Medical Plastics Data Service Magazine janauary - february 2015 by Medical Plastics Data Service

Table of

Contents Vol. 23

No. 1

Jan.-Feb. 2015

20 Cover Story • Manufacturing Medical Devices In India : Many Opportunities - Mr. Himanshu Baid, Managing Director, Poly Medicure Ltd., Co - Chairman of CII Medical Technology Group and Co – Chairman of PHD Chamber, Health Committee, Faridabad. Government of India has recognized Medical Device Sector as Sunrise Sector as part of the “Make In India” Program. Medical device manufacturing hubs and dedicated medical device testing labs are being set up across the country. There is a great opportunity for the medical devices and technology sector..... • How Do We Balance Between Compliance, Quality And Innovation? - Mr. C. Padmakumar, Chairman & Managing Director, Terumo Penpol Limited, Trivandrum It is important to have safe products and affordability. India needs to satisfy the requirement of the regulator and also needs innovation. The American and Japanese counterparts have now realized that the opportunity in India is not just low cost but also very high power scientific and engineering talent….

26 Global Trends • Understanding Barriers to Medical Device Quality • China: Medical Technology Potentials Are Enormous

34 Industry News • Industry Urges Govt. To Re-Draft D&C Act (Amendment) Bill To Meet Domestic Manufacturers’ Requirements • Medical Device Industry Wants Centre To Set Up Stand-In MTAB To Expedite Decision-Making Process For Sector

35 Product Gallery • New Sanitary Flanges With Barbs From Qosina

18 Did You Know? • About Trends In Medical Device Adverse Events

36 Events • • • • Jan.-Feb. 2015

Medical Fair India 2015 CMEF & ICMD (Spring) Medicall 2015 Plastivision Arabia 2016

: : : :

March 21-23, 2015, Pragati Maidan, New Delhi. May 15 – 18, 2015, Shanghai, China. 31st July, 1st & 2nd August, 2015,Chennai, India. January 10-13, 2016, Expo Center, Sharjah.

Flashback Sep. - Oct. 2002 From Editor’s Desk Dear Readers, A very important development with respect to Medical Devices Industry in India is under consideration by ministry of health regarding the quality control norms. A wide range of products including medical devices / equipments / biological materials as well as in-vivo and in-vitro diagnostic products will soon have to face government’s quality control norms as mandatory prerequisite for both by manufacturers as well as importers. However, in order to interact with the industry and discuss relevant issues, the Central Drugs Control Organisation ( CDSCO ) organized a workshop on Medical Devices between September 17 to 20, 2002 in New Delhi. The workshop was sponsored by WHO. This issue cover the various subjects discussed during the fourday workshop. As per the Drugs Controller General of India, Mr Ashwini Kumar, the aim of the workshop was to lay down product-specific norms for manufacture, storage, distribution and sale of medical devices. While we shall try to include all the presentations from the experts made during the workshop in our future issues, because of the space limitation, we have included only one presentation highlighting “ Medical Devices Manufacturing Industry In India “ in this issue. This issue also highlights the recent visit of Mr Leen Santema, the CBI consultant for Medical Devices as a part of the technical assistance mission by CBI. CBI, the Centre for the Promotion of Imports from developing countries, is an agency of the Netherlands Ministry of Foreign Affairs. In our November 2001 issue, we had introduced the various services provided by CBI and had given abstracts of the “EU MARKET SURVEY 2001” for Medical Devices and Medical Disposables. The presentation of Mr Leen Santema to Medical Devices firms also included “CE MARKETING ACTION PLAN” and discussed in chronological order all aspects of importance to the business – from becoming acquainted with the New Approach directive to the ultimate application of CE marking. CONTENTS • Cover Story - Government plans stricter quality control for medical devices • Quality - CE Marking Action Plan • Industry News - Breakthrough in bio pacemakers - Export & relish: Pharma readies its global guns - Becton plans to make India sourcing base - Apollo Hospitals to double bed capacity in 3years - Healthcare processes must be improved: Harvard expert • Global Trends - Latin America : A new emerging opportunity • Did You Know ? - About Occluded Endotracheal Tubes • Events - HOSPIMedica ASIA 2002 : A Report - HOSPIMedica INDIA 2003

Did You Know ?

About Trends In Medical Device Adverse Events US FDA has recognized that Medical Device adverse reflect quality manufacturing systems. The number of adverse event reports has increased dramatically and outpaced overall industry growth by a wide margin. The risk of adverse events is not evenly distributed across the industry. Certain therapeutic areas and product segments comprise a larger share of total adverse events; others have attributable adverse events growing at a faster rate than average. Cardiovascular, IVD, and general hospital/surgical devices make up most adverse event reports. General hospital/surgical and cardiovascular devices account for more than half of reported serious adverse events. Radiology (diagnostic imaging) and neurology are the areas growing most quickly. Taken together the top 20 product codes with the most serious adverse event reports between 2005 and 2009 account for 65% of all serious adverse event reports in this time period. Eleven of the 20 product codes with the most adverse events between 2005 and 2009 were related to cardiovascular devices. (Report on “Understanding Barriers to Medical Device Quality” by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH))

In a Nutshell.... “If you focus on results, You will never change. If you focus on change, You will get results”. - Jack Dickson

Jan.-Feb. 2015

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

ASSOCIATE EDITOR Ms. Nirzari Ann Chacko, B.E. (Biomedical Eng.)

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 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.

Jan.-Feb. 2015

Editor’s Desk

From the

“The 12th National Conference & Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2015” concluded with a very positive note and once again proved to be the most participative platform in the country. With active participation of more than 450 industry delegates for the conference , about 50 industry experts as speakers , about 30 technology and product providers as exhibitors and number of exhibition visitors from all over India as well as foreign countries including USA, UK, Germany, China etc., the event once again proved to be a great success. This unique opportunity to the Indian Medical Device Industry facilitates the implementation of Hon. Prime Minister’s vision to make the country, a global manufacturing hub through the “Make in India” program. However, while the national program is launched recently, this event is being organized since last 12 years with the objective of creating healthy growth of Medical Device Manufacturing in India. The event facilitates the Indian industry by providing: • Opportunity to interact directly with the Industry leaders & experts from India & Abroad. • Opportunity to collaborate with Technology & Service providers. • Linkages between Industry, Academic & Research Institutes • Interactions with Healthcare Professionals. While views and vision shared by other Industry experts during the event will be shared with our readers in future issues of this magazine, in this issue, we highlight abstracts of very important presentations made by two distinguished leaders of Indian Medical Device Industry. Mr. Himanshu Baid, Managing Director, Poly Medicure Ltd., Co- Chairman of CII Medical Technology Group and Co-Chairman of PHD Chamber, Health Committee shared opportunities for medical device industry in India covering various strengths of the Indian Industry supported by Government Programs and incentives. Thus concluding that “India’s traditional strength is manufacturing and it can deliver tremendous value, if it meets with regulatory and operational challenges.” While explaining “How Do We Balance Between Compliance, Quality And Innovation”, Mr. C. Padmakumar , Chairman & Managing Director, Terumo Penpol Limited , emphasised the need for Safe Products along with affordability for the masses. Sharing the “Terumo” experience, Mr. Padmakumar mentioned that their, “American and Japanese counterparts have now realized that the opportunity in India is not just low cost but also very high power scientific and engineering talent including design talent .” I hope, our readers will find articles by both visionaries, very thought provoking and informative. This issue also includes the abstract of a report by US FDA on “Understanding Barriers To Medical Device Quality” which reveals that there are systemic gaps within medical device industry’s quality approach that result in growing number of patients suffering from adverse events. The report also highlights specific aspects of regulatory agency’s approach and need for properly aligning the approach. This issue also includes our regular columns including “Industry News”, “Market Opportunities”, “Events” , “Did You Know” etc.

Cover Story

Manufacturing Medical Devices In India

Many Opportunities

Himanshu Baid - Managing Director Poly Medicure Ltd., Co- Chairman of CII Medical Technology Group and Co – Chairman of PHD Chamber, Health Committee Abstract of Presentation made by Mr. Himanshu Baid during the 12th National Conference and Technology Exhibition on Indian Medical Devices & Plastic Disposables/Implants Industry 2015, Ahmedabad.

• Challenges faced by the Industry includes a lack of clarity in Regulations, access to market, the issue of price control as well as very low investment in the sector. • Government of India has recognized Medical Device Sector as Sunrise Sector as part of the “Make In India” Program launched by Hon. Prime Minister Mr. Narendra Modi. • 100% FDI in Medical Devices Sector will bring new opportunities for this sector. • National Health Policy’2015, the new Health Policy has come after 13 years. • Government is already looking at the anomaly of inverted duty structure. • Government has already set up a taskforce in November’2014, to identify the issues related to promotion of domestic production of high end medical devices and pharma manufacturing equipments. • Medical device manufacturing hubs and dedicated medical device testing labs are being set up across the country. • Single window clearances will be available to medical device companies which will fuel the growth in investment in medical device sector. • “Buy India Policy”, a very important move for medical device sector to encourage health institutions to procure Indian made products. • There is a great opportunity for the medical devices and technology sector to innovate across the value chain, to serve Indian and foreign consumers, and unlock the value of Indian market. • India’s traditional strength is manufacturing and it can deliver tremendous value if it meets with regulatory and operational challenges.

Mr. Himanshu Baid started his presentation giving an overview on the Indian Medical Device Industry. He mentioned that, as per, “BCG Report”, the medical device sector in India is currently valued around 6.3 Billion Dollars against the global market of 280 billion dollars - just 2 to 2.5 percent market of the Global Medical Device Market, signifying a lot of opportunity today in India. Growing around 10-12% annually and by looking at the current growth rate, this sector is likely to reach around 20 Billion Dollars by 2025. He however, mentioned about the challenges faced by the Industry including a lack of clarity in Regulations, access to market, the issue of price control as well as very low investment in the sector. He mentioned that with less than 1% of GDP, the Government doesn’t spend enough on healthcare sector today as compared to neighbouring countries, like Bangladesh, Sri Lanka and Nepal. They have better GDP spent on healthcare compared to India. From the current budget allocation, it appears that healthcare is still not a priority. Mr. Baid mentioned that there is lack of innovation in the country. Still 80% of the population is not covered under any healthcare program. However, he also mentioned that there are lot of changes that are happening. First of all, the Government of India has recognized Medical Device Sector as a Sunrise Sector as part of the “Make In India” Program launched by Hon. Prime Minister Mr. Narendra Modi. Government saw the need of propelling the sector because 7080% of the devices are still imported to the country. The Government wants more investment to come into the sector and hence, recently, Government of India has notified 100% FDI in Medical Devices Sector. This is a very important step according to Mr. Himanshu Baid. This policy will bring new opportunities for the medical device sector. There will be more investment from private equity investors and the strategic investors from abroad. It will encourage more collaborations, acquisitions and joint ventures and develop new technologies. It will make industry attractive through innovations. Capital will flow seamlessly into the country now. Maximum benefit will go to small start up company, SME and MSME sectors. FDI will bring more specific innovations to products for domestic demands as needed for Indian patients. Also, the Non Compete Jan.-Feb. 2015

Cover Story Clause has been done away with. Another important change which has come is draft National Health Policy’2015. Our last Health Policy was made in 2002 and after 13 years the new Health Policy has come, as put on the website of Ministry of Health and Family Welfare. The most significant is that Government is now recognizing the need of investing more money on Healthcare. Like in education, government might bring a Healthcare Share to promote healthcare. The industry might see a fourfold growth in next five years. Focusing on inverted duty structure and manufacturing, Mr. Baid mentioned, today most of the raw materials are expensive than importing finished products into the country. Under the “Make In India” national agenda, government is already looking at this anomaly of inverted duty structure through this national health policy. Of course, the key objective is to bring in at affordable prices for life saving technologies. The most important fundamental question here under the policy is to pass a Health Right Bill making health a fundamental right, in the way it was done for education. Today as like education has become a fundamental right, so, can Government take an initiative and make health a fundamental right for everyone. Countries like Brazil, Thailand and even China is moving in that direction where there is a major law, and this is the big contributing growth to healthcare industry as such. Also, in turn it propels growth in medical technology industry. China spends more than 40 Billion dollars on Healthcare annually on public health, so with the same population in India, similar population level, if we look at that kind of number which is there, and to cover and balance 80% of the population which has not covered under any healthcare program, this is the kind of investment which is needed today in the healthcare industry. And also, definitely this will be a huge trigger in the growth of medical device industry also. Throwing light on the Government machinery, Mr. Baid mentioned that the secretary of Pharmaceuticals has been appointed as a key nodal officer to look in the issues of Medical devices and pharma manufacturing equipments companies. And, government has already set up a taskforce in November’2014, to identify the issues related to promotion of domestic production of high end medical devices and pharma manufacturing equipments. The taskforce is divided into three sub-groups. Each of the sub-groups is headed by a joint secretary level of officer, under different ministries, ministry of commerce, ministry of health and family welfare and ministry of pharma, all three ministries are looking into different issues. Under this taskforce the industry forums are already invited in these meetings, like CII, AIMED, different industry forums are there, which are presenting different issues, presenting proposal to the government, what are the issues which we should resolve immediately, and what will kick-start the industry. So, this is the first time that government has taken such a big initiative to promote domestic manufacturing of medical devices. He mentioned that, under EEPC, recently a new pharma equipment & medical device and surgical device panel was formed. Currently India exports approximately 1 billion dollar of medical devices and pharma equipments. Exports were not classified into medical devices and pharma equipments; they were logged under export promotion councils, like, Pharmexcil, Jan.-Feb. 2015

Manufacturing Medical Devices In India Chemexcil, Plex Council and EEPC. So the ministry of commerce recently decided to nominate and put up a separate panel under EEPC for the promotion of Medical Devices and Pharma Machinery. And, there was a long term industry demand to have a separate medical device export promotion council. But under EEPC, which is now monitoring this activity, Mr. Baid hoped that different policy issues will be taken up. Mr. Himanshu Baid also mentioned about the medical device manufacturing hubs and dedicated medical device testing labs being set up across the country. Single window clearances will be available to medical device companies. This will fuel the growth in investment in medical device sector. There will also be creation of ancillary industries, they will contribute to overall growth of this industry, will help in cost reduction because, low to medium skilled jobs can be passed on to smaller scale industries in MSME sector. Like the Automobile Sector, Mr. Baid hoped, if initiatives are taken by the government in medical device sector also, and if large companies come into India with big manufacturing base, it is going to help the MSME sector, the small companies and also speed up investments and start making good quality products. Mr. Himanshu Baid also mentioned that the Industry is optimistic that the proposed bill will go through in this current session of parliament as Drugs and Cosmetic Amendment Bill’ 2015. As and when the drug amendment act is enacted, the new regulatory system to be created for medical device sector will help to overcome challenges of regulation. Mr. Himanshu Baid also highlighted one more development regarding “Buy India Policy”, a very important move for medical device sector to encourage health institutions to procure Indian made products. It will go a long way in providing impedance to the growth in the domestic sector. He mentioned that the ministry of commerce and the ministry of health and family welfare are already working on a framework in consultation with all stakeholders, to promote Made in India products, and buy Indian products. There are so many different government initiates in place and growing needs of the medical and healthcare sector. There is a great opportunity for the medical devices and technology sector to innovate across the value chain, to serve Indian and foreign consumers, and unlock the value of Indian market. Finally, India’s traditional strength is manufacturing and it can deliver tremendous value if it can meet with regulatory and operational challenges. Mr. Himanshu Baid started his career as a Trainee Engineer with Philips Communications Industry AG, Nurenberg, Germany. After coming back from Germany in 1992, he was involved in his family business for 3 years, manufacturing Plastic Containers. In 1995 he started Poly Medicure Ltd. with his brothers and today the company has 6 plants out of which two are overseas in Egypt & China. Poly Medicure Ltd. is one of the fastest growing Medical Devices Company in India and through its R&D initiatives the company has filed approximately 50 International patents worldwide. The company manufactures over 100 different products & exports to more than 80 countries. The group has sales of over Rs 300.00 Crores.

Cover Story

Manufacturing Medical Devices In India

How Do We Balance Between Compliance, Quality And Innovation? Mr. C. Padmakumar - Chairman & Managing Director Terumo Penpol Limited, Trivandrum Abstract of Presentation made by Mr. C. Padmakumar during the 12th National Conference and Technology Exhibition on Indian Medical Devices & Plastic Disposables/Implants Industry 2015, Ahmedabad.

• It is important to have safe products & affordability. • India needs to satisfy the requirement of the regulator and also needs innovation. • The best way to get consistent quality is to have standardized processes and have S.O.Ps, but as the, Doctors and Patients want innovation, this leads to the need of striking right balance. • Medical devices are quite complex requiring various disciplines including Plastics, Light engineering, Chemistry, Bio-chemistry personnel etc. to collaborate for which a network of organizations is required. • There are some logical locations for clusters to exist in our country. • Along with satisfying the regulators, it is important that the patient safety is not compromised and new innovations take place. • Low cost innovations are carried out in India by institutes like Stanford India Biodesign. • European Regulators provide mentoring and hand holding to SMEs in Medical Device Sector who cannot afford resources like large companies; hence Indian regulators should look at the approach by the European Regulating agencies as well as encouraging efforts being made by USFDA. • The American and Japanese counterparts have now realized that the opportunity in India is not just low cost but also very high power scientific and engineering talent including design talent looking very seriously at investing more in India and taking advantage of the capabilities in India. • Good opportunity to take up medical components manufacturing in India, and hoping that the situation will change shortly, making good components available in India and not being imported.

How do we balance between Compliance, Quality and Innovation for Medical Device Manufacturing? It is a complicated business with prime focus on patient safety.

Mr. C. Padmakumar, a professional Manager with a Bachelor’s Degree in Commerce and an MBA in Marketing, is Chairman & Managing Director of Terumo Penpol Limited. He started his career as a Jr. Project Executive and worked his way up from the shop floor in India’s first Blood Bag company, Peninsula Polymers Limited (PENPOL). The company is now established as one of the largest manufacturing sites for Blood Bags in the world and is the market leader in India. Terumo Penpol products are sold in 80+ countries all over the world.

Explaining about the clusters, he mentioned that there are some logical locations for clusters to exist in our country, one, unlikely as it may sound is Trivandrum.

While it is very important to have safest products, how do we ensure access which is directly related to affordability, which involves costs. Every country has a very strict regulation for medical devices and India is no exception. We need to satisfy the requirement of the regulator and we also need innovation. For manufacturers the best way to get consistent quality is to have standardized processes and have S.O.Ps, stick to those SOPs. However, Doctors and Patients want innovation which means changing something. It means inherent trade off here. The trick is to try and strike the right balance. Introducing his personal growth process, Mr. C Padmakumar mentioned that he started as a young employee in a start up Indian company at a time when medical device industry was at its nascent stage. The Company then after growth, tied up with a major medical device company - a global leader called Terumo of Japan, as subsidiary and a joint venture partner. Subsequently, it is now a fully owned subsidiary of Terumo Cooperation from the last couple of years. Thus, he has a reasonable level of experience Purely Indian, Half Indian and now a part of Multinational. It includes experience in dealing with the multinational medical devices company and dealing with the Indian market and Indian hospitals, doctors, patients and with the regulators. Taking the growth story further, the Company had started in an isolated location with very less accessibility. Introducing the nature of Medical Device Industry, he mentioned that medical devices are quite complex requiring various disciplines including Plastics, light engineering, Chemistry, Bio-chemistry personnel and so on have to collaborate if you want to have a good medical device. Since, we can not have all these people in the same organization; we need a network of organizations. This shows importance of having a cluster of organizations which exists globally in places like Minnesota, Boston (In USA) in Dublin, in Japan, in Singapore and also in India.

Trivandrum – as a Potential Cluster Location For Medical Device Industry. He further gave following supporting facts showing why; Trivandrum has most of the necessary condition to actually have a successful medical device industry. • It has 2 reasonable sized medical device companies. One is Jan.-Feb. 2015

Cover Story HLL Lifecare, which is owned by the government of India, formally, Hindustan Latex Ltd. A large manufacturer of condoms and blood bags and other medical devices. The second is Terumo Penpol. • It has Shri Chitra Institute of Medical Science and Technology, which is a unique institution in India and may be in any part of the world devoted to research in medical devices and it is a part of a hospital. Half of this institute is actually a hospital and half of it is R&D set up. The Institute came up with the blood bags manufacturing technology, which initially his Company started as “Chitra blood bags”. They also have developed products like the heart valve. This source of interaction and information and the R&D center, is absolutely key factor in helping the industry to grow.

Manufacturing Medical Devices In India for Devices and Radiological Health (CDRH), as part of an effort to assess and understand gaps in medical device quality. Mr Padmakumar mentioned that this introspection by USFDA was in response to the criticism by the Industry. They interacted with Medical Device Industry professionals at various levels and also to Doctors as well as USFDA officers. He shared the important outcome of the report (summary of the said report is covered under the column “Global Trends” in this issue). He mentioned that European Regulators provide mentoring and hand holding to SMEs in the Medical Device Sector who can not afford resources like large companies. However, they have innovative approaches, more ideas, large no of young minds and hence they need help. And hence, the US FDA is looking forward to implementing the findings of the report very seriously.

• The place has academia - the Kerala University along with other engineering colleges as well as the Trivandrum medical college. All these are necessary for the medical device industry.

He suggested that the Indian regulators should look at the approach by the European Regulating agencies as well as the encouraging efforts being made by USFDA.

• I think all of us will agree that Technology is playing bigger and bigger role in medical devices, especially Information Technology. We are using a lot Software which are embedded in the medical devices these days. We have a very large TechnoPark in Trivandrum. With companies not just in BPO, but in softwares and a lot of work is going in Techno Park.

Mr. Padmakumar shared his experience of working with both Japanese as well as American companies over a period of time. He mentioned that Americans obviously have a very different philosophy from that of Japanese. They have been trying to adopt both cultures. However, he explained how the mindsets of Japanese and American principals have changed about India now. Initially, the US Company was not expecting much from Indian Company. However after visiting India and looking at the Terumo quality standards and products , meeting customers , talking to Doctors , talking to regulators and various other stakeholders , they realised that they can trust and just take Terumo products and sell them. It is simply too costly to make either in America or Japan. The American and Japanese counterparts have now realised that the opportunity in India is not just low cost but also very high power scientific and engineering talent including design talent. They also hold major innovation summit in Trivandrum. The Japanese and American principals are now looking very seriously at investing more in India and taking advantage of the capabilities in India.

• Last but not the least, Trivandrum has a small but growing set of ancillaries, some of these are being set up by Terumo Penpol and some of these are set up by HLL Lifecare. With these together, the chances of success for the cluster are much better. He also mentioned about Ahmedabad, Gandhinagar as another perfect locations for a cluster alongwith Delhi. There are many other locations. Since India is a very large country, we should not be worried about how many clusters come up. Coming back to balancing between Compliance, Quality and Innovations, he mentioned that along with satisfying the regulators, we have to be absolutely sure that the patient safety is not compromised; new innovations take place for the patients to benefit from newer treatments. How do we do that? He shared the example of his company which very closely interacted with Regulators resulting in knowledge sharing and benefit to both, the Company as well as the regulating agency. He also lauded efforts by Indian regulatory authorities to enhance the sectorial knowledge. He further gave the example of very good low cost innovation carried out in India by institutes like Stanford India Biodesign located in the premises of All India Institute of Medical Sciences (AIIMS) in New Delhi which he visited recently. The students in the institute work closely with Doctors, healthcare professionals and patients to understand problems faced by them. Explaining how they achieve development of low cost medical devices, he said they look at the need and determine critical quality requirements. More and more of such institutes are required in our country at different locations. Ahmedabad may be one such location. More Mr. C Padmakumar strongly recommended the delegates to go through a report on, “Understanding Barriers to Medical Device Quality” , prepared as a result of an initiative launched by the United States Food and Drug Administration (FDA), Centre Jan.-Feb. 2015

Mr. Padmakumar also mentioned that they have given proposal to Kerala Government for developing a cluster. Mr. Padmakumar concluded his presentation, with following remarks: • Over a period of 29 years of his business career, he has been fortunate to have passed through different phases. • When they started, there was no ecosystem for medical device manufacturing. There was no availability of components, no good quality fabrication work, and no availability of most of the supplies. Almost everything was imported. • Things have changed dramatically over the last 29 years. Most of the supplies are available in India. • For Terumo’s new blood bag factory in Vietnam, most of the pharma equipments are going from India and not from the sources of the principals. There are lots of changes. • He however mentioned about non-availability of precision plastic components as a big problem. Good components are not available in India and have to be imported. He hoped this situation will change shortly and mentioned that there is good opportunity to take up medical components manufacturing in India.

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Global TTrends rends Understanding Barriers To Medical Device Quality Abstract of a report by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), October 31, 2011 with a purpose to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement. In recent years, a growing number of patients have suffered from adverse events due to medical devices. To better understand the reasons for these lapses in quality and safety, the US FDA conducted interviews with medical device industry thought leaders and FDA leadership and in parallel analyzed FDA adverse event reports and recall data. Their efforts revealed that there are systemic gaps within the medical device industry’s quality approach that result in these issues. Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency’s regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA’s regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative. Executive Summary This report is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), as part of an effort to assess and understand gaps in medical device quality. The work focuses on marketed product quality assurance, rather than pre-market activities. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement. The work was conducted with input from several sources: interviews with internal and external quality experts; a set of blinded industry interviews, a scan of databases, relevant articles, and conferences; and an outside press search. These inputs uncovered several key facts about marketed medical devices as well as potential catalysts for quality improvement. • The medical device industry has enjoyed tremendous growth in both revenues and the technical complexity of the products that it produces over the past 10-20 years. • Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.1 • Quality risk is not evenly distributed across the industry. This reflects the heterogeneity and complexity of the devices, manufacturers, and use environments. Cardiovascular, in vitro diagnostic (IVD), and general hospital/ surgical devices account for nearly 60% of adverse events reports. Only 20 of the 1189 active product codes account for 65% of all serious adverse events reports between 2005 and 2009. • An analysis of root cause data reveals that failures in product design and manufacturing process control caused more than half of all product recalls. The root causes of quality issues are tied closely to device type. Therapeutic area was not as strong a predictor for recall root cause. • There are seven major opportunities for improving quality within the industry: Enhanced operating systems

a. Design and reliability engineering – specifically, validation of actual product use, design-for-reliability and manufacturability, and software robustness. b. Robust postproduction monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.1For purposes of this report, the term “serious adverse events” encompasses death, life- threatening events, hospitalization, disability, congenital anomalies, and/ or required interventions, and disabilities. This term should not be confused with the regulatory definition of “serious injury,” which is defined under the medical device reporting regulations (21 CFR Part 803.3). c. Supplier management processes, particularly in material and process change controls. Enhanced management infrastructure d. Quality metrics and measurement systems that go beyond regulatory compliance measures. e. Quality organization that integrates cross-functionally throughout the organization, rather than solely focused on compliance. f. Performance management, where those in key roles associated with quality outcomes, like design engineers, are measured and incentivized around quality performance. Enhanced mindsets and behaviors g. Quality culture can be improved where companies have experienced severe quality-related issues. • Broadly, companies are experiencing three key challenges related to improving quality: a. Low quality transparency, driven by a lack of information for consumers and decision-makers around comparative quality (i.e.,quality differences among competitor products), time to market competition, and cost pressures, limits significant quality upgrades. However, the economics of quality may be changing as risks and costs of poor quality increase and transparency into comparative quality increases. Continued On p 28

Jan.-Feb. 2015

Global TTrends rends China: Medical Technology Potentials Are Enormous Health Industry Summit (CMEF) in Shanghai opens path to Chinese market, features products for global distribution. Is China still a key driver for world economy? Some market observers underline that growth in 2014 was down to 7.4 per cent – the lowest rate within 24 years. However, this change is well within the range of the central administration’s policy aiming at sustainable dynamics. And what is even more important for the medical technology sector: As of 2013, the Chinese medical technology market sported in excess of 24 billion US-$ and the world’s highest sector growth rate – 25.9 percent. By 2020, the administration aims to increase spending in the sector to approx.1 trillion US-$. These impressive figures provide the perfect backdrop for Reed Sinopharm’s Health Industry Summit which beckons to medtech stakeholders from around the world this spring. The Current Situation Of China’s Healthcare Reform: According to results presented at the State Council of the People’s Republic on January 19, the envisaged basic system providing care to urban as well as rural regions has been established as planned. “The future target of the country’s healthcare reform is to optimize healthcare resources enabling residents to receive more effective prevention and clinical treatment while paying less money out of pocket”, explains the marketing manager of a large Chinese manufacturer who is active at a global level. Budgets From The Government: As a priority, the central government will re-enforce the services capability of countylevel hospitals, and support implementing a standard of care for community healthcare institutions. Furthermore, the administration is placing additional emphasis on strengthening medical IT infrastructure and telemedicine services. Influences On The Market: The strengthening of county-level hospitals and community healthcare institutions will lead to increased demand for medical devices. “Since the government aims at gradually implementing a system in which community healthcare institutions act as the patients’ first point of call for acute care, rehabilitation, and nursing services to reduce the number of outpatient cases in public hospitals, these institutions will need more diagnostic, rehabilitation, and hospital equipment”, according to the marketing manager. Further Drivers In The Market: In addition, aims of the central administration include installing at least one hospital with comprehensive services and one traditional Chinese medicine (TCM) hospital in each county. Also the government encourages the involvement of social capital in improving medical services, and creation of new non-profit healthcare institutions is encouraged based on the cooperation of social capital and public hospitals. The government will support those hospitals built with social capital to increase their number of beds. Drivers Of The Medical Devices Market: In China, currently devices made by Chinese manufacturers are mainly sold to public hospitals below category III – which is the top hospital category in the country – and to private hospitals. However, some large innovative domestic manufacturers have been successful in entering the top category market thanks to their strong technical and financial resources, impinging on the Jan.-Feb. 2015

monopoly of imported devices category III hospitals. Regions Make A Difference: Due to the unbalanced economic development in the various regions of China, healthcare resources mostly accumulate in the coastal areas, causing a large gap regarding medical technology and medical services skills between the coast, tier 1 cities, and the rural west of the country. In that rural area and parts of the under developed provinces, medical equipments are generally used for a longer period without replacement. Much of the equipment is comparatively old, and penetration of high-end and value-added imported devices is low. With the continuous large investment from both central and local administrations at the basic level of care, a larger number of county-level hospitals and community healthcare institutions will refurbish their infrastructure and purchase new medical equipment. “As far as middle and high-level equipment is concerned, for various reasons Chinese hospitals still prefer to buy imports. Both domestic and imported medical equipment will have an opportunity to grow by a large extent in China in the upcoming years”, explains the manager. Highend medical equipment used in China is mostly from foreign manufacturers; in the middle-high end range imports own 80% market share; in the middle to low end sector, imports have 40% while national manufacturers take 60% of the market, and lowend equipment used in China comes mostly from national manufacturers. Features Chinese Hospitals Focus On: Research and development of medical equipment requires huge staff and financial resources, with the added difficulty of highly restricted access and IPR (intellectual property rights) protection similar to the pharmaceutical industry. According to the marketing manager, roughly 80% of the domestic manufacturers focus on producing low value-added medical disposables, general surgical instruments, rehabilitation equipment, home-use devices, and low-end diagnostic equipment. Products with high value are mainly imports, which leaves hospitals with little choice. Summit To Present This Market Information: From May 15 to 18 in Shanghai, the Health Industry Summit in Shanghai – previously under the name of China International Medical Equipment fair (CMEF) – will sport more than 100 conference sessions, with more than half focusing on various fields of medical technology and market trends. “The conference portfolio will include the China Integrated Medical Imaging Summit, the In-Vitro Diagnostics China Summit, and many more”, explains James Wang, marketing director of the Summit. The China Healthcare Investment Summit – the key conference – will focus on topics such as China’s Health Reform and Healthcare Service Development, New Trends in Health Industry Regulations, and the Creation of the Intelligent Healthcare Ecosystem, drawing top level participation as business leaders and investors contemplate the next big moves related to investing in the booming China health market, outlines Wang. Entering The Market: CMEF has long been the leading medical equipment event in Asia, Wang goes on to say. “While sourcing

Global TTrends rends and trading activities may attract the crowds, however, it is for companies wishing to enter the Chinese market that CMEF plays a vital role: Finding the best partner and picking the right product suitable for the market makes all the difference between growing rapidly and losing out”. No other event in China provides a similar exposure to the thousands of key hospital decision makers and end users where real trends are shaped, to institutions and R&D firms where the next big opportunities are defined. Ultimately, underlines Wang, the needs of the market and the technology benefits shape the opportunities of the market in China. International Players At The Summit: Over 3,000 suppliers and nearly all of the key players in the market are represented at the show – including, e.g. GE, Siemens, Philips, Mindray, Neusoft, Toshiba etc. – from the U.S., Japan, Europe, Asia Pacific, and of course China. New Set-Up Of The Congress And Tradeshow And Investment Environment: The Health Industry Summit combines the medical and pharmaceutical value chains into one mega event which explores a multitude of synergies including distribution, international trade, and investment opportunities. “Investment in the health sector is on the rise, with 255 investments in the health sector in China worth 19.5 bn RMB from January to October 2014, representing a major jump in growth compared to 5.3 bn RMB in 2013”, says Wang. The event comes at the perfect time when China announces

major investments and developments in the health sector, including in the health services and new technologies in health IT systems and digital health platforms. “In the context of the envisaged size of the health industry in the country at 8 trillion RMB by 2020, the central administration has made steps to speed up licensing and registration for health food and nutrition products as well as other international technologies in the medical and pharmaceutical fields. Favourable tax policies on selected product imports are also on the agenda between key countries and China”, is Wang’s overview of trends. International Buyers: More than 10,000 international buyers from more than 140 countries will join the event. The health industry Summit will effectively combine the world’s largest integrated health expo (with 280,000square metres of exhibition space and an estimated 200,000 visitors) with a full Summit program to help the health industry in China to link up with its international counterparts. The event looks to be a highly anticipated prelude for larger changes and greater things to come in the health sector and the worlds of medical technology and pharmaceuticals. About the Health Industry Summit: Location: Shanghai, China Date: May 15 to 18, 2015. Focus: Medical Technology And Pharmaceuticals. Expected audience: 10,000 international buyers, 280,000 square metres of exhibition space, total 200,000 visitors) Further information: en.cmef.com.cn

Continued From p 26

b. Increasing complexity of medical devices and usage environments is straining the current quality system infrastructure. Companies report that they have not systematically upgraded their quality infrastructure due to the unclear economics and concerns about regulation. c. Companies perceive that the regulatory framework is misaligned with assurance of quality outcomes, in that compliance with regulations does not ensure quality, and that current intervention practices may de-incentivize improved quality. • Interviews and analysis also identified several steps the FDA can take to accelerate momentum around adoption of quality best practices. These steps should address seven key themes: a. Focus regulatory efforts to address industry quality gaps. b. Enhance visibility of comparative quality to harness market forces to drive quality. c. Optimize consistency and clarity of Agency expectations and requirements. d. Learn from practices of regulators of similar high-tech and complex industries. e. Bolster data collection and analysis to maximize potential impact. f. Leverage wealth of Agency data and analysis to continuously refine FDA’s compliance initiatives g. Increase level of engagement and collaboration with industry around enhancing product quality. Ref: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/ CDRHReports/UCM277323.pdf

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Industry News Industry Urges Govt. To Re-Draft D&C Act (Amendment) Bill To Meet Domestic Manufacturers’ Requirements The medical devices industry in the country is pushing for major reforms in the D&C Act (Amendment) Bill 2015. Concerned by the lackluster attitude in which the Bill has been drafted for the struggling medical devices sector, the Association of Indian Medical Device Industry (AIMED) has urged the Centre to re-draft the Bill again, by taking into consideration the recommendations of the industry. Experts stressed that the new Bill is creating a lot of confusion and chaos within the industry as it is tailor made to suit the pharma and MNCs needs than the domestic manufacturers’ requirements. Industry has always maintained that the Drugs and Cosmetics Bill 2015 should be named as Medical Devices and Patient Safety Bill 2015, to be presented as entirely separate regulations from pharma to encourage investment in this segment. They want the government to rename the regulatory body as Indian Healthcare Products Regulatory Authority (IHPRA) under the health ministry with separate divisions for drugs, cosmetics, medical devices and diagnostics. Likewise medical device manufacturers want the Centre to define GMP compliance as per IS: 15579/ ISO 13485 and delink Schedule M of

pharmaceuticals from Schedule M III for medical devices in Rule 76. This is because while the importers get license on the basis of third party certification of ISO13485 in three to four months, Indian manufacturers and exporters have to go through a joint inspection process for compliance to unknown and incompletely defined requirements. According to Rajiv Nath, forum coordinator, AIMED “Requirement of GMP of sterile pharmaceutical is arbitrarily applied as an overkill forcing the Indian manufacturers to face harassment and delay to make costly corrections for ever changing requirements The Centre also needs to re-define risk proportionate infrastructure requirements of Schedule M III. As these are listed in CDSCO’s website as guidelines but not followed by inspectors,we strongly feel these guidelines should be notified as rules.” The industry wants the Centre to take immediate action on correcting the definition of manufacturer in the Bill, as the current one is not appropriate in Indian context and can be misused. Nath cautioned that the definition as proposed will allow importers and MNC’s to claim ‘Made in China’ products to be labeled as

made in India and claim to be manufactured by them. “If proposed definition is allowed by law by oversight of our law makers it will be in conflict with labeling requirement of the Indian consumers protection act and the packaging rule and can even be misused and misrepresented by trading companies especially international MNC traders who will pass of the product as if manufactured by them rather than as marketed by them in their brand name on the labels. We fear that it will hurt the interest of the domestic Industry, especially since many World Bank financed tenders and state government tenders have clause giving a 10 to 15 per cent price benefit to the indigenous company to encourage a local long term supply source. If a Trader is going to be allowed to print his name as ‘manufacturer’ of product this will take away the competitive benefit being given to domestic producer,” pointed out Nath. He said that for over nine years the industry has been urging almost the same issues to various officers, and even after sympathetic assurances, it is yet to see any conclusive decision making. Ref: http://pharmabiz.com/ NewsDetails.aspx?aid=86170&sid=1

Medical Device Industry Wants Centre To Set Up Stand-In MTAB To Expedite Decision-Making Process For Sector Industry wants the Centre to set up a standin medical device technical advisory board (MTAB), until constituted officially by the Centre, as proposed in the draft Bill of 2015. Highly placed sources from the sector stressed that this is utmost essential under the current circumstances to ensure proper representation of the demands of the stakeholders during the decision making process. Experts pointed out that proxy constitution of such a board at least on a temporary basis can go a long way in addressing industry specific issues and expedite the process of making appropriate sector specific provisions for the industry as it should have been done for Bill 2015. This demand comes in the wake of the release of the draft notification of the Drugs and Cosmetics (Amendment) Bill 2015, which proposes setting up of MTAB specifically for addressing the current issues of this technical sector. While the

industry is enthusiastic about this news, they stressed that no good will come from such provision if it is not put into action. Association of Indian Medical Device Industry(AIMED) pointed out that the proposed provision should in fact be put into action, to genuinely discuss and deliberate over the representation of the stakeholders while considering the changes to be made in the draft Bill. It is understood that the industry is seriously concerned by highly misrepresented draft bill, which hardly addresses the issues of the medical device sector in its current form. In fact Rajiv Nath, forum coordinator of AIMED informed that there are many provisions which have been either unceremoniously deleted or added in the new revised bill which are against the interest of the industry. “To ensure that the benefit of constituting such board actually trickles down to help the stakeholders in

effect, it is essential to set up a proxy MTAB at the earliest. We hope to see experts from the industry especially from the ICMR, department of technology to be actively involved in decision making process while re drafting the Bill, to ensure fair representation of the demands of the industry.” He informed that ironically even for a technical sector like medical devices, para - meters are set like in drugs, while experts from the pharma industry draft provisions and laws for them than from medical device sector. “This mentality has to change if the sector needs to grow and keep up with the changing market dynamics and challenges. Thus to create an act that suitably addresses the industry’s demands, at least a ghost MTAB as a task force should be formed to ensure a judicious job rather than current approach of acting on comments,” Nath added. Ref: http://pharmabiz.com/ NewsDetails.aspx?aid =86168&sid=1

Jan.-Feb. 2015

Product Gallery New Sanitary Flanges With Barbs From Qosina Edgewood, NY – February 23, 2015- Qosina is pleased to announce the addition of seven new sanitary flanges with barbs, in stock and ready for immediate d e l i v e r y. Available in two sizes, 0.5 inch/0.75 mini (#51617 - #51619) and 1 inch/1.5 inch standard (#51620 - #51623). Sanitary flanges have an oversized hose barb design that facilitates a strong adhesion to a biopharmaceutical tubing line reducing the need for ties. Featuring a true bore design through the entire connector, the barb ensures a smooth transition from tubing to adaptor which reduces turbulence. A slight raise at the port ensures proper capturing of the gasket.These flanges accommodate various sized tubing including ¼ inch ID(0.25 inch, 6.4 mm) tubing,3/8 inch ID (0.375 inch, 9.5 mm), ½ inch ID (0.5 inch, 12.7 mm), and ¾ inch ID (0.75 inch, 19

mm). Qosina also carries clamps, flanges with gaskets, and end caps along with a variety of Bioprocessing components in their stock inventory. Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohyborst adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. Qosina offers low minimums and short lead times. Call our Customer Service Specialists to request a sample, obtain our latest catalog or place an order via phone +1(631) 2423000, fax +1 (631) 242-3230 or email info@qosina.com. Visit us at www.qosina.com to see our latest products. Custom sourcing services are available through our extensive resources. Contact: Ryan Edwards Qosina 150-Q Executive Drive, Edgewood, NY 11717. Phone +1 (631) 242-3000, Fax +1 (631) 242-3230 Email:redwards@qosina.com

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

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Jan.-Feb. 2015

Events MEDICAL FAIR INDIA 2015 To Give A Fillip To Indian Medical Industry 21st Edition of Medical Fair India 2015, the much awaited event for the Indian Medical Industry to take place from 21st-23rd March in Pragati Maidan, New Delhi Medical Fair India 2015, the most influential trade fair for medical products, pharmaceutical products, medical technological products and health care service facilities; in its 21st edition will showcase the latest technological advancements in a vastly diversified medical sector. Medical Fair India 2015 the flagship brand of Medica- the world’s largest annual medical event held in Düsseldorf, Germany. The event will be flagged off from March, the 21st to 23rd, 2015 at Pragati Maidan, New Delhi and would prove to be the bellwether amongst the medical events in the country. The current edition of Medical Fair India comes with a special focus on Hospital Infrastructure and planning, witnessing participation from over 20 countries with dedicated country pavilions from the U.S and the U.K, Germany, Taiwan, Korea, Belgium, China, Italy, Malaysia and Singapore. The event will have nearly 500 exhibitors from India and abroad showcasing their products and services which will help visitors to identify new providers, new agents and joint venture partners. It is aimed at sourcing out new products and technologies and to find new suppliers for stakeholders in the medical industry. Medical Fair India 2015 will be attended by a wide spectrum of experts in the medical field like doctors, practicing physicians, veterinarian, dentists, physiotherapists, ergo-therapists. The visitor profile will

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also include professionals like hospital directors/ managers, hospital owners, hospital administration managers and staff, medical specialists and superintendents, service providers. Biologists, microbiologists, biochemists from the research community along with general service providers like process engineers, NGOs for rehabilitation aids, distributors, visitors from academics and universities and visitors from government and international agencies will also be a part of the event. Medical Fair India 2015 will have special features like the coinciding of the 5th edition of Medgate Today Healthcare Awards. The coveted award platform evaluates hospitals, companies and healthcare professionals on their outstanding performance in healthcare and life sciences sector. Also, for the first time in the country, the event will have specific conferences on Hospital Infrastructure and Planning with the theme of Challenges and solutions in hospital planning and the second conference will be on Medical Device & Technology with the theme of Connect, Engage and Explore. Indian healthcare expenditure is amongst the lowest globally and there are significant challenges to be addressed both in terms of accessibility of healthcare service and quality of patient care. A significant portion of the Indian population is unable to access.

Events Calender • Medical Fair India 2015 21st International Exhibition and Conference Date: 21-23 March, 2015 Venue: Hall 11,12,12A, Pragati Maidan, New Delhi.

• CMEF & ICMD (Spring) Date : May 15 – 18, 2015 Venue : Shanghai, China. The 73rd China International Medical Equipment Fair The 20th International Component Mfg.& Design Show

• Medicall 2015 13th Edition India’s Largest Hospital - Needs Expo. Date : 31st July, 1st & 2nd Aug. 2015. Venue : Chennai Trade Centre, Chennai, India.

• Plastivision Arabia 2016 Region’s Leading Plastics Event Date: 10-13 January, 2016 Venue: Expo Center, Sharjah.

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Jan.-Feb. 2015

Events healthcare service because of inadequate healthcare infrastructure. Accessibility to healthcare infrastructure on an overall basis is relatively imbalanced and is extremely limited to rural areas of the country. The existing healthcare infrastructure is unplanned and is irregularly distributed. Further, there is a severe lack of trained doctors and nurses to service the needs of the large Indian populous. Healthcare infrastructure (majorly hospitals) requires necessary attention for India to revolutionize its medical and healthcare industry. The event serves as a perfect platform to network with thousands of healthcare professionals along with generating business and increasing sales. The conference topics and Speaker sessions will provide valuable insights on new trends which could widen the customer base and help companies to stay ahead of competition. With participation from international companies and other countries, building relations to gain access to India and the sub-continent will be facilitated. Some of the key associations supporting the event are Indian Association of Physical Medicine and Rehabilitation, Association of Healthcare Providers (India), ADMI - Association of Diagnostic Manufacturers of India, MSAHITA - Medical Surgery and Healthcare Industry Trade Association, Apollo Hospitals Group, Indian Association of Sports Medicine, Fortis Healthcare Limited along with other associations from the U.K, Germany, Korea. “Medical Fair India would act as an enabler in bringing the entire medical fraternity on one platform where suppliers and buyers from different segments of the industry will congregate and do business. The 2-day technical conference shall bring together

MEDICAL FAIR INDIA 2015 To Give A Fillip To Indian Medical Industry eminent speakers from the medical fraternity who shall deliberate on vital issues being faced by healthcare industry professionals.” said Udo Schürtzmann, Managing Director, Messe Düsseldorf India Pvt. Ltd. He further said, “India has embarked on a of healthcare services transformation. The present Indian Government has introduced structural reforms and has re-emphasized its vision to create the access for improving healthcare services and to provide affordable healthcare for all.” The private healthcare sector, in particular has witnessed unprecedented growth in the recent years and this holds immense business opportunities for companies interested to explore this huge potential. India’s health challenges, though unique and complex, also offers remarkable opportunities. The coming years will witness major expansions & progress in the direction to consolidate the India healthcare sector. About Medical Fair India The MEDICAL FAIR INDIA, held alternately in Mumbai and New Delhi every year, last time attracted 443 exhibitors and over 8,000 registered trade visitors across 3-day of the show to learn about the entire range of innovations from segments such as medical device technology, hospital, health centres and clinical equipment, rehabilitation, furnishings for pharmacies and care centres/ furniture. The 21stMEDICAL FAIR INDIA will be held in Halls 11, 12 and 12A of the Pragati Maidan Exhibition Centre in New Delhi from 21 to 23 March 2015. For further information: Ms. Shilpa Kabra Mobile: 9766705129 - shilpa@mutualpr.com

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

• • • • • • • • • • • • •

Contact : Anil Gupta +91-90999 15731 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount Jan.-Feb. 2015

Alpha Medicare and Devices Ltd. (taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : 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 : contact@alphamedicare.com Jan.-Feb. 2015

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

REGISTERED

0434

• • • • • • • • • • • •

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

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

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

Phone: (91-079) 26420281, 26440236

Manufacturer And Exporter Of a wide range Of Medical Devices

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

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

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

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

Jan.-Feb. 2015

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

National Healthcare An ISO 9001 : 2008 Company

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

Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in Jan.-Feb. 2015

AN ISO 13485-2012 CE certified Company

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

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

Our First Priourity is Customer Satisfaction

Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

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

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

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

Jan.-Feb. 2015

Medical Grade Products Speciality Adhesives and Chemicals • Epoxy Adhesives for Needles & Medical Devices • Si-PSA Adhesives for Transdermal Drug Delivery Systems • Food Grade Pigments for Medical Plastics • Fine Grade Solvents • Silicone Fluids for Condoms • Silicone for Hair Detangle

Thermoplastic Rubbers (TPR) Hardness ShoreA 50-80 Grade

• 100% Recyclable • 100% Non Toxic • Less Consumption of Lubricant Fluids • No Contamination Like Rubber Gaskets

Silicone Fluids For Disposable Syringes Ideal Lubricant For Syringe Barrels • 100% Non Toxic • Highly Hydrophobic • Easily movement of piston in the barrels • Viscosity available range from 1000-20,000Cst • Bio compatible

SI-22 Siliconisation Fluids Hypodermic needles, Glass Vials Rubber Caps, Glass Syringes, All Surgical Instruments and Blades, Catheter Tubes • 100% Non Toxic • Highly Hydrophobic • Non Transferable • Fast Drying • Dry Film Coating • Lubricates Easily • Highly Transparent • Confirms ISO 10993 Standards

Axxon Material Science For further information please contact : DP-80A, SIDCO Industrial Estate, Kakkalur, Thiruvallur, Tamil Nadu - 602 003, India E-mail : axxonmd40@yahoo.com, axxon.ms@gmail.com Mobile : +91-9443642810 / 09177044099