Medical Plastics Data Service Magazine July - August 2020

17

18

20

23

26

29

31

D A T A

S E R V I C E

Vol. 28

No. 4

july-August 2020

The Impact of COVID-19 on The Medical Device Industry In the demand scenario, while elective procedures have decreased significantly and the decrease in demand for devices used in these procedures, there is an increased demand for devices like…….

The Importance Of R&D And Innovation In The Post COVID19 World - Mr. Balagopal Chandrasekhar, Founder and former Managing Director, Terumo Penpol Ltd. “I have found the best Return On Investment (ROI) to come from investment in Research and Development.”. Record of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST ) as unrivalled among national labs in India.

Combating COVID-19 With Effective Change Management - Mr. Robin Banerjee Managing Director, Caprihans India Ltd. Explains how the company has kept pace with changing times particularly with respect to market trends and technologies and also their contribution to the Healthcare Industry towards COVID-19 management. In his opinion, the mankind cannot do away without “Plastics” which was invented to protect nature – to save wood, ivory and rare metals.

US Medtech Industry’s Response to COVID-19 and Opportunities for future - Dhiren V. Mehta, President and CEO, Allwin Medical Devices, California, USA Medtech industry responded to the challenge with the utmost speed and urgency. Although, beating COVID-19 has been thought to be a collective effort from a multitude of Medtech companies, here is a snapshot of a few responses from key drivers in the industry.

CASE STUDY Case Study On Solution To Protect Healthcare Professionals By Tekni-Plex How the IV-Pump manufacturer was able to solve a critical supply problem in 10 days which otherwise a new vendor would have taken six months.

FUTURE TRENDS & DEVELOPMENT Atma Nirbhar India in Medical Devices Sector - Mr. Sanjay Shah, CEO, Unikal Consultants What is to be Atma-Nirbhar in Medical Devices in India? How to go about it. The road map. Challenges to be faced and resources required.

INNOVATION & TECHNOLOGY Devices For Safe Transfer Of Corona Infected Patients And Protection Of Healthcare WorkerS

July-August. 2020 D A T A

S E R V I C E

13

32 37

40

42

15

14

D A T A

S E R V I C E

Vol. 28

No. 4

july-August 2020

MATERIALS • Polycarbonate Is The Material Of Choice For Medical Face Shields

• Industry Hails CDSCO’s Sugam Portal In Expediting Licensing Process For Ease Of Doing Business • DoP Appoints IFCI As PMA To Implement PLI Scheme To Promote Domestic Manufacturing Of Key APIs & Medical Devices • Medical device industry demands separate marketing practices code different from pharma industry

• • • •

Atal Innovation Mission To Support Startups With COVID-19 Solutions Medical Device Industry Suffers Up To 85% Drop In Revenues During Apr-June: MTaI Indian Company Manufactures N-100 Mask Which Filters 99.97% Air COVID-19 Treatment: CDSCO Shows Green Flag To Baxter India Oxiris Filter

• Qosina’s Swab Inventory Ranges in Application from COVID-19 Testing to Cleaning and Polishing

• About Use Of Biopolymer Materials For Medical Devices?

July-August. 2020 D A T A

S E R V I C E

D A T A

S E R V I C E

• Cover Story : The Medical Devices Sector In India : Task Force Recommendations (March – April 2015) • Market : Drug Device Combination Products : Market Review And Future Trends (March – April 2015) • Global Trends : Global Biomaterials Market For Implantable Devices Driven By Polymers (March – April 2015) • Did You Know : About Challenges Of Using Combination Products (March – April 2015) • Cover Story : Medical Device Manufacturing: Components Bonding and Joining Techniques (May – June 2015) • Manufacturing Policy : National Medical Device Authority (NMDA) (May – June 2015) • Global Trends : Medical Disposables Market Worth $245 Billion By 2018 (May – June 2015) • Did You Know : About Welding of Thin Polymeric Films For Medical Applications (May – June 2015) • Cover Story : Indian Medical Device Industry, Government Initiatives For Regulations, Safety & Competitiveness (July – August 2015) • Technology : Cold Plasma Treatment For Biomedical Applications (July – August 2015) • Technology : Plasma Treatment Improve Adhesion To Polymers (July – August 2015) • Global Trends : Impact Of New European Regulations On Outsourcing Of Medical Devices (July – August 2015) • Did You Know : Balancing Product Development Effectiveness with Regulatory Compliance (July – August 2015) • Cover Story : Medical Tubing And Extrusion Technology (September – October 2015) • Manufacturing : Make In India : From Slogan To Policy Implementation (September – October 2015) • Global Trends : Safety Considerations Related To Misconnections Between Medical Devices (September – October 2015) • Global Trends : Modern Medical Tubing for Medical Device Downgauging (September – October 2015) • Did You Know : About Hospital Errors on Medical Tubing Killing Patients (September – October 2015) • Cover Story : Global Medical Disposables Industry Scenario And Role Of Plastics (November – December 2015)

About Use Of Biopolymer Materials For Medical Devices?

Biopolymer Plastics include any polymer that will disintegrate in a biological system in reasonable timescale. For the Medical Devices, biodegradable polymer shows properties to get dismantled inside the human body by means of metabolism within a period between several days and years. As a result, the implanted devices manufactured from these materials will completely disappear without further action.

One of the common medical applications since 1960s is absorbent surgical suture .

There are five major groups of biodegradable plastic materials commercially available. The combination of these materials by copolymerization or compounding result in wide range of materials.

Polyglycolic Acid (PGA) : For implants such as plates, pins, rods and screws.

Polylatic Acid (PLA) : For implants such as anchors, meshes, pins, rods, and screws.

Polycaprolactone (PCL) : For implants such as adhesion barriers, suture, or drug delivery.

Polyanhydrides : Preferred for drug delivery.

Polylactic-Co-Glycolic Acid (PLGA) : Due to the wide range of material properties, utilized for implants such as grafts, sutures, surgical films, and nanoparticles.

Recent developments in biopolymer manufacturing have created new opportunities for increased integration of biopolymers into medical products, devices and services. Biopolymers are now also being credited with their extensive use in the pharmaceutical industry for healing of wounds of any shape, size, or depth.

As per a recent report by “IndustryARC” , during the forecast period of 20192025, the biopolymer market will undergo an outstanding growth with a CAGR of 19%.

“The future depends on what you do today”

- Mahatma Gandhi

July-August. 2020 D A T A

S E R V I C E

15

D A T A

S E R V I C E EDITOR

D A T A

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

S E R V I C E

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

COVID – 19 Impact On The Medical Device Industry 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

PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 • Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

We are in the midst of an unprecedented global health crisis. As a result, health care systems are overwhelmed, and the effective delivery of medical care to all patients has become a challenge worldwide. The Indian Medical Device Industry finds itself playing an urgent role in both helping detect the virus and supplying frontline healthcare workers with the equipment needed to fight it.

In this issue of “MPDS”, a galaxy of Indian Industry leaders share their experience and knowledge related to effective combating of current situation and the future short term and long term solutions for growth, post Covid -19.

In a very candid article, Mr Balagopal, Founder and Former Managing Director, Terumo Penpol Ltd, has summarized his life time of experience and knowledge by saying that, “I have found the best Return On Investment ( ROI ) to come from investment in Research and Development.” He has also emphasised on investing in Man Power. He has rightly louded the importance of national R & D labs saying that the record of Sree Chitra Tirunal Institute for Medical Sciences and Technology ( SCTIMST ) is unrivalled among national labs in India.

Mr Robin Banerjee, the Managing Director of Caprihans India Ltd, in a freewheeling interview to “Medical Plastics Data Service", apart from sharing about the company’s journey from concept to the current position in this product segment (including for Medical & Healthcare sectors) has explained how the company has kept pace with changing times particularly with respect to market trends and technologies and also their contribution to the Healthcare Industry towards COVID19 management. In his opinion, the mankind cannot do away without “Plastics” which was invented to protect nature – to save wood, ivory and rare metals.

One more article from Mr Dhiren Mehta, President & CEO, Allwin Medical Devices, Inc, USA has given global perspective in his article on, “US Medtech Industry’s Response to Covid -19 and Opportunities For Future”. Mr Dhiren Mehta is a first generation entrepreneur having successfully run his unit in Mumbai and Surat ( Gujarat ) for manufacturing of wide range of critical care medical devices for a long time and then established a new company in USA. Mr Mehta has very elaborately described how the US Companies responded to the challenge with utmost speed and urgency. He sees a huge change in the way we do business saying further that Medtech companies will have to consider strengthening crisis resilience and plan for recovery.

In yet another article , Mr Sanjay Shah, CEO, Unikal Consultants has described the road map for building “Atmanirbhar Bharat“ for the Medical Device manufacturing .

This issue includes a case study on providing solution to protect healthcare professionals . It also includes our regular features viz. Regulatory & Industry News, Innovations & Technology, Product Gallery , “Did You Know” column , Events etc.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

16

July-August. 2020 D A T A

S E R V I C E

The Impact of COVID-19 on The Medical Device Industry

We are in the midst of an unprecedented global health crisis. As a result, health care systems are overwhelmed, and the effective delivery of medical care to all patients has become a challenge worldwide. To free-up limited space for people being treated for the virus, hospitals have postponed, or cancelled, many elective operations — especially those deemed to be non-essential or non-urgent.

Medical device manufacturers have not escaped the pandemic’s impact.

The Industry finds itself playing an urgent role in both helping detect the virus and supplying frontline healthcare workers with the equipment needed to fight it. Industry players outside those realms must still adapt to a changing economic landscape in which supply chains, face-to-face sales interactions, and elective surgeries have all been disrupted.

This crisis calls on the medical device industry to work closely with customers, patients, regulators, and public organizations for the sake of public health. Medical device professionals will have an essential role to play in the fight against COVID-19.

Industries, markets and businesses the world over have been turned upside down by Covid-19, and this impact has been especially profound within the medical device sector.

While many countries have attempted to ease shortages by importing equipment, domestic manufacturing of many devices has also increased during the crisis.

The European Union has postponed its new set of Medical Devices Regulations for medtech Industry by one year.

Many companies from the biotech, pharma and medical devices industries started urgently to develop coronavirus test kits.

In the demand scenario , while elective procedures have decreased significantly and the decrease in demand for devices used in these procedures , there is an increased demand for devices like ventilators, PPE, and diagnostic kits. In last few months , CDSCO has issued several notifications to manufacturing and supply of COVID 19 related devices.

In the following articles in this issue, a galaxy of Indian Industry leaders share their experience and knowledge related to effective combating of current situation and the future short term and long term solutions for growth .

July-August 2020 D A T A

S E R V I C E

17

The Importance Of R&D And Innovation In The Post COVID19 World Balagopal Chandrasekhar Founder and former Managing Director, Terumo Penpol Ltd.

General observations based on my experience as an entrepreneur and investor and mentor for tech startups.

1. The R&D spend of companies and government in India is too low. The private sector still behaves as rent seekers, not builders of businesses with a long term vision.

2. R&D has changed mainly due to the impact of the Internet: information is easy to access anywhere. This enables collaboration, sharing of resources, and crowd sourcing solutions.

3. Indian labs and research institutes are a huge resource - industry is losing out by not seeing this fact. They have people with skills in all sorts of esoteric areas and fields, and proven capabilities.

4. Industry must learn to know where to look. As Pasteur said: chance favours the prepared mind. You must be worrying about a problem to see a solution in the most unexpected places.

5. Invest in your people regularly going to engg trade fairs and research labs and seminars and workshops, not so much for what is being discussed, as for what else you may find there. This can range from answers to research problems to processes you can use to reduce costs and improve quality, to equipment that may help you make something you could not otherwise do.

6. ‘Necessity is the mother of invention’. Innovation starts with you: if you are not worrying about something, if there is no necessity, there will be no innovation. I have found the best ROI to come from investment in research and development.

The course of industrial development in India has followed a path of dependence on imported knowhow and equipment, despite a substantial investment mostly by the Government of India in Science and Technology by setting up large National Labs in various fields of activity. This has been a puzzle, and the answer must be sought in the industrial policies of the period up to the mid-1980s, which were based on erecting tariff walls to protect local business and industry. This only resulted in creating an inefficient and uncompetitive local industry. When the economy started to open up, the private sector initially was in panic, leading to the creation of the Bombay Club, which tried to stop the opening up of the economy.

While matters have improved somewhat after that initial panic reaction, matters appeared to be settling down to the same lazy rent-seeking approach by the private sector. This is proved by the decline of the share of manufacturing industry in the GDP till it is today less than 15%. (The corresponding figure for China is around 40%!). Various explanations were put forward for this, some even claiming that, while China had become the factory of

18

the world, India would become the back office! But, this neglect of the manufacturing sector has proved costly, as India has fallen far behind China, and is now not likely to catch up. China has graduated from being a low cost manufacturer with cheap labour, to a high quality manufacturer of products developed using their local skills. Today, China is a global leader in engineering products in the construction field, chemical industry, electronics and communications sector, consumer products, household articles of various kinds. In fact, it can be said that almost 50% of the global manufacturing output today comes from China! Indian businesses today depend on importing most of their components and materials from China, and Chinese supply chains have become essential for many businesses and industries in India.

Why did India fall behind, and what did India do wrong? If we study the course of economic reform in India, we find it mostly consisted in easing the restrictions on international capital flows, enabling global finance capital to access Indian savings and stockmarkets. The more important liberalisation that was needed in domestic regulations governing the manufacturing sector were July-August. 2020

D A T A

S E R V I C E

not attended to, with archaic regulations dating back more than 100 years still on the statute books, holding back MSME sector from modernising, expanding, and diversifying. Policies privileged imports over domestic products, by setting high quality standards, high tariffs on import of components and materials, high interest rates, high power tariffs, etc. If we had supported domestic technical capability through supportive policies, we could have further developed the know-why and technical capability for a strong domestic power equipment manufacturing sector, domestic machine tool sector, construction equipment sector, and so on. Companies like BHEL, NTPC, BEML, HMT, SAIL, IPCL, and others were already strong and capable, and should have been helped by supportive policies to become world class enterprises like the many Chinese companies that have done so. Instead, our policies after liberalisation only served to restrict these companies and their capabilities, leading to their decline.

Technological capability is a capacity that has to be built. Unlike knowhow, it cannot be bought, or acquired through any other way. It can be built only by companies and labs working together to experiment with various solutions and methods, constantly engaging in trial and error, and learning incrementally. Such capacity requires to be supported by a higher education system that will ensure a pipeline of trained yougn scientists and researchers coming out of the universities, to join the labs in the big national R&D institutions, and companies. This did not happen, as our higher education system instead turned to meeting the needs of the rapidly expanding IT sector, which wanted large numbers of people with coding skills. This served to hollow out the engineering and technological capabilities of our universities, which became factories to produce large numbers of workers for the IT sector.

When the pandemic hit us, our economy was already in trouble, having been slowing down over the past several years, with manufacturing shrinking every year. Our imports from China were growing every year, while we exported raw materials to pay for the exports. Our external trade balance has been adverse for a long time, with inward remittances and IT service exports making up in some measure for this. This is hardly the sign of a healthy economy. But, the pandemic has brought out some features of our economy, that may turn out to our advantage if we adopt the right policy meausres.

MSMEs are small, and agile, and nimble, and hence are better placed to weather the crisis of uncertainty created by the pandemic. Large integrated companies and organisations will find it difficult to recover, or pivot due to changes in the business ecosystem. Such smaller companies will find it easier to develop new products, new designs, and new processes, which will enable them to produce what the emerging market needs. Their lower overheads will enable them to do this at a lower capital cost.

But, they will need to invest in R&D, and must be supported to do so through liberal research and development grants and assistance. While this may be difficult for banks and lenders to do, organisations like DST and NRDC should step in. This is how many companies in Japan were supported to innovate in the early stages of their development process.

Indian MSMEs should be helped to seek support from national R&D labs that have expertise in different domains, to solve their problems. This should be done by incentivising them to do so, through suitable policy measures. The CII, Industries Depts of State Govts, and the MSME Ministry of GOI should all get together for this task. There is considerable ignorance among MSMEs about the capabilities of national labs in various fields.

Only when MSMEs visit such national labs and see for themselves the capabilities that exist, will they develop the confidence to approach them.

The founder of SCTIMST, Dr M S Valiathan, once said that a necessary condition for great achievement in science and technology is the knowledge that you have done it before. We need to have many local examples of R&D efforts by Indian companies that have led to business success. I am glad that I was able to build the small enterprise I set up with knowhow from SCTIMST into a global scale plant making high quality biomedical devices and exporting to many countries. I know that the main reason for our success was the investment in R&D we have been making consistently from the very beginning, till today. If I could do that, with little money or business experience, anyone can do the same.

For too long in this country, businesses have been content to import knowhow, and even plant and machinery, adding very few innovations of their own. What little R&D that is done is mostly relabelling modernisation spending to take advantage of tax benefits that used to exist. It is only post-1991 that we have more companies coming forward to invest in R&D. We have seen the rise of companies like Biocon, TVS Motors, Mahindra & Mahindra, Sun Pharma, Dr Reddy’s Labs, and a few more, who have risen to global prominence on the strength of their innovative products abnd technologies. Such successful companies should open their labs and facilities for MSMEs to visit and see for themselves what can be accomplished by local science and technology efforts.

The record of SCTIMST in this respect is probably unrivalled among National Labs in the country. I have involved with the activities of TIMed, the medical devices incubator started at BMT Wing at SCTIMST around the same time, and am happy to see that activities have gained traction, and several incubatees are already benefiting from the unrivalled facilities for multidisciplinary research and testing available here. The Technology Conclave is a pioneering initiative started by SCTIMST, to familiarise industry with the work being done here and the technologies developed and available for transfer. This is already having an impact, as evidenced by the transfer of technology effected after the program was started. Other national labs should be encouraged to conduct similar programs.

I would now like to end by making some general observations based on my experience as an entrepreneur and investor and mentor for tech startups.

1. The R&D spend of companies and government in India is too low. The private sector still behaves as rent seekers, not builders of businesses with a long term vision.

2. R&D has changed mainly due to the impact of the Internet: information is easy to access anywhere. This enables collaboration, sharing of resources, and crowd sourcing solutions.

3. Indian labs and research institutes are a huge resourceindustry is losing out by not seeing this fact. They have people with skills in all sorts of esoteric areas and fields, and proven capabilities.

4. Industry must learn to know where to look. As Pasteur said: chance favours the prepared mind. You must be worrying about a problem to see a solution in the most unexpected places.

5. Invest in your people regularly going to engg trade fairs and research labs and seminars and workshops, not so much for what is being discussed, as for what else you may find there.

This can range from answers to research problems to processes you can use to reduce costs and improve quality, to equipment that may help you make something you could not otherwise do.

6. ‘Necessity is the mother of invention’. Innovation starts with you: if you are not worrying about something, if there is no necessity, there will be no innovation. I have found the best ROI to come from investment in research and development.

July-August. 2020 D A T A

S E R V I C E

19

Combating COVID-19 With Effective Change Management Robin Banerjee Managing Director, Caprihans India Ltd

Robin Banerjee, the Managing Director of Caprihans India Ltd is a senior professional executive with about four decades of experience in several large multinational corporations in more than 20 countries. “Caprihans” is the pioneer in producing PVC films through calendaring process in India .

In a free-wheeling interview to “Medical Plastics Data Service", apart from sharing about the company’s journey from concept to the current position in this product segment (including for Medical & Healthcare sectors), he also explains how the company has kept pace with changing times particularly with respect to market trends and technologies and also their contribution to the Healthcare Industry towards COVID-19 management. In his opinion, the mankind cannot do away without “Plastics” which was invented to protect nature – to save wood, ivory and rare metals.

“Caprihans India Ltd” has been manufacturing PVC Films for various industrial applications since long. Can you please throw some light on your company’s journey from concept to the current position in this product segment?

Caprihans brought into India the concept of producing PVC films through calendaring process. Being a pioneer in this industry, the company has earned typical expertise to produce quality products. I believe the manufacture of PVC films is both a science and an art. Science is easy to learn, but it takes a long time to master any art. The ability to juggle both the science and art of PVC technology, has enabled the company to occupy a premier position in the industry.

When did your Company start catering to the Medical & Healthcare segment? What are the products?

With Covid bringing a standstill to portions of the company’s operations suddenly in mid-March 20, it was a shock to all of us. It took us a few weeks to get over the

20

jolt. Except packaging requirements for pharma, the local authorities would not even allow our factory to even commence work. We quickly put our thinking caps. Lo and behold, several ideas crept out – how to use PVC to save and protect lives.

However, with the lockdown all around in April-May period, severe panic on catching the virus and migration of the work force, most vendor factories were without employees.

Inspite of the serious impediments, we took steps to innovate and develop various life-protecting products simultaneously.

Our new products launched so far, include: - PPE or Hazmat suits from PVC – perhaps the safest product under virus environment; - Face shields – which are unique in design capable of being worn for long hours without headaches; - Hospital Curtains and hospital bed linens from PVC – anti-microbial, anti-bacterial and perfumed; - Portable and foldable PP beds – anti-fungal, antibacterial, anti-microbial; July-August. 2020

D A T A

S E R V I C E

July-August 2020 D A T A

S E R V I C E

21

How has your company been able to keep pace with changing times particularly with respect to market trends and technologies?

Caprihans has two fullfledged government approved R&D Centres. Our focus is to keep innovating everything what we do. Most importantly, trying to understand the customer needs. An important area has been to develop products which are being imported.

This provides ready-made opportunities for faster commercialisation due to import substitution. We have been focussing to make international quality products, at local cost with Indian ethos.

What is your company’s contribution to the Healthcare Industry towards COVID-19 management?

We believe we have developed products which are unique. Each product type and variant is attempted to make invaluable lives, safe. Corona virus is a deadly submicroscopic infectious agent, creating havoc. Our products are structured to prevent both virus and blood penetration, or are anti-microbial and anti-bacterial. Which means, they are either very safe to use (say, the PPE suits) or would not let the deadly virus to sit on the product (say, the hospital curtains). Each of these products should be of significant importance to the healthcare segment.

Like most of the industry in India, your company might also have passed through difficulties during the pandemic lockdown and post lockdown opening periods.

Can you please share your experience?

Our manufacturing locations have gone through every possible difficulties which most industries would have faced. Starting from statutory limitation to the use of maximum labour force to keeping strict social distancing in the work place. The factory in Thane had the problem of transporting the employees from their homes, while the Mumbai local trains are not functioning. Staggering work hours, intermittent holidays, arranging transport for picking up and dropping employees, strict sanitation practices, continuous facility sanitization, checking every employee multiple times, are some of the new stuffs we introduced. With divine intervention, we did not have the additional challenge of migrating labour, as our employees are mostly local inhabitants.

According to you, what are the lessons for the industry from the COVID-19 experience?

22

When I saw the sad pictures of migrant labours walking hundreds of miles towards their homes as soon as the lockdowns were announced, it dawned on to me that businesses should have the resilience to face serious workplace distortions for atleast three months. It means that the businesses should have funding firepower to meet exigencies for atleast a quarter, should anything adverse happen. The migrant crisis essentially emerged, when they found they would not be paid or looked after by their employers as the businesses are shut due to the pandemic. This perhaps could have been avoided had the businesses planned for the worse.

My key learning is therefore to have three months’ cash burn, as ones cash balance.

What should be the “new normal” for the industry?

As regards the ‘new normal’, maintaining social distance and continual sanitization in workplace, together with hygienic habits like intermittent washing hands in soap water, will be here to stay for some time. Most people are not going to risk their lives by packing themselves like sardines either in transport or in work space. The virus in my view has changed for ever, the importance of health over wealth.

In the long term, how do you see the future growth prospects for Healthcare & Medical Plastics Sector –both for domestic and export markets?

I foresee healthcare sector as a huge opportunity for the Indian businesses. Especially in the sector of ‘nutrition’ and ‘immunity’ building. Health is now the wealth, and not the other way round. India has huge treasure of ayurvedic solutions for both nutrition and immunity building. A few examples are turmeric, tulsi, neem. Just to name a few. Being Indian in origin, we should be able to build a global business around it. However, there needs to be an appropriate credible quality certification eco system created with government sponsorship.

At the personal level, what is your advice to the plastic industry professionals for developing careers in the Medical Plastics Sector?

Even if plastics is often denoted as a bad word, the mankind cannot do away with it. Plastics was invented to protect nature – to save wood, ivory and rare metals. The medical world needs packaging that are safe and food-grade. As of now, no known substitute is available for plastics, barring the use of glass in certain sectors. I believe there is great opportunity in the medical plastics sector, especially in the areas of biodegradable, recyclable and sustainable plastics.

July-August. 2020

D A T A

S E R V I C E

Cover Story US Medtech Industry’s Response to COVID-19 and Opportunities for future

Dhiren V. Mehta President and CEO Allwin Medical Devices, California, USA

Medtech industry responded to the challenge with the utmost speed and urgency. To complement the efforts made by healthcare workers, many Medtech companies declared they would remain open to serve the community. Many medical device manufacturers are taking unprecedented steps to help. Although this may be a once in a lifetime occurrence, the Medtech industry will evolve to face similar challenges in the future, keeping in mind employee safety, patient interaction with healthcare professionals, production efficiencies and national security.

Although, beating COVID-19 has been thought to be a collective effort from a multitude of Medtech companies, here is a snapshot of a few responses from key drivers in the industry.

There were 26 COVID-19 cases on March 4, 2020, and today on July 27, 2020, there are 4.1 million in the USA solely. The US has reported the highest number of deaths worldwide - 145,000. This illustrates how one of the most powerful countries in the world has mishandled the pandemic. The reason for this grave situation is beyond the scope of this article.

On the contrary, the Medtech industry responded to the challenge with the utmost speed and urgency. They realized that the over-dependence on imports for PPE, ventilators, etc. have put them in a tough spot. The demand for face masks was increasing exponentially and soon, the US states were competing against each other for their stocks from whoever can supply. In totality, the United States went to war against the virus with a broken supply chain. However, not all was lost: To complement the efforts made by healthcare workers, many Medtech companies declared they would remain open to serve the community. Many medical device manufacturers are taking unprecedented steps to help.

Although, beating COVID-19 has been thought to be a collective effort from a multitude of Medtech companies, here is a snapshot of a few responses from key drivers in the industry.

Company

COVID-19

3M

Increased production of n95 masks multifold. 3M also published its price lists to help customers avoid inflated prices and to help fight PPE counterfeits during COVID-19.

Ford Abbott

US motor car pioneers partnered with GE and Airon to produce ventilators in a really quick period.

AbioMed

Received Emergency Use Authorization (EUA) from FDA on March 18 for its first molecular test for COVID-19, used on its m2000 RealTime system.

Impella RP temporary heart pump gained FDA Emergency Use Authorization (EUA) for an expanded indication to treat COVID-19 related acute right heart failure or decompensation, including pulmonary embolism.

AbviNOW Medical B. Braun

Introduced a way for full medical exams to be performed remotely amid COVID-19 using Artificial Intelligence (AI).

Received FDA Emergency Use Authorization (EUA) for the use of infusion pumps with nebulizers to treat COVID-19 patients.

BD

Received FDA Emergency Use Authorization (EUA) on July 2 for its portable, rapid, point-of-care antigen test for COVID-19.

Bio-Rad Laboratories

Received FDA Emergency Use Authorization (EUA) on April 29 for a COVID-19 total antibody serology test that detects all three antibodies (IgM, IgA, IgG) to the disease. The test features diagnostic specificity of more than 99% and a sensitivity of 98%.

Hologic

Created a fully automated test that detects genetic material from SARS-CoV-2, the new coronavirus strain, in under three hours.

Medtronic PMT Partners

Made progress in increasing ventilator production worldwide.

Its small, compact, and portable Oxylator® ventilation-resuscitation device was successfully used to treat a patient with COVID-19.

Roche’

Elecsys COVID-19 serology antibody test received FDA Emergency Use Authorization (EUA) on May 2, featuring specificity greater than 99.8% and sensitivity of 100%.

Steris

Received Emergency Use Authorization (EUA) from FDA to decontaminate N95 or N95-equivalent respirators up to 10 times using the Non-Lumen Cycle of the V-PRO® Low-temperature Sterilization System.

July-August. 2020 D A T A

S E R V I C E

23

Cover Story In a unique and previously unheard of partnership, Tesla will make Medtronic ventilators in a New York factory repurposed from the manufacture of solar power cells. Medtronic is trying to increase the production of ventilators critical for treating the sickest COVID-19 patients. This pairing is the result of great minds working together; in this case, those of Omar Ishrak and Elon Musk.

Midway during the war with this deadly virus, the United States realized its faulty supply chain and re-investigated. Local and national preparedness was found to be very crucial. Research indicated China, the main supplier, kept essential PPEs for its citizens. This was an eye-opener for the US, and so they began ramping up the production of essentials to avoid dependency on other countries and support their citizens fully.

Future of Medtech Industry COVID-19 is far from over now. Till we 'Vaccinate the World', elective surgeries will see a huge decline by roughly 60 to 80 percent. The financial resources available to patients will largely impact the choice of elective surgeries the patients will opt for during the on-going crisis.

Post COVID-19, as and when it happens, I see that there will be a huge change in the way we do business. Access to hospitals will be more restrictive and therefore, the industry will have to be more innovative in their marketing approach. Healthcare services will resort to telemedicine: The Digitization of Healthcare. I have personally used telemedicine which saved me time and money with the same result. Remote monitoring of a patient's health will be a new normal in a not-so-distant future. So a lot of focus will be on Medtech companies in the telehealth space.

Nevertheless, patients will still have to go to hospitals for surgeries. Operation theatres, medical equipment, and consumables will be needed. The elective surgeries and delayed essential surgeries resurgence will put a strain on hospitals' resources and finances, once things open back up.

Medtech companies will have to consider strengthening crisis resilience and plan for recovery. Building and stress-testing several scenarios for procedures and product demand will be critical for identifying areas of risk and opportunity while navigating through the crisis. Remote working will gain traction.

The infrastructure needed for the same will be acquired and policies will be in place for effective performance during similar situations.

The planning and actions taken in the short term can have significant implications, not only for Medtech’ s continued resilience during the crisis but in shaping its longer-term recovery for what is likely a significantly different future for healthcare and the Medtech companies.

Initiatives related to collections, reordering frequency, batch size, and payment terms will need reconsideration for cash flows.

Additionally, changes to production—just-in-time, inventory

24

pooling and rationalization, and standardization—will need to be evaluated.

Although this may be a once in a lifetime occurrence, the Medtech industry will evolve to face similar challenges in the future, keeping in mind employee safety, patient interaction with healthcare professionals, production efficiencies and national security.

Dhiren V Mehta is President and CEO of Allwin Medical Devices, Inc with headquarter in California, USA, and factory in Surat, India. He has a Chemical Engineering degree from University Department of Chemical Technology (UDCT), Mumbai and Management degree from Jamnalal Bajaj Institute of Management Studies.

Allwin Medical Devices, Inc is ISO 13485:2016 certified, US FDA registered company. Our portfolio consists of products for Urology, Gastroenterology, Women’s Health and Interventional Radiology. With a global footprint in over 40 countries, our aim is to deliver high quality products at affordable prices to alleviate patients’ pain with utmost safety and ease.

July-August. 2020 D A T A

S E R V I C E

Future Trends & Development

Atma Nirbhar India in Medical Devices Sector

Sanjay Shah CEO, Unikal Consultants The requirement for Atma-Nirbharta (Self Reliance) in any commercial activities is the need of the hour. A mantra given by our Respected PM Narendrabhai Modi.

What is to be Atma-Nirbhar in Medical Devices in India?

To be Atma-Nirbhar in any activities means we have to be capable to produce, to start with, same quality equipment / device as available in the market at a competitive cost.

These are tough challenges but unless we can pickup the gauntlet, we cannot be the winner. We cannot achieve our national goal.

How to go about it?

The road map for medical devices is discussed in this article.

Supported by data available from various sources and concepts from the author, based on his long experience in the field of medical device industry in India and out of it.

80% imports!

Around 65% of the manufacturers in India are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market with extensive service networks.

This requires technology and knowledge support for the set up and our small scale industry is not capable of the same. Few flashes in individual capacities are there but not in an organized manner.

Here, the biggest hurdle has been regulatory environment in India for medical devices. The real thrust cam only in last 5-6 years and efforts are done to bring devices in to mainstream regulations.

What are devices, their classifications and broad segments ?

In most of the developed world medical device regulation is independent of pharmaceuticals but under the Drug regulatory agencies. Efforts to take it away from the same delayed the implementation. Ultimately we have now a separate division (department) in CDSCO including regulatory framework. This has speeded up bringing all devices under the regulation as Medical Device rules. Drugs & Cosmetics Act & Rules has a specific schedule & rules for Medical Devices, after a long discussion.

Medical Devices – is well defined in our regulatory documents.

So without elaborating again, we may say it can include Medical Devices, In-vitro Diagnostic Devices, Equipment / Instruments like MRI, USG etc. / Software as Devices and for operating sophisticated devices.

For the implementation of regulatory compliance, we need trained and experienced regulatory officers. Elaborate training efforts were undertaken with the support of existing industry in India and in other countries. It is of course an ongoing process and well implemented by the DCG(I) office.

In India, within MDI, the Medical devices are segregated into following major segments:

For manufacturing medical devices; equipment, instruments we need approved quality standards. Presently we were using obsolete standards, if they are there; with up-dating time lag so long that by the time new version of the standard was published, concerned device design became obsolete!

Let us discuss what is required – challenges for resources faced: There are multiple requirements, which have to be worked on simultaneously and in coordination with Industry & concerned Government ministries. Let us go into details.

• Consumables & Disposables include needles and syringes, etc • Diagnostic Imaging includes MRI, X-Ray, Ultrasounds, etc • Dental Products includes dentures, braces, etc Orthopaedics & Prosthetics include knee implants, artificial joints Cardiac stents, angiographic catheters, balloon catheters etc.

• Patient Aids include hearing aids and pacemakers, etc • Diagnostic reagents Manufacturing in India – we are well aware from the data available that we have presently great limitation in manufacturing capabilities. Making few assembled disposable devices is all that we manufacture. Drug Eluting Stents was a first major breakthrough. Even many types of catheters and tubes are imported in large numbers because world manufacturers and their agents in India have little interest in shifting base in India.

India’s dependency for medical devices is supported by 75 to

A robust organization for understanding Devices and preparing or approving existing international standards is required. They also have to understand the specifications in Indian context.

Hope present efforts in this direction are successful.

If we have device manufacturing facilities and their standards for evaluating their performance, we need to test them for their quality – In-house & at External testing facilities. This is a very complex issue since each type of device is different in its usage and required different types of testing equipment and facilities. At the same time trained testing engineers. We can use international facilities but they are very expensive to use and may take long time. Again they may not carry out tests as per our specifications / test methods.

We need to Maintain Devices by creating maintenance facilities

July-August. 2020 D A T A

S E R V I C E

29

Future Trends & Development and expertise.

Qualified human resources in Production, QC/QA/RA, Maintenance, Servicing & Repairs – this is a most critical requirement. We require trained & qualified human resources.

Our training institutes and engineering / technology institutes need specialized courses for medical devices.

We require expertise to modify / improve existing devices as the technology up-grades and also as per the requirements of Indian patients and providers.

Innovate new Devices as per the requirement of medical fraternity for the betterment & for the use of patient’s ease. This is to be mentored from Indian perspective and later for exports. We can be a great based for Asian region to start with.

Again our educational institutes should come forward and take up challenge of developing skilled engineers / chemists /

technologists.

Mentoring of innovators including incubation centers will give wings to our young talent. Exposing to international designing concepts by bringing in foreign direct investment and involvement of international companies can help too.

We discussed various aspects of requirements and some solutions/suggestions.

Let us see what is the present scenario.

Do we have up to date data as of March 2020? We need them to address the issues hindering going for Atma-nirbharta in Medical Devices & Equipment/instruments.

Lot of information is available on Government website (Source: investindia.gov.in). The same is quoted below with actions taken by the Government. It needs to be implemented and mentored.

There Are Large Investment Opportunities In Medical Devices Manufacturing In India India is amongst the top-20 markets for medical devices in the world. Market size is expected to reach $ 50 bn by 2025. India is the 4th largest market for medical devices in Asia.

There are 750–800 domestic Medical Devices manufacturers in India, with an average investment of $2.3–2.7 mn and an average turnover of $6.2-6.9 mn.

The manufacturing is developing in its scale and geography: there are six Medical devices manufacturing “clusters” in the country (Refer to 'Data on Map' section below).

Clusters have “Medical Device Parks” developing around them: states have committed to set-up dedicated industrial parks where efficient domestic manufacturing at lower costs. In 2019, Andhra Pradesh, Telangana, Tamil Nadu, and Kerala have got in-principle approval from Government of India for new medical devices parks.

Thus we see that route to Atma-Nirbharta in Medical Device is long but if all stake players pitch-in, not diffcult and not too far.

We need guidance, cooperation, targets and drive to do it.

30

July-August. 2020 D A T A

S E R V I C E

Innovation & Technology

Devices For Safe Transfer Of Corona Infected Patients And Protection Of Healthcare Workers Health Care Workers (HCW) rarely have faced such danger at such massive scale. Reports of HCW getting infected and even dying during COVID-19 pandemic is much disturbing and tragic. A keyway of spread of deadly infectious virus is through tiny airborne particles generated during intubation called ‘AEROSOL’. As per WHO the Aerosol can spread or travel up to 8 meters in the air as such it is of utmost importance to prevent this from wide spreading.

All India Institute of Medical Sciences (AIIMS) & Iscon Surgicals Ltd (ISL), Jodhpur has addressed the issue of safety of HCW at two fronts.

1. Safe transfer of COVID-19 infected patient from home to hospital or COVID care centres, inside the Aerosol protection cabinet named as “SAARTHI” for patient transfer.

2. Prevention of travel of Aerosol particles in air and protecting HCW while preforming Intubation through unit named as “ABHEDYA-THE AREOSHIELD” a completely self-sealing Intubation Box.

SALIENT FEATURES : “ABHEDYA-THE AEROSHIELD” FOR INTUBATION & TRACHEOSTOMY • Sized to accommodate any size of patient long or short • Transparent slanting roof to provide excellent vision to all HCW at a time • Self-sealable multiple ports with silicon diaphragm to prevent spread of Aerosol outside the chamber.

• Enough space for easy movement of hands and handling of laryngoscope.

• Enough ports to accommodate all support equipment’s both ventilation & Suction lines.

• Rounded corners to prevent sealing of microorganisms and easy cleaning.

• Supplied with transparent front curtain of plastic which seals with base sheet to completely cover the patient.

• “ABHEDYA-T” Tracheostomy unit can accommodate three Surgeons all together at a time.

“SAARTHI” : The Aerosol protection cabinet for patient transfer • The first and only protection box available to carry any infected patient from home to hospital in ambulance as well.

• Transparent, Strong acrylic sheet easy to clean • Can be easily mounted on any stretcher.

• Once the patient is comfortably placed on the stretcher, the cabinet smoothly slides over and covers it. The transparent front curtain then covers the rest part of the body making the patient isolated totally • Openable windows to provide oxygen or any support system even in an ambulance The design and safety measures of SAARTHI restricts the flow of patient Aerosol outside the box hence saving HCW from risk of infection.

Contact : Iscon Surgicals Ltd. 22/4, Heavy Industrial Area, Jodhpur-342003 (RAJASTHAN) INDIA Cell:+91-9782600609 Tel. : 0091-291-2740553/2980666 E-mail : info@pricon.co.in Website : www.pricon.co.in July-August. 2020 D A T A

S E R V I C E

31

Materials Polycarbonate Is The Material Of Choice For Medical Face Shields Market research company, Future Market Insights, have published a report on the medical face shield market.

The report states that according to a study, the medical face shields market is anticipated to grow at over 11% Compound Annual Growth Rate (CAGR) through 2030. This is because medical face shields have proven to be an effective method for first line protection against airborne diseases like Zika, SARS, Ebola, flu, and now - Covid-19.

The key findings from the report included:

• Polycarbonate remains the material of choice for medical face shield manufacturers.

• Anti-fog medical face shields are likely to witness a higher demand than other variants.

• Disposable medical face shields will outsell reusable, as consumers look to minimise the threat of infection.

The Infectious Diseases Society of America (IDSA) has, in its recommendations, included use of Personal Protective Equipment (PPE) like face shields and masks, and although masks have been widely adopted, their effectiveness is not that well-known. However, face shields are considered more useful in mitigating respiratory viruses’ transmission like SARS-CoV-2, which would help in minimising droplets and contacting transmission. Studies have also pointed out that face shields may not be effective in the absence of masks though. The report states that the use of medical face shields, used in conjunction with face masks, is being explored, and it is highly likely that sales will soar dramatically in the next six months or so.

The report also comments that although growth in the medical face shield market will be heavily dependent on pharmaceutical interventions to tackle Covid-19, even after a vaccine becomes available, it is likely that the approach will remain preventative. In fact, customisable face shields could become a reality, especially as children head back to school.

“There is a growing consensus that Covid-19 may become endemic like coronaviruses. Til’ the time vaccines are available on a large scale, use of face shields and face masks will remain high. However, the long-term forecast on the market remains steady, as people are likely to take a preventive approach,” concluded the analyst. (https://www.medicalplasticsnews.com/news/polycarbonate-is-thematerial-of-choice-for-medical-face-shi/, 16 July 2020)

32

July-August. 2020 D A T A

S E R V I C E

Industry Hails CDSCO’s Sugam Portal In Expediting Licensing Process For Ease Of Doing Business The pharmaceutical industry in the country has hailed the Central Drugs Standard Control Organisation (CDSCO)’s online Sugam portal in expediting licensing process for ease of doing business as it has given more than one lakh approvals to manufacturers related to drugs and medical devices in the past five years since its inception.

Launched on November 14, 2015 by CDSCO in association with Centre for Development of Advanced Computing (C-DAC), Sugam portal has been able to approve 119,937 applications out of the 135,389 applications received related to import and registration of drugs, medical device and diagnostics, test license, biologicals, veterinary, BA/BE for export, global clinical trial, new drug, investigational new drugs and fixed dose combinations (FDCs) among others.

According to Regulatory Consultant Anupam H Bendre, “Before the Sugam portal was introduced, applications were made in hard copy dossier format to various divisions in CDSCO. The timelines for granting permissions or approvals for applications were almost three times more than what we have in current scenario. The to and fro of queries, documents and other issues in the submitted dossier led to the delay in permissions or approvals. The Sugam online account registration is one time process. Once the registration process is completed, applications can be made based upon the requirements.”

SUGAM application is a three step process beginning from online submission, review and final permission or approval.

“Sugam web portal has served as an online single window interface for industry professionals to not only apply for NOCs, licenses, registration certificates but has also been responsive to queries,” Bendre added.

While giving industry perspective, Ashok Kumar Madan, executive director, Indian Drug Manufacturers Association (IDMA) said, “Sugam portal is user-friendly and IDMA has conducted a series of workshops during the period of January to March 2020 with CDSCO for manufacturers on the use of Sugam portal. C-DAC officials who have developed this portal were also part of the team answering and explaining the industry during the workshops conducted throughout the country.”

C-DAC is an Indian autonomous scientific society, operating under the Ministry of Electronics and Information Technology (MeitY). Earlier the fees for applications were made in the respective bank and then the copy of challan/receipt was

submitted to CDSCO office. But now in Sugam portal, fee is calculated according to the applications and can be paid online on same portal in bharatkosh.gov.in. The receipt for payment is available on the portal which can be downloaded and submitted in the application.

Due to the introduction of Sugam portal, India is now in the state to compete with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions. Yet, there are some challenges faced by the medical device industry.

A separate medical device online portal was also started in line with new Medical Device Rules -2017 (MDR-2017) for applications related to medical devices and in-vitro diagnostics (IVDs).

According to Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices Industry (AiMeD), “The Sugam portal for medical devices is relatively new as compared to Sugam portal for pharmaceuticals and however has teething problems.”

He further elaborated, “Following problems have been faced while registering the medical device on the online portal. There is no option available to preview the application before final submission. There is no option of editing after save and continue option. A file number is generated even prior to final submission, every time a change or correction is attempted a new file number is generated. There is no option available as to how to delete the files which have been generated prior to final submission. There is no option available to add multiple devices, i.e. only one device can be entered in file. Finally, there is no option available to upload details of medical device in the format specified in GSR 102 (E) Rule 19 B (2) (ii) of medical device rules.

Uploading of data on Sugam portal is a mandatory exercise.

State licensing authorities are sending out notices to the pharmaceutical companies for not uploading data or for uploading incomplete data on Sugam portal.

While speaking at the annual general meeting (AGM) of IDMA in Mumbai recently, Mandeep Bhandari, joint secretary, Union Health Ministry had stated, "We are working with CDSCO to build capacities for effective accountability, transparency and digitisation in the pharmaceutical industry." (http://www.pharmabiz.com/NewsDetails.aspx?aid=130116&sid =1 , August 4, 2020)

DoP Appoints IFCI As PMA To Implement PLI Scheme To Promote Domestic Manufacturing Of Key APIs & Medical Devices The Department of Pharmaceuticals (DoP) has selected IFCI Ltd (the erstwhile Industrial Finance Corporation of India Ltd), a nonbanking finance company in the public sector, as the project management agency (PMA) for smooth implementation of the production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs)/active pharmaceutical ingredients (APIs) as well as medical devices.

IFCI Ltd has created web portals and email IDs for each of the PLI Schemes. It has unveiled web portal http://plibulkdrugs.ifciltd. com for implementation of PLI Scheme for promotion of domestic manufacturing of critical KSM/Drug Intermediates and APIs. For execution of PLI Scheme for promotion of domestic manufacturing of medical devices, it has launched another web portal plimedicaldevices.ifciltd.com.

July-August. 2020 D A T A

S E R V I C E

37

The web portals contain relevant information about the Schemes, application forms and contact details, in case of any query of the applicant. The application needs to be submitted through an online portal maintained by the PMA within four months from July 27, 2020, the date of issuance of guidelines for implementation of PLI Scheme for bulk drugs and medical devices.

IFCI Ltd will be responsible for appraisal of applications and verification of eligibility; examination of claims eligible for disbursement of incentive; compilation of data regarding progress and performance of the scheme including threshold investment and sales of manufactured goods of applicants selected under the scheme. The PMA will have the right to carry out physical inspection of an applicant's manufacturing units and offices through site visit.

An Empowered Committee (EC) chaired by CEO, NITI Aayog will consider applications, as found eligible by the PMA, for approval under the scheme. After receiving approval from the EC, the PMA will issue a letter to the selected applicant within 5 working days.

The approval letter will clearly mention the name of applicant, target segment, eligible product(s), proposed investment, baseline (if applicable), scheduled date of commencement of production, ceiling of annual incentive, yearly threshold of cumulative investment and incremental sales of manufactured goods applicable for determining eligibility for incentive.

PLI scheme which is applicable only for greenfield projects intends to boost domestic manufacturing of identified KSMs, DIs and APIs by attracting large investments in the sector and thereby reducing India’s import dependence in critical APIs. Under the scheme, financial incentives shall be given for six years based on sales made by selected manufacturers for 41 products which cover all the identified 53 APIs. The tenure of the scheme is from FY 2020-21 to FY 2029-30.

For fermentation based products including penicillin G, 7-ACA, erythromycin thiocynate, clavulanic acid, neomycin, gentamycin, betamethasone, dexamethasone, prednisolone, rifampicin, vitamin B1, clindamycin base, streptomycin, tetracycline, incentive for FY 2023-24 to FY 2026-27 would be 20%, incentive for 2027-28 would be 15% and incentive for 2028-29 would be 5%. The investment threshold limit for fermentation based products ranges from Rs. 50 crore to Rs. 400 crore.

For chemical synthesis based products-- cyclohexane diacetic acid (CDA), 2-methyl-5 nitro-Imidazole (2-MNI), dicyandiamide (DCDA), para amino phenol, meropenem, atorvastatin, olmesartan, valsartan, losartan, levofloxacin, sulfadiazine, ciprofloxacin, ofloxacin, norfloxacin, artesunate, telmisartan, aspirin, diclofenac sodium, levetiracetam, carbidopa, ritonavir, lopinavir, acyclovir, carbamazepine, oxcarbazepine, vitamin B6, levodopa, incentive for FY 2022-23 to FY 2027-28 would be 10%.

The investment threshold limit for chemical synthesis based products ranges from Rs. 20 crore to Rs. 50 crore. Manufacturers of critical KSMs/DIs and APIs registered in India can apply for the scheme.

The PLI Scheme for promoting domestic manufacturing of medical devices aims to provide financial incentive to boost domestic manufacturing and attract large investments in the medical device sector. Currently the medical device industry depends on imports up to an extent of 86%. Domestic manufacturing is limited to surgical, cardiac stents and general medical devices and consumables.

The Scheme targets four categories of medical devices viz. 1) cancer care/radiotherapy medical devices, 2) radiology & imaging medical devices (both ionizing & non-ionizing radiation products) and nuclear imaging devices, 3) anaesthetics & cardiorespiratory medical devices including catheters of cardio respiratory category & renal care medical devices, 4) AU Implants including implantable electronic devices.

The tenure of the Scheme is from financial year 2020-21 to financial year 2026-27. It is applicable for greenfield projects. The companies registered in India and having net worth (of applicant company including that of group companies) not less than Rs. 18 crore (i.e. 30% of the threshold investment for the first year) as on the date of application are qualified to apply under the Scheme.

A maximum of 28 applicants shall be selected under the Scheme.

A maximum of 10 applicants shall be selected under each target segment. A minimum of 3 applicants, if available, shall be selected under each target segment. Expenditure incurred on the new plant, machinery and equipment shall be considered as investment for determining eligibility under the scheme. http://pharmabiz.com/NewsDetails.aspx?aid=130429&sid=1

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

38

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) July-August. 2020

D A T A

S E R V I C E

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 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. 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. To review the implementation of the voluntary UCPMP, all the associations (Pharmaceuticals and medical devices) are 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. 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. http://www.pharmabiz.com/NewsDetails.aspx?aid=130582&sid =1, August 24, 2020

July-August. 2020 D A T A

S E R V I C E

39

Industry News Atal Innovation Mission To Support Startups With COVID-19 Solutions As Covid-19 pandemic and economic shutdowns are dealing a severe blow on the world economy, NITI Aayog’s flagship Atal Innovation Mission, (AIM) is on full swing to keep the entrepreneurial spirit high across the country by teaming up with other Ministeries and partners to support Startups with COVID19 innovative Solutions and to further fight COVID- 19 pandemics.

In this regard, AIM today coordinated and concluded a series of virtual COVID-19 Demo-Days- an initiative to identify promising start-ups with potential Covid-19 innovations to further help them deploy and scale-up their solutions nationwide. The initiative was launched in partnership with other government bodies including Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT); Department of Science and Technology (DST), Startup India, AGNIi, and other Ministries under the direction of Principal Scientific Adviser to GoI Dr. Vijay Raghavan, and Member Health, NITI Aayog Dr. Vinod Paul.

Over 1,000 COVID-19 related start-ups from a diverse set of categories including curative, preventive and assistive solutions were put through two rounds of evaluation, from which more than 70 start-ups were shortlisted for the Virtual COVID-19 Demo Days. These start-ups will receive support in the form of funding, access to manufacturing abilities, supply chain and logistics and finding the right vendors and mentors.

A total of nine DemoDays for Medical Devices, PPE, Sanitization, Technology solutions, etc were held and led by Mission Director AIM, NITI Aayog R. Ramanan. While sharing his views, he said that the joint initiative is expected to provide a much-needed fillip to India’s mobilization efforts relating to all COVID-19 related products/services/solutions and give the start-up ecosystem an effective platform to contribute during the current scenario. (https://www.medicircle.in/atal-innovation-mission-funds-9covid19-startups , July 15, 2020)

Medical Device Industry Suffers Up To 85% Drop In Revenues During Apr-June: MTaI Medical technology industry has suffered around 50-85 per cent drop in revenue during April-June with a decline in surgical procedures at hospitals due to COVID-19 situation, industry body MTaI said on Wednesday. Medical Technology Association of India (MTaI), which represents research-based medical technology companies in the country, said the government should consider reducing tax burden on medical devices in order to revive the sector.

Elaborating on the current situation, MTaI said elective procedures (surgeries) drive a large part of the demand for medical devices and the postponement has severely impacted the revenue streams of the medtech industry.

The estimated revenue downfall in the cardiology category is up to 60 per cent in the first quarter of the financial year, while in the orthopaedic industry devices segment there is a revenue fall of around 85 per cent, MTaI said in a statement.

Similarly, the opthalmology sector has also recorded a fall up to 75 per cent in its revenues during April-June, it added. Even the critical care device segment fell to nearly half, MTaI said. "Due to the shrinking margins of the hospitals, the channel and service dealership networks, and sub-dealers are already experiencing

significant workforce downsizing," it noted.

So far the global medtech fraternity have heeded to the government's request of protecting the jobs of its workforce, even while facing significant financial blows. However, if the situation does not improve, these efforts may not be sustainable, MTaI said.

"We request its immediate intervention to help the sector recover so that it can continue fulfilling its role in ensuring critical care services in the country," MTaI Chairman and Director General Pavan Choudary said.

"We request the government to consider giving basic customs duty exemption to the medical device industry to cope with the liquidity challenges during this time," it noted. It also sought revocation of health cess on medical devices.

The government should revoke the additional five per cent health cess on medical devices imposed from April 2020, MTaI said. A not-for-profit organisation, MTaI was established in 2016.

Currently, it has 37 members, including Johnson & Johnson Medical India, Bausch & Lomb, Boston Scientific and Alcon. (https://economictimes.indiatimes.com)

Indian Company Manufactures N-100 Mask Which Filters 99.97% Air Under Make in India drive, few creative minds have made a mask called XD100. The company named Excel 3D Advanced Technologies has made this reusable mask and now applied for a patent because of its unique design. Mumbai based Sameet Raut & his London based partners, Dr Rahul Gore and others, have developed and produced this mask in India. They have developed this mask keeping front-liners like doctors, nurses & others in mind.

In the N-100 mask category, there are only 9 companies in the world that make such masks. In India right now, front liners have been provided with an N-95 mask but this category of the mask which is N-100 is safer as it filters 99.97% of 0.3 microns particle size.

40

"We are into the 3D printing business and during this pandemic, we wanted to make the most efficient and affordable mask which will help frontliners and is far more superior than N-95 masks.

Also, there are no companies in India that make the N-100 or equivalent masks currently," said Sameet Raut. Sameet and his team took 4 months to design & develop this mask using advanced technologies while their other team was looking after documentation and legal permissions. "There is a USA based firm which sells N-100 mask in India. This firm manufactures the mask in China and they are costlier. We focused on the best quality by using the highest standard medical materials with a long life which will result in affordability. We provide 5 filters with this reusable mask " said Sameet Raut.

July-August. 2020

D A T A

S E R V I C E

Industry News XD100 is washable and its filtration capacity does not reduce with every wash like any other cotton mask, as it's medical-grade plastic and only filter needs to be changed.

The developer feels a single filter can be used for 10 days in the Non-COVID situation and in the COVID situation every shift it should be replaced. This mask was tested by DRDO, appointed

by ICMR and now the company has applied for FDA and has got the manufacturing code.

The company has sent the mask to the USA FDA for its NIOSH approval. Excel 3D is the only Indian company that is making an N-100 equivalent mask under the FFP3 category. Sameet feels this mask will be used in Industrial application for people working

in Cement, Chemicals, pharmaceutical companies and not just COVID situation.

XD100 mask filters 99.97% air which is 4% more than N-95 mask. The government has advised not to use the N-95 mask which has exhalation valve. Then how safe is this mask as there is a valve in this mask too? Sameet said," Valve of N-95 mask has been fitted separately, in XD100 mask we have integrated it in the design and considering the advisory from Indian government we have also arranged a filter in the exhalation valve". https://www.timesnownews.com/businesseconomy/companies/article/indian-company-manufactures-n100-mask-which-filters-99-97-air/633892

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

July-August. 2020 D A T A

S E R V I C E

41

Product Gallery Qosina’s Swab Inventory Ranges in Application from COVID-19 Testing to Cleaning and Polishing

Qosina is pleased to offer 3D-printed nasopharyngeal swabs, plus anterior nares swabs for nasal mucosa specimen collection during COVID-19 testing. For questions regarding these U.S.-made, high quality swabs, email sales@qosina.com.

Qosina also carries 57 unique styles of multipurpose and precision swabs that can be used across a broad range of applications including cleaning and polishing, applying or removing product, and sample and specimen retrieval. Ranging in lengths as short as 2.375 inches and as long as 16 inches, Qosina’s single-use, multi-purpose and precision swabs are available in an assortment of handle and tip styles for hard-toreach areas.

To learn more about Qosina’s vast swab collection, visit https://www.qosina.com/swabs.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical

42

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 one-centimeter 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.

July-August. 2020 D A T A

S E R V I C E

July-August. 2020 D A T A

S E R V I C E

43

44

July-August. 2020 D A T A

S E R V I C E

JIMIT MEDICO SURGICALS PVT. LTD.

July-August. 2020 D A T A

S E R V I C E

45

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.

46

July-August. 2020 D A T A

S E R V I C E

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

• • • • • • •

July-August. 2020 D A T A

S E R V I C E

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

47

• 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

48

• • • • • • • • • • •

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

July-August. 2020 D A T A

S E R V I C E