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CToabnletoef nts Vol. 23 No. 4 July.-Aug. 2015 20 Cover Story • Indian Medical Device Industry : Government Initiatives For Regulations, Safety & Competitiveness - The decision of the Department of Pharmaceuticals to come out with a draft National Medical Device Policy, 2015 is the first government initiative to give a proper direction to the growth of this sector in the country. Various other Government initiatives include……. 24 Technology • Cold Plasma Treatment For Biomedical Applications - Mrs. Purvi Dave, Scientist SC, Facilitation Center for Industrial Plasma Technologies Institute for Plasma Research, Gandhinagar, Gujarat - Cold Plasma (a kind of glow discharge) Treatment is very much useful for surface modification of bio-polymers / medical plastics. Bio-polymers / medical plastics are widely used for biomedical applications such as artificial organs (Prosthetic Materials) and cell scaffolds. • Plasma Treatment Improve Adhesion To Polymers 31 Global Trends • Impact Of New European Regulations On Outsourcing Of Medical Devices - Medical Device Companies will operate under a stricker regulatory environment in Europe following the approval of new regulations governing Medical Devices and In Vitro Diagnostics by the Council of the European Union. 32 Industry News • Provisions Of DPCO, 2013 Applicable To Notified Medical Devices: NPPA • Gujarat FDCA To Meet Commerce Ministry To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab • U.S.-India Business Council Concludes Successful Medical Device Trade Mission To India 18 Did You Know? • Balancing Product Development Effectiveness with Regulatory Compliance 36 Events • Medicall 2015 : October 9 - 11, 2015, Bombay Convention and Exhibition Center, India. • Compamed 2015 : November 16 - 19, 2015, Dusseldorf, Germany. • 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. • Medical Fair India 2015 : March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai. July. - Aug. 2015 17
Flashback ?YoDKuindow ? March 2003 Balancing Product Development Effectiveness with Regulatory Compliance From Editor’s Desk Medical device companies are experiencing growing pains as they navigate Dear Readers, the challenging waters of regulatory compliance while simultaneously keeping up with the pace of innovation. When it comes to implementing product Thailand and the neighbouring Indochina markets for development processes that comply with regulations, many have Vietnam, Laos and Cambodia have opened vast overcompensated, resulting in overly-bureaucratic systems that are impacting opportunities for the Indian medical technology Industry delivery performance and causing them to come up short on time to market, to take latest medical and healthcare products and R&D ROI, new product revenue, and schedule predictability goals. services to their doorsteps. Though a single process design has the advantage of one system for both Thailand is working towards achieving the goals outlined business and quality system needs, this approach increases opportunities for in the UN’s Millennium Development Goals established non-compliance and hinders project teams that need flexibility to adapt at the United Nations Millennium Summit in September business processes to specific project needs. 2000. Three of these goals call for specific improvements Implementing a program that couples product development effectiveness with in health such as reduction in child mortality, maternal compliance is no easy task, but deploying a methodology that includes deaths and combating the spread of HIV/AIDS, malaria improvements in process definition and work flow structure, innovation and TB. The healthcare industry in Thailand has seen governance and decision making, project teams and team structure, and major transformations taking place. The health status of software systems and tools can help companies realize benefits including: the Thai people have improved considerably and rapidly Meeting and exceeding development effectiveness goals, Achieving time to over the past 3 decades. market goals ,Hitting planned product launch dates , Eliminating unnecessary Indian visitors to HOSPIMedica THAILAND will also process bureaucracy as well as Accelerating product development process benefit tremendously from the participation several groups maturity. from China, India, USA and the Indochina region in A mature, high performing product development process with low compliance addition to the national pavilions like State of Bavaria / burden is the goal. Top performing medical device companies demonstrate State of North-Rhine Westphalia (Germany), Austrian how to achieve this goal and deliver safe, effective, and commercially successful Chamber of Commerce, Taiwan Medical Industry medical devices. Association and Thai Medical Device Suppliers’ Association. (Ref:http://ww2.frost.com/files/3914/2200/7195/Beyond_Compliance.pdf) This issue contains very informative articles covering various important subjects like Evaluation of Medical In a Devices, Regulatory Affairs, Medical Plastics Nutshell.... Materials and the latest developments taking place in the field of medical materials globally. “Genius is the ability to hold Dr. Norman Estrin has very elaborately discussed the one’s vision steady until it basics of US FDA : 510 (k) and the various requirements becomes reality” for its submission. Dr. Norman Estrin is a recognized authority in the medical device and cosmetic - Benjamin Franklin industries. He has had over 30 years of experience in directing scientific and technical and regulatory programs July. - Aug. 2015 in these industries. He is Regulatory Affairs Certified (“RAC”) by the Regulatory Affairs Professional Society. The use of plastics in medical applications is expected to continue its steady growth as new polymers edge out metals, ceramics, and other traditional materials. Innovative materials are replacing the conventional ones such as PVC. Medical devices are becoming smaller and lighter but have performance advantages over much larger and more expensive equipment. “Global Trends” highlights the recent trends in the field of Plastics used for medical applications. “Product Gallery”, a new feature in this issue, introduces products of interest to both the manufacturers as well as users and marketing companies. We are happy to mention once again that the internet has strengthened us by allowing us to provide much more information to our readers than we could before. We invite our readers to benefit from our web sites, www.medicalplasticsindia.com and www.medisourceasia.com . 18
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) Regulations, Safety And Competitiveness EDITORIAL ADVISORY BOARD Every medical device is designed for a purpose. A device is clinically effective when it produces the effect intended by the manufacturer relative to the medical condition. The Dr. TARANG PATEL performance of a medical device is closely linked to safety. For example, a blood collection syringe M.B.B.S., M.Ch. (ONCO) with a blunt needle would perform badly for collecting blood and could also inflict injury and hence Cancer & Reconstructive Surgeon the safety and performance of medical devices are normally considered together. The regulatory process ensures that the manufacturer has effectively implemented the risk management process Mr. C. BALAGOPAL and fulfilled other regulatory requirements. Director - Enter Technologies Pvt. Ltd. It is obvious therefore that establishing an appropriate regulatory framework for medical devices Chairman - Mobilexion Technologies Pvt. Ltd. will enable industry to better address the needs of the patients. However, it is also important for the government to understand that issues related to the pharmaceutical sector are different from that Trivandrum of medical devices. Dr. DILIP H. RAIKER Competitiveness Of Indian Medical Devices In Domestic Market Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) The Indian Medical Device Manufacturers are not able to tap the domestic market due to inherent Former Chief Manager(P), CIPET - Chennai challenges. The Department Of Pharmaceuticals is planning to initiate a nationwide study to scrutinize why the domestic manufacturers are not able to benefit from the local market opportunities in spite ING LOUIS C. SUHUURMAN of having substantial export market. This issue highlights the recent initiatives by government through Formerly Sales Director various departments is to facilitate the growth of the medical device industry in India. COLPITT B.V., Holland Beyond the need for proactiveness from the government, a recent study by “Infosys Management Consulting Services” has identified the various challenges and suggested following strategies for Dr. A.V. RAMANI the Industry to implement : Group Sr. Vice President (R&D), The TTK Group - “Understand dynamics of the market, local sentiments, challenges and opportunities better. - Partner with domestic technology companies for an efficient market entry and market growth Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd strategy. - Revolutionize domestic sales force. Dr. BHARAT GADHAVI - Add more value to healthcare providers and patients alike, not just through products, but also CEO, Medisurge Hospitals services wrapped around the product” Mr. A.S. ATHALYE The study further discusses success stories of indigenous companies having managed to navigate Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai the hurdles and emerged successful despite the challenges associated with Indian Medical Device Industry. Dr. SUJOY K. GUHA One of the domestic technology company, Institute Of Plasma Research, Gandhinager (Gujarat) B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. and the technology being offered by them regarding cold plasma treatment for Biomedical Applications is introduced in this issue. It is an eco- friendly process and can induce hydrophilicity IIT, Kharagpur / hydrophobicity to the polymer surfaces resulting in better cell adhesion, anti-bacterial properties, biocompatibility as well as bio-functionality compared to virgin ones. The Institute offers the Dr. G.S. BHUVANESHWAR technology through their Facilitation Centre for Industrial Plasma Technologies (FCIPT). Director - Innovation & Edn, This issue also covers the regular features including Global Trends, “Did You Know”, Industry Trivitron Healthcare Pvt. Ltd., Chennai and News, Events / Event Calendar etc. Jt. Co-ordinator - Regulation, AIMED, India. 19 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. July. - Aug. 2015
Cover Story Indian Medical Device Industry : Government Initiatives For Regulations, Safety & Competitiveness The recent initiatives by government through various departments is expected to make the Indian Medical Device Manufacturing Sector grow faster in the next five years. The initia- tives include the Bill to delineate Medical Devices from Drugs, removing Duty Anomalies, Materiovigilance Programme to monitor Safety of Medical Devices and many more. Major challenges faced by Indian Medical Device Industry being monitored in the country. The basic objective of MvPI are lack of regulatory structure, harmonized standards, is to collect safety data in a systematic manner so that accreditation and adverse custom duties. Absence of any regulatory decisions and actions on the use of medical regulations for curbing imports of poor quality or devices could be taken on time by the health authorities. substandard quality medical devices, lack of R&D These government initiatives should play a key role in capabilities with high reliance on outsourcing technology, developing this industry and ensure availability of quality are some of the leading factors affecting the medical devices at reasonable prices to the patient competitiveness of Indian medical consumables. community in the country. The decision of the Department of Pharmaceuticals to come One more development is regarding inverted duty struc- ture. It is expected that out with a draft the Department of Pharmaceuticals will National Medical shortly recommend to rectify the inverted duty Device Policy, 2015 is structure for the grow- ing medical devices the first government sector. An inverted duty structure impacts do- initiative to give a mestic industry ad- versely as manufactur- proper direction to the ers have to pay a higher price for raw growth of this sector in materials in terms of duty, while imported the country. The main finished products land at lower duty and cost objective of the policy lesser. The duty struc- ture will have to be is to set up National modified. For this, the Department of Indus- Medical Device trial Policy and Promo- tion( DIPP) and De- Authority, an partment of Pharma- ceuticals will jointly autonomous body for finalise the recommen- regulating the dations. manufacture and Establishing an appropriate regulatory framework for medical devices will enable industry to better address the sales. Such a national needs of Indian patients. The industry is encouraged that the government has taken cognizance of the fact that issues body should be able related to the pharmaceuticals sector are different from that of medical devices. The proposals for medical device parks, to strengthen the autonomous regulatory authority, 100 percent FDI, incentives for R&D, etc., will all foster the development of domestic base of this the industry. More details on each of the initiative is explained at length in the following press releases. sector, reduce dependence on import and bring affordability and availability of these critical products. Preference to local manufacturers in government purchases, institution of a regulatory framework around self-certification, and creation of a separate department for medical devices are some of the other suggestions put forth by AIMED. Another move initiated by the health ministry is to come out with a Materio-Vigilance Programme of India (MvPI) intended to ensure safety of medical devices used in the country. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not 20 July. - Aug. 2015
Cover Story Department Of Pharmaceutical To Study Government to Soon Remove Duty Factors Affecting Competitiveness Of Indian Anomalies in Medical Devices Sector Medical Devices In Domestic Market New Delhi: The government is working on several steps, includ- ing removing duty anomalies, to boost medical devices manu- Keen on pushing the interest of the medical device sector, the facturing sector and make it a $50-billion industry in the next five department of pharmaceutical (DoP) is soon planning to initiate years, as per a top official. a nationwide study to scrutinise why the domestic manufacturers are not able to get proper market opportunities in spite of having Secretary in the Department of Pharmaceuticals V K Subburaj substantial export market. To gauge the factors affecting said that soon recommendations will be made to rectify the in- competitiveness of Indian medical consumables, DoP called a verted duty structure for the growing medical devices sector. high level meeting with key stakeholders from the industry. He said the departments of health and pharmaceuticals along The focus of the meeting was to explore the reasons for with the Department of Industrial Policy and Promotion (DIPP) losing out to competing imports and identify the roadblocks are working on the matter and soon they will make recommen- that hamper the growth of domestic sector from within. dations to the Revenue Department on the issue. Experts state that unfair market conditions, lack of proper regulatory guidelines coupled with partial attitude that is An inverted duty structure impacts domestic industry ad- duly focused on imports are key reasons for lack of versely as manufacturers have to pay a higher price for raw dominance of domestic manufacturers in the country albeit material in terms of duty, while imported finished products having huge potential and required expertise to export to land at lower duty and cost lesser. “The important hurdle other countries. (which the sector is facing) is the regulatory mechanism The duty structure has to be modified. Health, DIPP and It is understood that through this initiative the government intends Pharma are jointly discussing the issue to finalise the recom- to aid the industry by providing infrastructural support to the mendations as per the opinion of Mr Subburaj at a CII function. deserving companies, while tweak preferential market access and public procurement policy as per the needs of the sector to Domestic medical devices makers have been asking the gov- benefit the industry. Rajiv Nath, forum coordinator of Association ernment to address this issue. “We will ensure that this defi- of Indian Medical Device Industry (AIMED) informed that the ciency gets corrected very shortly. That will set the tone for medical industry is looking forward to be part of this initiative as it comes devices industry in the country,” he added. as a welcome move finally taken to address the concerns of the industry. Commenting on the potential of the sector, he said: “Now we have to scale it to $50 billion and to enable that, we have to take “It is high time to finally confront the reality on why Indian policy decisions.” Currently, the medical devices industry in In- manufacturers are not able to get the opportunity to expand dia is estimated to be $5 billion annually. their business within the country, even when we have the expertise for the same. The government must take The secretary also said the department is working to create a cognisance of the fact that unfair market practices is rampant separate vertical for medical devices in the Drugs and Cosmet- in the country due to competition from lower cost imports ics Act. of China and other countries, contributed due to low duties and 17 percent subsidy by China on Chinese exports; “Once it becomes a $50-billion industry, I do not think we can competition from MNCs which are either not putting any afford to combine it with the Drugs and Cosmetics Act. There MRP or putting very high MRP as desired by corporate should be a separate Act for the sector. We have combined it hospitals are some of the major factors affecting us,” with drugs for long and that mistake is likely to be sorted out stressed Nath. shortly. I think very shortly we will have a separate vertical within this Act exclusively for medical devices,” Mr Subburaj said. He further added that proactiveness from the government to tackle these issues is the need of the hour to protect the interest To give an identity to the subject, he said, the government has of the stakeholders, who are currently suffering silently due to empowered the Pharmaceuticals Department to take the medical Centre’s indifference. devices sector. (Ref: http://www.pharmabiz.com/ArticleDetails.aspx?aid=89723&sid=1) Earlier, different departments were handling different issues related with the sector, such as quality control was looked after www. medicalplasticsindia.com by the Health ministry, FDI by the DIPP and export was taken care by the Commerce Ministry. THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTIC / DEVICES TECHNOLOGY AND TRADE The department, he said, is also working on the issue of the preference purchase procedures. “We are discussing with the electronics and MSME departments to see that products manufactured in India, especially made by medium and small scale sector, get preference for purchase,” he said. (Ref: http://profit.ndtv.com/news/pharma/article-government-to-soon- remove-duty-anomalies-in-medical-devices-sector-1211936) July. - Aug. 2015 21
Cover Story AdvaMed Demands Passage Of D&C Amendment Bill To Delineate Medical Ministry Of Health Launches Materiovigilance Programme To Devices From Drugs Monitor Safety Of Medical Devices The Advanced Medical Technology Association (AdvaMed), an In a strategic move to protect the health of the patients, the association of medical device manufacturers in India, has ministry of health & family welfare approved the commencement demanded the passage of Drugs and Cosmetics Amendment of the ambitious Materiovigilance Programme of India (MvPI) to Bill, delineating medical devices from drugs, in the upcoming monitor the safety of medical devices in the country. The MvPI session of parliament. was formally launched on July 6 at Indian Pharmacopoeia Commission (IPC), Ghaziabad by Dr G N Singh, Drug Controller Though the government had cleared the amendment to the Drugs General of India (DCGI). and Cosmetics Act bill delineating the medical devices from the pharmaceutical and drug products in the year 2013, the bill has It is understood that while IPC will function as the national not got complete formal nod of the parliament, due to which there coordination centre for MvPI, Sree Chitra Tirunal Institute of are so many legal hurdles that are becoming stumbling blocks Medical Sciences & Technology (SCTIMST) will be functioning for the growth of medical devices sector in the country. as National Collaborating Centre for the same. At the same time, the National Health Systems Resource Centre (NHSRC) under “The Bill is historic because it creates a distinction between the ministry of health will collaborate and work as technical drugs and medical devices for the first time in India’s support and resource centre. legislative history. We believe that by establishing an appropriate regulatory framework for medical devices, it will While stressing on the importance of this initiative, Dr Singh enable industry to better address the needs of Indian said this is an important step towards ensuring patient safety patients,” says Sanjay Banerjee, chair of AdvaMed India. measures in the country as medical devices are as crucial and important aspect of healthcare as drugs. First introduced in the Rajya Sabha in 2013, the Bill has since gone through several revisions. The health ministry has organised “Considering the current healthcare needs of the country, a series of consultations with other departments, industry and MvPI is a necessity essential to safeguard the interest of civil society to ensure that the amendments address all concerns the patients. Thus we would ask all the stakeholders to come adequately. forward and support us in this national cause.” He further stressed that this will go a long way in generating India’s In fact, the nascent medical devices sector entered the limelight safety data collection on the medical devices running in last year with Prime Minister Narendra Modi calling out to medical the market in a systematic manner so that regulatory device manufacturers to ‘Make in India’, and the department of decisions and recommendations on safe use of medical industrial policy and promotion (DIPP) opening up the sector to devices for India could be based on data generated here. 100 percent automatic foreign direct investment. Dr V Kalaiselvan, principal scientific officer, IPC informed that Once the final bill is passed, then, it is regarded as following the launch, the technical committee had a high level benchmark legislation because it outlines a regulatory meeting in which the members of the steering committee and system that is appropriate for medical devices, and is working group took important decisions on identifying the 10 broadly harmonised with international regulations. It will adverse effect monitoring centres and data management system, ensure quality of medical devices, and therefore patient along with finalising the other aspects relating to the modalities safety, and remove bottlenecks to easy availability. It will for the same. grow domestic manufacturing capacity, allow domestic industry to compete globally, and incentivise international Interestingly, this programme is meant to monitor medical industry to invest in ‘Make in India’. device associated adverse events (MDAE), create awareness among health care professionals about the “Without the legal backing, the medical devices are still importance of MDAE reporting in India and to monitor the considered as drugs. Because of this, medical devices risk-benefit profile of medical devices. It will also play key manufacturers are facing hurdles in product registration and role in generating independent, evidence-based approval for manufacture of new devices,” says Banerjee. recommendations on the safety of medical devices so as to communicate its results to the stakeholders. For decades, the medical device industry has gone unrecognised in India. Currently, of the 14000 types of medical devices that At present, there is no mechanism to monitor or regulate the exist, only 22 are on the government’s list and even these are use of medical devices in the country against any possible treated as drugs. The obfuscation of the two categories in India adverse events. Thus experts from the industry strongly feel has created ambiguity about safety standards and quality control, that this move will finally help in bringing some regulatory and limited the ability of the medical device industry to address semblance to the sector. Especially since monitoring for possible issues of access, availability, affordability and safety. adverse events pro-actively will not only help in ensuring better patient safety but also improve the standard of the industry as (Ref: http://www.pharmabiz.com/NewsDetails.aspx?aid=89447&sid=1) well. July. - Aug. 2015 (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=89344&sid=1) 22
Technology Cold Plasma Treatment For Biomedical Applications Mrs. Purvi Dave, Scientist SC increase in cell attachment. It is also reported that Hydroxyl groups Facilitation Center for Industrial contributes to cell colonization. Plasma Technologies Institute for Plasma Research, It is well known that cell walls of most bacterial strains are negatively Gandhinagar, Gujarat. charged. Therefore more negative surfaces construct an initial [email protected], www.plasmaindia.com defence line against microbial adhesion by an electrostatic repulsion. Air plasma treatment can introduce negatively charged We all have been taught that there are three states of matter: solid, functional groups on the surface. With increasing concentration of liquid and gas. The plasma is the fourth state of matter. In a more these groups, the surface becomes more hydrophilic and more simple way, we can say plasma is an ionized gas. Scientists say negatively charged. Thereupon due to the strong repulsive forces, that 99% of universe is in plasma state. If we supply sufficient the antibacterial effect increases [Fatemeh et al. Applied Surface, energy to gas either in the form of heat or electricity, electron comes Science 2015]. out from the atom or molecule and thus electrons, ions and reactive gaseous chemical species are generated. In plasma stateions, Similar type of research work in the field of surface electrons, neutrals, activated gaseous species coexist. We see modification of polymer surfaces by eco-friendly plasma natural plasmas around us in the form of lightening and aurora. process is being done at Facilitation Centre for Industrial Sun and stars are live example of natural plasma. Examples of Plasma Technologies (FCIPT), Institute for Plasma Research common man made plasmas are fluorescent lights, neon bulbs (IPR). IPR, Gandhinagar is an Autonomous R & D Institute and plasma arc, plasma TV etc.. Plasma arc is used for cutting under the Department of Atomic Energy (DAE), Government and welding of thick steel sheets. of India situated near Gandhinagar, Gujarat, India. Scientists and researchers around the world are working to FCIPT is a division under IPR, which mainly focuses on technology develop different plasma technologies for variety of development for social benefits and industries. FCIPT develops applications to serve mankind. Plasma state can be generated plasma based technologies and commercializes through in the laboratory. Plasma can be generally classified broadly Technology Transfer to Industrial Partners. as: (i) non-thermal or cold plasma and (ii) thermal or hot plasma. In our study, plasma is capable of reducing Water Contact Angle (WCA) from 100 ° (WCA of untreated PE) to as low as 15 ° in the Cold Plasma (a kind of glow discharge) Treatment is very much case of low pressure plasma treatment and 43 ° in the case of useful for surface modification of bio-polymers / medical atmospheric pressure plasma treatment. WCA is the measure of plastics. Bio-polymers / medical plastics are widely used for wettability of the material. Polyethylene is one of the promising biomedical applications such as artificial organs (Prosthetic medical plastic which is widely used in various prosthetics in Materials) and cell scaffolds. Surface properties of the biomedical industries. material play an important role in determining overall biocompatibility of the materials because the surface of the At FCIPT, IPR we have developed plasma surface modification materials will first come into contact with biological environment. The initial response of the biological process for polymers which uses ambient air to produce environment to such materials, therefore strongly depend on the surface properties of the materials. Thus the modification plasma at atmospheric pressure. After plasma treatment of the surface of the materials is the convenient and effective way to create and develop biomaterials for clinical polymer surface (Polyethylene, PET, PP) have become applications. hydrophilic in nature, which is of relevance to bio- Although many synthetic biomaterials have physical properties that meet and even exceed those of natural body tissue, they can often compatibility. This treatment can also be done by low pressure cause adverse physiological reactions such as infection, inflammation and thrombosis formation. Through surface air / oxygen plasma. Below figure shows oxygen plasma modification, bio-compatibility as well as bio-functionality can be achieved without changing bulk properties of the material. generated in our laboratory. In order to obtain optimal biological performance, it is usually In our study, necessary to apply surface treatments or coatings to biomaterials. Plasma treatments are used to incorporate plasma is capable chemically reactive functional groups on to the polymer surface and thus make them hydrophilic. of reducing Water Hydrophilicity plays an important role in cell and bacteria Contact Angle behaviour.It is reported that enhancing the surface hydrophilicity by introducing oxygen containing functional groups such as (WCA) from hydroxyl (-OH), carbonyl (-COOH), ketone (-C=O) leads to an 100°(WCA of un- treated PE) to as low as 15° in the case of low pres- sure plasma treat- ment and 43 ° in the case of atmo- spheric pressure plasma treatment. WCA is the measure of wettability of the material. Polyethylene is one of the promising medical plastic which is widely used in various prosthetics in bio- medical industries. Results of water contact angle and surface energy after atmospheric pressure air plasma is shown in figure-2. July. - Aug. 2015 24
Technology Incorporation of oxygen containing functional groups after plasma Plasma Treatment Improve Adhesion treatment is shown in below figure-3. This results are FTIR spec- To Polymers trographs. Polymeric materials are of great interest in various biomedical Another device fields. For instance, acrylic polymers are applied as prosthetic capable to form materials in ears, dentures, face prosthesis, breath tubes and plasma plume joints. Engineering polymers, such as PEEK, POM, polyamides is Non Thermal and PTFE are used widely in medical product manufacturing, such Plasma Torch as catheters, micro-catheters, nasogastric feeding tubes and (NTP). Recently endotracheal tubes. FCIPT, IPR has developed a One important property which create technical challenges in a compact device production environment is the characteristic low surface energy NTP. A plume of of polymers and the resulting intrinsically poor adhesion plasma comes characteristics. Various methods of improving adhesion are out of this de- available but often don’t lend themselves to production settings vice. This type and frequently involve the use of harsh and environmentally of plasmas is useful for healing skin wounds, blood clotting unfriendly chemicals to physically attack and etch the surface of in few seconds. The plasma torch is like a small pen which the material. Plasma surface modification offers a reliable and provides very narrow cold plasma plume which interacts with environmentally friendly alternative surface preparation for most skin or blood. Figure below shows view of a finger exposed engineering polymers. to this plasma. Dentists can use this torch for cleaning cavity in effective manner or for root canal treatment. The NTP has Plasma treatment a potential to use in cancer therapies as well. Conceptually techniques have this device can be inserted in to lungs with a probe and lung advantages over nodules / metastasis can be exposed other approaches for effective treatment. However this because it has the application is yet under evaluation. ability to uniformly modify the surface FCIPT, IPR welcomes interested and a few top organizations / industries to contact us monolayers of the at below contact details. material surface without any change Dr. Nirav Jamnapara in the bulk Technology Commercialization Cell properties. FCIPT, IPR [email protected], Plasmas can be a ww.plasmaindia.com P:07923269017. vacuum types (batch) or atmospheric types (in-line) and contain reactive gas species which, by careful choice of gas type and FCIPT, IPR has organized one day workshop on “Applications process parameters, can be used to increase the surface energy of Cold Plasma in Surface Engineering” on September 11, 2015. of a wide range of engineering polymers, and in doing so Registration is Free. Interested candidates can email us at significantly improve wetting characteristics and therefore [email protected] to register. Pre-registration is compulsory. For adhesion characteristics. more details of this workshop please visit www.plasmaindia.com. In-line atmospheric plasma surface treatment has been successfully demonstrated to increase the surface energy of PEEK from 35mN/m to >72mN/m, ensuring permanent PAD print adhesion. The treatment is active on PEEK for several weeks and so parts can be stored until needed. For PTFE catheters, air is ineffective due to the strength of the C-F bond. Batch processes are preferred which allow different plasma gases to be used and which are more effective in fluorine extraction from the surface. The surface energy of PTFE is raised from 18mN/m to >72mN/m in this case also. Both batch and in-line plasma treatments offer a reliable and repeatable surface preparation method for improving adhesion to a wide range of engineering polymers used in medical device manufacture. (Ref: http://www.medicalplasticsnews.com/technology/plasma- treatments-improve-adhesion-to-polymers/) 25 July. - Aug. 2015
Biomedical Technology Tips & Techniques By : D. L. PANDYA A Valuable Insight For Medical Device Industry, Biomedical Engineers & Doctors ENn2UlnEapdrWdgEaedtd!eit&dion Available Now in Soft Copy CD ROM : Rs. 500/- (Including Packing & Forwarding,Charges in India) Pdf File : Rs. 350/- Quite often, medical product manufacturers receive complaints of device malfunctions,serious injuries or deaths associated with medical devices. Manufacturers are also required to have additional postmarketing activities, postmarket surveillance for the monitoring of products after their clearance to market and device tracking for maintaining traceability of certain devices to the user level. Considering the current healthcare needs of the country , the Government of India has recently launched Materiovigilance Program to monitor Medical Device Associated adverse evnts ( MDAE ) , create awareness among healthcare professionals about reporting and monitoring risk – based profile of Medical Devices. The program will not only help in ensuring better patient safety but also improve the standard of Industry as well. The genesis of this book lies in a series of columns covered in our Medical Device technology magazine and internet portals over a period of more than 23 years. The book covers a wide range of Devices from simplest Infusion Devices, Endotracheal / Tracheostomy Tubes,Catheters ,Leukocyte reduction filters, Guide wires, Dialysis Filters, Vascular Haemostasis Devices, Blood Coating devices to artificial heart . It also highlights important issues like safety of healthcare professionals, reuse of single-use devices, cross-contamination, allergies to use of latex, sterilization methods, dialysis procedure etc. Readers would also enjoy and get enlightened by the quotes given on all the pages which speak volumes “In A Nutshell”. Foreword (First Edition) Biomedical Technology sector positions itself in a high value market place, but one where errors can be very expensive. Products are highly regulated and subjected to extensive quality controls. I find here a treasure of tips and techniques put together in a very simplified and user friendly manner. Whether one is a teacher or a student of Biomedical Engineering / Technology or a manufacturer / marketer of medical devices or a medical professional using the technology day in and day out, dipping into this collection will give one valuable insight. This book is written by a technocrat – an engineer with an academic inclination and compiled by him for an industry that he has been a part of for more than 25 years. This should be in every library and also in the personal possession of those who should know about handling of Biomedical Technology Products. Dr. R. A. Mashelkar Director General Council of Scientific & Industrial Research & Secretary, Government of India Department of Science and Technology
NEW!En2UlnapdrdgEaedtdeit&dion Biomedical Technology Tips & Techniques Product and Subject Index • Adverse Events • Healthcare Plastics Recycling • Packaging Failures • Ageing Population • Healthcare Professionals • Pediatric Medical Device • Artificial Heart • Healthcare Supply Chain • Phakic Intraocular Lenses • Bacteria Clog • Hemodialysis Catheter • Plastic Stents / Treatment Of Benign • Biopolymers • Heparin In Medical Devices • Blood Bags • Hospital Waste Esophageal • Blood Contacting Devices • Humanitarian Use Devices • Polymers • Bone Cement • I.V. Administration Sets • Prefilled Syringes • Cardiac Guide Wires • I.V. Bags • PU Dressings • Catheter Introducers • Intelligent Materials / Surgical • PVC : Environmental Perspective • Catheter Related Infections • PVC Tubing Reuse Of Single-Use • Catheters Implants • Centre For Devices And Radiological • Intravenous Filter Sets Devices • Intravenous Infusion Sets • Risk Management Health (CDRH) • IV Catheter • Safe Injection And Safety Practices • Combination Product • Knowledge Management • Safer Healthcare • Conductive Plastic • Leukocyte Reduction Filters • Sillicon Sensors For Catheters • Cornea • Luer Taper Fitting As Connectors • Steam For Sterilization • Coronary Drug-Eluting Stents • Medical Components • Sterilisation Methods • Dialysis Filters • Medical Device • Sterilisation Package • Dialysis Procedure • Medical Device Adverse Events • Sterilization • Distribution Channel • Medical Device Coatings • Sterilization Packaging • Endotracheal Tubes • Medical Device Innovation • Tracheostomy Tube • Engineered Medical Coatings • Medical Device Safety And • Transvaginal Surgical Mesh • FDA Regulations • Uhmwpe Fibers • Frugal Innovations Performance • Urological Devices • Global Medtech Manufacturers • Medical Devices • US Healthcare Industry • Haemodialysis Treatment • Medical Devices : Remote Monitors • Vascular Hemostasis Devices • Health Related Technologies • Medical Devices Containing Latex • Vinyl And The Environment • Health Technology • NeedlesOrthosis Callipers • Welding Of Thin Polymeric Films • Outsourcing • WHO Report Medical Devices ORDER FORM CD ROM : Rs. 500/- Payment : Enclosed by cheque in PDF Format : Rs. 350/- favour of “Classic Computer Services” Payable at Ahmedabad. Name : Cheque No. : Company : Date : Address : Amount Rs. : Bank : City : Pin Code : State : Country : Branch/Address : Phone : Fax : E-mail : Mail to Business Development Executive, “ Classic Computer Services”, B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta, Ahmedabad-15, India. Phone : +91 79-26740611 • Fax : +91 79-26754867 • E-mail : [email protected], [email protected] Website : www.medicalplasticsindia.com, medisourceasia.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. • 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] July. - Aug. 2015 28
Shree Dye Stuff AN ISO 13485-2012 CE certified Company Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing) Manufacturer & Exporter of Medical Disposable Devices & Surgical According to the customer requirment Products • Flexible PVC tubing grade compound • Flexible PVC moulding grade Range of Products : • Infusion Set compound • Blood Administration Set • Flexible PVC tube for I.V. Set, S.V. Set, • Measure Volume Set • Urine Collecting Bag X-ray opeque tube and Oxygen tube. • Urine Collecting Bag - Uro Meatry • Flexible PVC compound for Urine • Respiratory Exerciser • Twin Bore Nasal Oxygen Set bag roll • Oxygen Face Mask • Nebulizer Kit Contact Pragnesh Shah • Vaccum Suck Suction Set • Latex Surgical Gloves C-3 TPS 88, bharat Small Scale Industrial Area, • Umblical Cord Clamp B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Contact Yogesh Patel Mobile : +91 98246 49740, +91 93761 82700, M. : +91 98241 21383 +91 90168 13881 MEDICARE DEVICES E-mail : [email protected], 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, [email protected] C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 Our First Priourity is Customer Satisfaction E-mail : [email protected] Website : www.medicaredevices.com 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 July. - Aug. 2015 29
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.) 30 (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 July. - Aug. 2015
Global Trends Impact Of New European Regulations On Outsourcing Of Medical Devices During the last two decades, there has been a steady increase in Labeling and Packaging the outsourcing of medical device manufacturing to contract If packaging and labeling is outsourced, then suppliers must invest manufacturers, service providers, and component suppliers in in new equipment and software to implement on demand printing. European Countries.The medical device approval process in European Countries has generally been guided by national law Implementation of Revised ISO Standards where a conformity assessment is performed by a notified body In parallel with changes to the medical device regulations for and the device obtains a CE marking meaning it can be sold in Europe, the quality system standards (i.e., ISO 9001 and ISO the European Economic Area. 13485) will also be changing. ISO 9001:2015 is expected to be However, over the past few years there has also been an increase released in October 2015, and the DIS2 for ISO 13485:201x was in the frequency of recalls and increased scrutiny of the supply just released for comment. If these revised standards are chain by regulators.The new European Medical Device Regulation harmonized, then contract manufacturers will be forced to (EMDR) places additional burden on manufacturers and their implement these changes in order to meet the CE Marking suppliers. requirements. Medical device companies will operate under a stricter regulatory If contract manufacturers want to survive during this period of environment in Europe following the approval of new regulations tougher European regulation, contract manufacturers and governing medical devices and in vitro diagnostics by the Council component suppliers need to be proactive and get additional of the European Union. The Council proposes stricter requirements training. Training needs to include general quality system on medical device manufacturers, who would be required to: requirements, EMDR. Suppliers should also consider developing new quality agreements to address the new regulations. • Create a post-market surveillance system appropriate to a device’s type and risk class (Ref: http://www.meddeviceonline.com https://www.linkedin.com/pulse • Submit periodic safety update reports (PSURs) akin to http://www.mddionline.com pharmaceutical requirements • Appoint a person with “requisite expertise” in the field of medical devices to be responsible for regulatory compliance • Respond more quickly to public health threats or deaths linked to medical devices • Conduct clinical investigations demonstrating the safety and performance of highest-risk (Class III) devices • Consult with an expert panel to review the manufacturer’s clinical development strategy • Submit post-market clinical follow-up plans and post-market studies of an equivalent device, provided the device is designated as equivalent by the notified body, or designated as a modification of a device already marketed by the same manufacturer • Notified bodies will undergo a stricter designation process and increased monitoring by competent authorities, but they also will be given authority to carry out unannounced factory inspections This means trial costs are going to increase as there would be a need to collect additional clinical data to demonstrate efficacy and safety of a medical device. The EMDR is also pushing for greater data transparency meaning companies will need to prepare data in a traceable and readily available way to respond to any liability issues. Increased Frequency of Audits Manufacturers are required to demonstrate control of suppliers and records of evaluating suppliers. The most common practice is to categorize suppliers as having either “critical” or “non-critical” status. Increased frequency of audits and audits of more suppliers will July. - Aug. 2015 stretch the human resources of suppliers and manufacturers alike. Ultimately, manufacturers will need to consider alternative solutions to on-site audits, such as remote auditing and sharing audit reports with other manufacturers. 31
Industry News Provisions Of DPCO, 2013 Applicable To Notified Medical Devices: NPPA The National Pharmaceutical Pricing sales of the formulations, which include 14 and other details like ex-factory price/ Authority (NPPA) has clarified that notified medical devices. Accordingly, it has landed cost (including applicable duties); orthopaedic implants along with other been decided to seek the following distributor cost; maximum retail price medical devices will be treated as drugs, information/documents in order to examine (MRP); and percentage of increase in MRP hence provisions of DPCO, 2013 are price violation, if any, in respect of notified (year to year) in the last three years. applicable to notified medical devices. medical device, manufactured/imported/ marketed by the company, the NPPA further The NPPA said that Para 20 of the DPCO, Refuting the contention of the medical mentioned in its clarification. 2013 provides for monitoring the prices of devices manufacturers, especially the non-scheduled formulations and to ensure manufacturers of orthopaedic implants, that Earlier in May this year, the NPPA had that no manufacturer/importer/distributor is the provisions of DPCO 2013 are not sought detailed information about the prices allowed to increase the MRP of a non- applicable to medical devices, the NPPA of notified orthopaedic implants from the scheduled drug more than ten per cent of said, “Para 20 of DPCO, 2013 provides for manufacturers to initiate stringent action if MRP during preceding twelve months and monitoring of non-scheduled formulations. they are found to be charging exorbitant where the increase is beyond ten per cent, Orthopaedic implants along with other prices from the consumers in violation of it shall reduce the same to the level of ten medical devices are notified as ‘drug’ under Drugs & Cosmetics Act. The NPPA’s action percent of maximum retail price for next Drugs & Cosmetics Act & Rules thereunder. was in the wake of reports in the media that twelve months. The manufacturers/ Therefore your contention that the the prices of orthopaedic implants regulated importer/distributor shall be liable to deposit provisions of DPCO, 2013 are not as ‘drugs’ under Drugs & Cosmetics Act & the overcharged amount along with interest applicable to medical devices is totally Rules thereunder, are sold at exorbitant thereon, from the date of increase in price incorrect.” price with high profit/trade margin. in addition to the penalty. It may also be noted that Para 25 of DPCO, The NPPA had then asked the (Ref: http://www.pharmabiz.com/ 2013 requires every manufacturer/importer manufacturers of notified orthopaedic NewsDetails.aspx?aid=89286&sid=1) to issue a price list in Form V. Further Para implants to provide details like product 29 empowers the government to call for any specification with brief description/literature record and to inspect such report at the for different types of notified medical devices premise of the manufacturers relating to manufactured/imported by the company Gujarat FDCA To Meet Commerce Ministry To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab Gujarat Food & Drugs Control since they have already identified a suitable manufacturers, a process which is not only Administration (FDCA) is expected to meet location within the building, which is located time consuming but also very costly for commerce ministry to speed up the release in the middle of the thriving industrial belt. domestic manufacturers. of funds for setting up of the country’s first biocompatibility and medical device testing “The funds that we have sought is for Expressing strong support to this move, lab. The state drug regulator had earlier this infrastructural development, acquiring high experts pointed out that this will not only year drafted a proposal to the Centre to tech equipments for testing and getting offer an affordable option for the sanction a budgetary allocation of Rs.15 trained manpower. It is an ambitious project manufactures but will also instill confidence crore for the same. and will certainly help to support the industry in the long run, especially since, in spite of among the stakeholders. The Engineering Export Promotion Council it being one of the growing sector, India does (EEPC) under the commerce ministry not have a biocompatibility and medical (Ref: http://pharmabiz.com/ constituted to support the growth of device testing lab in the country. If things ArticleDetails.aspx?aid=89485&sid=1) engineering sector including medical go as planned, we hope to operationalise devices has given positive response this lab as early as end of this year.” towards setting up of this lab. It is understood that the status of this ambitious It is understood that medical device proposal is in the final stages of approval. manufacturers who wish to do business today are forced to pay huge price for their Dr. H G Koshia, commissioner of Gujarat products to be tested by international testing FDCA informed that once the funds are agencies. At present, domestic released, the work on the project will be manufacturers are forced to send their immediately commenced within the food devices to other countries like Singapore and drug testing facility in Baroda. He said to get their products tested before marketing that getting funds from the Centre is the it. International testing agencies do the tough task as once that is cleared, they will biocompatibility study for them, generating be able to make progress quickly especially the data and filing the reports for the 32 July. - Aug. 2015
Industry News U.S.-India Business Council Concludes Successful Medical Device Trade Mission To India The U.S.-India Business Council (USIBC) a number of sectors and maintains strong encouraged by the openness of the concluded its Medical Device Trade Mission potential to do the same in medical devices. Government of India to engage with industry to New Delhi and Gandhinagar. The With India’s first-rate engineering talent, on best practices and areas of potential delegation expressed its commitment to experience in IT innovation, and the Modi collaboration. Discussions included the addressing India’s most pressing public government’s Make in India focus, it is even importance of developing a critical mass of health challenges, and called for further more important for the government and patients with access to healthcare and dialogue with the government on issues industry to work toward creating the proper improving patient awareness of healthcare related to ease of doing business, disease ecosystem for medical device innovation. costs. USIBC members noted in their management, and the implementation of This will expedite the ongoing creation of meetings that they publish Maximum Retail training programs for medical device research and development and product Prices (MRP) on all medical devices sold regulators. innovation that medical device companies in India. The Indian medical device industry The delegation was chaired by Maulik offer India, leading to faster growth of is going through rapid transformation and Nanavaty, Senior Vice President and medical device manufacturing in the is projected to grow at a higher rate as President for Neuromodulation at Boston country. The time is opportune to fulfill the health insurance becomes more widely Scientific, and included participation from government’s mandate of Make in India and available and the country’s consumers Abbott, Medtronic, Zimmer, Johnson & Innovate in India,” said Maulik Nanavaty of continue to demand better healthcare Johnson, Quintiles, General Electric, Varian Boston Scientific. services. USIBC’s medical device members Medical, and AZB & Partners. are excited about the opportunities in India,” Meetings with the Government of India said Amy Hariani, Director and Legal Policy “Through this series of fruitful discussions, included the Ministry of Health, Department Council at the U.S.-India Business Council. we have identified opportunities to continue of Industrial Policy and Promotion, Drugs collaborating with the Government of India Controller General of India, Ministry of (Ref: http://firstreport.in/news-release-u-s-india- in support of its priorities to attract Commerce, Ministry of Finance, Department business-council-concludes-successful- investment and talent to the medical device of Pharmaceuticals, and the Ministry of medical-device-trade-mission-to-india- sector. India has made considerable strides Chemicals and Fertilizers. firstreportindiagmail-com-gmail/) in developing innovative industries across “USIBC member companies were 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 33 July. - Aug. 2015
Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 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] 34 July. - Aug. 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 July. - Aug. 2015 35
Events Since its première in 1992, every year, COMPAMED has taken and valves, among other things), materials/ substances, micro- place in Düsseldorf during the middle of November in parallel to and nanotechnology, made-to-order manufacturing, electronic the world’s largest medical trade fair, MEDICA, and since its start, manufacturing services (EMS), complex manufacturing and equip- it has been writing its story of success. Always scoring top results ment partnerships (e.g. OEM – Original Equipment Manufactur- in reference to the number of exhibitors and visitors on a yearly ers) as well as packaging and services. basis, COMPAMED has long since developed into the leading international marketing communication platform for suppliers of In parallel with the world’s largest medical trade fair, MEDICA 2015, the medical technology industry. It’s not just the numbers that are being held at a single time and a single location, it will cover the right with, for the first time, more than 700 exhibitors from 37 entire medical technology supply chain – from individual nations during last year’s trade fair. Also the quality of the range components to measuring techniques and quality testing through of offers has changed through the years and has continuously to sterile, packed end products. This coordinated tandem of trade improved at the same tempo the changes in the medical fairs and topics is a one of its kind event and a significant success technology market have. Where, at one time, simple parts, factor for both events. components and equipment for technical devices and medical products had primarily been presented, today, COMPAMED is a In 2014, MEDICA + COMPAMED welcomed a total of 130,000 hotspot for complex high-tech solutions. specialist visitors, around 17,000 of whom were particularly interested in the topics covered by COMPAMED. This is because, nowadays, suppliers and medical technology providers are cooperatively driving the development of new All information can be accessed online at systems and processes in close coordination. In the process, the http://www.compamed.de and http://www.medica.de. development competence of the suppliers, in part, is often the point of origin for groundbreaking innovations with regard to Events Calender efficient and effective medical care. The success of COMPAMED can also be explained by this close • Medicall 2015 integration of development processes on behalf of the suppliers 14th Edition Medicall 2015. as well as their customers. Holding MEDICA in parallel creates Date : 9th - 11th October, 2015. the ideal conditions for exhibitors. Thereby, COMPAMED is the Venue : Bombay Convention and Exhibition Center ideal place for suppliers to exchange information with medical technology providers and system partners. Alone the • COMPAMED 2015 approximately 4800 exhibitors of MEDICA are also potential High - Tech Solutions For Medical Technology visitors of COMPAMED. Date : 16th - 19th November, 2015. Venue : Dusseldorf, Germany. A significant change concerning the running time of COMPAMED and MEDICA will open up more opportunities to establish an in- • Plastivision Arabia 2016 tensive level of contact, do business, or even coordinate joint Region’s Leading Plastics Event projects. For the first time, both specialist trade fairs will be taking Date: 10-13 January, 2016 place at completely the same time during the course of four days Venue: Expo Center, Sharjah. from 16 to 19 November. The market for medical technology and medical products is very • 13th National Conference And Technology Exhibition on dynamic. The innovation cycle is considerably shorter than is the Indian Medical Devices & Plastics Disposables / case in other industries. The German medical technology Implants Industry 2016. manufacturers make about a third of their sales with products Date: 12-13 February, 2016 that haven’t even been introduced on the market for more than Venue: Ahmedabad Management Association, three years. In accordance with this, it is necessary for every Ahmedaad. specialist who deals with product development in the medical field to continually keep themselves up-to-date. • Medical Fair India 2016 22st International Exhibition and Conference The product range at the COMPAMED trade fair (in halls 8a and Date: 11-13 March, 2016 8b) includes the following key branches: Components for medi- Venue: Bombay Convention & Exhibition Center, cal technology (electronics, components, hoses, filters, pumps, Mumai. 36 July. - Aug. 2015
Operon 37 July. - Aug. 2015
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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 39 July. - Aug. 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 40 E-mail : [email protected] www.basilpolymers.com July. - Aug. 2015
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