Medical Plastics Data Service September - October 2017

CToabnletoef nts Vol. 25 No. 5 Sept. - Oct. 2017 22 Cover Story • Medical Device Industry In India – A Sunrise Industry - Srinivas R Pilli, Sr. Technical Office, Andhra Pradesh MedTech Zone ( AMTZ ). Global Medical Device Mare Market, Indian Medical Device Market, Medical Device Segments - India, Segment Wise Market Share, Import and Export Trens etc. 23 Industry Clusters • Favourable Ecosystem Lifts Med Device Manufacturing In Gujarat - D L Pandya, Editor & CEO, Medical Plastics Data Service and www.medisourceasia.com UNIDO initiated Cluster Development Program for Pharma / Medical Devices units in Gujarat. Industry Support Eco-System kept on growing resulting in not only continuing of the fast growth of the Industry but also upward movement of the Industry in the value chain. 26 Regulations • Update on European Regulations for Medical Devices - Sanjay Shah, Managing Director, Unikal Consultants, Ahmedabad. The compliance requirements and their implementations have been changing rapidly especially renewal or recertification, with reference to Indian scenario. 35 Global Trends • US Medical Device Makers Call For Trade Action Against India Citing recently imposed price controls, the representation made by Advamed – a trade association representing nearly 350 medical technology companies. • Medical Plastics Market worth 21.06 Billion USD by 2022 37 Industry News • Manufacturers Welcome Price Cap On Medical Devices • Gujarat Registers Maximum Number Of 170 Medical Devices Units In The Country Under CLAA Scheme • MTaI Puts Forward Key Recommendations To Govt For More Enabling Environment For Medical Devices Industry In India • Gujarat FDCA Writes To Health Ministry To Accelerate Process of Setting Up Much Awaited Medical Device Testing Lab At Vadodara 40 Product Gallery • Qosina Introduces New 2018 Catalog 20 Did You Know? • About Advanced Medical Polymer For Treating Diabetic Patients 46 Events • Compamed 2017 / Medica 2017: Nov. 13-16, 2017, Dusseldorf Germany • Plastivision Arabia 2017: Dec. 11-14, 2017, UAE • PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad • Medical Fair India 2018: March. 16-18, 2018, Mumbai Sept-Oct.2017 19

Flashback ?YoDKuindow ? Select Article Index About Advanced Medical Polymer For Treating Diabetic Patients Sept. 1997 to Mar. 2000 Diabetes care has seen several innovations through the years. One of the important devel- • Events (November 97) opments is insulin pumps, which for many patients provides an option to the traditional needle Mr. Sandeep Puri, Hydro S&S Industries Ltd. and syringe approach to insulin injections. In addition to software development, companies Mr. Vinit Jain, Technology International, are also focusing on device hardware that is smaller, lighter and made from specialized Vadodara polymers that provide the necessary properties to ensure a safe and functional product. High performance polymers have enabled companies to go beyond the functionality of • The Role Of Plasticizers In PVC Contain- ordinary plastic materials to develop innovative means for treating diabetic patients. Cyclic ers For The Collection And Storage Of Olefin Copolymer (COC), a glass-clear plastic resin, is currently used in numerous healthcare Blood And Blood Components applications and has become one of the materials of choice in insulin delivery systems. (January 98) Physical properties of COC such as high strength, dimensional stability and the ability to Dr. C. S. B. Nair, Director, Research & replicate fine features are important advantages as parts become smaller and thinner. In Development, Trivandrum addition, COC provides insulin compatibility, high purity, and a favorable extractables/ leachables profile which is key as expanding FDA guidelines present additional challenges • Role Of Medical Grade PVC Compounds for device design and approval. For Critical Medical Applications In developing new and advanced insulin delivery devices, COC’s unique advantages have (January 98) expanded the possibilities for innovative design and manufacturing. This medical grade poly- Mr. R. Kumar, Hydro S&S Industries Ltd. mer allows for the miniaturization of device components without the constraints of glass or ordinary plastic materials. • Plastic Medical Applications (Nov.98 Jan.99) Critical device components such as insulin reservoirs require the use of a proven polymer Robert Beard, P.E., Robert A Beard & Associ- material. In addition to compatibility with insulin, purity and very low leachables, COC ates, Inc. USA provides excellent moisture barrier and extremely low water absorption; both necessary properties for optimal long-term drug container storage. It features broad global regulatory • Plastic Medical Applications (November 99) compliance including USP Class VI and ISO 10993. COC is compatible with all conventional Mr. Robert Beard, U.S.A. sterilization methods from gamma to steam. (https://topas.com/insulin-delivery-devices-how-advanced-medical-polymer-solving-new- • Victrex Peek Polymer (September 99) design-challenges ) Mr. John Gallagher, The European Marketing Group, The Netherlands In a Nutshell.... • Four Goods Reasons To Switch To PVC (May 99) “Big data may tell you how many Dr. Leonardo Maggghetti, Mktg. Manager, customers you have won or lost but not S.I.F.R.A. EST Group, Italy necessarily why. This is the intelligence • Growth Of Plastics Use In Medical Devices that can really make a difference”. Is Spurred By Cost - Cutting - Modern Plastics Mid-November 1998 (March 99) -Jane Frost Chief Ececutive • The Facts About PVC (March 99) Market Research Society Reproduction Of an Article By Mr. Ole Grondahl Hansen As Printed In “Medical Sept.-Oct.2017 Device Technology” October 97 Issue • Polymeric Pressure Sensitive Adhesives for Medical Applications (November 2000) Dr. P.A. Mahanwar & Farhana Yasmeen, University Department of Chemical Technol- ogy, Matunga, Mumbai • Polymeric Pressure Sensitive Adhesives For Medical Applications (September 2000) Farhana Yasmeen, Mr. P.A. Mahanwar, University Department Of Chemical Technol- ogy, Matunga, Mumbai • Application Of Polymers In Innovative Medical Devices (May 2000) V.P. Malhotra, R.K. Raina, Sanjay Rajput, Shriram Institute For Industrial Research, New Delhi • Markets In Asia Plastics In Health And Medicare (March 2000) Prof Ashok Misra, IIT, Delhi 20

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. MEDICAL DEVICE INDUSTRY CLUSTERS AND THE ROLE OF FAVORABLE ECOSYSTEM : EDITORIAL ADVISORY BOARD Gujarat has been the pioneer state for the Indian Medical Device Dr. TARANG PATEL Industry. An important turning point for the Gujarat Industry was when some of the M.B.B.S., M.Ch. (ONCO) products were covered under Food and Drug Control Regulations and the units Cancer & Reconstructive Surgeon started facing challenges both for the quality requirements as well as manufactur- ing systems. Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Around this time, UNIDO initiated a cluster development program for the Pharma Chairman - Mobilexion Technologies Pvt. Ltd. and Medical Devices. The program was carried forward by Foundation of MSME Clusters (FMC). Trivandrum The programme addressed the transition challenges in a step-by-step approach Dr. DILIP H. RAIKER by building awareness among firms, sustaining a group approach to purchase of Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) business development service (BDS), creating institutional linkages and finally build- Former Chief Manager(P), CIPET - Chennai ing the capacity of existing and newly created associations to ensure the sustainability of the process. ING LOUIS C. SUHUURMAN Formerly Sales Director As a result of these initiatives, large number of units in Gujarat embarked on quality COLPITT B.V., Holland up-gradation, many of them made substantial investments. New Business Develop- ment Services (BDS ) providers were introduced in the areas of quality, factory level Dr. A.V. RAMANI training, contract business, export market and other support services. The Group Sr. Vice President (R&D), The TTK Group program created or strengthened linkages with various technical/develop- mental institutions in the state. Dr. Vinny Sastri President, Winovia LLC, U.S.A. The Industry Support Eco-System which included these institutions kept on growing resulting in not only continuing of the fast growth of the Industry but Dr. C.S.B. NAIR also upward movement of the Industry in the value chain. This issue includes a Director (R&D), Peninsula Polymers Ltd very elaborate explanation of how the favourable ecosystem has contributed in lifting Medical Device manufacturing in Gujarat. I had an opportunity to get involved Dr. BHARAT GADHAVI in the implementation of more than 30 different programs implemented as part of CEO, HCG Medisurge Hospitals this cluster development process. Mr. A.S. ATHALYE Over the years, various Medical Device Clusters have come up across the Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai country spread over states including Haryana, Delhi (NCR), Gujarat, Maharastra, Telangana, Karntaka, Tamil Nadu etc. In a very detailed report, “Medical Dr. SUJOY K. GUHA Device Manufacturing in India – A Sunrise Industry” compiled by the Andhra B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Medical Technology Zone (AMTZ) team under the leadership of Dr Jitender Sharma is available on “AMTZ” website. Abstracts of this report is reproduced in this issue IIT, Kharagpur by Mr Srinivas R Pilli, Sr. Technical Office, AMTZ. Dr. G. S. BHUVANESHWAR This issue also includes an important update on “European Regulations On Consultant, Medical Devices – Design, development, Medical Devices” by Mr Sanjay Shah along with the regular columns like Global Trends, Industry News, Product Gallery , “Did You Know ? “ etc. testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-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. Sept.-Oct.2017 21

Cover Story Medical Device Manufacturing in India - A Sunrise Industry Srinivas R. Pilli, Sr. Technical Officer Andhra Pradesh MedTech Zone (AMTZ) Medical Device Market • Patient aids • Consumables Medical Device Market Size – Global • Dental products • The global medical device market was estimated at USD 228 • IV diagnostics • Others bn in 2015 (INR 14.82 lakh crores). • Diagnostics imaging is the largest segment constituting 26% • Industry estimates suggest that the global medical device of the medical device market, with an annual sales estimate market will grow at a CAGR of 7.8% from 2010 to 2020. of USD 60 bn (INR 3.85 lakh crores) in 2015. • The market is expected to reach USD 332 bn (INR 21.58 lakh Table 1: Share of Medical Device Segments Globally crores) by 20201. Medical Device Segments USD bn (2015) INR crs (2015) Diagnostics imaging 59.28 3,85,320 IV diagnostics 54.5 3,54,250 Orthopedic and prosthetic devices 29.64 1,92,660 Consumables 34.2 2,22,300 Patient aids 22.8 1,48,200 Others 13.9 90,350 Dental products 13.68 88,920 Segment Wise Medical Device Sale Globally (2015) Figure 1 : Global Medical Device Market Size Figure 2 : Segment-wise sale globally Global Medical Devices Market • The global medical device market is categorized mainly into seven segments as listed below. The major equipments included under each of these segments have been detailed in Table.1. High Potential Segments in India. • Diagnostic imaging • Orthopedic and prosthetic devices Srinivasa R Pilli, holds his Masters in Biomedical Imaging from the University of Dundee, a collaboration between Institute of Medical Science and Technology (IMSaT) and Ninewells Hospitals UK; PG Diploma in Clinical Research for Medical Devices, Tenet Health Edutech Pvt. Ltd. He is also holds Bachelors and Diploma in Biomedical Engineering from JNT University and SGPR Govt Poly College. He is currently working as a Senior Technical Officer at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam, which is Asia’s first Integrated Medical Devices Manufacturing Park and it’s a “One stop solution” for Medical Device Manufacturers & Innovators. He has more than 9 years of experience in the field of Medical Devices industry. Mr Srinivasa is also an associate member of Institution of Engineers (AMIE), Biomedical Engineering Society of India (BMESI), International Association of Computer Science and Information Technology (IACSIT), Asia-Pacific Chemical, Biological& Environmental Engineering Society (APCBEES) and a Life member of Indian Science Congress and Voice of Healthcare(VOH). 1 Analysts: Device market growth will outpace pharma by 2018, http://www.fiercebiotech.com/medical-devices/analysts-device-market-growth-will-outpacepharma- by-2018, Cunningham, Dolan, et al, Medical Device Sectoral Overview, Whitaker Institute and NUI, Galway, April 2015, http://galwaydashboard.ie/ publications/medical-sector.pdf, (accessed on 10th July 2015), Opportunities, Ecosystems & Roadmap to Innovations in the Health Sector, Report of Sector Innovation Council for Health, NHSRC, KPMG Analysis 22 Sept.-Oct.2017

Cover Story Diagnostic imaging is the largest segment within Indian medi- cal device market in 2015. It constitutes USD 1.18 bn (INR • IV Diagnostics is the second largest segment with an esti- 7,650 crores)3 in 2015 and will grow to USD 2.47 bn (INR mated 24% share at approximately USD 54.5 bn (INR 3.54 15,561 Crores)3 in 2020. lakh crores). • India is one of the top 20 global medical device markets and the 4th largest medical device market in Asia5. • Dental products including dental implants, dental chairs and equipment account for the smallest share of USD 13.68 bn Indian Medical Device Market (INR 88,920 crore)1. • Americas (both North and South) is the largest medical device market globally at 45% of the total global medical device sale. • Western Europe is the second largest market at 27% of the total global medical device sale • Asia is the third largest market at 21% of the total global medical device sale1. Geography Wise Sale of Medical Devices (2015) Figure 4: Indian Medical Device Industry Market Size Figure 3 : Top Medical Device Markets Globally Medical Device Segments – India Geography USD Bn (2015) INR Cr.(2015) Diagnostic imaging is the largest segment within Indian medical device market in 2015. It constitutes USD 1.18 bn (INR 7,650 Americas 102.6 6,66,900 crores)3 in 2015 and will grow to USD 2.47 bn (INR 15,561 Crores)3 in 2020. Western Europe 61.56 4,00,140 • Others and IV diagnostics6 comprise largely of electrical Asia 47.88 3,11,220 and electronic devices. The others category (patient moni- tors, ECG machine, Defib, etc) is estimated at USD 0.94 Bn Eastern Europe 9.12 59,280 (INR 5,922 Crores) in 2015 and will grow to USD 1.98 Bn (12,880 Crores)3 in 2020. Similarly, the IV diagnostics market constituted of USD 0.39 bn (INR 2,550 crores) in 2015 and will reach USD 0.82 bn (INR 5,356 Crores) in 2020. Middle East and Africa 6.84 44,460 Geography-wise medical device market • It is estimated that 65-70% of the total global medical device market is driven by 20 global medical device companies2. Indian Medical Device Market • The Indian medical device market hasgrown from USD 2.02 bn (INR 13,130 Crores) in 2009 to USD 3.9 bn (INR 25,259 Crores) in 2015 at CAGR of 15.8%3. This accounts for approximately 1.7% of the global medical device market in 20153. • The Indian Medical Device market contributes to 4% of the Indian healthcare market which is pegged at USD 96.7 bn (INR 6.29 Lakh Crores), in 20154. • The industry estimate suggests that the Indian medical Figure 5 : Segment-wise Market Share device market will grow to USD 8.16 bn (INR 53,053 crore) in 2020 at CAGR of 16%4. 2 Cunningham, Dolan, et al, Medical Device Sectoral Overview, Whitaker Institute and NUI, Galway, April 2015(http://galwaydashboard.ie/publications/medical-sector.pdf, (accessed on 10th July 2015) 3 Espicom, India Medical Devices Report 2016, KPMG Analysis 4 KPMG- AMTZ Analysis 5 Draft National Medical Device Policy, 2015, Department of Pharmaceuticals, GoI 6 IV diagnostics comprises of medical equipment and reagents used for laboratory purposes Sept.-Oct.2017 23

Cover Story AMTZ holds Industry Awareness Training Programme on Quality Certification for • Similarly, Orthopedics & Prosthetics and Consumables will Medical Devices Manufacturers grow from a cumulative USD 0.90 bn (INR 5,850 crores) in 2015 to USD 1.88 bn (INR 12,220 crores)3 in 2020. 16th August, 2017 - Vadodara • Dental products and Patient Aids will grow from a cumulative The Andhra Pradesh MedTech Zone (AMTZ), India’s first in- USD 0.47 bn (INR 2,961 Crores)3 in 2015 to USD 1.1 bn tegrated state-of-the-art medical devices manufacturing park (INR 6,930 Crores) in 2020. in Visakhapatnam, organized a One - day industry training programme on quality certification with an aim to bring down • Growing Population the time and cost-run to obtain globally accepted quality • Ageing Population certification for Indian manufacturers. • Increasing Disease Burden of Chronic Diseases • Increasing Health Insurance Penetration The training programme, held on 9th August in Coimbatore • Growing Medical Tourism and 16th August on Vadodara and attended by medical de- • Demand for Healthcare Infrastructure vices manufacturers, medical professionals from Healthcare • Emerging Healthcare Service Formats & Academics and other industry stakeholders, was organized • Quality and Accreditation of Hospiatals as par with in association with Quality Council of India (QCI), National Accreditation Board for Certification Bodies (NABCB) and International Standards Association of Indian Medical Device Industry (AIMED). Import and Export Trend in Indian Medical Device The programme mainly focused on helping medical device Market manufacturers to understand Industry Certification for Medi- cal Devices (ICMED) certification and New Medical Device Import and Export Trade in the Last 5 years Rules, 2017 which are effective from 01st January 2018. • The import of medical devices has grown from USD 2.46 bn The programme’s objective was to fill the regulatory space in (INR 15,990 crores) in FY12 to USD 2.87 bn (INR 18,655 quality certification for medical devices in the country. The crores) in FY1613. key themes of the training sessions included EU regulatory, • The export of medical devices has grown from USD 0.78 bn medical device definition, life process and device risk classi- (INR 5,070 crores) in FY12 to USD 0.98 bn (INR 6,370 crores) fication; CE Marking and New MDR; ICMED 9000 certifica- in FY1613. tion, which is ISO 9001 plus additional requirements; ICMED • Between FY12 to FY16, the import trade of medical devices 13485, which is ISO 13485 plus additional requirements; and has increased by 16.8 per cent, whereas export trade has New Medical Device Rules, 2017. increased by 25.7 per cent13. Import Trade of Medical Device Thanking QCI and NABCB for organizing the event jointly “to • The total import of medical devices is more than 75 per cent exchange the knowledge share of regulations and certifica- of total medical devices sales in India13, however it is tion process for the medical device”, Dr Jitendar Kumar estimated that import trade will fall with increasing number Sharma, CEO and Director, AMTZ, said: “With this event, we of international and Indian manufacturer setting up medical will aim to create a more progressive practice towards device manufacturing set up in India. regulatory frame work in the medical device sector.” 13 Directorate General of Foreign Trade Dr. D L Pandya, CEO, Medical Plastics, applauded AMTZ and QCI organizing such first India’s industry awareness pro- 24 gram on ICMED and MDR to boost the quality certification and regulatory requirement to medical device manufacturers in advance. Mrutunjay Jena, Joint Director, QCI, said, “QCI & AIMED in partnership with AMTZ is initiating a number of voluntary awareness Programs to facilitate industry and demonstrate compliance to the best global standards of which ICMED is one of them.” Sept.-Oct.2017

Cover Story machine, etc.) has grown by 9.6% from USD 878 mn (INR 5,707 Crores) in FY12 to USD 964 mn (INR 6,266 Crores) in Import and Export of Medical Devices FY 1613. Export Trade of Medical Device Figure 7 : Import & Export of Medical Devices in India Figure 9: Export Trade of different segments of medical device Medical Device Segment wise Import Trade market • Diagnostic imaging, consumables and other medical devices form 86 per cent of total export trade in India in FY1613. • Amongst the exporters’ portfolio, USA was the chief destina- tion for export and contributes close to 15 per cent of the export trade. Singapore, Germany and China were the other leading export destinations with shares of 7.0 per cent, 6.7 per cent and 6.4 per cent respectively. The European Union (incl. Germany) cumulatively constitutes of 21.7 per cent of the total export trade13. Table 4: Segment-wise export trade of medical devices USD MN Figure 8: Import Trade of different segments in the medical Segments/Year 2011-12 2012-13 2013-14 2014-15 2015-16 device market Diagnostic Imaging 210 241 229 250 267 • Diagnostic imaging (e.g. CT scan, X-Ray, MRI, USG, X ray- Consumables 228 263 371 399 288 tubes etc.), IV Diagnostic (lab equipment and reagents, etc.) and Other Medical Device (ECG, opthal equipment, heart IV Diagnostics 24 31 45 37 39 lung machine, etc.) form 70% of total import in India in FY1613. Patient Aids 11 17 21 16 13 Orthos & Prosthetics 22 28 38 48 59 • USA, Germany, China, Japan, and Singapore constitute the Dental Products 21 19 18 19 23 five largest exporters of high technology medical equipment to India. In FY 2015 imports alone from these five countries Others 264 225 312 329 292 accounted for approximately 65 per cent of total import of high technology medical equipment while USA, remained the Total 781 825 1,035 1,097 983 largest exporter accounting for 28.1 per cent13. • Diagnostic imaging medical device export trade has grown Table 3: Share of Medical Device Segments Globally by 27.2 per cent from USD 210 mn (INR 1,365 Crores) in USD MN FY12 to USD 267 mn (INR 1,736 Crores) in FY1613. Segments/Year 2011-12 2012-13 2013-14 2014-15 2015-16 • Medical Consumables export trade has grown by 26.1 per cent from USD 228 mn (INR 1,482 Crores) in FY12 to USD Diagnostic Imaging 636 638 602 620 757 288 mn (INR 1,872 Crores) in FY1613. Consumables 266 286 280 306 273 • IV Diagnostic devices export trade has grown by 58.7 per cent from USD 24 mn (INR 156 Crores) in FY12 to USD 39 IV Diagnostics 225 250 277 281 322 mn (INR 254 Crores) in FY1613. Patient Aids 203 236 232 227 210 • Ortho and prosthetics export trade has grown by 173.8 per cent from USD 22 mn (INR 143 Crores) in FY12 to USD 59 Orthos & Prosthetics 184 204 204 234 249 mn (INR 384 Crores) in FY1613. Dental Products 67 77 97 89 98 • Patient Aids export trade has grown by 20.9 per cent from USD 11 mn (INR 72 Crores) in FY12 to USD 13 mn (INR 85 Others 878 926 941 974 964 Crores) in FY1613. Total 2,459 2,616 2,632 2,730 2,873 High Potential Manufacturing Segments in India • Diagnostic imaging medical device import trade has grown An Evaluation of factors such as import dependency, existing by 19% from USD 636 mn (INR 4,134 Crores) in FY12 to manufacturing capabilities and share of the segments in the overall USD 757 mn (INR 4,921 Crores) in FY 1613. medical device market in India was undertaken. Based on this, segments having high potential for investments for medical • IV Diagnostic medical device import trade has grown by 43.2% device manufacturing in India has been identified as below : from USD 225 mn (INR 1,463 Crores) in FY12 to USD 322 mn (INR 2,093 Crores) in FY 1613. • Other Medical Device (e.g. ECG, opthal equipment, heart lung Sept.-Oct.2017 25

Cover Story Table 5: High Potential Segments in India Key Segment / Sub-segment % of Import Share of Overall attractiveness dependency14 the overall for Indian Medical Device Manufacturers to market invest in this segment Consumables 35% 16% High Cardiac Catheter, Other needle, Syringe, Lab reagent, Suture, Strips & cartridge, Dialysers and Filters, cannula Medium Dental Product 60% 3% Very High Dental Implant, Artificial teeth, Dental instruments Diagnostic Imaging 52% 30% X-Ray tubes, USG Probe, Radiation beam delivery system, Radiation generator unit, CT Scan, MRI, PET Scan, ALPHA, BTA/GMA Radiation for other use in radiography equipment IV Diagnostics 67% 10% High Lab reagent & accessories 62% 8% High Orthopaedic & Prosthetics Artificial joints & joint implants Others 83% 24% Very High Artificial dialysis apparatus & haemodialyser, defibrillator, Lithotripsy equipment, ECHO, EEG, ECG, anesthesia equipments, Laparoscope, endoscope Patient Aids 50% 9% Medium Pacemaker, Hearing aid, Cochlear implant, Stents It was identified that segments for Diagnostic Imaging and Other medical devices have Very High potential, while IV Diagnostics, Orthopaedic & Prosthetics and Consumables have High potential. 26 Sept.-Oct.2017

® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical Devices GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] : Attention : 27 MEDICAL PRODUCTS MANUFACTURERS FOR Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact : Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : [email protected] • [email protected] Sept.-Oct.2017

National An ISO & CE certified Company Healthcare AMIGO SURGI CARE PVT. LTD. An ISO 9001 : 2008 Company Manufacturer of Manufacturing & Exports of Disposable Surgical Products Medical Disposables : I.V.CANNULAS / B.T.SETS / I.V.SETS / I.V. Set, B.T. Set, Urine Bag, SURGICAL LATEX GLOVES / CORD Measured volume set, Cord Clamp, Surgical CLAMPS / MEASURE Gloves etc. VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN Injection Moulded Medical Components and Extended Tubes : SET / CANNULA FIXATOR ETC. Only Manufacturer of IV CANNULA in GUJARAT I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Urine Bag Tubes etc. Mobile : 0091-9825057180 Contact : Tel.: 0091-2764-268249 Naresh Patel E-mail : [email protected] 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Website : www.ivcannulaindia.com Plant Address Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. E-mail : [email protected] Website: nationalhealthcare.in AVAILABLE AN ISO 13485-2012 PRE USED SYRINGE CE certified Company MANUFACTURING Manufacturer & Exporter of Medical EQUIPMENT Disposable Devices & Surgical Products Moulds : 2, 3, 5, 10ml Syringe Printing Machine : Range of Products : 2/3, 5, 10ml • Infusion Set Syringe 4 Parts Assembly Machine : • Blood Administration Set 2/3, 5, 10ml • Measure Volume Set • Urine Collecting Bag Contact : 7895648113 • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser [email protected] • Twin Bore Nasal Oxygen Set • Oxygen Face Mask Sept.-Oct.2017 • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com 28

Sept.-Oct.2017 29

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 : [email protected] Customer Care No. +91 9898162576 & 7600020901 30 Sept.-Oct.2017









Industry Clusters Favourable Ecosystem Lifts Medical Device Manufacturing In Gujarat Mr D L Pandya, Editor & CEO, MEDICAL PLASTICS DATA SERVICE and www.medisourceasia.com Gujarat has been the pioneer state for the Indian Medical Device created or strengthened linkages with technical/developmental Industry. I have already explained the origin and initial growth of institutions like : Gujarat Medical Device Industry in one of my articles in this publication earlier. For the benefit of the readers once again, 01 B.V.Patel Pharmaceutical Education and Research Centre the turning point for the Gujarat Industry was covering of I.V.sets, (PERD) Needles and some other products under Food and Drug Control regulations when the Gujarat Medical Device Companies 02 National Institute Of Pharmaceutical Education And entered the transition phase and started facing challenges both Research (NIPER) for the quality requirements as well as manufacturing systems. 03 Central Institute Of Plastics Engineering & Technology Around this time, UNIDO initiated a cluster development program (CIPET) for the pharmaceutical units in Gujarat which was extended to the medical device industry also. This program was carried 04 Indo-German Tool Room (IGTR) forward by Foundation of MSME Clusters (FMC). 05 Gujarat Industrial Development Corporation (GIDC) The programme addressed these challenges in a step-by-step approach by building awareness among firms, sustaining a group 06 Electronics & Quality Development Centre (EQDC) approach to purchase of business development service (BDS), creating institutional linkages and finally building the capacity of 07 National Institute Of Design (NID) existing and newly created associations to ensure the sustainability of the process. 08 Entrepreneurship Development Institute Of India (EDII) As a result of these initiatives large number of units in Gujarat 09 Facilitation Centre For Industrial Plasma Technologies, embarked on quality up-gradation, many of them made an Gandhinagar. investments varying from Rs 5 to 50 lakhs or even more. New Business Development Services (BDS ) providers were 10 Large No of Internationally Recognized Reputed Institutes introduced in the areas of quality, factory level training, contract Offering Academic & Professional Courses. business, export market and other support services. The program However, the growth did not stop at that level . The Industry Sup- port Eco-System which included the above mentioned institu- tions and some more available in Gujarat and particularly those of specific relevant to the Medical Device Manufacturing Sector kept of growing resulting in not only continuing of the fast growth of the Industry but also upward movement of the Industry in the value chain. Polymers, Major Raw Material For Medical Disposables The large scale presence of device testing lab in the country Pharmaceuticals, Polymers / would will be a great help to the Plastics as well as Engineering Industry both with respect of / Machinery sector Industry is compliance as well as quality . also a major contributory factor. One more project under imple- It will be very useful to know the mentation is the by Gujarat strengths and developmental FDCA is the detection detection activities being carried out by of serious adverse events (SAE) some of the contributing Insti- caused by the use of medical tutions to understand how the devices to ensure patient safety. Eco-System in Gujarat is help- This is being developed in ing the Industry to maintain leading position in the Indian Medical Device Manufacturing Sector. collaboration with NIPER. Gujarat FDCA And Its Catalytic Role Growth Of NABL accredited Medical Device Testing Facilities In Private Sector From the beginning to the current stage of development, the role of Gujarat FDCA has been exemplary. It has remained more a The private sector also plays an important role in the state eco- guiding and motivation force all through out the growth of medi- system. Recently one of the laboratories locates near Ahmedabad cal device companies in Gujarat. Under the leadership of Dr H G , “Accuprec Research Labs Pvt Ltd” , has received the Accredita- Koshia , with many innovative initiatives like E-Governance the tion from National Accreditation Board for Testing and Calibra- Gujarat FDCA has won even many awards not only in India but tion Laboratories (NABL). Established in 2012 with an objective from international agencies like WHO, Bill and Melinda Founda- to provide research and development solution for Pharmaceuti- tion etc. Many of these initiatives by Gujarat FDCA have been cals, Biotechnology, Food and Medical device, the fully equipped replicated by various leading states in the country. laboratory with high-tech advanced instruments and a big team of highly qualified technical personnel to carry our Research and The current on hand project of setting up of a dedicated medical Development activities had signed a Memorandum of Under- Sept.-Oct.2017 35

Industry Clusters standing (MoU) with Government of Gujarat in the year 2015. devices. This will reduce time and money for the Sate based Medical Device Companies due to reduction or elimination of the need Such platforms both by the Pharma and Medical Device Sectors for re-testing of products in other regulated countries, wherever contribute significantly towards the growth of the Medical Device they would like to register their products for exports. Sector in the state. Industry Associations Creating Platform For Facilitation Centre for Industrial Plasma Technolo- Technology And Market Developments gies (FCIPT) Polymers and Plastics are the major raw materials for Medical Facilitation Centre for Industrial Plasma Technologies (FCIPT) Disposables and Implants . “Plastindia” is the most significant links industries with Institute for PlasmaResearch (IPR), exhibition in the world organized by “Plastindia Foundation” and Gandhinagar, India. The knowledge - base in plasma sciences one of the largest Plastics Exhibition in the Asia Pacific Region. and associated technologies is exploited to generate advanced The coming event is expected to be located in 125,000 sq.m. and non conventional plasma based technologies for material area and will have 2000 Exhibitors including 600 oversea exhibi- processing and environmental remediation. tors . About 200,000 visitors are expected to visit. A focused “MEDICAL PLASTICS PAVALLION” at the forthcoming IPR is an autonomous institute under the Department of Atomic “PLASTINDIA 2018” event to be held in Feb. 2018, in Energy (DAE), Govt. of India. It is exclusively devoted to basic Gandhinagar, Gujarat. research in plasma sciences and development of technological applications. The major thrust is in magnetic confinement fusion The Medical Plastics Pavilion will be a knowledge platform com- and plasma assisted material processing. plete with posters , Audio-Visuals , Models , over 200 samples of medical plastic products and components and the presence of FCIPT takes up development of plasma processing technolo- experts .It aims to help existing and potential manufacturers and gies from concept to commercialization and promotes awareness investors to diversify and / or branch out into medical plastic and of technology through Technology transfer, Newsletters and Disposables products. It will alo have presence of manufacturers Direct marketing. / suppliers of materials, components, machineries, technology essential for manufacturing medical plastics products and FCIPT has developed many technologies for the benefit of Medical Device Industry also including technology for Biomedi- cal Waste Disposal. Supply Chain and Ancillary Units Make Rapid Strides Parallel to the growth of the medical device industry, a number of supply chain and ancillary units also started growing Biotechnopreneur Programme By EDII - A Unique technology sector is concerned. The previous two programmes, Programme For Promoting Entrepreneurs in the showing impressive results of 60% start-up rate. Field Of Life Science. Internationally Recognized Reputed Institutes Entrepreneurship Development Institute of India (EDII), Offering Academic & Professional Courses. Ahmedabad, has recently launched a unique programme for pro- moting innovative enterprises in various areas of Life Sciences. Gujarat boasts of one of one of the very few states with presence The programme is sponsored by Gujarat State Biotechnology of Science and Engineering Institutes providing garaduate and Mission (GSBTM) of the Government of Gujarat. The training post-graduate courses in Pure-Sciences, Pharmacy, Biomedical programme aims to provide comprehensive academic, practical Engineering , Polymer & Plastics Engineering and many more. and ground support to interested entrepreneurs in the areas such The presence of highly internationally recognized reputed Insti- as pharmaceuticals, biomedical engineering ( including medical tutes like Indian Institute Of Management, IIT, Ahmedabad Man- devices ) , biotechnology, etc. This ten month, weekend agement Institute, National Institute Of Design are a great programme is particularly suitable for candidates, who are pres- ently pursuing post graduate level studies in the above disciplines, Strong Growth of Supply – Chain, Ancillary working in pharmaceuticals in- Units And Service Providers dustry or biotechnology or bio- medical engineering companies Parallel to the growth of the in the relevant field as well as Medical Device Industry, num- those in the research and de- ber of supply chain and ancillary velopment organizations and units also started growing. At commercial functions such as present there are more than 150 marketing, technology access, small and big companies manu- etc. Reputed business, finance facturing important inputs start- and academic organizations ing from basic raw materials to such as GVFL, CIIE, IIM components, sub-assemblies, Ahmedabad and SkyQuest manufacturing / testing / steril- are the knowledge partners. ization and other machineries. There has been a significant This programme has been an innovation and totally a new ex- growth in the availability of service providers particularly for the periment in itself in the state of Gujarat, as well as perhaps, in the quality certifications as well as Business Development Activities. country, so far as such training programmes tailor made for bio- (The author is CEO of Medical Plastics Data Service and 36 www.medisourceasia.com) Sept.-Oct.2017

Regulations Update on European Regulations for Medical Devices Mr. Sanjay Shah, Managing Director, Unikal Consultants, Ahmedabad. The export of medical devices to European countries requires The new Regulations on medical devices compliance to the regulations. The compliance requirements and their implementations have been changing rapidly in last couple On 5 April 2017, 2 new Regulations on medical devices were of years, especially renewal or recertification, with reference to adopted, and they entered into force on 25 May 2017. These Indian scenario. replace the existing Directives. • Regulation (EU) 2017/745 of the European Parliament and of Many notified bodies have stopped their operations and those that remain have made implementation of requirements of vari- the Council of 5 April 2017 on medical devices, amending ous directives and guidance rigid (to the letter and not only in the Directive 2001/83/EC, Regulation (EC) No 178/2002 and spirit). This has brought down CE marked devices in India, it Regulation (EC) No 1223/2009 and repealing Council seems. Unfortunately there are no formal medical device Directives 90/385/EEC and 93/42/EEC umbrella organizations and hence no data is authentically • Regulation (EU) 2017/746 of the European Parliament and of collected and/or available. the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission May be data will be forthcoming in the future, after medical Decision 2010/227/EU device regulations in India are fully implemented and all manu- facturers will register and/or obtain manufacturing licenses, as The new rules will only apply after a transitional period. Namely, per the act & rules. 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring Looking at the European scenario, 2022) for the Regulation on in vitro diagnostic medical devices. Medical devices within the EU are currently regulated by the The new Regulations in a nutshell following 3 directives : 1. Council Directive 90/385/EEC on Active Implantable Medical The new Regulations contain a series of extremely important improvements to modernise the current system. Few among them Devices (AIMDD) (1990), are : 2. Council Directive 93/42/EEC on Medical Devices (MDD) (1993) • stricter ex-ante control for high-risk devices via a new pre-mar- &amendment 2007/47/EC ket scrutiny mechanism with the involvement of a pool of 3. Council Directive 98/79/EC on In Vitro Diagnostic Medical experts at EU level • the reinforcement of the criteria for designation and processes Devices (IVDMD) (1998) for oversight of Notified Bodies • the introduction of a new risk classification system for in vitro Ranging from simple sticking plasters and contact lenses to diagnostic medical devices in line with international guidance sophisticated pacemakers and hip replacements, medical devices • improved transparency through the establishment of a and in vitro diagnostic medical devices are important to our health comprehensive EU database on medical devices and of a and quality of life. People rely on these devices every day and device traceability system based on Unique Device expect them to be safe and incorporate the latest progress in Identification science and innovation. • the introduction of an “implant card” containing information about implanted medical devices for a patient Implementing measures for Directives • the reinforcement of the rules on clinical evidence, including The Commission has adopted several implementing measures an EU-wide coordinated procedure for authorisation of multi- based on the Medical Devices Directives. centre clinical investigations • the strengthening of post-market surveillance requirements for The European Commission provides a range of guidance docu- manufacturers ments to assist stakeholders in implementing directives related • improved coordination mechanisms between EU countries in to medical devices. the fields of vigilance and market surveillance Comments : Unique Identification Number system for each They pursue the objective of ensuring uniform application of the implant, PMS with well planned data gathering, Risk mitigation relevant provisions of the directives within the EU. process taking umbrella view and current update for every system document is a major outcome. Please note that all guidance and implementing measures under the current Directives will be reviewed over the next few years in The main reasons behind this change the light of the texts of the 2 new Regulations. 37 Many a times Notified Bodies insist on their implementation though they are guidance documents, may be for the good of Manufac- turers. e.g. MEDDEV 2.7/1 rev.4.0 on clinical evaluation. Sept.-Oct.2017

Regulations Problems with diverging interpretation of the current Directives as well as the incident concerning fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system in place at the time and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. The new regulations will ensure : • a consistently high level of health and safety protection for EU citizens using these products • the free and fair trade of the products throughout the EU • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years Implementing measures for Regulations The draft Implementing Regulation on the codes for the designa- tion of Notified Bodies in the field of medical devices and in vitro diagnostic medical has been published. In view of the above quotes and details from the EC website there is going to be stricter implementation for conformity pro- cess and every manufacturer not only needs to remain current with their documentation, they will need to be updated with the changes in Rules. Role of Notified Body auditors is going to be challenging. In future articles, based on readers’ feedback, specific situations and requirements will be analysed. Note: The author has heavily relied on and quoted from the website of European Agency ec.europa.eu for this article. Explanatory notes are from the author. SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : [email protected] 38 Sept.-Oct.2017

Global Trends US Medical Device Makers Call For Trade Action Against India American medical device companies have written to the US officials that they would not expand price controls beyond stents\". government asking that it suspend or partly or fully withdraw India's benefits under the Generalized System of Preferences (GSP) \"in The National Pharmaceutical Pricing Authority had capped stent view of its failure to provide equitable and reasonable access to and knee implant prices after studies by it revealed huge trade its market for medical devices\". GSP allows developing margins being used to induce hospitals and doctors to use these countries duty-free access to the US for some products. devices at exorbitant prices to patients. The companies cited recently imposed price controls on stents Avamed feared that other countries might attempt similar price and knee implants as examples of discrimination against US controls. \"Indonesia, Bangladesh and Pakistan are reportedly device companies. considering India-type price controls. Even more troubling, China recently published a national pricing policy, in which it explicitly He representation to the United States Trade Representative required manufactures to report prices in India,\" it stated. (USTR) was made by Advamed (Advanced Medical Technology Association), a trade association representing nearly 350 medi- The Association of Indian Medical Device cal technology companies including the biggest stent manufac- Industry (AIMED) turers, Abbott, Boston Scientific and Medtronic. countered Advamed's claims by pointing out that the Advamed's representation to USTR comes while the annual GSP US adopted policies to favour its own companies. \"The product and country practices review process in underway. US has technical barriers to trade under USFDA, while Under GSP, 3,500 product lines are eligible for the benefits of these are near non-existent in India for US device com- duty-free access to US markets. These products include panies. Indian manufacturers are barred from selling engineering goods such as mechanical and electrical machinery to the US government-funded health programmes and and equipment, tools, agricultural implements, organic and defence as India is not listed under the US Trade Agree- inorganic chemicals, plastic and copper. ment Act. We are also discriminated against as the US has a 'Buy American' policy. No such government sup- Advamed claimed that NPPA's price cap of stents \"dispropor- port exists in India for domestic manufacturers. These tionately harmed imported stents\". lobbying forces only care about access to Indian mar- kets. Most of them just import. Hardly any of them Referring to the price control of knee implants following stent price manufacture in India,\" said Rajiv Nath of AIMED. He caps, the association expressed apprehension that price control added that Advamed's representation showed the true could extend to other medical devices. AdvaMed stated that it nature of the foreign device companies, who were recently learned that NPPA has already calculated ceiling prices members of the Confederation of Indian Industries (CII) for a number of other medical devices and was just waiting for and Federation of Indian Chambers of Commerce & the prime minister's order. \"If price controls extend to all US ex- Industry (FICCI) but were hardly interested in the ports of medical devices, except capital equipment and in vitro diagnostics (because neither category has ever been mention welfare of India or its industry. as candidates for price controls), over $700 million of US exports could be adversely affected,\" it added. (Ref : Times of India dated Oct 25, 2017) Interestingly, Advamed claimed that the order capping knee implant prices came \"despite repeated assurance by GOI Medical Plastics Market worth 21.06 Billion USD by 2022 As per the recent study on “ Medical Plastics Market “ by Type as steam, radiation, or ethylene oxide. The two main applica- (PVC, PP, Engg, Plastics, PE, PS, Silicones), Application (Im- tions of medically approved PVC compounds are flexible plants, Disposables, Drug Delivery Devices, Syringes, Diagnos- containers and tubing. tic Instruments, Catheters, Surgical Instruments), and Region - Global Forecast to 2022 the medical plastics market is projected Disposables is the largest application segment of the to grow from USD 13.85 Billion in 2016 to USD 21.06 Billion by medical plastics market. 2022, at a CAGR of 7.3% . This growth can be attributed to the Disposable medical devices can be disposed of once they are aging population, increasing demand for existing and new medi- used. Medical devices such as contact lenses, hypodermic cal technologies, and growing application globally. New product needles, disposable enemas, dialysis disposables, medical and launches and agreements & joint ventures undertaken by the cleaning gloves, and other medical products have been consid- players operating in the market are expected to fuel market growth. ered under this segment. Among the major disposable medical The Highlights of the study are as follows : devices, the dialysis disposables subsegment is expected to wit- ness the fastest growth rate globally, due to the increasing end- Polyvinyl Chloride was the largest type segment of the stage kidney disorder cases and high frequency of therapeutic medical plastics market in 2016. requirements. Polymers such as silicone hydrogel, polyethylene, PVC is the third most widely produced synthetic plastic polymer polystyrene, epoxy resins, and polypropylene are used for after polyethylene and polypropylene. The demand for PVC is manufacturing disposable medical devices. high, as PVC is compatible with different kinds of additives that make it a versatile polymer and thus, is suitable for use in the Asia-Pacific was the largest market for medical plastics in manufacturing of medical plastics. PVC is widely used in the 2016. manufacturing of Class I medical devices. Medical devices manu- Asia-Pacific was the largest market for medical plastics in 2016. factured using PVC can be easily sterilized using methods such Emerging technologies such as minimally invasive medical pro- Continued on P 40 Sept.-Oct.2017 39

Industry News Manufacturers Welcome Price Cap On Medical Devices The Association of Indian Medical Device Industry, which “Pressure has increased on India to revise its stance on price represents domestic manufacturers, has welcomed the caps for medical devices and not to extend it to other devices. government proposal to extend price caps to devices including But the government should do what is good for the country and catheters and balloons which are used in angioplasties. give advantage to common citizens who now have access to the best products at the most affordable prices and to domestic A government panel has recommended inclusion of these manufacturers,” said Rajiv Nath, forum co-ordinator, AiMeD. devices under price control following complaints of overcharging by hospitals. The National Pharmaceutical Pricing Authority “In the last six months we have seen a positive trend towards requested the government to classify balloons and catheters as increased sales for domestic manufacturers. We estimate the drugs and include them under the National List of Essential trend to continue and Indian manufacturers will grab 60 per cent Medicines. of market share by next year,” Nath said. The government had in February capped the price of stents by Earlier this year the Maharashtra Food and Drug Administration around 85 per cent. The move resulted in increased sales for had examined invoices in 12 major hospitals in the state and domestic manufacturers which are supporting more such actions. found that over 70 per cent of the cost paid for balloon catheters by patients is profit margin of manufacturers, distributors and A decision to extend price cap on other devices is expected to hospitals. In case of guiding catheters more than 47 per cent of hurt hospitals and impact their margins. Though some large the cost paid by patients was found to be profit margin of these chains believe price caps could have a short-term impact, given three stakeholders. their service diversification, there is displeasure in the private healthcare service providers over the government action. (Ref : Business Standard dated October 12, 2017) Gujarat Registers Maximum Number Of 170 Medical Devices Units In The Country Under CLAA Scheme Gujarat as of today has registered the maximum number of 170 The Centre has also been mulling for quite some time for setting licensed medical device units under the Central Licensing up the medical devices park in Gujarat in a bid to make India Approval Authority (CLAA) scheme as against a total of 284 self-reliant in the sector. The creation of manufacturing park for medical device units in the entire country. The state had 150 medical devices will boost the segment of hi-tech medical devices such high end medical device units 11 months back and has as medical devices manufacturing requires certain high also granted licenses to 56 new drug manufacturing units. investment facilities which are too capital intensive for individual manufacturers to invest upon. A park with in-house high The devices currently regulated under CLAA scheme include investment scientific facilities would help manufacturers reduce cardiac stents, drug eluting stents, catheters, intra ocular lenses, the cost of manufacturing by more than 40 per cent to 50 per I.V. Cannula, bone cements, heart valves, scalp vein set, cent. orthopaedic implants and internal prosthetic replacements. This will also help facilitate to create an ecosystem for CLAA has been formed to oversee the regulatory activities manufacturing of high end medical device manufacturing aimed related to grant of manufacturing license for hi-tech medical at import substitution and export opportunities and would be a devices in India. It aims at ensuring that the medical devices major boost to SMEs. being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of (Ref : http://www.pharmabiz.com/ the devices. NewsDetails.aspx?aid=104308&sid=1 (September 18, 2017) MTaI Puts Forward Key Recommendations To Govt For More Enabling Environment For Medical Devices Industry In India engineering complexity, for policy and decision clarity. The Medical Technology Association of India (MtaI), an association of research-based medical technology companies, Import substitution as a focus of policies needs to be replaced has put forward some key recommendations for the with greater efforts directed towards ensuring global consideration of the policy makers that would pave the way for competitiveness through export promotion and meeting global a more enabling environment for the medical devices industry quality standards. The recently presented NITI Aayog action in the country. agenda recognizes the significance of global companies’ presence for the domestic industry to compete with and grow. At a MedTech Summit held in New Delhi recently, the industry leaders stressed that in view of recent policy changes in the Make in India, a noble initiative, should however be implemented medical technology space, there is a need for the sub-sectoring in a phased manner. It must focus on the devices that have the and sub-categorization of medical devices on the basis of the potential to be made locally in the short run, instead of the Continued from P 39 Medical Plastics Market Major players such as Lubrizol (U.S.) have adopted developmental strategies such as expansions, agreements & collaborations, and cedures in the region have allowed it to produce better quality new product developments to grow in the medical plastics medical devices. The demand for medical devices has been in- market. creasing, owing to the rising awareness of early diagnosis and treatment of countless diseases in the Asia-Pacific countries. ( Ref : http://www.marketsandmarkets.com/PressReleases/ medical-plastics.asp ) 40 Sept.-Oct.2017

Industry News advanced technologies that require a more enhanced ecosystem and R&D rolling. This will simultaneously help achieve the twin and know-how that may take years to develop in the country. objectives of greater patient access as well as the availability of latest and high-quality technology. This means that policies must factor in the existing gaps in the domestic manufacturing industry, and promote ease of doing MTaI endorses the Trade Margin Rationalization Report of the business by way of reduced inter-organizational delays, Department of Pharmaceuticals, provided unique and deserving enhanced startup industrial finance, simplified regulations such sub-sectoral nuances are given due consideration. as single-window clearance, and greater investment in infrastructure. Sanjay Bhutani, director, MTaI asserted, “the Any access enhancing (price control) mechanisms must be industry continues to be largely under- understood and under preceded by a careful impact analysis on creation of geographical prioritized.” access barriers, on quality of outcomes, reverse medical tourism, and decreased incentive to innovate. Another key recommendation put forth at the Summit was to expand the bed capacity in the country. This is particularly crucial The MedTech Summit today brought together the much needed given the rising burden of diseases in the country today and the interface of policy makers, industry, doctors with the patients. lack of access to quality healthcare. Many pockets of the country Key departments and ministries such as the ministry of remain underserved, and are calling out for real-time scaling up commerce and industry, department of health and family welfare, of solutions to address this demand. The expansion of the and the NITI Aayog were represented at the Summit. The medical healthcare delivery system will automatically provide an impetus technology industry was represented by top MedTech companies for the medical devices market to grow. including inter alia Abbott Vascular, Alcon, Bard, Bausch & Lomb, Boston Scientific, Johnson & Johnson, KARL STORZ, Medtronic, Further, for long term advantage, infrastructural development Olympus, Terumo, and Vygon India. and fiscal incentives are needed to keep the wheels of innovation (Ref : http://pharmabiz.com/ NewsDetails.aspx?aid=104403&sid=1 (September 22, 2017) Gujarat FDCA Writes To Health Ministry To Accelerate Process of Setting Up Much Awaited Medical Device Testing Lab At Vadodara The Gujarat Food and Drug Control Administration (FDCA) has only dedicated biomaterials and implants testing lab in the written to the union health ministry to accelerate the process of country. The lab at Noida will be set up primarily to test electrical setting up the much awaited medical device testing lab at and electronic medical devices in the country. Vadodara in Gujarat, MoU for which has recently been signed between the Government of India and Gujarat Government. (Ref : http://pharmabiz.com/ NewsDetails.aspx?aid=104462&sid=1 (September 26, 2017) The drug testing lab project, which was originally recommended by the Union commerce ministry, will be developed with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC) of the union health ministry. “Ministry of Commerce has also sanctioned an amount of Rs.15 crore for the flagship project for which the site at drug testing lab at Vadodara has already been approved based on a recently concluded audit. The Union health ministry has also appointed HLL, a central government agency for procurement of equipment through a global tendering process,” according to an official associated with the development. Gujarat FDCA in the past had also sent a proposal to HLL for urgent procurement of testing equipment towards setting up the testing lab. Setting up of a dedicated medical device testing lab in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety as the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care. Proposal for setting up a testing lab is the culmination of an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half years ago which realised the need for setting up a dedicated medical device testing lab to ensure quality assurance of medical devices manufactured in the country. Till date, products are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Though the government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida subject to getting approvals, medical device testing lab in Gujarat would be the first and the Sept.-Oct.2017 41

Product Gallery Qosina Introduces New 2018 Catalog Ronkonkoma, NY, October 12, additions. Our product develop- ment team can work to custom- 2017– Qosina is pleased to ize a part to your exact specifi- cations. Speak with a customer release its new 2018 product service specialist to discuss your project in detail via phone catalog, which features over +1(631) 242-3000 or email 5,000 stock components. The four-color, glossy print catalog consists of more than 500 pages with full-scale illustrations on a [email protected]. one-centimeter grid and includes Founded in 1980, Qosina is a approximately 150 new parts, worldwide supplier of thousands such as connectors, O-rings, for- of stock OEM components in- ceps, valves, stopcocks, and cluding bioprocessing accesso- catheter accessories. Also fea- ries, compression fittings, tured in the new catalog is NRFit™ (ISO-80369-6) connec- Qosina’s wide selection of com- tors and caps, ENFit™ (ISO- ponents that meet the ISO 80369 80369-3) components, luers, standard for small-bore connec- clamps, clips, check valves, tions in a healthcare setting. stopcocks, hemostasis valves, Readers can tuohy borst conveniently search the catalog by category or function to locate adapters, swabs, spikes, syringes and tubing to the medical and the appropriate product for any application. Qosina’s product pharmaceutical industries. Qosina is based in Ronkonkoma, NY catalog is often considered the authoritative resource for the in a 95,000 square-foot facility with an ISO Class 8 Clean Room medical OEM, bioprocessing and pharmaceutical industries, as and is ISO 9001, ISO 13485 and ISO 14001 registered. well as for medical device engineers. Contact : Qosina Corporation, Deanna Whelan Qosina offers low minimums and short lead times. Log on to 2002-Q Orville Drive North, Ronkonkoma, NY 11779 qosina.com to see pricing, obtain a copy of the 2018 catalog, request complimentary samples and place orders. Sign up for Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 our monthly e-newsletter to stay current with the newest product Email: [email protected] 42 Sept.-Oct.2017

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com Sept.-Oct.2017 43

Manufacturer And Exporter Of a ISO 9001-2000 wide range Of Medical Devices Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Products available with CE marking Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com GMP PACK-EQUIP ISO - 9001-2008 Certified Company (Mfg. Packaging Machinery) S. Nath & Co. Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Excellence in Quality CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Manufacturer & Exporter of Phone : 25855027 (M) 9825380739 Surgical Disposable Products since 1980 Works : IDEAL® 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Infusion Set • Blood Administration Set Sept.-Oct.2017 • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 44

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com Sept.-Oct.2017 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • I.V. Infusion Sets • Blood Administration Sets • Scalp Vein Set • Urine Collection Bags • Ryles / Feeding Tubes • Catheters and Tubes • Surgical Gloves. Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 45

Events The 18th Edition of Medicall Held at Mumbai, Bombay Convention & Exhibition Center Oct 6,7 & 8 2017 Events Calender Medicall, India’s largest B2B Medical Equipment and Hospital Need Exhibi- tion, is promoted by Dr. S Manivannan, promoter director of 1000 bedded • Compamed 2017 / Medica 2017: Kauvery Group of Hospitals. Early in his career, he identified that nursing homes, small clinics and hospitals in tier 2 and 3 cities faced a distinct disad- The world’s leading trade fair for the medical vantage in the market while procuring consumables and equipment for their industry business. They neither had the choice nor the price advantage enjoyed by the Date : November, 13-16, 2017 biggies. Thus Medicall was born. Venue : Dusseldorf, Germany Medicall served as a marketing platform wherein the equipment companies • 4th PLASTIVISION Arabia 2017 : showcased their products to Hospital owners and decision makers. Interna- tional companies participated in Medicall to understand & exploredthe Indian International Plastics, Printing & Packaging Medical Devices market and appointed appropriate dealers and distributors Exhibition in the region. Date: Dec. 11-14, 2017. Venue: Sharjah, UAE. Medicall has maintained its position as the largest and best attended Medical shows in India. • PLASTINDIA 2018 : In its 18th edition at Mumbai, Medicall attracted more than 310 exhibitors and 10th International Plastics Exhibition, 9800 professional visitors.It was a true bazaar for hospital equipment and Conference & Convention supplies, ranging from surgical gloves to the most sophisticated medical equip- Date: Feb. 7-12, 2018. ment used worldwide.Medicall shows are held at Chennai, Mumbai, New Delhi, Venue: Gandhinagar – Ahmedabad, Gujarat, Ahmedabad, Kolkata, Hyderabad and Colombo. India. Medicall Mumbai was a perfect getaway to meet one's peers, to compare and • Medical Fair India : choose equipment and best of all to refresh the knowledge base in the intel- lectually stimulating BrainStorm Medicall. A favourite with many International 24th International Exhibition And Conference product companies, Medicall has these come repeatedly to widen their dealer Date: March 16-18, 2018. and distributor base. Diversity is a given in this expo. Venue: Goregaon (East), Mumbai. The show stoppers of Medicall are its seminars and workshops. Much care is put into this section to ensure they are not didactic and unidirectional but highly interactive and responsive. The Interactive healthcare Intelligentsia at BrainStorm Medicall dishes out nuggets of wisdom in a nutshell. At Medicall, medicine meets management. A wide range of topics werediscussed at Medicall Mumbai : How to buy the right Medical Equipment, Hospital Projects, Digital Hospital, Branding & Marketing for Hospitals and a workshop on Critical Care Never Miss Medicall www.medicall.in 46 Sept.-Oct.2017