Medical Plastics Data Service Magazine September - October 2020 by Medical Plastics Data Service

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Vol. 28

No. 4

Sept.-Oct. 2020

How Can India Become A Global Medical Device Manufacturing Hub ? Mr C. Padmakumar, Director, Kerala Lifesciences Industries Parks Private Limited & former Chairman and Managing Director, Terumo Penpol, Trivandrum India cab be a Global Medical Device manufacturing and Research hub. What will it take to get there ? This article will look at these questions and propose answers based on evidence of the global medical device industry and the …….. Role Of Industrial Parks For The Growth Of Indian Medical Device Industry Globally, Industrial Parks have been found to be an important method of industrialization, rather more important and beneficial for the developing counties than the developed nations. The Government of India has already decided to offer grant-in-aid of 13.5 USD million each to……… Bio 360°Life Sciences Park (LSP) and MedSpark In Thiruvananthapuram, Kerala

QUALITY Quality Certifications In Medical Device Sector Mr Anil Jauhri, Ex-CEO, National Accreditation Board for Certification Bodies (NABCB), Delhi Why Certification ? While notifying compliance to MDR 2017, one of the conditions prescribed by CDSCO is that companies should have an ISO 13485 certificate by a certification body accredited by NABCB. It explains the risk of unauthentic certificate . Quality Requirements For Medical Textiles, PPES / Face Masks Mr K. R. Navaneethakrishnan, MSc, ERT, Assistant Director, GLR Laboratories Pvt Ltd, Chennai. Although PPEs are used for personal protection , they themselves may cause adverse reactions like acne , skin rash and contact dermatitis which may arise from some components . One of the quality that certify a medical device as safe is its property of being biocompatible.

MATERIALS Understanding The Complexities Of Medical Grade Polymers Ms Jennifer Green, Technical Marketing Manager, Medical Polymers, Lubrizol Life Science Health, Medical Device, USA What is a Medical Grade Polymer ? Considerations when selecting Medical Polymers ? Beyond Biocompatibility: whay a robust medical polymer goes further. Is a non-medical grade polymer good enough ? What does “Medical Grade Polymer “ mean to Lubrizol ? Polymers for Prevention and Cure : The role plastics play in improving health and safety Ms Drashti Shah, Freelance Writer and Strategist Business Manager, Shaili Endoscopy The development of plastics from 1930s enabled a complete revolution in how medical devices were made.They have not only made far safer, but also faster and more affordable healthcare and operational practices.

WASTE MANAGEMENT Rational Use of Personal Protective Equipment: An Environmental Perspective Mr Sharang S. Ambadkar, Managing Director, FeelGood Econurture LLP, Mumbai Dr. Mayur R. Moreker, Associate Professor of Ophthalmology, Bombay Hospital Institute of Medical Sciences, Mumbai, Dr. Shilpa R. Moreker, Consultant Pathologist and Laboratory Director, NM Medical Centre, MumbaI Biomedical waste produced in healthcare facilities as well as in our homes during the covid pandemic. Responsibility of citizens , need for education, awareness and innovations. Also how to limit the infection for our Safai Sevaks.

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Vol. 28

No. 4

Sept.-Oct. 2020

GLOBAL TRENDS • Placing A Medical Device On The Great Britain, Northern Ireland And European Union (EU) Markets From 1 January 2021 • Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing

• AiMeD Applauds Dr. P. D. Vaghela For Contribution To Indian Medical Device Industry At His Farewell • AiMeD Unveils Figure Of The Growth Rate Of Indian Medical Device Industry During Covid-19 • Health Ministry Issues Draft National List Of Essential Assistive Products

• Hindustan Syringes Sends Over 56 Million Pieces to Covax Facility • Japan Commits Rs 3500Cr To Strengthen Indian Health Sector • Medical Device Industry Demands Separate Marketing Practices Code Different From Pharma Industry • COVID-19 Treatment: CDSCO Shows Green Flag To Baxter India Oxiris Filter • SCTIMST Inks MoU With Tynor Orthotic To Boost Orthotic Devices For More Industry News available at : http://www.medisourceasia.com/industrynews/2020/in09-20/index.htm • IPC Rolls Out PPE Adverse Event Reporting Form As Part Of MvPI For Patient And Health Worker Safety • NATHEALTH And APACMED Join Hands To Advance Medical Technology For UHC In India • Kraton’s BIAXAM Kills Up To 99.99% Of Microbes Including SARS-CoV-2

• About Complying With Global Medical Device Packaging Requirements

EVENTS • MEDICA and COMPAMED 2020 to be launched as 'virtual.MEDICA' and 'virtual.COMPAMED'

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Nov. 2015 to June 2016 • Cover Story : Most Widely Used Medical Disposable Products (November – December 2015) • Global Trends : The Eleven Most Implanted Medical Devices In America (November – December 2015) • Global Trends : Fecal Incontinence Device (November – December 2015) • Global Trends : Lubrizol To Invest $ 15 mn In Lifesciences Business (November – December 2015) • Did You Know : About Failure of Endotracheal Tubes (November – December 2015) • Cover Story : 13th National Conference & Exhibition on "Indian Medical Devices & Plastics Disposables / Implants Industry 2016" supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. (January – February 2016) • Cover Story : Indian Medical Device Industry: Integrating Market, Technology, Innovation And Ecosystem (March – April 2016) • Cover Story : (ICMED)” - country’s first indigenous quality assurance system for medical devices was launched in New Delhi. (March – April 2016) • Cover Story : Amendment Of Drug Rule 76 To D e l i n k M e d i c a l D e v i c e s F r o m Pharmaceutical And Revision Of Schedule MIII And Its Alignment With IS/ISO 13485 Notified (March – April 2016) • Cover Story : Medical Devices With BIS Certification Is In Vogue With The “Make-In -India” Policy: DGAFMS, Ministry Of Defence (March – April 2016) • Markets : Southeast Asia: Region On The Rise For The MedTech Industry (March – April 2016) • Materials : Thermoplastic Polyurethanes: Enabling Innovative Competitive Technologies Through Advanced Materials (March – April 2016) • Did You Know : About Effect of Medical Device Quality Performance on Business Performance (March – April 2016) • Cover Story : Effective Vendor Management For Medical Device Industry (May – June 2016)

About Complying With Global Medical Device Packaging Requirements. It is not only important for the Medical Device manufacturer to see that the products are delivered to the users in safe and sound condition, it is also essential to see that necessary tests are performed in order to meet with the regulatory requirements. It is therefore essential to keep in mind from the initial stage of the product development process. It is the responsibility of Medical Device manufacturer to guarantee that the products will be protected during transportation, and that they comply with health and safety regulations. Pharmaceutical and medical products have certain special characteristics (such as their limited shelf life). For this reason, their requirements for transportation and commercialization must be aligned with them. There are international protocols aimed at guaranteeing safety focus on factors such as the seal integrity, materials or how the package reacts to the passage of time - the major once are : • ISO 11607 Packaging for terminally sterilized medical devices. • EN 868 Packaging materials and systems for medical devices to be sterilized, general requirements and test methods. • ASTM D1585 Guide for Integrity Testing of Porous Medical Packages. • ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. • ASTM F3475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. • BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). • ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. • ISO 11137, which measures Gamma and E-beam sterilization. (Source : https://www.safeloadtesting.com/latest-innovations-in-medicaldevice-packaging/ )

I'm not a teacher: only a fellow traveller of whom you asked the way. I pointed ahead- ahead of myself as well as you. - George Bernard Shaw

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

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EDITORIAL ADVISORY BOARD 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 Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG 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 Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon

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In one of the recent webinars, the former Secretary, Department of Pharmaceuticals, Ministry Of Chemicals & Fertilizers, Govt. Of India shared the vision to promote Indian Medical Device Industry as the global leader for quality medical devices and to ensure availability, accessibility and affordability in the country. However, a million dollar question is how can India become a global medical device manufacturing hub? Citing a study of the medical device industry by Michael Porter and colleagues, Mr C. Padmakumar, Director, Kerala Lifesciences Industries Pvt. Ltd & Former Chairman and Managing Director, Terumo Penpol has very elaborately discussed the key factors necessary to the growth of a medical device cluster. Taking the city of Trivandrum as a case of a medical device cluster in the making, Mr Padmakumar has explained how it measures against the Porter’s criteria for a successful cluster. In his recommendations, Mr Padmakumar has mentioned “Medical Device Parks” as an important tool to encourage more businesses to start and flourish. And rightly so. Globally, Industrial Parks have been found to be an important method of industrialization. For the developing countries, Industrial Parks are rather more important and beneficial than the developed nations. Quality Certifications is one major requirement for the companies to get international acceptability when seeking access to global markets as explained by Mr Anil Jauhari, Ex- CEO, National Accreditation Board for Certification Bodies (NABVB ). Along with the importance of Certifications, Mr Jauhari has explained the risk of unauthentic certifications as well as how to check authenticity. We have a recent case of growth of PPE industry in India from almost zero pre pandemic period to an industry with great export potential. As per an “Invest India” report, “The industry achieved 56 times growth just in initial 60 days.” As per the report, it has demonstrated, “a remarkable journey of collaboration between governments at the central and state levels, industries and workers to revamp existing production lines to manufacture a completely unknown product from scratch - a testimony of India’s concerted efforts of improving domestic manufacturing capacity on the back of its industrious manufacturing sector at such challenging times.” However to sustain the growth, product quality is very important. In an very analytical article, Mr K R Navaneethakrishnan, Assistant Director, GLR Laboratories Pvt Ltd has explained the quality requirements for Medical Textiles, PPEs, Face Maks etc. This includes biocompatibility tests. This is very important since as per CDSCO, PPE kits are now considered medical devices. One more pillar of strength for the industry is the raw materials used. In an article on, "Understanding The Complexities of Medical Grade Polymers", Ms Jennifer Green, Technical Marketing Manager, Lubrizol Life Science Health, USA, has elaborated various considerations when selecting medical polymers and how, Non-Medical Grade Polymer is not "Good Enough". MPDS encourages contributions by young professionals as can been seen from two important articles highlighting importance of Medical Polymers as well as importance of "Rational Use Of PPEs" from an environmental perspective. These and many more columns in the magazine including Global Trends, AiMed, Industry News, Events, “Did You Know” etc. etc. will be of great value to the readers.

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How Can India Become A Global Medical Device Manufacturing Hub C. Padmakumar Director, Kerala Lifesciences Industries Parks Private limited & former Chairman and Managing Director, Terumo Penpol .

India Can Be A Global Medical Device Manufacturing And Research Hub. Farfetched idea ? Or doable ? If it is doable, what will it take to get there ? This article will look at these questions and propose answers based on the evidence of the global medical device industry and the Indian medical device industry in particular. Let us start with a look at the history of the medical device industry and see what lessons we can learn.The medical device industry is heavily dominated by US companies(11 of the top 20 global companies) followed by European(7/20) and Japanese companies(2/20).US companies have been at the forefront of the growth of the global industry as they spread their wings from their lucrative domestic market to all corners of the globe.The US medical device industry has led by focusing on innovation. The Indian medical device industry is still a small one although it has grown substantially from very small and humble beginnings.Although it accounts for a fraction of the global industry,there has been a significant expansion of human resources,research capabilities and labs,and manufacturing facilities of international standards over the past 35 years.Indian companies are beginning to make forays into the global market and have penetrated even the most advanced markets such as the US and Europe apart from selling products to markets in Latin America,Asia,the Middle East and Africa. A study of the medical device industry by Michael Porter and colleagues identified the role of medical device clusters in the development of the industry.The key factors necessary for the growth of a medical device cluster are: 1) A large teaching hospital 2) At least one large medical device company 3) Engineering colleges 4) A university 5) Availability of multidisciplinary talent 6) Collaborative research It will be instructive to look at the case of a medical device cluster in the making in the city of Trivandrum.Let us see how Trivandrum stacks up against Porter’s criteria for a successful cluster.

1. A large teaching hospital: Trivandrum has the Trivandrum Medical College Hospital, one of the largest and oldest medical teaching institutions in the country. The Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST), an autonomous superspecialty hospital and research institute is also located here. So is the Regional Cancer Centre, one of the top ranked cancer hospitals in India. 2. At least one large medical device company: Terumo Penpol Private Limited, HLL Lifecare Limited have their headquarters in Trivandrum and have large manufacturing plants and R&D centres in the city. TTK Healthcare Limited has a manufacturing facility for heart valves in Trivandrum. 3. Engineering colleges: there are several private engineering colleges and the prestigious College of Engineering (CET), Trivandrum run by the Government. The Government Engineering College, Barton Hill, is also well regarded. 4. A university: The Kerala University is located in Trivandrum. 5. Availability of multidisciplinary talent: Kerala is an education hub with the highest literacy rate in India. All the required talent for the medical device industry is available thanks to the range of specialised educational institutions which offer courses and degrees and post graduate degrees in biology, microbiology, biomedical engineering, chemistry and its various subdisciplines, biotechnology and IT. 6. Collaborative research: the state of Kerala boasts of a number of highly specialised research institutions and many of the key ones are located in Trivandrum. SCTIMST, the Rajiv Gandhi Centre for Biotechnology, NIIST (formerly the Regional Research Laboratory),Terumo Penpol and HLL Lifecare are some of the leading research centres in the city.The prestigious Institute of Advanced Virology is being set up by the Government of Kerala at the Bio 360 Life Sciences Park,Trivandrum. September-October 2020

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I took the example of Trivandrum to illustrate the point about the need to develop clusters and because most people in India will not connect a city like Trivandrum with a medical device cluster. The US has 20 clusters which make it the medical device powerhouse of the world. India has medical device industries clustered in Haryana, Delhi, Gujarat, Agra, Bangalore and Pune. The country needs to develop each cluster taking cues from Michael Porter ’s research and implementing a holistic approach to cluster development. The Government of India has recently approved the setting up of 4 Medical Device parks in India including the MedSpark, Trivandrum. This decision fits in well with Porter’s recommendation to have regional clusters. The Government should strengthen the foundations of the medical device industry in India so that it becomes broad based and also deepens its knowledge base. It will be good to identify specific therapeutic areas and technologies where India can specialise and take a leading position globally. The following is a set of recommendations to help achieve the goal of making India a global medical device manufacturing and research hub:

appears that we may have to live with the virus for quite a while and this will have an impact on our supply chains making them shorter and bringing suppliers closer to manufacturing plants. The cluster concept fits well in this scenario. - India must embrace a Quality First mission for medical devices. The single most important factor driving performance in medical devices is quality products to a s s u r e p a t i e n t s a f e t y. Currently Indian products do not enjoy a high reputation in the global market with honorable exceptions. There can be no compromise on quality. In conclusion, I believe we have many of the necessary conditions to succeed as a global medical device manufacturing and research hub, but they are not sufficient. If we can fill the gaps and implement the recommendations above, I see a very bright future for our country in this field. Reference:The Minnesota Medical Devices Cluster Microeconomics of Competitiveness Professor Michael E. Porter Project Adviser: Professor Jorge Ramirez-Vallejo Harvard Business School May 6, 2011 Ankur Puri Ipek Demirsoy Lucinda Woods Mi Zhou Thongchai Rattanaruengyot

- Identify potential medical device clusters across India. - Where some or many of the necessary conditions already exist (such as in the example of Trivandrum given above), these clusters should be prioritised. - Government must devise attractive incentives for R&D as this is the critical factor for the medical device industry. - Government must incentivise higher education and skill development in the science subjects to foster a pool of talent locally. - Government must reach out to large medical device companies across the globe and invite them to participate in India’s plans with specific focus on research and development. - Medical device parks should offer common facilities to medical device startups and SME’s to bring down the capital cost and encourage more businesses to start and flourish. - Indian industry needs to invest heavily in research and development. Our record is not good in this aspect and we wili need to change if we aspire to compete in the global market. - There are a number of research labs in the Government sector with good infrastructure and well trained scientific talent which are currently under utilised. We must find a way to increase the interaction between industry and research labs. - A major factor which drives the success of the industry and is also its biggest constraint is the regulatory system. We need strong regulations to protect the health of patients but we also need simple and clear regulations which will allow companies to bring innovations in medical care quicker to patients. There is a definite need to invest in the training and skill development of the regulatory agencies to achieve these twin goals. - The current covid pandemic has forced businesses to rethink their supply chains and review their business strategies. It September-October 2020 D A T A

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Role Of Industrial Parks For The Growth Of Indian Medical Device Industry Industrial Parks – Definition and Roles According to the United Nations definition, “Industrial Parks (IPs) are the small and middle size organizations that have integrated business and production, benefiting from the common infrastructure services that have allocated in standard fabric buildings”. Globally Industrial Parks have been found to an important method of industrialization.

Vision Of Department Of Pharma-ceuticals, Ministry Of Chemicals & Fertilizers, Government Of India. The vision is to promote Indian Medical Device Industry as the global leader for quality medical devices and to ensure availability, accessibility and affordability of medical devices in the country through promoting make in India vision of the honourable Prime Minister of India.

One of the focus area is promoting Medical Device Parks with a view to achieve following objective and benefits:

Objective

Benefits

• Easy access to world class common infrastructure facilities

• Lowers the cost of production

• Easy access to testing facilities

• Economies of scale

The Government has already decided to offer grant-inaid of 13.5 USD million each to 4 Medical Device parks. On and above the already developed Andhra Medical Technology Zone ( AMTZ ), number of states in the country including Tamil Nadu, Gujarat, Kerala, Telangana, Rajasthan etc. are already in process of implementing Medical Device Parks.

Common Infrastructure Facilities In Medical Device Parks Some of the common infrastructure facilities identified by the Government include : • Component Testing Centre/ESDM/PCB/Sensors facility • Electro-magnetic interference & Electro Magnetic Compatibility Centre • Biomaterial / Biocompatibility /Accelerated Aging testing centres • Medical grade moulding / milling / injection moulding / machining / tooling centres • 3D designing and printing for medical grade products • Sterilization/ETO/Gamma Centres • Animal Lab and Toxicity testing centres • Radiology Tube/Flat Panel Detectors/MRI Magnets/ Piezoelectrical crystals/power electronics facility • Centre of Excellence/Technology Incubator/ ITI/Training Centres

• Single window for regulatory ] approvals

• Centre of excellence

Why Medical Device Parks ? Industrial Parks provide incentives to the entrepreneurs by reducing the challenges of where and how to begin, produce etc. In other words, entrepreneurs can invest fast and can enter the market with minimal biases. For the developing countries, Industrial Parks are rather more important and beneficial than the developed nations. Eventually, Industrial Parks lead to significant regional development in all locations where they have come up; besides it has also been noticed that in the long run, IPs have revived the stagnation in the regions by accumulating and providing more employment and promoting balanced economic growth. Once implemented, the park in addition to operations and maintenance of the facilities, can cater to up gradation of skills, technology, manpower training, common sourcing and marketing as its next level of activities. There can also be product linkages with and another unit in the sense different units in the cluster making components for a product while another at the end assembling the entire unit of product intended to be marketed as the final product.

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Bio 360° Life Sciences Park (LSP) and MedSpark In Thiruvananthapuram, Kerala Government of Kerala, through its premier Industrial Promotion agency Kerala State Industrial Development Corporation (KSIDC), is establishing a state- of-the-art Bio 360° Life Sciences Park in 200 acres of land at Thonnackal in Thiruvananthapuram with all support infrastructure facilities, to provide impetus to Life Science Sector. The Honourable Chief Minister of Kerala has inaugurated the commencement of work of the Medical Devices Park (MedSpark) in a function chaired by the Minister for Industries, held on 24th September 2020, in the premises of the Bio 360o Life Sciences Park, Trivandrum. The Honourable Chief Minister has expressed confidence that with the functioning of the Life Sciences Park and the MedSpark, Trivandrum will position itself as the important hub of Medical devices and Life Sciences industries in the country. KSIDC, in association with Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMS&T) is jointly developing a Medical Devices Park (MedSpark) at a project cost of Rs. 260 crores, in 9 acres of land in the Life Sciences Park, as a comprehensive entity where medical device innovators can engage in the end to end process of ideation to marketable product. The Medical Devices Park (MedSpark) would be focusing innovation in high-risk medical devices mainly implants and extracorporeal devices, the sector in which the SCTIMST has considerable expertise and experience. The proposed medical devices park has unique advantages in terms of its location and involvement of SCTIMST as technology partner, which no other medical devices park in other parts of India can offer. The Med-Spark will have facilities like Prototyping & Incubation Centre, Knowledge Resource Centre, Animal House, etc.

The Life Sciences Park has been conceived as a cluster of industries and R&D institutions in the Life Sciences Sector, which includes Biotechnology, Pharmaceuticals and Medical Devices & Diagnostics. The Park would provide developed plots for large and Integrated Life science based companies to set up their campuses and ready-to-use modular officies, wet and dry lab space for intermediate, small and start up companies. The first phase of the project is coming up in around 75 acres of land, while the second phase is planned in about 123 acres of land. KSIDC has almost completed the land development and basic infrastructure development works of the first phase of the project by providing dedicated power supply system with a capacity of 6MVA, dedicated water supply lines capable of supplying 1 MLD of water, internal road network, drainage system etc. The expenses for land acquisition and developments in Phase-I, total expense of Rs. 374.73 Crores is envisaged . Of the total 75 acres of land in Phase I, KSIDC has in possession 69.75 acres and Infrastructure development & common facilities are developed in 17 acres. The land acquisition for the second phase of LSP is in final stages .

The park is strategically located along National Highway and close to both Thiruvananthapuram International Airport and the proposed Vizhinjam International Sea Port and would be a focal point for convergence of research innovation and skill development to further advance the frontiers of science.

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Quality

Quality Certifications In Medical Device Sector

Anil Jauhri Ex-CEO, National Accreditation Board for Certification Bodies (NABCB)

Introduction The WTO regime, through the Agreement on Technical Barriers to Trade commonly called the TBT Agreement, recognizes that member nations may need to impose technical regulations, loosely standard enforced by law, on grounds such as health, safety, environment, deceptive trade practices and national security. This would mean that medical devices are readily amenable to regulations on grounds of patient safety and health. Unfortunately, India has not paid due attention to medical device industry allowing it to remain unregulated for a long time and its only in last 5 years that serious action to regulate them has been taken by CDSCO. The notification of Medical Devices Rules, 2017 was one milestone; abandoning the approach of notifying individual devices by notifying a definition of medical devices with effect from 1 Apr 2020 is another significant step forward. The industry currently is in transition before regulations begin applying from 1 Oct 2021.

Role Of Certification In Regulation

may not be the best approach as far as regulation of industry is concerned – its more cumbersome and expensive affecting the competiveness of Indian industry. Rightly, the MDR, 2017 does not require certification although it prescribes compliance to BIS standards as the first choice. It instead prescribes audit by the notified bodies for class A and B devices and by the regulator for class C and D devices with an option that notified bodies could also be used for class C and D device industry.

Why Certification The question then arises that if regulation does not require certification, what would be its need or relevance once MDR, 2017 becomes fully applicable by 1 Oct 2023. The immediate answer is that while notifying compliance to MDR, 2017 under the new definition of medical devices, CDSCO has also notified a transitional phase in which industry has been given time to voluntarily register and one of the conditions prescribed is that they should have an ISO 13485 certificate by a certification body accredited by NABCB, the national accreditation body, or any IAF member accreditation body like UKAS I UK, or DAKKS in Germany or ANAB/IAS/UAF in USA.

Certification, whether process, product or system, is usually a voluntary activity unless notified by the regulators. Regulations normally rely on inspection, audit and/or testing activities for checking compliance to laid down standards.

Therefore all medical device manufacturers have to initially go for ISO 13485 certification which otherwise is voluntary.

India is one of the few countries where concept of mandatory BIS certification has been used in many products – cement, steel, bottled water are just a few examples of such an approach which

The next question could be that if MDR, 2017 does not require certification, what would be the value of such ISO 13485 certification post implementation of MDR, 2017.

Anil Jauhri is former CEO of the National Accreditation Board for Certification Bodies (NABCB), a constituent Board of the Quality Council of India, and national accreditation body. He has 40 years of experience in the field of quality, standards, certification and accreditation having worked earlier in the Bureau of Indian Standards, the national standards body, and the Export Inspection Council, India's official export regulator and certification body under the Ministry of Commerce & Industry. He is nationally and internationally recognized expert having worked with such international bodies as UNFCCC, UNIDO, PTB, FAO and APO and was invited as an expert by WTO in 2013 and 2015. He has been part of India's trade negotiations with various countries, notably with the USA as part of Indian delegation led by the Commerce Minister in 2015 and 2017 in Washington DC. He secured a number of international equivalences for NABCB such as Product certification, Inspection, various management systems like Food safety, Information security, Occupational Health and Safety and Energy management systems. Besides being instrumental in supporting regulators like PNGRB, FSSAI, CDSCO, BEE etc. he also led development of a number of voluntary certification schemes of QCI notably AYUSH Mark, ICMED, Yoga certification etc. He continues to provide expertise to Ministries such as Commerce, AYUSH and office of Principal Scientific Adviser besides being an evaluator for the International Accreditation Forum as well as Asia Pacific Accreditation Cooperation.

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Quality The answer is that any manufacturer certified to ISO 13485 would be allowed a reduction in audit time for the purpose of audit by the notified body under MDR, 2017 since QMS prescribed under Fifth Schedule of MDR is broadly aligned with ISO 13485. Further, since ISO 13485 is an international standard and is directly or indirectly referenced in most regulations around the world, certification to it is an excellent way to demonstrate compliance to it with an internationally acceptable certificate. Any medical device manufacturer eyeing the overseas market would be well advised to continue with ISO 13485 certificate to enhance his credentials.

Risk of Unauthentic Certificates Unaccredited Certificate

Unauthentic Certificate

Authentic, Internationally Acceptable Certificate

The world market is full of private certification bodies issuing certificates to industry and it is important to distinguish an authentic certificate from many unauthentic, fake or even fraudulent certificates going around. Unfortunately, there is a plethora of unauthentic certificates in the medical device sector which should get weeded out with the stipulation of accredited certificate under IAF system by CDSCO for voluntary registration. An authentic certificate should contain the following : 1. Name and address of the organization certified 2. Scope of certification describing its activities under certification – e.g. production, packing and sale of ……… like …….(broad list of products) 3. Standard (or sometimes scheme or regulation) against which certification is granted e.g. ISO 9001 or ISO 13485 (standard) or ICMED 13485 (scheme) – in general guidance standards (e.g. ISO 10002 or ISO 31000) are not amenable to certification – these have to be formal requirement standards or specifications or regulations. 4. Date of issue and expiry of certificate 5. Unique identification number of the certificate 6. Name and address of the certification body (CB) 7. Logo of the certification body 8. Accreditation symbol indicating the name of the accreditation body (AB) which has accredited the certification body (in most countries, in the absence of any law requiring certification bodies to register, accreditation is the only way of recognizing a competent, authentic certification body) 9. IAF Mark – indicating that the certificate is covered under the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) and hence is internationally equivalent and acceptable in the market

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How to Check Authenticity To check the validity of ISO 13485 certificates, you need to follow the steps given below : 1. Get a copy of the MDQMS certificate 2. Check whether the certificate has the logo of the certification body (CB) and the accreditation body (AB). If it does not have logo of the AB, its unaccredited certificate and even if legally valid, it would not be part of international system and the certification agency is not under any oversight. Request your certification agency to issue an accredited certificate or change your certification agency. 3. If the certificate carries logo of AB also, check if the AB is part of the IAF (International Accreditation Forum) system – its name can be checked from IAF website www.iaf.nu for each country. If the AB is listed there, the certificate is likely to be genuine. If not, the certificate is not authentic and seek an authentic certificate under IAF system. 4. Check whether it carries the logo of IAF; you can find the sample image of logos in IAF website. If YES the certificate is likely to be genuine and indicates it is internationally equivalent. if NO the certificate may not be internationally equivalent. Note that use of IAF Mark is optional and its absence does not necessarily mean the certificate is not internationally equivalent. 5. IAF is creating a database of certificates – see link https://www.iafcertsearch.org/ - you can verify your certificate on this website. However, this database is new and is in the process of being developed – so absence on this website does not mean your certificate is not genuine. 6. All CBs are authorized to issue certificates for Standards and Scope Sectors for which they have been accredited by the respective Abs. 7. The national AB in India is NABCB. Currently, NABCB provides accreditation for a number of management systems standards which includes ISO 9001 as well as ISO 13485. 8. Go to NABCB website and click on ‘Accredited CBs and Ibs’; select ‘MDQMS’ from the list. 9. You will be able to view the list of Cbs accredited by NABCB. The list has 11 names currently. Are you able to find the name of the CB of your interest? If YES, go to next Step; if NO go to Step 11. 10. Click on the name of the CB selected and look for the following 2 facts: a. Whether the CB is authorized to certify for Scope Sector in which your activity falls; and b. The date on the MDQMS certificate issued is within the date range of ‘Valid from’ and ‘Valid upto’ If it meets both these conditions, the certificate is VALID. 11. It is likely that the CB is authorized by an AB of some other country as ascertained in Step 4.

Quality 12. In such a case, go to the AB’s website as given on IAF website and repeat steps 8 to 10 by clicking on the name of the CB. 13. Each CB has to provide a means of verifying its certificates – you can use the mechanism to verify that the certificate is in CB’s database especially if your certificate has been issued through a franchisee of a foreign CB. 14. Some ABs also provide a means of verifying certificates issued under their accreditation – you can check on the concerned AB website. 16. In case you still have doubt, refer the copy of the certificate to NABCB for verification at nabcb@qcin.org. It will help you verify even from foreign AB member of IAF. The same approach applies to verifying ISO certificate for any management systems standard say ISO 9001 or ISO 14001.

Certification Going Forward As already indicated, even when medical devices are fully regulated, ISO 13485 certificate would remain relevant both for seeking audit time reduction under MDR, 2017 and international acceptability when seeking access to global markets. Even though regulations typically do not prescribe or demand certification, many times the market or the buyers do. It is possible that buyers, esp government buyers, may demand BIS certification in addition to the licence you may get from the CDSCO or SLA. QCI and AIMED had jointly launched an ICMED scheme which endeavoured to fill the regulatory vacuum that existed when it was launched in 2016. It was envisaged that it would be a vehicle

to certify Indian industry to international standards especially though its product certification variant ICMED Plus which is yet to be launched. This was designed to help Indian industry demonstrate compliance to international standards as exist in global markets, an option not available under BIS certification since it certifies only to BIS standards. Its felt that globally, standards demanded from the Indian industry would remain different from BIS standards unless BIS adopts all international standards and therefore ICMED scheme can serve the industry. In the foreseeable future, CDSCO should consider providing consideration to voluntary certifications in its regulatory regime by, for example, recognizing any certification which meets its regulations fully or partially (only for QMS or for product compliance) by BIS or NABCB accredited CBs to reduce the regulatory oversight burden on it and the states. This is the approach which is gaining ground in other sectors globally and CDSCO, and indeed other Indian regulators, should be leading such developments rather than following them.

Conclusion The above narration indicates that voluntary certification in medical devices sector would remain relevant even after devices are fully regulated under MDR, 2017. Should CDSCO provide consideration to them as has been suggested in previous para, the value of voluntary certifications would increase further. It would be important that each manufacturer weighs the benefits of holding certification and chooses the right certification with authentic accreditation which provides maximum benefit to it in the market.

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Quality

Quality Requirements For Medical Textiles, PPES / Face Masks K. R. Navaneethakrishnan, MSc, ERT Assistant Director, GLR Laboratories Private Limited, Chennai.

Personal Protective Equipment (PPE) have become a mandatory part of our life, given the unforgiving grudge of the global pandemic on the human race. PPEs play a significant role in preventing transmission of infectious agents, not only in hospitals, but also in various activities such as cleaning, waste management and safe burials, and community care related to the outbreak. March 2020, saw an incredible increase in the import of personal protective equipment kits by various countries which led to a global shortage of supplies. In India, the PPE industry grew a stunning 56 times in the last couple of months. As many as 600 companies in India are registered to manufacture the protective gears. As per a notification released by MoH &FW vide S.O. 648(E), PPE kits are considered as a medical device, in pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). CDSCO notification dated 03 Sep 2020 listed out 24 devices as Personal Protective Equipment’s. Some examples of PPE include : • Face shield, • Face Mask (Disposable, Surgical, N95), • Gowns (surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns) • Gloves (Latex surgical gloves, Non-latex surgical gloves, Nitrile gloves, Examination gloves) With the increase in the demand for PPEs, it is necessary that manufacturers lay a d e q u a t e emphasis on the selection of raw materials as the quality of finished device is heavily dependent on t h e s e r a w materials. Although PPEs are used for personal protection, they themselves may cause adverse reactions. Adverse reactions that are commonly reported are acne, skin rash and contact dermatitis which may arise from some components (adhesives, rubber straps or metal clips) of the N95 mask. Skin reactions to gloves included complaints of dry skin, itch, and rash. Type I immunoglobulin E-mediated September-October 2020 D A T A

natural rubber latex hypersensitivity is an important, often undiagnosed, occupational health hazard for healthcare workers, especially in those with high exposure.

Biocompatibility tests (ISO 10993) for PPE / Medical Textiles One of the quality parameters that certify a medical device as safe is its property of being biocompatible. Biocompatibility tests are recommended for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. US FDA Guidance document issued on 04 September 2020 states that the term “human body” refers to either patient tissues or the clinical practitioner. Therefore "masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility."

Te s t i n g f o r biocompatibility considerations should be performed on the device in its final and finished form. As per ISO 109931:2018, majority of PPE devices are classified as Surface Contacting Devices with contact duration lesser than 24 hours. Below is a snapshot of the testing requirements for surface (Skin, Mucous membrane, Breached/compromised surfaces) contacting medical devices based on their contact surface and duration. S E R V I C E

Quality The following biocompatibility tests are usually recommended for PPEs. The principle behind each of these tests and the results they produce is briefly discussed below: • Cytotoxicity test (ISO 10993-5:2009) • Irritation/ Intracutaneous reactivity test (ISO 10993-10:2010) • Sensitization test (ISO 10993-10:2010)

Cytotoxicity test Biological Evaluation of Medical Devices - Part 5, Tests for in vitro Cytotoxicity, ISO 10993-5:2009(E). In vitro cytotoxicity testing is a rapid, standardized, sensitive, reliable, and cost-effective means to determine whether a material contains significant quantities of biologically harmful extractables. Qualitative cytotoxicity evaluation is appropriate for screening purposes, where the cells are examined microscopically using cytochemical staining if desired and changes are assessed: for example, general morphology, vacuolization, detachment, cell lysis and membrane integrity. Whereas, quantitative cytotoxicity evaluation involves MTT assay/ NRU assay/ CFU assay which measure cell death, inhibition of cell growth, cell proliferation or colony formation. The number of cells, amount of protein, release of enzymes, release of vital dye, reduction of vital dye or any other measurable parameter may be quantified by objective means.

• The second phase is elicitation, i.e. the production of a cellmediated allergic response by exposure of a sensitized individual to the same allergen. Prolonged use of PPE may cause allergic contact dermatitis and are may be due to allergen. Allergens causing allergic contact dermatitis include • Rubber accelerators commonly used in latex and non-latex gloves - Zinc Diethyl Dithiocarbamate (ZDEC) - Thiurams - Thiazoles and - Diphenylguanidines • Textile dyes in clothing - Azo dyes • Metals in masks and boots • Formaldehyde and other preservatives found in N95 respirators and other surgical masks The Guinea Pig Maximization Test (GPMT) is preferred test method for studying sensitization (ISO 10993-10:2010).

Skin Irritation test Irritation test is recommended for most PPE. Skin irritation is to determine irritant effects of PPE and its extracts on skin tissues. Skin irritation test evaluate local tissue response characterized by the usual signs of inflammation—redness and swelling—and sometimes accompanied by heat and pain. It is reported that residual concentrations of ethylene oxide present in gas-sterilized devices can produce an irritant response if they are not reduced to acceptable levels before the device is used; and residues of such contaminants as chemical detergents in a particular batch of materials or devices can cause unexpected irritation responses in users or patients.

Skin irritation test (Dermal irritation) • Topical application for at least 4 hours • Erythema & oedema formation • Primary or cumulative (for repeated dose) irritation index

Any cytotoxic effect can be of concern. It is primarily an indication of potential for in vivo toxicity and the device cannot necessarily be determined to be unsuitable for a given clinical application based solely on cytotoxicity data. Given the extreme sensitivity of this test, medical devices demonstrated to be cytotoxic must be assessed along with in vivo studies to evaluate the risk to human life.

Sensitization test Sensitization (e.g. delayed-type hypersensitivity) tests are used to estimate the potential for contact sensitization by PPE, materials and/or their extracts, using an appropriate model. These tests are important because repeat exposure or contact to even small amounts of potential leachable can result in sensitization, which can lead to allergic reactions. Skin sensitizers are substances that elicit an allergic response following contact with the skin, termed allergic contact dermatitis (ACD) in humans. Sensitization involves two phases: • The first phase is the induction of specialized immunological memory in an individual following exposure to an allergen.

The biocompatibility assessment is a part of the overall safety assessment of a device. Of course, the primary purpose of a device biocompatibility assessment is to protect patient safety. Ultimately, evaluating the biocompatibility of a device is a risk assessment exercise. There is no risk-free device or device material. Biocompatibility plays major role to minimize risk while maximizing benefit to patients while using PPE/ Medical Textiles. If a device is cytotoxic in vitro but does not produce any irritation or sensitization responses in animals, a biological safety evaluation can be performed to support and document the safety of the device. A Biological Safety Evaluation Report from an expert toxicologist can be a strong supporting document for regulatory submissions. Therefore, it is important that the biological safety of all PPEs is thoroughly evaluated through adequate testing for biocompatibility and risk assessment, to ensure their quality and safety. References Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process, ISO 109931:2018(E). Biological Evaluation of Medical Devices - Part 5, Tests for in vitro Cytotoxicity, ISO 10993-5:2009(E). Biological Evaluation of Medical Devices - Part 10, Tests for Irritation and Skin Sensitization, ISO 10993-10:2010(E). September-October 2020

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Materials

Understanding The Complexities Of Medical Grade Polymers Jennifer Green Technical Marketing Manager, Medical Polymers Lubrizol Life Science Health, Medical Device, USA

The appropriate selection of component materials is often very important in the development and sustainability of a medical device. For many devices, that selection often begins with a designer’s consideration of a range of known medical polymers.

So, What is a Medical Grade Polymer? While the question seems simple enough, it may surprise you that a globally accepted, agreed-upon definition and standard does not exist.

abrasion resistance while maintaining manufacturing efficiencies in the guidewire production process. Selection of a material for a pacing or neuromodulation lead may hinge more on a material’s blood/tissue biocompatibility and resistance to degradation inbody (oxidative and hydrolytic resistance) over many years, its dielectric properties, its physical strength and flexibility and the ability to produce the material in thin-walled constructions and assemble over electrical wires and other components.

Globally, the vast majority of polymers produced are used in industrial and consumer segments, with only a small percentage the polymer volume being used in medical devices. In order to differentiate grades supplied into the medical device market, raw material suppliers distinguish these material as “medical grade.” Currently there is no regulatory definition of a medical grade polymer and no prescriptive regulatory requirements for raw materials used in medical devices, so material suppliers and others in the medical device industry have assigned their own meaning to “medical grade polymer.” Consequently, polymers designated as medical grade from different suppliers are not necessarily equivalent in performance, quality and associated support. This situation can create confusion and uncertainty for the device designer when selecting materials. When it comes to specifying medical device materials, considerations need to be given not just to product specification and required performance attributes but the robustness of quality systems, manufacturing consistency, management of changes and understanding the possible implications on a finished device so the process is well managed by the supplier and effective communication systems are in place. In this article, the Lubrizol Life Science Health (LLS Health) team examines the complexities surrounding medical grade polymers and what you should know when selecting your medical device materials.

Considerations When Selecting Medical Polymers Medical device development is often a long-term endeavor, requiring rigorous testing, quality control systems, and compliance to an ever-evolving set of regional and global regulatory requirements. As the need for new and innovative medical devices grows, the need for materials (especially polymers) to support device development becomes stronger. The choice of polymer for a specific device application is often based on many considerations. For example, an interventional guidewire may need a polymer coating to provide a cushioning tip, biocompatible hydrophilic surface, radiopaque character and

A list of common considerations in polymer selection are shown below: • Biological Performance - Biocompatibility - Biostability - Hemocompatibility - Infection risk • Application Performance - Strength - Flexibility - Fatigue resistance - Heat and/or electrical resistance • Chemical Resistance - Cleaning product resistance - Drug resistance - Sterilization stability • Processability - Thermal methods (extrusion, molding, forming) - Solvent (casting, dipping, spinning) - Secondary assembly (reflow, bonding) - Compatibility with other materials within the device

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Materials • Regulatory and Compliance Requirements - Does the material contain REACH, RoHS or other substances of concern? - Has the material been used in devices cleared by regulatory agencies? • Cost: - Volume specific pricing - Annual access, licensing and/or royalty fees In addition to balancing the complex set of material related requirements above, a device designer may also consider whether to evaluate only materials designated by a supplier as “medical grade.” This consideration can quickly become challenging, as although regulatory scrutiny of devices and demands for polymer performance has increased, there is no universally accepted or regulated definition of a “medical polymer.”

Beyond Biocompatibility: Why A Robust Medical Polymer Goes Further While formulation, manufacturing and testing of materials for biocompatibility is a distinct and important characteristic of a medical grade polymer, other services such as regulatory support, change management and security of supply are of utmost importance, and may sometimes be overlooked during initial material selection activities. The Association of German Engineers, VDI, recently published a voluntary guidance document for defining “Medical Grade Plastics.” The document attempts to provide both polymer suppliers and medical device manufacturers and designers clarity on best practices relating to polymer use.

designed for medical applications. In other cases, a non-medical grade polymer may have been used in a device for decades, as it was evaluated prior to the availability of medical grade materials and the validation cost to the OEM to change materials is significant. Often, however, any efficiencies accrued by selecting a non-medical grade polymer are more than negated when changes or discontinuations are made to non-medical grade polymers. Non-medical grade polymers are designed for applications that do not require evaluation of impact on biocompatibility and medical device regulatory and compliance status. These situations can leave OEMs in danger of getting stuck in a constant and costly revalidation loop for their important product lines without the benefit of supporting material biological and medical regulatory information. In rare cases, a medical grade polymer that meets all the device’s performance needs may not be available as a standard “off-theshelf” grade. As non-medical grade polymers are designed to address a very wide variety of applications, they can sometimes offer unique chemistries, functional additives and performance options not available as standard in medical grade polymers. In these instances, direct discussion with the material supplier to discuss options for medical grade customizations may be warranted. While non-medical grade polymers are of high quality and performance, in most cases, medical grade polymers are best positioned to address both the immediate and long-term requirements for high performing sustainable medical devices.

What Does “Medical Grade Polymer” Mean to Lubrizol?

Within the document, the following are described as essential for a medical grade plastic: • Intended to be used in a medical device, in-vitro diagnostic or pharmaceutical packaging application • Maintained under a change management system for the polymer ’s specification, composition, regulatory status and manufacturing technology and site • Quality management system for a polymer ’s development, production and handling • Provided by the supplier with support to the end device owner to fulfill required regulatory requirements • Security of supply, availability and logistics considerations While a globally accepted definition for a medical grade polymer is not yet established, the above attributes speak to LLS Health’s core definition of a medical grade thermoplastic polyurethane (TPU). As a leader in TPU materials for medical devices, we are encouraged and supportive of efforts to clarify and explain essential requirements for medical grade polymers.

Is a Non-Medical Grade Polymer “Good Enough”? In some cases, a non-medical grade polymer may seem attractive from a perceived efficiency perspective, especially when OEMs plan to conduct their own biocompatibility evaluation(s). In such cases, it can be easy to overlook the value of change control and notification for materials specifically

LLS Health provides a full range of TPU material solutions and specializes in polymer customization to help achieve optimal clinical outcomes for medical device manufacturers. We work in collaboration with our customers to create polymer solutions for use in medical devices.

• • • •

Lubrizol’s medical grade TPUs offer the following support: • Assistance with regulatory and product compliance requirements such as providing information necessary to support device filings with the US FDA and other national/regulatory bodies Biocompatibility testing performed and results summaries available Comprehensive quality systems with manufacturing and quality record retention ISO 9001 certified manufacturing facilities with plant audits or audit packets available upon approval Extensive commercial product change management and change notification process: - Ensures changes are not made to process, procedures or composition without review and approval by all key LLS Health product design groups - If a change to commercial product manufacturing location, composition, specification or other significant properties is necessary, notification will be provided prior to implementing the change in commercial products. September-October 2020

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Materials • Documentation of the change will be provided, including reason and timing of the change. • Documentation will be provided as far in advance as possible ahead of the change. • Every effort will be made to ensure minimal impact to the material end user or processor, including (where possible), options for last-time-buy of products prior to change implementation to allow for technical and regulatory evaluation of any required material changes. When it comes to selecting materials for development of a medical device, it is clear OEMs have many options and factors to consider. It is not only important to work with a partner that has the expertise to help sift through those complexities, but also work with a polymer supplier that has a robust portfolio of materials, capabilities and quality and regulatory support systems in place to ensure optimal performance of your medical device throughout its lifecycle. Our team understands polymer selection, can answer your questions, and help you identify the right materials

for your medical device. Disclaimer:

Lubrizol Advanced Materials, Inc makes no warranties, express or implied, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No warranties or guarantees are made as to the suitability of the products for the applications disclosed. Full-scale testing and end product performance are the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the customer assumes all risk and liability of any use or handling of any material beyond Lubrizol Advanced Materials, Inc.'s direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation, nor as an inducement to practice any patented invention without permission of the patent owner.

www. .com THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTICS/DEVICES TECHNOLOGY AND TRADE

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Materials

Polymers for Prevention and Cure The role plastics play in improving health and safety Drashti Shah Freelance Writer and Strategist

Business Manager, Shaili Endoscopy

Even before COVID 19 came along and the use of medical disposable plastics for PP, PE, PC, ventilators, thermal scanners, and disposables like respirators, gloves, masks, etc. drastically increased - medical plastics played an important role in improving health and safety. While the medical device industry started with a heavy dependence on glass, rubber, and metal-think glass IV bottles, metal operating instruments susceptible to rust, and rubber tubing-the development of plastics from 1930s enabled a complete revolution in how medical devices were made. From using polyvinyl chloride(PVC) for IV bags and tubing to fluoropolymers for IV catheters, medical plastics have revolutionized the way plastics are used for healthcare. They’ve not only made for safer, but also faster and more affordable healthcare and operational practices.

fields, and compression. Expanded polystyrene (EPS) reinforces reliability and wards off contamination. It’s also considered nontoxic. Polymer packaging is one of the many important reasons healthcare workers and patients can remain protected.

Let’s have a look into the role medical plastics play in improving health and safety.

1. As a disposable replacement for reusable medical devices and instruments to prevent infection Many a times reusable, or multiple use, medical devices and instruments pose a genuine threat to patients because of improper cleaning and care. Because of the complex design of some instruments, even after following the manufacturers instruction, microscopic human remains can remain lodged in the equipment. When an item is used only once, it cannot transmit infectious agents to subsequent patients. Thus saving a patient from ill health or life threatening communicable diseases. Because of the wide variety of plastics and their inexpensive nature, plastics started being used more and more as a disposable alternative for infection control. These disposable medical devices generally depend on injection-molded plastic assembled via various methods in sterilized clean rooms. In a device such as a syringe that must undergo extreme pressure, polypropylene is used because of their strength. PVC can also be used because of its flexibility. Some other common examples are hypodermic needles, syringes, applicators, bandages and wraps, drug tests, exam gowns, face masks, gloves, suction catheters, and surgical sponges. Each day, more healthcare professionals are switching from reusable instruments to disposable, single-use ones.

2. In medical packaging Everyone knows how important it is for medical instruments to be contaminant free, rust free, and completely sterilized before their introduction into a patient’s body. These days, medical instruments and devices reach their intended destination (hospitals and clinics) via multiple handlers, multiple channels and sometimes after an extended transportation period. Now, it’s more important than ever to have appropriate packaging for the safety of medical products. This is where medical packaging comes in. Plastic packaging materials like Medical polymer films and barrier packaging shield products from exposure to ambient conditions and protect them from vibration, stress, magnetic

3. As diagnostic tools for preventing diseases It is widely agreed that it’s better to prevent diseases and health problems using early diagnosis rather than treating them afterwards. From using plastic labware for testing blood, urine or other bodily fluids and tissues for an effective early diagnosis of diseases (like diabetes, kidney diseases or other metabolic and non-metabolic diseases) to using plastic in diagnostic kitsplastics have come a long way. If a patient’s condition is diagnosed correctly, the patient can avoid the effects of a fully engaged condition and with early treatment the disease may be completely avoided.

4. In minimally invasive surgeries With the advent of plastics and plastic engineering, treatment that could earlier be done only by using open surgery can now probably be done using medical plastics. For example, traumatic open heart surgery for blocked arteries has been replaced with minimally invasive surgery involving plastic heart catheters. Same goes for blockages in various other parts of the body. Treatment and recovery time has been drastically cut in half. So has the cost of post-operative care. Besides all the general implications of polymers in health and safety mentioned above, they also play a role as suture materials, tissue adhesives, and vascular grafts, materials for cosmetic implants, dental composites, contact and intraocular lenses, and much more. The use of polymers in medicine is vast and innumerable. And with the growing technology and research their importance in healthcare and safety will only increase. Drashti Shah is a content writer and strategist with an educational background in entrepreneurship and management. After working full time as a business manager at Shaili Endoscopy, she now focuses her attention on helping businesses and publications around the world make sales and connect with their audiences. September-October 2020

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Waste Management

Rational Use of Personal Protective Equipment: An Environmental Perspective Sharang S. Ambadkar Managing Director, FeelGood Econurture LLP, Mumbai

Dr. Mayur R. Moreker Associate Professor of Ophthalmology, Bombay Hospital Institute of Medical Sciences, Mumbai

Dr. Shilpa R. Moreker Consultant Pathologist and Laboratory Director, NM Medical Centre, Mumbai

The need for Personal Protective Equipment for health care workers and its availability: While battling COVID-19; it is vital for healthcare workers to use appropriate Personal Protective Equipment (PPE) to protect themselves from hospital acquired infections. On 15th May 2020; our Ministry of Health and Family Welfare issued revised guidelines for rational use of PPE for healthcare workers in nonCOVID areas of hospitals. [1] Between 01st March 2020 to 18th May 2020, our PPE industry witnessed 56 times growth; moving from zero, to production of nearly 4.5 lakh PPE kits every day (Fig. 1).

increased to 27,083 kg in only 14 days between 18-05-2020 and 31-05-2020; which further increased to 81,400 kg in the 30 days of June 2020. In the city on Mumbai; in March, bio-medical waste collected from COVID Care centres and hospitals, was 3.48 lakh kg bio-medical waste generated with an average of 11,230 kg daily. While in April it was 12,675 kg, in May it increased to 17,631 kg and June saw the biggest jump with 22,023 kg daily. Until July 15, the daily average fell to 13,725 kg which was 38% below the average of bio-waste collected in June. In July, BMC has collected a total of 6.60 lakh kg of bio-medical waste.

Biomedical waste produced in our homes during the Covid-19 Pandemic: In these testing pandemic times, generation of biomedical waste may not be limited to healthcare facilities alone; but may also; most likely be added upon by households due to use of disposable PPE like single use disposable face masks, N95 respirators and gloves; followed by their inappropriate disposal i.e. disposal without waste segregation into household and medical waste. (Fig. 2).

Figure 1. PPE industry in India has witnessed 56 times growth in 60 days https://www.investindia.gov.in/siru/personal-protectiveequipment-india-INR-7000-cr-industry-in-the-making It is undoubtedly of paramount importance to safeguard all our healthcare workers from COVID-19. But it has been observed that many times; citizens at large; use PPE like disposable N95 respirators and disposable nitrile gloves; which are actually meant for healthcare workers working in COVID and non-COVID areas of our healthcare facilities. Thus, while there may now not be a scarcity of PPE; an important aspect that is likely to get neglected is an enormous amount of plastic waste that is being generated.

Biomedical waste produced in healthcare facilities during the Covid-19 Pandemic: A comparison of the biomedical waste generated only in healthcare facilities; i.e. isolation wards, institutional quarantine centres, sample collection centres and laboratories; in different time frames in a single state i.e. Punjab; shows a total of 72,194 kg collected in 53 days between 25-03-2020 and 17-05-2020;

Figure 2. Household waste disposed showing food waste mixed with other household waste and also the disposable face masks being segregated by a stick (Picture Courtesy: Sharang Ambadkar) The onus of segregation of such waste and the risk of infection from such waste then comes upon the Safai Sevaks i.e. waste collection personnel (Fig. 3); and if this is not done; such waste degrades or breaks down into smaller sized particles (under 5 mm) i.e. microplastics; and then get environmental access; by inappropriate disposal in landfill, dump sites, fresh water, oceans or plainly through littering at public spaces; causing environmental imbalance.

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Waste Management Conclusion:

Figure 3. A Safai Sevak in Mumbai after having segregated biomedical waste - in this picture disposable masks from other household waste (Picture Courtesy: Sharang Ambadkar)

Responsibility of citizens related to biomedical waste during the Covid-19 Pandemic - Simple Solutions:

In conclusion we reiterate, citizens using reusable and biodegradable masks which can be washed and reused shall help to limit wastage. There is a need for disposing of waste from singleuse Personal Protective Equipment generated at the household level with utmost care possibly by wrapping the PPE in a newspaper or a paper bag and mentioning medical waste with red coloured highlighter which could help in segregation and also limit the infection of our Safai Sevaks. References: 1. Ministry of Health and Family Welfare, Government of India. Directorate General of Health Services [Emergency Medical Relief]. Novel Coronavirus Disease 2019 (COVID-19): Additional guidelines on rational use of Personal Protective Equipment https://www.mohfw.gov.in/pdf/UpdatedAdditionalguidelinesonra tionaluseofPersonalProtectiveEquipmentsettingapproachforHe althfunctionariesworkinginnonCOVID19areas.pdf 2. R, Muthukumar. India’s ‘Recycle Man’ Can Convert Used PPE Kits & Face Masks Into Bricks https://www.thebetterindia.com/235645/face-mask-recycle-ppemasks-waste-bricks-gujarat-low-cost-innovation-covid-19-ecofriendly-ros174/

The onus is then on us citizens to appropriately dispose single use disposable face masks, N95 respirators and gloves. These can be wrapped in newspapers or paper bags and marked as biomedical waste with a red highlighter before disposal; so that the waste segregation personnel would easily spot such waste and appropriately segregate them easily. Further, while the healthcare workers use their PPE judiciously; it may be important that those of us who are not health care workers; should not resort to using PPE meant for healthcare workers; like citizens using disposable N95 respirators or even non-judiciously insisting on health-care workers using ‘full PPE” in non-COVID areas of laboratories or hospitals; when such use is actually not warranted or recommended.

Need for education, awareness and innovations: It may thus also be pertinent now that healthcare workers working in Covid and non-COVID areas of hospitals; educate and create awareness amongst their patients and general public at large. One such small step could be taken if other-wise healthy patients with non-respiratory symptoms; visiting healthcare facilities wearing N95 respirators; can be made aware of the presence of more cost-effective and environment friendly options like biodegradable engineered filtration layer masks at par with N95 respirators. Such awareness, will not only ensure the availability of PPE to our healthcare workers; but also go a long way in maintaining a vital ecological

Figure 4. A P-block 2.0 made using 52% of shredded PPE material, 45% paper sludge, and 3% binding agent -formulated gum base. (Picture Courtesy: Binesh Desai)

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Global Trends Placing A Medical Device On The Great Britain, Northern Ireland And European Union (EU) Markets From 1 January 2021 Overview From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. This guidance provides information on how the UK system will operate, including for: • Getting your device certified • Conformity marking your device • Registering your device with the MHRA This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. For Northern Ireland, different rules will apply to those in Great Britain after the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’ This guidance does not cover other ‘New Legislative Framework’ products, which are subject to separate guidance. The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval. This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.

Summary of key requirements for placing a device on the Great Britain market From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are: • CE marking will continue to be used and recognised until 30 June 2023 • Certificates issued by European Economic Area (EEA)-based

Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023 • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021 • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering: • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices • 8 months for other Class IIb and all Class IIa devices • 12 months for Class I devices • The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA. • If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person is set out below. The information as given on the weblink https://www.gov.uk/guidance/regulating-medical-devices-from1-january-2021 includes the following : • Legislation that will apply to Great Britain • The EU Medical Devices Regulation (MDR) and EU in vitro Diagnostic Medical Devices Regulation (IVDR) from 1 January 2021 • The role of the MHRA • Requirements for those manufacturing and supplying devices in the UK • Regulation of medical devices in Northern Ireland • Placing a medical device on the EU market • CE marking for the EU market after the transition period

Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing Ronkonkoma, NY, USA, October 6, 2020—Qosina is pleased to announce they now carry a sterile 3D-printed nasopharyngeal COVID-19 testing swab for nasal mucosa specimen collection. Developed by Resolution Medical, an in vitro diagnostic and medical device manufacturer, the innovative 3D-printed sterile swab is a cost-effective alternative to the traditional, flocked nasopharyngeal swab. It is produced quickly by using alreadyexisting, industry-approved materials and the Carbon Digital Light SynthesisTM (Carbon DLSTM) 3D printing process. The swab is 5.9 inches in length, and the swab head features a soft, lattice-style cage around a flexible helical core, allowing the swab to more easily conform to the organic pathway of the nasal cavity. The unique, lattice-structured dome tip combines comfort and durability for optimal patient experience and captures sufficient specimen for testing. This sterile swab comes individually packaged and has a shelf life of six months. “As a leader in swabs provided to the medical industry, we are excited to add the 3D-printed swab to our product offering,” said Scott Herskovitz, President and CEO of Qosina Corp. “Its creative design meets the growing demand from our customers for high quality COVID-19 testing swabs. Our mission is to provide the best customer experience possible by helping our customers find, order and receive quality medical components September-October 2020 D A T A

quickly and accurately, and this partnership is the perfect fit to support our mission.” To order the sterile 3D-printed COVID-19 testing swab or Qosina’s additional sterile swab offerings, contact Qosina at +1(631) 242-3000, or email sales@qosina.com. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries.

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AiMeD Applauds Dr. P. D. Vaghela For His Contribution To Indian Medical Device Industry At His Farewell Vaghela initiated a 5% surcharge in the budget as import duty protection to protect the beleaguered domestic Manufacturing while creating a corpus for Public Healthcare. He did not allow price caps of stents & knee implants to be removed as sought by the USA as that would have been detrimental to consumers and domestic manufacturers. Under his leadership DoP introduced a scheme for 4 Medical Devices Parks and PLI scheme as making in India enablers under the government’s Atmanirbhar campaign; the PLI Scheme is reportedly being revised to enable wider acceptability,” said Mr Nath.

AiMeD Delegates presenting a momento of gratitude to DoP Secy Dr Vaghela. New Delhi: Association of Indian Medical Device Industry (AiMeD), an umbrella association of Indian manufacturers of medical devices held a farewell meeting of Secretary, Department of Pharmaceuticals, Dr PD Vaghela who retired on the 30th September 2020 for his great contribution towards the betterment of the Indian Medical Device industry. Dr PD Vaghela will now serve as the Chief of Telecom Regulatory Authority of India (TRAI) for the next three years. The various pharma and medical devices industry associations expressed their gratitude to Dr Vaghela. They have expressed hope that the next Secretary DoP, S Aparna, an IAS officer from the Gujarat cadre 1988 will continue to take forward the good initiatives to make India Atmanirbhar in the Medical Devices sector.

“Mr Vaghela led by example and he along with his 2 Joint Secy and team was available 24×7 on COVID-related medical devices production debottlenecking issues during the complete lockdown. He also created the Pharma & Medical Devices Bureau as a single window for current and potential investors. The otherwise sleepy DoP Dept. reportedly became motivated, active & sprightly & most staff moved under a new Pharma bureau in new offices in Jhandewalan. He even allocated specific duties in Dept. for Medical Devices which had been shunted in the past amongst various officers for short durations without the development of domain knowledge and ownership in the department. Dr Vaghela reportedly encouraged teamwork by providing leadership and direction. Even NPPA became a facilitator in addition to being a regulator with the onset of COVID,” Mr Nath mentioned.

Calling Dr PD Vaghela a positive change agent during the last one year, Mr Rajiv Nath, Forum Coordinator AiMeD highlighted the key initiatives led by him.

“India imports over 85% of its requirement of medical devices and has a huge import bill that crossed Rs. 42000 Cr last year due to nominal custom duties of zero to 7.5%.“We are glad that initiatives like Aatmanirbhar Bharat under leaders like Dr Vaghela will help India in the process to end the huge import dependency and will also strengthen India’s resolve to vie for being the 2nd factory in the world for medical devices.” added Mr Rajiv Nath.

“During his tenure, DoP sponsored 2 conferences for AiMeD on Regulations for enabling the capacity building of the medical devices industry to enable them to be globally competitive. Dr

https://www.biovoicenews.com/aimed-applauds-dr -pd-vaghelafor-his-contribution-to-indian-medical-device-industry-at-hisfarewell/ , October 1, 2020 ( 1 )

AiMeD Unveils Figure Of The Growth Rate Of Indian Medical Device Industry During Covid-19 Pandemic October 01, 2020 AiMeD is an umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical devices including consumables, disposables, equipment, instruments, electronics, diagnostics, and implants.

manufacturing capacity by AiMeD through its members and beyond by reaching out to garment manufacturers, automakers, auto component manufacturers, and electronic component manufacturers as preparedness for possible unprecedented, unpredictable demands.

New Delhi: As India geared up to fight the Covid-19 crisis, the Association of Indian Medical device industry relentlessly worked at the forefront to combat the crisis. Rajiv Nath, Forum Coordinator, AiMED on the behalf of the Indian medical device industry was in regular consultation with the Govt & assured Commerce Minister, Piyush Goyal & Govt full support to the Govt's spirited fight against the Covid-19 crisis.

AiMeD is an umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical devices including consumables, disposables, equipment, instruments, electronics, diagnostics, and implants.

Huge efforts were put into increase medical device

With a primary membership of over 350 manufacturers and additionally of over 200 Associate Members representing the interest of over 1200 Manufacturers of Medical devices, however, with over 2000 products AiMeD should be over 7000 factories September-October 2020

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and bigger than Pharma to address the manufacturer's problems.

increased to 140 with 25.55 crores annual capacity.

Rajiv Nath recognized that the government interventions under the able leadership of Cabinet Secretary, Rajiv Gauba, and DOP Secretary, Dr PD Vaghela helped the Medical devices industry scale up production during the pandemic.

Similarly, the number of Indian firms manufacturing, ventilator manufacturers went up from 8 to 17, mask manufacturers from 30 to 108, swab manufacturers from zero to five, and sanitizer manufacturers from 35 to 49, and RT PCR Kit manufacturer from 0 to 8.

AiMeD worked closely with Govt of India i.e. Dept of Pharmaceuticals, Ministry of Commerce, NPPA & CDSCO, etc. as a Facilitator between the Govt and the Manufacturers of Medical Devices e.g. gloves, masks, sanitizers, ventilators, diagnostic & testing kits for COVID-19, etc. for ramping up capacity and addressing production bottlenecks in this national emergency to fight against COVID-19 pandemic during the complete lockdown period. AiMeD provided the Indian Govt, a single point of contact access to domestic manufacturers and on behalf of manufacturers provided them various services like advocacy on policy issues, information services, regulations for medical devices, education and training services, testing assistance, and guidance for quality certification (ISO, CE, ICMED QMS), lobbying for funding for R&D from the Govt, encourage innovations from member units, Improve clinician and patient access to the modern, innovative and reliable medical device technologies through organizing and supporting meetings, seminars, symposia, exhibitions, and demonstration, to promote global harmonization and make India a MedTech superpower & also strengthen India to be the second factory in the world for medical devices & a dependable manufacturer of quality products in the global supply chain. The Government of India through its flagship "Make in India" initiative relied heavily on the Indian manufacturers to meet the rising demand of essential healthcare equipment's for the country, pushing the Indian medical devices sector to become self-reliant especially for the essential 39 Covid medical devices. AiMeD worked with QCI to expedite finalization of ICMED Plus Certification as well as with consultants consortium to provide online training on Quality Management System Certification to new entrepreneurs from automakers, garments, textile, auto parts industry who had ventured into medical devices manufacturing to build capacity & capabilities to meet QCIs ICMED certification and regulatory compliance so that they could have the confidence to seek global certification of CE and US FDA Compliance for enabling global competitiveness. Four batches of over 115 Manufacturers or their representatives have intensely trained over seven modules over 11 sessions spread over 2 weeks in April &May 2020. Before the outbreak of COVID-19, there were only 20 firms manufacturing 62 lakhs PPE kits per year, but within two-three months, the number of manufacturers listed with AiMeD

Find the comparison sheet of the growth rate before & after Covid-19 with an annual capacity below: AiMeD ensures convergence at one common platform, when needed, for ensuring the overall growth of the Indian medical devices industry and further address the needs of all members of the medical device industry irrespective of their affiliation or their company size. It also helps in the wider dissemination of information to each player in the industry. AiMeD has been horizontally divided into common working groups like - R&D and product development, legal & tax issues, export-related issues, medical device regulatory issues common to all vertical groups of different families of product lines with zonal representations and cluster heads. "COVID-19 crisis has shown that the Indian medical devices sector can rise to the challenge. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Inter-Ministry Group coordinating with domestic manufacturers via AiMeD had addressed production bottlenecks and challenges so that not only capacity got utilized but also ramped up rapidly," said Rajiv Nath. Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD) is also the Board Member of Kalam Institute of Healthcare Technology & Member National Medical Device Promotion Council & Ex-Chairman IPC Committee on Medical Device Standard & Chairman - Technical Committee - ICMED Certification by QCI as well as Member of Expert Advisory Group (EAG) for Biomedical Device and Technology Development (BDTD) by Dept of Science & Technology & Member of Medical Devices - Expert Advisory Group to CDSCO for Regulation in India. He also serves as Advisor to Haryana Govt and to UP Govt for their forthcoming Medical Device Park. Rajiv Nath is also the Managing Director of Hindustan Syringes & Medical Devices Ltd; Trustee - Safe Point India - a CSR Initiative of HMD (Hindustan Syringes & Medical Devices Ltd) He is also the President of All India Syringes and Needles Manufacturers Association (AISNMA). https://health.economictimes.indiatimes.com/news/medicaldevices/aimed-unveils-figure-of-the-growth-rate-of-indianmedical-device-industry-during-covid-19-pandemic/78425869

Health Ministry Issues Draft National List Of Essential Assistive Products October 3, 2020 The Union health ministry has released the draft National List of Essential Assistive Products (NLEAP). The list is aimed to provide assistive technologies (ATs) and devices for elderly, persons with disabilities (PwDs), patients with non-communicable diseases (NCDs) such as stroke, diabetes,

congenital birth defect associated disabilities and people in humanitarian crisis and disasters. The ministry has invited suggestions and comments on the list from the stakeholders by October 10, 2020. Earlier, the Indian Council of Medical Research (ICMR) had initiated steps to prepare a list of assistive products on the pattern

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of WHO’s Priority Assistive Products List (WHO-APL). A total of 383 assistive products (APs) have been included in the NLEAP through a consultative process. As India already has a National List of Essential Medicines (NLEM), hence during various Expert Group meetings by ICMR, it was agreed that the list may be termed as NLEAP. In January 2020, Director General (DG), ICMR, Balram Bhargava constituted a National Expert Committee (NEC) under the leadership of Dr R K Srivastava, Ex. DGHS, to assist in preparation of a list of assistive products. The NEC recommended creation of 4 sub-groups, each representing their specialties like public health, physical medicine & rehabilitation (PMR), geriatrics and engineering. Each of the specialties had one leader with involvement of two more members. These Sub-Groups were: public health specialists led by Dr Harshad Thakur, Director, National Institute of Health and Family Welfare (NIHFW), physical medicine and rehabilitation professionals led by Rajendra Sharma, Consultant, Dr Ram Manohar Lohia Hospital, Delhi, geriatric medicine experts led by Dr A B Dey and engineering professionals led by Dr PVM Rao, IIT-Delhi.

agency for care of persons with disabilities. An overarching legal provision in form of Rights of Persons with Disabilities Act 2016 (RPwD Act, 2016) was enacted by MoSJE. RPwD Act has clearly delineated the steps for provision of assistive products. It directs every Ministry to develop their own systems for care of PwDs. Health and healthcare has been mentioned more than 25 times in the said act. Subsequently, Union health ministry has included the assistive products under the list of health products vide notification dated February 11, 2020. The Assistance to Disabled Persons for Purchase/Fitting of Aids/Appliances (ADIP) Scheme under MoSJE is providing ATs to the PwDs. It was conceived in 1981 to provide “durable, sophisticated, scientifically manufactured modern, standard aids and appliances” to disabled persons. Since that period the ATs like sticks, walkers, spectacles, wheelchairs, tricycles, smart cane, cochlear implants are being extended to the needy people. The NLEAP will facilitate ADIP scheme to provide better products to those who need them. http://pharmabiz.com/NewsDetails.aspx?aid=131530&sid=1

Lead Expert of each sub-group was given liberty to include more members. Dr Sanjiv Kumar, Ex. National Health Systems Resource Centre (NHSRC) ; Dr Arvind Mathur, renowned geriatrician; Dr. S.L. Yadav, AIIMS; Dr. Balakrishnan, IIT-Delhi; Dr Shipra Chaudhary, RML Hospital; Dr Shweta Bhandari, and Dr Suman Badhal, Safdarjang Hospital; Dr Monika Saini, Dr Rajni Bagga, Dr Manoj and Dr Niraj –NIHFW; contributed towards finalisation of the complete master list of assistive products. In addition to this Prakash Bachani, Scientist, Bureau of Indian Standards (BIS) and Dr Sangeeta Abrol, Ministry of Health & Family Welfare contributed by providing BIS-ISO standards and health ministry perspectives. Each sub-group met many times to discuss the assistive products from their specialty angles. During its meetings, NEC and Sub-Groups felt the need to go beyond simple list to classify them age-wise (different requirements in different age groups), disability-wise (21 disabilities as per RPwD Act 2016 or Visual, Hearing, locomotor, Cognitive, Communication, Self-Care), system-wise (Primary, Secondary or Tertiary Health Care Systems), cost-wise (Low, Medium or High), provision-wise (Govt., Private, Insurance, Welfare, NGO), Indigenous vs. Imported (available in India or to be imported),BIS-ISO Standards, and Technology-wise (Simple, complex, advanced including softwares). Current list was prepared after Expert Group consultations and referring to Safdarjung list, CGHS list, ALIMCO list, Mobility India list, EU list, BIS-ISO list, textbooks, and National Trust (with a network of more than 700 NGOs). ICMR aims to deliberate, contribute and guide the way forward towards building a National list of Essential Assistive Products (NLEAP) -India, with focus on the principal themes of appropriateness, quality, affordability, accessibility and standardization of ATs and strategies for strengthening and service provision. By 2022, existing 1,50,000 Sub Centres and Primary Health Centres will be converted to HWCs. Ministry of Social Justice and Empowerment(MoSJE), Government of India is the nodal

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Industry News Hindustan Syringes Sends Over 56 Million Pieces to Covax Facility NEW DELHI: Hindustan Syringes and Medical Devices, one of the largest suppliers of syringes, has sent its first shipment of 56 million pieces of auto disable syringes to Covax facility as the race for safe and effective vaccine continues.

In the last few days demand has come forward from other countries like Japan and US for disposable syringes and Indonesia for auto disposable syringes as the countries rise start to stockpile.

The Covax facility, which seeks to pool in resources to accelerate the development of promising candidates for Covid-19 which will be made accessible to all the participating countries, has ordered 140 million pieces which are to be supplied between August and December.

The company has even scaled up its production capacity to one billion from 700 syringes a year. However, the Indian government is yet to make a move. “We plan to allocate 50% of the total for the government of India and 50% for export as we have got a global responsibility. added Nath.

“We have shipped out more than 56 million pieces of 5 ml auto disabled (AD) syringes for intra muscular syringes,” said Rajiv Nath, managing director of Hindustan Syringes, even as the company awaits advisory from the Indian government’s on the procurement of syringes for vaccination.

https://economictimes.indiatimes.com/industry/healthcare/biote ch/pharmaceuticals/hindustan-syringes-and-medical-devicesships-over-56m-syringes-to-covaxfacility/articleshow/78439487.cms , Oct 02, 2020

Japan Commits Rs 3500Cr To Strengthen Indian Health Sector The Govt. of Japan has committed Official Development Assistance loan of an amount of JPY50 billion (approx. Rs. 3,500 crore) for the COVID-19 Crisis Emergency Response Support. The Notes were exchanged between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, Government of India, and Suzuki Satoshi, Ambassador, Embassy of Japan to India for a health sector programme loan to fight the COVID-19 crisis. Subsequent to the Exchange of Notes, Loan Agreement for this programme loan was signed between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, Ministry of Finance, Government of India and Katsuo Matsumoto, Chief Representative, JICA, New Delhi. This programme loan aims to support India’s efforts in fighting COVID-19 and to prepare the health system to manage future epidemics and also to improve the resilience of India’s health systems against infectious diseases.

In addition, notes were also exchanged between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, and Suzuki Satoshi, Ambassador, Embassy of Japan to India for Grant Assistance of an amount of JPY 1 billion (= approx. Rs. 70 crore) from Government of Japan. This Grant-in-aid from Government of Japan is for providing medical equipment to strengthen the public health and medical system in India. This will strengthen the health care facilities for managing critical and serious patients suffering from COVID-19 infection. India and Japan have had a long and fruitful history of bilateral development cooperation since 1958. In the last few years, the economic cooperation between India and Japan has strengthened and grown into strategic partnership. This further consolidates and strengthens the Strategic and Global Partnership between India and Japan. https://www.biospectrumindia.com/news/22/17126/japancommits-rs-3500cr-to-strengthen-indian-health-sector.html

Medical Device Industry Demands Separate Marketing Practices Code Different From Pharma Industry As the characteristics of the medical device industry are different from the pharmaceutical industry, the medical device industry has sought a separate marketing practices code for the medical devices industry. The medical devices industry associations raised this issue at a review meeting held by the Department of Pharmaceuticals (DoP) on August 21, 2020, to review implementation of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). The meeting, held through video conferencing, was chaired by DoP secretary Dr P D Vaghela. “The characteristics of the medical device industry are somewhat different from the pharma industry and though the associations have requested in earlier meetings to have a separate code for the medical devices industry, AiMeD is in agreement with the government to start with pharma defined code first but with some changes. Innovative and high-end medical devices such as robotics require proper training to impart skills to users unlike drugs. However, training can be given ethically with no lavish conferences and free travel to exotic tourist destinations,” stated Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD) further adding that AiMeD has uploaded UCPMP on its website and formed the ethics committee as well as held meetings, invited suggestions and complaints from its members.

“Ethical marketing is being a challenge in India of medical devices if manufacturers and importers use artificially inflated high maximum retail price (MRP) high trade margins to induce hospitals and retailers to push their products. We have been seeking that MRP should not be over four to five times of import landed price or ex factory price (on which GST is charged initially) instead of prevailing MRP that go up to 20 times," Nath further added. The orthopaedic implant Industry is challenged by the co existence of hundreds unlicensed manufacturers of implants that are allowed to market their unlicensed implant without regulatory approval which creates an unethical and unfair marketplace, stated Anu Dureja of Siora Surgicals and AiMeD member. “Exorbitantly high demands for sponsorships by doctors, hospitals has been challenging for us” stated Kanwar Sehgal of Endomed Technologies. “These huge expenses can’t be matched by the small and midsize segment of the medical devices industry and denies access of affordable Indian products to Indian patients,” he explained. The DoP secretary had asked all the associations including medical devices to implement UCPMP. Secretary (DoP) showed his displeasure at the status of implementation of UCPMP and exhorted all associations to implement the code without

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Industry News exception. He mentioned that suggestions can be discussed in separate meetings under JS (Policy) to be called next week for medical Devices separately. He also asked the associations to quote exact provisions of laws of other countries as precedence and reference while giving suggestions in respect of UCPMP.

requested to provide the details of their Ethics Committee for Pharma Marketing Practices (ECPMP) and Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP) along with contact numbers and procedure of filing complaint so that the same can be uploaded on the website of DoP.

Despite government mandate on UCPMP and as envisaged by DoP, details have not been uploaded related to the Ethics Committee for Pharma Marketing Practices (ECPMP) and Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP) of all the associations along with contact number and procedure of filing complaints on the website of DoP.

A meeting to review the implementation of UCPMP was held under the chairmanship of Secretary (DoP) on February 17, 2020. Secretary, DoP enquired how many associations have uploaded the UCPMP on their website and have formed the two Committees.

To review the implementation of the voluntary UCPMP, all the associations (Pharmaceuticals and medical devices) are

http://pharmabiz.com/NewsDetails.aspx?aid=130582&sid=1, August 24, 2020

COVID-19 Treatment: CDSCO Shows Green Flag To Baxter India Oxiris Filter Gurugram: Healthcare firm Baxter India on Tuesday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of its Oxiris blood purification filter for the treatment of Covid-19 patients. The filter is intended to be used in the critically ill Covid-19 patients in need of blood purification where excessive inflammatory mediators are present, Baxter India said in a statement. "The Covid-19 cases in India have been spiralling and putting pressure on our the healthcare system. This approval has come at a crucial time when such filter sets are much required to ease the burden on healthcare providers," Baxter India General Manager Ravinder Dang said.

The company hopes that the availability of Oxiris will go a long way in fighting the Covid-19 cases in India, he added. During blood purification therapy, the patient's blood passes through the Oxiris filter set, where it can adsorb inflammatory mediators, and remove fluid, electrolytes and uremic toxins, before returning the patient's blood to the body, Baxter India said. Baxter India is a wholly-owned subsidiary of Baxter International Inc. It started operations in India in April 1997. https://medicaldialogues.in/news/industry/pharma/covid-19treatment-cdsco-shows-green-flag-to-baxter-india-oxiris-filter67426?infinitescroll=1, July 8, 2020

SCTIMST Inks MoU With Tynor Orthotic To Boost Orthotic Devices The main objective of this Institute-Industry collaboration is to develop a cluster of orthoses for catering to clinical conditions such as osteoarthritis and diabetic foot ulcer Image credit- shutterstock.com Development of orthotic devices may soon receive a boost with a Kerala based scientific institution collaborating with a Mohali based private manufacturer for co-development of such devices catering to clinical conditions such as osteoarthritis and diabetic foot ulcer. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala (SCTIMST), an Institute of National Importance under the Department of Science and Technology, Government of India, has signed an MoU with Tynor Orthotics Private Limited (Tynor), Mohali, to set up an Orthotics and Rehabilitation R&D vertical to promote indigenous device development in this sector towards the goal of ‘Aatmanirbhar Bharat’, a high priority target of the Govt of India. Tynor, a manufacturer and exporter of high quality and affordable orthopedic appliances and fracture aids in India, will collaborate with SCTIMST for the co-development of Orthotic devices and to promote joint research programs in Orthotics and Rehab. Tynor has funded SCTIMST for Research and Development of two off-loading devices in patients with diabetic foot ulcers and osteoarthritis. The project is planned for one year with Tynor contributing Rs 27 lakhs to the program. The main objective of this Institute-Industry collaboration is to develop a cluster of orthoses for catering to clinical conditions such as osteoarthritis and diabetic foot ulcer.

SCTIMST has done considerable amount of R&D work in biomedical devices over the last 30 or more years and has established itself as a pioneer in this field. This collaboration with an Industry leader for co-development of ortho-rehab devices in the country is a commendable step. Tynor has planned to set up India’s first R&D Center in Orthopedic Appliances, Fracture Aids, Walking Aids, Compression Garments, and Footcare Products. This center has been named TORNADO (Tynor Ortho Research N Appliance Development Organization) and aims to bring about technology and innovation-based disruption at the scale of a tornado. This will be a novel center in which a Cross-Functional Team consisting of experts from Engineering, Orthopedics, Biomedical Sciences, Design shall be brought together to brainstorm and develop products as per the requirements of the Indian patient. Industry-academia collaboration is the key to achieve this feat. https://www.biospectrumindia.com/news/74/17228/sctimstinks-mou-with-tynor-orthotic-to-boost-orthotic-devices.html

For More Industry News available at : http://www.medisourceasia.com/industrynews/2020/ in09-20/index.htm

• IPC Rolls Out PPE Adverse Event Reporting Form As Part Of MvPI For Patient And Health Worker Safety • NATHEALTH And APACMED Join Hands To Advance Medical Technology For UHC In India • Kraton’s BIAXAM Kills Up To 99.99% Of Microbes Including SARS-CoV-2 September-October 2020

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JIMIT MEDICO SURGICALS PVT. LTD.

• Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

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Events

MEDICA and COMPAMED 2020 to be launched as 'virtual.MEDICA' and 'virtual.COMPAMED' with three focal areas MEDICA 2020 and COMPAMED 2020, the world-leading information and communication platforms for the medical technology industry and supplier industry for the medical technology industry, will take place entirely online from 16 to 19 November. Within the framework of 'virtual.MEDICA' and 'virtual.COMPAMED', decision-makers from all sectors of the healthcare industry can then expect a comprehensive range of products and services at virtual.MEDICA.de and virtual.COMPAMED.de consisting of three focal areas: The Conference Area (conference and forum program), the Exhibition Space (for exhibitors and product innovations) and the Networking Plaza (networking/ matchmaking). The next events, MEDICA 2021 and COMPAMED 2021, will be held as a hybrid event next year. The hybrid concept consists of combining live platforms for professional visitors to the Düsseldorf trade fair centre and digital offers. “Our hygiene and infection protection plan was positively received by the exhibitors and the successive relaxations of the international travel rules in early summer meant that we had realistic hopes that both trade fairs would be able to be held successfully and safely. The development of the global pandemic must now, however, be re-evaluated. Against the backdrop of a multitude of travel limitations and considering the very international demographic of MEDICA and COMPAMED in terms of both exhibitors and visitors, we must now focus solely on the virtual format this year”, explains Wolfram Diener, Chairman and CEO of Messe Düsseldorf. “The essence of the MEDICA and COMPAMED brand is global broadcasting for exhibitors and visitors. This central core is still present this year, just not in the form of an event that demands physical presence, due to the pandemic. With the annual rotation of MEDICA and COMPAMED, we are now staying in touch with our customers by creating a comprehensive virtual and globally accessible market place for the community with a high-profile programme. This is a good starting point for the joint launch in the trade show year 2021, when we will again offer the successful combination of live platforms for trade visitors at the Düsseldorf Exhibition Center and digital offerings," Wolfram Diener continues. In recent years, we have repeatedly found that a total of over 80% of our exhibitors have come from abroad, from around 70 different nations. Our visitors come from around 170 nations, putting our proportion of international visitors at 70%. Both events together brought in a total of over 6,300 exhibitors and 121,000 professional visitors last year.

Laying an excellent foundation with established online portals “Over the past few years, we have constantly expanded our digital offers and therefore have established internet-based industry platforms in the form of our MEDICA and COMPAMED web portals. We can now implement these in order to offer our customers the appropriate tools for networking and facilitating the valuable transfer of knowledge, even in these challenging times” emphasises Horst Giesen, Global Portfolio Director for Health & Medical Technologies at Messe Düsseldorf. “On the dates of MEDICA 2020 and COMPAMED 2020, we will seek out the best elements for streaming from the 600 previously planned sessions for the specialist forums and conferences, working together with our cooperating associations and partners. Participants can expect to see highlights with high relevance to Corona in particular in these virtual formats. In addition, there will be diverse web presentations from exhibitors on their innovations and an online matchmaking area for making valuable business contacts, including a video web meeting function” promises Horst Giesen, giving an overview of the agenda. The content of the MEDICA specialist program has its finger firmly on the pulse, with digital program events relating to technical, economic and healthcare policy trends and queries this year. The MEDICA forums include the following: the MEDICA CONNECTED HEALTHCARE FORUM, the MEDICA HEALTH IT FORUM, the MEDICA LABMED FORUM, the MEDICA TECH FORUM, the MEDICA ECON FORUM and the COMPAMED HIGH-TECH FORUM and the COMPAMED SUPPLIERS FORUM. All information on taking part in the virtual editions of MEDICA 2020 and COMPAMED 2020 can be found online at virtual.MEDICA.de and virtual.COMPAMED.de. https://www.medicatradefair.com/en/Press/Press_Material/Press_Releases/Press_ Releases/MEDICA_and_COMPAMED_2020_to_be_launched_ as_virtual.MEDICA_and_virtual.COMPAMED_with_three_focal _areas Contact for exhibitors + general customer enquiries: Messe Düsseldorf - Info Service, Tel. +49(0)211-4560-01, E-Mail: info[at]messe-duesseldorf.de Contact for media enquiries: Messe Düsseldorf - Press Team MEDICA + COMPAMED, Martin Koch/ Larissa Browa, Tel. +49(0)211-4560-444/ -549, E-Mail: KochM[at]messe-duesseldorf.de, BrowaL[at]messe-duesseldorf.de September-October 2020

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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 • 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.

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I.V. Infusion Sets Blood Administration Sets Scalp Vein Set Urine Collection Bags Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.

• ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter

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Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

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