Medical Plastics Data Service March - April 2018

CToabnletoef nts Vol. 26 No. 1 Jan. - Feb. 2018 18 Cover Story Challenges and Opportunities For Medical Disposables & Implants Industry in India Himanshu Baid, Managing Director, Poly Medicure Ltd. & Chairman-CII Medical Technology Division The removal of existing barriers for growth & innovative initiatives from government will ultimately lead to increased investment in the Indian Medical Devices Industry. All stakeholders can work together today to contribute for the future vision of “Affordable and quality healthcare to all. Growth Dynamics For Indian Medical Device Industry • Three issues are of critical importance - unavailability of right quality raw materials & components, lack of skilled workers and capacity to implement quality needs.” • New medical devices procurement guidelines propose to make 20-50% of components in India.” 23 Materials Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Medical Polycarbonate lends its outstanding properties to achieve high performing yet portable medical device design…` 25 Global Trends The Asean Medical Device Market The region’s medical device market is expected to grow strongly and access to the market will improve in the coming years due to…….. 29 AiMeD & Regulatory Updates • AIMED urges GoI to take policy decisions to boost Domestic Mfg & to Make Healthcare Affordable in India • New guidelines for medical device grouping to streamline licensing • Govt. invites proposals from labs for testing medical devices, IVDs as per new MD rules • Gujarat FDCA sends draft notifications to state govt for approval to implement new Medical Devices Rules 32 Industry News • QCI, UL team up with govt and industry to spur robust quality ecosystem to build 'Brand India' in medical devices • Hindustan Syringes and Medical Devices gets ‘India Design Mark’ 33 Product Gallery • Cost-Effective Off-the-Shelf and Custom Tubing Solutions • Slide Clamps 16 Did You Know? • About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets 34 Events & Events Calender • Medical Manufacturing Asia 2018 : 29 – 31 August, 2018 • Medicall : 27 – 29, July, 2018 • Medicall : 21-23 September, 2018 • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 : 26-27 October, 2018 • K 2019 : 16 – 23 October , 2019 Mar.-Apr. 2018 15

Flashback ?YoDKuindow ? About Serious Health Consequences Due Select Article Index to Faulty Tracheostomy Tube Sets. Jan. 2008 to Aug. 2008 What is tracheostomy ? • Opportunity for Innovation in Medical Device Industry Clusters A tracheostomy is an artificial opening in the neck into the windpipe (trachea). (January – February 2008) This opening is called a stoma. It allows air to go in and out of the lungs. It also allows any mucus to be removed. A small tube (the tracheostomy tube) is • California Biomedical Industry inserted through this opening. Breathing occurs through this tube. Thus it (January – February 2008) creates safe airway access and provide a pathway to remove fluid from the trachea and lungs. • About Medical Device Innovation (January – February 2008) There are different types of tracheostomy tubes that vary in certain features for different purposes. These are manufactured by different companies. • Developments In Polymeric Materials For Patient is given the tube that best suits his/her needs. The frequency of these The Storage Of Blood And Blood Compo- tube changes will depend on the type of tube and may possibly alter during nents (March April 2008) the winter or summer months. Dr. C.S.B. Nair, Smt. R. Vidya and Smt. P.M. Ashalatha, Terumo Penpol Ltd. However, a specific type of tracheostomy tube will be the same no matter which company manufactures them. • Medical Device Industry : Pros & Cons of E-Business (March April 2008) A commonly used tracheostomy tube consists of three parts: outer cannula with flange (neck plate), inner cannula, and an obturator. The outer cannula is • About Self-Expanding Plastic Stents Used the outer tube that holds the tracheostomy open. In The Treatment Of Benign Esophageal Conditions (March – April 2008) Incidents may occur when Tracheostomy Tube Set connector disconnect from the tracheostomy tube during use on a ventilated patient. If the connec- • Medical Textiles : Emerging Opportunities tor detaches from the tracheostomy tube shaft during use, it can deprive the (May – June 2008) patient of adequate ventilation and would require immediate medical inter- vention including changing the tracheostomy tube and placing a new tube. • Plastics In Healthcare-Expanding Horizons The use of affected products may cause serious adverse health consequences (May – June 2008) including oxygen deprivation, brain damage and death. Mr. Ravi Jalali, General Manager, Business Development - Polymers, Reliance Industries The FDA has identified this device as a Class I recall, the most serious type of Ltd. recall. Use of these devices may cause serious injuries or death. • Molding & In-Line Assembly Automation (https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526022.htm) For Medical Plastic Components (May – June 2008) In a Mr. Jignesh Bavishi, Hekuma GmbH (Neejtech Nutshell.... India) “The only thing worse than • European Medical Device Vigilance System being blind is having sight Guidelines (May – June 2008) but no vision” • Heparin in Medical Devices Linked to 11 U.S. Deaths (May – June 2008) -Helen Keller • Diabetes Disposables : Focus Insulin Delivery Systems (July – August 2008) • Bonding Medical Devices (July – August 2008) Mr. Barun Bharadwaj, Henkel Adhesives Tech- nologies India Pvt. Ltd. • FDA 510(k) Process Provides Framework for Effective Medical Device Regulation (July – August 2008) • About The Economics of Prefilled Syringes (July – August 2008) 16 Mar.-Apr. 2018

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. This issue has focus on discussing Challenges and Opportunities for Indian Medical Device Sector particularly for Medical Disposables EDITORIAL ADVISORY BOARD & Implants sub-sector. Dr. TARANG PATEL In his article, Mr Himanshu Baid, Managing Director, Poly Medicure M.B.B.S., M.Ch. (ONCO) Ltd. & Chairman – CII Medical Technology Division, while critically Cancer & Reconstructive Surgeon analyzing needs of this Sector, has very rightly mentioned that : Mr. C. BALAGOPAL “The key issue remains that an import dependent economy cannot suddenly shift to Director - Enter Technologies Pvt. Ltd. indigenous manufacturing simply through driving policy decisions in a sector such as Chairman - Mobilexion Technologies Pvt. Ltd. healthcare. To gradually transition from an import dependent to an export-oriented sector, the Government with all stakeholders, needs to come together to prepare and Trivandrum develop our medical technology ecosystem. To create such a healthy ecosystem in the near term, we will have to grant equal importance to imports and domestic manufacturing Dr. DILIP H. RAIKER with a view to improve clinical outcomes and have continued access to global technology Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) enabling a smooth transition.” Former Chief Manager(P), CIPET - Chennai He has given indepth explanation for three Industry proposals : ING LOUIS C. SUHUURMAN Formerly Sales Director 1. Healthcare expansion by ramping up government spending on Healthcare. COLPITT B.V., Holland 2. Single window regulation for Medical Device related manufacturing 3. Economic incentives and rationalized duty structure. Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group He has also emphasized that, “Besides affordability of healthcare (which is currently 75 per cent out of pocket), the three pillars of medical technology remain safety, Dr. Vinny Sastri quality and efficacy of devices”. President, Winovia LLC, U.S.A. The editorial article on “ Growth Dynamics For Indian Medical Device Industry” highlights Dr. C.S.B. NAIR – unavailability of right quality raw materials & components , lack of skilled workers and Director (R&D), Peninsula Polymers Ltd capacity to implement quality needs as issues of critical importance. The article also introduces a report for Mexico analyzing the “Roadmap for the Medical Device Industry” Dr. BHARAT GADHAVI which suggests various “Supplier Development” activities. It also shares opinions of CEO, HCG Medisurge Hospitals various Industry leaders on the subject as part of the previous survey carried out by “MEDICAL PLASTICS DATA SERVICE”. Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai We are also happy to mention that, “The Department of Pharmaceuticals” has proposed that the domestically sourced components have to contribute 25 – 50 % Dr. SUJOY K. GUHA of the cost of medical devices procured by the government. “On draft of the B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. proposed guidelines , created to give preference to products made in India, DOP has sought comments from all stakeholders”. IIT, Kharagpur “AiMeD” has also urged Government to take policy decisions to boost Domestic Dr. G. S. BHUVANESHWAR manufacturing & to make healthcare affordable in India. In another such development, Consultant, Medical Devices – Design, development, The quality council of India (QCI) alongwith UL has initiated efforts to further quality ecosystem in the country through standardization in Medical Devices also with an testing and quality management. objective to “Build Brand India” in Medical Devices. One more positive development is Adjunct Professor, Dept. of Engineering Design, Indian the guidelines issued by the Union Health Industry for grouping Medical Devices in oder to streamline the application process for obtaining manufacturing or importing Institute of Technology, Madras. licence. PUBLISHED BY : Along with the newly initiated column, “AiMED & Regulatory Updates”, this issue highlights Global Trends, Industry News, Materials, Products Gallery “Important Classic Computer Services Events as well as our regular enlightening column, ”Did You Know ?”. 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-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Mar.-Apr. 2018 17

Cover Story Challenges and Opportunities For Medical Disposables & Implants Industry in India With 17% of world population and a dependent to an export oriented mar- GDP growth rate of 7.2%, India is ket. The key issue remains that an amongst the fastest growing import dependent economy cannot economies of the world. The Indian suddenly shift to indigenous manu- healthcare sector grew at a rate of facturing simply through driving 18% from 2010 till 2016 and is policy decisions in a sector such expected to advance at a rate of 15% as healthcare. To gradually transi- during 2016-20 to reach USD 280 tion from an import dependent to billion by 2020. an export-oriented sector, the Gov- With 1/6th of world’s population and ernment with all stakeholders, a growing demand for healthcare needs to come together to prepare services, India is also likely to and develop our medical technol- witness a spur in the demand for ogy ecosystem. To create such a allied technologies, medical healthy ecosystem in the near term, devices, medical equipment and we will have to grant equal impor- medical consumables which will tance to imports and domestic aid in delivery of affordable manufacturing with a view to im- healthcare. Medical Technology can prove clinical outcomes and have be instrumental in shaping healthcare continued access to global for all in India as it provides the technology enabling a smooth opportunity to leapfrog over India’s transition. longstanding healthcare challenges To gradually transition from an Industry proposes three thrust – accessibility, affordability and import dependent to an export- areas : quality. oriented sector, the Govern- 1. Healthcare expansion by ramp- Current global medical technology ment with all stakeholders, ing up government spending on market is around US$ 350 Billion. needs to come together to Healthcare: Which is expected to grow to US$ 500 billion+ by 2025. The Indian The size of the Indian medical market is among the top twenty in the technology market is a key world by market size, but its only 2% constraint for investment in India, in value. particularly in local manufacturing. On most healthcare metrics India The Indian medical device sector prepare and develop our medi- has one of the lowest ratios, be it is expected to grow at a CAGR of cal technology ecosystem. doctors, per capita health care 15 % for next 4-5 years. Medical spend as a percentage of GDP, or Technology can be instrumental in Himanshu Baid, even hospital beds. The US$50 shaping healthcare for all in India. billion opportunity for Medtech in • It plays a key role throughout the Managing Director, Poly Medicure Ltd. India can only be realized if patient’s care continuum – preven- & Chairman-CII domestic demand is unlocked. tive, diagnostic, as well as pallia- Further - more, a significant part tive treatments Medical Technology Division of the demand generation oppor- tunity will be with the recently • It has positively impacted the healthcare delivery and patient outcomes announced Ayushman Bharat programme that aims to provide healthcare benefits for the 10 crore poor Medical Technology in India, like in several other countries families or around 40 per cent of the population. This makes in the world, is largely import dependent. Over 70 per cent the program the world’s largest government-funded health of high end medical devices and critical care equipment are care program. Every family will receive a benefit coverage up imported whereas large volume and comparatively low to to Rs 5 lakhs per year under the National Health Protection medium - end consumables, disposables and equipment’s Scheme, which is likely to cost the government around Rs are mostly locally manufactured. 1000-1200 as the premium of each family. The Government While the inverted duty regime is being touted as one of the has urged the Indian Medical Devices Industry to brace for primary reason for this imbalance over the years, the country’s meeting the demands of the ambitious health insurance Make in India initiative is being implemented through a ‘policy scheme. The Government expects the Medical Devices push’ to encourage local manufacturing and shift from an import industry to double in next five years. With this clear approach 18 Mar.-Apr. 2018

Cover Story ing domestic opportunity, all stakeholders are optimistic about tional. The projects are delayed in various states. the future of ‘Make in India’ and are expecting manufacturing investments to follow in the very near future. The medical devices industry is just like the automobile industry, as a lot of Research and Development (R&D) We need to wait and watch how the government is going to takes place. By allowing weighted tax deduction of upto fulfill the promise of bringing over 10 crore Below the Poverty 200 percent on R&D investments for the sector will Line (BPL) families under a health insurance scheme and promote innovation. Currently it is reduced to 150 per cent enhanced health insurance cover up to 5 lakh. Funding such and further it is said to be reduced to 100 per cent. a large project in short term will be challenging. Stakeholders need to take cognizance of the fact that it is not a 2. Single window regulation for medical device related desirable situation for a country with over a billion population to manufacturing: be 70 per cent import dependent on medical devices. Besides affordability of healthcare (which is currently 75 per cent A Single window clearance for not only setting up the out of pocket), the three pillars of medical technology manufacturing facility but also for day-to-day operations would remain safety, quality and efficacy of devices. At present, go a long way in addressing the primary concerns of investors there is no nodal agency for assessing and evaluating in local manufacturing in India. Alignment of policy implemen- technology in India. tation across different state and national bodies will help reduce the challenges of running efficient operations in India. The government should have a separate department under Designating areas as Medical technology hubs is not enough. the Ministry of Health and Family Welfare (MoH&FW). The medical devices cater more to the healthcare than the pharma- The supporting infrastructure and desired talent needs to be ceutical sector. Too many governing bodies with diverse require- put in place. When designating areas as hubs, the govern- ments and standards, viz Department of Pharmaceuticals, Bio ment needs to make sure the inbound and outbound clear- Technology, Telecommunications, Ministry of Environment and ances (e.g., customs) are streamlined, logistical challenges Forest, Ministry of Science and Technology, Ministry of Commerce, are addressed with sufficient Third Party Logistics (3PL) are hindrance to promotion of new technology. These affect ease capacity and finally enough technical training is in the vicinity of doing business as the decision making becomes slow. For the to provide trained manpower to the hubs. industry to grow and make it a hub, we need a nodal department which focusses on the segment. 3. Economic incentives and rationalized duty structure: It is important to create incentives to enhance the attractive- Product performance reports are a globally accepted means of ness of local manufacturing. As we know, the cost of capital in showing efficacy of medical technology, an aspect which has not India today is high and traditional incentives such as capital found the same degree of importance in drafting policy and regu- subsidy and soft loans will help companies to consider invest- lation. In other words, a onesize-fits-all approach may not work ing in India. Finally, there is a need to establish appropriate here and careful mapping of the medtech landscape is needed duty structures for imported raw materials (to address the to identify the devices and equipment that are viable to making in inverted duty structure challenges), which will encourage India. indigenous manufacturing. National Pharmaceutical Pricing Authority’s (NPPA) and Depart- For the medical devices industry, the recent budget was a ment of Pharmaceuticals are in discussion about categorization disappointment. In 2016, the government had reduced the of medical devices into different segments for the purpose of custom duty for some of raw materials to 2.5 per cent, but it fixing of trade margins. But the medical devices industry is was not done for in Vitro Diagnostic (IVD)s, which is a part of continuing to be divided on the move of rationalization of trade the sector. If the government really wants to “Make in India” margins. Rationalization of the price is necessary through an they should have reduced the custom duty of all the raw average pricing formula. The industry also suggests : materials used in the medical devices, including IVDs. The government announced a lot of measures to boost local manu- • Transparent and evidence based pricing and reimbursement facturing, but they are not implemented as yet. For example, policies should be promoted the number of medical parks, which were announced in various states, is still a non-starter as none of them are opera- • No arbitrary price control mechanisms should apply Poly Medicure Ltd. Poly Medicure Ltd is one of the leading medical devices manufacturer and exporter from India with dominant position in medical consumables market over 20 years with focus on innovation, safety and quality and have a vision of a world with highest quality of healthcare is made available to all. POLYMED have 5 manufacturing facilities in India (3 facilities in Faridabad and 1 each in Jaipur and Haridwar), 2 facilities overseas (One facility in China – wholly owned subsidiary and One joint venture in Egypt.) Poly Medicure has spent Rs. 60 crore on the new green field project at IMT Faridabad, another 50-60 crore will be spent on the capacity expansion, automation and new products to be launched. Polymed produces over 100 different types of medical devices, the category ranges from Infusion Therapy, Central Venous Catheter, Blood Management System, Surgery and Wound Drainage, Anesthesia, Urology and Dialysis. With 98% percent of products of the renal care imported, the company will launch portable artificial kidney dialyser, which will help in continuous blood cleansing. A filter developed indigenous in India will help decrease the cost and more people will be able to afford it. Mar.-Apr. 2018 19

Cover Story Rules. The rules suggested phase out use of chlorinated plastic bags and gloves. The industry is concerned as there is no alter- • Recently Government broadened Medical Device definition to native to some of the chlorinated bags (Urine Bags, Drainage attract FDI. – delinked with D&C Act – (Same should apply for bags etc.). Rules & Regulations) The removal of existing barriers for growth & innovative The industry welcomes CDSCO’s recent notification on waving initiatives from government will ultimately lead to increased off ADC/NOC condition of export consignments to all countries. investment in the Indian Medical Devices Industry by domes- This was a long standing demand of domestic manufacturers. tic and global players alike, whether in the form of local manu- This waiver of ADC/NOC will reduce the procedures for export facturing, fostering Research & Development and Innova- clearance from the port where shipments were getting delayed tion, partnerships for skill development, among other things. for requirement of additional paper work. This is an important step taken by CDSCO to accelerate exports and reduce bottle All stakeholders can work together today to contribute for necks for domestic manufacturers. the future vision of “Affordable and quality healthcare to all”. Also, the Ministry of Environment and Forest notified last month exclusion of Blood Bags from Bio Medical Waste Management Growth Dynamics For Indian Medical Device Industry The Medical Device Industry industry are biomedical, automation, process design, product design, qualityengineering but often they are also related to the Medical Devices are an extremely diverse group of products. This pharmaceutical or chemical industries. covers very simple applications suchas first-aid bandages, tongue depressors, walking frames and plastic tubing, to more complex Regulations influence businesses to a large extent, which have devicessuch as implanted cardiac and neurological devices, to comply with complex regulatory,customs, health safety and robotic surgical systems, and magnetic resonanceimaging security regulations and are responsible for meeting requirements devices. such aslabelling, packaging or post-sales monitoring. Regula- tion is an important driver behind innovations andcross-industry The industry is characterised by high interdisciplinary with trends. extremely high innovation dynamics. MedicalDevices firms rely strongly on research, technology and engineering and thus On the downstream we find the customers such as hospitals, require a wide-rangeof skill sets such as medical and technical laboratories, doctors’ consultancies and thepatients themselves, skills. Both high-technology solutions and basic or frugal and other actors such as logistical companies, medical equip- supplies characterise the industry. ment stores,pharmacies,other retailers and insurance companies. The Medical Devices industry is globalised and specific parts of A Make in India for Medical Device Industry the final product are delivered in differentplaces of the world. The If Indian Medical System needs to get some sort of independence, industry is specifically sensitive to copycats and firms are careful Make in India approach needs to become deep rooted in the in notbeing copied by others or overseas. This is why the differ- Indian Medical Devices Industry. Interestingly the range is also ent industry segments in the value chainoften do not trust each huge, as compared to medicinal products. However, medical other, which is a barrier to information sharing and collaboration. devices industry of India is miniscule in comparison with global Challenges Make in India ini- production, with disproportionate reliance on im- tiative assumes ports and indigenous manufacturing being mostly The key challenges of the industry include the paramount impor- restricted to products in the lower end of the tech- move to value-based health care, where the tance, not only to nology value chain. With such high dependence emphasisis on solutions, security and affordable reduce technology of imports, not surprisingly, they contribute nearly costs; increasing global pressure on healthcare gap but also to 25 per cent of an average treatment cost. While costs, growingregulatory reforms and scrutiny to reducethe cost of the per capita spending on Medical Devices in numerous issues, including the processby which treating illness. India is the lowest among BRIC countries, it products gain marketing approval; and resource represents a sizeable growth opportunity. constraints. Thus, a Make in India initiative assumes Medical Device Industry Value Chain paramount importance, not only to reduce technology gap but also to reduce the cost The medical devices value chain ranges from research, technology and development, raw ma- But there are of treating illness. But there are challenges. terials /component / sub-asemblymanufacturing, Three issues are of critical importance - assembly, distribution, to marketing, sales and challenges. unavailability of right quality raw materials& post salesservices. Diverse interactions components, lack of skilled workers and characterise the industry depending on the type of product. capacity to implement quality needs. Central actors are medical technology companies and manufac- Despite sufficient human capital in the country, the industry faces turers (eg. responsible for machining, packaging or sterilising the the problem of inadequacy of the available skilled and trained product). Manufacturers are suppliers of specific parts (eg. origi- manpower in both quantitative and qualitative terms. However, nal equipmentmanufacturers), engineering firms, software com- we would like to highlight only one important bottle neck here. panies, clinical trial organisations, and certifying bodies. Access to critical raw materials: Quality of critical raw materi- Upstream actors include research institutions, private research als / components is not up to the mark in India. Hence a number laboratories involved in testing, Thedominant disciplines of this of critical raw materials are required to be imported in order to 20 Mar.-Apr. 2018

Cover Story meet international product quality requirements. However the high technology base in India.” import duty on these raw materials / components as well as high As per Mr C. Balagopal, if effective steps are taken for various costs of low volume imports results in high cost of assembling in issues discussed earlier in this debate, it will lead to the develop- India which in turn turns out as a non-viable exercise. ment of Indian Medical Device Industry. It will also create the Substituting imported parts / components with that could necessary conditions for development all along the supply chain be manufactured by Indan Companies (as starting from basic raw materials, intermediate done by “Medical Device Three issues are of components, sub contracting/ vendoring, Industry Clusters” in other developing coun- critical importance outsourcing of processes like steriliza- tries) would promote growth of the sector tion, testing, warehousing, transportation etc. along with a greater transfer of technology - unavailability of Supporting the need for strong supply chain, Mr in design , development and advanced manu- right quality raw Ajay Pitre cited the case of aerospace industry. facturing processes in the country . Products materials& compo- The similarity as per him is because of both have / components quality standardizations and nents, lack of reliability requirements of highest order. He also the standardization in the components skilled workers further says that , “The other area where special- manufacturing processes and facilities and capacity to ized supply chains have contributed to the including appropriate regulatory norms (not implement quality device industry has been in the field of packag- the same as finished products but appropri- needs. ing. Validation requirements for medical device ate for raw materials/components manufac- sterile packaging are extremely stringent and the turing) will contribute significantly towards advancements in packaging materials and thegrowth of Medical Device Industry in conversion technologies made by service India. providers play a key role in enabling the device A report on the “Roadmap for the Medical Device Industry” in industry. He also feels that, “Government needs to financially Mexico by “ProMexico” ( www.promexico.gob.mx ) has identified support service providers in these supply chain areas who could “Supplier Development” as major focus area and suggested the form a supplier backbone.” following : Emphasizing on warehousing requirements, Mr Himanshu Baid “Supplier Development must take into account the significant gap mentioned that, “higher Volume products should be centralized in the sector’s supply chain, which will not have capabilities from so that they can be easily distributed to various parts of the coun- other sector to convert and that start by creating national compa- try. Warehouses with proper storage facilities should be created nies in these niches or attracting companies from other regions in each District for storage of products to ensure efficient distri- and developing strategic alliances with Mexican companies. The bution to smaller healthcare centres. Al so this will ensure shorter TRM work group identified the following main projects : delivery times. Public Private Partnerships will definitely make this more affordable.” • Creation of a supplier integration program. • Consolidation of a National Supplier Development Council for Share of Medical Device Companies involved in one or more phases of Medical Device manufacturing process : Global the Health Sector. and Indian Scenario • Promotion of sector events that allow the presentation of structural projects to opinion leaders. As per a 2014 report on “ Production , Research And Innovation • Replication of the R&D Investment Program by bid purchases In The Medical Device Industry in Italy”prepared by “Assobiomedica Research Centre ( CSA )” - “56% of companies model (YSSEMYM). are involved in distribution, 40% in production and 4% in • Implementation of the Supplier Development Program in services” . …” Overall, there are 243 companies that target their activity on one ormore phases of the medical device manufactur- companies that are affiliated to the chambers and with ing process: 10% are involved in design or prototyping,70% manu- government tractor companies. facture components or semi-finished products, 32% manufac- • Promotion of the national development of high specialty ture accessories or finishedproducts and 20% intervene in the medical devices. final phases of the manufacturing process and are involved inassembly, sterilisation, labelling or logistics.” Role and Importance Of Supply Chain ( Raw Materials / Com- ponents / Semifinished Products etc. including services) For the Growth Of Indian Medical Device Industry. Medical Plastics Data Service interacted with the leaders of the Indian Medical Device Industry and compiled their opinions on “Indian Medical Device Industry 360 degree View”. The leaders opined on the role and importance of supply chain as follows (Detailed report attached.) : “A strong supply chain supports the Medical Device Industry to improve Global Competitiveness. As shared by Mr KishorKhanna, A positive approach will be collaboration with the industry and academia to develop indigenous manufacturing base of all possible materials required by the industry. Not only input material but also the availability of high tech machinery essential for moulding, extrusion and assembly is not at par with other countries. A synergetic approach is required where the industry, academia and government work towards developing the Mar.-Apr. 2018 21

Cover Story New medical devices procurement guidelines propose to make 20-50% of components in India NEW DELHI : The Department of Pharmaceuticals has 40% of the cost of implants in order for the device to be proposed that domestically sourced components have to eligible for procurement, according to DoP’s draft. Local contribute to 25-50% of the cost of medical devices procured content should contribute to 25% of the cost of medical elec- by the government, depending on the category of the device. tronics, hospital equipment, surgical instruments and diagnostic A draft of the proposed guidelines, created to give preference reagents/in-vitro diagnostics, according to it. to products made in India, has sought comments from all stakeholders by April 5. DoP has prescribed the requirements based on its current un- derstanding of the medical devices market in India, according At the same time, the proposed guidelines lack measures to to the draft. At the same time, it also said it is in the process of help the local industry grow and imposes conditions that may collecting “accurate and reliable” data on criteria like the total hurt the quality of medical devices procured through these capacity and production of various categories of devices in tenders, claimed a lobby group of domestic firms in the sector. the country. The guidelines also may not be possible to implement for high- Purchase preference shall be given to local suppliers by all end, critical products for which there is currently no ecosys- procuring entities, stated the draft. tem available to manufacture locally, according to two lobby groups representing several multinational medical device firms. https://economictimes.indiatimes.com/industry/healthcare/ biotech/pharmaceuticals/new-medical-devices-procurement- Domestically sourced components have to contribute to at least half the cost of medical disposables and consumables and guidelines-propose-to-make-20-50-of-components-in-india/ articleshow/63372115.cms SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : [email protected] 22 Mar.-Apr. 2018

Materials Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Medical technology continues to advance by leaps and bounds but bringing life-saving products to market requires more than medical breakthroughs: it also requires materials that can meet the rigorous challenges these applications demand. Polycarbonate resins and blends developed by Covestro help bring medical and healthcare applications to life. Imagine not being able to climb stairs or stand and wash dishes without getting winded. Unfortunately this is a common reality for individuals suffering from respiratory conditions. Ventilators can help reduce the work of breathing by unloading the ancillary respiratory muscles, but are often bulky and heavy, creating additional user limitations. A better solution by reducing the overall size of the ventilation system to support patient mobility and indepen- dence will be the desire from chronic respiratory disease patients. US respiratory OEM Breathe Technologies Inc. selected medical Makrolon® from Covestro to achieve the R&D goals for their Non-Invasive Open Ventilation System (NIOV). The main properties of Makrolon® 2858 polycarbonate are : • Medium viscosity • Easy release • Medical device grade • Available in transparent and opaque colors • Suitable for ETO and steam sterilization at 121 °C • Biocompatible according to many ISO 10993-1 test requirements OEM : Breathe Technologies Inc. Makrolon® polycarbonate from Covestro helps Breathe Technolo- Supplier : Covestro gies Inc. achieve the high-performing yet portable device design. Application : Breathe Non-Invasive Open Ventilation The Breathe NIOV System is a one-pound, non-invasive (NIOV) System mechanical ventilator that can be used in home and institutional settings. Breathe Technologies explains that the device utilizes Product : Makrolon® 2858 novel venturi principle technology in a comfortable facial inter- Medical Makrolon® polycarbonate from Covestro lends its face that can be worn while talking and exercising. outstanding properties and light weight to help Breathe Technologies Inc. achieve the high-performing yet portable The patient interface and air/oxygen path components utilize device design. injection-molded Makrolon® 2858. This grade is suitable for ETO and steam sterilization at 121 Deg C and is biocompatible according to many ISO 10993-1 test requirements, making it an ideal choice for medical devices. Makrolon® 2858 also features easy release and medium viscosity and is available in transpar- ent and opaque colors. The device components made of Makrolon® are intricate in design and require optimal functional- ity for patient safety. The Breathe NIOV System has received five 510(K) clearances from the U.S. FDA for use with compressed oxygen or compressed air for home and institutional use, and includes invasive and noninvasive circuits. The needs are real, and the ideas to meet those needs are here… Covestro helps them materialize. Local Contact : Covestro India: [email protected] www.covestro.in About Covestro : With 2017 sales of EUR 14.1 billion, Covestro is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotiveconstruction, wood processing and furniture, and electrical and elec- tronics industries. Other sectors include sports and leisure, cosmetics, health and the chemical industry itself. Covestro has 30 production sites worldwide and employs approximately 16,200 people (calculated as full-time equivalents) at the end of 2017. Mar.-Apr. 2018 23

® 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] : 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] 24 Mar.-Apr. 2018

Global Trends THE ASEAN MEDICAL DEVICE MARKET The region’s medical device market is expected to grow strongly and access to the market will improve in the coming years due to a number of factors : 1. Size of middle class in the region is rapidly expanding. Asian Development Bank expects this group to grow from 24% of the total population in 2010 to 65% by 2030. Additionally, demographic trends such as population aging and urbanisation, is expected to fuel demand for better quality healthcare, and contribute to the expansion of Southeast Asia’s medical device market. 2. Penetration of medical devices into ASEAN is still relatively low, thus, there is much room for growth and market expansion. The heterogeneity of the ASEAN market allows medical device companies to adopt different market strategies and provides ample room for device segmentation. 3. Another important consideration for medical device companies entering the ASEAN market is the lack of domestic competition in the region. Overall, ASEAN is a net importer of medical devices. Vietnam for example, currently imports 90% of all the medical devices used in the country. Country Profiles Malaysia Singapore • A middle-income country with a per capita healthcare spending of US$457. Well-positioned to ride medtech wave Its medical device market is valued at • Singapore has the most advanced more than US$1.9 billion. Domestic healthcare spending economy in the region and has an estab- has more than doubled in value since 2005. lished public healthcare system. Along with its strong • Malaysia has a rapidly growing healthcare sector and aims intellectual property protection, existing research to move up the value chain in medical device manufactur- infrastructure and educated workforce, Singapore makes a ing. The country is also a major producer of rubber-based strong choice for foreign device companies looking to medical devices, and produces a significant portion of the establish a foothold in the region. world’s surgical gloves, catheters, amongst others. • In attracting foreign medical device manufacturers, the government has launched a series of incentive schemes, Thailand including tax-relief and training grants. From 2000 to 2015, the value-add of Singapore's medtech manufacturing grew • Medical device market continues to grow rapidly. from S$800 million, or 0.6 per cent of the country's gross The country’s per capita healthcare spending is domestic product, to S$3.5 billion. US$360, up from $113 in 2004. Growth of the • As part of the Research, Innovation and Enterprise (RIE) healthcare sector is forecasted to be 10%, as 2015 plan, the government established Sector Specific Accelerators (SSA) to identify, invest and grow start-ups in opposed to GDP growth of less than 2%. The medical strategic but nascent sectors, such as medical and clean device sector is currently worth more than US$1.1 billion. technology. A total of S$70 million has been committed • Thailand’s local medical device manufacturers are focused under the SSA Programme to encourage the formation and on the production of low-tech basic devices like syringes, growth of start-ups in medical technology. test kits and surgical gloves. The Thai government has made some efforts to attract foreign manufacturers by promising corporate tax exemptions for a number of years. Health tourism is a major industry, with Bangkok serving about 30% of health tourists coming to Asia. MEDICAL MANUFACTURING ASIA 2018 : Delivering solutions for the future of medtech Mark your calendar for the 4th Manufacturing Processes for Medical Technology Exhibition and Conference from 29-31 Aug 12 Jan 2018 – Innovative medical technology is an increasingly important driver for delivering efficiencies in the global healthcare system. Through advances in medical technology, precision engineering, micro-manufacturing processes, and IT, medical devices and solutions have be- come more sophisticated, accurate and effective. As a specialist exhibition on manufacturing processes for medical technology, the 4th edition of MEDICAL MANUFACTURING ASIA will focus on new manufacturing technology and automation which play vital roles in driving innova- tion and operations. The upcoming edition will highlight companies that cover the spectrum of additive manufacturing or 3D printing technologies, imaging and diagnostic imaging solutions, as well as nano manufacturing and automated solutions. As Singapore continues to grow its medtech presence on the bition strongly reflects Singapore’s focus on moving upstream to world stage, with a sizeable number of complex scientific instru- not just production but also value engineering. For companies ments already designed and manufactured here, the 3-day exhi- keen on engaging global medtech companies and see Singapore Mar.-Apr. 2018 25

Global Trends medtech sectors. Jointly organised by SPETA (Singapore Preci- sion Engineering and Technology Association) and Messe as an ideal base to develop products for the Asian region, MEDI- Düsseldorf Asia, the exhibition is modelled after the No.1 global CAL MANUFACTURING ASIA 2018 provides a highly relevant trade fair in the medtech sector, COMPAMED, held in Düsseldorf, springboard. Germany. MEDICAL MANUFACTURING ASIA 2018 comes against a The 4th edition of MEDICAL MANUFACTURING ASIA is fast gain- dynamic backdrop which sees the Asia Pacific medtech market ing traction as the region’s leading specialist trade exhibition for expected to surpass the European Union by 2020 as the world’s the medtech and medical manufacturing sectors. Following the second largest medtech market after the United States1, while success of the 2016 edition, the exhibition welcomed 200 on the global front, the medtech sector is expected to grow 5% or companies from 18 countries, and 5,420 trade visitors from 52 more annually through to 2022, to reach nearly US$530 billion2. countries. For booth space booking and more information on MEDICAL MANUFACTURING ASIA 2018, please visit With Singapore’s positioning as Asia’s top location for medtech and home to over 30 globally-recognised medtech companies, www.medmanufacturing-asia.com. MEDICAL MANUFACTURING ASIA 2018 continues to attract a highly international exhibitor base coming mainly from Asia and About Messe Düsseldorf Asia Europe and a trade visitor base that is predominantly represented by the medical devices and instruments, medical and healthcare, Messe Düsseldorf Asia is a subsidiary of Messe Düsseldorf and electrical and electronic sectors from around the region. in Germany, one of the world’s leading trade fair organisers, Complementing the exhibition is the half-day forum on High-tech- nology for Medical Devices where exhibitors will present and responsible for organising more than 20 global No. 1 exhi- share latest developments and trends on the global and domes- tic fronts and market opportunities for medtech products from bitions in various industries including medicine and health, Europe. Organised by IVAM Microtechnology Network, the Ger- man-based international association has an extensive member- specifically MEDICA, COMPAMED and REHACARE IN- ship with companies in the fields of microtechnology, nanotechnology, advanced materials, and photonics. TERNATIONAL held in Düsseldorf, Germany. With exten- MEDICAL MANUFACTURING ASIA 2018 is also synergistically sive expertise in organising trade fairs in Southeast Asia, co-located with the region’s leading medical and healthcare exhibition, MEDICAL FAIR ASIA – thus providing an end-to-end Messe Düsseldorf Asia has developed a portfolio of numer- solutions and business sourcing platform across the entire value chain for the medical, healthcare, medical manufacturing and For more information on the exhibition, please contact : Press Contact : Exhibitor Contact : Melvin Chye Daphne Yeo Marketing & Communications Executive Senior Project Manager Tel: (65) 6332 9652 Tel: (65) 6332 9682 [email protected] [email protected] 26 Mar.-Apr. 2018

National An ISO & CE certified Company Healthcare AMIGO SURGI CARE PVT. LTD. An ISO 9001 : 2008 Company Manufacturer of Manufacturing & Exports of Disposable Surgical Products Medical Disposables : I.V.CANNULAS / B.T.SETS / I.V.SETS / I.V. Set, B.T. Set, Urine Bag, SURGICAL LATEX GLOVES / CORD Measured volume set, Cord Clamp, Surgical CLAMPS / MEASURE Gloves etc. VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN Injection Moulded Medical Components and Extended Tubes : SET / CANNULA FIXATOR ETC. Only Manufacturer of IV CANNULA in GUJARAT I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Urine Bag Tubes etc. Mobile : 0091-9825057180 Contact : Tel.: 0091-2764-268249 Naresh Patel E-mail : [email protected] 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Website : www.ivcannulaindia.com Plant Address Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. E-mail : [email protected] Website: nationalhealthcare.in AVAILABLE AN ISO 13485-2012 PRE USED SYRINGE CE certified Company MANUFACTURING Manufacturer & Exporter of Medical EQUIPMENT Disposable Devices & Surgical Products Moulds : 2, 3, 5, 10ml Syringe Printing Machine : Range of Products : 2/3, 5, 10ml • Infusion Set Syringe 4 Parts Assembly Machine : • Blood Administration Set 2/3, 5, 10ml • Measure Volume Set • Urine Collecting Bag Contact : 7895648113 • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser [email protected] • Twin Bore Nasal Oxygen Set • Oxygen Face Mask 27 • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com Mar.-Apr. 2018

28 Mar.-Apr. 2018

AIMED urges GoI to take policy decisions to boost Domestic Mfg & to Make Healthcare Affordable in India 1111111111111111122222222222222222••333333333333333334444444444444444455555555555555555AIPM66666666666666666n77777777777777777iradMe88888888888888888n99999999999999999ifae00000000000000000eu11111111111111111Drf22222222222222222nea33333333333333333ew44444444444444444nc55555555555555555ette66666666666666666uida77777777777777777lrc88888888888888888sli99999999999999999noM00000000000000000gmt11111111111111111oa22222222222222222o33333333333333333er44444444444444444kfs55555555555555555Let66666666666666666Fhe77777777777777777t88888888888888888eDaA99999999999999999sr00000000000000000Icne11111111111111111ci22222222222222222ne11111111111111111ifm22222222222222222rms33333333333333333os44444444444444444pam55555555555555555o,66666666666666666n77777777777777777rNut88888888888888888Ce99999999999999999foah00000000000000000rn11111111111111111/ci22222222222222222notT33333333333333333ua44444444444444444var55555555555555555eri66666666666666666wnir77777777777777777fsgf88888888888888888h99999999999999999eBob00000000000000000a11111111111111111ay22222222222222222ssr33333333333333333oru44444444444444444mi55555555555555555vec66666666666666666earc77777777777777777srne88888888888888888s99999999999999999uae00000000000000000efnd11111111111111111aa22222222222222222de11111111111111111scd22222222222222222tp33333333333333333mu44444444444444444urt55555555555555555aoen66666666666666666nr77777777777777777iss88888888888888888duh99999999999999999rfl00000000000000000iiao11111111111111111vnc22222222222222222beg33333333333333333tb44444444444444444ub55555555555555555iFre66666666666666666oeD77777777777777777slr88888888888888888dIs99999999999999999cl00000000000000000ylib11111111111111111an22222222222222222ueit33333333333333333motr44444444444444444r55555555555555555nia66666666666666666nmo77777777777777777ng88888888888888888tat99999999999999999itn00000000000000000Cno11111111111111111u22222222222222222ofbf11111111111111111osa22222222222222222er33333333333333333cmd44444444444444444It55555555555555555onu66666666666666666oidr77777777777777777ni88888888888888888finga99999999999999999Ig00000000000000000mnu1111111111111111122222222222222222npbI33333333333333333neoy44444444444444444d55555555555555555tr66666666666666666hutm77777777777777777isb88888888888888888ca99999999999999999taar00000000000000000nysl11111111111111111o.22222222222222222em33333333333333333ed44444444444444444au55555555555555555Pr66666666666666666vk77777777777777777sr88888888888888888eee99999999999999999t00000000000000000sui11111111111111111nd22222222222222222og11111111111111111o22222222222222222.f 333333333333333334444444444444444455555555555555555 New Delhi, 9th April, 2018: The government has been taking into manufacturing by manoeuvres of Preferential Market Access, measures to control prices of medicines and some devices like Non Tariff Margins and punishing boldly errant Cos doing unethi- coronary stents etc. over last two years. This has been a wel- cal marketing. come move. However, much more needs to be done and in a more planned manner in place of a piecemeal approach. To AiMeD welcomes FDI in manufacturing by overseas manufac- begin with, we need to understand that price control or MRP turers but not in Import based Pseudo Manufacturing of these capping is important but a small step in making healthcare importer/ overseas manufacturers lobbies claiming to be Indian affordable in the long run. Industry. \"There is an urgent need for an integrated and calibrated devel- Private healthcare providers have been profiteering from opment policy to put ‘Make In India’ initiative in medical devices Medical Products Margins in attempt to cross subsidize easily sector in top gear and reduce high import dependency on foreign comparable procedure costs to inflate overall treatment costs, made devices in order to promote indigenous manufacturing of leading to very high out- of- pocket cost of healthcare. At 60%, drugs and devices which would go a long way in making healthcare India's out-of-pocket expenditure on health is one of the highest affordable.\" said Mr Rajiv Nath, Forum Coordinator, (AIMED) in the world and has lead to many bankruptcies.. Association of Indian Medical Device Industry. \"Isn't Imports a trading activity so if we talk about Rationalisation As a first step, the government may consider granting tax / duty of Trade Margins it has to include Imports, you can't have incentives and Price Preference in public procurement among importers having over 200% Margin as was indicated in NPPA other things to protect and promote domestic manufacturing. report on Catheters &Guidewires and the whole supply chain have only a 35-50% Trade Margin!\" Asked Rajiv Nath , Forum Coordi- Simultaneously, price control measures should be undertaken. nator of AiMeD. As of now, only coronary stents and some orthopaedic devices are being considered. But, the list needs to be expanded to \"Everyone in a supply chain has intermediate costs and value include more devices. addition - so what value addition importers are doing and the question is what's a rational margin for them ? Some price control measures that could be undertaken are : • Tax Based Measures Government should introduce an Inno- Why those intermediate costs like R&D are not part of the Import landed price ? To avoid custom duties ? vative Tax Structure of stalling Artificial Inflation of MRP e.g.1% GST Cess on MRP to have a disincentive to importers and This proves our point why FDI has hurt Indian Mfg as earlier manufacture from labelling device with excessive MRP. Distributors used to import from overseas manufacturers at their standard price that included R&D costs and Market Creation and Consider this option for Devices not Notified as Drugs. development costs built into the import price . • Trade Margin Rationalisation : AiMeD has proposed to DoP After the Subsidiary of the overseas MNC displaced the Distribu- to fix the trade margin to a maximum of 50-100% (depending tor they started importing at lower Transfer Pricing to reduce upon value) between import landed price / Ex Fcy price and impact of Customs Duty and started booking their market devel- MRP. If DoP accepts our formula, after consulting with AHPi opment and Market Creation costs in Indian subsidiary which in and IMA it will provide tremendous savings to consumers as most cases have an opaque balance sheet of a private limited MRP will be substantially reduced. company. FDI was not used to put up factories but finance inven- tories, build warehouses and finance market expansion many • MRP Capping (This is the least favoured option if above 2 are times at cost of existing manufacturing capacity of other existing proven non effective) indigenous players\" he explained. Make in India of medical devices is already suffering and follow- www.medicalplasticsindia.com ing MTAI recommended formula will make Indian Mfg at a further competitive disadvantage - GoI needs to take policy decisions to The Only Indian Portal Site On Medical Plastics/ give strategic advantage to domestic Mfg while safeguarding Devices Technology And Trade consumers or India will remain 70-90% import dependent. Only when it will be advantageous to manufacture in India only then will these importer / Overseas manufacturers move manufactur- ing to India to retain market share and gain from that competi- tiveness created . India needs to Learn from China who succeeded to drive FDI Mar.-Apr. 2018 29

New guidelines for medical device grouping to streamline licensing The Union health ministry has issued a set of comprehensive and cannot be considered as members of a Family. guidelines for grouping medical devices which is expected to streamline the application process for obtaining manufacturing Regarding In Vitro Diagnostics Test Kit, the guidelines state that or import licence. The norms will come in handy for individuals or it is a device that consists of reagents or articles which are from companies applying for a licence and are aimed at regulating same licence holder, intended to be used in combination to medical devices industry in the country on par with international complete a specific purpose, sold under single proprietary test standards. kit name and compatible when used as a test kit. An In-Vitro Diagnostics Kit does not include the instruments such as analysers The guidelines, prepared in accordance with the Medical Devices needed to perform the test. Rules, 2017, categorise medical devices into six brackets -- Single, Family, IVD Test Kit, System, IVD Cluster and Group. An appli- By way of illustration, an Enzyme Linked Immunosorbent Assay cant is allowed to group medical devices having same or similar (Elisa) Test Kit, used to check presence of Human Immunodefi- intended uses or commonality of technology and submit a single ciency Virus (HIV) infection, may contain controls, calibrators and application for a licence to manufacture or import it. washing buffers. All the reagents and articles are used together to detect HIV and therefore can be licenced as Test Kit. These According to the notification, a single medical device is a product reagents and articles can be supplied separately as replacement sold as a distinct packaged entity and does not meet the criteria items for that particular test kit. for other specified categories. It may be sold in a range of pack- age sizes but must be licensed separately. Even if the devices A set of medical devices belongs to the System category if they are a part of a Group, it must be licensed separately before it is are intended to be used in combination to complete a common sold in the market, the guidelines say. purpose, compatible when used as a system and are sold under single proprietary system name. For instance, condoms are sold in packets of 3, 10 or 16 but can be licensed as a single medical device application. However, if a An In Vitro Diagnostics Cluster comprises a number of in-vitro company that assembles a first aid kit decides to supply each of diagnostics reagents or articles which are from same licence the devices in the kit individually, each product supplied holder, of a common methodology, are sold under single propri- separately must be licensed as a single medical device. etary name and are compatible when used as a test kit. A medical device Family is a collection of products from the same A medical device Group is a collection of two or more products, licence holder, have same risk classification class, have a supplied in a single package by same license holder, may have common intended use, have the same design and manufactur- different proprietary names and intended purposes. They might ing process and their variations should be within the scope of the be designed and sold by different licence holders. permissible variants. The collection of medical devices in a Group may differ in the To give an example, spherical contact lens with additional number and combination of products, while maintaining the same features of UV protection can be licenced as part of a Family, as proprietary name and intended purpose. To give an instance, a this feature does not affect the basic design or manufacturing of first aid kit consisting of medical devices such as bandages, the lens. But contact lenses are available as toric lens and spheri- gauzes, drapes and thermometers, when assembled together cal lens. These products have different intended purposes and as one package, can be licenced as a Group. performances. They are designed and manufactured differently (March 21, 2018 http://pharmabiz.com/NewsDetails.aspx?aid=107907&sid=1) 11223344556677889900112233445566778899001122334455667788990011221122334455667788990011223344556677889900112233445566778899001122112233445566778899001122334455667788990011223344556677889900112211223344556677889900112233445566778899001122334455667788990011221122334455667788990011223344556677889900112233445566778899 Govt invites proposals from labs for testing medical devices, IVDs as per new MD rules Government has invited proposals from all NABL accredited central medical device testing lab for the purpose of testing and laboratories in the country which are having capacity and capa- evaluation. bility for testing and evaluation of the medical device including in vitro diagnostics (IVDs) to be notified as central medical device In this regard, it is also required to get such laboratories regis- testing lab in accordance with the new Medical Device Rules tered under Rules 81 to Rule 86 of Chapter X of MDR-2017, if (MDR) 2017 which came into effect from January 1, 2018. they are involved in medical device and IVDs testing on behalf of the stakeholder. According to the government notification dated 31st January, 2017, all the testing labs may get registered with Central Drugs Further, Rule-19 in chapter-III, of Medical Device Rule, 2017, Standard Control Organization (CDSCO) and also inform details prescribes that the Central Government may, by notification, may about their activities. also designate any laboratory having facilities for carrying out test and evaluation of medical devices including in vitro diagnos- Similarly those labs, who are willing to get designated as medical tics medical device, as central medical devices testing labora- device testing laboratories under said rules shall communicate tory with the provision that no medical device testing laboratory, their details about which medical device or IVDs can be tested at shall be so designated unless it has been duly accredited by the their laboratories along with persons involved in the testing. National Accreditation Board for testing and calibration laborato- ries (i.e. NABL). This information is being sought in light of MDR-2017 and those labs which are found suitable may officially be designated as (March 9, 2018, http://pharmabiz.com/NewsDetails.aspx?aid=107686&sid=1 ) 30 Mar.-Apr. 2018

Gujarat FDCA sends draft notifications to state govt for approval to implement new Medical Devices Rules In order to implement New Medical Devices (MD) Rules 2017 in trol Organization (CDSCO) on the categorisation of medical de- an effective manner, the Gujarat Food and Drug Control Admin- vices for implementation of New Medical Devices (MD) Rules 2017. istration (FDCA) has sent draft notifications to the state govern- ment for approval to designate notified bodies and officers for The Central Licensing Authority will notify medical devices based oversight of medical devices units under the current regulatory on four classes i.e Class A, Class B, Class C and Class D depend- framework. ing on the risk involved. Gujarat has the maximum number of 250 licensed medical Once notified, compliance to the new medical devices rules will be devices units which include both low risk and high risk devices. implemented with the help of medical device officers designated by the central and state governments for the purpose. New MD Rules 2017 effective from January 1, 2018 cover not only medical devices but also in vitro diagnostics, disinfectants, Medical Devices Rules 2017 were notified last year and is into ef- surgical sutures, ligature, condoms, bandages, etc. It sets new fect since January 1, 2018. Industry and legal experts however standards for manufacturing and use of medical devices. As per have been raising some of the contentious issues related to com- the new rules, manufacturers are expected to adhere to stringent pliance to guidelines which have not been finalised as yet and quality management system, while carrying out manufacturing of timelines for its effective compliance. medical devices. One such issue is related to the guidelines on essential principles The state regulator is also planning to conduct workshops to of safety and performance as stipulated in Rule 6 of MD Rules, sensitise drug inspectors on newly notified medical device rules 2017, which has not been notified as yet and hence the concern is 2017. that the companies might not have the time to comply with it as the rules has already come into effect. The subjects included post grant Meanwhile, Maharashtra Food and Drug Administration (FDA) is compliance, data protection, product recalls and product liabilities also awaiting notifications from the Central Drugs Standard Con- among others. (March 29, 2018, http://pharmabiz.com NewsDetails.aspx?aid=108068&sid=1 ) Mar.-Apr. 2018 31

Industry News QCI, UL team up with govt and industry to spur robust quality ecosystem to build 'Brand India' in medical devices Our Bureau, Bengaluru roadmaps and institutions for their effective management’. Friday, March 16, 2018, 15:30 Hrs [IST] While India today has more than 19,000 standards, around 5,000 The Quality Council of India (QCI) and UL, an independent, of them are updated and about 135 are mandated for regulation. global safety science company have brought together govern- A phased approach to increase the level of regulation to match ment agencies and industry associations to further the quality other comparable markets will give the domestic industry the right ecosystem in the country through standardization in medical impetus to compete on global as well as domestic scale. devices. Commenting on the first-of-its-kind effort by the Government to Chaired by the Ministry of Commerce and moderated by the devise a comprehensive Standards strategy, Anil Jauhri, CEO, Quality Council of India and UL, the Standards Roundtable saw National Accreditation Board for Certification Bodies, India said, active participation of government agencies such as the National “The Government is actively pushing the Standards agenda, and Accreditation Board for Testing and Calibration Laboratories hopefully, with the draft INSS, where the roles of each (NABL) and the Telecommunication Engineering Centre (TEC), stakeholder are clearly defined, we can create an action plan to and 16 industry associations representing diverse sectors, as further standardization in India with greater participation from the well as premier industry bodies such as the Confederation of industries.” Indian Industries (CII) and Associated Chambers of Commerce and Industry of India (Assocham). Other strategic discussions in the event under the theme, “Accelerating Standards Development For Building Brand India” A critical agenda of the Standards Roundtable was the draft centered around speeding up the process of creating domesti- Indian National Standards Strategy (INSS) released by the Min- cally relevant, technologically sound, science-based and globally istry of Commerce recently. The draft INSS focuses on, among harmonized standards that can foster better safety, sustainability other objectives, ‘using standards as an enhancer for competi- and healthy outcomes for the country. Experts reiterated the need tiveness in the domestic and international markets’ and ‘adopt- for the industry to proactively support the standardization ing best practices in standardization, conformity assessment and program of the Bureau of Indian Standards (BIS). technical regulations, and creating an integrated infrastructure, http://pharmabiz.com/NewsDetails.aspx?aid=107828&sid=2 Hindustan Syringes and Medical Devices gets ‘India Design Mark’ Hindustan Syringes and Medical Devices Limited (HMD), which Reacting to this granting of ‘India Design Mark’, Rajiv Nath, Joint today exists as the country’s leading manufacturer of SMART Managing Director of Hindustan Syringes and Medical Devices (auto disable) syringes, was recently granted the most signifi- Ltd (HMD), said, “We are delighted to be honoured by the most cant distinction ‘India Design Mark’ by the India Design Council. significant recognition for our safety IV Cannulas assuring excellence in aspect of design, quality and safety. It has been granted the ‘India Design Mark’ for its recently intro- duced product ‘Safety Cathy IV Cannula” which is used for drug “Our product samples were evaluated by the Jury of India delivery. It was given this after having successfully completed Design Mark. The Jury was satisfied with the uniqueness and the evaluation by the jury during an award ceremony in benefits of the Design of our product and the India Design Mark Coimbatore. is awarded to HMD.” The India Design Council exists as an autonomous body under It may be noted that the India Design Mark aims to use the Ministry of Commerce and Industry Government of India. design as strategic element for business excellence, to promote design as a tool for innovation and economic competitiveness in The India Design Mark is a design standard, which symbolises industry and to promote the concept of environment friendly excellence in form, function, quality, safety, sustainability and designs. innovation and communicates that the product is usable, durable, aesthetically appealing and socially responsible. Rajiv Nath also stressed that the Government urgently needs to deploy “Safety I V Cannulas” to Limit HIV & Hepatitis Epidemics It needs to be understood the Safety IV Cannula , used for giving in the Country and to protect Healthcare workers from accidental infusion of drugs, has a protective device “SAFETY SIP CLIP” needle stick injuries while treating infected patients. which encapsulates the tip of the used needle when introducer needle is extracted from the Catheter; Post Cannulation. “We have been exporting millions of our Safety I V Cannuls to Sweden, Norway, Denmark and other European Countries but The “Safety Sip Clip” prevents accidental needle stick injury, (we) are challenged by the discerning Indian doctors who provided that general effective and safe working procedures and demand quality. The Design Mark should help us gain confidence precautions are maintained during its use and disposal. and trust of those doctors as we did for our Ribbon Packed DISPOVAN Syringes,” said PardeepSareen, Chief of Marketing, The award was announced by Pradyumna Vyas, Member Secre- at HMD. tary, India Design Council in the presence of eminent personali- ties associated with public and private healthcare, government HMD is the most prominent and key player in India and abroad in establishments and healthcare consultancies. the manufacturing and supply of Syringes, Needles, I.V.Cannulas, Safety I.V.Cannulas, Surgical Blades, Safety Scalpels, Scalpvein “While this is a prestigious recognition for us at HMD to make the Sets, Nonreusable (AD)Syringes, Blood collection tubes and blood quest for the India Design Mark more popular the procurement collection systems etc. etc. officer in Private & Public Healthcare need to give a preference to Medical Devices with the Design to encourage Manufacturer http://ehealth.eletsonline.com/2018/03/hindustan-syringes-and- to invest in Quality & Design,” said Pradyumna Vyas, Member medical-devices-gets-india-design-mark/ Secretary, India Design Council, on the occasion. 32 Mar.-Apr. 2018

Product Gallery Qosina Provides Cost-Effective Off-the-Shelf and Custom Tubing Solutions Ronkonkoma, NY, USA, April 5, Founded in 1980, Qosina is a leading 2018—Qosina offers a wide selection of global supplier of OEM single-use com- in-stock tubing for prototyping and large- ponents to the medical and pharmaceu- scale production requirements. The tical industries. Qosina’s philosophy is high-quality, medical-grade tubing is to address its customers’ need to reduce competitively priced, conveniently pack- time-to-market by providing thousands aged in small coils and available in a of stock components. The company’s diverse range of sizes and materials vast catalog features more than 5,000 including PVC, silicone, FEP, HDPE or products shown in full-scale illustrations DEHP-free PVC. Qosina also carries on a one-centimeter grid. Qosina offers platinum-cured silicone tubing, which free samples of most items, low mini- can withstand repeated compression, mum order requirements, just-in-time and peroxide-cured silicone tubing for delivery, modification of existing molds, increased resilience and durability. and new product design and develop- Qosina’s off-the-shelf tubing solutions in- ment. Qosina is ISO 9001, ISO 13485 clude popular brands such as Tygon®, and ISO 14001 registered, and operates PharmaFluor® and C-Flex®. in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Additionally, Qosina customizes tubing Qosina’s full component offering, which to exact specification with cut-to-length, includes the newest products. multi-lumen and multi-layer configurations, along with custom durometers, sizes, colors and materials. Qosina also provides visit www.qosina.com or call +1 (631) 242-3000. medical tubing sampling kits for all project needs. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 [email protected] Qosina’s Slide Clamps Remain an Integral Part of the Company’s History Ronkonkoma, NY, USA, March 9, jaw and closed. Customizable options 2018—Since Qosina’s inception in 1980, are available as well. the company has consistently stocked its core product, the slide clamp. It was Founded in 1980, Qosina is a leading the first component Qosina ever sold and global supplier of OEM single-use com- remains one of its top-selling product ponents to the medical and pharmaceu- lines. tical industries. Qosina’s philosophy is to address its customers’ need to reduce In its first catalog nearly 40 years ago, time-to-market by providing thousands Qosina featured six unique slide clamps. of stock components. The company’s Through the years, the company has al- vast catalog features more than 5,000 tered its slide clamp offering, adding new, products shown in full-scale illustrations innovative parts and removing obsolete on a one-centimeter grid. Qosina offers ones. However, Qosina has consistently free samples of most items, low mini- carried five of its original six slide clamps, mum order requirements, just-in-time proving that these components can delivery, modification of existing molds, stand the test of time. and new product design and develop- ment. Qosina is ISO 9001, ISO 13485 Qosina’s inexpensive and ergonomic and ISO 14001 registered, and operates slide clamps are used to control the flow in a 95,000 square-foot facility with an of fluid in a line. They feature a gradu- ISO Class 8 Clean Room. To learn about Qosina’s full ated opening through which the tube passes, and when the tube component offering, which includes the newest products. is pushed into the narrow end of the opening, it clamps off, reducing or shutting off the flow of fluid. visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow, Qosina carries approximately 50 off-the-shelf slide clamps in an assortment of colors, sizes and configurations, including open- +1 (631) 242-3000 [email protected] Mar.-Apr. 2018 33

Events Again, the integral programme components of the trade fair made MEDICAL FAIR INDIA 2018 even more attractive for visitors. MEDICAL FAIR INDIA Worth mentioning here is CLIN LAB INDIA, a conference with continues on course exhibition organised by Scherago and Messe Düsseldorf India; for growth in terms of content it focuses on molecular diagnostics, point-of- care applications and immune-biological laboratory medicine. The Quality and quantity of visitors makes for high spirits among increasing digitalisation of medicine was centre stage at the ‘In- exhibitors ternational Conference on Digital Health and Medical Equipment’ by Voice of Healthcare and the Lounge Area ‘FTR4H’ (Future for MEDICAL FAIR INDIA, India’s No. 1 Trade Fair for Hospitals, Health) played a prominent role within the trade fair as a platform Health Centres and Clinics, impressively continues its rate of for the creative start-up community. Here the discussions related growth and keeps pace with the positive trend in the industry. to presentations and brief lectures revolved around sounding out This conclusion can be drawn from the successful course of the market relevance and maturity of innovations and placing MEDICAL FAIR INDIA 2018 in Mumbai. 16 – 18 March saw 12,350 young entrepreneurs with potential business partners. trade visitors come to the Bombay Convention & Exhibition Centre to learn from 551 exhibitors about innovations for health MEDICAL FAIR INDIA is held alternately at venues in Mumbai care and current trends. and New Delhi every year. Focal ranges include: medical prod- ucts and medical device technology, laboratory technology and “This means that the number of visitors has gone up yet again by diagnostics, equipment and furnishings plus furniture for hospi- 15% compared to the event at the same location two years be- tals and health centres and the global trend areas of Health IT fore. In interviews exhibitors said they were very satisfied with and Mobile Health solutions, to name but a few themes. the quality of visitors and their demands,” explains Thomas Schlitt, Managing Director at Messe Düsseldorf India, and adds: “Rising The target group encompasses decision-makers from the medi- incomes, population growth and increasing health consciousness cal field (such as physicians and medical professionals), hospital all result in steady market growth and a call for improved health managers as well as representatives from the medical trade and care. This is also reflected by the development of MEDICAL FAIR industry. Due to its spectrum of topics covered the event is equally INDIA. It is not only a platform for supply and demand. It is also attractive for architects and building planners, for enterprise about joint ventures for product development, manufacturing and consultants or for the scientific and research community. sales.” The next MEDICAL FAIR INDIA http://www.medicalfair-india.com. Since there are currently only about 60 national medical device will be held from 21 to 23 February 2019 – in keeping with the technology producers, the majority of products and technologies schedule – in New Delhi, at the Pragati Exhibition Center. for medical needs are imported. This opens up excellent busi- ness opportunities for multi-national vendors. At the same time, Contact : there is a need for them to closely cooperate with Indian partners Messe Düsseldorf India Pvt. Ltd. Love Bhardwaj so as to rise to the challenges specific to the Indian market in an Project Manager optimal way. Underlining this on behalf of many exhibitors, Simon Tel: +91(0)11-4855-0061 Bensassi, International Sales Director of Surgival from Spain, said: E-mail: [email protected] “This was the first time we have participated at MEDICAL FAIR INDIA. We have reached many high-quality visitors. What was Events Calender especially important to us was gaining insights into the Indian market. Who are the decision- makers? What about the govern- • Medical Manufacturing Asia 2018 ment and what about pricing? How much is invested and where? 4th Manufacturing Processes for Medical Technology These were questions we had interesting conversations about.” Exhibition and Conference Date : August 29 – 31, 2018 Brian Krawczyk, Director of Global Business Development at VIA Venue : Marina Bay Sands Singapore Global Health (USA), also believes his company has achieved the aims it set itself for participation at the trade fair: “To us this • Medicall was an extremely useful event for finding good distribution India’s Larges B2B Medical Equipment Exhibition partners in India.” John Mason, Sales Director at Seers Medical Date : July 27 – 29, 2018 (Great Britain), shares his view: “There was a very good mixture Venue : Chennai Trade Center, Chennai, India of visitors from both private and public health care. Visitors come from all over the country. We will also be taking part in MEDICAL • Medicall FAIR INDIA 2019 in New Delhi.” India’s Larges B2B Medical Equipment Exhibition Date : September 21-23, 2018 Also taking positive stock was the Brazilian manufacturers’ asso- Venue : Pragati Maidan, New Delhi, India ciation ABIMO. Karina Yamamoto (Trade Promotion Coordina- tor) emphasised: “The Indian market is developing at warp speed • 15th National Conference And Technology Exhibition and it is very important for us to get a foot in the door here and On Indian Medical Devices & Plastics Disposables / learn to understand the market. In addition to Indian visitors we Implants Industry 2018 also succeeded in making contacts in Bangladesh, China and Date : October 26-27, 2018 even Saudi Arabia and the United Arab Emirates.” Venue : Ahmedabad Management Association, Ahmedabad, Gujarat 34 • K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany Mar.-Apr. 2018

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com Mar.-Apr. 2018 35

Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking 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, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... 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 GMP I. V. SETS AND MEDICAL ISO - 9001-2008 DISPOSABLES MANUFACTUR- Certified Company ING UNIT FOR SALE S. Nath & Co. Unit in Good Running Excellence in Quality Condition Manufacturer & Exporter of • Holding Gujarat State FDA Mfg. Licence Surgical Disposable Products since 1980 • Located in Industrial Area in Ahmedabad • Built up Area More Than 390 Square Meter IDEAL® • Machinery / Equipments in Good Working Condition • Includes : Assembly Furniture, Clean Room Systems, • Infusion Set • Blood Administration Set E.T.O. Sterilizer, Laboratory Equipments, Urine Bag • Urine Collection Bag Mfg. Machines, Packaging Equipments, Utilities Etc. • Urine Specimen Container • Promoters Interested to sell because of other • Umblical Cord Clamp business commitments. • No Short Term / Long Term Liability Address Contact : E-mail [email protected], S. Nath & Co. [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Mar.-Apr. 2018 Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 36

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 : Dr. Inder Jain +91 9820321901 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 ISO 9001:2008 CERTIFIED COMPANY MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Address : • I.V. Infusion Sets Apex Medical Devices • Blood Administration Sets • Scalp Vein Set Plot No. 10/B, • Urine Collection Bags Shyam Ujjawal Indurstrial Estate, • Ryles / Feeding Tubes Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, • Catheters and Tubes Ahmedabad-382445. Gujarat, India. • Surgical Gloves. Phone No. : +91-79 - 29701333 Contact : E-mail : [email protected] Mr. Bhavin Shah Website : www.apexmedicaldevice.com MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Mar.-Apr. 2018 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 37

ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 38 Mar.-Apr. 2018