Table of
Contents Vol. 23
No. 3
May-June 2015
22 Cover Story
• Medical Device Manufacturing: Components Bonding and Joining Techniques - Medical devices in every aspect of their production demand highest level of quality. Reliability, and reproducibility. The assembly of sub components are also critical in manufacturing of Medical products. The bonding and joining technique must not interfere with the function or standards applied to Medical Device. The methods for joining plastics and composites can be divided into following major categories..........
26 Manufacturing Policy • National Medical Device Authority (NMDA) - Recommended By Task Force To Strengthen “Make In India” Drive - The Department of Pharmaceuticals will within six months, bring a detailed proposal for creation of the National Medical Devices Authority with vision, mission, objectives, constitution…….
28 Product Gallery • New Kynar® Connectors from Qosina
31 Global Trends • Medical Disposables Market Worth $245 Billion By 2018 - Global medical disposables market will be dominated by 10 largest national markets, combining to absorb over two-thirds of the total value of global demand in 2018…….. Average annual growth in these markets will range from 3.6 percent in Japan to 15 percent in China.
34 Industry News • • • •
India Developing Federal Medical Device Surveillance System Medical Devices Industry In India Underinvested: WHO Imported Medical Devices Inflate Patient’s Bill Gujarat Has Maximum Units Under Operation In Medical & Dental Instruments: Study
20 Did You Know? • About Welding of Thin Polymeric Films For Medical Applications
38 Events • Medical Fair India 2015 • Medicall 2015
: March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai. : July 31 & 1-2nd August, 2015, Chennai Trade Center. 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. May - June 2015
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Flashback March 2003 From Editor’s Desk Dear Readers, The domestic medical device industry has advanced rapidly over the past twenty years since China started its economic reform policy in 1979. Presently, with 2900 medical device manufacturers, total output value is USD 2 billion with a capacity to produce 12000 specifications, 3500 varieties in 47 categories. By the year 2000, total output value was expected to reach USD 3.62 6.04 billion. Still the imported medical equipment and instruments occupy 86 % of the total values meaning that China is a very promising market for the medical products. Some of the favorable factors for the large potential are release of import restrictions and development of Medical & Hygiene Industry. This has resulted in increasing market demand for: • High & New Technology Medical Products • Physical Therapy & Household Healthcare Products • OEM Products The economy of China is the fastest growing in the world. In fact, it grew at an astonishing 8.1% in the previous quarter. China was also among the fastest growing markets for Indian exports during the 1990s, according to the research house Center For Monitoring Indian Economy (CMIE). Starting from a low base of $48.7 million in 1991-92, exports from India to China have exploded to $925.7 million in 2001-02. The growth rate during the decade: a whopping 34.2% a year. Pharmaceutical exports account for 9% of total exports to China. CHINA MED 2003 will therefore, be an excellent opportunity to explore Chinese market. This issue contains an important presentation by Dr. C.S.B. Nair regarding use of materials for artificial organs for replacement of human body parts and for the manufacture of various implants and devices, which have revolutionised the healthcare system. This first part of the article introduces Pharmacopoeia requirements for materials for medical applications. The next issue will highlight differences in the requirements between Pharmacopoeia of different countries and also important criteria for medical devices required to guarantee their performance under actual use. This issue also features our regular columns : Global Trends, Industry News, Business Opportunities, important forthcoming events etc.
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Did You Know ?
?
About Welding of Thin Polymeric Films For Medical Applications Nearly all thermoplastics can be used in film form as thin, soft, flexible, elastomeric materials that can be folded or creased without damage. In selecting films for medical devices, The factors to be considered include cost, biocompatibility, sterilizability, mechanical toughness, elasticity, optical clarity, leachability, barrier properties, drug interaction, and sealing and assembly characteristics. Films most commonly used in the medical industry include high- and low-density polyethylene and polypropylenes , plasticized PVC, polyurethane elastomers, and breathable specialty films such as polyester. A clear understanding is required not only of a material’s properties, but also of how a particular welding process will affect it. The weldability of plastics is affected by various factors, including type of polymer; resin grade; presence of plasticizers, lubricants, and other additives; and moisture content. Thermal properties, molecular characteristics, and crystallinity of a polymer affect processing and film properties; additives influence extrusion and orientation processes and improve film properties; and reductions in the thickness of a film can lower costs and increase the area obtained from a given weight of polymer yield per square meter. In the 1970s, PVC became the material of choice for Band-Aids, and later the use of polymeric film patches in surgical draping became popular, replacing latex films. In the 1990s, the use of organ bags, drug-delivery patches, and breathable films for wound care increased dramatically, making films much in demand in the medical industry. However, health and environmental concerns about PVC and latex films have driven the development of alternative materials for these applications. Thermoplastic polyurethane, is well suited for use in flexible medical products such as storage and collection bags and other types of flexible containers and similar articles. Polyurethane films offer some important advantages over other films, including PVC. They have similar welding characteristics to PVC, provide strength equal to PVC in a thinner film, contain no plasticizers, are sterilizable by either EtO or gamma radiation, and have good alcohol resistance. Polyurethane films also can be readily sealed using radio frequency (RF) welding techniques.
In a Nutshell.... “I fear the day that technology will surpass our human interaction. The world will have a generation of idiots.” - Albert Einstein
May - June 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 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948
Editor’s Desk
From the
Joining of plastics components is a practice of keen interest in the medical device industry. A large number of medical disposable products are assembled using different joining and bonding methods. Medical Devices are becoming more complex and more sophisticated, both in performance specifications and structural complex city. Bonding of medical components involves a thorough understanding in design, material compatibility, performance testing, assembly methods and regulatory affairs. As the requirements for the components increases, so does the requirements for joining them. Considering the importance and interest to the industry, this issue gives a very comprehensive compilation of various methods of joining and bonding alongwith applications, features and advantages as well as limitations for the commonly required techniques. National Medical Device Authority The task force, under the chairmanship of the Secretary, Department of Pharmaceuticals, has recommended creation of an autonomous body. The draft National Medical Device Policy – 2015 recognised the need for strengthening make-in-India drive for medical device industry. Based on this, Department of Pharmaceuticals has shortlisted various measures including formation of “National Medical Device Authority”. The draft lists various salient features for the policy alongwith the incentives to the industry, provisions for institutional framework as well as measures to improve affordability for the masses. The draft policy is uploaded on the Department’s web site inviting comments / suggestions from industry. System for Medical Device Surveillance and Adverse Event Reporting One more important development is regarding development of system for medical device surveillance and adverse event reporting by Government of India, the implementation of which to be co-ordinated by Sree Chitra Tirunal Institute Of Medical Sciences, Trivandrum. It is expected that the information gained from the monitoring system will help regulators make decisions and recommendations based on domestic use of medical devices. As per the World Health Organisation, Indian Medical Device Industry is not only “underinvested” but also heavily import-oriented. The WHO recently announced formation of National Health Systems Resource Center (NHSRC), the first WHO collaborating centre in South East Asia Region. This issue, along with the cover story, also includes other regular columns including industry news, global trends, product gallery, “Did You Know’ as well as information on important industry events.
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.
May - June 2015
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Cover Story Medical Device Manufacturing: Components Bonding and Joining Techniques Medical devices whether temporary or permanent, used externally or inside the body, are becoming more complex and more sophisticated both in terms of their performance specification and structural complexity. Medical devices have complex shapes that cannot be molded directly. As a consequence, many devices currently used are multi-component and require methods of assembly in their production. Many types of medical devices are made of plastics which are required to be joined together in some manner. In these cases, the plastic parts may need to be separately made and joined together. So, Joining and Bonding are critical steps in manufacture of the components from polymers and polymeric composites which are used in manufacturing of Medical Devices. Medical devices in every aspect of their production demand highest level of quality. Reliability, reproducibility and the assembly of sub components are also critical in manufacturing of Medical products. Non-compatible materials (e.g. Mix-matched polymers) used in the manufacture of medical devices pose difficulties in the assembly process. The bonding and joining technique must not interfere with the function or standards applied to Medical Device. One of the most prevalent concerns when bonding materials for medical device manufacturing is how to get a strong bond between mismatched substrate surfaces. Generally, when bonding like materials, there are adhesives available that will strongly bond the two surfaces at the interface of the substrates. However, in many medical device manufacturing scenarios, the need to bond different materials with very dissimilar physical and chemical properties frequently arises. For example, a reasonably rigid material such as polycarbonate (PC) may need to be bonded together to a more elastic polyethylene (PE) material. Since the chemical properties of these materials is quite different, they will tend to bond differently to various adhesives. A certain adhesive may bond well to the PC, but not well, if at all, to the PE, and vice versa. There are methods to chemically treat the surface of one or both of the materials using primers, or other mechanical means to get a strong adhesive bond. While many of these chemical methods work quite well, they require the use of materials that may expose the manufacturer to dangerous or toxic matter. Such materials
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may also require expensive or time-consuming disposal methods. Most importantly, many toxic or dangerous materials cannot be used in the manufacture of medical devices as they are going to be implanted in the human body. Nowadays, there are thousands of grades of polymers available at the market for Medical Device Manufacturing. These cover a wide range of properties, from soft to hard, ductile to brittle, and weak to tough. The wide variety of polymers and polymeric composites makes it possible to select and even customize the material to specific application. As the requirements for the components increase, so do the requirement of joining. Joints in Medical Device Manufacturing are necessary always when; part integration is impossible because of complexity and/or high cost, using different materials in the same component, disassembly is required and repair of damage is needed. Joining is generally the final step in any fabrication cycle. The effectiveness of joining operation can have a large influence on application of any polymer or composite material used in Medical Device production. Blood and gas filters, IV spikes, drug delivery systems, surgical tools, diagnostic cassettes, fluidic devices, cardiometry reservoirs, face masks, implantable devices, insulin pumps, surgical gowns, blood donation kits, dialysis tubes, disposable clothing, pump cylinders, blood basins, sensor components, dialysis systems, condiment dispensers and blister packages, are some of the common Medical Products and Components which are using Plastic Joining and Bonding processes in their manufacturing. The methods for joining plastics and composites can be divided into following major categories: Mechanical Fastening, Adhesive and Solvent Bonding, And Welding. 1 Mechanical Fastening : Mechanical fastening has limited applications in Medical Device assembly. Mechanical fastening presumes the use of additional parts such as polymeric screws, bolts and it involves the use of separate fasteners or it relies on integrated design elements such as snap fit or press-fit joints. Mechanical fastening can be used to join both similar and dissimilar materials. May - June 2015
Cover Story Structural adhesives, in both liquid and tape formats, are used in a growing number of medical applications as replacements for mechanical fasteners. Solvent Bonding This method uses a solvent to fuse two plastics together. Simple in principle and simple in use. Solvent bonding is inexpensive and very fast. However this method demands the use of thermoplastic which will dissolve to fuse together. The application of a solvent at the bond lines induces sufficient mobility for the polymer chains to interdiffuse. Because the solvent must strongly plasticize the polymer surface, this joining technique is primarily applied to glassy amorphous thermoplastics, such as polycarbonate (PC), acrylic (AK) and Polystyrene (PS) resins. These techniques have found wide use by virtue of their low cost and adaptability to high speed production. In addition adhesive and solvent bond provide a relatively uniform distribution of stresses over the assembled areas and high strength to weight ratio.
The one advantage of Mechanical fastening is ease of disassembly. While, Disadvantages include reduced aesthetics, poor hermetic sealing and increased inventory. 2 Adhesive Bonding And Solvent Bonding : In Adhesive Bonding, an adhesive is placed between the parts to be bonded where it serves as the material that joins the part and transmits the load through joint. Adhesive bonding involves the use of a polymeric adhesive, which undergoes a chemical or physical reaction, for eventual joint formation. Adhesive bonding is well regarded in the industry because it does not have the health and safety issues that solvent welding has. In addition, adhesive bonding does not require the high capital equipment costs as do ultrasonic or vibration welding. No one adhesive technology can fulfill all requirements in bonding disposable medical devices. A balance of adhesive properties is needed to assure successful bonding of medical devices. The types of adhesives commonly used for medical device assembly include cyanoacrylate, lightcurable cyanoacrylate, light-curable acrylics, epoxies, urethanes and dual ultraviolet (UV)/moisture curable silicones. Many medical devices, including reusable surgical instruments like endoscopes and laparoscopes, are assembled using a variety of biocompatible adhesives. These adhesives must be able to tolerate repeated sterilization cycles that may include steam autoclaving, chemical treatment, and radiation Anaerobic sealants, cyanoacrylates, light-curable acrylics, and silicones are used in diverse lifesaving applications ranging from automotive air-bag sensors to catheters and blood oxygenators. May - June 2015
Solvent Bonding is only for joining of amorphous thermoplastics, whereas adhesive bonding can be used with almost any plastic also Joints with large, induced gaps cannot be secured via solvent bonding. 3 Welding (Fusion Bonding) : Many medical devices can be joined without consumable adhesives or fasteners. Although snap and pressfit applications are the least expensive options, they are often not permanent or secure enough. When that is the case, welding is often the best solution. In welding, heat is applied to melt the polymeric material at contacting surfaces enabling through intermolecular diffusion and polymeric chains entanglement process to form a joint. Welding processes for Medical Device assembly are often categorized and Identified by the heat method that is used. All processes can be divided into two major categories: External Heating and Internal Heating. Internal heating methods are further divided into two categories: internal mechanical heating and internal electromagnetic heating. External Heating method relies on convection and/or conduction to heat to the weld surface. These processes include hot tool, hot gas, extrusion, implant induction and implant resistance welding. Internal mechanical heating methods rely on conversion of mechanical energy into heat through surface friction and intermolecular friction. These Processes include ultrasonic, vibration and spin welding. Internal Electromagnetic heating methods rely on absorption and conversion of electromagnetic radiation into heat. These processes include infrared, laser, radio frequency and microwave welding. It is important to understand and compare different methods in order to determine which may be best for a given application. Some of the popular plastics welding methods for Medical Devices are presented here.
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Cover Story Ultrasonic Welding The ultrasonic welding process is used quite commonly for medical devices because its strengths nicely complement the requirements of medical device assembly. Economics often favor ultrasonic welding because cycle times are typically very short. In ultrasonic welding, high-frequency vibrations generate heat at the interface of the parts to be joined, melting the plastic and creating a strong bond. Ultrasonic Welding is very popular technique for fusion and bonding of thermoplastics and thermoplastic components. This technique is efficient, non-contaminating and requires no consumables. It produces a clean weld site with highly uniform joint quality, providing exceptional performance, consistency and reliability. Ultrasonic welding is often used in mass production because the welding times are relatively short (often less than 1 s).Ultrasonic welding is a flexible technique that can also be used for small lot size production – as long as the fixtures are designed to be flexible. It is applicable to both amorphous and semi crystalline thermoplastics. However, Limitations includes; high capital & running cost of equipment and poor gap filling. RF Welding Radio Frequency (RF) welding, which is also often referred to as “dielectric welding” is a process that relies on internal heat generation by dielectric hysteresis losses in thermoplastics with polar side groups. It is most commonly used to weld PVC bladders, such as intravenous drip bags for the medical industry. RF welding has the advantages that it is a relatively fast process with typical cycle times ranging from less than 1s to 5s. It also does not require any special joint designs and produces welds that are relatively appealing cosmetically.RF welding is almost exclusively used for welding thin sheets or films. Thickness usually ranges from 0.03 to 1.27 mm (0.001 to 0.050 in), depending on the material and application.
size considerations. Laser welding still has relatively high capital costs,faster cycle times come with higher capital costs also the process is sensitive to part fit-up. Plasma Processing : The medical device industry is highly regulated which demands reliable and reproducible components and manufacturing processing. Bonding mismatched plastics can be challenging for engineers and technicians in medical device manufacturing, even when the proper adhesives are utilized for maximum adhesion results. Low temperature gas plasma can be a simple, safe, inexpensive, and powerful alternative to prepare materials for bonding for the manufacture of medical devices. Plasma processing is an excellent choice for increasing the surface energy of polymers enabling more wettable surfaces. A Number Of Other Techniques Are Used For Joining & Bonding : Hot gas welding, Speed tip welding, Extrusion welding, Contact welding, Hot plate welding, High-frequency welding, Injection welding, Ultrasonic welding, Friction welding, Spin welding, Laser welding, Solvent welding and plasma processing are some of the commonly used techniques. The applications, important features and the limitations for each technique is summarised in the attached table.
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The limitation of RF welding is due to the fact that a strong electric field must be generated and this can only be achieved when the welding electrodes are brought together in close proximity (0.03 to 1.27 mm). Another limitation of the process is that the materials being joined must have the proper electrical properties. Common applications include blister packs for packaging and medical applications such as IV bags and Urine Bags. Laser Welding When welding seams in the micrometer range are required, there is only one economical solution – laser plastic welding. Laser welding is a vibration-free, particulate-free, and, in most cases, flash-free process that is nearly silent.Other aspects make this joining technique additionally interesting for medical applications, such as: flexible production options, stress-free processing, very fine process control and hygienic high-precision processing chains – all assuring high quality and profitability.The process is nearly independent of part-
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May - June 2015
Cover Story Applications Mechanical Blood Collection Fastening Tubes
Techniques Used For Joining and Bonding Features and Advantages Immediate Full Strength
Syringes, Catheters, Even Stress Oxygenators and distribution, Fills Surgical equipment such large gaps as Endoscopes and Laparoscopes
Adhesive Welding
Easy to use
Removable
Joins dissimilar materials, Aesthetically acceptable
Easily automated
Limitations Tolerance Specific, Not suitable for smaller components
Longer Set Up and Processing Time, Requires fixture time
Difficult to automate
Offer stress concerntration
Prior Surface preparation is required
Can cause contamination
Health and safety Catheters, Low cost and issues, Harmful for Not usable on Membrane Solvent Solvent Can cause High strength adaptability to Fast Process operators because thermosets,Poor Oxygenators, Bonding to weight ratio stress cracking high speed of the fumes that gap filling Microfluidic production. are generated devices Respiratory Filters, Does not Most widely used Ultrasonic Blood Filters, introduce any High capital costs method due to Cannot be used on Fast, clean, vibrations can Catheters, additional and Tooling costs Ultrasonic Thermosetic clean weld and damage efficient and Cannulas, for fixtures are Welding Plastic, Plastics produce high materials such as Luers,Trocars, adhesives into repeatable process must be compatible electric compohigh strength joints nents Masks, Blister the device consistently Packs Capable of Surgical High capital costs, Capability of producing strong, Surface preparation Plastics must be instruments, Vibration pressure-tight not required, rigid/flat,Must have Not usable on Capital expenditure welding more Filters, I-V units, Welding either flat or slightly Thermosets and special tooling Adaptable to than one part at a joints and also Bedpans, are required curved interfaces works with multiautomation time Insulated trays plane surfaces Spin Welding
RF Welding
Joins circular Ease Of Assembly, Valves,Fluid filters, parts under Simple and highly Provides fast cycle Flow diverters, pressure with a energy efficient times Surgical trocars circular, spinning process motion One of the most IV bags, widely used Relatively fast and Does not require Disposable methods, Energy Efficient, any special joint hospital products, Exclusively used Typical cycle time designs or solvents Blister packs, and adhesives Blood and Urine for welding thin less than 5 sec sheets Bags
Infrared welding
Particularly Non-contact Instrument panels appropriate for process, Joints and Filter higher-tempera- are free from Assemblies tures processing contamination
Suitable for Complex curved joints
For Complex For parts having Higher joint Filter cartridges, geometries, irregular shape, or Hot plate strength and Costartificial joints, large/multiple curved or internal welding effective braces and splints small parts and walls parts Microfluidic High Speed, Precision, Useful when Sensor, PTCA Laser Shorter Cycle cleanliness, and catheter, Micro Micrometer Welding High speed Atomizer and Cell range is required time, Particle-free processing Production culture Flask Suitable for Suitable for Improved lubricity Plasma chemicalMicrotiter Bonding misand surface Processing resistant Plates matched plastics adhesion materials May - June 2015
Suitable for parts Spin welding can with a circular joint generate line only particulates
Limitation to Circular Areas only
For limited joint Material Must have Material must a relatively high have a relatively Complexity and dielectric constant high dielectric loss Component size Higher tooling and Temperature Process may maintenance costs control requires create smoke and (requires infrared constant current fumes platen) Higher power consumption (required for heaters)
Require Warm-up time (Preheating)
Laser welding plants are expensive
High Capital cost of Equipments and Mainly Restricted High maintenance To flat shapes only cost
Higher tooling costs
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Manufacturing Policy National Medical Device Authority (NMDA) - Recommended By Task Force To Strengthen “Make In India” Drive The Drugs and Cosmetics (Amendment) Bill, 2015 for providing a separate chapter for regulation of the complete range of medical devices is now under legislative process. Besides, the others issues facing the Indian medical device industry include training and capacity building programme, interaction with medical device regulators, policy to promote local manufacture of Medical devices, granting subsidies and incentives and promoting higher education relevant to medical devices industry to bring fresh talent and techniques into research and development. There does not exist a single nodal authority for medical device industry. Recognizing this policy deficit, the Government constituted a Task Force 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 Task Force in its report released by Honourable Minister of Chemicals and Fertilizers on 08.04.2015 had made a set of recommendations for the promotion of the Medical device industry. Objective: The National Medical Device Policy-2015 has the objective of strengthening the Make in India drive in Medical device sector by reducing the dependence on imports and setting up a strong base for Medical devices especially those having critical implications in terms of affordability and availability for patients. Salient Features:
i An autonomous body “National Medical Device Authority” (NMDA) to be created under the Department of Pharmaceuticals; which may be headed by an officer of the rank of Additional Secretary/ Joint Secretary to the Government of India. The Authority shall have a Member Secretary of the rank of Joint Secretary/ Director; two eminent medical practitioners; two eminent medical device technologists or scientists; and Secretary General of Quality Council of India (exofficio). The Authority shall. a Provide a single window mechanism to the industry with an objective of promotion of the medical device industry to make the country not only self-reliant but also a global hub of production and innovation in medical devices. b Be responsible for setting up and managing, through appropriate corporate body/ SPV, Medical Devices Mega Parks of approximately 500 hectares and above, of various specialisations in the vicinity of Centres of Excellence. c Create benchmarks as per international best practices and update all the stakeholders on global development. d Develop knowledge networks with partners from industry. e Identify and prevent creation of unnecessary and unjustified technical barriers to trade especially by new or changing technical regulations. f Support and prepare indigenous businesses to face
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competition, access foreign markets, and find new business partners abroad. g Search, collect, collate and analyze relevant data. h Promote, co-ordinate and issue guidelines for the development of risk assessment methodologies and monitor, conduct and forward messages on the risks associated with medical devices to the Central Government, State Governments and other enforcement agencies. i Promote networking of national and international organizations within and outside India with the aim of facilitating scientific co-operation, coordination of activities, exchange of information, implementation of joint projects and exchange of expertise. j Take all such steps to ensure that the public, medical professionals and interested parties receive rapid, reliable, objective and comprehensive information through appropriate methods and means. k Promote general awareness as to medical device safety and medical device standards. l Undertake any other task assigned to it by the Central Government.
ii The Government on the recommendations of NMDA, subject to availability of Budgetary resources, may consider all or an appropriate mix of the following incentives for both Greenfield and Brownfield units: a Preference in government procurement may be considered for medical devices which are being manufactured in India with an additional preference for medical devices manufactured under MSME sector. b R&D by agencies like ICMR, DBT, CSIR, DIETY & DoP should be supported/ coordinated through the single window facilitating body. c Low cost funding like interest subsidy to MSME d Concessional power tariff for up to 5-10 years e Provide seed capital, viability gap funding and co-fund startup projects f Support commercialization of innovations g Provide longer term view (10 years window) for 200 % weighted tax deduction on approved expenditure on R&D as the gestation period in high in this industry. h Tax/ duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment i Minimum/ zero duty on the import of raw materials and manufacturing equipments for production of medical devices. j Restrictions on import of second hand diagnostic equipment/ tools k Higher taxes after 5-7 years of usage for imported second hand devices l Incentivize and promote exports in the medical devices sector. Institutional Framework: • Medical device testing centers to be set up preferably in the PPP mode - Common medical device testing facilities can be May - June 2015
Manufacturing Policy set up by government in major medical device manufacturing hubs to facilitate testing/ evaluation of medical devices. Recurring expense can be borne by the industry. • Designate “Centres of Excellence” (CoE) for supporting product development and validation- The centers having existing requisite facilities and expertise for different categories of medical devices (Example: Department of Electronics and Information Technology (DEITY), Bureau of Indian Standards (BIS), Indian Institute of Technology, Madras (IIT-M), Indian Institute of Technology, Delhi (IIT-D), Indian Institute of Science, Bangalore (IISc-B), Central Institute of Plastics Engineering (CIPET), Defence Research and Development Organization(DRDO). These Centres of Excellence would support: • • •
Product development - design and prototyping Validation and certification of the medical use of devices Adopt, implement and advocate policies on efficacy and safety testing
• Strengthen a Made in India marking (BIS) specific to Medical devices in line With International standards like CE and FDA • Set up a Skill Development Committee under National Medical Devices Authority with representatives from Medical devices industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC), which would: a Identify skill gaps and reduce shortages b Design curriculum and explore possibilities for on-line/ elearning modules to meet specific requirement of medical device segment c The committee would engage with HSSC affiliated Vocational Training Providers as well as potential ITIs, Polytechnic and other institutes for skill development d Set up satellite training campus around manufacturing hubs for skill upgrading e Liaise across the Medical devices industry for job placements. f Provide counseling to candidates seeking skill development and address issues like student loan, scholarships, job placements etc. • Since the medical devices sector is highly innovation and technology intensive, it is recommended to create a system where Industry may place/ make available their IP in noncore activities available to the exchange which may help technological up-gradation of the sector. • Set up/ promote Incubation centers through appropriate incentive structure/ cost sharing. Such centers would address gaps in capabilities within R&D infrastructure, testing calibration etc. Affordability: • Separate price control for medical devices- The medical devices may be included as separate entry in the list of commodities controlled under the Essential Commodities Act. • The Government may announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by May - June 2015
notifying a separate Medical Devices Prices Control Order (MDPCO). • A separate division may be created in National Pharmaceuticals Pricing Authority for pricing of the devices by suitably amending the resolution constituting NPPA. Implementation: In the first phase, the Department of Pharmaceuticals will within six months, bring a detailed proposal for creation of the National Medical Devices Authority with vision, mission, objectives, constitution, Head Quarters and likely budgetary allocation for appraisal and approval of the competent authority. The Department of Pharmaceuticals will come up with separate proposals for amending the Essential Commodities Act, amending the scope of functions of NPPA, and the National Medical Devices Pricing Policy. Department of Pharmaceuticals has invited comments / suggestions on the draft National Medical Device Policy - 2015 which is uploaded on their website, www.pharmaceuticals.gov.in.
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Product Gallery New Kynar® Connectors from Qosina Edgewood, NY –June 17, 2015- Qosina is pleased to announce the addition of an extensive line of Kynar® Connectors (#1139011404), in stock and ready for immediate delivery. Configurations include female luer lock to barb, nonvented female luer lock cap, female luer lock to female luer lock, male luer lock to barb, and non-vented male luer lock cap. Barbs are offered in a variety of sizes including, 1/16, 3/32, 1/8, 5/32, 3/16, and 1/4 inch. Kynar® (PVDF) is a tough engineering thermoplastic with a balance of physical and chemical properties, and is used in applications requiring the highest purity, strength, and resistance to solvents. These natural colored
®
components are Autoclave, E-Beam, EtO, Gamma and Steam sterilization compatible. Qosina offers an array of barbed luers in various sizes and materials including ABS, nylon, polycarbonate, polypropylene and PVC. In addition, Qosina carries a variety of Tygon®, C-Flex®, and silicone tubing. Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, caps, 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. Qosina offers low minimums and short lead times. Call our Customer Specialists to request a sample, obtain our latest catalog or place an 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: QOSINA Ryan Edwards 150-Q Executive Drive, Edgewood, NY 11717 Phone: +1 (631) 242-3000 Fax: +1 (631) 242-3230 Email: redwards@qosina.com
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
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VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are entrusted with the responsibility to manage in India on behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Accredited. We are involved on the certification activities in the following areas : • ISO 9001:2008 - QMS • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing • CE Marking • GMP We have collaboration with European Notified Body for CE Marking & SA 8000 certifications. We have assisted over 6500 clients all over the country, as an expansion plan we also require well qualified personnel’s in various districts to conduct the audits and provide after sale services, for Business Associates kindly apply for your location with complete details. Business Plan preferred.
We are a leading Consulting organization providing an integrated services with focus on project technology :
Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850
Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.
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: shankarbkm@gmail.com OR virtueinternationals@gmail.com
F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com
CE & ISO 9001 – 2008 Certified Company
AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Medical Devices & Surgical Products:
Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch
Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699
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 May - June 2015
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.ivcannulaindia.com www.amigo-india.com Plant Address Plot No. 780, Near Canera Bank, Rakanpur (Santej) - 382721. Gujarat, India. 29
Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
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
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May - June 2015
Global Trends Medical Disposables Market Worth $245 Billion By 2018 World medical disposables demand to increase 6.6% annually through 2018 and reach nearly $245 Billion. The upgrading and enforcement of infection prevention standards, coupled with an expanding volume of hospital, surgical and outpatient procedures, will promote overall gains. Global medical disposables market will be dominated by the United States, China, Japan, Russia, Germany, France, Brazil, India, Italy and the United Kingdom, who will comprise the 10 largest national markets, combining to absorb over two-thirds of the total value of global demand in 2018. During the forecast period, average annual growth in these markets will range from 3.6 percent in Japan to 15 percent in China. Among the major disposable medical supply product segments, dialysis disposables will post the fastest increases in global demand based on an expanding prevalence of end-stage renal disorders and the high frequency of therapeutic requirements. Segments projected to command average or better worldwide revenue growth include incontinence goods, infusion and hypodermic devices, nonwoven products, respiratory supplies and devices, sterilization supplies, and various other offerings such as urinary catheters and accessories, first aid kits, ostomy appliances, transdermal patches and waste disposal supplies. Advances in disposable medical supplies are contributing significant improvements to the safety and outcome of patient procedures. Products such as Level 4 microbial resistant surgical gowns and drapes have reduced the risk of spreading air and
blood borne infections during surgery. New polymer and bioengineered tissue sealants are decreasing the length of many surgical procedures and are promoting the faster recovery of postoperative patients. Drug delivery is another fast growing application for disposable medical supplies. New and improved safety engineered prefillable and hypodermic syringes and IV catheters have substantially lowered the risk of accidental staff and patient needlesticks before and after medication injections. Innovations in prefilled inhalers and transdermal patches are expanding the range of chronic conditions adaptable to cost effective self-treatment. In addition to drug delivery, innovations in disposable medical supplies are enabling patients to perform other health care functions themselves, including urinary drainage, and chronic wound management. Demand for disposable medical supplies in the United States, Western Europe, Japan, and most other developed countries will expand at a below average pace as their medical delivery systems are well established, meet the health care needs of most residents and have already adopted stringent infection prevention standards. By contrast, growth in Brazil, Russia, India, China and many other emerging economies will exceed the world average as health care sectors are expanded, modernized, and adapted to formal infection prevention protocols. (Ref: http://www.reportsnreports.com/market-research/medical-devices/ )
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 May - June 2015
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Industry News India Developing Federal Medical Device Surveillance System The Indian government is developing a system of medical device surveillance and adverse event reporting, dubbed the Materio-vigilance Programme of India. It will be run out of 10 Indian medical schools, led by the Sree Chitra Thirunal Institute of Medical Sciences and Technology in the South Indian city of Thiruvananthapuram, according to Indian news outlet Pharmabiz.com. The Indian Pharmacopoeia Commission, located near New Delhi, will play a coordinating role, as well as the Central Drug Standard Control Organization, the country’s equivalent to the FDA. In addition, a proposed World Health Organization center for crucial medical devices and health technology policy would provide technical support, according to the article. Currently, a committee formed to implement the program is designing adverse event
reporting forms and studying how to do to causality assessments. The government has devoted about $15 million to setting up surveillance programs for pharmacovigilance, biovigilance, and haemovigilance, as well as medical device monitoring, or materiovigilance. Among emerging markets, India is one of the most accepting of new devices because it has many modern, privately run hospitals, and lacks a strict process for device regulation or approval. But this move shows the Indian government is looking to increase its oversight of a med tech market worth $3.1 billion annually. The information gained from the monitoring system will help regulators’ make decisions and recommendations based on domestic use of devices. China is also implementing systems to gather domestic data in the form of more invasive local clinical trials, which would be required as a condition for device approval.
The article alludes to the global metal-onmetal hip debacle, which left a stream of injured patients in its wake, and demonstrates the dangers of other countries’ reliance on the FDA and European regulators. The plan to create an adverse event reporting and post-market monitoring system comes in the context of a federal proposal to create a separate medical device regulatory regime. In India, they are currently regulated as drugs, in spite of the myriad differences between the two sets of products. Mr. Varun Saxena FierceMedicalDevices 25 May 2015 - See more at: http://novamedica.com/ media/theme_news/p/ 2579#sthash.Ca9eXJPN.dpuf (Ref: http://novamedica.com/media/ theme_news/p/2579
Medical Devices Industry In India Underinvested: WHO NEW DELHI: The ambitious ‘Make in India’ campaign of Prime Minister Narendra Modi throws up opportunities for growth of domestic medical devices industry, which is not only “underinvested” but heavily import-oriented at present, the World Health Organisation (WHO) has said.
Health Technology Policy.
“There is a need for appropriate and applicable health care technology in India. Our medical devices industry is underinvested and heavily import-driven at present.
Menabde also handed over the designation of WHO collaborating centre commencement at NHSRC to Health secretary B P Sharma.
“But with the current ‘Make in India’ campaign, there is a huge opportunity for growth and expansion of the medical device industry. This would highly improve the access of essential medical devices and health care technology to patients in India,” WHO Representative to India, Nata Menabde, was quoted as saying in a Health Ministry statement. She said this during an event to formally announce the commencement of National Health Systems Resource Centre (NHSRC), as the WHO collaborating centre for Priority Medical Devices and
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This was announced by the WHO Country office for India in collaboration with the Health Ministry and NHSRC yesterday. This is the first WHO collaborating centre in South East Asia Region, the Health Ministry statement said.
Noting that prioritising medical devices and health technology in the country is an “important agenda” item, Sharma said that it is critical to have the specifications in place for the medical devices and equipments that are already procured and used in the system.
Its works includes framing of technical specifications for technologies procured under National Health Mission, best practices for technology life-cycle management and maintenance, secretariat for assessment and uptake of innovations into public health systems among others, the statement said. PTI Mar 21, 2015, 08.40PM IST (Ref: http://articles.economictimes .indiatimes.com/2015-03-21/news/ 60346504_1_health-ministry-nationalhealth-mission-nata-menabde)
“There is also need for dedicated medical devices testing laboratories to ensure the safety and efficacy of these devices,” he said. The division of healthcare technology and innovation at NHSRC has been working in the area of health technologies and related policy interface. May - June 2015
Industry News Imported Medical Devices Inflate Patient’s Bill It has been noted that using imported highend medical devices in complex disease management highly inflates a patient’s bill. Around 75 per cent of the bill is incurred by the usage of imported devices. In comparison, India-developed low-end devices currently constitutes only 5 per cent of a patient’s bill.
towards developing a more self-reliant country in manufacturing high-end medical devices.” Stating that the Indian medical device industry is developing very fast, he noted that the cost benefit that Indian manufactures are offering is immense.
“Indian doctors have been using it for the past 15 years and they opine that the products’ standards have evolved to match international quality. There was a ray of hope in India for affordable stents when former President of India Dr. A.P.J. Abdul Kalam came out with a stent called Kalam-Raju Stent that could be manufactured for Rs. 5,000 to Rs. 7,000. This stent was never patronised and plans to further do research Dr. Praveen Chandra, chairman, and improve the stent were shelved. In India, interventional cardiology, Medanta Heart U.S. multinationals dominate with more than Institute, also the organising secretary of the 70 per cent market share with a price range conference said: “For the first time in a of Rs. 45,000 to Rs. 1.20 lakh per stent,’’ he medical conference in India, we have said. facilitated doctors and industry from India Manufactures, too, add that India has to interact on a common platform and have the potential of making high-end medical discussion to work closely and purposefully devices for the management of complex The expenditure and our dependence on imported medical devices can be curbed if the government allows Indian manufactures to start producing high-end medical devices, noted senior cardiologists from across the country. They have gathered at the threeday National Interventional Council organised by the Cardiological Society of India, which will conclude today.
diseases and thus bring down the patients’ bills considerably. “To be self-reliant, the government can help us by creating industry-friendly infrastructure and giving us subsidies,’’ noted Mr. Gurmit Singh Chug, managing director, Translumina Theraputics. “India has always been considered to manufacture low-end and low-cost products with no clinical evidence to prove their efficacy. This now holds untrue. A drugeluting stent manufactured in India called YUKON PC was reported to be equally safe and efficacious by three acclaimed international journals, namely the Journal of American College of Cardiology, European Heart Journal and EuroIntervention ,’’ he added. Updated: April 5, 2015 07:49 IST (Ref: http://www.thehindu.com/news/ cities/Delhi/imported-medical-devicesinflate-patients-bill/article7069663.ece)
Gujarat Has Maximum Units Under Operation In Medical & Dental Instruments: Study The State, However, Ranked 4th With 8.2% Share In Total Output and dental instruments and supplies in the country by Assocham. Of the total number of 65 factories in medical and dental instruments and supplies segment in Gujarat, 58 such factories were under operation as of 2011-12.
Gujarat accounted for highest share of over 18 per cent in terms of total number of 316 factories operating in the medical and dental instruments and supplies sector across India, according to the sector specific analysis undertaken by the Associated Chambers of Commerce and Industry of India (Assocham).
However, with an output worth just about Rs 439 crore, Gujarat is ranked fourth with a meagre 8.2 per cent share in the total output worth about Rs 5,300 crore of medical and dental instruments and supplies sector generated across India. The state, however, had third highest share of 10.1 per cent in terms of direct employment generated by medical and dental instrument factories operating throughout the country.
“Gujarat also had the highest share of over 19 per cent in total number of 338 factories in the sector of medical and dental instruments and supplies,” according to analysis of the state-wise distribution of manufacturers of medical
Clocking a compounded annual growth rate (CAGR) of over 15 per cent, imports of medical devices and equipments in India is likely to cross $4 billion mark by 2018-19 from a level of about $2.3 billion as of 2013-14, as per Assocham.
May - June 2015
“Growth of medical goods’ exports to India is expected to continue as a result of our burgeoning middle class, growing medical tourism industry, swelling private sector healthcare investment, aging population and heightened government commitment to provide health services to the rural population,” noted a study titled ‘Indian Medical Devices Industry: The way ahead,’conducted by Assocham. “As currently much of the medical devices in India are imported therefore, going forward it is imperative for India to focus on development of domestic manufacturing capabilities for ensuring the nation’s health security,” said DS Rawat, secretary general of Assocham while releasing the findings of the chamber’s study. He further added that “Absence of a clear and consistent regulatory framework, lack of adequate incentives and funding for manufacturing devices, absence of
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Industry News medical devices’ specific legislation, dearth of trained workforce for maintenance of medical devices, insufficient financing and lack of coordination between diverse stakeholders are certain key constraints faced in establishing this industry in India.There is a need for infrastructure creation for setting up green-field medical devices and equipment parks” Over 18,100 people were employed in 316 factories under operation in medical and dental instruments and supplies sector in India producing a total output worth over Rs 5,300 crore as of ASI survey of 2011-12, highlighted the Assocham study. Maharashtra had second highest share in of over 12 per cent in the total number of factories in the aforesaid sector while Uttar Pradesh (UP) had the second highest share of 10.4 per cent in total number of factories under operation followed by Maharashtra (10.1 per cent). Karnataka alone had over one-fourth share with over Rs 1,360 crore worth of
output generated across 25 operating factories in medical and dental instruments and supplies segment in the state.While Haryana had highest share of over 25 per cent in terms of direct employment generated by medical and dental instruments’ manufacturers across India followed by UP (11.6 per cent). In its study, Assocham has suggested that Government needs to expedite the process of relaxing FDI policy for cashstarved medical devices sector attract more investments and boost domestic manufacturing. “FDI inflow is expected to spur research and development (R&D) and manufacturing innovations, in turn increasing the efficiency and effectiveness of medical devices,” it said. It has further recommended to encourage innovative financing mechanisms and funding sources and to establish a large scale medical devices capital fund to invest in needed, viable, medical devices development and commercialisation, besides the fund would also support a national medical devices network.
BS Reporter | Ahmedabad May 14, 2015 Last Updated at 20:58 IST (Ref: http://www.business-standard .com /article/companies/Gujarat -hasmaximum-units-under-operation-inmedical-dental-instruments-study15051400642_1.html)
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 36
May - June 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 May - June 2015
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Events Events Calender • Medical Fair India 2015 22st International Exhibition and Conference Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Mumai. • Medicall 2015 13th Edition Medicall 2015 Date : 31st July, 1st & 2nd August 2015 Venue : Chennai Trade Centre 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
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
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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
May - June 2015
Operon
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May - June 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
May - June 2015
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
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GMP ISO - 9001-2008 Certified Company
•
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.
S. Nath & Co.
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 42
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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 May - June 2015
