research scholar have completed PhD and also currently supervising three more PhD students in the area of water resources management. He is Board member of Gujarat Meritime Board Trust. He is also academic council member of Indus university and Ganpat university.

*********************************************************************** Mr. Saumil Mistry Engineer – Sales Project Engineering Ferromatik Milacron India Pvt. Ltd. Mr. Saumil Mistry has done B.E. - Mechanical Engineering from Indus Institute of Technology & Engineering, Gujarat. He is associated with Ferromatik Milacron India Pvt. Ltd. since 2013. Currently he is working in Sales Project Engineering Group as an Engineer. He has worked in Manufacturing at various areas of Assembly, Testing & Planning. He is active member of Development & Technology Transfer Team of FMI. He is having experience of handling complete project requirement. *********************************************************************** Mr. Parthiv Desai Director, SITECH, Vadodara Mr. Parthiv Desai is Industrial Designer and Plastics Technologist and an Innovator (Patents holder). He is Promoter - Director of SITECH. He has done Diploma & Post Diploma in Plastics Mold design from CIPET and Diploma in Finance Management, AMA. He is a member of VCCI, IPI, TAGMA, AIPMA. SITECH started in late 1996 by a team of multidisciplinary experts with a common vision of making design viable to industries. Our passion for design and innovation has always helped us in reaching to a next level. SITECH provides services like Industrial design, Conceptual product development, Design validation, Design for manufacturability and reverse engineering. Health-care is always been a fascinating domain for use to work on. We have been successfully associated with well-known Medical and Pharmaceutical companies and have an experience of working on Drug Delivery products, Diagnostic products, healthcare, Implants, Surgery and many more. SITECH’s expertise help our clients to regulate standards by selecting correct materials and processes. We believe in an error free design process which starts with conceptualization and ends with prototyping and validation. Our well documented design process helps developing unique products without infringing on competitor’s IP. SITECH represents our continuous efforts of making life better by design. Through creativity, hard work and dedication, SITECH strives to be a backbone of creative economy. *********************************************************************** Dr. G. P. Vadodaria, PhD. (IITD) Principal - L.D. College of Engineering, Ahmedabad Dr. G. P. Vadodaria completed his bachelors’ degree in the field of Civil engineering from M.S. University of Baroda in the year 1991. Thereafter he joined C U Shah Polytechnic College, Surendranagar as a lecturecturer in civil engineering in march ‘95. He topped GPSC examination and posted as a lecturer at L D Engineering

Above all, in spite of being academician, played an important role in establishing a new concept in university examination system i.e. electronic delivery of question paper. After serving for more than six years in Gujarat Technological University, he is serving as the Principal of L.D. Engineering College, Ahmedabad and member secretary of ACPC catering admissions of Gujarat State since Nov 2014. *********************************************************************** Mr. Deepak Dave Former President, Medical Surgical And Healthcare Industries Trade Asso. & Ashutosh Export International, Mumbai. Dr. Deepak Dave is CEO of Ashutosh Export International, Mumbai, presently carrying on the business in the Medical Devices and Surgical Equipments including Disposable Products. He has done his graduation from Mumbai University with specializing in the field of Economics & Marketing. Post graduation in MBA. He has been in this field of Medical Devices and Surgical instruments and Equipments for past 24 Yrs. He started the career working with an MNC in Mumbai as Asst. Purchase Officer and relinquished the job after 9 Yrs of very rich experience in the field of Local Purchases & Imports. He entered into the field of Medical Disposable business in the year 1987. It has been his privilege to be associated with the first in bringing new products and concepts for the INDIAN market and consumers which much necessary for the growth of Indian market in terms of availability and prices. Having the exposure for more than 15 years of international market in the medical and surgical products and devices including the Healthcare sector, he further developed into selling some of the patient friendly products for specialized products at affordable prices in INDIAN market. To keep with the newer products introduced after innovation by manufacturer

of international brands is also Mr. Deepk’s passion. He has been the only person in INDIA to set up 6 Human Milk Banks in INDIA. His wishful dream is to create a “White Revolution” by setting up Human Milk Bank in each and every hospital work for better future generation to come of this country. *********************************************************************** Mr. Devendra Patel Director - Medisoft Telemedicine Pvt. Ltd., Ahmedabad Mr. Devendra holds Bachelor of Engineering degree in Electronics & Communications Engineering from DDIT, Nadiad, Gujarat, India. Mr. Devendra Patel is an entrepreneur and has established enterprises in healthcare IT and medical tourism services. He is the Founder and Director of “Medisoft Telemedicine Pvt. Ltd.” and possesses over 18 years of leadership experience in the field of healthcare IT. Medisoft Telemedicine has done pioneering work in Healthcare IT, Ehealth and Telemedicine field. He is also co-founder and managing partner of “The Meditour” medical tourism company. He is co-author of book on Telemedicine titled as “Introduction of Telemedicine”. *********************************************************************** Er. U. KARTHIK PREMKUMAR,B.E. Faber Sindoori Management Services Pvt. Ltd. Ahmedabad. Manager - Biomedical Engineer He has done Bachelor of Engineering (Electronics & Instrumentation Engineering) & Diploma in Electrical & Electronics Engineering. He has been in this field for the past 15 years and has served different healthcare companies, institutions & hospitals. He has worked in Managerial position in various science institutes and Hospitals. Presently he is working with Faber Sindoori Management Services Pvt. Ltd. (a sister concern of Apollo group) as Manager - biomedical engineer at Apollo Hospitals International Limited. *********************************************************************** Dr. Alok Ray Head, Center for Biomedical Eng., IIT & All India Institute Of Medical Sciences, New Delhi Dr. Alok R. Ray is Professor at Centre for Biomedical Engineering, Indian Institute of Technology, Delhi. He is concurrently Professor at All Indian Institute of Medical Sciences, New Delhi, India. Dr. Ray is also Director of Stanford-Indian Biodesign program. He has received his Ph.D. from University of Delhi on Biopolymers. He was a Fogarty Fellow of National Institute of Health, USA at Centre for Polymeric implants, University of Utah, USA during 1982 to 1984. He was a fellow at University of Liverpool, UK. He was a visiting professor at All Union Cardiology Institute, Moscow, University of Leiden, Netherlands and Max Planck Institute for Polymer sciences, Mainz. Prof. Ray has made notable contributions in the area of biocompatible materials. Unique feature of his research is that starting from synthesis/modification, characterization, he has gone up to the stage of engineering and designing of such materials for use in human medicine and surgery viz.: medical devices and implants, drug delivery systems, catheters used for blood vessels. Prof. Ray has acquired the reputation of being a leader in the area of compatibility of materials with living

Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles tissues. His work in this area has been highly cited and the work reported has been further extended by other authors worldwide. He has developed nine biomedical products and published over 150 articles in professional journals and is a consultant to several industries. Prof. Ray has been awarded TATA INNOVATION FELLOWSHIP for the year 2007-2008 in recognition of his research contribution in the area of material used in Human Medicine and Surgery. *********************************************************************** Prof. Himanshu A Patel Head, Biomedical Dept. U. V. Patel College of Engineering, Mehsana He has done B.Tech (IC), M.Tech (BME), IIT-BHU, Varanasi, and he is pursuing his Ph.D studies. He is Head, BME Dept., U.V.Patel College of Engineering, Ganpat University, Kherva, Mehsana. His Area of Interests are: • Medical Image Processing. • Bio-mechanics. • Medical Instrumentation • Control system engineering. *********************************************************************** Dr. Arvind Kukrety Deputy Drugs Controller, Central Drugs Standard Control Organization, Zonal Office, Ahmedabad Arvind Kukrety is working as Deputy Drugs Controller India in Central Drugs Standard Control Organisation, Ahmedabad Zone since 2015. He has done M.Pharm from Jamia Hamdard University, Delhi.

He has got 24 years of working experience in the field of manufacturing of drugs, Quality Assurance and drug regulation. He started his carrier from M/s Winthrop (now known as Win-Medicare) as production supervisor and left the organization as Assistant Manager technical before joining CDSCO in 1998. During his stint in Industry, he worked in various capacities in the manufacturing of oral, external and parenteral dosage forms. In 2003, during WHO GMP workshop he was assessed as the best among the participants and was selected thereafter for various WHO assignments. As short term consultant for WHO he was part of NRA assessment teams for Indonesia & Thailand. As facilitator, he participated in WHO GMP workshops for inspectors of Indonesia and China. In 2005, Ministry identified him as GMP expert for assessment of vaccine manufacturing PSU. He was trained as trainer in GMP and GCP and was associated in various workshops for training of inspectors in India. He also represented in Govt. of India missions in South Korea and Suriname. In CDSCO HQ he worked in new drugs, Biological, import and export, Global clinical trial divisions. He was exposed to dossier assessment procedures of biological in 2008 in Canada. He has played a major role in preparation of Guidance documents for Biological and similar biologic guidelines. In 2011, he led the first team from CDSCO for inspection of foreign manufacturing sites in China. He is actively involved in framing of risk based inspection policy and their evaluation.

K. R. Navaneethakrishnan, M.Sc (PhD) Assistant Director GLR Laboratories Pvt. Ltd., Chennai Toxicologist with more than 19 years’ experience in toxicology and biocompatibility studies. Has worked in GLP certified Contract Research OrganizationsAssistant Director, GLR Laboratories Pvt. Ltd; Toxicology Study Director, IIBAT and Quality Assurance Executive-SGS LSS. Good experience in toxicology/ biocompatibility testing of medical devices, agrochemicals and pharmaceuticals especially in vivo toxicology tests. Successful background in setting up of Quality Systems in Test Facility according to the OECD Principles of GLP and ISO 17025. Has faced several GLP and ISO 17025 audits. Additionally, has faced several national and international client audits. Done Master’s in Regulatory Affairs and pursuing PhD in Nanotoxicology. He has attended many international and national conferences. Has organized national and international workshops/ training programs related to medical devices. Adding to credits, also published scientific papers in peer reviewed international journals related to nanoparticles. ***********************************************************************

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

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 Concentration Mask • Breathing Filter

• • • • • • • • • • •

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

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901

Jan.-Feb. 2017

Venue : Ahmedabad Management Association, Atira Campus, Ahmedabad-380 015. Schedule : March 17 & 18 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 2017 No.

Company Name

Products / Services

Website

ET Elastomer Technik GmbH,

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

www.elastomer-technik.com

American Plastic Technology

Projects for Manufacturing I.V. Solutions, Injectables, Dialysis Solutions & Dialyzers, Autoclaves, Sterilizers, Pharma Machinery, I.V. Sets & Other Disposables etc.

www.americanplastictech.com

Lubrizol Advanced Materials India Pvt. Ltd.

Medical Disposables, Catheters and Medical Thermoplastic Polyurethane Resins.

www.lubrizol.com

Synergistix India Pvt. Ltd.

NuSil Silicones LLC: Medical-grade silicones including primers, gels, adhesives, oils, dispersions, elastomers (LSR & HCR) for drug delivery medical implants, general healthcare and skin care industries. Epoxy Technology LLC: Adhesives for medical applications including: sensors, instruments, hearing aids, dental equipment, pacemakers, endoscopes and catheters.

www.synergistixindia.com

Sitech : Design Innovations

New Product Development, Design to Manufacture, Medical Device & Equipment Development, Drug delivery, Diagnostic products.

www.sitech.in

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

Accuprec Research labs Pvt. Ltd. Bio-compatibility testings (As per ISO 10993 guidelines), Cell-line based testings, Clinical

www.accuprec.com

services (BA/BE, PMS) (As per ICMR / ICH-GCP guideline).

Symbiorph Clinical Trialogy

Medical Device Regulatory Compliance Consulting Company

www.symbiorphclinicaltrialogy.com

Pradeep Surgipack

Peel-Open Flat Pouches & Reels, Peel-Open Gusset Pouches , Peel-Open Self-Seal Pouches, Coated Tyvek Sheets , Uncoated Tyvek Pouches, Grid-Lacquered & All-Over Coated Pouches, Header Bags, Poly Coated Pouches products.

www.pradeepsurgipack.com

Operon Strategist

Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification in the fields of Medical Devices.

www.operonstrategist.com

Steri Techno Fab

Products Autoclave, Eto Sterilizer, Uv Sterilizer, Ultrasonic Cleaner, Eto Cartridges, Eo Cartridges & Other Sterilization Material

www.steritechno.com

Malaysian Rubber Export Promotion Council

Rubber Medical Devices - Latex Gloves, Nitrile Gloves, Dental Gloves, Foley Catheter, Dental Dam, Probe Cover, Finger Cot, Condom

www.mrepc.com

Central Institute of Plastics Engineering & Technology

Tool Room, Testing, Consultancy Services, Training & Academic Activities for Plastics Industries.

www.cipet.gov.in

Medical Plastics Data Services

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

www.medicalplasticsindia.com

Medisourceasia

Web Portal For Medical Technology And Markets In Asia

www.medisourceasia.com

Connell Bros. (India) Pvt. Ltd.

Suppliers for : Silicone oils, emulsions, Dispersion for Medical devices Lubrication and Fabrication, Silicone tubing’s, Silicone topical excipients, Silicone elastomers

www.connellbrothers.com

Suresh Enterprises

Silicone & Viton Rubber Extruded and Moulded Products

www.sevitsil.com

Jan.-Feb. 2017

Exhibitor Profiles No.

Company Name

Products / Services

Website

Excel Formulations

State-of-the-art ETO formulation and bottling facility

www.excelformulations.com

Ami Polymers Pvt. Ltd.

Platinum Cured Silicone Tube, Radiopaque Tube, O-Rings, Custom Made Gasket, Silicone Sleeves for printing purpose, Medical Components

www.amipolymer.com

Indian Innovators Association

Voice of Indian Innovators. Works to develop markets for “designed in India” products.

www.indiainvents.in

Medical Textiles- SITRA

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

www.sitra.org.in

Plastindia Foundation

Apex body of major associations, organizations and institutions connected with plastics, promoting development of plastic industry. Next event : PLASTINDIA 2018

www.plastindia.org

Pharmadox

FDA / WHO Consultant: Pharmaceuticals & Medical Devices includes orthopedic implants.

www.pharmadocx.com

Raman Discovery Enterprises

Offers newly developed and patented medical devices for commercialization.

Oswin Plastics Pvt. Ltd.

For Disposable Equipments, Flow case pipes, Tubings, Hose for Breather circuits

Om Enterprise

Blister Packing, Vacuum Forming, Transparent Packings and Boxes, Cam Shells, Sliding System, Sealing Technologies (Hot and Cold)

Jan.-Feb. 2017

www.oswingroup.com

Exhibitor Profiles ET Elastomer Technik GmbH, Gandhinagar, India www.elastomer-technik.com Products : Industry - Medical Technology/Pharma/Baby Care List of Products : 1. Precision O-Rings (1-410mm inner diameter) 2. Breathing bags 3. Balloons 4.Medical tube 5. Cable and drainages 6. Seals and sealing rings 7. Tooth Protector 8. Short- and long-term 9. Customize mould parts, Food, Push Buttons, Bellows, Closure Valves, Housing Seals. 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, 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 larynge implant for people who suffered from ‘Mustard Gas’attacks during the gulf war. Since then ET started a wide range of different implants.

Contact : American Plastic Technologies Inc., 9451, Ainslie Street Schiller Park/Chicago, IL 60176. USA E-mail : raodesign@qol.com P No. 847-671-6182

Lubrizol Advanced Materials India Pvt. Ltd., Mumbai, India. www.lubrizol.com/en/Life-Sciences Medical Disposables, Catheters and Medical thermoplastic polyurethane resins. Lubrizol LifeSciences is a healthcare solution partner that provides support from idea to production by supplying customizable polymers, complex drug formulation and contract manufacturing services for medical device manufacturers. Now with Vesta’s medical manufacturing and Particle Sciences’ complex drug formulation capabilities, LifeSciences is the only partner providing full service, development and product solutions. Contact : Lubrizol Advanced Materials India Pvt. Ltd. 5th,6th & 7th Floor , Jaswanti Landmark, LBS Marg, Vikhroli (West) Mumbai- 400079, India. Ph. +91 66027800

Synergistix India Pvt.Ltd., Chennai, India www.synergistixindia.com

In 2004 ET decided to start a second plant in Hammelburg/Germany. A clean room class 8 as well as a tool shop were installed in 2006 and 2 years later they established the ISO 13485. In 2010, ET Elastomer Technik GmbH has started their production facility at Gandhinagar, Gujarat under the name of “ET Elastomer Technik India Private Limited.

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 reliable development of high-end items. Contact : ET Elastomer Technik GmbH Abtsäckerstraße 16, 74248 Ellhofen, Tel. : +49 (0)9732/ 78865 - 12, Fax : +49 (0)9732/ 78865-18 E mail : info@elastomer-technik.com ET Elastomer Technik India Private Limited B 183-184 GIDC Electronic Estate, Sector 25 Gandhinagar 382024 Contact Person:-Mr.Hardik Patwa(Administrator) Phone: +91 79 23287624, Mobile: +91 97277 63274,+91-9974624358 Email: admin@elastomer-technik.in

Synergistix India Pvt. Ltd. is one of the professionally managed companies focusing on sales/marketing, technical services, logistics and distribution. The Company is managed by a team having several decades of experience in the defined functions. The Company’s key strength is the ability to sell concepts, solutions and Stretching to meet Customer Expectations. They are systems driven and have invested heavily in developing internal processes that would deliver services to their Customers/Principals most eff iciently. The company has been doing this for more than a decade now with 80% plus customers retained! They have built up a significant customer base over a decade, spanning diverse applications in: Plastics & Polymers, Lubricants, Water & Environment, Electronics, Medical/Pharmaceuticals and this list is growing.

American Plastic Technologies Inc. USA www.americanplastictecnologies.com Supply Turnkey Manufacturing Plants For : Intravenous Solutions Manufacturing Plants, Injectable Medicines Manufacturing Plants, Oral Rehydrating Solutions Manufacturing Plants, Dialysis Solutions Manufacturing Plants, Dialyzers Manufacturing Plants, Medical Waste Disposal And Management, Water Purification Equipment, Autoclaves / Sterilizers, Pre-Fabricated Steel Buildings.

Contact : Synergistix India Pvt.Ltd. 4th Floor, Kaba Plaza, 57,L.B.Road, Adyar, Chennai – 600020 Phone : 044-42114825 E: mail@synergistixindia.com

Shree Infosys, Vadodara, India www.sitechplm.com New Product Development, Product re-design : Optimization of material / process, Complete solution : Design to Manufacture, Medical Device & Equipment Development - Drug delivery, Diagnostic products, healthcare, Implants, Surgical & Interventional Device Disposable products / Electronic device enclosures Sitech is innovative leading human centric Product design Company. Sitech is solution provider for “Design to Manufacturing process”. We help companies make great products by optimizing their lifecycle processes, from planning and development through manufacturing and support. Jan.-Feb. 2017

Exhibitor Profiles Sitech has developed many innovative products for wide range of applications, particularly, in Medical and Pharma-industries. Our experience and knowledge of this sector will help you to meet regulatory standards by selecting correct material, process, documentation and you develop unique products without infringing on competitor IP. SITECH help customer to dramatically compressed cycle times for design and development, by leveraging shared intellectual capital, better concurrent engineering practices and standards for design, prototype and validation. SITECH are conscious not only for the End-product quality but also for entire error free development cycle. On occasions, we have been involved with the client’s R&D, Design and product Development departments for their special task or system development. Contact : Shree Infosys, 102, Shreem Apartment, Opp. Mahindra Gujarat Tractor Ltd., Mujmahuda, Vadodara – 390 011. Gujarat, India. Phone : +91 265 2343058, 2320257 | Mobile : +91 9825420257 Email : parthiv@sitech.in

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.

Accuprec Research Labs Pvt. Ltd., Ahmedabad, India www.accuprec.com Our Services : Analytical (HPLC/UV) method development & Validation (AMV), Bio-compatibility testings (As per ISO 10993 guidelines), Cell-line based testings, Clinical services (BA/BE, PMS) (As per ICMR / ICH-GCP guideline), DMPK Studies, Formulation & Development Services, Genetic testings, IPR management services (Patent, TM, Design and Copyright drafting, filing, Valuation of IP, Licensing agreements for IPR), Microbiological testing, Phytochemical studies (Heavy metal testings using ICP-OES), Pharmacological screening, Stability studies (As per ICH guidelines), Sterility testing, Toxicological testing (in-vitro, ex-vivo and in-vivo) (As per OECD / Schedule Y /AYUSH guideline) Accuprec Research Labs Pvt. Ltd., a contract research organization having head quarter at Ahmedabad, Gujarat, India and having branch office at Sudbury, ON, CA and Pittsburgh, PA, USA. Our research lab is approved by FDCA and certif ied by ISO 9001:2008, GLP, CPCSEA and NABL*. We are providing ultimate solutions for all kinds of research related services ranging from drug discovery to development. Currently we are providing research and testing solutions to our clients which includes small to large industries of Pharmaceutical / Biotech / Herbal/ Ayurvedic/ Neutraceuticals/ Medical device manufacturers Jan.-Feb. 2017

from India, CA, USA, UAE and Europe. Contact : Dr. Manish A. Rachchh Director (R & D) & CEO Accuprec Research Labs Pvt. Ltd., Opp. Zydus Pharmez, Changodar - Bavla Highway, Nr. Matoda Patia, Post: Matoda, Ahmedabad 382213, Gujarat, India (M) +91- 9099981023, 9099981023, 99099 19545 E-mail: info@accuprec.com ; manish.rachchh@accuprec.com

Symbiorph Clinical Triology, Ahmedabad, India www.symbiorphclinicaltrialogy.com Symbiorph Clinical Trialogy is Ahmedabad based Medical Device Regulatory Compliance Consulting and advising Company. We support the medical device manufacturer to realize the concept of “MAKE IN INDIA” and help them in Global Medical Device Product Registration. Core Services : Indian Medical Device Manufacturing License as per revised requirements, CE Marking, US FDA 510K, Risk ManagementISO 14971, Clinical Evaluation-MEDDEV 2.7.1 Rev 4, June 2016, Medical Device Software Validation (IEC 62304), Usability Engineering (EN 62366), IEC 60601-Compliance, Sterilization-EO Validation (ISO 11135) Global Product Registration : US FDA 510K, Latin America (Brazil, Mexico etc.); South East Asian (Thailand, Australia etc.); MENA (Egypt, Israel etc.); GCC (UAE, Saudi, Kuwait etc.); CIS (Russia, Kazakhstan etc.) We are advising the medical device manufacturers in such a manner that they can appoint more than ONE distributors in these countries, thereby to remove the dependency on the single distributor. Contact : Siddharth Jain, Chief Regulatory Advisor Symbiorph Clinical Triology, 1365, Jalkukadi Ni Pole, Behind Raipur Post Office, M.G Haveli Road, Manekchowk, Ahmedabad-380001, Gujarat, India Mobile : +91-9998038576 E-mail : siddharth@symbiorph.in;

Pradeep Surgipack, Bangalore, India www.pradeep-surgical.com Peel-Open Flat Pouches & Reels, Peel-Open Gusset Pouches , PeelOpen Self-Seal Pouches, Coated Tyvek Sheets , Uncoated Tyvek Pouches, Grid-Lacquered & All-Over Coated Pouches, Header Bags, Poly Coated Pouches Manufacturers of medical grade sterilization packaging products which are used to pack medical devices that need to be sterilized. Located in Bangalore our QMS is ISO 13495 certified and our products are CE certified. Our range of products include peel-open flat & gusset pouches & reels, Tyvek pouches & reels & Coated Tyvek lidding sheets, peel-open self-seal pouches, peel-open and tear-open coated pouches & Header bags. Our core raw materials include, medical grade coated & uncoated papers, coated & uncoated Tyvek, laminated films & specialized sterilization indicator inks. We are specializing in customization and short-runs. With all manufacturing & QC facilities under one roof, we can assure excellent quality with timely deliveries at affordable costs. Contact : Pradeep Surgipack, 1/A, Bikasipura Road, JC Industrial Estate, Yellachenahalli, Off Kanakapura Road, Bangalore – 560062. Tel: 080-65700607 / 080-26860865 Email: radeep.surgipack@gmail.com / pradeep@pradeep-surgical.com

Exhibitor Profiles Operon Strategist, Pune, India

CIPET, Ahmedabad, India 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 : Anil Chaudhari, Operon Strategist, MSR Capital, office no.10, 3rd floor, Pimpri colony, Near city international school, Pimpri, PUNE 411 018 P: +91(020)65283428 M: 9823283428 E: info@operonstrategist.com, anil@operonstrategist.com

www.cipet.gov.in

Central Institute of Plastics Engineering and Technology (Ministry of Chemicals & Fertilizers) offers wide spectrum of courses and programmes at different level in myriad domain of Plastics, Manufacturing, Design (CAD/CAM/CAE), CNC Tooling, Microprocessor based Processing, Testing, Research & Development. Courses offered are: Courses: - M.Sc. (POLYMER SCIENCE) - M.E. / M.Tech. in Plastics Engineering / Technology Contact : Pushpak Patil / Placement Officer / CIPET - AHMEDABAD T +91-79-40103934 | M 8460403804 | Skype: cipetplacement

Medical Plastics Data Services, Ahmedabad, India www.medicalplasticsindia.com

Steri Techno Fab, Ahmedabad, India

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, DIAGNOSTICS AND PHARMACEUTICAL INDUSTRY www.steritechno.com

AUTOCLAVE, ETO STERILIZER, UV STERILIZER, ULTRASONIC CLEANER, ETO CARTRIDGES, EO CARTRIDGES & OTHER STERILIZATION MATERIAL STERI TECHNO FAB is ISO 9001:2008, ISO 13485:2012 and CE Certified organization with large experience in sterilization process for hospitals, pharma industries and medical devices. STERI TECHNO FAB is an organization driven by certif ied, experienced and dedicated team. Our hi-tech and compact designs have a unique combination of technology and innovation born out of catering to special users requirements. Contact : STERI TECHNO FAB, 137 Fortune Industrial Park, KathwadaSingarava Road, Kathwada, Ahmedabad-382430. P: +919099922299, +918511931234. Email Id :- info@steritechno.com, yash3303@gmail.com,

Malaysian Rubber Export Promotion Council, Mumbai, India

www.mrepc.com Rubber Medical Devices - Latex Gloves, Nitrile Gloves, Dental Gloves, Foley Catheter, Dental Dam, Probe Cover, Finger Cot, Condom. The Malaysian Rubber Export Promotion Council (MREPC) is an export promotion agency for rubber and rubber manufactured products from Malaysia. It acts as a link between buyers/importers and rubber product manufacturers in Malaysia. Contact : Samir Shah - India Representative Malaysian Rubber Export Promotion Council 907, Tulsiani Chambers, Nariman Point, Mumbai 400021, Maharashtra, India, TEL: +91 22 6221 6725 FAX: +91 22 6223 2359 MOBILE: +91 9619555899 EMAIL: sshah@mrepc.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 Prof iles, 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 Manufacturers 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 : 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

Connell Brothers Co. (Ind.) Pvt. Ltd. Mumbai, India. www.connellbrothers.com

Products/Services : We are India’s leading suppliers forSilicone oils/ emulsions/ Dispersion for Medical devices , Lubrication and Fabrication, Silicone tubings, Silicone topical excipients, Silicone elastomers Jan.-Feb. 2017

Exhibitor Profiles 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 [artner 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 speciality 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 : Mr. Javed Shaikh / Mr. Abhishek Shukla Connell Brothers Co. (Ind.) Pvt. Ltd. 3rd Floor, Zenith House, Opp. Race Course, Mahalaxmi, Mumbai – 400034. P: 022-66138300.

Suresh Enterprises, Mehsana, Gujarat. www.sevitsil.com Silicone & Viton Rubber Extruded and Moulded Products Sevitsil is a brand name of Suresh Enterprises. We are into this business since 1978. We started as small trading firm in Mumbai with solo motive to serve various government departments, after initial struggle with courage and dream to serve throughout India we started a manufacturing unit. In 1992 we shifted to Mehsana for betterment and expansion, today we have Clean Room Class 100,000 and US FDA certified DMF No 28622. Contact: Mr. Kunj R. Shah, C1/55 Suresh Enterprises, Lane Opp to Water tank, GIDC Phase – II, Dediasan, Mehsana -384002. Gujarat, India. P: 02762-224814, 224240, 255239. Mobile: +91-9727738001.

Excel Formulations, Ahmedabad, India www.excelformulations.com We, at EXCEL FORMULATIONS take this opportunity to introduce ourselves as one of the leading manufacturers of ETO sterilization gas mixtures in India. EXCEL FORMULATIONS, established in 2007, is amongst India’s leading manufacturer of ETO (Ethylene Oxide) Gas mixtures. We are ISO 9001, 14001 & 18001 and D&B SMERA certified company. We are one of the Export House certified by Government of India. We are manufacturing various types ETO gas mixtures in cylinders as well as Disposable E.O Cartridges. We established a state-of-the-art EtO formulation and bottling facility at Sanand, Dist. Ahmedabad, 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 Jan.-Feb. 2017

standards at the plant. This in turn ensures that the products manufactured are reliable and are of the highest quality. Our experienced technical staff, supported by a network of field personnel, ensures prompt and efficient service to our customers. Contact : DIPESH PATEL, Partner, EXCEL FORMULATIONS, REGD. OFFICE : 401, Sanidhya- A, Opp. Anandnagar Shopping Center, Prahladnagar 100ft. Road, Satellite, Ahmedabad-380015, GUJARAT, INDIA Telefax: +91-79-40067245, +91-9228008275, +919825095666 Email : info@excelformulations.com, info@etosterilization.in FACTORY : Plot No. 32, Sonal Industrial Estate, Khoda Village Road, Sanand, Ahmedabad, Gujarat

Ami Polymer Pvt. Ltd., Mumbai, India www.amipolymer.com Platinum Cured Silicone Tube, Radiopaque Tube, O-Rings, Custom Made Gasket, Silicone Sleeves for printing purpose, Medical Components (Silicone Tips, Silicone Washer, Silicone Cork/Stopper, Silicone ‘Y’ connector, Pig Gasket, ‘C’ Clamp, Male Thread Gasket, Grip Bush, Silicone Tire/Band) We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets & customized polymer solution for pharmaceutical industrial application. Serving since 1996, our well known brands are Imapure™, Imaprene™, Imaweld™, Imafit™, Imavac™, Imawrap™, Etc. DMF #26201 accredited by US FDA for platinum cured silicone tube& braided hoses. Having 80000 sq. ft. manufacturing & packaging facility are certified clean room of class 10000. Capable of developing customized product as per requirement. We have started a new medical division for developing medical products. Contact : Mr. Elvis Mendonsa (CEO – Medical Division), Ami Polymer Pvt. Ltd., 319, Mahesh Industrial Estate, Opp. Silver Park, Mira Bhayander Road, Mira Road (East), Mumbai 401104, Thane. Maharashtra. INDIA. P: +912228555107, Email : info@amipolymer.com

Indian Innovators Association, New Delhi, India www.indiainvents.in Indian Innovators do not want awards, they demand rewards. Indian Innovators Association works to develop markets for designed in India products. Services : Independent Innovators : Participation in international innovators exhibitions sponsored by IFIA. Students : Starting ‘Student Ideation centers’ in partnership with Emerging Ventures Exchange. Research Institutes : Developing technology commercialization plans in partnership with SkyQuest and General Inventions Start-ups: Mentoring to get ‘right valuation’ in deals in partnering with EVx Product manufacturing companies : Innovation Audit service to develop scenarios and strategic plans. Exhibitors : Support for Innovation exhibition with participation by innovators from 100+ member associations of IFIA. Contacts : Dr A. S. Rao , President , Indian Innovators Association, Hyderabad. indiainvents@gmail.com PSS Prabakar Rao, Secretary, Indian Innovators Association, New Delhi, iia.iiif2016@gmail.com.

Exhibitor Profiles Medical Textiles- SITRA, Coimbatore, India. www.sitra.org.in 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 : Dr. Ketankumar Vadodaria, Head - incharge - Medical textiles/ Tel : 0422 -4215338/ S.Thiruppathi - senior scientific officer, SITRA CoE Medical textiles, 13/37 Avinashi road, Coimbatore -641014 Tel : 0422-4215333 Extn.369 Mobile : 9790225424 Email : techtextrg@sitra.org.in

PLASTINDIA FOUNDATION, Mumbai, India. www.plastindia.org Plastindia Foundation is the apex body of major associations, organizations and institutions connected with plastics, with common objectives to promote the development of plastic industry and to assist the growth of plastics and related materials and their products. The Foundation is dedicated to the national progress through plastics. High lights of PLASTINDIA 2018: Gross Area – 1125,000 sqms, Targeted exhibitors – 2000 Nos., Overseas participation – 600 Nos from 40 countries, Business Visitors – around 200,000 Nos. Concurrent Events : PROPLAST 2017 for Finished Products, International Conference, Plasticon Awards, B2B Meets Industry Focused Pavilion : Composites, Automotives, Medical & Health Care, Sports, 3D Printing & Prototyping Contact : 401-B, Landmark, Suren Road, Off Andheri Kurla Road, Andheri East, Mumbai – 400093, India. Tel. : +91-22-26832911 upto 14, Fax : +91-22-26845861, E-mail : info@plastindia.org

Founded in 2007, Pharmadocx is an India based Medical Devices Consultation firm. Guiding Companies to set up Manufacturing unit & Obtaining Drug License. Designing of plant, Supervision of construction & FDA licensing. Up gradation of existing plant as per M-III guidelines. GMP Documentation of plant. Turn Key Projects. Pharmadocx provides services for following types of plants. Medical Devices, Orthopedic Implant Plant, Surgical Dressing Plant, Medical Oxygen Plant, Diagnostic Kits, Pharmaceutical Formulation, API, Homoeopathic & Ayurvedic, Unani & Siddha Medicine, & Cosmetics Plant. Contact : Yashdeep Dahiya (CEO), PHARMADOCX, Opposite Dewan Mill, Old DC Road, Sonepat (HR) 131001, INDIA Ph. No. +91 130-2200630 (M.)+91 9896133556. E-mail : whogmp@pharmadocx.com, Blog : Pharmadocx.wordpress.com SkypeName : Yashdeep Pharmaceuticals

Oswani Plastics Pvt. Ltd., Mumbai, India. www.oswingroup.com For Disposable Equipments : Flow case pipes, Tubings, Hose for Breather circuits. Oswin Plastics Pvt Ltd is part of OSWIN GROUP which manufactures pipes , profiles and molded articles from engineering and non engineering polymers. Processes handled : Extrusion, Corrugation, Injection Molding, Blow Molding, Insert Molding. Industries we cater : Medical, House Hold appliance, Automobile, LED Lighting, Sanitary, Hardware, Telecommunication, Electrical switch gear, Packaging Contact : Mr. V. Newton / Mr. K. Khimasia Oswani Plastics Pvt. Ltd. 142/48 Ghaswala Ind. Estate, Opp. 24 Karat cinema, S.V Road, Jogeshwari (west) Mumbai - 400102 Telephone : +91-22-6771301 / 02 / 03 Email : info@oswingroup.com / newton@oswingroup.com /kunj@oswingroup.com

OM ENTERPRISE, Ahmedabad, India.

BLISTER PACKING, VACUUM FORMING, TRANSPARENT PACKINGS AND BOXES, CAM SHELLS, SLIDING SYSTEM, SEALING TECHNOLOGIES ( HOT AND COLD) WE PROVIDE JOB WORK , MACHINES , MOULDS AND SEALING TECHNOLOGIES , TOATAL SOLUTIONS

www.pharmadocx.com

SINGS LONG WE ARE ENGAGED IN BLISTER PACKING VACUUM FORMING IN PVC, PET, ABS, ACRYLIC MATERIAL AND TRENSPARENT SEALABLE PACKING AND BOXES. WE ALSO PROVIDE CAM SHELL PACKINGS AND TOTAL SEALING HOT AND COLD TECHNOLOGIES

Medical Devices Plant Designing, Liasoning for Form-28 Drugs License. GMP Documentation, SOP, SMF, DMF, Device Validation.

Contact : OM ENTERPRISE, LL - 24, Harekrishna Complex , Opp. Kothawala Flats , Pritamnagar, Paldi, Ahmedabad - 380 006 , Gujarat, India. Ph. : 079 40098277. M. : 093277 08277, 092272 02415, M.: 099787 18110. E mail: omenterpriseplasticpacking@rediffmail.com.

PHARMADOCX, Haryana, India.

Jan.-Feb. 2017

Supporting Associations 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. 2017

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. 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,

Supporting Associations 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 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 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 Jan.-Feb. 2017

Supporting Associations 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 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 Jan.-Feb. 2017

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.

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.

Supporting Associations business environment.

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

AN ISO 13485-2012 CE certified Company 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

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 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.

GMP. & ISO 9001 – 2000 Certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products: 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 Jan.-Feb. 2017

Product Gallery Medical OEM Tubing Solutions From Qosina Ronkonkoma, NY – February 14, 2017 – Qosinaoffersa wide selection of in-stock and custom medical tubing for your prototyping and large-scale production requirements. Whether your project requires PVC, Silicone, FEP, HDPE or DEHP-Free PVC tubing, Qosina supplies various sizes and durometers off- the-shelf to meet yourever-changing needs. For over 35 years, our Sales and Product Development Teams have been providing our customers with custom tubing solutions. Qosina has the capability to provide cut-tolength tubes and multi-lumen configurations, along with custom durometers, sizes, colors and materials. With popular brands such as Tygon®,C-Flex® and PharmaFluor® available for immediate shipment, our tubing is competitively priced and is easily customized to your specification. Let Qosina be your trusted supplier for medical OEM tubing. Contact a member of our Sales Team for complimentary samples today. Qosina offers low minimums and short lead times. Log on to qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be

Jan.-Feb. 2017

sure to sign up for our monthly e-newsletter to stay current with our newest product additions.Our product development team can work with you to customize a part to your specifications. Call our customer service specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com. Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories,compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, 13485 and 14001 registered. Contact : Deanna Whelan Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779. Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230. Email: deanna@qosina.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

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. 2017

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

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. 2017

: 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 56

Jan.-Feb. 2017

List & Profile Of Advertisers Company Name 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. American Plastic Technologies, INC, USA. Ami Polymer Pvt. Ltd., Thane

Products / Services

Bio Compatibility Services for Medical Devices Surgical Products Surgical Disposable Products Surgical Disposable Products Sterilization Equipment Turnkey Manufacturing Plants For I.V. Solutions, I.V. Sets, Pharmaceuticals etc., Specialized In Medical Grade Silicone Tubes, Radiopaque Tubes & Customized Medical & Surgical Products Amigo Surgi Care Pvt. Ltd., Gandhinagar Surgical Disposable Products AMTZ, Andhra Pradesh India’s 1st Integrated Medical Devices Manufacturing Park Angiplast Pvt. Ltd., Ahmedabad Medical Disposable Products & Components Apex Medical Devices, Ahmedabad Medical Disposable Devices & Surgical Products Beacon Plastics, Ahmedabad 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., Haryana Plastic Auxiliary Equipments Caliber Assurance Services, Bangalore ISO 13485 Certified R&D, QA and RA Consultancy Firm 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 Ferromatik Milacron India Pvt. Ltd., Cleaner and Precise Injection Moulding Solution for Medical Ahmedabad Equipment, All Electric Machine Glowtronics / Wifiltronics Pvt. Ltd., OEM, Designers and Manufacturers of Medical Devices, Mysore Electro-Surgical & Precision Stamped Parts GLR Laboratories Pvt. Ltd., Chennai Nonclinical safety testing of pharmaceuticals, chemicals, medical devices and other products Gujarat State Biotechnology Mission, Biotechnology Policy For Gujarat Gandhinagar. 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 INEOS Styrolution India Limited, Global styrenics supplier with focus on styrene monomer, New Delhi polystyrene, ABS and styrenic specialties. Jain Rubbers Pvt. Ltd., Tamilnadu Rubber Products For Disposables And Rubber Stoppers For Pharmaceutical Packaging Jimit Medico Surgicals, Ahmedabad Medical Disposables products KLJ Polymers and Chemicals Ltd., Polymer compounds like PVC, XLPE, PP, TPR, TPE, EVA, New Delhi EPR, ZHFR, Master Batches etc Kuraray India Private Limited, Manufacturer Of Innovative Polymers for applications like New Delhi medical tubes and pouches, orthopedic gels, patch adhesives and elastic nonwovens. Lakshmi Designers, Bangalore Medical disposable products and Infrastructure Life-O-Life Technologist, Ahmedabad Respiratory Disposale and Medical Surgical Devices Lubrizol LifeSciences, Mumbai. Medical Disposables, Catheters and Medical Thermoplastic Polyurethane Resins. Maider Medical Industry Equipment Co., Sterile Medical Automation Equipment Ltd., China MEDICALL, Chennai Medical company conference

Website

P. No.

www.accuprec.com www.airwayssurgical.com www.alphamedicare.com www.atplworld.com www.ambicamedicareengg.com www.americanplasticstechnologies.com

8 54 60 10 75 67

www.amipolymer.com

www.amigo-india.com www.amtz.in www.angipalst.com www.apexmedicaldevices.com

52 19 55 61 56

www.medicaredevices.com

www.bhavyapolymers.com

www.bryairsystems.com www.caliberassurance.com www.covestro.com

70 80 1

www.eewaengineering.com www.excelformulations.com www.milacronindia.com

84 11 81

www.glowtronics.com ; www.wifiltronics.com www.glrlabs.com

www.btm.gujarat.gov.in

www.i-kare.in

www.ignisol.net www.styrolution.com

72 6

www.jainrubbers.com

www.jimitsurgicals.com www.kljindia.com

61 69

www.elastomer.kuraray.com

www.Ldmoulds.com/medical www.lubrizol.com

12 41 18

www.maiderchina.com

www.medicall.in

Jan.-Feb. 2017

List & Profile Of Advertisers Company Name

Products / Services

Website

Mesco Surgical, Ahmedabad Messe Düsseldorf India Pvt. Ltd., New Delhi Morrisons Lifecare Pvt. Ltd., Chennai

Medical Disposable Products Medical Technology & Conf.

www.mescosurgical.com www.md-india.com; www.medicalfair-india.com www.morrisonslifecare.com

www.nationalhealthcare.in www.conairgroup.com/india

64 13

www.operonstrategist.com

www.plastindia.org

61 17

www.pradeepsurgipack.com www.pragatiplastics.com

57 16

www.pvclplastics.com

www.qosina.com

www.RAUMEDIC.com

71 73

www.snathco.com www.panacol.com; www.hoenle.de

61 9

www.medisourceasia.com/ productgallery/sanidhya.htm www.medical-part.com.tw

www.sitechplm.com

www.smcltd.com

www.sterimedgroup.com

www.surgipackindia.com

www.symbiorphclinicaltrialogy.com www.webptc.com

43 60

www.unikalindia.com

www.veripackindia.com www.polymatindia.net

4 67

www.welset.com www.yhsjmould.com

15 3

National Healthcare, Ahmedabad NU-VU Conair Pvt. Ltd., Ahmedabad

Operon, Pune Pack-Equip, Ahmedabad PLASTINDIA FOUNDATION, Mumbai

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

R R Patel Gases (P) Ltd., Ahmedabad RAUMEDIC, Pune S.Nath & Company, Ahmedabad San Printech Pvt. Ltd., Mumbai Sanidhya Enterprice, Ahmedabad Shin Yan Sheno Precision Industrial Co., Ltd., Taiwan Sitech Software, Baroda SMC Medical Manufacturing Pvt. Ltd., Karnataka

Surgical Disposable & Medical Devices Medical Disposables products Plastics auxiliary equipment such as Dehumidifying Dryers, Chillers, Conveying System, Blending System, Mould Temperature Controllers etc., Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification for Medical Devices, Pharmaceuticals, etc. Packaging Machinery Apex body of major associations, organizations and institutions connected with plastics, promoting development of plastic industry. Next event : PLASTINDIA 2018 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 Manufacturer of Industrial adhesives & innovative UV - and UV-LED curing systems Injection Moulded Medical Components Molds of Medical Parts and components New Product Development, Design to Manufacture, Medical Device & Equip. Development, Drug delivery, Diagnostic products.

can design, develop prototypes, build tools, manufacture components, assemble and package your finished device while managing entire supplychain along the way Sterimed Surgicals India Pvt. Ltd., Steripore Non Woven Microporous tape, Cuff & Plain New Delhi Endotracheal Tube, Customized Gynecological & Other Kits, Medical Disposables Surgi Pack India Pvt. Ltd., Mumbai Manufacturers for Surgical Peelable & Tearable Puches, Lids & Reels for Medical Disposables & Devices. Symbiorph Clinical Trialogy, Ahmedabad Medical Device Regulatory Compliance Consulting Company Proven Trade Contacts, New Delhi An International monthly magazine for hospital, medical, healthcare and related trades Unikal Consultant, Ahmedabad Integrated services with focus on project technology: Quality Management System, Medical Devices CE marking, FDA 510k, Audit Documentation, Training and c-GMP VERIPACK, Mumbai A world leader in Thermoforming Machines Vinit Performance Polymers, Mumbai Engineering Plastic Stock Shapes and custom components for Medical Devices Welset Plast Extrusions Pvt. Ltd., Mumbai Medical Grade PVC Compounds Yuhuan Shengjiu Mould Co., Ltd., China Molds for Medical Instrument

Jan.-Feb. 2017

P. No. 64 79

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

Jan.-Feb. 2017

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.

GMP ISO - 9001-2008 Certified Company

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 Address

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com Jan.-Feb. 2017

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 61

Contents Foreword Preface to First Edition Preface to Second Edition Acknowledgments Chapter 1 : Introduction to Medical Device 1.1 Medical Devices: Managing The Mismatch 1.2 “Catheters”.... 1.3 Self-Expanding Plastic Stents Used In The Treatment Of Benign Esophageal Conditions 1.4 A Combination Product 1.5 Defining A Medical Device Chapter 2 : Adverse Events . 2.1 Trends In Medical Device Adverse Events 2.2 How Easily Bacteria Clog The Medical Devices…!! 2.3 Risk Management For Medical Devices 2.4 Complications Associated With Urological Devices 2.5 Catheter Introducers – A Potentially Life Threatening Episode 2.6 Human Factors Leading To Medical Device Adverse Events 2.7 Luer Taper Fitting As Connectors In The Medical Industry 2.8 Problems With Transvaginal Surgical Mesh 2.9 Heparin In Medical Devices Linked To 11 U.S. Deaths 2.10 Preventing Dangerous Hemodialysis Catheter

Disconnections 2.11 Particulate Matter In Blood Bags 2.12 Complications Related To The Use Of Bone Cement 2.13 Failure Of The Tracheostomy Tube 2.14 Potential Cross-Contamination Linked To Haemodialysis Treatment 2.15 Complications Related To The Use Of Vascular Haemostasis Devices 2.16 Occluded Endotracheal Tubes 2.17 Allergic Reactions To Medical Devices Containing Latex 2.18 IV Catheter-Associated Infections 2.19 That Long Needles ‘Cut Injection Pain’ For Babies 2.20 Old Dialysis Filters Are Responsible For Kidney Patient Injuries Chapter 3 : Applications 3.1 PU Dressings Help Wounds To Heal 3.2 The Economics Of Prefilled Syringes 3.3 Coronary Drug-Eluting Stents 3.4 Intravenous Infusion Sets ( IV Set ) In Anaesthesia Practice Chapter 4 : Regulations & Quality Issues 4.1 Challenges Of Using Combination Products 4.2 FDA Regulations Regarding Medical Devices Chapter 5 : Markets & Emerging Trends 5.1 What Global Medtech Manufacturers Need To Copy From India And China Jan.-Feb. 2017

5.2 India’s Success In Developing Its Own Health Related Technologies 5.3 The WHO Report On Medical Devices And Equipment 5.4 Humanitarian Use Medical Devices (Huds) 5.5 The Ageing Population In Europe Chapter 6 : Innovation & Product Developments 6.1 High Impact Frugal Innovations In India 6.2 Medical Device Innovation 6.3 Replacement Cornea Makes Clear Difference 6.4 First Medical Device Derived From New Class Of Biopolymers: Absorbable Suture Product 6.5 Remote Monitors For Medical Devices 6.6 Silicon Sensors For Use In Catheters 6.7 Phatik Intraocular Lenses 6.8 Temporary Artificial Heart 6.9 Coatings For Blood-Contacting Devices 6.10 Knowledge Management 6.11 Why The Great Scientist APJ Abdul Kalam Developed Orthosis Callipers Weighing Just 300 Gms ! 6.12 Why I.V. Administration Sets Require In-Line Filters? Chapter 7 : Materials : Medical Polymers, Biopolymers & Other Materials 7.1 Polymers To Restore The Sound Of Music? 7.2 Conductive Plastic Which May Preserve Eyesight...!! 7.3 UHMWPE Fibers 7.4 Engineered Medical Coatings Advancing The Performance Of Medical Devices 7.5 Intelligent Materials To Revolutionise Surgical Implants 7.6 Medical Device Coatings 7.7 Why You Should Not Use PVC Tubing In The O2/ Aircircuit If You Are Using Forane Chapter 8 : Manufacturing : Technologies & Trends 8.1 Welding Of Thin Polymeric Films For Medical Applications 8.2 When To Consider Outsourcing Medical Device Manufacturing To A Contract Manufacturer? 8.3 Health Technology Assessment (HTA) 8.4 Ultrasonic Welding For Assembling Of Medical Components 8.5 Filters In Intravenous Filter Sets 8.6 Hypotension And Bedside Leukocyte Reduction Filters Chapter 9 : Packaging & Sterilization 9.1 Determining Breathable Area Of Sterilization Package? 9.2 Packaging Failures: The Largest Source Of Sterility Recalls 9.3 Sterilization Of Plastics 9.4 Using Steam For Sterilization 9.5 Packaging Combination Products (Medical Devices) 9.6 How Different Sterilisation Methods Were Developed? 9.7 The Importance Of Keeping Premixed IV Bags Covered In Their Plastic Overwraps

10.2 10.3 10.4 10.5 10.6 10.7

Prevention Of Catheter-Related Infections Dialysis Procedure Five Steps To Safer Healthcare Healthcare Supply Chain The “Distribution Channel” For Hospitals The Reuse Of Single-Use Devices

Chapter 11 : Environment, Waste management & Safety Concerns 11.1 PVC : The Environmental Perspective For Health Products 11.2 Establishing A Healthcare Plastics Recycling Program 11.3 Healthcare Plastics Recycling 11.4 Shared Responsibility For Medical Device Safety And Performance 11.5 Safeguarding Cardiac Guide Wires To Avoid Breakage 11.6 Infectious Hospital Waste 11.7 Safety Of Healthcare Professionals 11.8 Vinyl And The Environment? Chapter 12 : Industry, Government Research & Academic Institutiona 12.1 Sterilization Packaging Manufacturers Council 12.2 Pediatric Medical Device Institute 12.3 The Center For Devices And Radiological Health (CDRH) 12.4 The US Healthcare Industry About the Author Product and Subject Index References ADDENDUM 1.

About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices

About Implants As The Fastest Growing Application For Medical Plastics

About Best Practices to Ensure Good Supplier Management

About Effect of Medical Device Quality Performance on Business Performance

About Failure of Endotracheal Tubes

About Hospital Errors on Medical Tubing Killing Patients

Balancing Product Development Effectiveness with Regulatory Compliance

About Welding of Thin Polymeric Films For Medical Applications

About Challenges Of Using Combination Products

10. About Trends In Medical Device Adverse Events

Chapter 10 : Healthcare Practices, Procedures & Techniques 10.1 Safe Injection And Safety Practices Jan.-Feb. 2017

Events Events Calender • Medical Fair India 2017 : 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi.

• Medicall 2017 : 17th Edition Date: 28-30 July, 2017 Venue: Chennai.

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

• Medicall 2017 :

Obelis European

18th Edition Date: 06-08 Oct., 2017 Venue: Mumbai.

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.

• PLASTINDIA 2018 : 10th International Plastics Exhibition, Conference & Convention Date: 07-12 Feb., 2018 Venue: Gandhinagar - Ahmedabad. Gujarat.

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

National Healthcare

•

I.V. Infusion Sets

An ISO 9001 : 2008 Company

•

Blood Administration Sets

Manufacturing & Exports of Medical Disposables :

•

Scalp Vein Set

•

Urine Collection Bags

I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

Injection Moulded Medical Components and Extended Tubes : 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 64

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

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. 2017