Medical Plastics Data Service Magazine March - April 2015 by Medical Plastics Data Service

Vol.23

No. 2

Mar.-Apr. 2015

Our 23rd year of Publication

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS, DIAGNOSTICS AND PHARMACEUTICAL INDUSTRY

www.medicalplasticsindia.com

Envisioned Harmonized Ecosystem g o n f i r High E u t c a f nd M nu a M ed s u ica no Validation Centers

for

Infrastructure

ce evi

In d

ige

Facilitating Body

Med Tech Parks

Administrative Department (DoP&M)

R&D Capability

CoEs

Manufacturing Hubs

Incubation Centers

Skill Development

Regulatory Body

Skill Development Committee

Also : Drug Device Combination Products – Market Review and Future Trends International Component Manufacturing & Design Show Simultaneous event : China Int’l Medical Equipment Fair (CMEF) www.ICMD.com.cn May 15-18, 2015 National Exhibition and Convention Center (Shanghai)

One stop solution provider for R & D, design and manufacturing of medical devices by covering the upstream industry

An Authentic Portal Site On Medical Technology And Markets In Asia

Table of

Contents Vol. 23

No. 2

Mar.-Apr. 2015

22 Cover Story

• Promotion Of Domestic Production Of High End Medical Devices - The Government is taking several steps to boost the domestic production of high end Medical Devices including Medical Devices Parks, creating nodal Institute for undertaking Research & Development , providing incentives as well as......... • The Medical Devices Sector In India : Task Force Recommendations - A Task Force headed by Secretary , Department Of Pharmaceuticals, has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production. It includes ........... • “Medical Plastics Data Service” Thanks And Welcomes Mr. C. Balagopal To The Editorial Advisory Board

27 Market • Drug Device Combination Products : Market Review And Future Trends The therapeutic and diagnostic products that combine drugs, devices, and/or biological products are called Combination Products . The global market for such products has been differentiated into eight segments based on..........

30 Global Trends • Global Biomaterials Market For Implantable Devices Driven By Polymers Biomaterials have a key requirement of being biocompatible .The global maket is estimated to be worth ...........

32 Industry News • Medical Device Industry Welcomes Task Force’s Recommendations • Health Ministry Okays Plan To Monitor Medical Devices; Vigilance Cells To Be Set Up Nationwide

25 Product Gallery • 2015 Qosina Catalog with Thousands of Stock Components

18 Did You Know? • About Challenges Of Using Combination Products

34 Events • • • • •

Mar.-Apr. 2015

Medical Fair India 2015 : March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai. CMEF & ICMD (Spring) : May 15 – 18, 2015, Shanghai, China. Medicall 2015 : October 9 - 11, 2015, Bombay Convention and Exhibition Center, India. Plastivision Arabia 2016 : January 10-13, 2016, Expo Center, Sharjah. 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 12-13 February, 2016, Ahmedabad

Flashback Nov. - Dec. 2002 From Editor’s Desk Dear Readers, About 60 Indian Medical Device Companies exhibited in the “MEDICA2002” trade show held in Dusseldorf (Germany) in November. This is indicative of the growing competence of Indian Companies for the Global Markets. Many more companies will follow in the coming years. It is therefore appropriate that our magazine “MEDICAL PLASTICS DATA SERVICE” and the medical technology portal web site, www.medisourceasia.com , covers issues relevant for the Global Markets. This issue covers presentation by Dr S N Pal on “CE Marking”. The letters CE ( French for “ European Conformity” ) indicate that a product confirms to the European applicable and legal demands , in terms of safety, health , environment and consumer protection. CE marking can be seen as sort of a passport that allows manufacturers to circulate their products freely within the internal market of the EU. Exporters to European Union need information to formulate their market and product strategies. CBI, the Centre for the Promotion of Imports from developing countries has published “EU Market Survey 2002” for Medical Devices and Medical Disposables. The emphasis of the survey lies on those products, which are of importance to developing country suppliers. Abstracts from the report is also highlighted in this issue. Important contents of this magazine are also put on our web site, www.medicalplasticsindia.com. CONTENTS • Cover Story - CE Marking of Medical Devices • Global Trends - EU MARKET SURVEY - Medical Devices and Medical Disposables • Quality - CE Marking Action Plan • Industry News - Wockhardt surgeons use new method to remove artery for bypass - Cadila in talks with foreign companies to make auto- disposable syringes - Healthcare to contribute 8.5% to GDP by 2012: CII- Mckinsey study • Networking Opportunities From: medisourceasia.com • Did You Know ? - About The Ageing Population In Europe • Events - Medica / ComPaMED - HOSPIMedica INDIA 2003 - HOSPIMedica THAILAND 2003 - CHINA MED 2003 • Events Calender

Did You Know ?

About Challenges Of Using Combination Products

Combination products have numerous advantages but convergent technologies also have many perceived risks. Industry experts recommend avoiding combination products unless there are no alternatives. Converging genomics, diagnostics and therapies lead to personalized medicine but many hurdles scientific, regulatory, financial etc. must be overcome. Another issue is changing regulatory environment. Historically medical devices and pharmaceutical sectors are operated under different sets of regulations in most developed countries. Regulators are now reviewing existing regulatory pathways as great number of innovative combination products appear on the market and in R&D pipeline offering challenges for any regulatory agency because of differing views of timelines, policies, development cycles and multiplicity of configurations. The normal review paradigm is difficult to apply to combination products because of their interactions. The third is product development path wherein integration of research stage combination technologies & product development program is risky and tends to entail higher development and manufacturing costs. In addition, using components from disciplines not part of the core business require complex management structures and collaboration with unfamiliar business partners. This complexity, combined with higher costs of regulatory compliance, slows the introduction and increases the entry costs of new technologies. Final concern is patient compliance. The drug-eluting stent is one such example where patients who receive stents without a drug coating have an occlusion of the vessel within 6 months, whereas rest enosis rates for patients with drug-eluting stents are in the low single digits. However, current drug-eluting stent treatments require long-term anti-platelet therapy—an offlabel use for drug manufacturers. The result may be problems with patient compliance and an increased risk of heart attacks. It should thus be emphasized that adoption of convergent technologies and their increasing benefits will be accompanied by emergence of new risks. Ref: http://www.nature.com/nbt/journal/v24/n3/full/nbt0306-277b.html

In a Nutshell.... “It takes Considerable Knowledge Just to realize The extent of your Own Ignorance” - Albert Einstein

Mar.-Apr. 2015

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

ASSOCIATE EDITOR Mr. Rahil Engineer, B.E. (Biomedical Eng.)

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94

Editor’s Desk

From the

Indian Medical Device Manufacturing Industry : The Driver For “Make In India “ Compaign As per Mr. Rajiv Nath, Forum Coordinator, AIMED, “ Make In India Idea is simple ,yet powerful and visionary”. A Task Force on “ Promotion of Domestic Production Of High-End Medical Devices and Pharmaceutical Manufacturing Equipment “was set up by the Department of Pharmaceuticals as an initiative to implement the Prime Minister’s vision of “ Make In India “. As detailed in this issue of our magazine , the Task Force has recommended measures to enhance policy and Institutional Support; fiscal and financial support as well as measures for creating an Institutional set-up for efficacy & safety testing, promoting skill development aligned to the need of the industry, strengthening the R & D Capability of the sector, pricing strategy for the sector along with conducine regulatory environment. Accordingly, the Government will set up Medical Devices Parks in the Country, and the first such park will come up in Gujarat soon. NIPER Ahmedabad, will be the nodal Institute to undertake Research & Development. DoP has has already taken up issues of incentives and taxation so that indigenously produced medical devices can compete with the imported ones. The Government has also felt need for separate department to handle the issues of facilitation and regulation of high end medical devices. This issue also introduces the newly emerging innovative medical products – the Combination Products - with technologies that combine drugs, devices, and/or biological products . These products are expected to have major impact on the overall medical device market. One more market analysis under the “Global Trends” column in this issue is about Global Biomaterials Market. As explained , Polymer Biomaterials Segment is estimated to grow with a fastest growth rate during the period 2013 to 2019 due to the increasing applications into healthcare and its unique properties such as flexibility , biocompatibility and durability. For the information of our readers , the International Component Manufacturing & Design Show ( ICMD ) to be held simultaneously with CMEF in Shanghai , China between May 15 – 18, 2015 is an Unique opportunity for Indian Medical Device Manufacturers. It offers one stop solution for sourcing Materials , Design , R & D, Components , Manufacturing Equipments, Technology along with a wide range of related Products & Services.

DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Mar.-Apr. 2015

Cover Story Promotion of Domestic Production of High End Medical Devices The Government is going to set up Medical Devices Parks in the country, and first such park will come up in Gujarat soon. The Union Minister of Chemicals and fertilizers Shri Ananth Kumar said this while releasing the recommendations of the Task Force on Promotion of D o m e s t i c Production of High End Medical Devices & Pharmaceutical Manufacturing Equipment. He said that only 30% of the country’s requirement of Medical Devices is being met through indigenous production, and that of low end category. The Minister said that the Government is taking several steps to boost the d o m e s t i c production of high end medical devices & pharmaceutical manufacturing equipment. He said that NIPER, Ahmedabad will be the nodal institute for undertaking research and development in the area. Shri Ananth Kumar said that the recommendations made by the Task force will be implemented in a time bound manner. He said that the Department has already taken up issues of incentives and taxation on such devices with the finance Ministry so that the indigenously produced medical devices can compete with the imported ones. The minister said that need is being felt to have a separate department to handle the issues of facilitation and regulation of high end medical devices & pharmaceutical manufacturing equipment, as their consumption is increasing very fast and there is need to make India self-dependent in the sector. He said that on the lines of National List of Essential Medicines, there should be a National List of Essential Medical Devices to enable providing affordable, quality products to masses easily. The Minister of state for chemicals and fertilizers Shri Gangaram Hansraj Ahir said on the occasion that the Government is working hard to achieve the objective of “Make in India”. Medical devices’ industry is a multi-product industry, producing wide range of products. Taking all the products category of

‘Medical Devices’ together, India is importing around 69% of its total requirement. The imports of high-end Medical devices are much higher, going up to around 87% for the category of Medical Electronics, Hospital Equipment, Surgical Instruments. In view of the prevailing scenario, the Task Force on ‘Promotion of D o m e s t i c Production of H i g h - e n d Medical Devices a n d Pharmaceutical Manufacturing Equipment’ was set up by the Department of Pharmaceuticals as an initiative to implement the PM’s visions of ‘Make in India’. The Task Force was headed by Secretary, Department of Pharmaceuticals and consisted of representatives from Planning Commission, Department of Health & Family W e l f a r e , Department of Health Research, DCGI, Department of Commerce, Department of Industrial Policy and Promotion, Department of Electronics and Information Technology and various Industry Associations including AIMED, CII, FICCI, ASSOCHAM, FOPE etc. The Task Force has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production of medical devices. The Task Force has recommended measures to enhance policy and institutional support; suggested strengthening of infrastructural support; and, recommended fiscal and financial support to the sector. In addition, the Task Force has also recommended measures for creating an institutional set-up for efficacy & safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D Capability of the sector, pricing strategy for the sector and conducive regulatory environment. Reference : Press Information Bureau Government of India Ministry of Chemicals and Fertilizers http://pib.nic.in/newsite/PrintRelease.aspx?relid=118080 Mar.-Apr. 2015

Cover Story The Medical Devices Sector in India; Task Force Recommendations Background Medical devices’ industry is a multi-product industry, producing wide range of products. Manufacturing and trade in medical devices is also growing quite steadily. Double digit growth rates indicate its importance in health care. Medical devices’ industry mostly depends on imports. Most hi- tech innovative products and technology originate from a well developed eco-system and innovative cycle which needs to be developed in India to promote indigenous industry and to reduce our dependence on imports. The ‘Make in India’ campaign of Hon’ble Prime Minister Narendra Modi’s government has a mandate to boost the medical device manufacturing sector in India for all types of medical devices and equipments used in manufacturing of Pharmaceuticals. To implement the initiative a Task Force was constituted under the chairmanship of the Secretary, Department of Pharmaceuticals (DoP) to address issues relating to the promotion of domestic production of high end medical devices and pharmaceutical manufacturing equipment in the country. The Terms of Reference (ToR) for the Task Force is given in the detailed report.

The need to address various basic concerns facing the industry including human resources, finance, market, ease of doing business, promotion of R&D and innovation etc was identified. Specific issues that have to be deliberated upon intensively were identified and more focused sub-groups were formed to address these issues including : Sub-group 1: Sector overview Sub-group 2: Policy & Infrastructure Sub-group 3: Regulatory All the recommendations from different sub-groups were reviewed, collated and a concise actionable set was created. However participation of the industry / stakeholders from manufacturing equipment used in pharmaceutical was lacking and the Task Force did not receive inputs from them despite all attempts. An overview of the device industry and the different elements required to build the envisioned harmonized ecosystem is given below.

Medical Devices Sector Overview Medical devices sector in India is very small by size as compared to the rest of manufacturing industry, though India is one of the top twenty markets for medical devices in the world and is the 4th largest market in Asia after Japan, China and South Korea. Although accurate data is not available, an educated guess would place the retail market at Rs. 60,000-70,000 Crores. Segments The Medical Devices market can be classified into two major categories: • Devices that do not require any external energy source. • Devices that require external energy source to be operational (powered). Powered devices are further divided into three product categories: a. Equipments, b. Implants, and c. Disposables. a. Equipments Equipments account for the largest share of the total market followed by medical implants and disposable segments respectively. This segment is also the fastest growing and is largely dependent on imports currently. This can be further segmented into the following categories – • Surgical Equipments : Prominent factors that drive demand are advancements in surgery and surgical device designs, availability of high skilled surgeons, growing breed of corporate hospitals and advanced surgical facilities like advanced robotics, minimally invasive surgical techniques and imaging. • Diagnostics: Increase in the prevalence of diseases, their complexity and the need for quick diagnosis has created a high demand for Mar.-Apr. 2015

diagnostic services and devices like Cardiac imaging, CT scans, X-ray, Molecular Imaging, MRI and Ultrasound-imaging including hand - held devices. • Life Support: As life support technologies evolve and improve, use of equipments like ventilator and automated external defibrillator outside of the hospital environment has increased. Also, as consumer spending power increases demand for such systems is expected to grow. b. Implants The market for implants is witnessing some amount of innovations in terms of catering to large unmet needs in certain disabilities e.g. blindness. A microchip retina implant is under trial which will allow blind patients to read letters & recognize foreign objects. c. Disposables Medical disposable products for medical electronic equipment are used by all hospitals and private nursing homes in the country, including diagnostic and pathological laboratories. The market is becoming increasingly competitive due to low entry barriers (for MNCs), increasing number of players and an expanding consumer base. Examples include disposable medical and electronic probe assemblies for minimally invasive applications, disposable catheter cables, disposable EEG sensors/lead wires, disposable SpO2 sensors, panel mount receptacles, etc. Present status During the period 2011-12 to 2014-15 both import and export of medical devices have grown at more than 10% rates. Import as well as export of Medical Electronics and Hospital Equipment has been the highest amongst all the devices in terms of value. Along with surgical instruments they form more than 50% of total sales with majority being imported (87.4%).

Cover Story Summary of Imports of Medical Devices in India (All values in Rs. Crore)

Summary of Exports of Medical Devices in India (All values in Rs. Crore)

Summary of Sales of Indigenous versus Imported Medical Devices in India in 2013-14 (All values in Rs. Crore)

Factors driving the growth of medical devices sector 1. Market Factors Growing population, ageing, income base and associated disposable income, increasing socio-economic inclusion of rural and deprived in mainstream economy, heightened manufacturing innovation to create customized products to meet the needs of all income segments, changing disease prevalence pattern (e.g. early onset of diabetes and heart diseases) and growing awareness among the middle class to focus on early detection and disease prevention. 2. Non-market Factors Development of infrastructure, favorable regulations, FDI inflow, outsourcing of manufacturing and R&D activities to India, government initiatives to improve healthcare access through insurance schemes such as RSBY (Rashtriya Swasthya Bima Yojana), Aarogyasri, etc. The lack of regulatory systems, harmonized standards, accreditation, legal requirements, proper guidance on quality and best practices etc. are affecting the medical devices industry adversely.

Recommendations Policy support

1.2. Administrative Department Department of Pharmaceuticals be strengthened and 1. Create necessary bodies to drive the policies rechristened as Department of Pharmaceuticals and Medical 1.1. Facilitating body Devices. Necessary revisions in the scope of services along Set up an independent body with a permanent office and with creation of a separate post of Director in the department support staff to promote and facilitate the medical device to deal with issues related to the Medical devices sector. industry with representatives from all related government 2. Preferential treatment in government procurement departments as well as Industry.

Mar.-Apr. 2015

Cover Story Infrastructure 1. Set up manufacturing hubs/ clusters in PPP mode 2. Set up Medical device parks 3. Financing support and Other support

Facilities for efficacy and safety testing 1. Medical device testing centers should be set up preferably in the PPP mode 2. Designate “Centers of Excellence” (CoE) for supporting product development and validation 3. Strengthen a made in India marking (BIS) specific to Medical devices

Skill development Set up a Skill development committee with representatives from Medical devices industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC).

R&D capability 1. 2. 3. 4.

Set up a system for IP exchange Set up/ promote Incubation centers Provide requisite financing support Promote industry specific “independent software vendor” by extending similar benefits.

Policy for pricing 1. Separate price control order for medical devices 2. Price control body 3.Pricing & reimbursement policy

Duty structure Tax/ duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment. 1. Discounts on import duties 2. Restrictions on import of second hand diagnostic equipment. 3. Incentivize and promote exports in the medical devices sector. 4. Taxes should be levied with reference to MRP.

Regulatory 1. Formulate “Medical Device Regulatory Act” 1.1. Medical devices should be treated distinctly from drugs and a separate chapter for medical devices should be made in the existing Drugs & Cosmetics Act. 1.2. A distinct regulatory pathway to be created for clinical trials of Medical Devices 1.3. Formulation of a risk based regulatory system for medical devices based on justified regulatory control mechanisms. 1.4. Harmonization with regulations guiding radiation-emitting medical products with the help of bodies like AERB 1.5. A policy on safety, efficacy and adverse reaction reporting based on International quality standards 1.6. Penal provisions to be made moderate for Medical devices 1.7. Labeling of MRP on Unit packs on imports should be made mandatory 1.8. Design a system to restrict usage of diagnostic equipment beyond their shelf life 2. Designate regulatory bodies for medical devices 2.1. Regulatory body for medical devices 2.2. Regulatory clearances to be provided by single window 2.3. Regulatory officials to be positioned across the regulatory landscape 2.4. Continuous training of regulatory staff at centre as well as state level The envisioned ecosystem • Medical Device Regulatory Act • Tax discounts • Pricing control policies • Financing support Mar.-Apr. 2015

Product Gallery 2015 Qosina Catalog with Thousands of Stock Components Edgewood, NY April 16, 2015 The New 2015 Qosina Catalog o f f e r s e a s y b r o w s i n g o f thousands of stock components on a one-centimeter grid. Qosina has the largest selection of parts for the medical OEM, kit packer and pharmaceutical industries, offering free samples, low minimums, and Justin-Time (JIT) delivery. The vast product range, along with complimentary samples, makes Qosina the first stop for all design engineers and purchasing agents who are sourcing components for current and future projects. Qosina offers high volume pricing discounts and supply chain management services. Featuresof the new catalog include a category structure based on product function, a robust index to effortlessly find components by application or keyword, and more products in fewer pages with easy to read tables, while maintaining life size images. To request a copy for your reference shelf, contact a Customer Specialist at +1 (631) 242-3000, info@qosina.com or visit our website at www.qosina.com. Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohy borst adapters, swabs and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. Call our Customer Specialists to request samples, obtain our latest catalog or place and order via phone +1 (631) 242-3000, fax +1 (631)-242-3230 or e-mail info@qosina.com. Visit us at www.qosina.com to see our latest products. Custom sourcing services are available through our extensive network. Contact:David Walker QOSINA 150-Q Executive Drive Edgewood, NY 11717 Phone: +1 (631) 242-3000 Fax: +1 (631) 242-3230 Email: dwalker@qosina.com 25

Editorial Advisory Board “MEDICAL PLASTICS DATA SERVICE” THANKS AND WELCOMES

MR. C. BALAGOPAL TO THE EDITORIAL ADVISORY BOARD

Mr. C. Balagopal Formerly Managing Director, Terumo Penpol Ltd. • Resigned from the IAS in 1983 to promote joint-venture Company with the support of National Research Development Corporation and KSIDC to make innovative biomedical devices in India using indigenous technology. • Acquired technology, conducted feasibility studies, market research, arranged finances, recruited project team, set up Blood Bag Factory at Puliyarakonam, Trivandrum • Managing Director, Peninsula Polymers Limited renamed in 1999 as TERUMO PENPOL Limited. • PENPOL entered into a Joint Venture with TERUMO CORPORATION, Japan. TERUMO CORP is the world leader in high-tech medical products. The plant is now the biggest of its kind in Asia outside Japan. More than 1000 skilled people work in the factory. Today the company is a wholly owned subsidiary of Terumo Corp. Awards : • Management Leadership Award of Trivandrum Management Association • National R&D Award for successful commercialization of Indigenous Technology by Ministry of Science & Technology, Govt. of India in 1995 • Winner of National Export Awards every year from 1994-95 onwards • Outstanding Entrepreneurship Award from Kerala State Industrial Development Corporation • Business Excellence Award 2011 from The Trivandrum Chamber of Commerce and Industry Affiliations : MHR 11 Committee, Bureau of Indian Standards, Member, Medical Equipment Division, CII, Charter Member, and first President, TiE Kerala Chapter Has attended ISBT Conferences in various parts of the world, and has presented papers at international conferences. Has advised various agencies on aspects of setting up a modern Blood Service, and helped to draw up detailed plans for setting up a State Blood Transfusion Service for several State Governments. TPL has been recognized by ISBTI and other National Organizations for CSR activities aimed at promoting Voluntary Blood Donation. TPL has a strong community development program at Vilappil Panchayat aimed at supporting the Government Lower Primary Schools, and the public health system. Balagopal has written a book ON A CLEAR DAY YOU CAN SEE INDIA based on his experiences as an IAS officer in Manipur in India’s North East. This book is published by Harper Collins and was released in Delhi and Trivandrum in October 2013. He is working on his second book on his experiences as an IAS officer in Kerala. Balagopal is married to Vinita and they have four children. They spend their time between Trivandrum and Bengaluru. After retiring from TPL, Balagopal continues to support startup ventures, both as investor and mentor. He plans to get more involved with community development projects in Vilappil Panchayat and is in the process of setting up a Trust for the purpose. Balagopal enjoys reading, writing, long walks, music, golf, travel, meeting people, and keeping in touch with friends.

Mar.-Apr. 2015

Market Drug Device Combination Products : Market Review and Future Trends What Are Combination Products? The therapeutic and diagnostic products that combine drugs, devices, and/or biological products are called combination products and can include following types: drug-device, biologicdevice, drug-biologic and drug-device-biologic. These products have emerged as innovative medical products due to their contribution in advancing medical care and are thus expected to have major impact on the overall medical devices market. For example, smart implants may provide a means of remotely monitoring and managing therapeutic dosing; in turn, wireless communication with implants may allow health care services for chronic disease to shift from the hospital to the home setting. Market Review The global drug device combination products market has been differentiated into eight segments based on the product types. The major product types include drug eluting stents, prefilled syringes, antimicrobial-coated catheters, co-packaged products that are required to be delivered sequentially for therapeutic effect, and infusion pumps, photo sensitizers, orthopedic combination products, wound care combination products, inhalers, transdermal patches and others which include intraocular implants and drug eluting beads. The global drug device combination products market was valued at USD 66 billion in 2012 and is expected to grow at a CAGR of 7.9% from 2013 to 2019, to reach an estimated value of USD 115billion in 2019 according to the Transparency Market Research report. Geographically, North America dominated the global drug device combination products market and is expected to continue to lead in terms of revenue generation throughout the forecast period. The market in North American region was valued at USD 28.5 billion in the year 2012. Asia-Pacific is considered as the most lucrative market for drug device combination products owing to the increase in incidences of cardiovascular diseases, diabetes related disorders and obesity through 2019. The leading players in the market for drug device combination products are Abbott Laboratories, Inc., Medtronic, Inc., Boston Scientific Corporation, CareFusion Corporation, Allergen, Inc. and others. Major Growth Drivers Various emerging technologies such as implants with drugs to permit faster healing, relief from pain and decreased morbidity currently form the major driver for the growth of this market. High Mar.-Apr. 2015

incidence rates of chronic pain causing diseases, prostate cancer, diabetic retinopathy, cardiovascular diseases, colorectal cancer, asthma, obesity along with rapidly aging global population also form the key drivers for the global drug device combination products market. The following scenarios regarding drug/device combinations approval may take place: • The device and drug are approved and on the market individually. - When the drug and the device are both approved, the biocompatibility of the device and the toxicology of the pharmaceutical are known. It must be shown that the stability and bioavailability of the drug have not been compromised by the new drug-device combination. • The device is approved, but the drug is not approved. - When the device is approved and the drug is not, the drug will need to go through the extensive evaluations typically done for a new drug product, plus those studies indicated in the first scenario above. • The device is not approved, but the drug is approved. - Most of these devices today fall into a category where a known drug is available but the delivery system needs enhancement to achieve improved therapy. • Neither the device nor the drug is approved. - In this scenario, when neither drug nor device is approved, significant device evaluations (IDE, PMA) and drug evaluations (IND, NDA) will be required. Depending upon the exact nature of the device, a range of biological effects may need evaluation per ISO 10993. First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993-1 should be consulted to determine areas of concern for these devices. Future Trends The anticipated developments in the device combination product category between now and 2020 will lead to new clinical products. Three types of developments are expected. 1 First, additional products designed for implanted delivery of insulin and other drugs. 2 Second, new developments in drug impregnated devices are expected. 3 Finally under development are new developments in drug delivery systems to simplify reliable use by unsophisticated patients in home settings, including the increasing elderly population. It is expected that in the future large numbers of combination products will be filed as technological advances continue to ‘unite’ different product types and thereby effectively ‘blur’ the historical lines of separation between FDA’s medical product centers, i.e., the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Furthermore, statistics vary on the potential of the combination product market, with estimates ranging from 10%-14%8 annual growth.

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

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

Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Mar.-Apr. 2015

Supernova novo-10 Kit Ket IV

Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Microdrip Infusion Set • Urine Collection Bag • Cord Clamp

• Blood Transfusion Set • Measured Volume Set • Gloves (Rubbers) (Sterile & Non Sterile) • Infant Mucus Extractor

NOVA MEDICAL DEVICES Contact Person : N. A. Patel (Managing Director) Anant Patel (Manager) +91 99253 72428 +91 95589 44364 +91 94081 42799 6/7, F/F, Maruti Industrial Estate, Nr. Sindhvaimata Temple, Ramol Road, C.T.M. Cross Road, Ahmedabad-380 026 (India) Phone : 079-2585 0383 E-mail : novamedicaldevices@yahoo.com info@novamedicaldevices.com Website : www.novamedicaldevices.com

A NMD GROUP OF COMPANY Mar.-Apr. 2015

Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE

Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630. Ta.: Kathlal, Dist. Kheda, Gujarat. Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964

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

Global Trends Global Biomaterials Market For Implantable Devices Driven By Polymers Biomaterials are either of synthetic or natural origin used in effective treatment of several diseases such as cardiovascular, dental problems, tissue damage, bone cancer and orthopedic injuries. These biomaterials have a key requirement of being biocompatible i.e. they should be physiologically acceptable and not provoke any immunogenic reaction in the human body. Biomaterials of significant importance which have been proven to be safe, reliable, and affordable include ceramics, metals, polymers and biomaterials derived from natural origin. The global biomaterials market is estimated to be worth US$88.4 bln by 2017 as per Markets and Markets. The market estimated at US$44 bln in 2012 and is poised to grow at a CAGR of 15% from 2012 to 2017. The global biomaterial market is broadly segmented into two categories, by type and by application. By type, it is broadly categorized into metals, ceramics, polymers and natural biomaterials. In 2012, the metal as a biomaterial accounted for largest market share in the global biomaterials market, followed by rapidly growing polymer biomaterials segment. Polymers are estimated to grow with a fastest growth rate during the forecast period of 2013 to 2019 owing to the increasing applications into healthcare and its unique material properties such as flexibility, biocompatibility and durability. Polymers are being used in a variety of implants such as percutaneous transluminal coronary angioplasty (PTCA) catheters, heart valves, contact lenses, intraocular lenses and for constructing rigid bases for dental prosthesis and dentures. Other applications in which polymers are used as biomaterials include urology and gastroenterology. The biomaterial applications market is broadly segmented into orthopedic, cardiovascular, neurological, dental, tissue engineering, wound healing, plastic surgery, ophthalmology and other applications such as gastrointestinal, urinary, bariatric surgery, and drug delivery system. In 2012, the cardiovascular biomaterial segment contributed 34.5% to the global biomaterial market, followed by the orthopedic segment which commanded major share in the global biomaterials market due to increasing number of hip and knee replacement performed across all geographies and increasing usage in sports medicine. However, ophthalmic applications are expected to propel the growth of biopolymers in particular as children, adults and elderly population is considered susceptible to ophthalmic disorders. Plastic surgery and wound healing applications are expected to witness the highest growth in the coming years. The biomaterial polymers market is expected to show the highest growth at a CAGR of 22.1% (2012-2017) due to tremendous ongoing research for the development of biodegradable and bio-compatible polymeric biomaterial and its use in a wide range of applications. In developed nations like the United States, Canada, Germany, France, the U.K., Italy and Spain, the market is witnessing growth owing to high adoption rate of medical implant procedures compared to sluggish adoption in other parts of the world. As the baby boomer population enters their sixties, the incidences for eye disorders, dental issues, bone-related diseases and fractures are increasingly becoming common in the U.S. creating demand for

biomaterials. The National Joint Registry reported that these replacement procedures are increasing. North America and Europe are expected to maintain their leading positions in the global biomaterials market throughout the forecast period from 2013 to 2019. However, countries in the Asia-Pacific such as Japan, South Korea, China, India and Taiwan are playing a key role in the growth of biomaterials market in the region. Due to rising awareness of biomaterial products in Asia, and increased conferences and collaborations, the Asian market is expected to grow at a CAGR of 21.5% from 2012 to 2017. Increasingly, biomaterial manufacturers are finding stiff competition in established markets in developed countries which have compelled them to focus on the underserved emerging markets. This approach will drive the biomaterials market in the Asia-Pacific and Latin American countries in the coming years. Some of the major companies operating in the biomaterials market include Biomet, Inc., AdvanSource Biomaterials Corporation, Celanese Corporation, Ceradyne, Inc., Collagen Matrix, Inc., DuPont, Royal DSM, Evonik Industries AG, Corbion Purac, and Invibio, Inc. Ageing population, worldwide increase in life expectancy due to improved healthcare continues to propel the medical implants market to alleviate increasing morbidity among geriatrics.

Shree Dye Stuff Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing)

According to the customer requirment • Flexible PVC tubing grade compound • Flexible PVC moulding grade compound • Flexible PVC tube for I.V. Set, S.V. Set, X-ray opeque tube and Oxygen tube. • Flexible PVC compound for Urine bag roll Contact Pragnesh Shah C-3 TPS 88, bharat Small Scale Industrial Area, B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Mobile : +91 98246 49740, +91 93761 82700, +91 90168 13881 E-mail : shreedyestuff@gmail.com, Pritishah777@gmail.com

Our First Priourity is Customer Satisfaction Mar.-Apr. 2015

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 : 28/29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (F) 22731656 (M) 9825474789 E-mail : sanidhya.ent@gmail.com Mar.-Apr. 2015

Industry News Medical Device Industry Welcomes Task Force’s Recommendations Welcoming Centre’s forward-looking recommendations for the industry, Association of Indian Medical Device Industry (AIMED) expressed relief that it will facilitate creation of vibrant eco-system for domestic manufacturing of medical device in the country. The association also pointed out that prompt and efficient implementation of the same can also help in reducing humungous import dependency in this sector, to aid India turn net exporter within a few years time. Ananth Kumar, Union minister for chemicals and fertilizers, had on Wednesday released the recomendations of the Task Force on medical devices industry. It is understood that the said recommendations has given due weightage to the long standing demands of the industry regarding financial support to manufacturing units, reversal of inverted duty structure, MRP based taxation system, etc. The highlight of the recommendations, according to industry experts is the decision

to create separate department and law book for medical devices, to give the required push for medical device manufacturing in the country. Rajiv Nath, forum coordinator of AIMED said, “We are very enthused by the recommendations of the task force on medical device industry as it sets a clear and definite road map for the industry. However, all said and done, these recommendations need to be supplemented with additional measures to fully realize the vision of ‘make in India’ and to become factory of the world.” He pointed that along with zero duty on raw materials, duty on finished imported goods also needs to be raised to maximum level to dis-incentivise imports and attract foreign investments in Indian manufacturing. While on the creation of new law book and rules for medical devices, Nath stressed that there must be an altogether new Act for medical devices rather than a new chapter being added to the existing Drugs and Cosmetics Act, 1940.

Industry strongly feels that that the new legislation must also ensure that traders and pseudo manufacturers are not permitted to pass-off as manufacturer. Sources emphasized that there must be separate departments for medical devices and pharmaceuticals working under the same ministry which could be called Ministry of Life Sciences or Ministry of Healthcare Products. Also that both departments should be under one coordinating minister to ensure faster decision making. Welcoming task force’s recommendation to have a new medical device parks, Nath pointed out that it was equally important that government invests in strengthening the infrastructure facilities at existing industrial parks. He expressed hope that government would go extra mile to see that task force recommendations are implemented at the earliest. Suja Nair Shirodkar Saturday, April 11,2015,08:00 Hrs [IST] (Ref : http://www.pharmabiz.com/ NewsDetails.aspx?aid=87704&sid=1)

Health Ministry Okays Plan To Monitor Medical Devices; Vigilance Cells To Be Set Up Nationwide After several horrific cases of malfunctioning medical de vices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning, the health ministry has approved a materio vigilance programme in an effort to ensure safety of medical devices.

Technical support for the programme is to be provided by the Division of Healthcare Technology, a proposed World Health Organisation collaborating centre for priority medical devices and health technology policy in the National Health Systems Resources Centre.

Despite being a $3.1 billion market for medical devices, India has no system for registering adverse events caused by medical devices or for tracking the safety record of medical devices and is dependent on data from the developed countries The proposed plan, to be coordinated by the Indian Pharmacopoeia Commission in Ghaziabad, envisages a nation-wide programme, involving district hospitals, medical colleges and corporate hospitals.

The Materio Vigilance Programme of India (MvPI) is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated here.

The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram is to be the national collaborating centre for the programme, which is to be run in collaboration with the Central Drug Standard Control Organisation (CDSCO).

The programme is meant to monitor medical device associated adverse events (MDAE), create awareness among health care professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices. It is also meant to generate independent, evidence based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

supposed to meet every three months to examine the reported adverse events and confirm the events to be reported to the drug committee. Based on these reports, a decision will be taken on whether any change is required in the labeling of the devices, or whether a recall or a ban on the product is called for. To begin with, MvPI cells are to be established in 10 medical colleges. These will be funded by the government to report online. The programme will be along the lines of the existing pharmacovigilance programme and haemovigilance programme. (Ref: http://economictimes.indiatimes. com/industry/healthcare/biotech/health care/health-ministry-okays-plan-tomonitor-medical-devices-vigilance-cellsto-be-set-up-nationwide/articleshow/ 46579794.cms)

The Pharmacovigilance Commission is Mar.-Apr. 2015

National Healthcare An ISO 9001 : 2008 Company

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

Injection Moulded Medical Components and Extended Tubes :

PACK-EQUIP (Mfg. Packaging Machinery) 91, Avnish Society, Opp. Pavitrakunj Society CTM Cross Road, Amraiwadi Ahmedabad-380 026 Phone : 25855027 (M) 9825380739

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

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

ISO : 13485 : 2012

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

CERTIFIED COMPANY

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

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850

E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Mar.-Apr. 2015

Events Medicall, India’s largest B2B Medical Exposition, is promoted by Dr. S Manivannan, founder director of Kauvery 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. In its 13th edition, Medicall has become a truly international show, with over 500 exhibitors from more than 20 countries and professional visitors exceeding 10,000. Medicall shows are held at Chennai and Mumbai. Come August, the medical fraternity embarks on it’s annual pilgrimage to Chennai, the Mecca of the medical legion. 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 uni-directional but highly interactive and responsive. The Interactive healthcare Intelligentsia at BrainStorm Medicall dishes out nuggets of wisdom in a nutshell.

Events Calender • Medical Fair India 2015 22st International Exhibition and Conference Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Mumai. • CMEF & ICMD (Spring) Date : May 15 – 18, 2015 Venue : Shanghai, China. The 73rd China International Medical Equipment Fair The 20th International Component Mfg.& Design Show • Medicall 2015 14th Edition Medicall 2015. Date : 9th - 11th October, 2015. Venue : Bombay Convention and Exhibition Center • Plastivision Arabia 2016 Region’s Leading Plastics Event Date: 10-13 January, 2016 Venue: Expo Center, Sharjah. • 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. Date: 12-13 February, 2016 Venue: Ahmedabad Management Association, Ahmedaad.

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

Mar.-Apr. 2015

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 Mar.-Apr. 2015

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Operon

Mar.-Apr. 2015

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

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

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Anil Gupta +91-90999 15731 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 Mar.-Apr. 2015

GMP ISO - 9001-2008 Certified Company

S. Nath & Co.

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

•

I.V. Infusion Sets

•

Blood Administration Sets

•

Scalp Vein Set

Excellence in Quality

•

Urine Collection Bags

Manufacturer & Exporter of Surgical Disposable Products since 1980

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

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

BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.

BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com Mar.-Apr. 2015

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

Venus manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set, X-Ray Opaque Tubes • L. D. Tube For Carman Cannula • P. P. Stick For Urinbag. • Henging Tube For Urinebag

Venus

MEDICAL DISPOSABLE 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. Phone (F) : 079-22749329 (R) : 079-26621269 Mobile : 098240 32063 E-mail : vs.6163@rediffmail.com 39

SHAILESH SURGICAL Leading Manufacturers and Exporters of Surgical Disposable Products PRODUCTS MANUFACTURED ISO 9001

REGISTERED

0434

• • • • • • • • • • • •

I.V. INFUSION SETS SCALP VEIN SETS BLOOD ADMINISTRATION SETS BLOOD DONER SET URINE COLLECTION BAG RYLES/FEEDING TUBES DISPOS ABLE SYRINGES & NEEDLES DISPOSABLE GLOVES SURGICAL DRESSINGS ADHESIVE TAPES PLASTER OF PARIS FORMULATIONS Office: L-8, “Manhattan”

Near Lion’s Hall, Mithakhali, Ellisbridge, Ahmedabad-380 006, India

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

Phone: (91-079) 26420281, 26440236

Manufacturer And Exporter Of a wide range Of Medical Devices

Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

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

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

Mar.-Apr. 2015

Medical Plastics Data Service Magazine March - April 2015

Articles inside

Global Trends

Product Gallery

Cover Story