Table of
Contents 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 • • • • Sept-Oct.2017
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
19
Flashback Select Article Index
Sept. 1997 to Mar. 2000 • Events (November 97) Mr. Sandeep Puri, Hydro S&S Industries Ltd. Mr. Vinit Jain, Technology International, Vadodara • The Role Of Plasticizers In PVC Containers For The Collection And Storage Of Blood And Blood Components (January 98) Dr. C. S. B. Nair, Director, Research & Development, Trivandrum • Role Of Medical Grade PVC Compounds For Critical Medical Applications (January 98) Mr. R. Kumar, Hydro S&S Industries Ltd. • Plastic Medical Applications (Nov.98 Jan.99) Robert Beard, P.E., Robert A Beard & Associates, Inc. USA • Plastic Medical Applications (November 99) Mr. Robert Beard, U.S.A. • Victrex Peek Polymer (September 99) Mr. John Gallagher, The European Marketing Group, The Netherlands • Four Goods Reasons To Switch To PVC (May 99) Dr. Leonardo Maggghetti, Mktg. Manager, S.I.F.R.A. EST Group, Italy • Growth Of Plastics Use In Medical Devices Is Spurred By Cost - Cutting - Modern Plastics Mid-November 1998 (March 99) • The Facts About PVC (March 99) Reproduction Of an Article By Mr. Ole Grondahl Hansen As Printed In “Medical Device Technology” October 97 Issue • Polymeric Pressure Sensitive Adhesives for Medical Applications (November 2000) Dr. P.A. Mahanwar & Farhana Yasmeen, University Department of Chemical Technology, Matunga, Mumbai • Polymeric Pressure Sensitive Adhesives For Medical Applications (September 2000) Farhana Yasmeen, Mr. P.A. Mahanwar, University Department Of Chemical Technology, 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
Did You Know ? About Advanced Medical Polymer For Treating Diabetic Patients
?
Diabetes care has seen several innovations through the years. One of the important developments is insulin pumps, which for many patients provides an option to the traditional needle and syringe approach to insulin injections. In addition to software development, companies are also focusing on device hardware that is smaller, lighter and made from specialized 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 ordinary plastic materials to develop innovative means for treating diabetic patients. Cyclic Olefin Copolymer (COC), a glass-clear plastic resin, is currently used in numerous healthcare applications and has become one of the materials of choice in insulin delivery systems. Physical properties of COC such as high strength, dimensional stability and the ability to replicate fine features are important advantages as parts become smaller and thinner. In addition, COC provides insulin compatibility, high purity, and a favorable extractables/ leachables profile which is key as expanding FDA guidelines present additional challenges for device design and approval. In developing new and advanced insulin delivery devices, COC’s unique advantages have expanded the possibilities for innovative design and manufacturing. This medical grade polymer allows for the miniaturization of device components without the constraints of glass or ordinary plastic materials. Critical device components such as insulin reservoirs require the use of a proven polymer material. In addition to compatibility with insulin, purity and very low leachables, COC provides excellent moisture barrier and extremely low water absorption; both necessary properties for optimal long-term drug container storage. It features broad global regulatory compliance including USP Class VI and ISO 10993. COC is compatible with all conventional sterilization methods from gamma to steam. (https://topas.com/insulin-delivery-devices-how-advanced-medical-polymer-solving-newdesign-challenges )
In a Nutshell.... “Big data may tell you how many customers you have won or lost but not necessarily why. This is the intelligence that can really make a difference”.
-Jane Frost Chief Ececutive Market Research Society
Sept.-Oct.2017
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.
EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, 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: 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
Editor’s Desk
From the
MEDICAL DEVICE INDUSTRY CLUSTERS AND THE ROLE OF FAVORABLE ECOSYSTEM : Gujarat has been the pioneer state for the Indian Medical Device Industry. An important turning point for the Gujarat Industry was when some of the products were covered under Food and Drug Control Regulations and the units started facing challenges both for the quality requirements as well as manufacturing systems. Around this time, UNIDO initiated a cluster development program for the Pharma and Medical Devices. The program was carried forward by Foundation of MSME Clusters (FMC). The programme addressed the transition challenges in a step-by-step approach by building awareness among firms, sustaining a group approach to purchase of business development service (BDS), creating institutional linkages and finally building the capacity of existing and newly created associations to ensure the sustainability of the process. As a result of these initiatives, large number of units in Gujarat embarked on quality up-gradation, many of them made substantial investments. New Business Development Services (BDS ) providers were introduced in the areas of quality, factory level training, contract business, export market and other support services. The program created or strengthened linkages with various technical/developmental institutions in the state. 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 also upward movement of the Industry in the value chain. This issue includes a very elaborate explanation of how the favourable ecosystem has contributed in lifting Medical Device manufacturing in Gujarat. I had an opportunity to get involved in the implementation of more than 30 different programs implemented as part of this cluster development process. Over the years, various Medical Device Clusters have come up across the country spread over states including Haryana, Delhi (NCR), Gujarat, Maharastra, Telangana, Karntaka, Tamil Nadu etc. In a very detailed report, “Medical Device Manufacturing in India – A Sunrise Industry” compiled by the Andhra 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 by Mr Srinivas R Pilli, Sr. Technical Office, AMTZ. This issue also includes an important update on “European Regulations On Medical Devices” by Mr Sanjay Shah along with the regular columns like Global Trends, Industry News, Product Gallery , “Did You Know ? “ etc.
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 Medical Device Market Size – Global • The global medical device market was estimated at USD 228 bn in 2015 (INR 14.82 lakh crores). • Industry estimates suggest that the global medical device market will grow at a CAGR of 7.8% from 2010 to 2020. • The market is expected to reach USD 332 bn (INR 21.58 lakh crores) by 20201.
• • • • • •
Patient aids Consumables Dental products IV diagnostics Others Diagnostics imaging is the largest segment constituting 26% of the medical device market, with an annual sales estimate of USD 60 bn (INR 3.85 lakh crores) in 2015. Table 1: Share of Medical Device Segments Globally 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
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
Figure 2 : Segment-wise sale globally
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-outpacepharmaby-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 • IV Diagnostics is the second largest segment with an estimated 24% share at approximately USD 54.5 bn (INR 3.54 lakh crores). • Dental products including dental implants, dental chairs and equipment account for the smallest share of USD 13.68 bn (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.
Diagnostic imaging is the largest segment within Indian medical device market in 2015. It constitutes USD 1.18 bn (INR 7,650 crores)3 in 2015 and will grow to USD 2.47 bn (INR 15,561 Crores)3 in 2020. • India is one of the top 20 global medical device markets and the 4th largest medical device market in Asia5. Indian Medical Device Market
• 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
Medical Device Segments – India
Figure 3 : Top Medical Device Markets Globally Geography
USD Bn (2015)
INR Cr.(2015)
Americas
102.6
6,66,900
Western Europe
61.56
4,00,140
Asia
47.88
3,11,220
Eastern Europe
9.12
59,280
Middle East and Africa
6.84
44,460
Diagnostic imaging is the largest segment within Indian medical device market in 2015. It constitutes USD 1.18 bn (INR 7,650 crores)3 in 2015 and will grow to USD 2.47 bn (INR 15,561 Crores)3 in 2020. • Others and IV diagnostics6 comprise largely of electrical and electronic devices. The others category (patient monitors, ECG machine, Defib, etc) is estimated at USD 0.94 Bn (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.
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 device market will grow to USD 8.16 bn (INR 53,053 crore) in 2020 at CAGR of 16%4.
Figure 5 : Segment-wise Market Share
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 • Similarly, Orthopedics & Prosthetics and Consumables will 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. • Dental products and Patient Aids will grow from a cumulative USD 0.47 bn (INR 2,961 Crores)3 in 2015 to USD 1.1 bn (INR 6,930 Crores) in 2020.
• Growing Population • Ageing Population • Increasing Disease Burden of Chronic Diseases • Increasing Health Insurance Penetration • Growing Medical Tourism • Demand for Healthcare Infrastructure • Emerging Healthcare Service Formats • Quality and Accreditation of Hospiatals as par with International Standards
AMTZ holds Industry Awareness Training Programme on Quality Certification for Medical Devices Manufacturers 16th August, 2017 - Vadodara The Andhra Pradesh MedTech Zone (AMTZ), India’s first integrated state-of-the-art medical devices manufacturing park in Visakhapatnam, organized a One - day industry training programme on quality certification with an aim to bring down the time and cost-run to obtain globally accepted quality certification for Indian manufacturers. The training programme, held on 9th August in Coimbatore and 16th August on Vadodara and attended by medical devices manufacturers, medical professionals from Healthcare & Academics and other industry stakeholders, was organized in association with Quality Council of India (QCI), National Accreditation Board for Certification Bodies (NABCB) and Association of Indian Medical Device Industry (AIMED). The programme mainly focused on helping medical device manufacturers to understand Industry Certification for Medical Devices (ICMED) certification and New Medical Device Rules, 2017 which are effective from 01st January 2018.
Import and Export Trend in Indian Medical Device Market Import and Export Trade in the Last 5 years • The import of medical devices has grown from USD 2.46 bn (INR 15,990 crores) in FY12 to USD 2.87 bn (INR 18,655 crores) in FY1613. • The export of medical devices has grown from USD 0.78 bn (INR 5,070 crores) in FY12 to USD 0.98 bn (INR 6,370 crores) in FY1613. • Between FY12 to FY16, the import trade of medical devices has increased by 16.8 per cent, whereas export trade has increased by 25.7 per cent13. Import Trade of Medical Device • The total import of medical devices is more than 75 per cent of total medical devices sales in India 13, however it is estimated that import trade will fall with increasing number of international and Indian manufacturer setting up medical device manufacturing set up in India.
The programme’s objective was to fill the regulatory space in quality certification for medical devices in the country. The key themes of the training sessions included EU regulatory, medical device definition, life process and device risk classification; CE Marking and New MDR; ICMED 9000 certification, which is ISO 9001 plus additional requirements; ICMED 13485, which is ISO 13485 plus additional requirements; and New Medical Device Rules, 2017. Thanking QCI and NABCB for organizing the event jointly “to exchange the knowledge share of regulations and certification process for the medical device”, Dr Jitendar Kumar Sharma, CEO and Director, AMTZ, said: “With this event, we will aim to create a more progressive practice towards regulatory frame work in the medical device sector.” Dr. D L Pandya, CEO, Medical Plastics, applauded AMTZ and QCI organizing such first India’s industry awareness program 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.”
13 Directorate General of Foreign Trade
24
Sept.-Oct.2017
Cover Story Import and Export of Medical Devices
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 FY 1613. Export Trade of Medical Device
Figure 7 : Import & Export of Medical Devices in India Medical Device Segment wise Import Trade
Figure 9: Export Trade of different segments of medical device 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 destination 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 device market • Diagnostic imaging (e.g. CT scan, X-Ray, MRI, USG, X raytubes etc.), IV Diagnostic (lab equipment and reagents, etc.) and Other Medical Device (ECG, opthal equipment, heart lung machine, etc.) form 70% of total import in India in FY1613. • USA, Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India. In FY 2015 imports alone from these five countries accounted for approximately 65 per cent of total import of high technology medical equipment while USA, remained the largest exporter accounting for 28.1 per cent13. Table 3: Share of Medical Device Segments Globally USD MN
Segments/Year
2011-12
2012-13
2013-14
2014-15
2015-16
Diagnostic Imaging
636
638
602
620
757
Consumables
266
286
280
306
273
IV Diagnostics
225
250
277
281
322
Patient Aids
203
236
232
227
210
Orthos & Prosthetics
184
204
204
234
249
Dental Products
67
77
97
89
98
Others
878
926
941
974
964
Total
2,459
2,616
2,632
2,730
2,873
• Diagnostic imaging medical device import trade has grown by 19% from USD 636 mn (INR 4,134 Crores) in FY12 to USD 757 mn (INR 4,921 Crores) in FY 1613. • IV Diagnostic medical device import trade has grown by 43.2% 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
Segments/Year
2011-12
2012-13
2013-14
2014-15
Diagnostic Imaging
210
241
229
250
2015-16 267
Consumables
228
263
371
399
288
IV Diagnostics
24
31
45
37
39
Patient Aids
11
17
21
16
13
Orthos & Prosthetics
22
28
38
48
59
Dental Products
21
19
18
19
23
Others
264
225
312
329
292
Total
781
825
1,035
1,097
983
• Diagnostic imaging medical device export trade has grown by 27.2 per cent from USD 210 mn (INR 1,365 Crores) in FY12 to USD 267 mn (INR 1,736 Crores) in FY1613. • Medical Consumables export trade has grown by 26.1 per cent from USD 228 mn (INR 1,482 Crores) in FY12 to USD 288 mn (INR 1,872 Crores) in FY1613. • IV Diagnostic devices export trade has grown by 58.7 per cent from USD 24 mn (INR 156 Crores) in FY12 to USD 39 mn (INR 254 Crores) in FY1613. • Ortho and prosthetics export trade has grown by 173.8 per cent from USD 22 mn (INR 143 Crores) in FY12 to USD 59 mn (INR 384 Crores) in FY1613. • 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 Crores) in FY1613.
High Potential Manufacturing Segments in India An Evaluation of factors such as import dependency, existing manufacturing capabilities and share of the segments in the overall medical device market in India was undertaken. Based on this, segments having high potential for investments for medical device manufacturing in India has been identified as below :
25
Cover Story Table 5: High Potential Segments in India Key Segment / Sub-segment
% of Import dependency14
Share of the overall Medical Device market
Overall attractiveness for Indian Manufacturers to invest in this segment
Consumables Cardiac Catheter, Other needle, Syringe, Lab reagent, Suture, Strips & cartridge, Dialysers and Filters, cannula
35%
16%
High
Dental Product Dental Implant, Artificial teeth, Dental instruments
60%
3%
Medium
Diagnostic Imaging 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
52%
30%
Very High
IV Diagnostics Lab reagent & accessories
67%
10%
High
Orthopaedic & Prosthetics Artificial joints & joint implants
62%
8%
High
Others Artificial dialysis apparatus & haemodialyser, defibrillator, Lithotripsy equipment, ECHO, EEG, ECG, anesthesia equipments, Laparoscope, endoscope
83%
24%
Very High
Patient Aids Pacemaker, Hearing aid, Cochlear implant, Stents
50%
9%
Medium
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
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Alpha Medicare and Devices Ltd.
(taking care…Since1984)
Manufacturers & Exporters of Disposable Medical Devices
GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com
0434
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National Healthcare An ISO 9001 : 2008 Company
Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.
Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.
Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in
AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp
Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES
8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com
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An ISO & CE certified Company
AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.
Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.
AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 pawantiwari1978@gmail.com
Sept.-Oct.2017
Sept.-Oct.2017
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ISO 9001-2015 ISO 13485-2012 CE WHO GMP
Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter
• • • • • • • • • • •
Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter
Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901
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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 Industry. I have already explained the origin and initial growth of Gujarat Medical Device Industry in one of my articles in this publication earlier. For the benefit of the readers once again, the turning point for the Gujarat Industry was covering of I.V.sets, Needles and some other products under Food and Drug Control regulations when the Gujarat Medical Device Companies entered the transition phase and started facing challenges both for the quality requirements as well as manufacturing systems. Around this time, UNIDO initiated a cluster development program for the pharmaceutical units in Gujarat which was extended to the medical device industry also. This program was carried forward by Foundation of MSME Clusters (FMC). The programme addressed these challenges in a step-by-step approach by building awareness among firms, sustaining a group approach to purchase of business development service (BDS), creating institutional linkages and finally building the capacity of existing and newly created associations to ensure the sustainability of the process. As a result of these initiatives large number of units in Gujarat embarked on quality up-gradation, many of them made an investments varying from Rs 5 to 50 lakhs or even more. New Business Development Services (BDS ) providers were introduced in the areas of quality, factory level training, contract business, export market and other support services. The program
created or strengthened linkages with technical/developmental institutions like : 01 B.V.Patel Pharmaceutical Education and Research Centre (PERD) 02 National Institute Of Pharmaceutical Education And Research (NIPER) 03 Central Institute Of Plastics Engineering & Technology (CIPET) 04 Indo-German Tool Room (IGTR) 05 Gujarat Industrial Development Corporation (GIDC) 06 Electronics & Quality Development Centre (EQDC) 07 National Institute Of Design (NID) 08 Entrepreneurship Development Institute Of India (EDII) 09 Facilitation Centre For Industrial Plasma Technologies, Gandhinagar. 10 Large No of Internationally Recognized Reputed Institutes Offering Academic & Professional Courses. However, the growth did not stop at that level . The Industry Support Eco-System which included the above mentioned institutions 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 Pharmaceuticals, Polymers / Plastics as well as Engineering / Machinery sector Industry is also a major contributory factor. It will be very useful to know the strengths and developmental activities being carried out by some of the contributing Institutions to understand how the Eco-System in Gujarat is helping the Industry to maintain leading position in the Indian Medical Device Manufacturing Sector.
Gujarat FDCA And Its Catalytic Role From the beginning to the current stage of development, the role of Gujarat FDCA has been exemplary. It has remained more a guiding and motivation force all through out the growth of medical device companies in Gujarat. Under the leadership of Dr H G Koshia , with many innovative initiatives like E-Governance the Gujarat FDCA has won even many awards not only in India but from international agencies like WHO, Bill and Melinda Foundation etc. Many of these initiatives by Gujarat FDCA have been replicated by various leading states in the country. The current on hand project of setting up of a dedicated medical Sept.-Oct.2017
device testing lab in the country would will be a great help to the Industry both with respect of compliance as well as quality . One more project under implementation is the by Gujarat FDCA is the detection detection of serious adverse events (SAE) caused by the use of medical devices to ensure patient safety. This is being developed in collaboration with NIPER.
Growth Of NABL accredited Medical Device Testing Facilities In Private Sector The private sector also plays an important role in the state ecosystem. Recently one of the laboratories locates near Ahmedabad , “Accuprec Research Labs Pvt Ltd” , has received the Accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL). Established in 2012 with an objective to provide research and development solution for Pharmaceuticals, Biotechnology, Food and Medical device, the fully equipped laboratory with high-tech advanced instruments and a big team of highly qualified technical personnel to carry our Research and Development activities had signed a Memorandum of Under-
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Industry Clusters standing (MoU) with Government of Gujarat in the year 2015. This will reduce time and money for the Sate based Medical Device Companies due to reduction or elimination of the need for re-testing of products in other regulated countries, wherever they would like to register their products for exports.
Industry Associations Creating Platform For Technology And Market Developments Polymers and Plastics are the major raw materials for Medical Disposables and Implants . “Plastindia” is the most significant exhibition in the world organized by “Plastindia Foundation” and one of the largest Plastics Exhibition in the Asia Pacific Region. The coming event is expected to be located in 125,000 sq.m. area and will have 2000 Exhibitors including 600 oversea exhibitors . About 200,000 visitors are expected to visit. A focused “MEDICAL PLASTICS PAVALLION” at the forthcoming “PLASTINDIA 2018” event to be held in Feb. 2018, in Gandhinagar, Gujarat. The Medical Plastics Pavilion will be a knowledge platform complete with posters , Audio-Visuals , Models , over 200 samples of medical plastic products and components and the presence of experts .It aims to help existing and potential manufacturers and investors to diversify and / or branch out into medical plastic and Disposables products. It will alo have presence of manufacturers / suppliers of materials, components, machineries, technology essential for manufacturing medical plastics products and
devices. Such platforms both by the Pharma and Medical Device Sectors contribute significantly towards the growth of the Medical Device Sector in the state.
Facilitation Centre for Industrial Plasma Technologies (FCIPT) Facilitation Centre for Industrial Plasma Technologies (FCIPT) links industries with Institute for PlasmaResearch (IPR), Gandhinagar, India. The knowledge - base in plasma sciences and associated technologies is exploited to generate advanced and non conventional plasma based technologies for material processing and environmental remediation. IPR is an autonomous institute under the Department of Atomic Energy (DAE), Govt. of India. It is exclusively devoted to basic research in plasma sciences and development of technological applications. The major thrust is in magnetic confinement fusion and plasma assisted material processing. FCIPT takes up development of plasma processing technologies from concept to commercialization and promotes awareness of technology through Technology transfer, Newsletters and Direct marketing. FCIPT has developed many technologies for the benefit of Medical Device Industry also including technology for Biomedical 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 Programme For Promoting Entrepreneurs in the Field Of Life Science. Entrepreneurship Development Institute of India (EDII), Ahmedabad, has recently launched a unique programme for promoting innovative enterprises in various areas of Life Sciences. The programme is sponsored by Gujarat State Biotechnology Mission (GSBTM) of the Government of Gujarat. The training programme aims to provide comprehensive academic, practical and ground support to interested entrepreneurs in the areas such as pharmaceuticals, biomedical engineering ( including medical devices ) , biotechnology, etc. This ten month, weekend programme is particularly suitable for candidates, who are presently pursuing post graduate level studies in the above disciplines, working in pharmaceuticals industry or biotechnology or biomedical engineering companies in the relevant field as well as those in the research and development organizations and commercial functions such as marketing, technology access, etc. Reputed business, finance and academic organizations such as GVFL, CIIE, IIM Ahmedabad and SkyQuest are the knowledge partners. This programme has been an innovation and totally a new experiment in itself in the state of Gujarat, as well as perhaps, in the country, so far as such training programmes tailor made for bio-
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technology sector is concerned. The previous two programmes, showing impressive results of 60% start-up rate.
Internationally Recognized Reputed Institutes Offering Academic & Professional Courses. Gujarat boasts of one of one of the very few states with presence of Science and Engineering Institutes providing garaduate and post-graduate courses in Pure-Sciences, Pharmacy, Biomedical Engineering , Polymer & Plastics Engineering and many more. The presence of highly internationally recognized reputed Institutes like Indian Institute Of Management, IIT, Ahmedabad Management Institute, National Institute Of Design are a great
Strong Growth of Supply – Chain, Ancillary Units And Service Providers Parallel to the growth of the Medical Device Industry, number of supply chain and ancillary units also started growing. At present there are more than 150 small and big companies manufacturing important inputs starting from basic raw materials to components, sub-assemblies, manufacturing / testing / sterilization and other machineries. There has been a significant growth in the availability of service providers particularly for the quality certifications as well as Business Development Activities. (The author is CEO of Medical Plastics Data Service and 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 compliance to the regulations. The compliance requirements and their implementations have been changing rapidly in last couple of years, especially renewal or recertification, with reference to Indian scenario. Many notified bodies have stopped their operations and those that remain have made implementation of requirements of various directives and guidance rigid (to the letter and not only in the spirit). This has brought down CE marked devices in India, it seems. Unfortunately there are no formal medical device umbrella organizations and hence no data is authentically collected and/or available. May be data will be forthcoming in the future, after medical device regulations in India are fully implemented and all manufacturers will register and/or obtain manufacturing licenses, as per the act & rules.
Looking at the European scenario, Medical devices within the EU are currently regulated by the following 3 directives : 1. Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990), 2. Council Directive 93/42/EEC on Medical Devices (MDD) (1993) &amendment 2007/47/EC 3. Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. Implementing measures for Directives The Commission has adopted several implementing measures based on the Medical Devices Directives. The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. They pursue the objective of ensuring uniform application of the relevant provisions of the directives within the EU. Please note that all guidance and implementing measures under the current Directives will be reviewed over the next few years in the light of the texts of the 2 new Regulations. Many a times Notified Bodies insist on their implementation though they are guidance documents, may be for the good of Manufacturers. e.g. MEDDEV 2.7/1 rev.4.0 on clinical evaluation. Sept.-Oct.2017
The new Regulations on medical devices On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices. The new Regulations in a nutshell The new Regulations contain a series of extremely important improvements to modernise the current system. Few among them are : • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification • the introduction of an “implant card” containing information about implanted medical devices for a patient • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multicentre clinical investigations • the strengthening of post-market surveillance requirements for manufacturers • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance Comments : Unique Identification Number system for each implant, PMS with well planned data gathering, Risk mitigation process taking umbrella view and current update for every system document is a major outcome. The main reasons behind this change
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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 designation 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 process 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.
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Sept.-Oct.2017
Global Trends US Medical Device Makers Call For Trade Action Against India American medical device companies have written to the US government asking that it suspend or partly or fully withdraw India's benefits under the Generalized System of Preferences (GSP) "in view of its failure to provide equitable and reasonable access to its market for medical devices". GSP allows developing countries duty-free access to the US for some products.
officials that they would not expand price controls beyond stents".
The companies cited recently imposed price controls on stents and knee implants as examples of discrimination against US device companies.
Avamed feared that other countries might attempt similar price controls. "Indonesia, Bangladesh and Pakistan are reportedly considering India-type price controls. Even more troubling, China recently published a national pricing policy, in which it explicitly required manufactures to report prices in India," it stated.
He representation to the United States Trade Representative (USTR) was made by Advamed (Advanced Medical Technology Association), a trade association representing nearly 350 medical technology companies including the biggest stent manufacturers, Abbott, Boston Scientific and Medtronic. Advamed's representation to USTR comes while the annual GSP product and country practices review process in underway. Under GSP, 3,500 product lines are eligible for the benefits of duty-free access to US markets. These products include engineering goods such as mechanical and electrical machinery and equipment, tools, agricultural implements, organic and inorganic chemicals, plastic and copper. Advamed claimed that NPPA's price cap of stents "disproportionately harmed imported stents". Referring to the price control of knee implants following stent price caps, the association expressed apprehension that price control could extend to other medical devices. AdvaMed stated that it recently learned that NPPA has already calculated ceiling prices for a number of other medical devices and was just waiting for the prime minister's order. "If price controls extend to all US exports of medical devices, except capital equipment and in vitro diagnostics (because neither category has ever been mention as candidates for price controls), over $700 million of US exports could be adversely affected," it added. Interestingly, Advamed claimed that the order capping knee implant prices came "despite repeated assurance by GOI
The National Pharmaceutical Pricing Authority had capped stent and knee implant prices after studies by it revealed huge trade margins being used to induce hospitals and doctors to use these devices at exorbitant prices to patients.
The Association of Indian Medical Device Industry (AIMED) countered Advamed's claims by pointing out that the US adopted policies to favour its own companies. "The US has technical barriers to trade under USFDA, while these are near non-existent in India for US device companies. Indian manufacturers are barred from selling to the US government-funded health programmes and defence as India is not listed under the US Trade Agreement Act. We are also discriminated against as the US has a 'Buy American' policy. No such government support exists in India for domestic manufacturers. These lobbying forces only care about access to Indian markets. Most of them just import. Hardly any of them manufacture in India," said Rajiv Nath of AIMED. He added that Advamed's representation showed the true nature of the foreign device companies, who were members of the Confederation of Indian Industries (CII) and Federation of Indian Chambers of Commerce & Industry (FICCI) but were hardly interested in the welfare of India or its industry. (Ref : Times of India dated Oct 25, 2017)
Medical Plastics Market worth 21.06 Billion USD by 2022 As per the recent study on “ Medical Plastics Market “ by Type (PVC, PP, Engg, Plastics, PE, PS, Silicones), Application (Implants, Disposables, Drug Delivery Devices, Syringes, Diagnostic Instruments, Catheters, Surgical Instruments), and Region Global Forecast to 2022 the medical plastics market is projected to grow from USD 13.85 Billion in 2016 to USD 21.06 Billion by 2022, at a CAGR of 7.3% . This growth can be attributed to the aging population, increasing demand for existing and new medical technologies, and growing application globally. New product launches and agreements & joint ventures undertaken by the players operating in the market are expected to fuel market growth. The Highlights of the study are as follows : Polyvinyl Chloride was the largest type segment of the medical plastics market in 2016. PVC is the third most widely produced synthetic plastic polymer after polyethylene and polypropylene. The demand for PVC is high, as PVC is compatible with different kinds of additives that make it a versatile polymer and thus, is suitable for use in the manufacturing of medical plastics. PVC is widely used in the manufacturing of Class I medical devices. Medical devices manufactured using PVC can be easily sterilized using methods such Sept.-Oct.2017
as steam, radiation, or ethylene oxide. The two main applications of medically approved PVC compounds are flexible containers and tubing. Disposables is the largest application segment of the medical plastics market. Disposable medical devices can be disposed of once they are used. Medical devices such as contact lenses, hypodermic needles, disposable enemas, dialysis disposables, medical and cleaning gloves, and other medical products have been considered under this segment. Among the major disposable medical devices, the dialysis disposables subsegment is expected to witness the fastest growth rate globally, due to the increasing endstage kidney disorder cases and high frequency of therapeutic requirements. Polymers such as silicone hydrogel, polyethylene, polystyrene, epoxy resins, and polypropylene are used for manufacturing disposable medical devices. Asia-Pacific was the largest market for medical plastics in 2016. Asia-Pacific was the largest market for medical plastics in 2016. Emerging technologies such as minimally invasive medical proContinued on P 40
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Industry News Manufacturers Welcome Price Cap On Medical Devices The Association of Indian Medical Device Industry, which represents domestic manufacturers, has welcomed the government proposal to extend price caps to devices including catheters and balloons which are used in angioplasties. A government panel has recommended inclusion of these devices under price control following complaints of overcharging by hospitals. The National Pharmaceutical Pricing Authority requested the government to classify balloons and catheters as drugs and include them under the National List of Essential Medicines. The government had in February capped the price of stents by around 85 per cent. The move resulted in increased sales for domestic manufacturers which are supporting more such actions. A decision to extend price cap on other devices is expected to hurt hospitals and impact their margins. Though some large chains believe price caps could have a short-term impact, given their service diversification, there is displeasure in the private healthcare service providers over the government action.
“Pressure has increased on India to revise its stance on price caps for medical devices and not to extend it to other devices. But the government should do what is good for the country and give advantage to common citizens who now have access to the best products at the most affordable prices and to domestic manufacturers,” said Rajiv Nath, forum co-ordinator, AiMeD. “In the last six months we have seen a positive trend towards increased sales for domestic manufacturers. We estimate the trend to continue and Indian manufacturers will grab 60 per cent of market share by next year,” Nath said. Earlier this year the Maharashtra Food and Drug Administration had examined invoices in 12 major hospitals in the state and found that over 70 per cent of the cost paid for balloon catheters by patients is profit margin of manufacturers, distributors and hospitals. In case of guiding catheters more than 47 per cent of the cost paid by patients was found to be profit margin of these three stakeholders. (Ref : Business Standard dated October 12, 2017)
Gujarat Registers Maximum Number Of 170 Medical Devices Units In The Country Under CLAA Scheme
The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
The Centre has also been mulling for quite some time for setting up the medical devices park in Gujarat in a bid to make India self-reliant in the sector. The creation of manufacturing park for medical devices will boost the segment of hi-tech medical devices as medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufacturers to invest upon. A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent.
CLAA has been formed to oversee the regulatory activities related to grant of manufacturing license for hi-tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.
This will also help facilitate to create an ecosystem for manufacturing of high end medical device manufacturing aimed at import substitution and export opportunities and would be a major boost to SMEs. (Ref : http://www.pharmabiz.com/ NewsDetails.aspx?aid=104308&sid=1 (September 18, 2017)
Gujarat as of today has registered the maximum number of 170 licensed medical device units under the Central Licensing Approval Authority (CLAA) scheme as against a total of 284 medical device units in the entire country. The state had 150 such high end medical device units 11 months back and has also granted licenses to 56 new drug manufacturing units.
MTaI Puts Forward Key Recommendations To Govt For More Enabling Environment For Medical Devices Industry In India The Medical Technology Association of India (MtaI), an association of research-based medical technology companies, has put forward some key recommendations for the consideration of the policy makers that would pave the way for a more enabling environment for the medical devices industry in the country. At a MedTech Summit held in New Delhi recently, the industry leaders stressed that in view of recent policy changes in the medical technology space, there is a need for the sub-sectoring and sub-categorization of medical devices on the basis of the Continued from P 39
Medical Plastics Market
cedures in the region have allowed it to produce better quality medical devices. The demand for medical devices has been increasing, owing to the rising awareness of early diagnosis and treatment of countless diseases in the Asia-Pacific countries.
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engineering complexity, for policy and decision clarity.
Import substitution as a focus of policies needs to be replaced with greater efforts directed towards ensuring global competitiveness through export promotion and meeting global quality standards. The recently presented NITI Aayog action agenda recognizes the significance of global companies’ presence for the domestic industry to compete with and grow. Make in India, a noble initiative, should however be implemented in a phased manner. It must focus on the devices that have the potential to be made locally in the short run, instead of the Major players such as Lubrizol (U.S.) have adopted developmental strategies such as expansions, agreements & collaborations, and new product developments to grow in the medical plastics market. ( Ref : http://www.marketsandmarkets.com/PressReleases/ medical-plastics.asp ) Sept.-Oct.2017
Industry News advanced technologies that require a more enhanced ecosystem and know-how that may take years to develop in the country. This means that policies must factor in the existing gaps in the domestic manufacturing industry, and promote ease of doing business by way of reduced inter-organizational delays, enhanced startup industrial finance, simplified regulations such as single-window clearance, and greater investment in infrastructure. Sanjay Bhutani, director, MTaI asserted, “the industry continues to be largely under- understood and under prioritized.” Another key recommendation put forth at the Summit was to expand the bed capacity in the country. This is particularly crucial given the rising burden of diseases in the country today and the lack of access to quality healthcare. Many pockets of the country remain underserved, and are calling out for real-time scaling up of solutions to address this demand. The expansion of the healthcare delivery system will automatically provide an impetus for the medical devices market to grow. Further, for long term advantage, infrastructural development and fiscal incentives are needed to keep the wheels of innovation
and R&D rolling. This will simultaneously help achieve the twin objectives of greater patient access as well as the availability of latest and high-quality technology. MTaI endorses the Trade Margin Rationalization Report of the Department of Pharmaceuticals, provided unique and deserving sub-sectoral nuances are given due consideration. Any access enhancing (price control) mechanisms must be preceded by a careful impact analysis on creation of geographical access barriers, on quality of outcomes, reverse medical tourism, and decreased incentive to innovate. The MedTech Summit today brought together the much needed interface of policy makers, industry, doctors with the patients. Key departments and ministries such as the ministry of commerce and industry, department of health and family welfare, and the NITI Aayog were represented at the Summit. The medical technology industry was represented by top MedTech companies including inter alia Abbott Vascular, Alcon, Bard, Bausch & Lomb, Boston Scientific, Johnson & Johnson, KARL STORZ, Medtronic, Olympus, Terumo, and Vygon India. (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 written to the union health ministry to accelerate the process of setting up the much awaited medical device testing lab at Vadodara in Gujarat, MoU for which has recently been signed between the Government of India and Gujarat Government.
only dedicated biomaterials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country. (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
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Product Gallery Qosina Introduces New 2018 Catalog Ronkonkoma, NY, October 12, 2017– Qosina is pleased to release its new 2018 product catalog, which features over 5,000 stock components. The four-color, glossy print catalog consists of more than 500 pages with full-scale illustrations on a one-centimeter grid and includes approximately 150 new parts, such as connectors, O-rings, forceps, valves, stopcocks, and catheter accessories. Also featured in the new catalog is Qosina’s wide selection of components that meet the ISO 80369 standard for small-bore connections in a healthcare setting. Readers can conveniently search the catalog by category or function to locate the appropriate product for any application. Qosina’s product catalog is often considered the authoritative resource for the medical OEM, bioprocessing and pharmaceutical industries, as well as for medical device engineers. Qosina offers low minimums and short lead times. Log on to qosina.com to see pricing, obtain a copy of the 2018 catalog, request complimentary samples and place orders. Sign up for our monthly e-newsletter to stay current with the newest product
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additions. Our product development team can work to customize a part to your exact specifications. Speak with a customer service specialist to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com. Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, compression fittings, NRFit™ (ISO-80369-6) connectors and caps, ENFit™ (ISO80369-3) components, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, ISO 13485 and ISO 14001 registered. Contact : Qosina Corporation, Deanna Whelan 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Email: deanna@qosina.com
Sept.-Oct.2017
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REGISTERED FIRM Wide Range Of Products :
The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.
Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com
GMP ISO - 9001-2008 Certified Company
S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980
IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address
S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com
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PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Sept.-Oct.2017
Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com
High Concentration Mask
Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber
Breathing Filters
Airovent T-Humidifier
Anaesthesia Circuits
Incentive Spirometer
ET Holder with Bite Block
Expandable Catheter Mount
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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I.V. Infusion Sets
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Blood Administration Sets
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Scalp Vein Set
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Urine Collection Bags
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Ryles / Feeding Tubes
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Catheters and Tubes
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Surgical Gloves.
Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com Sept.-Oct.2017
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Events The 18th Edition of Medicall Held at Mumbai, Bombay Convention & Exhibition Center Oct 6,7 & 8 2017
Medicall, India’s largest B2B Medical Equipment and Hospital Need Exhibition, is promoted by Dr. S Manivannan, promoter director of 1000 bedded 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 disadvantage in the market while procuring consumables and equipment for their business. They neither had the choice nor the price advantage enjoyed by the biggies. Thus Medicall was born. Medicall served as a marketing platform wherein the equipment companies showcased their products to Hospital owners and decision makers. International companies participated in Medicall to understand & exploredthe Indian Medical Devices market and appointed appropriate dealers and distributors in the region.
Events Calender •
Compamed 2017 / Medica 2017: The world’s leading trade fair for the medical industry Date : November, 13-16, 2017 Venue : Dusseldorf, Germany
• 4th PLASTIVISION Arabia 2017 : International Plastics, Printing & Packaging Exhibition Date: Dec. 11-14, 2017. Venue: Sharjah, UAE.
• PLASTINDIA 2018 : 10th International Plastics Exhibition, Conference & Convention Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India.
• Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai.
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Medicall has maintained its position as the largest and best attended Medical shows in India. In its 18th edition at Mumbai, Medicall attracted more than 310 exhibitors and 9800 professional visitors.It was a true bazaar for hospital equipment and supplies, ranging from surgical gloves to the most sophisticated medical equipment used worldwide.Medicall shows are held at Chennai, Mumbai, New Delhi, Ahmedabad, Kolkata, Hyderabad and Colombo. Medicall Mumbai was a perfect getaway to meet one's peers, to compare and choose equipment and best of all to refresh the knowledge base in the intellectually stimulating BrainStorm Medicall. A favourite with many International product companies, Medicall has these come repeatedly to widen their dealer and distributor base. Diversity is a given in this expo. 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 Sept.-Oct.2017
