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 Manufacturing of High End nous Facilitating Medica Body for Indige Infrastructure Validation l Devices Centers Administrative Med Tech CoEs Regulatory Department Parks Body (DoP&M) Skill R&D Manufacturing Development Capability Hubs Incubation Skill Development Centers Committee Also : Drug Device Combination Products – Market Review and Future Trends International Component Manufacturing & Design Show An Authentic Portal Site On Medical Technology And Markets In Asia 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
CToabnletoef nts Vol. 23 No. 2 Mar.-Apr. 2015 22 Cover Story 27 • 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 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 • 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 Mar.-Apr. 2015 17
Flashback ?YoDKuindow ? Nov. - Dec. 2002 About Challenges Of Using Combination Products From Editor’s Desk Combination products have numerous advantages but convergent technologies also have Dear Readers, many perceived risks. Industry experts recommend avoiding combination products unless there are no alternatives. About 60 Indian Medical Device Companies exhibited Converging genomics, diagnostics and therapies lead to personalized medicine but many in the “MEDICA2002” trade show held in Dusseldorf hurdles scientific, regulatory, financial etc. must be overcome. (Germany) in November. This is indicative of the Another issue is changing regulatory environment. Historically medical devices and growing competence of Indian Companies for the pharmaceutical sectors are operated under different sets of regulations in most developed Global Markets. Many more companies will follow in countries. Regulators are now reviewing existing regulatory pathways as great number of the coming years. It is therefore appropriate that our innovative combination products appear on the market and in R&D pipeline offering challenges magazine “MEDICAL PLASTICS DATA SERVICE” for any regulatory agency because of differing views of timelines, policies, development cycles and the medical technology portal web site, and multiplicity of configurations. The normal review paradigm is difficult to apply to combination www.medisourceasia.com , covers issues relevant for products because of their interactions. the Global Markets. The third is product development path wherein integration of research stage combination technologies & product development program is risky and tends to entail higher development This issue covers presentation by Dr S N Pal on “CE and manufacturing costs. In addition, using components from disciplines not part of the core Marking”. The letters CE ( French for “ European business require complex management structures and collaboration with unfamiliar business Conformity” ) indicate that a product confirms to the partners. This complexity, combined with higher costs of regulatory compliance, slows the European applicable and legal demands , in terms of introduction and increases the entry costs of new technologies. safety, health , environment and consumer protection. Final concern is patient compliance. The drug-eluting stent is one such example where patients CE marking can be seen as sort of a passport that who receive stents without a drug coating have an occlusion of the vessel within 6 months, allows manufacturers to circulate their products freely whereas rest enosis rates for patients with drug-eluting stents are in the low single digits. within the internal market of the EU. However, current drug-eluting stent treatments require long-term anti-platelet therapy—an off- label use for drug manufacturers. The result may be problems with patient compliance and an Exporters to European Union need information to increased risk of heart attacks. formulate their market and product strategies. CBI, It should thus be emphasized that adoption of convergent technologies and their increasing the Centre for the Promotion of Imports from benefits will be accompanied by emergence of new risks. developing countries has published “EU Market Survey 2002” for Medical Devices and Medical Ref: http://www.nature.com/nbt/journal/v24/n3/full/nbt0306-277b.html Disposables. The emphasis of the survey lies on those products, which are of importance to developing In a country suppliers. Abstracts from the report is also Nutshell.... highlighted in this issue. “It takes Considerable Knowledge Important contents of this magazine are also put on Just to realize The extent of your our web site, www.medicalplasticsindia.com. Own Ignorance” CONTENTS - Albert Einstein • Cover Story - CE Marking of Medical Devices • Global Trends - EU MARKET SURVEY - Medical Mar.-Apr. 2015 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 18
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) Indian Medical Device Manufacturing Industry : The Driver For “Make In India “ Compaign EDITORIAL ADVISORY BOARD As per Mr. Rajiv Nath, Forum Coordinator, AIMED, “ Make In India Idea is simple ,yet powerful and visionary”. Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) A Task Force on “ Promotion of Domestic Production Of High-End Medical Devices Cancer & Reconstructive Surgeon 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 Mr. C. BALAGOPAL India “. As detailed in this issue of our magazine , the Task Force has recommended Director - Enter Technologies Pvt. Ltd. measures to enhance policy and Institutional Support; fiscal and financial support as Chairman - Mobilexion Technologies Pvt. Ltd. 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 Trivandrum 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 Dr. DILIP H. RAIKER first such park will come up in Gujarat soon. NIPER Ahmedabad, will be the nodal Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Institute to undertake Research & Development. DoP has has already taken up issues Former Chief Manager(P), CIPET - Chennai 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 ING LOUIS C. SUHUURMAN handle the issues of facilitation and regulation of high end medical devices. Formerly Sales Director This issue also introduces the newly emerging innovative medical products – the COLPITT B.V., Holland Combination Products - with technologies that combine drugs, devices, and/or biological products . These products are expected to have major impact on the overall medical Dr. A.V. RAMANI device market. One more market analysis under the “Global Trends” column in this Group Sr. Vice President (R&D), The TTK Group 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 Dr. C.S.B. NAIR due to the increasing applications into healthcare and its unique properties such as Director (R&D), Peninsula Polymers Ltd flexibility , biocompatibility and durability. For the information of our readers , the International Component Manufacturing & Dr. BHARAT GADHAVI Design Show ( ICMD ) to be held simultaneously with CMEF in Shanghai , China CEO, Medisurge Hospitals 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, Mr. A.S. ATHALYE Components , Manufacturing Equipments, Technology along with a wide range of related Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Products & Services. Dr. SUJOY K. GUHA 19 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: [email protected] Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-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
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Cover Story Promotion of Domestic Production of High End Medical Devices The Government is going to set up Medical Devices Parks ‘Medical Devices’ together, India is importing around 69% of its total requirement. The imports of high-end Medical devices are in the country, and first such park will come up in Gujarat much higher, going up to around 87% for the category of Medical Electronics, Hospital Equipment, Surgical Instruments. In view soon. The Union Minister of Chemicals and fertilizers Shri of the prevailing scenario, the Task Force on ‘Promotion of Ananth Kumar said this while releasing the Domestic Production of recommendations of the Task Force on Promotion of High-end Medical Devices Domestic and Pharmaceutical Production of Manufacturing Equipment’ was High End Medical set up by the Department of Devices & Pharmaceuticals as an initiative to Pharmaceutical implement the PM’s visions of Manufacturing ‘Make in India’. The Task Force Equipment. He was headed by S e c r e t a r y, said that only 30% Department of Pharmaceuticals of the country’s and consisted of representatives requirement of from Planning Commission, Medical Devices is Department of Health & Family being met through Welfare, Department of Health Research, DCGI, Department of indigenous Commerce, Department of Industrial Policy and Promotion, Department of Electronics and Information Technology and production, and various Industry Associations including AIMED, CII, FICCI, ASSOCHAM, FOPE etc. that of low end The Task Force has given recommendations to address category. The concerns and constraints facing the sector and suggested measures that would augment domestic production of medical Minister said that devices. The Task Force has recommended measures to enhance policy and institutional support; suggested the Government strengthening of infrastructural support; and, recommended fiscal and financial support to the sector. In is taking several addition, the Task Force has also recommended measures for creating an institutional set-up for efficacy & safety steps to boost the testing, promoting skill development aligned to the need of the industry, strengthening the R&D Capability of the sector, domestic pricing strategy for the sector and conducive regulatory environment. production of Reference : high end medical Press Information Bureau Government of India devices & Ministry of Chemicals and Fertilizers http://pib.nic.in/newsite/PrintRelease.aspx?relid=118080 pharmaceutical Mar.-Apr. 2015 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 22
Cover Story The Medical Devices Sector in India; Task Force Recommendations Background The need to address various basic concerns facing the industry Medical devices’ industry is a multi-product industry, producing including human resources, finance, market, ease of doing wide range of products. Manufacturing and trade in medical business, promotion of R&D and innovation etc was identified. devices is also growing quite steadily. Double digit growth rates Specific issues that have to be deliberated upon intensively were indicate its importance in health care. Medical devices’ industry identified and more focused sub-groups were formed to address mostly depends on imports. Most hi- tech innovative products these issues including : and technology originate from a well developed eco-system and innovative cycle which needs to be developed in India to promote Sub-group 1: Sector overview indigenous industry and to reduce our dependence on imports. Sub-group 2: Policy & Infrastructure Sub-group 3: Regulatory The ‘Make in India’ campaign of Hon’ble Prime Minister Narendra Modi’s government has a mandate to boost the medical device All the recommendations from different sub-groups were manufacturing sector in India for all types of medical devices reviewed, collated and a concise actionable set was created. and equipments used in manufacturing of Pharmaceuticals. To However participation of the industry / stakeholders from implement the initiative a Task Force was constituted under the manufacturing equipment used in pharmaceutical was lacking chairmanship of the Secretary, Department of Pharmaceuticals and the Task Force did not receive inputs from them despite all (DoP) to address issues relating to the promotion of domestic attempts. production of high end medical devices and pharmaceutical manufacturing equipment in the country. The Terms of Reference An overview of the device industry and the different elements (ToR) for the Task Force is given in the detailed report. 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 diagnostic services and devices like Cardiac imaging, CT scans, to the rest of manufacturing industry, though India is one of the X-ray, Molecular Imaging, MRI and Ultrasound-imaging including top twenty markets for medical devices in the world and is the hand - held devices. 4th largest market in Asia after Japan, China and South Korea. Although accurate data is not available, an educated guess would • Life Support: place the retail market at Rs. 60,000-70,000 Crores. As life support technologies evolve and improve, use of equipments like ventilator and automated external defibrillator Segments outside of the hospital environment has increased. Also, as The Medical Devices market can be classified into two major consumer spending power increases demand for such systems categories: is expected to grow. • Devices that do not require any external energy source. b. Implants • Devices that require external energy source to be operational The market for implants is witnessing some amount of innovations in terms of catering to large unmet needs in certain (powered). disabilities e.g. blindness. A microchip retina implant is under Powered devices are further divided into three product trial which will allow blind patients to read letters & recognize categories: foreign objects. a. Equipments, c. Disposables b. Implants, and Medical disposable products for medical electronic equipment c. Disposables. are used by all hospitals and private nursing homes in the country, including diagnostic and pathological laboratories. The market a. Equipments is becoming increasingly competitive due to low entry barriers Equipments account for the largest share of the total market (for MNCs), increasing number of players and an expanding followed by medical implants and disposable segments consumer base. Examples include disposable medical and respectively. This segment is also the fastest growing and is electronic probe assemblies for minimally invasive applications, largely dependent on imports currently. disposable catheter cables, disposable EEG sensors/lead wires, disposable SpO2 sensors, panel mount receptacles, etc. This can be further segmented into the following categories – Present status • Surgical Equipments : During the period 2011-12 to 2014-15 both import and export of Prominent factors that drive demand are advancements in medical devices have grown at more than 10% rates. surgery and surgical device designs, availability of high skilled surgeons, growing breed of corporate hospitals and advanced Import as well as export of Medical Electronics and Hospital surgical facilities like advanced robotics, minimally invasive Equipment has been the highest amongst all the devices in terms surgical techniques and imaging. of value. Along with surgical instruments they form more than 50% of total sales with majority being imported (87.4%). • Diagnostics: Increase in the prevalence of diseases, their complexity and the need for quick diagnosis has created a high demand for Mar.-Apr. 2015 23
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 Factors driving the growth of medical devices sector Imported Medical Devices in India in 2013-14 (All values in Rs. Crore) 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 departments as well as Industry. 2. Preferential treatment in government procurement 24 Mar.-Apr. 2015
Cover Story Product Gallery Infrastructure 2015 Qosina Catalog with Thousands of Stock Components 1. Set up manufacturing hubs/ clusters in PPP mode Edgewood, NY 2. Set up Medical device parks April 16, 2015 - The New 2015 3. Financing support and Other support Qosina Catalog offerseasy Facilities for efficacy and safety testing browsingof thousands of stock 1. Medical device testing centers should be set up preferably in components on a one-centimeter grid. the PPP mode Qosina has the largest selection of 2. Designate “Centers of Excellence” (CoE) for supporting parts for the medical OEM, kit packer and product development and validation pharmaceutical industries, offering free samples, low minimums, and Just- 3. Strengthen a made in India marking (BIS) specific to Medical in-Time (JIT) delivery. The vast product range, along with complimentary samples, makes Qosina the first stop for devices all design engineers and purchasing agents who are sourcing components for current and future projects. Skill development Qosina offers high volume pricing discounts and supply chain management services. Set up a Skill development committee with representatives Featuresof the new catalog include a category structure from Medical devices industry, academia (NIPERs) and based on product function, a robust index to effortlessly find components by application or keyword, and more Healthcare Sector Skill Council (HSSC) under National Skill products in fewer pages with easy to read tables, while maintaining life size images. To request a copy for your Development Council (NSDC). reference shelf, contact a Customer Specialist at +1 (631) 242-3000, [email protected] or visit our website at R&D capability www.qosina.com. 1. Set up a system for IP exchange Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and 2. Set up/ promote Incubation centers pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, 3. Provide requisite financing support hemostasis valves, tuohy borst adapters, swabs and spikes. Qosina operates an ISO 9001 and ISO 14001 4. Promote industry specific “independent software vendor” by registered facility. extending similar benefits. Call our Customer Specialists to request samples, obtain our latest catalog or place and order via phone +1 (631) Policy for pricing 242-3000, fax +1 (631)-242-3230 or e-mail [email protected]. Visit us at www.qosina.com to see our 1. Separate price control order for medical devices latest products. Custom sourcing services are available through our extensive network. 2. Price control body 3.Pricing & reimbursement policy Contact:David Walker Duty structure QOSINA Tax/ duty structure to be designed to promote local manufacturing 150-Q Executive Drive Edgewood, NY 11717 of quality medical devices and diagnostic equipment. Phone: +1 (631) 242-3000 Fax: +1 (631) 242-3230 1. Discounts on import duties Email: [email protected] 2. Restrictions on import of second hand diagnostic equipment. 25 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
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 bio- medical 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. 26 Mar.-Apr. 2015
Market Drug Device Combination Products : Market Review and Future Trends What Are Combination Products? incidence rates of chronic pain causing diseases, prostate cancer, diabetic retinopathy, cardiovascular diseases, colorectal cancer, The therapeutic and diagnostic products that combine drugs, asthma, obesity along with rapidly aging global population also devices, and/or biological products are called combination form the key drivers for the global drug device combination products and can include following types: drug-device, biologic- products market. device, drug-biologic and drug-device-biologic. These products have emerged as innovative medical products due to their The following scenarios regarding drug/device combinations contribution in advancing medical care and are thus expected approval may take place: to have major impact on the overall medical devices market. • The device and drug are approved and on the market For example, smart implants may provide a means of remotely individually. monitoring and managing therapeutic dosing; in turn, wireless communication with implants may allow health care services for - When the drug and the device are both approved, the chronic disease to shift from the hospital to the home setting. biocompatibility of the device and the toxicology of the pharmaceutical are known. It must be shown that the stability Market Review and bioavailability of the drug have not been compromised by the new drug-device combination. The global drug device combination products market has been differentiated into eight segments based on the product types. • The device is approved, but the drug is not approved. The major product types include drug eluting stents, prefilled - When the device is approved and the drug is not, the drug will syringes, antimicrobial-coated catheters, co-packaged products that are required to be delivered sequentially for therapeutic effect, need to go through the extensive evaluations typically done and infusion pumps, photo sensitizers, orthopedic combination for a new drug product, plus those studies indicated in the products, wound care combination products, inhalers, transdermal first scenario above. patches and others which include intraocular implants and drug • The device is not approved, but the drug is approved. eluting beads. The global drug device combination products market - Most of these devices today fall into a category where a known was valued at USD 66 billion in 2012 and is expected to grow at drug is available but the delivery system needs enhancement a CAGR of 7.9% from 2013 to 2019, to reach an estimated value to achieve improved therapy. of USD 115billion in 2019 according to the Transparency Market • Neither the device nor the drug is approved. Research report. - In this scenario, when neither drug nor device is approved, significant device evaluations (IDE, PMA) and drug evaluations Geographi- (IND, NDA) will be required. cally, North Depending upon the exact nature of the device, a range of America biological effects may need evaluation per ISO 10993. First dominated consideration should be given to vertical standards (an FDA the global guideline or ISO standard in use for a specific device). In the drug device absence of such guidance, ISO 10993-1 should be consulted to combination determine areas of concern for these devices. products market and Future Trends is expected to continue to The anticipated developments in the device combination product lead in terms category between now and 2020 will lead to new clinical products. of revenue generation Three types of developments are expected. throughout the forecast period. The market in North American region was 1 First, additional products designed for implanted delivery of valued at USD 28.5 billion in the year 2012. Asia-Pacific is con- insulin and other drugs. sidered as the most lucrative market for drug device combi- nation products owing to the increase in incidences of car- 2 Second, new developments in drug impregnated devices are diovascular diseases, diabetes related disorders and obe- expected. sity through 2019. 3 Finally under development are new developments in drug The leading players in the market for drug device combination delivery systems to simplify reliable use by unsophisticated products are Abbott Laboratories, Inc., Medtronic, Inc., Boston patients in home settings, including the increasing elderly Scientific Corporation, CareFusion Corporation, Allergen, Inc. and population. others. It is expected that in the future large numbers of combination products will be filed as technological advances continue to ‘unite’ Major Growth Drivers different product types and thereby effectively ‘blur’ the historical lines of separation between FDA’s medical product centers, i.e., Various emerging technologies such as implants with drugs to the Center for Biologics Evaluation and Research (CBER), the permit faster healing, relief from pain and decreased morbidity Center for Drug Evaluation and Research (CDER), and the Center currently form the major driver for the growth of this market. High 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. Mar.-Apr. 2015 27
VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are a leading Consulting organization providing an integrated services with We are entrusted with the responsibility to manage in India on focus on project technology : behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Quality Management System as per Accredited. ISO 9001, ISO 13485, Medical Devices We are involved on the certification activities in the following CE marking as per MDD/93/42, FDA areas : 510k, Audit, Documentation, training • ISO 9001:2008 - QMS and c-GMP. • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS Sanjay Y .Shah – Owner Promoter • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS M : +91 98240 17850 • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing Obelis European • CE Marking • GMP Authorized Representative Center (O.E.A.R.C) based in We have collaboration with European Notified Body for CE Mark- Brussels, Belgium since 1988 is one of the largest ing & SA 8000 certifications. Regulatory Centers in Europe, assisting non-European We have assisted over 6500 clients all over the country, as an manufacturers’ successful endeavors into Europe. expansion plan we also require well qualified personnel’s in vari- ous districts to conduct the audits and provide after sale services, F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. for Business Associates kindly apply for your location with com- Tel. : +91 79 66090225 E-mail : [email protected], [email protected] plete details. Business Plan preferred. Website : www.unikalindia.com For further details OR clarification pleases contact : Virtue Certification Systems Pvt. Ltd. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Sama Road, Vadodara – 390008. Gujarat. Ph. : 91-265 – 2794158 / 98250 43523 Email: [email protected] OR [email protected] Products GMP. & ISO 9001 – 2000 Certified Company • Flexible Packaging Material • Paper Pouch AMIGO SURGI CARE PVT. LTD. • Aluminium Foil • Foil Seal Manufacturer of • Ribbon Pack Pouch Disposable Surgical Products: Contact : I.V.CANNULAS / B.T.SETS / I.V.SETS / Jignesh Patel : +91 94265 25388 SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE +91 90163 36699 VOLUME SETS ETC. Kavya Packaging Manufacturers / Exporters / Hospital Suppliers Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Dealer are requested to Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : [email protected] Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) 28 (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • [email protected] • [email protected] 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 IV Manufacturer & Exporter of Medical Manufacturers and Suppliers of Medical Disposable Devices & Surgical Products Disposable & Surgical Products Range of Products : • Blood Transfusion Set Product Range: • Infusion Set • Measured Volume Set • TRANSFUSION / DIALYSIS RANGE • Microdrip Infusion Set • Gloves (Rubbers) • UROLOGY RANGE • Urine Collection Bag • GASTRO - ENTROLOGY RANGE • Cord Clamp (Sterile & Non Sterile) • ANAESTHESIA RANGE • Infant Mucus Extractor • SURGERY RANGE • MISCELLANEOUS RANGE NOVA MEDICAL DEVICES Contact Person : Specialized in Handling Large Quantity & Contract Manufacturing N. A. Patel (Managing Director) Anant Patel (Manager) +91 99253 72428 +91 95589 44364 +91 94081 42799 Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL 6/7, F/F, Maruti Industrial Estate, Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Nr. Sindhvaimata Temple, Ramol Road, C.T.M. Cross Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Road, Ahmedabad-380 026 (India) Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Phone : 079-2585 0383 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 E-mail : [email protected] [email protected] Website : www.novamedicaldevices.com A NMD GROUP OF COMPANY Mar.-Apr. 2015 29
Global Trends Global Biomaterials Market For Implantable Devices Driven By Polymers Biomaterials are either of synthetic or natural origin used in biomaterials. The National Joint Registry reported that these effective treatment of several diseases such as cardiovascular, replacement procedures are increasing. North America and dental problems, tissue damage, bone cancer and orthopedic Europe are expected to maintain their leading positions in injuries. These biomaterials have a key requirement of being the global biomaterials market throughout the forecast period biocompatible i.e. they should be physiologically acceptable and from 2013 to 2019. not provoke any immunogenic reaction in the human body. Biomaterials of significant importance which have been proven to However, countries in the Asia-Pacific such as Japan, South be safe, reliable, and affordable include ceramics, metals, polymers Korea, China, India and Taiwan are playing a key role in the and biomaterials derived from natural origin. growth of biomaterials market in the region. Due to rising awareness of biomaterial products in Asia, and increased The global biomaterials market is estimated to be worth conferences and collaborations, the Asian market is expected to US$88.4 bln by 2017 as per Markets and Markets. The market grow at a CAGR of 21.5% from 2012 to 2017. Increasingly, estimated at US$44 bln in 2012 and is poised to grow at a CAGR biomaterial manufacturers are finding stiff competition in of 15% from 2012 to 2017. The global biomaterial market is established markets in developed countries which have compelled broadly segmented into two categories, by type and by application. them to focus on the underserved emerging markets. This By type, it is broadly categorized into metals, ceramics, polymers approach will drive the biomaterials market in the Asia-Pacific and and natural biomaterials. In 2012, the metal as a biomaterial Latin American countries in the coming years. Some of the major accounted for largest market share in the global biomaterials companies operating in the biomaterials market include Biomet, market, followed by rapidly growing polymer biomaterials segment. Inc., AdvanSource Biomaterials Corporation, Celanese Polymers are estimated to grow with a fastest growth rate Corporation, Ceradyne, Inc., Collagen Matrix, Inc., DuPont, Royal during the forecast period of 2013 to 2019 owing to the DSM, Evonik Industries AG, Corbion Purac, and Invibio, Inc. increasing applications into healthcare and its unique material properties such as flexibility, biocompatibility and durability. Ageing population, worldwide increase in life expectancy due to Polymers are being used in a variety of implants such as improved healthcare continues to propel the medical implants percutaneous transluminal coronary angioplasty (PTCA) catheters, market to alleviate increasing morbidity among geriatrics. 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 Shree Dye Stuff orthopedic, cardiovascular, neurological, dental, tissue engineering, wound healing, plastic surgery, ophthalmology and Manufacturer of PVC Compound, other applications such as gastrointestinal, urinary, bariatric (Surgical Grade, Molding & Tubing) surgery, and drug delivery system. In 2012, the cardiovascular biomaterial segment contributed 34.5% to the global According to the customer requirment biomaterial market, followed by the orthopedic segment • Flexible PVC tubing grade compound which commanded major share in the global biomaterials • Flexible PVC moulding grade market due to increasing number of hip and knee replacement performed across all geographies and increasing usage in compound sports medicine. However, ophthalmic applications are expected • Flexible PVC tube for I.V. Set, S.V. Set, to propel the growth of biopolymers in particular as children, adults and elderly population is considered susceptible to ophthalmic X-ray opeque tube and Oxygen tube. disorders. Plastic surgery and wound healing applications are • Flexible PVC compound for Urine expected to witness the highest growth in the coming years. bag roll The biomaterial polymers market is expected to show the highest growth at a CAGR of 22.1% (2012-2017) due to Contact Pragnesh Shah tremendous ongoing research for the development of biodegradable and bio-compatible polymeric biomaterial and C-3 TPS 88, bharat Small Scale Industrial Area, its use in a wide range of applications. In developed nations B/h Gujarat Offset, Narol - Vatva Road, like the United States, Canada, Germany, France, the U.K., Italy Ahmedabad - 382 445 and Spain, the market is witnessing growth owing to high Mobile : +91 98246 49740, +91 93761 82700, adoption rate of medical implant procedures compared to sluggish adoption in other parts of the world. As the baby +91 90168 13881 boomer population enters their sixties, the incidences for eye E-mail : [email protected], disorders, dental issues, bone-related diseases and fractures are increasingly becoming common in the U.S. creating demand for [email protected] Our First Priourity is Customer Satisfaction 30 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 : [email protected] Mar.-Apr. 2015 31
Industry News Medical Device Industry Welcomes Task Force’s Recommendations Welcoming Centre’s forward-looking to create separate department and law Industry strongly feels that that the new recommendations for the industry, book for medical devices, to give the legislation must also ensure that traders Association of Indian Medical Device required push for medical device and pseudo manufacturers are not Industry (AIMED) expressed relief that it will manufacturing in the country. permitted to pass-off as manufacturer. facilitate creation of vibrant eco-system for Sources emphasized that there must be domestic manufacturing of medical device Rajiv Nath, forum coordinator of AIMED separate departments for medical devices in the country. The association also pointed said, “We are very enthused by the and pharmaceuticals working under the out that prompt and efficient implementation recommendations of the task force on same ministry which could be called of the same can also help in reducing medical device industry as it sets a clear Ministry of Life Sciences or Ministry of humungous import dependency in this and definite road map for the industry. Healthcare Products. Also that both sector, to aid India turn net exporter within However, all said and done, these departments should be under one a few years time. recommendations need to be coordinating minister to ensure faster supplemented with additional measures to decision making. Ananth Kumar, Union minister for fully realize the vision of ‘make in India’ and chemicals and fertilizers, had on to become factory of the world.” Welcoming task force’s recommendation to Wednesday released the recomendations have a new medical device parks, Nath of the Task Force on medical devices He pointed that along with zero duty on raw pointed out that it was equally important that industry. It is understood that the said materials, duty on finished imported goods government invests in strengthening the recommendations has given due weightage also needs to be raised to maximum level infrastructure facilities at existing industrial to the long standing demands of the to dis-incentivise imports and attract foreign parks. He expressed hope that government industry regarding financial support to investments in Indian manufacturing. While would go extra mile to see that task force manufacturing units, reversal of inverted on the creation of new law book and rules recommendations are implemented at the duty structure, MRP based taxation system, for medical devices, Nath stressed that etc. there must be an altogether new Act for earliest. medical devices rather than a new chapter The highlight of the recommendations, being added to the existing Drugs and Suja Nair Shirodkar according to industry experts is the decision Cosmetics Act, 1940. 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 Technical support for the programme is to supposed to meet every three months to malfunctioning medical de vices, like babies be provided by the Division of Healthcare examine the reported adverse events and being burnt to death due to short circuits in Technology, a proposed World Health confirm the events to be reported to the incubators or hip implants causing blood Organisation collaborating centre for drug committee. Based on these reports, poisoning, the health ministry has approved priority medical devices and health a decision will be taken on whether any a materio vigilance programme in an effort technology policy in the National Health change is required in the labeling of the to ensure safety of medical devices. Systems Resources Centre. devices, or whether a recall or a ban on the product is called for. Despite being a $3.1 billion market for The Materio Vigilance Programme of India medical devices, India has no system for (MvPI) is meant to enable safety data To begin with, MvPI cells are to be registering adverse events caused by collection in a systematic manner so that established in 10 medical colleges. These medical devices or for tracking the safety regulatory decisions and recommendations will be funded by the government to report record of medical devices and is dependent on safe use of medical devices for India online. The programme will be along the on data from the developed countries The could be based on data generated here. lines of the existing pharmacovigilance proposed plan, to be coordinated by the programme and haemovigilance Indian Pharmacopoeia Commission in The programme is meant to monitor programme. Ghaziabad, envisages a nation-wide medical device associated adverse events programme, involving district hospitals, (MDAE), create awareness among health (Ref: http://economictimes.indiatimes. medical colleges and corporate hospitals. care professionals about the importance of com/industry/healthcare/biotech/health MDAE reporting in India and to monitor the The biotechnology wing of the Sree Chitra benefit-risk profile of medical devices. It is care/health-ministry-okays-plan-to- Thirunal Institute of Medical Sciences and also meant to generate independent, monitor-medical-devices-vigilance-cells- Technology in Thiruvananthapuram is to be evidence based recommendations on the the national collaborating centre for the safety of medical devices and to to-be-set-up-nationwide/articleshow/ programme, which is to be run in communicate the findings to all key 46579794.cms) collaboration with the Central Drug stakeholders. Standard Control Organisation (CDSCO). The Pharmacovigilance Commission is 32 Mar.-Apr. 2015
PACK-EQUIP National Healthcare (Mfg. Packaging Machinery) An ISO 9001 : 2008 Company 91, Avnish Society, Opp. Pavitrakunj Society Manufacturing & Exports of CTM Cross Road, Amraiwadi Medical Disposables : Ahmedabad-380 026 I.V. Set, B.T. Set, Urine Bag, Phone : 25855027 (M) 9825380739 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 : [email protected] 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: [email protected] • Web: www.jimitsurgicals.com Mar.-Apr. 2015 33
Events Medicall, India’s largest B2B Medical Events Calender Exposition, is promoted by Dr. S Manivannan, founder director of Kauvery • Medical Fair India 2015 Hospitals. Early in his career, he identified 22st International Exhibition and Conference that nursing homes, small clinics and hospitals in tier 2 and 3 Date: 11-13 March, 2016 cities faced a distinct disadvantage in the market while procuring Venue: Bombay Convention & Exhibition Center, consumables and equipment for their business. They neither had Mumai. the choice nor the price advantage enjoyed by the biggies. Thus Medicall was born. • CMEF & ICMD (Spring) Date : May 15 – 18, 2015 In its 13th edition, Medicall has become a truly international show, Venue : Shanghai, China. with over 500 exhibitors from more than 20 countries and The 73rd China International Medical Equipment Fair professional visitors exceeding 10,000. Medicall shows are held The 20th International Component Mfg.& Design Show at Chennai and Mumbai. • Medicall 2015 Come August, the medical fraternity embarks on it’s annual 14th Edition Medicall 2015. pilgrimage to Chennai, the Mecca of the medical legion. A perfect Date : 9th - 11th October, 2015. getaway to meet one’s peers, to compare and choose equipment Venue : Bombay Convention and Exhibition Center and best of all to refresh the knowledge base in the intellectually stimulating BrainStorm Medicall. A favourite with many • Plastivision Arabia 2016 International product companies, Medicall has these come Region’s Leading Plastics Event repeatedly to widen their dealer and distributor base. Diversity is Date: 10-13 January, 2016 a given in this expo. Venue: Expo Center, Sharjah. The show stoppers of Medicall are its seminars and workshops. • 13th National Conference And Technology Exhibition on Much care is put into this section to ensure they are not didactic Indian Medical Devices & Plastics Disposables / and uni-directional but highly interactive and responsive. Implants Industry 2016. Date: 12-13 February, 2016 The Interactive healthcare Intelligentsia at BrainStorm Medicall Venue: Ahmedabad Management Association, dishes out nuggets of wisdom in a nutshell. 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 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com 34 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. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] Mar.-Apr. 2015 35
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: 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 : [email protected] • [email protected] Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Anil Gupta +91-90999 15731 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com 38 Mar.-Apr. 2015
GMP MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS ISO - 9001-2008 Certified Company • I.V. Infusion Sets • Blood Administration Sets S. Nath & Co. • Scalp Vein Set • Urine Collection Bags Excellence in Quality • Ryles / Feeding Tubes • Catheters and Tubes Manufacturer & Exporter of • Surgical Gloves. Surgical Disposable Products since 1980 Contact : IDEAL® Mr. Bhavin Shah • Infusion Set MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • Blood Administration Set • Urine Collection Bag 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi • Urine Specimen Container Mill, Narol - Isanpur Highway, Narol, • Umblical Cord Clamp Ahmedbad-382405. (India) Phone : (O) 079- Address 25733318 (R) 079-25430211 (M) +91-9825018952 S. Nath & Co. Email : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Website : www.mescosurgical.com Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] Venus manufacturers PVC COMPOUNDS according to the customer requirements of BASIL manufacturers PVC COMPOUNDS ac- strength, flexibility, x-ray traceability, transpar- cording to the customer requirements of strength, flexibility, x-ray traceability, transpar- ency, colour and extraction resistance. ency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE are pa- tronized by Health Care Industries For BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible Extrusion Grade PVC Compounds • Flexible PVC Tube For I.V.Set, S.V.Set, X-Ray • 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 Opaque Tubes • P. P. Stick For Urinbag. • Flexible PVC Layflate Film For Medical PVC Bags • Henging Tube For Urinebag • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound Venus • Injection Moulded Parts like PVC Chambers, Roller MEDICAL DISPOSABLE Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products. 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. BASIL POLYMERS Phone (F) : 079-22749329 3-B, Verdan Exclusive, Near Stadium Petrol Pump, (R) : 079-26621269 P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Mobile : 098240 32063 Phone : 079-26565981 - 82 - 83 E-mail : [email protected] Mobile : 9909036411 / 9824045178 39 E-mail : [email protected] www.basilpolymers.com Mar.-Apr. 2015
SHAILESH SURGICAL Leading Manufacturers and Exporters of Surgical Disposable Products PRODUCTS MANUFACTURED ISO 9001 • I.V. INFUSION SETS • SCALP VEIN SETS REGISTERED • BLOOD ADMINISTRATION SETS • BLOOD DONER SET 0434 • 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 Phone: (91-079) 26420281, 26440236 Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Products available with CE marking Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, REGISTERED FIRM 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 Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com 40 Mar.-Apr. 2015
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