Medical Plastics Data Service January - February 2017

CToabnletoef nts Vol. 25 No. 1 Jan.-Feb. 2017 24 Cover Story : Event Highlights 14th National Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/ Cover Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Story Export Promotion and Research Organizations. 49 Conference Theme : “Manufacturing Medical Devices in India : Growth Opportunities” Highlights : Workshops : 1. Technology Driven Transactions : Skill Panel Discussions: 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. 4. Medical Plastics : Materials, Processes & Markets AMTZ Investor’s Meet AiMeD Members Meet 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 & 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 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. 20 Jan.-Feb. 2017

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. EDITORIAL ADVISORY BOARD From the Editor’s Desk Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) “MEDICAL PLASTICS DATA SERVICE” : NOW IN THE 25TH Cancer & Reconstructive Surgeon YEAR OF PUBLICATION. Mr. C. BALAGOPAL In first editorial of our first issue of magazine before about 24 Director - Enter Technologies Pvt. Ltd. years, I had mentioned that, “Medical Plastics Products (Now Chairman - Mobilexion Technologies Pvt. Ltd. Devices) manufacturing Industry in India today is witnessing a transformation from an unorganized, uncontrolled industry to a controlled and Trivandrum organized industry”. Initial phase of introduction of Device Legislation was just started. Dr. DILIP H. RAIKER Now at the beginning of our 25th year of publication, we are in the growth Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) acceleration phase. Former Chief Manager(P), CIPET - Chennai Our journey of Successful and Consistent 24 years’ service to the Indian ING LOUIS C. SUHUURMAN Industry has been possible because of generous support from our readers, Formerly Sales Director advertisers and valuable contributions of articles by Industry Leaders and COLPITT B.V., Holland Professionals. We are extremely grateful to all for the kind support and co-operation. Dr. A.V. RAMANI As rightly mentioned by Mr Kishore Khanna, Managing Director, Romsons Group of Group Sr. Vice President (R&D), The TTK Group Industries, in his vision statement reproduced in this issue, “Indian Medical Device Industry shall develop into a global manufacturing hub. “Mr. Kishore Khanna Dr. Vinny Sastri has very precisely enumerated the enablers and opportunities to support President, Winovia LLC, U.S.A. his strong confidence in the Indian Industry. Dr. C.S.B. NAIR Roadmap For Indian Medical Device Industry. Director (R&D), Peninsula Polymers Ltd Despite of many achievements, there are still many challenges faced by Indian Dr. BHARAT GADHAVI Industry. In an “Roadmap for Indian Medical Device Industry” covered in this issue, CEO, Medisurge Hospitals Mr. Rajiv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD) has given a very detailed analysis of the achievements in the Healthcare Mr. A.S. ATHALYE Sector, Challenges faced by Indian Industry as well as how the Government can Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai facilitate to make India a Global Hub for Medical Device Manufacturing. Dr. SUJOY K. GUHA “Innovate-in India” – India’s Opportunity To Leapfrog Beyond Manufacturing B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Dr. G. D. Agrawal, Chairman & Managing Director, G. Surgiswear Limited, has IIT, Kharagpur explained how utilizing brains of India can lead to leapfrog beyond manufacturing into “Innovate-in India” Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastic Disposables / Implants Indsurty 2017. Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Being organized year after year since 2001 with a sole objective of promoting “Make- in-India” mission and close involvement and support of Leading Industry Associations PUBLISHED BY : in Medical Devices, Plastics and Pharma Sectors, a well as Government , Regulatory, Research and Academic Organizations. Also actively supported and participated Classic Computer Services by large number of Raw Materials, Equipments and Service Providers, it has truly B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta become The Annual Celebration Of Knowledge Sharing, Brain Storming and Networking. 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 21

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” 08:30-09.30 Day -1 : March 17, 2017 Time 9.00 am to 6.00 pm 09:30-11.35 11:30-13:30 Registration And Welcome Drinks 14:00-15:45 Inaugural Session : 16:05-17:20 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. 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 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. Session III: Andhra Pradesh MedTech Zone (AMTZ) Investor’s Meet 22 Jan.-Feb. 2017

Programme Schedule 17:20-18:15 Meeting Of “Association for Indian Medical Device Industry (AIMED)” Members. 08:00-09:30 Coordinator : Shri Rajiv Nath : Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) and 09:30-11:30 Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad. 12:00-13:30 Day -2 : March 18, 2017 14:30-17:30 Track I : Time: 10:00 AM to 17:30 PM Registration and Welcome Drink 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 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. 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 23

IPnrvoigteradmSmpeeaSkcehresd&ulPeanel 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 ap- proaches. 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. 14:00-17:30 Track III : 14:00 PM to 16:30 PM 10:00-11:15 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 : Engineering- Sales 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 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 24 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 Dr. Jitendar Kumar Shri H.G. Koshia Joint Drugs Controller General Sharma Commissioner, (India), Central Drugs Standard Director & CEO Food & Drug Control Control Organisation (CDSCO), Andhra Pradesh MedTech Administration Ministry of Health & Family Welfare Zone, Andhra Pradesh (Gujarat State), Government of India, Gandhinagar. New Delhi. Shri Kishore Khanna Managing Director, Dr. Arvind Kukrety Shri Rajiv Nath Romsons Group Deputy Drugs Controller, Central Forum Coordinator, of Industries, Agra. Drugs Standard Control Association of Indian Organisation Zonal Office, Medical Device Industry Ahmedabad. (AIMED), New Delhi, & Joint Managing Director Hindustan Syringes & Medical Devices Ltd. Dr. G. S. Ms. Sashi Rekha Mr. Ravi Mr. V. K. Sharma Bhuvaneshwar Director, National Shrivastava CEO, Director, Sharma Accreditation Board Omni Lens Pvt. Ltd., Pharmaceutical Pvt. Consultant Medical for Certification Ahmedabad. Ltd., Vadodara. Bodies (NABCB), Devices and Former Head New Delhi. Biotechnology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum. Dr. G.D. Agarwal Dr. Kiran Kalia Dr. A. S. Rao Mr. Anand Chairman & Director, National President, Srinivasan Managing Director, Institute of Indian Innovators Head of Polycarbo- G Surgiwear Ltd, Pharmaceutical Association, nates ISC (Indian Shahjahanpur Education and Hyderabad. sub-continent), Research (NIPER), Covestro (India) Dr. Prashant Jha Ahmedabad Mr. Manoj Pvt. Ltd, Mumbai Fellowship Bhardwaj Director, School Mr. Dhiren Mehta Managing Director, Mr. Sarabjot Singh Of BioDesign, All Managing Director, SMC Medical Director, Sterimed India Institute Of Surgimedik Manufacturing Pvt. Surgical India Pvt. Medical Sciences, Healthcare India Ltd., Bangalore Ltd., New Delhi India Pvt. Ltd., Mumbai. Mr. Partha Mr. Umang Shah Ms. Elena Mr. Sanjay Mohapatra Lead National Sales Draganoiu Chotalia Manager – Healthcare & Manager, Clariant Global Technology Technical Sales & Technical Support, Chemicals (India) Ltd., Manager Marketing And INEOS Styrolution Mumbai Lubrizol Medical Segment India Limited, New LifeSciences, Expert Covestro Delhi. Mumbai (India) Pvt. Ltd, Mumbai Jan.-Feb. 2017 25

Invited Speakers & Panel Experts Day -2 : March 18, 2017 Mr. Ganesh Sabat Dr. Atul Sardana Mr. N.R. Saiyad Mr. Sanjay Shah CEO, Sahajanand Director, Alfa Senior Drug Inspector, Managing Director, Medical Corpuscles Pvt. FDCA, Gujarat. Unikal Consultants, Technologies Pvt. Ltd., New Delhi. Ahmedabad. Ltd., Surat Dr. Hemant Desai Ms. Swarna Mr. Ravi Shankar Mr. S. Sridharan Vice President– Sundar Senior Srivastava Managing Operations, Consultant & Chairman & MD, Director, Eucare Makcur Program Manager Invent Bio-Med Pvt. Pharmaceuticals Laboratories, Healthcare, Frost & Ltd., Mumbai. Pvt. Ltd., Ahmedabad. Sullivan, Mumbai. Chennai. Mr. Vipul Sheth Mr. Prakash Dr. Inder Jain Managing Director, Dr. Subroto Bachani Scientist Managing Director Matrix Meditec Pvt. Mukherjee E & Head (MHD), Airways Surgical Ltd., Ahmedabad. Associate Dean, Bureau of India Pvt. Ltd., Facilitation Centre Standard, New Mumbai. Mr. Hiten Bheda for Industrial Delhi. Managing Plasma Dr. Chirag Patel Director, Vinit Technologies, Dr. Ketan Kumar Assistant Performance Gandhinagar. Vadodaria Professor, Polymers Pvt Mr. Siddharth Principal Research Microbiology, Ltd., Mumbai. Jain CEO and Investigator, The Shree Krishna Chief Regulatory South India Textile Hospital, Dr. J. S. I. Advisor, Research Karamsad. Rajkumar, PhD Symbiorph Association, Tamil Director/Scientist Clinical Trialogy, Nadu. K. R. toxicology Ahmedabad. Shri N.K. Balgi Navaneethakrishnan GLR Laboratories Director, M.Sc (PhD) Pvt. Ltd., Chennai Dr. B. Rajan Ferromatik Assistant Director Director/ Milacron India GLR Laboratories Mr. Saumil Mistry Toxicology Pvt. Ltd., Pvt. Ltd., Chennai Engineer – Sales Scientist Ahmedabad Project GLR Laboratories Mr. Ketan Panchal Engineering Pvt. Ltd, Chennai Mr. Sachin Production Manager, Ferromatik Jadhav Lubrizol Indo German Tool Milacron India Pvt. Mr. Parthiv Desai Lifescience, Room, Ahmedabad. Ltd. Director, Sitech, Mumbai Vadodara. Dr. G.P. Vadodaria, Mr. Deepak Dave Er. U. Karthik PhD. (IITD) Former President, Mr. Devendra Premkumar Principal Medical Surgical And Patel Director, Manager- L.D. College of Healthcare Industries Medisoft Biomedical Engineering, Trade Asso. & Telemedicine Engineer, Apollo Ahmedabad Ashutosh Pvt. Ltd., Hospitals Export International, Ahmedabad. International Ltd., Prof. H.T. Mumbai. Ahmedabad Kashipara Dr. Alok Ray Prof. H. A. Patel Former Head, Head, Center for Head, Department Jan.-Feb. 2017 Biomedical Biomedical Eng., of Biomedical Department, U.V. IIT & All India Engineering, U. V. Patel College of Institute Of Patel College of Engineering, Medical Sciences, Engineering, Kherva New Delhi. Kherva. 26

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 disseminate information about the inventions made and capabilities. innovation, Development Communication between three pillars Inventor, user & manufacturer Indian brain is best in the world. Unfortunately brain power is not required. Inventors should approach the world with businessman directed to right direction. To utilise this power one needs to attitude. Mr. Sanjay Chotalia Manager – Technical Sales & Marketing And Medical Segment Expert, Covestro (India) Private Limited, Mumbai Arise & Enhance : Biocompatible Polycarbonates for Medical Covestro High Performance Polycarbonate is a proven choice in Devices the global medical market. We enhance design freedom by weight reduction, heat resistance, toughness & transparency 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. Ms. Elena Draganoiu Global Technology Manager Lubrizol LifeSciences Compatibility of Thermoplastic Polyurethanes with Drugs for a recent increase. A comprehensive evaluation of the in vitro IV Sets compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties, indicated that TPU sets did not Compatibility between medications and intravascular (IV) affect the pH, impurity and particulates of the drug products tested, administration sets is important for assuring predictable delivery being similar or better to compared to TPE and PVC IV sets. 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 Dr. Subroto Mukherjee Associate Dean Facilitation Centre for Industrial Plasma Technologies, Gandhinagar. PLASMAJET - A NOVEL DEVICE FOR BIOMEDICAL An atmospheric pressure plasmajet is developed with argon and APPLICATIONS oxygen as plasma forming gases, and then it is directed to the Plasma the fourth state of matter after solid, liquid and gas, patient’s skin having fungal infection (Tinea Cruris). The initial comprises of ions, electrons, unionized gas atoms/molecules. results indicate that patients are getting cured in 3 to 4 sittings Depending on the nature of plasma generation either the plasma where each sitting ~ 15 minutes. Further studies on the mechanism will have low heat content but high in chemical reactivity (commonly of fungal infection with plasma and micro-biological tests are going known as cold plasma and used for surface modification) or will on. This work is done in collaboration with IIEST, Howrah and have high heat content (commonly known as hot plasma and used IPGMER, Kolkata. Now plasmajet is planned to be put on some for bulk material modification, waste disposal). At FCIPT division cancer cells to test its performance in collaboration in BSG-BARC. of IPR, work on both cold and hot plasmas is being undertaken for various applications for societal benefit. Plasmajet is a device, The talk will highlight development of the plasmajet at FCIPT and which produces a cold plasma at atmospheric pressure and is also mention some other technologies which may benefit the extremely useful for biomedical applications. biomedical community. Mr. Partha Mohapatra Lead- Healthcare, ( India ) & Technical Support INEOS Styrolution India Limited Medical regulatory compliance Styrenics solution provided by Service Package”. There are two main pillars. First, our Medical INEOS Styrolution Grade Styrenics comply with Bio-compatibility, such as ISO 10993 “INEOS Styrolution offers Medical Industry with “Healthcare and USP Class VI. Second, we do not intentionally change product Jan.-Feb. 2017 27

Invited Speakers & Panel Experts : Presentation Abstracts formulation and guarantee customers NOC (Notification of G3, Luran ® HD SAN, NAS ®SMMA, Styrolux ®SBC, Zylar ®MBS Change) up to 3 years. These our Healthcare Packages have been & Terlux ® MABS, which is meant for various medical device highly appreciated by many Medical Device customers where strict applications like Connectors, Adaptors, IV set, Stop Cock, Valves, regulatory compliance is required.” The medical regulatory Drip Chamber, DPI Inhalers, Airways, Nebulizer Housing, Face compliance of Styrenics products offered by INEOS Masks & Respiratory Filters etc. STYROLUTION are Novodur ® HD ABS, Novodur HD GF ABS Dr. Milind Antani Nishith Desai Associates, Mumbai Workshop On “Technology Driven Transactions “with Focus that determination. It will show the methodologies one should On Medical Devices Pharmaceuticals & Healthcare Sector employ, and those that one should not. It will show the sources of Investments. 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 When one negotiates a license of technology, they need to know that determination. 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 Mr. Hiten Bheda Managing Director Vinit Performance Polymers Pvt Ltd., Mumbai Converting Performance Polymers Into Implants / Devices As per required Designs, Selection, Criteria is Driven by Material Attributes that include Mechanical, Thermal, Electrical, Electrical, Engineering and high performance plastics have been used in life Tribological, Bio-Compatibility, etc. and Compliance to Regulatory sciences as materials of construction for Medical Devices, Requirements, Presentation in Context of Current Scenario and Instruments, Sizing Specimens and Handling Equipments. way Forward gives glimpse on the subject These materials are available as stock shape like Rods, Plates and Blocks which can be converted into desired form using numerical Machining Techniques. K. R. Navaneethakrishnan, M.Sc (PhD) Assistant Director challenges faced in broader disciplines including in determining Dr J. S. I. Rajkumar, PhD Toxicologist the relevant biocompatibility endpoints for an evaluation (test Dr B. Rajan, PhD Toxicologist selection (if needed); considerations for use of animal testing vs. GLR Laboratories Pvt. Ltd., Chennai. in vitro testing; sample preparation of nanoscale, bio absorbable, and in situ polymerized materials; evaluation of color additives); Workshop On Biocompatibility : Updated Information, general biocompatibility testing considerations, including test article Clarifications and Recent Advancements preparation; specific considerations for the following testing specially for devices utilizing nanotechnology. 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 UL India, Banglore Validation Needs For Packages Of Medical Devices. preserve the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental According to the World Health Organization (WHO), healthcare- exposure, or be compromised through normal handling associated infections (HAIs) are the mostfrequent adverse event encountered during storage and transportation. As a result, rigorous in the delivery of healthcare services worldwide, affecting hundreds testing of packaging systems used with medical devices is of millions of patients each year. Ensuring the sterility of medical devices is an important tactic in the overall effort to reduce the mandatory in most major jurisdictions around the world. rate of infections in hospitals and other healthcare settings. Regulators in the EU, the U.S. and other major healthcare markets Effective packaging and packaging materials are essential to help have implemented strict requirements for packaging systems and 28 Jan.-Feb. 2017

Invited Speakers & Panel Experts : Presentation Abstracts packaging materials used to preserve the sterility of medical validation testing methods applicable to packaging systems and/ devices, protect their functionality and retain their biological safety. or materials used in conjunction with sterile medical devices. In the EU, medical device directives and regulations mandate Beginning with a review of the importance of packaging validation that medical device packaging materials and systems conform for medical devices, the presentation then presents a summary of with the requirements of the ISO 11607 series of standards, ISO 11607, the standard for packaging materials used for sterilized Packaging for terminally sterilized medical devices. And in the medical devices, and provides details on validation testing as U.S., the FDA accepts evidence of compliance with ISO 11607 in prescribed in the standard. The presentation concludes with some support of 510(k) applications for the approval and registration of recommendations for manufacturers on the selection and medical devices. evaluation of suitable packaging and packaging materials for medical devices. In this UL presentation, we’ll discuss the requirements and Mr. Umang Shah National Sales Manager Clariant Chemicals (India) Ltd., Ahmedabad POLYMER COMPOUNDS & MASTERBATCHES - HELPING • Various Innovative solutions of Masterbatch and compounds YOU DELIVER SAFE TREATMENTS GLOBALLY from CLARIANT. • Key differentiators for Medical Masterbatch compared to • Various Applications conventional MB. • CLARIANT’s overview and focus for the Medical & Pharma • Regulatory requirements Segment. • Medical & Pharma MB overview for Drug Delivery, Invasive, Diagnostics and Pharma Packaging Mr. Siddharth Jain CEO and Chief Regulatory Advisor Symbiorph Clinical Trialogy, Ahmedabad Global Product Registration-Medical Device medical devices. Despite the significant presence of domestic players in the industry, In the recent years, MNCs and domestic players have designed the Indian medical devices market is still largely dependent on and developed India specific medical devices in their R&D centers imports. located in India. These products have been designed to suit the needs of the developed market – in terms of product specifications However, ‘Local innovation’ by MNCs as well as domestic players and pricing. Interestingly, these products have also created is expected to drive indigenous manufacturing and lead to rapid demand in other developing markets outside India. growth of exports. Challenges across multiple dimensions that were disablers to the Export of medical devices have grown at a rate of around 12% export of indigenous medical devices need to be addressed. These over the past five years, reaching a value of USD 1.2 billion in include poor knowledge for country specific regulatory requirement, 2014. This indicates strong performance of the domestic poor regulatory documentation and providing the Marketing manufacturing industry although limited in size. The Consumables Authorization to single distributors are some specific and implants segment accounts for more than 40% of exports road blocker for Indian medical device export industries. from India with USA being the leading destination of export of Dr. Chirag Patel addressed by device manufacturing industry. The development of Assistant Professor, Microbiology newer preventive technology in device manufacturing industry will Shree Krishna Hospital, Karamsad need an eyesight to be developed in the manufacturers. In the emerging world of antimicrobial resistance in potentially infectious Biofilms in Indwelling medical devices healthcare associated pathogens, to prevent them to harm further in patients and control this challenge before it becomes threat to The Indwelling medical devices are used frequently in patients mankind, its indeed research done from manufacturers are of great typically critical patients in multiple ways for multiple purpose and future value. 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 29

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 How Can Government Facilitate to Make India a Global getting CE and ICMED Certification. On our request Hub For Medical Equipment Manufacturers. to create a Separate Rule Book for Devices, the Mo-H&FW responded favourably and subsequently on Most of the policy decisions taken in the past have been 19 October, 2016 the initial draft of the separate rules based on White Papers published at the behest of MNCs to regulate medical devices was shared with the who are ruling the roost in CII and FICCI – (importers with stakeholders and uploaded on website for public overseas manufacturing facilities) who are comfortable comments. Comments have been collected and to access the large unregulated Indian market with minimal collated and the draft updated and rules are in process tariff barriers and while they make right sounding noises of notification. Also in response to our request for a they have been opposing most of the five corrective Separate Law from Drugs & Cosmetics Act, a draft strategic actions suggested by AiMeD that could Medical Device Bill has, meanwhile, been prepared strengthen Make in India or help make Indian by MOH&FW and is going internal review within the manufacturers more competitive and thereby increase Ministry, thereafter Stakeholders will be invited for their market share, such as: Tariff Correction, with the plea consultations and thereafter we expect this to be that it affects affordability and accessibility to poor patients. uploaded on the website for public comments before Our contention is being to make manufacturing viable and being presented to the parliament by ministry. profitable as before and reverse ongoing trend of manufacturers becoming importers / traders. Later iv) On our request to government to review and pull back domestic competition will bring down prices. Regulations, its Auto Approval Brownfield FDI Policy - it’s ok to retain (Short Term Correction of Amending Rules , Schedule MIII, this for 100% Green Field Projects for manufacturing, Guidelines, etc.) with the plea that it would lead to further not trading - for ensuring choice of Indian brands to confusion and affects accessibility and better to wait till a Indian consumers , RBI has initiated investigation on law is passed. Our contention being to use the available the 100% FDI policy for potential misuse and its impact. short term solutions of administrative circulars and of executive orders rather than delay till availability of lengthy About Challenges Faced By Indian Medical Devices legislative process. Mandatory MRP & Price Capping – Industry With the plea that it will scare away investment. Our The Indian medical device industry is facing the challenge contention being that affordability and competition is of having to compete with imports with deep pocketed getting skewed - not lower ex-factory price but higher retail MNC importers and pseudo manufacturers in a very price wins and consumers are suffering from artificial adverse eco system that is encouraging imports-based inflation and domestic manufacturers suffer from loss of trading instead of manufacturing so that even existing market share unless they match ever increasing MRP and Indian manufacturers are shifting to imports as that is more trade margin. ICMED – Self Certification and Self convenient and more profitable than to produce in India. Regulation, with the plea that it creates a parallel From being a manufacturing-led economy, India is mechanism with CDSCO so better to have only one control becoming a trading and services- led economy in the past and are afraid it could be used as a non-tariff barrier in decade. Manufacturing was brought back into focus by due course. Our contention being it provides credibility to the honourable Prime Minister with his slogan and vision Indian products and low cost access to local certification of Make in India and starting point is to make illegal – rather than getting expensive overseas certification for pseudo manufacturers by clearly defining it as falsely and CE / ISO 13485 etc. and respect for Indian brand, a law to purportedly claiming to being an Indian manufacturers regulate all devices may not be there for a few years and without actual manufacturing it in India – manufacturing a law can permit voluntary certification. Preferential Market site and country of origin needs to be clearly labeled to Access – With the plea that it restricts access to quality ensure transparency and tracking and the site where there products in the absence of regulations. Our contention is is a value addition of over 40% and there’s a change of it will boost domestic manufacturing and also stop usage sub-heading of classification indicating transformation of of USFDA compliance as a mandatory qualifying criteria an output from more than one input so at least it’s an in many tenders. Why should Indian manufacturers be assembly of components. denied access to our own Indian market unless they comply with a foreign country regulatory approval of Jan.-Feb. 2017 CE / USFDA ? It’s unfair. Use ICMED! (Based On a Recent Interview Published in “eHealth”) 31

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. 32 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 This landmark public-private partnership will help India become the top 5 5 global hub for medical device manufacturing - Rajiv Nath, Forum global hub for medical device manufacturing,” said an elated Mr Rajiv Nath, Coordinator, AiMeD Forum Coordinator, AiMeD. • We are delighted to join hands with AiMeD to bring in investment to the “We know the roadblocks that need to be addressed for both Indian and medical devices sector in India and convert India into a global medical Overseas Investors and will focus on getting collaborations and joint devices manufacturing hub - Deepak Bagla, Managing Director, Invest ventures with midsized Indian companies with midsized overseas India manufacturers and OEM relationships with large overseas companies. This MoU will create basis for implementing a coordinated cooperation in New Delhi, 15th Feb, 2017 : In a landmark public-private collaboration achieving the manufacturing objectives as was recently done for Indian aimed at making India a global manufacturing hub of medical devices, the Cellular Industry. I have a vision of India being amongst Top 5 Manufacturing Association of Indian Medical Device Industry (AiMeD) and Invest India Hubs of Medical Devices and this MoU will help realize it by giving a big today signed a MoU which will promote and facilitate ‘Ease of Doing strategic push to manufacturing and innovation in Indian medical device Business, Promote Manufacturing and provide Hand Holding Services while industry while promoting Ease of Doing Business in India,” Mr Nath added. aiming to transform India into a Global Medical Devices Manufacturing Hub in keeping with ‘Make in India’ mission. 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 AiMeD is the leading voice of domestic medical device manufacturers while India and convert India into a global Medical Devices Manufacturing Hub.” Invest India is the official investment promotion and facilitation agency of the Government of India, mandated to facilitate investments into India.The According to credible estimates, India imports over Rs 30,000 crores of MoU was signed by Mr Rajiv Nath, Forum Coordinator, AiMeD on behalf of medical devices, which is nearly 70% of our requirement. In addition, there the industry body and Mr Deepak Bagla, Managing Director, Invest India. is an equally huge export potential to the tune of Rs 50,000 Crore! Significant Points and Objectives of the MoU : Medical device sector is being seen as the next big thing after IT and Defence i. AiMeD to provide support to Invest India to enhance domain knowledge and India has the potential to emerge as a major exporter on the lines of in medical devices and components sector and jointly aim to build capacity pharma products. and capability in Government of advanced India has now manufacturing added medical technologies and devices as one of negotiating skills for the flagship sector technology tie ups. to catapult its ii. Invest India to support ambitious ‘Make and supplement in India’ mission. AiMeD’s efforts to The MoU between achieve the AiMeD and Invest broader vision to India is in tune establish India the with realizing Global Manufacturing these national HUB for medical devices and objectives. components. iii. AiMeD and Invest India About AiMeD: will jointly work with AIMED is an various Central umbrella Government and State association of Government Indian Departments & Agencies to establish appropriate policies and regulatory manufacturers of framework to promote manufacturing of medical devices and components medical devices covering all types of medical devices including on a day to day basis. consumables, disposables, equipments, Implants, instruments and iv. AiMeD and Invest India will reach out to all Tier 1, Tier 2 and Tier 3 diagnostics. AIMED has a primary membership of over 350 manufacturers companies in major medical devices destinations like Taiwan, Japan, and additionally of over 150 associate members representing the interest South Korea, Italy, Israel, Germany, USA etc with the objective of of over 800 manufacturers of medical devices to address the manufacturer’s technology sourcing and manufacturing JVs for India. problems. To know more about AIMED, please visit www.aimedindia.com v. AiMeD and Invest India will jointly host international road shows including conferences, seminars, exhibitions to promote manufacturing in India About Invest India: Invest India is the official Investment Promotion and and to apprise potential investors of the policies, investment and Facilitation Agency of the Government of India, mandated to facilitate manufacturing opportunities available in India related to medical device investments into India. Invest India has a team of domain and functional and component sector. experts who provide sector-and state-specific inputs, and hand-holding support to investors through the entire investment cycle, from pre-investment “We are honoured and delighted to join forces with Invest India to work as decision-making to after-care. their knowledge partners on practical strategies to realize Make in India. For more information please contact : Rituparna Madhukalya, Jan.-Feb. 2017 Mob: 08826639144, Email: rituparna@fourthestateindia.com 33

Quality Advanced Process Validation For Medical Device Test Method Validation Manufacturers Background : Test methods are one of the most critical Background : Due to the complexity of many medical elements in the design, development, manufacture and devices, routine end-product testing alone is insufficient release of products. They provide the objective evidence to assure the quality, safety and effectiveness of the device for the safety and effectiveness of devices. It is thus or its components. imperative that device manufacturers ensure their test methods used in the determination of safety and With a focus on in-depth process validation methods and effectiveness for their product are suitable, capable and statistical rigor, this four-day advanced session will explain reliable for their intended use. Inadequate test method the intent and importance of process validation with validation can have severe regulatory and business respect to the regulations and standards, emphasizing consequences. In the past few years, regulatory bodies the connectivity between design controls, risk have added additional focus on test method suitability and management and statistical techniques. The training will reliability in their audits and inspections. also provide participants the fundamental knowledge and tools to establish and implement effective process This two-day session will explain the intent and importance validation lifecycle systems. Hands-on, interactive of test method validation with respect to the regulations exercises will highlight and reinforce the principles learned. and standards. The training will also provide participants the fundamental knowledge and tools to establish and Objectives : implement effective test method validation procedures and • Understand the intent and purpose of regulations as it processes. Hands-on, interactive exercises will be used to highlight the principles learned. applies to process validation and production controls • Know how design controls and risk management feed Objectives : • Understand the intent and purpose of regulations as it into process validation • Learn the fundamentals of Test Method Validation and applies to test methods across the product lifecycle • Learn the basic principles of Test Method Validation to Measurement Systems Analysis • Learn to identify which processes to verify and which determine suitability and capability of the test method for its intended use process to validate • Understand the requirements for the qualification of test • Be able to develop a Master Validation Plan equipment • Learn to calculate basic quality metrics and determine • Understand requirements for calibration • Understand how to conduct a gauge repeatability and sample sizes reproducibility (Gauge R&R) for variable data and • Learn to use statistical methods like design of attribute data • Learn the principles of method transfer experiments (DOE) to determine critical process and • Lear how to develop and complete test method raw material parameters protocols and reports • Learn the principles of Installation Qualification (IQ), • Understand the validation life-cycle and changes to test Operation Qualification (OQ) and Performance methods Qualification (PQ) using protocols and reports • Understand the basics of risk management and The Links For the Above Two Training Programs : developing a Process Failure Mode and Effects Analysis • Advanced Process Validation Training, May 16-19, (PFMEA) • Identify key outputs from process validation 2017, Chicago IL • Learn to formulate methods for process monitoring and http://winovia.com/advanced-process-validation/ control • Understand the concepts of statistical process control • Test Method Validation Training, July 18-19, 2017, (SPC) and statistical quality control (SQC) Chicago, IL • Understand how to maintain the validated state and the http://winovia.com/test-method-validation/ criteria for revalidation 34 Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles Dr. S. Eswara Reddy He is actively representing nine national and state level is responsible for the brand “ROMSONS”. His (Joint Drugs Controller General (India), committees. He is Chairman of the very important indomitable stance for research and development has Central Drugs Standard Control Organisation, committee “Track & Trace”, for preparation of led to the nurturing of the brand “Romsons”, which is Ministry of Health & Family Welfare guidelines to prevent of menace of spurious drugs. today an eminent player in the healthcare sector, serving Government of India, New Delhi) millions of patients in the country &worldwide. He has played a pivotal role in transformation of pharma Dr. S. Eswara Reddy is the Deputy Drugs Controller Of and medical devices sectors in Gujarat to emerge as a His contribution to the medical fraternity has been India, Central Drugs Standard Control Organisation, favorable investment destination with proactive & recently recognised at ASICON for undertaking the Ministry of Health & Family Welfare, Govt. of India. He pragmatic approaches. He was instrumental in the Mission “Make in India”. He has also been honoured holds a Masters Degree in Pharmacy and Ph.D. and implementation of e-governance in FDCA and is by the Government of Uttar Pradesh with the “Udyog has rich experience in manufacturing of pharmaceuti- winner of one state level and three national level Ratan Award” for Quality Management Practices in cals, academic and in Regulations. awards. Business. He had also been bestowed with Presidential Award for Innovative Achievement in Medical Devices. He started his career as a Drugs Inspector in CDSCO, *********************************************************************** West Zone, Mumbai in 1998 and has good experience Shri Rajiv Nath In the early 70s, at the age of 20 he was the youngest in GMP, GCP and GLP audits and promoted as an (Jt. Managing Director, Hindustan Syringes & member to join the family business of disposable Assistant Drugs Controller of India in 2009. Medical Devices Ltd., Faridabad medical devices and started his career manually Forum Coordinator operating moulding & extruder machines, working on He participated in many national and international semi- Association of Indian Medical Device Industry (AIMED)) assembly& packing lines. At the age of 30, he took over nars / workshops / meetings on various areas of Drugs the business and brought all kinds of technical regulations and undergone training from USFDA, KFDA, Mr. Rajiv Nath is Jt. Managing Director of Hindustan advancements, process upgradation and mustered all South Korea and WHO, Geneva. He is regularly invited Syringes & Medical Devices Ltd. which is having a the mechanisms to arrive at state-of-the-art to make presentations at various seminars and work- turnover of over 500 Crores & Trustee – Safe Point India manufacturing. Today Romsons has to its credit 10 shops. He also published articles in various journals. – a CSR Initiative of HMD (Hindustan Syringes & design patents with the backing of the dedicated state- Medical Devices Ltd.). He is President of All India of-the-art R & D unit approved by the Department of *********************************************************************** Syringes & Needles Mfg. Association. (AISNMA) & as Science & Technology. Dr. Jitendar Kumar Sharma well as the Founder and Forum Coordinator – Director & CEO Association of Indian Medical Device Industry (AIMED) He has travelled across the globe in search of business Andhra Pradesh MedTech Zone, Andhra Pradesh with over 350 Members nationwide whereby Medical and learned the dynamics of international business. As Device Manufacturers all types of technologies have a result today Romsons is one of the pre-eminent brands Known in media circles as the “Med Tech Man” Dr. been attracted nationwide on one Platform. in the disposable medical devices field. Romsons is a Jitendar Sharma is the Director & CEO of Andhra name to reckon with medical disposable devices in over Pradesh MedTech Zone which is Asia’s first medical As Forum Coordinator of AIMED, Mr. Nath has taken 90 countries, where the company exports. devices manufacturing city. He is the Adviser for Health many initiatives of establishing a Collaborative to the Hon’ble Chief Minister, Govt. of Andhra Pradesh Framework with various Dept. of the Govt. and Media Mr. Khanna is also an important stakeholder in the and a Fellow at Joanna Briggs Institute of Evidence to bring to their attention issues troubling the industry Indian Medical Device Industry. He is the co-founder Based Medicine at University of Adelaide, Australia and attract investments into India in his quest to make and co-ordinator of AIMED, which is the most influential besides the program Director for Health Technology India as the Preferred Manufacturing Destination and association in the Indian Medical Device Industry. Assessment (HTA) fellowships in India. Earlier he the leading Supplier of Medical Device Worldwide. Mr. Khanna is also an active member and integral part established the Healthcare Technology Division and was of the management committee of National Chamber of the Founder Director of WHO Collaborating Centre for Position held : Commerce and Industry, Agra. Medical Devices at NHSRC under Ministry of Health & • Jt.Managing Director of Hindustan Syringes & Medical Family Welfare, Government of India. His past Mr. Khanna possesses a strong commitment towards experience includes that at Sri Sathya Sai Medical Devices Ltd. (HMD) social responsibility and runs a Romsons Charitable Institutions- one of India’s largest non-for profit • President of All India Syringes & Needles Mfg. Society which is focused on serving the needy. He is healthcare organizations, as consultant to World Bank, also the Vice President of Agra Charitable Eye Centre. as Consultant to the World Health Organization, Geneva Association. (AISNMA) *********************************************************************** and advisor to Health Technology Innovation Centre at • Forum Coordinator of Association of Indian Medical Dr. G.S. Bhuvaneshwar Indian Institute of Technology (IIT). He has contributed Consultant, Medical Devices – Design, development, through several research papers, seven books on health Device Industry (AIMED) testing and quality mgmt., Adjunct Prof., Dept. of technologies & assessments, six compendiums on • Jt. Coordinator of Indian Medical Device Regulatory Engineering Design, IIT, Madras technical specifications for medical technologies and a number of WHO reports on health technologies. He has Review Group (IMDRRG) He graduated with a B.Tech (Electronics) in 1972 and been a key designer and coordinator for several • Jt. Coordinator of UDAIMED M.S. (Bioengineering) from IIT Madras. He later technology intensive health programs in India such as • A Member of International Association of Safe obtained a PhD in Biomedical Technology from the national biomedical equipment maintenance SCTIMST in 1994. He has been honored with several program, the national diagnostics program and national Injection Technology (IASIT) and served on the Board. awards, notably the Distinguished Alumnus Award of dialysis program besides creating the National • Member of “International Safe Healthcare and HIV IIT Madras in 1999, Materials Society of India Medal Materiovigilance Program for adverse event tracking lecture and NRDC awards for meritorious inventions. due to medical devices, program for setting up of /AIDS Working Group”. In May 2016 he was elected “Fellow, Biomaterials medical devices testing laboratories and the program • Member of “India Coalition on Injection Safety” Science & Engineering (FBSE)” by the International for medical technology innovations uptake in public • Member of Think Tank Pharma Forum Union of Societies of BSE at the World Biomaterials health system. He teaches courses on health policy & Congress held in Montreal, Canada. health technology in several countries, including India. An active Member of expert committee and Task Force for Medical Devices Regulation in India. From Sep 2012 to Dec 2015, he was Director of *********************************************************************** Innovation at Trivitron Healthcare Pvt, LTd., Chennai – Dr. H. G. Koshia *********************************************************************** a leading company of Indian origin with a major focus (Commissioner, Shri Kishore Khanna in In vitro Diagnostics. Food & Drugs Control Administration, Gujarat) Managing Director Romsons Group of Industries, Agra Previously, he retired as Head of the Biomedical Dr. H.G. Koshia is currently Commissioner, Food & Technology Wing of Sree Chitra Tirunal Institute for Drugs Control Administration, Gujarat and his key Re- Qualifications: B.Sc., LL.B., MBA (OMP) Medical Sciences & Technology (SCTIMST), sponsibilities are Enforcement of “Drugs & Cosmetic Trivandrum in 2012 after a long distinguished career Act, 1940 and Rules” & Enforcement of “Food Safety & Current Professional Activities: Managing Director, spanning 36 years. Standard Act, 2006” and rules, in Gujarat State. Overlooking the complete management of the Romsons Group of Industries. His long career has covered the very important aspect Jan.-Feb. 2017 of medical device testing / validation with active Experience & work responsibilities: Rich experience of 50 years in the medical device industry and more 35 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

Invited Speakers & Panel Experts : Profiles involvement in the development of test systems for heart in International Market. Due to his extensive knowledge Shri V.V. Giri. She is member of many professional valves, blood oxygenators, vascular grafts, and experience in Restructuring Operations, societies like Indian Science Congress, Society of hydrocephalus shunt systems, with many of them International Marketing, International Business Biological Chemists, India, Society of Toxicology – India, having computer based data acquisition and control. Relations, Collaborations and Joint Ventures, he has Indian Association of Micronutrients, New Delhi, and been appointed as Director (Global Trade) in 2011. Organization of Women Scientists in Developing World In 2008, he lead a small team in the institute, which (OWSD), Italy. drafted a Bill for the Medical devices regulation at the He traveled across the globe in search of business and behest of the Government of India. learned dynamics of international business. His She has delivered 75 presentations and guest lectures visionary approach to serving his clients has enabled at various national and international platforms that During his 4 decade long career, he has worked closely him to anticipate and meet the changing imperatives of includes plenary / lead lectures. She has 3 chapters in with clinicians and surgeons and been closely involved the marketplace. book published by international publishers. She is in clinical trials, animal studies and clinical ethics. He actively involved in teaching masters, doctoral students has to his credit 9 patents, 5 book chapters and 33 He has played a very active role in acquiring “SHARMA and specializes in exploring biochemical aspect of research publications. ORTHOPEDIC” the reputation of a leading brand in diabetes. She has 35 years of research and 31 years orthopedic implants and making the strong presence of teaching experience with 71 publications in various *********************************************************************** across India and emerging as a fast growing brand national and international peer-reviewed journals. She Ms. Sashi Rekha across the Globe. has guided 22 Ph.Ds, over 50 M.Sc. dissertation Director, National Accreditation Board for Certification students.Currently,7 students are working under her for Bodies (NABCB), New Delhi He has prepared “SHARMA ORTHOPEDIC” for their doctoral degree. She has received several continual growth by developing its distinctive business extramural research grants from different funding Ms. Sashi Rekha has a graduation in Food Technology model, client relationships and depth of staffing agencies and has completed 16 major research projects from the University of Agricultural Sciences, Hebbal, expertise. from University Grants Commission (UGC), Department Bangalore and a post-graduation in Food Technology of Biotechnology of Ministry of Science and Technology from CFTRI, Mysore. She has worked with Cadburys *********************************************************************** (DBT), Govt. of India, Gujarat State Biotechnology India Ltd. for two years looking after production and Dr. G D Agrawal Mission (GSBTM) Gandhi Nagar, Ministry of Earth quality control of ice cream in franchisee ice cream Chairman & Managing Director Sciences (MoES), New Delhi and Defense Research factories. G. Surgiwear Limited, Shahjahanpur and Development Organization (DRDO), New Delhi. She then joined the Bureau of Indian Standards Dr. Agrawal is a science graduate and has done MBBS *********************************************************************** (National Standards Body) and has worked with them and Masters in general surgery from King George Dr. A.S. Rao at Hyderabad, Bangalore, Chennai and Delhi in Product Medical College, Lucknow. President-Indian Innovators Association, Hyderabad Certification, Management Systems Certification, Laboratory as well as Standards formulation activities His Interest and Specialization lies in Creating New Dr. Aynampudi Subbarao (Dr. A.S.Rao) is an innovation for over 21 years. Medical Devices. consultant with a rich perspective gained from working in industry, government and academia. He was in She joined National Accreditation Board for Certification His Developments & creations include Hydrocephalous industry during license raj period marketing products Bodies as Director (Operations) on 01 April, 2015 and Shunt System; Penile Prosthesis, Peritoneo-venous which are imitations, made with foreign collaboration has been handling Inspection bodies and Certification shunt, Combined disposable drape, Hydroxyapatite and with CSIR technology. Worked for two decades in bodies Accreditation programmes. bone substitute; First aid products for Army: Rakshika, DSIR, Government of India, went thru the technology Universal emergency splint and many more; Glaucoma absorption phase with TAAS, new product development *********************************************************************** Shunt and Glaucoma device; Cranial Flap closing with PATSER and creativity with TePP. As a part time Mr. Ravi Shrivastava systems of many types; Buzywoman one boil food academic, regularly contributed articles and authored (CEO, Omni Lens Pvt. Ltd., Ahmedabad) products & Many Many more books -Management of Technology Change published in 1994 was the first book on MOT in India. Full time Mr. Ravi Srivastava has about 27 years in handling sales He has published research articals in international mentor to innovators, his current passion is connecting and marketing functions in domestic and international journals. He has received 20 National awards and has innovators to the market. Formally associated with IIT business. He has worked with well-established global to his credit 3 International Patents and has applied for Hyderabad and devotes maximum time to the NGO – western multinational companies and start up compa- 50-60 Patents. Indian Innovators Association. Organised India’s first nies of repute from India. International Innovation Fair in 2016 in Bangalore and *********************************************************************** now working on 2017 fair coming up at Visakhapatnam. He is currently designated as CEO with major respon- Dr. Kiran Kalia sibilities of Global Business development in Omni Lens Director - National Institute of Pharmaceutical *********************************************************************** (P) Ltd., manufacturing wide range of CE certified oph- Education and Research (NIPER), Ahmedabad Mr. Anand Srinivasan thalmic medical devices and other pharmaceutical prod- Head of Polycarbonates ISC (Indian sub-continent) ucts meeting International standard. His Key responsi- Dr. Kiran Kalia is presently serving as the Director of Covestro (India) Private Limited, Mumbai bilities include strategic planning, identification of National Institute of Pharmaceutical Education and emerging market areas, new product development be- Research (NIPER), Ahmedabad at Gandhinagar. She Mr. Anand Srinivasan is the Head of Polycarbonates sides strengthening the present business in Interna- graduated in Biochemistry and received her PhD degree ISC (Indian sub-continent). A Chemical engineer by tional markets like U.S., Latin America, Europe, Japan, in 1984 from Industrial Toxicology Research Centre training, he joined Bayer Corporation at Pittsburgh post China, Korea etc. besides strengthening existing (ITRC), Lucknow. She was an awardee of prestigious his Master’s Degree from Penn State University, USA business. DBT overseas research associateship and was the in 1998. He started off as a process engineer, and visiting Professor at School of Health Sciences, Purdue moved on to project engineering. He has travelled widely in about 90 countries across University, USA in 2006-07.Her current areas of interest/ U.S., Latin America, Europe, Africa, Middle East, UAE, expertise include several aspects of diabetic The next opportunity was at the Baytown Texas Korea, China and many other Asian countries. nephropathy, metal toxicity and presently interested in (Covestro) site, where he was the Air Compliance lead. proteomic and genomic biomarkers. She is the task In 2009 he decided to move back to India and took up *********************************************************************** force member of many national level committees of the commission of a new molecule, as plant manager Mr. V. K. Sharma, decision making under Govt. of India. She is also one at the Agro plant in Ankleshwar, Bayer CropScience. DIRECTOR (GLOBAL TRADE) of the core members of policy making in Department of Sharma Pharmaceutical Pvt. Ltd., Vadodara. Pharmaceutics, Govt. of India. She is a INSA visiting After production, Anand headed the Supply Chain fellow and the Fellow of Gujarat Science Academy. Center for Covestro India (formerly Bayer Mr. Vivekanand Sharma is a Director of Sharma MaterialScience).He was instrumental in establishing Pharmaceutical Pvt. Ltd. He got an Engineering She is reviewer of various National and International the nicer globe initiative, where chemical companies (Mechanical) degree from Parul University, Vadodara. Journals and recipient of numerous Awards and have come together for a common vision, to address Mr. V. K. Sharma has started his career in 2006 as a scholarships including 8th “International Prestigious transportation distribution safety in India. Design Engineer and through his vision and keen Sardar Patel Award” for Excellence in Women interest in product design; he was also much interested Empowerment. She was awarded with the “President Jan.-Feb. 2017 in Production as well as Strategic Planning. Within 2 Guide award” by His Excellence The President of India years of time, he has started to build a business relation 36

Invited Speakers & Panel Experts : Profiles He has actively lead initiatives at the Texas Chemical business strategy consulting, business process actively engaged in business development/ marketing Council and now participates at the Indian Chemical consulting, supply chain and logistics, new product of styrene’s products for healthcare industry. He is Council. introduction, lean manufacturing, program management involved in new projects developments with as well as IT/ ITeS consulting, infrastructure and pharmaceutical packaging & medical disposable device He recently took over the position of heading the services. industry. He provides technical/development support to Polycarbonates business for the Indian sub-continent. customer from initial stage to project commercialization Apart from being technically skilled, he is a musician, *********************************************************************** stage. He possesses diverse technical sales marketing artist, and a fitness fan. Mr. Sarabjot Singh experience in the field of medical grade styrenic Director - Sterimed Surgical India Pvt. Ltd., New Delhi polymers. *********************************************************************** Dr. Prashant Jha Mr. Singh is an entrepreneur and Founding Member of *********************************************************************** Fellowship Director, School Of BioDesign, Sterimed Group of Industries. He has done Diploma in Mr. Umang Shah All India Institute Of Medical Sciences, New Delhi Polymer Technology from Indian Plastic Institute (IPI). National Sales Manager Clariant Chemicals (India) Ltd., Mumbai Dr. Prashant Jha is a physician, engineer, entrepreneur He has over 30 years of experience in the field of and a medical editor. He teaches at AIIMS & IIT Delhi manufacturing of Disposable Medical Products and 17 Mr. Umang Shah is working with CLARIANT Chemicals where he directs a post-graduate Fellowship program years of experience in the field of manufacturing of India Ltd. CLARIANT is one of the world’s leading in medical device innovations and entrepreneurship. Industrial and Medical Adhesive Tapes. Specialty chemical companies. He is a National Sales He also serves as an adjunct professor of Healthcare Manager – Masterbatches & Compounds for Medical & Innovations at various medical, engineering and Mr. Sarabjot Singh is also experienced in the field of Pharma Segment since Dec, 2015 and based at head business universities in Japan, Australia and Europe. manufacturing of Hotmelt Adhesives and manufacturing quarter in Navi Mumbai. Dr. Jha has invented over a dozen medical devices in of Nonwoven bags. domains of gastroenterology, women’s health, ENT, Earlier, he has worked with SABIC Innovative Plastics paediatrics and Intensive care medicine. He is a serial *********************************************************************** & GE Plastics India for more than 22 years. He has rich entrepreneur and has set up enterprises in healthcare, Ms. Elena Draganoiu & multi-functional experience and handled various key education and internet technologies over last 15 years. Global Technology Manager responsibilities as a Key Accounts Manager – Sales & He is the founder & editor of BMJ Innovations, world’s Lubrizol LifeSciences, Mumbai Marketing, Application Development Specialist, first general medical innovations journal and also serves Technical Services Manager at Mumbai. Engineering as the Senior Editor for The BMJ in South Asia. Ms. Elena Draganoiu, Ph.D. is global technology Plastics Compounding at Vadodara Plant, Application manager in Lubrizol LifeSciences, where she is Development Centre at Gurgaon and GE’s Global R&D *********************************************************************** responsible for leading technical programs in the area center at Bangalore. Mr. Dhiren Mehta of pharmaceutical ingredients. She holds a Ph.D. in Managing Director Pharmaceutics from the University of Cincinnati and has *********************************************************************** Surgimedik Healthcare India Pvt. Ltd., Mumbai extensive experience in pharmaceutical formulation. Mr. Ganesh Sabat Her work at Lubrizol has been focused on acrylic acid (CEO, He has completed his Graduation in Chemical and thermoplastic polyurethane technology platforms Sahajanand Medical Technologies Pvt. Ltd., Surat) Engineering from UDCT, Mumbai and has done for pharmaceutical and medical solutions. Marketing Management & Management Studies from Mr. Sabat has got more than 15 years of global experi- JBIMS, Mumbai. *********************************************************************** ence of working in USA and India. He has got more Mr. Sanjay Chotalia than 5 years of experience in medical device industry. He has extensive professional experience in developing Manager – Technical Sales & Marketing And Medical Currently Mr. Sabat is working as the CEO of SMT Pvt. products and business in the areas of Medical Devices. Segment Expert - Covestro (India) Private Limited, Ltd. He has successfully expanded SMT presence in Mumbai India as well as in 40 countries across the world. Under He is Managing Director of Surgimedik Healthcare India his leadership, SMT is developing as a global leader in Pvt Ltd, Mumbai. Mr. Sanjay Chotalia is working with Covestro for more cardiovascular market. than 4 years as Manager – Technical Sales & Marketing He has Professional Experience as Managing Director, for west India region for Polycarbonate resin & Medical Mr. Sabat has completed his MBA from Washington CEO, President & Product Manager in various national segment expert. University in Saint Louis. He also holds a degree from and international companies like Medi Surg GmbH, ICSI, India and has completed his graduation in sci- Germany; Allwin Medical Devices, USA; DVM He has completed MBA in Marketing, Bachelors in ence with Physics (Hons). As a young and dynamic pro- International, India; Bard, USA. Polymer Engineering from Pune university and Diploma fessional, he wants to strongly position Indian medical in Plastics Engineering from Mumbai university. device industry in the global field. *********************************************************************** Mr. Manoj Bhardwaj He has 9 years of experience in Technical Sales and *********************************************************************** Managing Director Application Developments of Engineering Plastics like Dr. Atul Sardana SMC Medical Manufacturing Pvt. Ltd., Bangalore Polycarbonate, Nylon6, PBT, Polyacetal. Director - Alfa Corpuscles Pvt. Ltd., New Delhi Mr. Manoj Bhardwaj is the Managing Director of SMC He also has rich experience in Handling Electrical & Dr. Atul Sardana (MBBS, MS, FIAGES) is a minimal Medical Manufacturing headquartered at Bangalore, Electronics, Medical, Consumer and Industrial access surgeon with a knack for applying technology India. segments with very good exposure to west India region to conventional surgical principals which benefits and customer base. patients. Dr. Atul Sardana has been working in the health SMC Medical Manufacturing is a fully owned subsidiary care sector since 1990 starting as a social worker in of SMC Ltd headquartered in Somerset, Wisconsin US. *********************************************************************** one of Delhi’s large government hospital. He has over The core competencies of SMC Ltd spans across Mr. Partha Mohapatra 30 national and international clinical publication and medical device design, tool design and build, molding, Lead- Healthcare, (India) & Technical Support presentations and is a honorary member of the World manufacture and assembly of medical devices as well INEOS Styrolution India Limited, New Delhi Association of laparoscopic Surgeons, and a member as industrial automation and robotics. of the Indian Association of Gastrointestinal and Mr. Partha Mohapatra is working as Lead Healthcare Endoscopic Surgeons and the BIS Technical Committee He is a polymer engineer with over three decades (India) & Technical Support with INEOS Styrolution India on Surgical Instruments. experience in Manufacturing, Consulting and IT sectors. Limited. He was awarded the fellowship of Indian Association of He has hands on experience in compounding of In his present role, he is actively involved in Application Gastrointestinal and Endoscopic Surgeons in 2007. He polymers, alloys and blends as well as downstream & Product Development along with Technical support, was actively involved in training of surgeons in the field polymer processing operations like extrusion, injection with key focus on new business opportunities for of Advanced Solid Organ Laparoscopic Surgery, Endo molding, welding, machining, printing, decoration, etc. styrene in medical device industry. stapling Principles and Techniques, and Laparoscopic He also has experience in manufacture of extrusion and Hernia Surgery at Ethicon Institute of Surgical injection molding machines, product design, mold Mr. Mohapatra is Post graduate in Plastic technology Education, New Delhi and is a faculty for the conduct design and mold making. from CIPET, Hyderabad and has an M.B.A (Marketing) of the fellowship of Indian Association of Gastrointestinal from I.G.N.O.U ( Delhi ) with 19 years’ experience in Besides polymer science, his background includes plastics processing & raw material industry . He has 37 expertise in processing of engineering plastic & is Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles and Endoscopic Surgeons. He is also an active member validations, process validation for sterilization and Company manufacture of Cardiovascular Device of AIMED (All India Medical Device Manufactures stability studies and Plant design to comply with specially diagnostic Angiography and Angioplasty Association). He is a certified internal auditor of quality international requirements. He has worked on various material including coronary stent, Drug coated stent management systems for medical device manufacturing stages of regulatory submissions including and Working on New Innovation of vascular devices as per ISO 13485:2003 from TUV SUD biocompatibility, pre-clinical & clinical studies. He has like Retrieval device, Perfusion catheter, Distal been a Consultant for UNIDO cluster program for QMS protection device, Thrombolytic catheter, Bioabsorbable He served as the head of Technical operations at & CE marking of Medical Devices and Bio Pruner stent etc. They have Indian FDA approvals and will also Biosurge Technologies, Mumbai and later was the Mentor with EDI & MSME Cluster. receive CE certificate very shortly. They have dedicated founder chairman at Alfa Corpuscles Private Limited infrastructure and research development facility and where he currently serves as the Head for R & D and He has widely travelled in USA, Canada, Europe, China, and trained staff. Product Development. Alfa Corpuscles has been UAE for consultations / Audits / executing projects; supported by the Technology Development Board, DBT, attending conferences and technical presentations. *********************************************************************** ICMR and GSBTM. Mr. Vipul Sheth He has been a Speaker at various WHO-GMP (Managing Director, He has three national patents for his invention of the WORKSHOPS - NEW DELHI/HYDERABAD and also Matrix Meditec Pvt. Ltd., Ahmedabad) “Laparoscopic Access Trocar”, “Safety Syringe” and served as member of first Core group of DCGI (Indian “Oral Vaccine Reconstitution & Delivery Device” and FDA) for Medical Device Regulations revision. Mr. Vipul Sheth is Managing Director of Matrix Meditec one PCT filed for his invention of the “Safety Syringe”. (P) Ltd. – the company engaged in manufacturing and His efforts on the safety syringe have been *********************************************************************** exporting of orthopaedic implants and instruments. He acknowledged by the “Wellcome Trust, UK” and the Ms. Swarna Sundar is also heading company named Life Sight Surgicals invention has been awarded the Silver Prize at the Seoul Senior Consultant - Healthcare Frost & Sullivan, (P) Ltd - a company engaged in manufacturing and trad- International Invention Fair 2012. He also has the Mumbai ing of Ophthalmic Instruments and intra ocular lenses. distinction of being honoured twice by display of his He has significant contribution in bringing and educat- innovative technologies during the exhibition on She graduated from University of Madras, Chennai and ing phaco emulsification technique in India. “Innovations in Medical Science and Biotechnology at has done Masters in Applied Science from Dalhousie the Rashtrarapati Bhawan. University, Canada. He is a distinguished personality in the field of medical devices & instrumentation having experience of more *********************************************************************** She has Functional Expertise of 11+ years of market than 20 years. He has been representing CARL ZEISS, Mr. Naimuddin R. Saiyed research & analysis and applying customized research Germany for more than a decade. He has also attended Sr. Drug Inspector, FDCA, Gujarat and analytical solutions in diverse healthcare domains numerous workshops / seminars organized by on a global scale. She has Particular expertise in SYNTHS, ZEISS in Davos, Switzerland, USA Germany. Mr. Naimuddin R. Saiyed is Sr.Drugs Inspector, FDCA, Competitive intelligence, Acquisition due diligence, and Mr Sheth is a science graduate and his company Ma- Gujarat. He has done B. PHARM – LMCP, LL.B from Value proposition; Market assessment, modeling and trix Meditec is actively involved in bringing new / unique Guj Uni., and Diploma in Management from IGNOU. trend forecasting; New product development and launch technologies in the field of orthopaedic implants and strategies; Develop market entry and expansion instruments. He has 8 years of mfg. experience (tablet,svp) and very strategies. good regulatory experience. He has worked for 8 years *********************************************************************** as Drugs Inspector in Sales Segment Regulation. As She has experience in broad range of sectors, including Dr. Subroto Mukherjee Sr.Drugs Inspector, since last 6 years, he has been Advanced Medical Technologies; surgical and patient Associate Dean - Facilitation Centre for Industrial looking after regulating Blood Bank, Blood Storage and monitor technologies; Emerging Medical Technologies Plasma Technologies, Gandhinagar. mfg. of Medical Devices. / Next-generation Healthcare; In-vitro Diagnostics; Consumer healthcare and general healthcare system Dr S Mukherjee is Head – FCIPT Division, and He has attended various workshops on Medical Device trends market. Associate Dean – Academics of Institute for Plasma Regulations at PERD, Ahmedabad; at Gandhinagar Research. He has 115 peer reviewed journal papers, Head Office and GFSU by CDSCO. She has worked with prominent companies in medical 13 patents, guided 13 PhD scholars, and has devices and technologies market, like GE Healthcare, contributed towards transferring FCIPT’s knowhow in *********************************************************************** Phillips Healthcare, Siemens Medical, Medtronic, industrial plasma applications for benefit of society. He Mr. Sanjay Shah Johnson & Johnson, among others. is the 1st recipient of “BUTI Foundation Award” for Managing Director-Unikal Consultants, Ahmedabad outstanding contribution in plasma sciences and is a She has Published her work (s) on Diagnosis of Carpal fellow of the Alexander von Humboldt foundation. He Mr. Sanjay Shah is founder promoter of Unikal Tunnel Syndrome in peer-reviewed journals and received the VASVIK-2016 award in the field of Consultants. presented at international conferences. “Materials and Metallurgical Science and Technology” and was elected Fellow of Gujarat Science Academy He is an experienced Quality Management System *********************************************************************** Consultant, knowledgeable in ISO 9001 & ISO 3485 Mr. Ravi Shankar Srivastava in 2016. system. He has experience in training related to QMS; Chairman & MD c-GMP & WHO GMP. Invent Bio-Med Pvt. Ltd., Mumbai His areas of research are industrial plasma applications, plasma applications in biology and developing plasma He has done MS by research from University Mr. Ravi Shankar Srivastava is Chairman & MD of Invent technologies for societal benefit. Department of Chemical Technology, Bombay Bio-Med Pvt. Ltd., Mumbai. University and BS (Chemistry & Physics) from Bombay *********************************************************************** University. Mr. Srivastava is B.sc (Hons) Diploma in Business Mr. Prakash Bachani development, certificate on Biotechnology from SIS Scientist E & Head (MHD) He has presented papers and talks on various aspects Institute, Government of India. He has also done MBA Bureau of India Standard, New Delhi of Coronary Stents including Drug Eluting Stents and (Marketing) and completed OMP4 one year post on Regulatory Aspects of Medical Devices. graduate management program from SPJIM, Mumbai. Mr Prakash Bachani is MIE (Electrical Engg.) GOLD MEDALIST, Institution of Engineers, India. He is He has experience in Quality System Audits & He has worked in multinational pharmaceutical presently posted as Scientist E & Head (MUBO-1), Consultancy for CE Certification for all Class of Sterile/ company at senior level. He has also worked in Pfizer Mumbai in Bureau of Indian Standards, for Certification Non-sterile Medical Devices. He also has experience (Schneider) medical device company of Switzerland, & Marks Deptt. In Mumbai at national level. in US FDA 510 k CDRH regulatory submissions for took training in Australia, Singapore, Paris, Toulouse. Medical Devices & PMA. He has more than 10 years He has 32 years experience in Bureau of Indian experience in projects related to international He has participated & attended many international Standards. At the Technical level, he has overseen the technology transfers and setting up new plants for cardiology and interventional therapeutics programs and following activities:1. Product Certification, 2. System medical devices like Coronary stents, Drug Eluting trainings. He has also attended national workshop on Certification (QMS), 3. Hallmarking of Gold and Silver, stents, Ophthalmic Implants (IOL), Orthopaedic medical device regulations. 4. Standards Formulation (Electrotechnical), 5. implants, IUDs etc. Laboratory Management. He started trading company initially at Mumbai. Then He has designed & executed DQ, IQ, OQ, PQ he expanded to manufacturing, under the name of Jan.-Feb. 2017 Invent Bio-Med Pvt. Ltd., at Surat. An ISO 9001 – 2008 38

Invited Speakers & Panel Experts : Profiles In conformity assessment of the products in He spends his free time to support social causes SEATC, BNHS, etc. Serving as Editor, Editorial board electrotechnical area, includes cables; conductors; through family trust providing medical help and member and reviewer for many peer reviewed energy meters; electrical accessories like switch, plugs vocational training in suburb of Mumbai, is associated international journals. Attended more than 20 and sockets, MCBs; electrical appliances like geysers, with education trust BNKCT as Managing Trustee. workshops, International and national conferences fans, motors, pumps, ballasts; GLS Sodium and training programmes. Actively involved as committee compact fluorescent lamps; luminaries etc. *********************************************************************** member for international conferences worldwide.Apart Mr. Siddharth Jain from this specialization, Worked as Research fellow in He has participated and presented several papers CEO and Chief Regulatory Advisor Integrated Coastal Marine Area Management, Chennai relating to Standardization, Certification in the field of Symbiorph Clinical Trialogy, Ahmedabad for marine toxicology project for creating critical limits Electrical Engg. at various seminars organized in the for heavy metal pollution and also worked as Research country. He has also participated in the meetings of IEC Mr. Siddharth Jain is CEO and Chief Regulatory Advisor Associate for climate change project. for Rotating Machinery in China, Power Capacitors in of Symbiorph Clinical Trialogy. He is based in Russia and Transformers in Japan. Ahmedabad and has extensive experience in Medical *********************************************************************** Device Clinical Evaluation Report Preparation, Post Dr. B. Rajan *********************************************************************** Market Clinical Follow-up (PMCF), Risk Management, Director/Toxicology Scientist Dr. Chirag Patel CE Certification and Global Product Registration in Latin GLR Laboratories Pvt. Ltd, Chennai Assistant Professor, Microbiology America, GCC, MENA, South East Asia and US FDA. Shree Krishna Hospital, Karamsad He has total 04 years of experience in Medical Device Dr. B. Rajan,Study Director/Toxicology Scientist, GLR Regulatory Affair Compliance and currently advising Laboratories Pvt. Ltd., has a PhD in Biochemistry, from He is practising since 10 years as Infection many Orthopaedic Implant Manufacturers, Disposable University of Madras, India. He has been working in preventionist, Clinical Microbiologist, academician and Manufacture and Laparoscopic Instrument & Equipment the field of nanoscience, nanotoxicity and guide for MBBS and MD students in medical college. Manufacturer across India. He has done Post Graduate nanotherapeutics for over 6 years. He was a recipient in Microbiology from the B.R Doshi School of of various prestigious fellowships from government of He has published 6 international and national level Bioscience, Sardar Patel University, Vallabh Vidyanagar India like fellowship in sciences for meritorious students research papers and has 7 international and national and further did Post Graduate Diploma in Clinical Basic Scientific Research (BSR) scheme of the level papers under acceptance. Research from Xcellon Institute, a sister concern University Grant Commission (UGC), New Delhi and company of Claris Pharmaceuticals affiliate to Ganpath Senior research fellowship (SRF) of Indian Council of He has completed 9 Research projects and is currently University. He has also published his research paper Medical Research (ICMR), New Delhi. He has quite a working on 8 other projects. on Naphthalene Degradation by Bacteria Consortium few peer-reviewed literatures in reputed international (DV-AL) developed from Alang-Sosiya Ship breakage journals and he has also presented his research work His Primary areas of interest are: Indwelling medical yard, Gujarat in Science Direct Journal. in various international conferences. Currently he is device associated infections, Multi-drug resistant involved in the biocompatibility testing of medical organism in healthcare associated infections, Microbial *********************************************************************** devices. diversity in Blood stream infection and Respiratory tract Dr. Ketankumar Vadodaria infections. (Head, *********************************************************************** Medical Textiles- The South India Textile Research Mr. Narasinh K. Balgi *********************************************************************** Association (SITRA), Coimbatore) Director - Ferromatik Milacron India Limited, Mr. Hiten Bheda Ahmedabad Managing Director Dr. Ketankumar Vadodaria is heading Centre of Vinit Performance Polymers Pvt Ltd., Mumbai Excellence – Medical Textiles Division at The South Mr. N. K. Balgi is Director on Board of Ferromatik India Textile Research Association (SITRA), Milacron India Pvt. Ltd (FMIPL). He holds Bachelor Mr. Hiten Bheda , a Chemical Engineer by training has Coimbatore. He is in the field of textiles for more than degree in Engineering. been associated with plastics since the beginning of 9 years and has worked in manufacturing, R&D labs, his career. He pursued a BS degree in Chemical Quality Assurance, Technical Services, Teaching, He has been serving the Plastics Industry for the last Engineering from the University of Tennessee, Consultancy etc. 46 years and has wide-spread experience in Quality Department of Chemical and Polymer Engineering, Assurance, Manufacturing Systems, Technology Knoxville, USA where his interest in Polymer processing This has given him a vast exposure to various Management and has exposure to Sales & Marketing, was nurtured. techniques in short staple fibre spinning, weaving, Finance, Human Resource Development & garment making, melt spinning as well as advanced Organizational Development. He did his Masters in Chemical engineering from the electro-spinning in various parts of the country and He has worked with : Klockner Windsor India and Larsen University of Connecticut. During those years he was abroad. & Toubro - Plastics Machinery Division, before taking fortunate to learn about polymer processing and train over leadership position at Ferromatik Milacron India. under some of the renowned professors of Rheology. He has obtained his Masters and Bachelors in Textile Under his leadership the company has attained Engineering from M.S. University of Vadodara, Gujarat. leadership position in the Indian market and has spread He was associated in conversion of Engineering Plastics He did his Doctorate in Textiles in Nanotechnology & it’s presence over 46 countries. He is recipient of “The and have worked on Casting of Polyamides, Smart Fibres from Herriot-Watt University, United James A.D.Geier Leadership Award” - an award Polyurethanes as well as extrusion of EP and High Kingdom. instituted by Milacron in the name of their outstanding Performance Polymers. He has closely worked with leader - in the year 2008. many OEM’s and Govt institutions for successful He has presented papers in national / international application of these products involving extensive design seminars & Conferences. He has also published Industry Representations: and testing of materials for qualification. national and international journal papers. He is also - Fellow Member of Indian Plastics Institute [IPI] since invited for lecturers in conferences / seminars. Currently he is Managing Director of Vinit Performance 2009. Polymers Pvt Ltd., engaged in conversion and CNC *********************************************************************** - Member of Society of Plastics Engineers. machining of engineering plastics and high performance Dr. J. S. I. Rajkumar, PhD - Member of Governing Council of Indo- German Tool plastics under POLYMAT brand. The company Director/Scientist toxicology pioneered extrusion of high temp materials like PEEK Glr Laboratories Pvt. Ltd., Chennai -rooms. in India. - Member of Regional Advisory Committee of C.I.P.E.T. Dr. J. S. I. Rajkumar, PhD., Doctorate in Zoology from - Imm. Past Chairman of Governing Council, Indian He has served the trade in the capacity of Hon Secretary Madras University, working as Study Director/Scientist AIPMA, Hon editor of Plastic News, and currently is toxicology at GLR Laboratories Private limited, Chennai. Plastics Institute Vice President West Zone AIPMA. He has represented Have published more than 55 scientific papers both in - Convener and Founding Director of Plastics AIPMA for Govt advocacy on fiscal matters like budget peer reviewed national and international journals. and GST. Active member of SPE, he is keen to further Presented and published more than 45 scientific articles Machinery Manufacturers Assn. cause of plastic processing through knowledge in international conferences and proceedings. Written enhancement. 3 books and 5 book chapters. Hold prestigious *********************************************************************** memberships in world renowned societies, ACS, Mr. Ketan Panchal He is member of Tau Beta Pi, a honorary engineering Production Manager fraternity based in the USA. Indo German Tool Room, Ahmedabad Jan.-Feb. 2017 39

Invited Speakers & Panel Experts : Profiles Mr. Ketan Panchal has done Diploma in plastic College, Ahmedabad. He completed his master’s of international brands is also Mr. Deepk’s passion. engineering and B.tech in mechanical engineering. He degree in the year 2000 from L D College of Engineering is presently working as Head of Production at Indo and PhD in the field of water resources management He has been the only person in INDIA to set up 6 Human German Tool Room - Ahmedabad from IIT Delhi in July 2008. Milk Banks in INDIA. His wishful dream is to create a “White Revolution” by setting up Human Milk Bank in He has 26 years of experience in the field of tool and During his research work he published 05 research each and every hospital work for better future generation die making. He has previously worked with Milton papers in peer reviewed journals (ASCE (Irrigation and to come of this country. Plastics- Halol; Elemex Industries – Baroda; Karnavati drainage), ICE (Proceedings of Water resources Plastomach – Ahmedabad and now with Indo German management) and Journal of Hydrology (Elsevier)), 20 *********************************************************************** Tool Room since 1993. papers in proceedings of international conference which Mr. Devendra Patel includes paper presentation at EWRI conference at Director - Medisoft Telemedicine Pvt. Ltd., Ahmedabad *********************************************************************** Bangkok & International Conference on Information Mr. Saumil Mistry Technology in Construction” INCITE at Tsinghua Mr. Devendra holds Bachelor of Engineering degree Engineer – Sales Project Engineering University, Beijing and 13 paper in proceedings of in Electronics & Communications Engineering from Ferromatik Milacron India Pvt. Ltd. national conference. Also, he had been to National DDIT, Nadiad, Gujarat, India. University of Singapore on 4th January,2011 to present Mr. Saumil Mistry has done B.E. - Mechanical research paper under IPWE-2011. He is also a life Mr. Devendra Patel is an entrepreneur and has Engineering from Indus Institute of Technology & member of various international organizations such a established enterprises in healthcare IT and medical Engineering, Gujarat. He is associated with Ferromatik s international association of hydrologists (IAH), tourism services. Milacron India Pvt. Ltd. since 2013. international association of engineers (IAE), Institute of Engineers (IE), Indian Association of Hydrologists, He is the Founder and Director of “Medisoft Currently he is working in Sales Project Engineering ICE (UK) and Indian Association of Hydrologists. He Telemedicine Pvt. Ltd.” and possesses over 18 years Group as an Engineer. has supervised more than 30 thesis at masters level of leadership experience in the field of healthcare IT. and two research scholar have completed PhD and also Medisoft Telemedicine has done pioneering work in He has worked in Manufacturing at various areas of currently supervising three more PhD students in the Healthcare IT, Ehealth and Telemedicine field. Assembly, Testing & Planning. He is active member of area of water resources management. He is Board Development & Technology Transfer Team of FMI. member of Gujarat Meritime Board Trust. He is also He is also co-founder and managing partner of “The academic council member of Indus university and Meditour” medical tourism company. He is having experience of handling complete project Ganpat university. requirement. He is co-author of book on Telemedicine titled as Above all, in spite of being academician, played an “Introduction of Telemedicine”. *********************************************************************** important role in establishing a new concept in university Mr. Parthiv Desai examination system i.e. electronic delivery of question *********************************************************************** Director, SITECH, Vadodara paper. After serving for more than six years in Gujarat Er. U. KARTHIK PREMKUMAR,B.E. Technological University, he is serving as the Principal Faber Sindoori Management Services Pvt. Ltd. Mr. Parthiv Desai is Industrial Designer and Plastics of L.D. Engineering College, Ahmedabad and member Ahmedabad. Manager - Biomedical Engineer Technologist and an Innovator (Patents holder). He is secretary of ACPC catering admissions of Gujarat State Promoter - Director of SITECH. He has done Diploma since Nov 2014. He has done Bachelor of Engineering (Electronics & & Post Diploma in Plastics Mold design from CIPET Instrumentation Engineering) & Diploma in Electrical & and Diploma in Finance Management, AMA. He is a *********************************************************************** Electronics Engineering. He has been in this field for member of VCCI, IPI, TAGMA, AIPMA. Mr. Deepak Dave the past 15 years and has served different healthcare Former President, Medical Surgical And Healthcare companies, institutions & hospitals. SITECH started in late 1996 by a team of Industries Trade Asso. & Ashutosh Export multidisciplinary experts with a common vision of making International, Mumbai. He has worked in Managerial position in various science design viable to industries. Our passion for design and institutes and Hospitals. Presently he is working with innovation has always helped us in reaching to a next Dr. Deepak Dave is CEO of Ashutosh Export Faber Sindoori Management Services Pvt. Ltd. (a sister level. SITECH provides services like Industrial design, International, Mumbai, presently carrying on the concern of Apollo group) as Manager - biomedical Conceptual product development, Design validation, business in the Medical Devices and Surgical engineer at Apollo Hospitals International Limited. Design for manufacturability and reverse engineering. Equipments including Disposable Products. *********************************************************************** Health-care is always been a fascinating domain for use He has done his graduation from Mumbai University Dr. Alok Ray to work on. We have been successfully associated with with specializing in the field of Economics & Marketing. Head, Center for Biomedical Eng., IIT & All India well-known Medical and Pharmaceutical companies and Post graduation in MBA. He has been in this field of Institute Of Medical Sciences, New Delhi have an experience of working on Drug Delivery Medical Devices and Surgical instruments and products, Diagnostic products, healthcare, Equipments for past 24 Yrs. Dr. Alok R. Ray is Professor at Centre for Biomedical Implants, Surgery and many more. Engineering, Indian Institute of Technology, Delhi. He He started the career working with an MNC in Mumbai is concurrently Professor at All Indian Institute of SITECH’s expertise help our clients to regulate as Asst. Purchase Officer and relinquished the job after Medical Sciences, New Delhi, India. Dr. Ray is also standards by selecting correct materials and processes. 9 Yrs of very rich experience in the field of Local Director of Stanford-Indian Biodesign program. We believe in an error free design process which starts Purchases & Imports. He entered into the field of with conceptualization and ends with prototyping and Medical Disposable business in the year 1987. He has received his Ph.D. from University of Delhi on validation. Our well documented design process helps Biopolymers. He was a Fogarty Fellow of National developing unique products without infringing on It has been his privilege to be associated with the first Institute of Health, USA at Centre for Polymeric competitor’s IP. in bringing new products and concepts for the INDIAN implants, University of Utah, USA during 1982 to 1984. market and consumers which much necessary for the He was a fellow at University of Liverpool, UK. He was SITECH represents our continuous efforts of making growth of Indian market in terms of availability and a visiting professor at All Union Cardiology Institute, life better by design. Through creativity, hard work and prices. Moscow, University of Leiden, Netherlands and Max dedication, SITECH strives to be a backbone of creative Planck Institute for Polymer sciences, Mainz. economy. Having the exposure for more than 15 years of international market in the medical and surgical products Prof. Ray has made notable contributions in the area *********************************************************************** and devices including the Healthcare sector, he further of biocompatible materials. Unique feature of his Dr. G. P. Vadodaria, PhD. (IITD) developed into selling some of the patient friendly research is that starting from synthesis/modification, Principal - L.D. College of Engineering, Ahmedabad products for specialized products at affordable prices characterization, he has gone up to the stage of in INDIAN market. To keep with the newer products engineering and designing of such materials for use in Dr. G. P. Vadodaria completed his bachelors’ degree in introduced after innovation by manufacturer human medicine and surgery viz.: medical devices and the field of Civil engineering from M.S. University of implants, drug delivery systems, catheters used for Baroda in the year 1991. Thereafter he joined C U Shah blood vessels. Polytechnic College, Surendranagar as a lecturecturer in civil engineering in march ‘95. He topped GPSC Prof. Ray has acquired the reputation of being a leader examination and posted as a lecturer at L D Engineering in the area of compatibility of materials with living 40 Jan.-Feb. 2017

Invited Speakers & Panel Experts : Profiles tissues. His work in this area has been highly cited and He has got 24 years of working experience in the field K. R. Navaneethakrishnan, M.Sc (PhD) the work reported has been further extended by other of manufacturing of drugs, Quality Assurance and drug Assistant Director authors worldwide. He has developed nine biomedical regulation. He started his carrier from M/s Winthrop (now GLR Laboratories Pvt. Ltd., Chennai products and published over 150 articles in professional known as Win-Medicare) as production supervisor and journals and is a consultant to several industries. left the organization as Assistant Manager technical Toxicologist with more than 19 years’ experience in before joining CDSCO in 1998. During his stint in toxicology and biocompatibility studies. Has worked in Prof. Ray has been awarded TATA INNOVATION Industry, he worked in various capacities in the GLP certified Contract Research Organizations- FELLOWSHIP for the year 2007-2008 in recognition of manufacturing of oral, external and parenteral dosage Assistant Director, GLR Laboratories Pvt. Ltd; his research contribution in the area of material used forms. Toxicology Study Director, IIBAT and Quality Assurance in Human Medicine and Surgery. Executive-SGS LSS. Good experience in toxicology/ In 2003, during WHO GMP workshop he was assessed biocompatibility testing of medical devices, *********************************************************************** as the best among the participants and was selected agrochemicals and pharmaceuticals especially in vivo Prof. Himanshu A Patel thereafter for various WHO assignments. As short term toxicology tests. Successful background in setting up Head, Biomedical Dept. consultant for WHO he was part of NRA assessment of Quality Systems in Test Facility according to the U. V. Patel College of Engineering, Mehsana teams for Indonesia & Thailand. As facilitator, he OECD Principles of GLP and ISO 17025. Has faced participated in WHO GMP workshops for inspectors of several GLP and ISO 17025 audits. Additionally, has He has done B.Tech (IC), M.Tech (BME), IIT-BHU, Indonesia and China. In 2005, Ministry identified him faced several national and international client audits. Varanasi, and he is pursuing his Ph.D studies. as GMP expert for assessment of vaccine Done Master’s in Regulatory Affairs and pursuing PhD manufacturing PSU. He was trained as trainer in GMP in Nanotoxicology. He has attended many international He is Head, BME Dept., U.V.Patel College of and GCP and was associated in various workshops for and national conferences. Has organized national and Engineering, Ganpat University, Kherva, Mehsana. training of inspectors in India. He also represented in international workshops/ training programs related to Govt. of India missions in South Korea and Suriname. medical devices. Adding to credits, also published His Area of Interests are: scientific papers in peer reviewed international journals • Medical Image Processing. In CDSCO HQ he worked in new drugs, Biological, related to nanoparticles. • Bio-mechanics. import and export, Global clinical trial divisions. He was • Medical Instrumentation exposed to dossier assessment procedures of biological *********************************************************************** • Control system engineering. 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 Dr. Arvind Kukrety from CDSCO for inspection of foreign manufacturing Deputy Drugs Controller, Central Drugs Standard sites in China. He is actively involved in framing of risk Control Organization, Zonal Office, Ahmedabad based inspection policy and their evaluation. 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. ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter 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 41

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 & Informa- tion 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 1 ET Elastomer Technik GmbH, Medical Moulded Parts For OEM's From Liquid Silicone Using The Highest Medical- www.elastomer-technik.com Grade Materials. 2 American Plastic Technology Projects for Manufacturing I.V. Solutions, Injectables, Dialysis Solutions & Dialyzers, www.americanplastictech.com Autoclaves, Sterilizers, Pharma Machinery, I.V. Sets & Other Disposables etc. 3 Lubrizol Advanced Materials Medical Disposables, Catheters and Medical Thermoplastic Polyurethane Resins. www.lubrizol.com India Pvt. Ltd. 4 Synergistix India Pvt. Ltd. NuSil Silicones LLC: Medical-grade silicones including primers, gels, adhesives, oils, dis- www.synergistixindia.com persions, elastomers (LSR & HCR) for drug delivery medical implants, general healthcare and skin care industries. Epoxy Technology LLC: Adhesives for medical applications in- cluding: sensors, instruments, hearing aids, dental equipment, pacemakers, endoscopes and catheters. 5 Sitech : Design Innovations New Product Development, Design to Manufacture, Medical Device & Equipment www.sitech.in Development, Drug delivery, Diagnostic products. 6 FDCA, Gujarat Implementing various acts and rules related to drugs, cosmetics, medical devices, food www.fdca.guj.nic.in and safety, cigarette and other tobacco products. 7 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). 8 Symbiorph Clinical Trialogy Medical Device Regulatory Compliance Consulting Company www.symbiorphclinicaltrialogy.com 9 Pradeep Surgipack Peel-Open Flat Pouches & Reels, Peel-Open Gusset Pouches , Peel-Open Self-Seal www.pradeepsurgipack.com Pouches, Coated Tyvek Sheets , Uncoated Tyvek Pouches, Grid-Lacquered & All-Over Coated Pouches, Header Bags, Poly Coated Pouches products. 10 Operon Strategist Turnkey Projects, Regulatory, Quality Assurance, Validation and Certification in the fields www.operonstrategist.com of Medical Devices. 11 Steri Techno Fab Products Autoclave, Eto Sterilizer, Uv Sterilizer, Ultrasonic Cleaner, Eto Cartridges, Eo www.steritechno.com Cartridges & Other Sterilization Material 12 Malaysian Rubber Export Rubber Medical Devices - Latex Gloves, Nitrile Gloves, Dental Gloves, Foley Catheter, www.mrepc.com Promotion Council Dental Dam, Probe Cover, Finger Cot, Condom 13 Central Institute of Plastics Tool Room, Testing, Consultancy Services, Training & Academic Activities for Plastics www.cipet.gov.in Engineering & Technology Industries. 14 Medical Plastics Data Services A Techno-Economic News Magazine For Medical Plastics And Pharmaceutical Industry. www.medicalplasticsindia.com 15 Medisourceasia Web Portal For Medical Technology And Markets In Asia www.medisourceasia.com 16 Connell Bros. (India) Pvt. Ltd. Suppliers for : Silicone oils, emulsions, Dispersion for Medical devices Lubrication and www.connellbrothers.com Fabrication, Silicone tubing’s, Silicone topical excipients, Silicone elastomers 17 Suresh Enterprises Silicone & Viton Rubber Extruded and Moulded Products www.sevitsil.com 42 Jan.-Feb. 2017

Exhibitor Profiles No. Company Name Products / Services Website 18 Excel Formulations State-of-the-art ETO formulation and bottling facility www.excelformulations.com 19 Ami Polymers Pvt. Ltd. Platinum Cured Silicone Tube, Radiopaque Tube, O-Rings, Custom Made Gasket, www.amipolymer.com Silicone Sleeves for printing purpose, Medical Components 20 Indian Innovators Association Voice of Indian Innovators. Works to develop markets for “designed in India” products. www.indiainvents.in 21 Medical Textiles- SITRA Centre of Excellence for Medical Textiles, promoted by Ministry of Textiles, Government www.sitra.org.in of India. 22 Plastindia Foundation Apex body of major associations, organizations and institutions connected with plastics, www.plastindia.org promoting development of plastic industry. Next event : PLASTINDIA 2018 23 Pharmadox FDA / WHO Consultant: Pharmaceuticals & Medical Devices includes orthopedic implants. www.pharmadocx.com 24 Raman Discovery Enterprises Offers newly developed and patented medical devices for commercialization. 25 Oswin Plastics Pvt. Ltd. For Disposable Equipments, Flow case pipes, Tubings, Hose for Breather circuits www.oswingroup.com 26 Om Enterprise Blister Packing, Vacuum Forming, Transparent Packings and Boxes, Cam Shells, Sliding System, Sealing Technologies (Hot and Cold) Jan.-Feb. 2017 43

Exhibitor Profiles ET Elastomer Technik GmbH, Gandhinagar, India Contact : American Plastic Technologies Inc., 9451, Ainslie Street Schiller Park/Chicago, IL 60176. USA E-mail : raodesign@qol.com www.elastomer-technik.com P No. 847-671-6182 Products : Industry - Medical Technology/Pharma/Baby Care Lubrizol Advanced Materials India Pvt. Ltd., Mumbai, List of Products : 1. Precision O-Rings (1-410mm inner diameter) 2. Breathing bags India. 3. Balloons 4.Medical tube 5. Cable and drainages 6. Seals and sealing rings 7. Tooth Protector 8. Short- and long-term 9. Custom- www.lubrizol.com/en/Life-Sciences ize mould parts, Food, Push Buttons, Bellows, Closure Valves, Housing Seals. Medical Disposables, Catheters and Medical thermoplastic polyurethane resins. ET Elastomer Technik GmbH was founded 1992 in Lauffen am Neckar / South Germany. Lubrizol LifeSciences is a healthcare solution partner that provides support from idea to production by supplying customizable The company started injection moulding of joints and gaskets. In polymers, complex drug formulation and contract manufacturing 1994 ET had its first big success in producing a breathing bag out services for medical device manufacturers. Now with Vesta’s of Liquid Silicone Rubber. From there on ET Elastomer Technik was medical manufacturing and Particle Sciences’ complex drug known in the market and worked close to the medical and auto- formulation capabilities, LifeSciences is the only partner providing motive industry, where silicone could push the boundary of other full service, development and product solutions. Elastomers. Contact : Lubrizol Advanced Materials India Pvt. Ltd. In 1996, ET found a bigger production site in Ellhofen / Germany. In 5th,6th & 7th Floor , Jaswanti Landmark, LBS Marg, Vikhroli (West) this new factory, ET also begins the facilities for the manufactur- Mumbai- 400079, India. Ph. +91 66027800 ing of long term implants. One of their first projects was a larynge implant for people who suffered from ‘Mustard Gas’attacks dur- Synergistix India Pvt.Ltd., Chennai, India ing the gulf war. Since then ET started a wide range of different implants. www.synergistixindia.com In 2004 ET decided to start a second plant in Hammelburg/Ger- NuSil Silicones LLC: Medical-grade silicones including primers, many. A clean room class 8 as well as a tool shop were installed in gels, adhesives, oils, dispersions, elastomers (LSR & HCR) for drug 2006 and 2 years later they established the ISO 13485. delivery medical implants, general healthcare and skin care In 2010, ET Elastomer Technik GmbH has started their production industries. Epoxy Technology LLC: Adhesives for medical facility at Gandhinagar, Gujarat under the name of “ET Elastomer applications including: sensors, instruments, hearing aids, dental Technik India Private Limited. equipment, pacemakers, endoscopes and catheters ET Elastomer Technik GmbH is specialised in manufacturing silicone Synergistix India Pvt. Ltd. is one of the professionally managed medical products using the highest medical-grade materials, meet- companies focusing on sales/marketing, technical services, logistics ing US FDA requirements with quick development and turnaround. and distribution. The Company is managed by a team having several Products include a wide range of O-Rings and moulded shapes for decades of experience in the defined functions. The Company’s short- and long-term implantation. Complete product assembly key strength is the ability to sell concepts, solutions and Stretching services are offered with on-site clean room and tool shop. to meet Customer Expectations. They are systems driven and have • ET provides custom-made silicone products and solutions for a invested heavily in developing internal processes that would deliver services to their Customers/Principals most efficiently. The wide range of industrial applications and consumer needs. company has been doing this for more than a decade now with • Serving globally active customers from various industries, includ- 80% plus customers retained! They have built up a significant customer base over a decade, spanning diverse applications in: ing medical engineering, automotive, and electronics, we have Plastics & Polymers, Lubricants, Water & Environment, Electronics, become a trusted partner of choice for the timely and reliable Medical/Pharmaceuticals and this list is growing. development of high-end items. Contact : ET Elastomer Technik GmbH Abtsäckerstraße 16, 74248 Contact : Synergistix India Pvt.Ltd. Ellhofen, Tel. : +49 (0)9732/ 78865 - 12, Fax : +49 (0)9732/ 78865-18 4th Floor, Kaba Plaza, 57,L.B.Road, Adyar, Chennai – 600020 E mail : info@elastomer-technik.com Phone : 044-42114825 E: mail@synergistixindia.com ET Elastomer Technik India Private Limited B 183-184 GIDC Electronic Estate, Sector 25 Gandhinagar 382024 Shree Infosys, Vadodara, India Contact Person:-Mr.Hardik Patwa(Administrator) Phone: +91 79 23287624, Mobile: +91 97277 63274,+91-9974624358 www.sitechplm.com Email: admin@elastomer-technik.in New Product Development, Product re-design : Optimization of American Plastic Technologies Inc. USA material / process, Complete solution : Design to Manufacture, Medical Device & Equipment Development - Drug delivery, www.americanplastictecnologies.com Diagnostic products, healthcare, Implants, Surgical & Interventional Device Disposable products / Electronic device Supply Turnkey Manufacturing Plants For : Intravenous Solutions enclosures Manufacturing Plants, Injectable Medicines Manufacturing Plants, Oral Rehydrating Solutions Manufacturing Plants, Dialysis Solutions Sitech is innovative leading human centric Product design Manufacturing Plants, Dialyzers Manufacturing Plants, Medical Company. Sitech is solution provider for “Design to Manufacturing Waste Disposal And Management, Water Purification Equipment, process”. We help companies make great products by optimizing Autoclaves / Sterilizers, Pre-Fabricated Steel Buildings. their lifecycle processes, from planning and development through manufacturing and support. 44 Jan.-Feb. 2017

Exhibitor Profiles Sitech has developed many innovative products for wide range of from India, CA, USA, UAE and Europe. applications, particularly, in Medical and Pharma-industries. Our experience and knowledge of this sector will help you to meet Contact : Dr. Manish A. Rachchh Director (R & D) & CEO regulatory standards by selecting correct material, process, Accuprec Research Labs Pvt. Ltd., Opp. Zydus Pharmez, Changodar documentation and you develop unique products without - Bavla Highway, Nr. Matoda Patia, Post: Matoda, Ahmedabad - infringing on competitor IP. 382213, Gujarat, India SITECH help customer to dramatically compressed cycle times for (M) +91- 9099981023, 9099981023, 99099 19545 design and development, by leveraging shared intellectual capital, E-mail: info@accuprec.com ; manish.rachchh@accuprec.com better concurrent engineering practices and standards for design, prototype and validation. Symbiorph Clinical Triology, Ahmedabad, India SITECH are conscious not only for the End-product quality but also for entire error free development cycle. www.symbiorphclinicaltrialogy.com On occasions, we have been involved with the client’s R&D, Design and product Development departments for their special task or Symbiorph Clinical Trialogy is Ahmedabad based Medical Device system development. Regulatory Compliance Consulting and advising Company. Contact : Shree Infosys, 102, Shreem Apartment, Opp. Mahindra Gujarat Tractor Ltd., Mujmahuda, Vadodara – 390 011. Gujarat, We support the medical device manufacturer to realize the concept India. Phone : +91 265 2343058, 2320257 | Mobile : +91 9825420257 of “MAKE IN INDIA” and help them in Global Medical Device Email : parthiv@sitech.in Product Registration. Food and Drugs Control Administration (FDCA), Gujarat Core Services : Indian Medical Device Manufacturing License as per revised requirements, CE Marking, US FDA 510K, Risk Management- www.fdca.guj.nic.in ISO 14971, Clinical Evaluation-MEDDEV 2.7.1 Rev 4, June 2016, Medi- cal Device Software Validation (IEC 62304), Usability Engineering (EN Food and Drugs Control Administration (FDCA), Gujarat plays 62366), IEC 60601-Compliance, Sterilization-EO Validation (ISO 11135) important role in enforcement of “Drugs and Cosmetics Act 1940 & Rules” and enforcement of : “Food Safety and Standard Act, Global Product Registration : US FDA 510K, Latin America (Brazil, 2006” and Rules in Gujarat State. It plays pivotal in Pharma and Mexico etc.); South East Asian (Thailand, Australia etc.); MENA medical devices sectors in Gujarat to make the state a favorable (Egypt, Israel etc.); GCC (UAE, Saudi, Kuwait etc.); CIS (Russia, investment destination towards inclusive development and Kazakhstan etc.) growth. It has played a vital role in the implementation of e- governance in FDCA and is winner of one state level and three We are advising the medical device manufacturers in such a manner national level awards. that they can appoint more than ONE distributors in these coun- tries, thereby to remove the dependency on the single distributor. Accuprec Research Labs Pvt. Ltd., Ahmedabad, India Contact : Siddharth Jain, Chief Regulatory Advisor www.accuprec.com 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 Our Services : Analytical (HPLC/UV) method development & Peel-Open Flat Pouches & Reels, Peel-Open Gusset Pouches , Peel- Validation (AMV), Bio-compatibility testings (As per ISO 10993 Open Self-Seal Pouches, Coated Tyvek Sheets , Uncoated Tyvek guidelines), Cell-line based testings, Clinical services (BA/BE, PMS) Pouches, Grid-Lacquered & All-Over Coated Pouches, Header Bags, (As per ICMR / ICH-GCP guideline), DMPK Studies, Formulation & Poly Coated Pouches Development Services, Genetic testings, IPR management services (Patent, TM, Design and Copyright drafting, filing, Valuation of IP, Manufacturers of medical grade sterilization packaging products Licensing agreements for IPR), Microbiological testing, which are used to pack medical devices that need to be sterilized. Phytochemical studies (Heavy metal testings using ICP-OES), Located in Bangalore our QMS is ISO 13495 certified and our prod- Pharmacological screening, Stability studies (As per ICH guidelines), ucts are CE certified. Our range of products include peel-open flat & Sterility testing, Toxicological testing (in-vitro, ex-vivo and in-vivo) gusset pouches & reels, Tyvek pouches & reels & Coated Tyvek lid- (As per OECD / Schedule Y /AYUSH guideline) ding sheets, peel-open self-seal pouches, peel-open and tear-open coated pouches & Header bags. Our core raw materials include, Accuprec Research Labs Pvt. Ltd., a contract research organization medical grade coated & uncoated papers, coated & uncoated Tyvek, having head quarter at Ahmedabad, Gujarat, India and having laminated films & specialized sterilization indicator inks. We are spe- branch office at Sudbury, ON, CA and Pittsburgh, PA, USA. cializing in customization and short-runs. With all manufacturing & QC facilities under one roof, we can assure excellent quality with Our research lab is approved by FDCA and certified by ISO timely deliveries at affordable costs. 9001:2008, GLP, CPCSEA and NABL*. Contact : Pradeep Surgipack, 1/A, Bikasipura Road, JC Industrial We are providing ultimate solutions for all kinds of research related Estate, Yellachenahalli, Off Kanakapura Road, Bangalore – 560062. services ranging from drug discovery to development. Currently Tel: 080-65700607 / 080-26860865 Email: we are providing research and testing solutions to our clients which radeep.surgipack@gmail.com / pradeep@pradeep-surgical.com includes small to large industries of Pharmaceutical / Biotech / Herbal/ Ayurvedic/ Neutraceuticals/ Medical device manufacturers 45 Jan.-Feb. 2017

Exhibitor Profiles Operon Strategist, Pune, India CIPET, Ahmedabad, India www.operonstrategist.com www.cipet.gov.in Turnkey Projects, Regulatory, Quality Assurance, Validation and Central Institute of Plastics Engineering and Technology (Ministry Certification in the fields of Medical Devices. of Chemicals & Fertilizers) offers wide spectrum of courses and programmes at different level in myriad domain of Plastics, Operon Strategist is one of the renowned consultancy companies Manufacturing, Design (CAD/CAM/CAE), CNC Tooling, for Designing of the layouts, Designing of the classified area crite- Microprocessor based Processing, Testing, Research & ria, Validation and implementation for medical device industry. They Development. Courses offered are: have many Medical device projects going on under their credential with the value for money effectiveness. The company has large num- Courses: ber of satisfied customer base with the repeat order guarantee. They - M.Sc. (POLYMER SCIENCE) have highly technical and experienced staff to handle all levels and - M.E. / M.Tech. in Plastics Engineering / Technology sizes of the projects. Contact : Pushpak Patil / Placement Officer / CIPET - AHMEDABAD Contact : Anil Chaudhari, Operon Strategist, MSR Capital, office T +91-79-40103934 | M 8460403804 | Skype: cipetplacement no.10, 3rd floor, Pimpri colony, Near city international school, Pimpri, PUNE 411 018 P: +91(020)65283428 M: 9823283428 Medical Plastics Data Services, Ahmedabad, India E: info@operonstrategist.com, anil@operonstrategist.com www.medicalplasticsindia.com Steri Techno Fab, Ahmedabad, India A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, www.steritechno.com DIAGNOSTICS AND PHARMACEUTICAL INDUSTRY AUTOCLAVE, ETO STERILIZER, UV STERILIZER, ULTRASONIC Periodicity : Once every two months. CLEANER, ETO CARTRIDGES, EO CARTRIDGES & OTHER STERILIZA- Publisher : Classic Computer Services. TION MATERIAL Target Audience : All who are involved or interested in Medical Plas- STERI TECHNO FAB is ISO 9001:2008, ISO 13485:2012 and CE tics user industries ranging from Pharmaceutical Industries, Medi- Certified organization with large experience in sterilization process cal Plastic Devices/ Equipments Manufacturers /Marketing Compa- for hospitals, pharma industries and medical devices. STERI TECHNO nies, Hospitals, Doctors, Medical & Pharmacy Colleges, Research FAB is an organization driven by certif ied, experienced and Institutes. dedicated team. Our hi-tech and compact designs have a unique combination of technology and innovation born out of catering to Editorial Content : Applications, Book Review, Company Profiles, special users requirements. Country Profiles, Design, Discovery, Eminent Institutions, Eminent Personalities, Events, Global Opportunities and Trends, Health Contact : STERI TECHNO FAB, 137 Fortune Industrial Park, Kathwada- update, Import - Export News, Industry News, Manufacturing, Singarava Road, Kathwada, Ahmedabad-382430. P: +919099922299, Markets, Materials, Product Profiles, Products & Processes, +918511931234. Email Id :- info@steritechno.com, Regulatory Affairs, Sterilization, Quality, Technology. yash3303@gmail.com, Advertising Opportunities : Malaysian Rubber Export Promotion Council, • Suppliers of Machineries/Equipments/Raw Materials/Services to Mumbai, India Medical Plastics Processors. • Vendors to Medical Devices/Equipments Manufacturers Supply- www.mrepc.com ing Raw Materials / Clean Room Equipments / Assemblies / Sub- Rubber Medical Devices - Latex Gloves, Nitrile Gloves, DentalGloves, Assemblies / Components / Technology etc. Foley Catheter, Dental Dam, Probe Cover, Finger Cot, Condom. • Medical Equipments/Devices Manufacturers/Suppliers and The Malaysian Rubber Export Promotion Council (MREPC) is an Marketing Companies. export promotion agency for rubber and rubber manufactured • Technical/Management Consultants for Plastic and Medical products from Malaysia. It acts as a link between buyers/importers Devices Industries. and rubber product manufacturers in Malaysia. Contact : Samir Shah - India Representative Contact : D L Pandya - Editor & CEO,Classic Computer Services, Malaysian Rubber Export Promotion Council B-4, Mandir Apartments, Opp. P & T Colony, Jodhpur Char Rasta, 907, Tulsiani Chambers, Nariman Point, Mumbai 400021, Ahmedabad – 380 015, India. P : +91 79-26740611, F : +91 79-26754867 Maharashtra, India, TEL: +91 22 6221 6725 FAX: +91 22 6223 2359 E : mpds00@vsnl.com / dlpandya@gmail.com MOBILE: +91 9619555899 EMAIL: sshah@mrepc.com Connell Brothers Co. (Ind.) Pvt. Ltd. Mumbai, India. 46 www.connellbrothers.com Products/Services : We are India’s leading suppliers for- Silicone 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. standards at the plant. This in turn ensures that the products (CBC), with its headquarters in the US, is well accepted as a reliable manufactured are reliable and are of the highest quality. and trustworthy [artner by customers as well as suppliers. Our experienced technical staff, supported by a network of field Established in 1999, Connell-India is part of the Asia Pacific region personnel, ensures prompt and efficient service to our customers. distribution network, consisting of 38 offices and 34 warehouses in 17 different countries, CBC, a business unit of USD 3.2 billion Contact : DIPESH PATEL, Partner, EXCEL FORMULATIONS, (Sales) Wilbur Ellis Co., is a new age, high-commitment distribution REGD. OFFICE : 401, Sanidhya- A, Opp. Anandnagar Shopping partner that more than meets the growing needs of the industry. Center, Prahladnagar 100ft. Road, Satellite, Ahmedabad-380015, GUJARAT, INDIA Telefax: +91-79-40067245, +91-9228008275, +91- Mascot PC & HC Division of Connell India with its vast experience 9825095666 Email : info@excelformulations.com, in providing specialty products & services to the Pharmaceutical, info@etosterilization.in Biotech & Medical devices industries, understands the importance FACTORY : Plot No. 32, Sonal Industrial Estate, Khoda Village Road, of use of superior quality products in formulations and processes. Sanand, Ahmedabad, Gujarat We are complete solution providers offering speciality silicones for Medical devices fabrication and lubrication, wound care and scar Ami Polymer Pvt. Ltd., Mumbai, India care applications, silicones for topical/ dermatological formulations, Silicone tubings for Pharmaceutical & Biotech www.amipolymer.com processing and silicone Anti-foams (Simethicones for Pharmaceutical and Biotech processing). Platinum Cured Silicone Tube, Radiopaque Tube, O-Rings, Custom Made Gasket, Silicone Sleeves for printing purpose, Medical We represent Dow corning for the mentioned applications. Components (Silicone Tips, Silicone Washer, Silicone Cork/Stopper, Silicone ‘Y’ connector, Pig Gasket, ‘C’ Clamp, Male Thread Gasket, Contact : Mr. Javed Shaikh / Mr. Abhishek Shukla Grip Bush, Silicone Tire/Band) Connell Brothers Co. (Ind.) Pvt. Ltd. 3rd Floor, Zenith House, Opp. Race Course, Mahalaxmi, Mumbai – 400034. We are specialized in manufacturing Platinum Cured Silicone Tubes, P: 022-66138300. Braided Hoses, Inflatable Seals / Gaskets & customized polymer so- lution for pharmaceutical industrial application. Serving since 1996, Suresh Enterprises, Mehsana, Gujarat. our well known brands are Imapure™, Imaprene™, Imaweld™, Imafit™, Imavac™, Imawrap™, Etc. DMF #26201 accredited by US FDA www.sevitsil.com for platinum cured silicone tube& braided hoses. Having 80000 sq. ft. manufacturing & packaging facility are certified clean room of Silicone & Viton Rubber Extruded and Moulded Products class 10000. Capable of developing customized product as per re- quirement. We have started a new medical division for developing Sevitsil is a brand name of Suresh Enterprises. We are into this busi- medical products. ness since 1978. We started as small trading firm in Mumbai with solo motive to serve various government departments, after initial Contact : Mr. Elvis Mendonsa (CEO – Medical Division), Ami Polymer struggle with courage and dream to serve throughout India we Pvt. Ltd., 319, Mahesh Industrial Estate, Opp. Silver Park, Mira started a manufacturing unit. Bhayander Road, Mira Road (East), Mumbai 401104, Thane. Maharashtra. INDIA. P: +912228555107, In 1992 we shifted to Mehsana for betterment and expansion, Email : info@amipolymer.com today we have Clean Room Class 100,000 and US FDA certified DMF No 28622. Indian Innovators Association, New Delhi, India Contact: Mr. Kunj R. Shah, C1/55 Suresh Enterprises, Lane Opp to www.indiainvents.in Water tank, GIDC Phase – II, Dediasan, Mehsana -384002. Gujarat, India. P: 02762-224814, 224240, 255239. Mobile: +91-9727738001. Indian Innovators do not want awards, they demand rewards. Indian Innovators Association works to develop markets for Excel Formulations, Ahmedabad, India designed in India products. www.excelformulations.com Services : Independent Innovators : Participation in international innovators We, at EXCEL FORMULATIONS take this opportunity to introduce exhibitions sponsored by IFIA. ourselves as one of the leading manufacturers of ETO sterilization Students : Starting ‘Student Ideation centers’ in partnership with gas mixtures in India. Emerging Ventures Exchange. Research Institutes : Developing technology commercialization EXCEL FORMULATIONS, established in 2007, is amongst India’s plans in partnership with SkyQuest and General Inventions leading manufacturer of ETO (Ethylene Oxide) Gas mixtures. We Start-ups: Mentoring to get ‘right valuation’ in deals in partnering are ISO 9001, 14001 & 18001 and D&B SMERA certified company. with EVx We are one of the Export House certified by Government of India. Product manufacturing companies : Innovation Audit service to We are manufacturing various types ETO gas mixtures in cylinders develop scenarios and strategic plans. as well as Disposable E.O Cartridges. Exhibitors : Support for Innovation exhibition with participation by innovators from 100+ member associations of IFIA. We established a state-of-the-art EtO formulation and bottling facility at Sanand, Dist. Ahmedabad, Gujarat and supplies various Contacts : Dr A. S. Rao , President , Indian Innovators Association, combinations of Ethylene Oxide with Carbon dioxide in different Hyderabad. indiainvents@gmail.com sized cylinders. PSS Prabakar Rao, Secretary, Indian Innovators Association, New Delhi, iia.iiif2016@gmail.com. The plant that manufactures mixtures of ethylene oxide and carbon dioxide is manned by skilled team with a strong quality orientation. 47 This ensures strict adherence to safety, health and environment Jan.-Feb. 2017

Exhibitor Profiles Medical Textiles- SITRA, Coimbatore, India. Founded in 2007, Pharmadocx is an India based Medical Devices Consultation firm. Guiding Companies to set up Manufacturing unit www.sitra.org.in & Obtaining Drug License. Centre of Excellence for Medical Textiles, promoted by Ministry Designing of plant, Supervision of construction & FDA licensing. Up of Textiles, Government of India. gradation of existing plant as per M-III guidelines. GMP Documenta- tion of plant. Turn Key Projects. The South India Textile Research Association (SITRA) is a premier National level autonomous organization for Research, Consultancy Pharmadocx provides services for following types of plants. and Human Resources Development in the field of Textiles. SITRA Medical Devices, Orthopedic Implant Plant, Surgical Dressing Plant, is the designated Centre of Excellence for Medical Textiles, Medical Oxygen Plant, Diagnostic Kits, Pharmaceutical Formulation, promoted by Ministry of Textiles, Government of India. As a Centre API, Homoeopathic & Ayurvedic, Unani & Siddha Medicine, & of Excellence for Meditech, SITRA has addressed itself to a number Cosmetics Plant. of multi-varied activities such as: • Testing and Evaluation (Physics, Microbiology, Bio-Technology, Contact : Yashdeep Dahiya (CEO), PHARMADOCX, Opposite Dewan Mill, Old DC Road, Sonepat (HR) 131001, INDIA Analytical Chemistry) Ph. No. +91 130-2200630 (M.)+91 9896133556. • Standard Formulation (BIS, International bodies) E-mail : whogmp@pharmadocx.com, • Incubation Services Blog : Pharmadocx.wordpress.com • Detailed Project Reports (DPRs) SkypeName : Yashdeep Pharmaceuticals • Pilot Scale Production (Medical/Technical Textile Products such Oswani Plastics Pvt. Ltd., Mumbai, India. as Face Mask, Sanitary Napkin & many more) • Training and Seminar www.oswingroup.com • Technical Consultancy • Testing Instrument / Product Machine – Technology For Disposable Equipments : Flow case pipes, Tubings, Hose for Breather circuits. Development Oswin Plastics Pvt Ltd is part of OSWIN GROUP which manufactures • Prototype Development / Contract Research pipes , profiles and molded articles from engineering and non • Information Resources engineering polymers. Contact : Dr. Ketankumar Vadodaria, Head - incharge - Medical Processes handled : Extrusion, Corrugation, Injection Molding, textiles/ Tel : 0422 -4215338/ Blow Molding, Insert Molding. S.Thiruppathi - senior scientific officer, SITRA CoE Medical textiles, Industries we cater : Medical, House Hold appliance, Automobile, 13/37 Avinashi road, Coimbatore -641014 LED Lighting, Sanitary, Hardware, Telecommunication, Electrical Tel : 0422-4215333 Extn.369 Mobile : 9790225424 switch gear, Packaging Email : techtextrg@sitra.org.in Contact : Mr. V. Newton / Mr. K. Khimasia Oswani Plastics Pvt. Ltd. 142/48 Ghaswala Ind. Estate, Opp. 24 Karat PLASTINDIA FOUNDATION, Mumbai, India. cinema, S.V Road, Jogeshwari (west) Mumbai - 400102 Telephone : +91-22-6771301 / 02 / 03 Email : info@oswingroup.com / www.plastindia.org newton@oswingroup.com /kunj@oswingroup.com Plastindia Foundation is the apex body of major associations, OM ENTERPRISE, Ahmedabad, India. organizations and institutions connected with plastics, with common objectives to promote the development of plastic industry BLISTER PACKING, VACUUM FORMING, TRANSPARENT PACKINGS and to assist the growth of plastics and related materials and their AND BOXES, CAM SHELLS, SLIDING SYSTEM, SEALING products. The Foundation is dedicated to the national progress TECHNOLOGIES ( HOT AND COLD) through plastics. WE PROVIDE JOB WORK , MACHINES , MOULDS AND SEALING High lights of PLASTINDIA 2018: TECHNOLOGIES , TOATAL SOLUTIONS Gross Area – 1125,000 sqms, Targeted exhibitors – 2000 Nos., SINGS LONG WE ARE ENGAGED IN BLISTER PACKING VACUUM Overseas participation – 600 Nos from 40 countries, Business FORMING IN PVC, PET, ABS, ACRYLIC MATERIAL AND Visitors – around 200,000 Nos. TRENSPARENT SEALABLE PACKING AND BOXES. WE ALSO Concurrent Events : PROVIDE CAM SHELL PACKINGS AND TOTAL SEALING HOT AND PROPLAST 2017 for Finished Products, International Conference, COLD TECHNOLOGIES Plasticon Awards, B2B Meets Contact : OM ENTERPRISE, LL - 24, Harekrishna Complex , Opp. Industry Focused Pavilion : Kothawala Flats , Pritamnagar, Paldi, Ahmedabad - 380 006 , Gujarat, Composites, Automotives, Medical & Health Care, Sports, 3D India. Ph. : 079 40098277. M. : 093277 08277, 092272 02415, Printing & Prototyping M.: 099787 18110. E mail: omenterpriseplasticpacking@rediffmail.com. Contact : 401-B, Landmark, Suren Road, Off Andheri Kurla Road, Andheri East, Mumbai – 400093, India. Tel. : +91-22-26832911 upto Jan.-Feb. 2017 14, Fax : +91-22-26845861, E-mail : info@plastindia.org PHARMADOCX, Haryana, India. www.pharmadocx.com Medical Devices Plant Designing, Liasoning for Form-28 Drugs License. GMP Documentation, SOP, SMF, DMF, Device Validation. 48

Supporting Associations Mr. Rajiv Nath Most of the unit members hold approved Drug Manufacturing License, GMP, ISO & CE certifications with product barcodes. Forum Coordinator, Our main objective is to contribute to the development and growth of the inter-disciplinary areas of Medical Devices Industries in all Association of Indian aspects and specialties. Main Activities of the Association: Association of Indian Medical Device • Organizing Meetings, Seminars, Symposia, Exhibitions & Industry (AIMED) Demonstrations • Conducting Training Programs for Skill Development, Manage- Medical Device Industry ment & Marketing (AIMED) • Training Man Power [Technical, Non-Technical] • Exchange information between the Members regarding AI-MED is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including changing Government policies & regulations consumables, disposables, equipments of diagnostics represent- • Representation of the issues with Government Authorities like ing the interest of over 700 Manufacturers of Medical Devices to cover issues and address the manufacturer’s problem. FDA, Excise, VAT • Assistance and Guidance to the Members for quality The aim behind forming AI-MED is allow the Government to ac- cess a single point of contact and provide various services to the certifications like ISO, CE, and GMP. manufacturers like Advocacy on policy issues, Information ser- vices, Regulations for medical devices, Education and Training, Society for Biomaterials and Artificial services, Testing Assistance and guidance for Quality Certifica- Organs – India (SBAOI) tion (ISO, CE, GMP), Lobbying for funding for R&D from the Gov- ernment, encourage innovations from member units, Improve INDIA is one of the fastest growing health care markets in the clinician and patient access to the modern, innovative and reli- world. The current estimate of health care device market is about able medical device technologies through organizing Meeting, $1billion with a projected growth rate of 18%. Realizing this huge Seminars, Symposia, Exhibitions and Demonstrations and also, potential, Indian industry as well as academician has started show- to promote global harmonization of Indian device industry. ing keen interest in biomaterials and medical devices research. As a result, establishments like National Laboratories, Indian In- AI-MED will ensure convergence at a one common platform, when stitutes of Technology and other leading Universities have started needed, for ensuring overall growth of Indian Medical Devices research as well as teaching programs. Many of the establish- Industry and further address the needs of all members of the ments work in close association with the industry also. As an Medical Device Industry irrespective of their affiliation or their outcome of this, apart from the ongoing research activities, indig- company size. It will also help in wider dissemination of informa- enously developed implants and devices like artificial heart valve, tion to each player of the industry. AI-MED would be horizontally hydrocephalus shunt, blood oxygenator etc. are also available in divided into common groupings like – Legal Issues, Tax Issues, the Indian market. Export Related Issues, Medical Device Regulatory Issues com- In order to develop coherence among the scientists and engi- mon to all vertical groups of different families of product lines neers working in this field, way back in 1986 Dr. Chandra P. with Zonal Representations. Sharma along with his colleagues founded the society, Society for Biomaterials and Artificial Organs - India. AI-MED has initiated the formation of the IMDRRG (Indian Medi- cal Device Regulatory Review Group) This is an open informal Shri H.G. Koshia forum – broad based consisting of Regulators, the Regulated Commissioner Industry, the conformity assessment quality system auditing bod- ies like SGS/TUV/Intertek/UL/DNV/BSI, Testing Facilities and Food & Drug Control other Stake Holders – Consultants/Doctors/Nurses/Patients to Administration, Gujarat review proposed regulations on ongoing basis and ensure that these are aligned to the GHTF (Global Harmonization Task Force) Food & Drugs Control Administration, Guidelines - AI-MED wishes to collaborate with the Govern- Govt. Of Gujarat (FDCA) ment. Currently we have over 400 individuals and organization Drugs Control Administration (DCA), Gujarat came into existence representatives receiving e-mails with opportunity to use this fo- on 1st May 1960 after separation of Gujarat State from Greater rum for informal and candid e-mail exchange as well as pass on Bombay State and Mr. B.V. Patel became the first director of DCA, information to members of their organizations. Gujarat. Mr. M. M. Saiyed DCA, Gujarat was entrusted implementation of Drugs & Cosmet- President ics Act – 1940 & Rules 1945 and Drugs Magic Remedies (Objec- tionable Advertisement) Act – 1954. Mr. B.V. Patel played a vital MEDICAL DISPOSABLE role in establishing well defined administrative structure, policies MANUFACTURERS' and procedures of DCA, Gujarat. He seeded the present culture ASSOCIATION (MDMA) of this department - industry friendly, prompt & strict action against law breakers. He also took initiative to establish state of art Drug We are an Association of Medical Disposable Manufacturers Laboratory equipped with latest equipments at Vadodara. popularly known as MDMA [Medical Disposable Manufacturers;' Association] in Gujarat. We have more than 40 members. The Dr. M. A. Patel was followed by SHRI A. G. Shah, Shri G. R. Bhagat, Medical Disposable Manufacturing Industry is in existence for the last more than 30 years and many of our units are major 49 suppliers of Disposable Medical Devices like Intravenous Infu- sion Sets [I.V. Sets], Blood Transfusion Sets [B.T. Sets] to the local regions, export markets and central government for tender supply. Jan.-Feb. 2017

Supporting Associations Dr. S. P. Adeshara, Mona Khandhar, (I.A.S.), DR. S. Murlikrishna, Association Of Diagnostics ( I.A.S. ) & Dr. H. G. Koshia as Commissioners of FDCA, Gujarat. Manufacturers Of India (ADMI) Since, 22nd January 2009 Dr. H. G. Koshia is Commissioner, FDCA, Gujarat. ADMI is a non-profit making company, incorporated in the year of 2002 with its registered office in the State of Gujarat. With effect from 5th August 2011, PFA and seven other acts The management of the business affairs and control of the com- related to food have been repealed by “The Food Safety and pany are rested with the Managing Committee, which is elected Standards Act, 2006” (FSSA). based on the tenets as enshrined in the constitution of ADMI. The office bearers are elected every three years. Dr. H.G. Koshia, Commissioner, Food & Drugs Control Adminis- tration, Gujarat His Key Responsibilities are Enforcement of Medical Surgical and Healthcare Industry “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Trade Association (MSAHITA) Safety & Standard Act, 2006” and rules, in Gujarat State. He is actively representing nine national and state level commit- The aim of MSAHITA is “OUR STRENGTH IS ALWAYS IN tees. He is Chairman of the very important committee “Track & HELPING OTHERS BY UNITING, IT CAN MAKE A DIFFER- Trace”, for preparation of guidelines to prevent of menace of ENCE.” spurious drugs. Every Trade has a collective community for the betterment and showcase of Strength, Unity and uniform trade policy governed Dr. Koshia regularly interact with officials of US FDA, Health by the association for the well being of its members. Our trade Canada, MHRA, DCGI, technocrats, academicians, IDMA, Chem- lacked the effective way of voicing our concern and grievances ists & Druggists Association etc. to ensure a consultative at all levels, weather it was amongst us or being targeted as soft approach towards inclusive development and growth. and most sullied business organization. The treatment given to the patients are at par with the interna- He has played a pivotal role in transformation of pharma sector tional level, as the cost is much less and the patients care is in Gujarat to emerge as a favorable investment destination with equally good here in the private sector. We provide better and proactive & pragmatic approaches. cheaper healthcare products, services and expenses to the indi- viduals. It is here that our trade plays a very important role. The He has played a vital role in the implementation of e-governance relentless efforts for up gradation by our trade there is a constant in FDCA and is winner of one state level and three national level urge to grow along with the international standards. awards. There is tremendous scope and wide variety of product range, always a place for every new comer who has been accommo- FDCA implementing various Acts and rules related to Drugs, dated. It has therefore become the need of the hour for the well Cosmetics, Medical Devices, Food & Safety, Cigarettes & other being and the prestige of our trade at large to get the recognition tobacco products etc. and reorganization to get our identities as of well groomed and respected traders amongst other trade as well. The pharmaceu- Medical Device Industry In Gujarat: tical industry is a classic example. The health sector being one of Gujarat State has the largest number of licensed Medical the most vital sector and even accepted by the government. Devices Companies which are nurtured by Gujarat FDCA Dept. with an exemplar nary approach and has been receiving recog- Gujarat State Plastic Manufacturers’ nition in the country. The present culture of this department is Association (GSPMA) industry friendly, prompt & still known for taking strict action against law breakers. Established in 1970, the Gujarat State Plastic Manufacturers’ Association (GSPMA) is one of the leading plastic manufactur- Testing Laboratories: ers associations in the country, representing Plastic Industry at Food & Drug Laboratory (FDL), Vadodara is the first NABL ac- State as well as Central level. At present, total membership credited Government laboratory in the country. In addition to FDL, strength of the Association stands at around 2500. GSPMA is Vadoadara, FDCA has two other Regional Food Laboratories for also one of the founder members of the PLASTINDIA FOUNDA- testing of food samples, one at Rajkot and one at Bhuj. FDCA is TION, an apex body engaged in the research & development in also setting up one more state of art Food & Drug Laboratories in the Plastic Industry throughout the country and dedicated to the state. national progress through plastics. GSPMA is working for the cause of Plastic Industry since last Training: more than four decades. GSPMA has been engaged in the Training of FDCA officers of both cadres, Drug & Food, has been promotion of image of Gujarat based units in the country and has a regular practice. It includes induction training of newly appointed been functioning as a major link between the Industry & the officers and in service training as well. The objective of training is Government. to sharpen their knowledge not only to maintain performance of GSPMA also participates in the national/ international plastics FDCA but also to achieve newer landmarks. exhibition from time to time. GSPMA had organized national level e-Governance: Jan.-Feb. 2017 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. 50