Medical Plastics Data Service Magazine January - February 2020

Table of

Contents Vol. 28

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No. 1

Jan.-Feb. 2020

COVER STORY Medical Device Industry Supplier Quality Management & Regulatory Expectations Outsourcing of Raw Materials, Components, Sub-Assembly –Processes etc. can significantly improve operational efficiency and fill gaps for the medical device manufacturers. On and above the basic qualifications, the supplier should exhibit certain qualities like……

Importance Of Implementing ISO 13485 – Suppliers’ Perspective - Mr. Sanjay Shah, CEO, Unikal Consultants, Ahmedabad

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EVENT REPORT Event Report on “Medical & Healthcare Plastics Pavilion” @ PLASTIVISION INDIA 2020 Indian Medical Disposables Industry & Contribution Of Plastics - Shri Kishore Khanna, Managing Director, Romsons Group of Companies, Agra and Joint Coordinator, Association of Indian Medical Device Industry (AiMed) How plastics have revolunized healthcare, transition to plastics in medical plastics devices, global demand for medical polymers, Indian medical device scenario, how Government is boosting growth of medical device industry…..

Abstracts Of Presentations By Expert Speakers

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MARKETS Trends In Medical Device Distribution In India Mr. Sanjay Jha, Director, Collateral Medical (Colmed), Mumbai With a rapidly expanding healthcare sector, India is today a lucrative market for companies manufacturing and selling medical devices and equipment.

Even as the diversity and complexity of the Indian market remains a challenge for distributors, a series of new developments and trends are laying ground for improved regulatory standards, cost effective interventions as well as improved supply chain management…..

AiMeD & REGULATORY UPDATES • Govt. Issues Notification To Regulate All Medical Devices From April 1., Industry Concerned Over Compliance Costs • Medical Device Industry Seeks Predictable WTO Permissible Tariff Structure To Boost Domestic Market • Health Ministry Seeks Stakeholders Suggestions On Framing Recruitment Rules For Medical Device Regulators

INDUSTRY NEWS • • • • •

Trivitron Healthcare Eyes Over Rs 1,000-Crore Revenue In FY'22 Nagpur: Research Will Make Cochlear I50% Cheaper Says Nitin Gadkari Medtech Firm Axio Biosolutions Lands $5.2M Funding Led By Omidyar Medical Devices Trade Margins Likely To Be Capped At 30% NGOs Ask Govt To Reject US’ Demand To Adopt “TRIPS-Plus” IP Provisions And To Do Away With Price Caps On Medical D

PRODUCT GALLERY • Adhesives for Bonding Components

DID YOU KNOW? • About Cardiac stents account for 47.95% of Serious Adverse Events

EVENT CALENDER • Medical Fair India 2020 • Medicall 2020 at Hyderabad, • Medicall 2020 at Chennai, • The 16th National Conference and Technology Exhibition on Indian Medical Devices & Plastics Disposables/Implants Industry 2020, Ahmedabad

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Flashback Select Article Index

Sept. 2013 to Mar. 2014 • Cover Story : Plastics: Empower Medical Device Industry Growth (September - October 2013) • Materials : Hexamoll Dinch - A Non Phthalate Plasticizer for Medical Devices (September - October 2013) • Materials : Polycarbonate and Copolyester Resins for Medical Components (September - October 2013) • Materials : PET has Advantages for Medical Packaging (September - October 2013) • Global Trends : Global Medical Polymer Market To Hit $3.5bn In 2018 (September - October 2013) • Learning Zone : Material Of Dissolvable Sutures Can Treat Brain Infections (September - October 2013) • Did You Know : About Conductive Plastic Which May Preserve Eyesight...!!

(September - October 2013) • Cover Story : PVC The Most Widely Used Polymer In Medical Applications (January - February 2014) • Cover Story : The Introduction Of Non DEHP Plasticizers And Its Impact On Blood Transfusion Technologies (January - February 2014) - Dr. C. S. B. Nair, Technical Advisor, Terumo Penpol Ltd. • Cover Story : Effect Of Barium Sulphate As A Filler In Thermoplastic Polymer For Medical Applications (January - February 2014) - Mrs. Stuti R. Shah, Lecturer in Plastics Engg.

Dept. Govt. Poly. Tech. , - Dr. Radhashyam Giri, Asst. Prof., CIPET A’bad, Govt. of India - Dr. Subhas.C.Shit, Prof. & Head CIPET Ahmedabad, Govt. of India • Global Trends : PVCMed Alliance Reiterates Willingness Of The Industry To Innovate And Improve Products For Quality Health Care (January - February 2014) • Did You Know : About PVC : The Environmental Perspective for Health Products (January - February 2014) • Cover Story : Medical Device Manufacturing: Balancing Innovation, Quality And Compliance (March - April 2014)

Did You Know ?

About Cardiac stents account for 47.95% of Serious Adverse Events

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Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission ( IPC) coordinates adverse event reports from manufacturers, legal representatives and patients or users.

Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch Materiovigilance Programme of India ( MvPI ).

The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority. Before 2015, no systematic structure was in place to collate adverse events associated with medical devices.

The MvPI is being coordinated by the IPC at Ghaziabad which functions as the NCC and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.

Cardiac stent was the most reported medical device for serious adverse events (SAEs) with 926 events out of 1,931 adverse events reported so far, as per Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Coordinating Centre (NCC) for the Materiovigilance Programme of India (MvPI) started in 2015.

Cardiac stents SAEs alone accounted for 47.95% of the total adverse events.

To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting. http://pharmabiz.com/NewsDetails.aspx?aid=120896&sid=1 , Feb. 3 , 2020

“In the long history of humankind (and animal kind, too) those who learned to collaborate and improvise most effectively have prevailed.”

– Charles Darwin

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Jan.-Feb. 2020

EDITOR D.L.PANDYA, B.E.(Chem), M.I.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 Mr. ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. 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.

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

Jan.-Feb. 2020

Editor’s Desk

From the

“Medical Plastics Data Service (MPDS)” is supporting the “MakeIn-India” mission through various activities. One such recent activity was creation of “MEDICAL AND HEALTHCARE PLASTICS PAVILION” during “PLASTIVISION INDIA 2020” exhibition organized by The All India Plastics Manufacturers Association (AIPMA). The Pavilion was supported by AIPMA under the Chairmanship of Dr. Asutosh Gor and it was conceptualized and co-ordinated by “MPDS”. The objective and mission was to create inter-sectorial coordination between Indian Polymer / Plastics Sector and Indian Medical Device Industry for the broader objective to support Make-In-India mission.

The pavilion included, (1) A knowledge platform complete with posters, audiovisuals, models and more than three hundred samples highlighting current status and future market potential in the Medical Plastics sector. (2) Exhibits by materials, machinery and technology suppliers. (3) Seminars and presentations by more than 20 industry experts covering all important aspects including manufacturing, technology and marketing.

The pavilion was a great success and attracted large number of existing plastics companies looking for Development / Diversification as well as industry professionals interested in medical plastics sector. The pavilion was inaugurated by Shri Kishore Khanna, Managing Director, Romsons Group of Companies, Agra and Joint Coordinator, Association of Indian Medical Device Industry (AiMed).

Shri Kishore Khanna also in a very detailed presentation highlighted how the plastic material has revolunized healthcare industry and the various Government support activities to the Indian Medical Device Industry. The highlights of presentations by Shri Kishore Khanna as well as various industry experts during the seminar are included in issue of this magazine.

This issue also includes the importance of quality management and regulatory expectations for the suppliers of the Medical Device industry which can include polymeric and other raw materials, components, sub-contractors etc.

The key attributes of a good supplier on and above the basic qualification is also highlighted. The article by Mr. Sanjay Shah, CEO, Unikal Consultants, highlights the importance of implementing ISO 13485 from the Suppliers’ perspective.

In one more very well researched and analytical article, Mr. Sanjay Jha, Director, Collateral Medical (Colmed) has detailed new trends that are expected to impact the Medical Devices distribution in the coming years including: 1. Distribution Rationalization 2. Pricing Regulations by Government and its implication on Distribution 3. Reducing Quality Differentiation 4. Improved supply chain management using Artificial Intelligence & Machine learning 5. Greater consolidation of businesses and growing role of private equity players This issue also coves the regular features including Industry News, AiMed and Regulatory Highlights, Product Gallery, Events, Did You Know etc.

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Cover Story

MEDICAL DEVICE INDUSTRY SUPPLIER QUALITY MANAGEMENT & REGULATORY EXPECTATIONS Outsourcing of raw materials, components, sub-assembly, processes etc can significantly improve operational efficiency and fill gaps for the medical device manufacturers when they are struggling with in-house. However, failing to properly manage suppliers and vendors presents huge risks for product safety and compliance.

Although a viable supplier business model demands high quality products and services, the responsibility for maintaining regulatory compliance ultimately rests on the Medical Product manufacturers.

Monitoring and managing quality is extremely important when outsourcing that could potentially impact the product including outsourced products / services like components, contract manufacturing, consulting etc.

Good Quality Management System require manufacturers to develop and maintain procedures that ensure all purchased / outsourced products / services adhere to defined set of requirements.

This starts with evaluating suppliers, contractors and consultants on the basis of their ability to meet specified requirements including quality requirements. The evaluation needs to be documented.

Once identified and shortlisted, a thorough audit should be planned and executed either on – or – off site, depending on the nature of the product or service provided.

Purchasing document would include , among other documents, an agreement for the supplier to agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.

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Key attributes of a good supplier On and above the basic qualification of a supplier there are certain qualities the supplier should exhibit like : - A reasonable customer response time when responding to a quote or a query.

- To communicate about any problems quickly so that the manufacturer do not face unnecessary delays to production.

- Most economical and with fastest lead time.

- If possible, highly recommended by someone known or trusted.

It’s much better to discover that a supplier might not be a good fit before added to the approved supplier list. The forms and process for adding a supplier can be lengthy and difficult to complete, costing time for the manufacturer.

Companies have often a tendency to want to minimize the numbers on the approved supplier list. It is therefore important to : a) Choose the right supplier in the first place and b) Immediately remove suppliers from the approved list who don’t turn out to be a good fit.

Jan.-Feb. 2020

Cover Story

Regulatory Compliance For Medical Device Component Manufacturers

Mr. Sanjay Shah, Managing Director, Unikal Consultants, Ahmedabad.

In the healthcare world we know what are called medical devices and what the definition of medical device is. We also know their importance in today’s patient health management & treatment.

At the same time generally we know a lot more about medicines, even about alternate medicines like ayurvedic, homeopathic or unani but the awareness of what are called medical devices and for need of medical devices was till now very limited, sometimes confusing.

Let us analyze this a little dipper to understand need for regulating medical devices and their “raw materials”.

There are many dissimilarities between medicines and medical devices but they are both necessary in patient cure and management of improving their life. Broadly described as follows: 1. Medical devices are mechanical, rather than chemical Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. At the soft end, they are simple, everyday products like sticking plasters or spectacles; at the sharp end, they might be sophisticated surgical supplies, like cardiac stents or joint prostheses. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry.

2. Medical devices have different efficacy dynamics to pharmaceuticals The efficacy of a medicine is simpler to demonstrate than for a medical device, because it is determined by the pharmacodynamics of its active ingredient. The effectiveness of a medical device depends upon many more variables – it design, the care setting, individual patient characteristics and the skills and experience of the clinician ‘applying’ the device.

3. Research and development (R&D) models are different Designing of a medical device is a complex process and needs many different studies before even it is used. So its components and parts are very critically controlled. Most medical devices cannot be evaluated using randomised clinical trials due to ethical and practical issues in the choice of comparator – for example, what would be an ethical comparator for a cardiac pacemaker? One more critical aspect of design of medical device is that there cannot be a placebo, very unlike medicines to compare the effectiveness.

Medical devices are, nonetheless, evaluated for efficacy and safety, based on data acquired from clinical investigations.

4. Medical devices have regulatory systems based on shorter product life cycles Like pharmaceuticals, the medical device industry has its own regulatory systems. Medical devices have shorter product life cycles, since technical improvements are typically available Jan.-Feb. 2020

within two years of a previous iteration, whereas improvements in medicines are more likely to take decades. Trying to apply the same regulations to medical devices as to pharmaceuticals would therefore delay access to vital medical resources and procedures without increasing patient safety.

5. The complete performance of medical device is based on their risk to benefit assessment.

This means that not only the medical device used should be useful but at the same time should have benefits more than the risk involved in using them.

6. Sales and marketing models differ In pharmaceuticals, the prescribing doctor is the primary target of sales and marketing activities. In medical devices, there are many more stakeholders who can influence the adoption and use of a device, including hospital managers, nurses and case workers. Medical devices therefore have greater emphasis on training, education, service and maintenance, as well as distribution, which greatly impacts their business models.

Let us analyse above differences to better understand need for regulations for medical devices and criticality of its components.

Medicines have active compounds and filler or inactive compounds. It is easier to understand and control these active compounds. Medical devices have many components and all of them form a critical component of a device.

Medical Devices have many forms of part or component inputs.

1. There are components which are assembled to make a device. Each component, though not a device by itself has an important, if not a critical role to play. The components are used in the device as such or sometimes treated.

So we can realize the importance of maintaining their quality.

In today’s world of GMP, GLP, GDP it becomes critical that their manufacturers follow basic good manufacturing practice, test them using good laboratory practices and even transport or distribute them taking care that they are not damaged during transit, so good distribution practices.

2. There are components supplied as sub assembly. This means some of the components are assembled at the premises of their supplier to form a particular part of a medical device as an integral part. They need to follow same fundamental care because again most of these subassemblies are put together without much treatment or process of full cleaning and quality.

3. Sometimes medical devices are bulk supplied as non-sterile components. They are finally sterilized and packed at the manufacturer and supplier of medical devices.

From few of the above examples and comparison to medicines

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Cover Story it becomes very clear that performance, safety and criticality of use (usability) of medical device is largely dependent on components and in most of the cases of manufacturer there are multiple part suppliers. These parts are assembled and if need be sterilized at the final manufacturer.

Thus consistency of the product quality and performance is dependent on component manufacturers as much as final device manufacturers.

Thus like API manufacturers are part of regulated industry there should be basic and minimum compliance responsibility and regulations should be for the component manufacturers.

Let us examine what it can be. As described earlier GMP and GLP as well as GDP becomes core of the regulatory need.

What does it mean and what are the standards that can control them?

International standardization on Quality Management System has published ISO 13485 standard and the same is adopted by international community like US FDA under their 21CFR, European Union and MDSAP as EN ISO 13485. India was late to regulate medical devices and still made a beginning. We have taken as usual a very thoughtful and planned route, though belated, with minimum System requirements based on ISO 13485.

The supplier qualification and if required audit has been now widely recommended, even insisted upon. Especially if component supplier is not following audited QMS they need to be audited and approved by the final manufacturer of medical devices.

Thus supplier evaluation, qualification and approval have to be an integral part of the manufacturer’s QMS. Again like GMP in pharmaceutical industry; it is not a onetime exercise but should be followed at a planned interval. The requirements also should be clearly stated in the agreement between component manufacturer/supplier and final device manufacturer. Any changes in the specifications, composition of the component/part should need a prior approval. Major or minor non-compliance of the System need to be addressed and communicated / reported to the manufacturer of the device in a time bound manner. Traceability from raw material used to the component manufactured is required. Thus a system is required with documentation and records.

What is the title of ISO 13485 and where does it specify need to control components?

ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes What does introduction of this standard says about its application to: “The requirements in this International Standard can also be used by suppliers or other external parties providing product

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(e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services.”

Further it states that - “Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices.”

Though these are non-binding guidelines flowing clauses of the standard are more specific: Clause 7.4.1 from the standard I quoted here. Its requirements can be expanded subsequently. Underlined information is from the author of this article.

7.4.1 Purchasing process: The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information. The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be: a) based on the supplier’s ability to provide product that meets the organization’s requirements; b) based on the performance of the supplier; c) based on the effect of the purchased product on the quality of the medical device; d) proportionate to the risk associated with the medical device. The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process. Non-fulfillment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.”

The product standard compliances are a different but critical aspect and at least risk based approach and biocompatibility requirements as per ISO 10993-1 should be adhered to by the component manufacturer.

Conclusion: From above points, a broad requirement emerges which becomes specific based on the criticality and risk of the device.

It is in the interest of component manufacturer, device manufacturer and above all user patients, that risk based regulations using Quality Management System (QMS) principles are a must for all aspects of medical device manufacturing including component manufacturers/suppliers.

Why all these discussions now? See the increase in the use of and expansion of the medical device industry. The global medical device market is predicted to reach $440 billion as per 1988 predictions, growing at a rate of about 4.4 per cent per year. Compare this with the anticipated growth of the prescription drug market – an annual rate of 2.5 per cent.

Jan.-Feb. 2020

PLASTIVISION INDIA 2020, an event organized by All India Plastics Manufacturers Association (AIPMA) included the “MEDICAL & HEALTHCARE PLASTICS” Pavilion under the Chairmanship of Dr Ashutosh Gor. It was conceptualized and co-ordinated by “Medical Plastics Data Service” with a mission to create Inter Sectorial coordination between Indian Polymer / Plastics Sector and Indian Medical Device Industry Sector for the broader objective to support Make-In-India mission.

The Pavilion was a great success and attracted large number of existing Companies looking for Development / Diversification as well as Industry professionals interested in Medical Plastics Sector.

The Pavilion also included Seminars and Presentations by Industry Experts highlighting important issues. The seminar was inaugurated by Mr. Kishore Khanna, Managing Director, Romsons Groups of Companies, Agra & Jt. Co-ordinator, Association Of Indian Medical device Industry (AiMeD).

Jan.-Feb. 2020

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Cover Story

Indian Medical Disposables Industry & Contribution Of Plastics

Shri Kishore Narain Khanna Managing Director Romsons Group Of Industries & Jt. Co-ordinator, Association Of Indian Medical device Industry (AiMeD)

PLASTICS REVOLUTIONISING HEALTHCARE 1. Humans have used medical devices for thousands of years.

2. Metal was the principal material for a very long time 3. Scientists began experimenting with plastics in the late 18th century 4. Refined Production Techniques led to mass production of plastics 5. Which in turn led to the Revolution in Medical Device Innovations 6. Modern Healthcare would not be possible without the use of Plastics.

7. Things we take for granted like syringes, heart valves, Intravenous bags and what not, are all made of plastics.

8. The list of plastic materials in Hospitals is almost endless.

The Transition to Plastics in Medical Devices Syringes are a good example of how plastics have benefited public health through single-use applications.

1. They are disposable 2. Eliminate Blood-bourne diseases such as HIV, Hep-B, etc.

3. No need to re-sterilize 4. Much more economical than the metallic Glass Syringes 5. Reduce the risk of Needle Stick injuries 6. Reduce the risk of im-proper re-sterilization (for reuse).

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Jan.-Feb. 2020

Cover Story Global Demand For Medical Polymers Global demand for medical polymers reached nearly $280 Billion in 2019, and that amount is expected to exceed $409.5 Billion by 2023.

• ANGIOPLASTY - The angioplasty catheter is a good example of a life saving medical device that would not be possible without plastics.

- Ballon angioplasty is a minimally invasive non-surgical alternative to coronary artery bypass grafting surgery. The angioplasty ballon is used to compress obstructing plaque in a clogged artery against the arterial wall so that blood can flow freely again.

- The doctor positions the ballon of he angioplasty catheter at the site of the blockage and gently expands it to compress the plaque and create a wider opening in the artery.

Advantage of PLASTICS in Medical Devices • With a better understanding of medical grade engineering polymers in mind, let's explore a few advantages they have to offer the health care industry : Comparatively Light Weight Versatility (infinite possibilities in Healthcare) Easy Sterilization Greater Safety Improved Quality Of Life Cost-Effective Great Potential for Future Innovations • NEW GENERATION OF POLYMERS ARE NOW AVIALBLE FOR MORE COMPLEX AND CHALLENGING MEDICAL DEVICE APPLICATIONS, Such As

• Critical Surgeries with Catheters : Thin tubes called catheters are used to unblock blood vessels. The deposit obstructing the vessels can be broken down with a tiny spiral-shaped implant called a vessel support.

The vessel support is made of a plastic developed specifically for the medical field and charged with active substances.

EPIDURAL CATHETERS : An epidural catheter is a very fine plastic catheter (tube) that is placed through the skin into the epidural space in your spine. ... The catheter allows access to the epidural space to inject medication such as l o c a l anaesthetics and/or narcotics for relief of pain.

• STENTS : a stent is a plastic tube inserted into the lumen of an anatomic vessel or duct to keep the passageway open, and stenting is the placement of a stent.

• Prosthetics : Prosthetics make life better for countless amputees. Many of the advancements in comfort, range of motion and durability come from plastics.

Jan.-Feb. 2020

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Cover Story MODERN APPLICATIONS IN MEDICAL DEVICES • 3D PRINTING USED FOR : Recent advances of 3D printing in healthcare have led to lighter, stronger and safer products, reduced lead times and lower costs.

• Custom parts can be tailored to each individual. 3D printing in healthcare makes it possible for medical professionals to provide patients with a new form of treatment in a number of ways.

INDIAN MEDICAL DEVICE SCENARIOS

• Key Driving Factors of the Medical Device Industry

• In current scenario, there is an immense need to use medical devices effectively to address the huge gap between demand and supply of healthcare services in India. The medical devices sector in India is at a nascent stage with most of the indigenous manufacturing restricted to medical consumables.

In true sense, imports still constitute over 75% of the current medical devices market. India is looking forward to improving self- sufficiency in medical devices as a part of the “Make in India” initiative.

HOW GOVERNEMNT IS BOOSTING MEDICAL INDUSTRY IN INDIA THROUGH : AYUSHMAN BHARAT • Ayushman Bharat scheme, introduced in September 2018, has brought transformative changes in the health space.

• The scheme, targeted at providing free and quality healthcare services to the deprived section of the society, has brought revolutionary changes in the way health services are financed and delivered.

• Health insurance coverage, which was just around 20 per cent before the launch of the scheme has jumped to more than 60 per cent now. Around 50 crore, or 40 per cent of the population, is insured with `5 lakh annual coverage at one go.

• This is the world’s largest healthcare intervention so far as the number of targeted people is concerned.

HOW GOVERNEMNT IS BOOSTING MEDICAL INDUSTRY IN INDIA THROUGH : MAKE IN INDIA • Niti Aayog, the government’s think tank, has started work on the plan, which comes as the US spars with India over price curbs imposed on medical devices to make them affordable.

• The mega plan is to eventually make India a manufacturing hub for medical devices of international standards that caters to the domestic and overseas.

Plastics and Future Looking ahead, there is much that plastics can contribute to society, much more potential to revolutionise.

Considering the speed of technological change is increasing exponentially such that life in 2030 will be un recognizable compared with life today, Plastics will play a significant role in this change .3rd generation engineering polymer have the potential to bring scientific and medical advances, to alleviate suffering and help reduce mankind's environmental footprint on the planet. For instance, Plastics are likely to play an increasing role in medical applications, including tissue and organ transplants.

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Jan.-Feb. 2020

SEMINAR ON MEDICAL PLASTICS SECTOR ABSTRACTS OF PRESENTATIONS BY EXPERT SPEAKERS January 16, 2020 : 3:00 PM Title : Material Selection & Processing Of Plastics For Medical Applications By : Dr. D. D. Kale (Ex Professor of Polymer Technology, UDCT, Mumbai, and Ex Vice President SPE, India) The importance of Medical devices in India is increasing every year and hence need special attention. The commodity plastics like polyethylene and Polypropylene as well as specialty polymers and compounds are used for manufacturing of medical devices. However, the compounding and processing of base polymers require some precautions. The additives are selected carefully and so also finishing. The reprocessing of medical devices is not the same as routine reprocessing. The composition of body fluids is not the same throughout the body. The implants have different requirements and standards depending upon the time necessary for the implants. Some of the devices are made from bio degradable polymers. The processing of biopolymers is different. Some aspects of selection, processing and reprocessing are briefly discussed.

January 17, 2020: 11:30 AM Title : Diversifying into Medical Plastics Disposables Manufacturing? Understand the basics By : Mr Anil Choudhary, Director, Operon Strategist, Pune The Setting up the medical devices manufacturing unit is a Multi-skilled activity and organisation has to be very cautious about all the elements while designing of facility, Selecting the equipment, Setting up the requisite qualified manpower, Regulatory aspects, long term goals about expansion etc while setting up the unit. The presentations touch base with the basic consideration while setting up the unit.

January 17, 2020 : 11:30 AM Title : Export Opportunities for Medical Plastics Disposables (Focus on Afro-Asean Countries) By : Mr. S. Abidi, Research Advisor, GOG-AMA Centre of International Trade & Editor, Foreign Trade Update.

Medical Plastics Disposable sector is a sunrise value-added sector in India, especially in Gujarat and has high growth potential globally, especially in Africa and Asean countries.

Disposable medical supplies consist of medical apparatuses, devices, or consumables that are intended for one time or temporary use in medical settings. These supplies are an essential component in hospital settings, as they save time and reduce healthcare-associated costs. Few examples of plastics disposables medical supplies include drug tests disposables, exam gowns, face masks, gloves, suction catheters, surgical sponges, hypodermic needles, syringes, and applicators among others. These are used in applications such as dialysis consumables, radiology consumables, infusion products, intubation & ventilation supplies, hypodermic Jan.-Feb. 2020

products, sterilization consumables, nonwoven medical supplies etc. The disposable medical supplies market covers most medico-surgical specialities such as cardiovascular, cerebrovascular, ophthalmology, gynecology, urology, orthopedics, and others. For example, cardiovascular segment accounted for the majority of the market share, i.e., two-ninths share of the total market in 2016, owing to the rise in cardiovascular diseases globally. For instance, according to the World Health Organization, an estimated 17.7 million people died from CVDs (cardiovascular diseases) in 2015, which represents 31% of total global deaths.

African and Asean nations due to their rising per capita GDP, growing migration of population to urban areas, rising diseases such as cardiovascular, diabetes etc. rising private medical healthcare facilities and health insurance are all contributing to the growth of medical plastic disposables and present a lucrative market for Indian manufacturers and merchant exporters.

This talk will provide an overview of the Afro-Asean market to enable exporters to take informed decisions and take a significant market share.

January 17, 2020 : 3:00 PM Title : Novel S-TPE solution for IV tubing By : Mr. Partha Mohapatra, Lead – Healthcare (India), INEOS Styrolution India Ltd. INEOS Styrolution has newly developed S-TPE (Styrene Thermoplastic Elastomer), called “Styroflex 4G80”, for IV tubing application. The key advantages of this material are, less drug absorption due to its plasticizer-free composition, excellent bonding performance with other IV components, good kinkresistance and clarity. Styroflex 4G80 can be processed on standard tubing extrusion equipment at superior processing rates when compared to other materials. Styroflex 4G80 has been developed through collaborations with global OEM’s and would be an attractive alternative material for next generation IV system.

Styroflex 4G80 is available with INEOS Styrolution ’s medical grade package which includes up to 12 months notification of change (NOC), locked formulations as defined in a Drug Master File (DMF), and a variety of regulatory compliance documents and biocompatibility information (e.g. USP Class VI, ISO 10993).

January 17, 2020 : 3:00 PM Title : Formulating Life-enhancing solutions for Healthcare Devices By : Mr. Suresh V., Market Development – Healthcare Devices – Indian Sub-continent, Covestro India Pvt. Ltd., Mumbai Covestro has a practiced heritage and demonstrated track record of developing bold solutions that help bring innovative medical and healthcare applications to life- from “Concept to Mass

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Cover Story production”. With our combination of technically advanced materials and deep expertise, we help OEMs meet the critical design, manufacturing and end-use performance parameters of a variety of medical devices and packaging applications.

• • • •

Formulating the life-enhancing Solutions; in the presentations we will be talking about the global trends in the healthcare industries that are common to India and solutions from Covestro that can support the Indian medical device manufacturers to accelerate the localization.

January 18, 2020 : 3:00 PM Title : PET Bottle & Non-bottle Applications in Pharma & Medical Sectors By : Mr. Rajesh Kumar Gera - AVP Business Development, Reliance Industries Limited - PET Division

Suresh V, Market development – Health Devices for Covestro India, is 15 + years of experience in marketing various engineering plastics and in his 9 years of endeavor with Covestro he has been deeply working in developing the Indian Medical devices market.

January 17, 2020 : 3:00 PM Title : Medical Device : New Product Development Process Right from conceptualization to manufacturing – Complete process will be discussed.

By : Mr. Harsh Raval, Parisudh Innovations, Vadodara Phase I : Phase II : Phase III : Phase IV : Phase V : Phase VI : Phase VII :

Research & Pre development Survey Project Detailing Conceptualization Product Detail Engineering Design Validation – Virtual Simulation (FEA) Design Verification – 3D Printing / Prototyping PackagingDesign

January 18, 2020 : 11:30 AM Title : Approaches to Biocompatibility Testing of Medical Devices made from Medical Plastics By : Dr. T. S. Kumaravel, Chairman, GLR Laboratories Pvt. Ltd., Dr. S. S. Murugan, Managing Director, GLR Laboratories Pvt. Ltd., Dr. N. Parthiban, Assistant Director – QA, GLR Laboratories Pvt. Ltd., K. R. Navaneethakrishnan, Assistant Director, GLR Laboratories Pvt. Ltd. These polymers are widely used in several medical devices, either individually or in combinations with other materials. Moreover, these materials have certain chemical footprints, that make them unique in terms of biocompatibility. We will discuss these in light of recent developments in ISO 10993 and the US FDA guidance. For the benefit of the manufacturers, we will discuss the device classifications, how to review critical sections of biocompatibility reports, and quality requirements of biocompatibility studies.

January 18, 2020 : 3:00 PM Title : Opportunities in Medical Device Packaging By : Dr. R. Rangaprasad, Business Head, Packaging360, Mumbai, India www.packaging360.in India’s medical devices market is the fourth largest in Asia — after Japan, China and South Korea — at over $10 billion and is projected to grow to $50 billion by 2025. Currently, India has 750-800 medical device manufacturers, with an average investment of Rs 170-200 million and an average turnover of Rs 450-500 million.

The Medical device packaging industry is therefore, presented with a glorious opportunity for design innovations & deliver world class solutions, both for domestic & overseas markets.

This paper covers the following areas of this fascinating domain.

• Fundamentals of Medical Device Packaging • Design of Medical Device Packaging • Standards & Regulations

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Package Testing & Validation Innovations in medical device packaging Challenges in Medical Device Packaging Opportunities in India

PET Bottles are used in Pharma sector for more than two decades in India. They are primarily used for the OTC products incl. antacids, cough syrups, vitamins, etc and for select capsules. PET bottles have replaced conventional packaging materials in Pharma sector due to its inherent advantages coupled with cost-competitiveness. The PET packaging for Pharma products in India/abroad include ‘Bottles & Jars’ and the non-bottle applications include: “Blood Collection Tubes (BCT) and thermoformed APET sheet products and blisters” among other items.

The physicals and cost-advantages of this packaging material has now also extended to ‘PET Injection Moulded Products’; which can have potential applications in Pharma and medical sectors. It has also proved to be a ‘Greener Packaging’ option for Pharma & medical sectors (both PET and APET items). The PET bottles are one of the most recycled products globally incl.

India and the recycled PET bottles & thermoformed APET items are used to make fibres/straps.

January 18, 2020 : 3:00 PM Title : Indian Medical Devices Industry – Opportunities and Challenges By : Mr. D.L. Pandya, Editor & CEO, Medical Plastic Data Service & www.medisourceasia.com Introducing Medical Devices - Classifications & Examples, Global Life Science & Medical Device Industry, Types of Companies Into, Manufacturing & Marketing of Medical Devices, Healthcare Market In India, Indian Medical Device Industry & Markets, Important Features of Indian Medical Devices Market, Medical Device Regulations in India, Future Trends & Opportunities : Global, Future Trends & Opportunities : India, Product Development Process For Medical Devices, Healthtech Startups In India, AGNIi: An Innovation Facilitation Program/Other Sources of Technology, National Medical Devices Promotion Council & Other Initiatives, Strategy to Enter Indian Medical Device Market, Important Features of Medical Supply Chain In India, Risks For Entrepreneurial Ventures & Quality of Successful Entrepreneurs.

January 18, 2020 : 3:00 PM Title : “Polymer Modification with Color and Function - Innovative Products for Medical, IVD and Pharma Packaging.”

By : Mr. Umang Shah: National Sales & Marketing Manager – Masterbatch & Compounds for Medical & Pharma Segment, CLARIANT Chemicals India Ltd, Mumbai 1. Healthcare Products & Process for new developments.

2. What is Important/ Interesting for Customers ?

3. PROTECTION of healthcare products:- end to end solutions from API to patient.

4. Focus on Regulatory changes: USP 661.1, ICH Q3D 5. Clariant at a glance. Why CLARIANT ?

Jan 19, 2020 : 3:00 PM Title : Opportunities in polymeric based medical textiles By : Dr. Ketan Vadodaria, Associate Senior Faculty, Textile Jan.-Feb. 2020

Cover Story Design Department, National Institute of Design, Ahmedabad Medical textiles is an emerging field in technical textiles. Still, many medical textile products are imported and not manufactured in India due to many reasons such as lack of knowledge.

Globally, the Medical textile field has expanded into the multibillion-dollar industry. With the growth of the healthcare sector and the aging population, the demand for medical textiles is increasing in India. Medical textiles are the combination of materials and textile structures used in our day to day life to infection control and lifesaving advanced needs in hospitals. Medical textile products are ranging from wipe adult/incontinence/baby diapers, sanitary napkins to implantable and from artificial organs to mobile and off-site health monitoring systems on apparels to infection control products such as surgical gowns, facemasks, hospital pillows, and bedsheets. Hernia mesh, vascular grafts, tendons, ligaments are few of the more advanced

®

medical textile structures. The list is long. In order to make medical textiles, different polymers and biopolymers are used.

The lecture focuses on opportunities, challenges in polymeric based medical textiles.

January 19, 2020 : 3:00 PM Title : Healthcare Plastics Waste Recycling : Improves Environment , Economy, Job Creation and Public Health By : Mr. D.L. Pandya, Editor & CEO, Medical Plastic Data Service & www.medisourceasia.com About Healthcare Waste and its impact, Circular Economy, Waste Management in Healthcare, Plastics : Significant Share., Common Recyclable Plastics : Products and Materials Used, PVC : A Material with High Recycling Potential, International Bench Mark Activities, Economic, Social and Environmental Value of Recycling Recyclability of Healthcare Plastics.

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

Manufacturers & Exporters of Disposable Medical Devices

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

ISO 13485 : 2003 • Exporting our products to almost more than 23 countries.

Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com Jan.-Feb. 2020

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Market

Trends In Medical Device Distribution In India

Mr. Sanjay Jha Director, ColMed India is currently the 4th largest medical devices market in Asia after Japan, China and South Korea and the medical devices market in the country is expected to grow to USD 50 billion by 2025.

With a rapidly expanding healthcare sector, India is today a lucrative market for all global companies manufacturing and selling medical devices and equipment. Most global companies are already selling products in India or are planning to enter the market. Even as the diversity and complexity of the Indian market remains a challenge for distributors, a series of new developments and trends are laying ground for improved regulatory standards, cost effective interventions as well as improved supply chain management.

Prominent new trends that are expected to impact the medical devices distribution in recent years are : 1. Distribution Rationalization: For OEMs, managing distribution networks and sales channels effectively has always been a significant area of concern. Today, many OEM's have devised a strategy in which they focus on their core job of developing products, leaving the distribution conundrum to specialist group purchasing organizations. As seen

in the USA, the complete Distribution model is outsourced to a few National Distributors, commonly referred to as Group Purchasing Organizations (GPO), who through their expertise and established tiers of distribution, make available the medical products to Healthcare Professionals. ColMed is one such Indian company, which has been at the forefront of this revolution in India. The GPO's big-dollar investment in quality manpower and sophisticated inventory control systems, help local distributors in Tier 2 & Tier 3 cities in catering to health centers, by enabling them to procure quality products at affordable price.

It is a win-win model for all, since OEM's can focus on enhancing Product Aware-ness, GPOs can use their expertise of distribution, Tier 2 & Tier 3 distributors can purchase products at low price in spite of limited buying volumes, and customers get access to a wide array of products at reason able price.

2. Pricing Regulations by Government and its implication on Distribution Recognizing the need to improve regulatory standards for medical devices, the government has initiated measures to set up a separate regulatory authority for this sector that hitherto came under the domain of drug regulator Central

Collateral Medical (Colmed is the abbreviation) is India's leading medical device, instruments, consumables & disposables marketing and distribution company in India. Our customers include medical professionals, purchase managers; and endusers such as patients, expecting mothers, etc. We serve our customers through direct mail. We have 100+ industry-specialised support staff, field sales representatives, backed with sophisticated organized order processing enterprise resource planning software to streamline procurement, ordering, invoicing, dispatch & accounting.

We support medical professionals by providing products and services in an efficient and transparent way. Our customers are connected, informed and are known to adapt to using technology to their advantage.

We are committed to providing the industry with high-quality medical devices at the lowest possible prices. We believe that this will not only improve the quality of healthcare access, but will also increase healthcare access.

Our industry-specialised, highly trained support staff and field sales representatives are proof of our customer-centric philosophy. We keep abreast of industry competition and trends within our core markets, and our customers have come to rely on our ability to adapt to changing markets and the industry's evolving needs.

We work as a team, sharing ideas and conventions, to deliver the best possible outcomes to our customers. We ensure integrity by delivering on our promises and making things happen.

Our team’s desire is to make significant contributions to the communities in which we work. We have a restless desire to take things to the next level, to stretch our abilities and become the number one full-service provider to independent hospitals and doctors who operate under controlled budgets.

Our robust partnerships with various national & international OEMs like 3M, J&J, Roche, BPL, Cochlear give us an edge over our competition. We always strive for symbiotic association with various Brands. There are many success stories of exclusive OEM tie ups which has led to various Medical Devices & Consumable companies in reaching length and breadth of India, using our professional service & robust distribution partners pan India.

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Jan.-Feb. 2020

Market Drugs Control Standard Organization.

The government is planning to set up a Medical Devices Authority (MDA) that will devise Indian regulatory norms for the entire spectrum in the medical devices sector that till now adheres to FDA regulations. The government is also working on rules for rationalizing the trade margins for medical devices that have been categorized as drugs. In fact, price caps have already been introduced on devices such as stents, reducing the profit margins of hospitals as well as distributors.

All these measures are set to make regulations more stringent for devices, even as price regulations will have an impact on trade margins. Distributors are now trying to work on finding innovative distribution strategies that are more cost effective.

3. Reducing Quality Differentiation: A number of factors have helped bridge the brand differentiation between the products of MNCs and local manufacturers. These factors include improvement in quality of Indian manufacturing and wide scale acceptability of Indian manufacturer products which offer good results at lower costs. The wide brand choices have reduced brand differentiation, which has helped local OEMs to compete with International MNCs. Though manufacturing remains limited to producing low technology products, a few domestic companies and MNCs with manufacturing facilities in India have successfully developed low cost products that are on par in terms of quality with existing products that require complex technical know-how to manufacture. These products have succeeded in developing a niche market in many regions globally. For example, Indian manufactured heart valves have found new export markets in Myanmar, Kenya and Thailand. This has helped the medical devices exports register strong growth.

5. Greater consolidation of businesses and growing role of private equity players A rapidly growing healthcare distribution business is fast catching the attention of private equity players who have turned towards investing in medical distribution businesses. This will result in greater standardization of practices and inflow of more expertise in the sector.

Apart from entrance of more private equity players, a greater consolidation of businesses also seems to be on the cards. Globally, pharmaceutical and devices distribution have consolidated to a large extent. However, in India it is still largely fragmented. A series of acquisitions and mergers are already underway in the sector and the trend is likely to continue. As we move towards greater consolidation, this will also result in better supply chain management practices and improved technological prowess.

(Based on views shared by Mr Sanjay Jha, Director , ColMed as pushed on the following web link : https://www.biospectrumindia.com/views/70/15585/trends-inmedical-devices-distribution-2019-and-beyond-.html)

4. Improved supply chain management using Artificial Intelligence & Machine learning Supply chain management is often highly under-rated part of an efficient distribution network. A report by an American healthcare supply chain management company concluded that improving supply chain management can enable health systems to reduce their supply expenses by an average of 17.7%, equivalent to USD 11 million annually per hospital.

Growing realization about the need to institute efficacious supply chain management practices have led distributors to turn to sophisticated technologies like artificial intelligence (AI) and machine learning that can leverage big data and help standardize processes. This in turn results in better predictability, optimization of supplies and reduction of wastage and expenses. AI based algorithms that use vast data for predictive analysis proves to be particularly useful in supply chain applications. Similarly, a McKinsey study found that using AI to enhance supply chain management could cut forecasting errors by 20% to 50%.

As Medical Device & Consumable distribution moves towards optimization of resources, AI based applications are set to become a norm in supply chain management practices.

Jan.-Feb. 2020

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Govt. Issues Notification To Regulate All Medical Devices From April 1., Industry Concerned Over Compliance Costs The government on February 11 announced that all medical devices will now be considered as drugs, bringing them under the purview of regulation by the Central Drugs and Standard Control Organization (CDSCO) from April 1.

Indian medical devices industry expressed concern over government notification to regulate all medical devices as drugs, on grounds that the move may impose additional costs of compliance and could be detrimental for medium and small enterprises engaged in low-risk medical devices manufacturing.

For Class A and Class B - the low risk and low moderate risk devices like certain types of catheters, disinfectants, needles, syringes, among others, the government has given 30 months for mandatory compliance. For devices under Class C and Class D used to treat orthopedic implants, surgical dressings, cardiac stents, among others, the government has given 42 months for compliance.

Apprehensions "While manufacturers have no problem coming under the Risk Proportionate Medical Devices Rules 2017, we are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non conformity can be treated as a criminal offence by any drug Inspector at his discretion and we can be taken to a court," said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD).

"We have been seeking an assurance from Ministry of Health & Family Welfare (MoH&FW) that this is a temporary measure until the NITI Aayog drafted bill to regulate devices separately from drugs becomes a separate law," Nath added.

The Medical Technology Association of India (MTaI), that represents multinational device makers, however, welcomed the government's move.

"We welcome the government's decision to regulate all devices, which has also been a long standing ask of the industry. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for 2 years, are in line with the government's vision to provide equitable access to quality healthcare. We are also happy that the Health Ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring," said Pavan Choudary, Chairman and

Director General, MTaI.

Need regulatory certainty But analysts, while welcoming the decision to regulate medical devices sought more certainty on whether this will be a stop gap arrangement, as the government policy think tank is working on having a separate regulatory body for medical devices.

They say that medical devices and drugs are different, as the nature of risk and product life-cycle of drugs is very different from medical devices that typically have varied risk and lower product life cycles.

"Rather than stop gap arrangements which increase regulatory uncertainty and ambiguity, the medical devices sector is desperately in need of a well thought out and balanced legislation which needs to be within the ambit of the law and caters to requirements of the industry and patients. Anything other than this would impact this a multi-billion dollar industry and also carries with it the danger of limiting access to quality healthcare for Indians," said Ashwin Sapra, Partner - Pharma, Cyril Amarchand Mangaldas.

Public health groups welcome the notification to cover all the devices, but said that it will be a long wait before all its higher risk devices are regulated. The expressed skepticism about the Indian drug regulator ability to regulate devices of such wide order.

"While this is positive, consumer groups remain skeptical about how the CDSCO's current ability to regulate devices under the wider scope. We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record.

"We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme," said Malini Aisola, Co-Convenor, All India Drugs Action Network (AIDAN). (https://www.moneycontrol.com/news/business/companies/ governments-medical-devices-move-industry-expressesconcern-over-compliance-costs-4937511.html)

Medical Device Industry Seeks Predictable WTO Permissible Tariff Structure To Boost Domestic Market Medical device industry has sought a phased manufacturing plan and predictable WTO permissible tariff structure to boost domestic medical device industry.

This plan as recommended should be linked with manufacturing capacity and international competitiveness capabilities (as

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evidenced by exports performance) to not only stem the rising tide of imports but reverse it.

The said agenda has been supported by Department of Pharmaceuticals (DoP) in their pre-budget memorandum submitted to Union Finance Ministry in 2017. However, this was Jan.-Feb. 2020

not acted upon as Union Health Ministry did not support this recommendation in writing though the industry was assured verbally.

Industry rues that there is no change in custom duty for 10 items, where the duty is already 5% and a minimal basic duty of 5% for 7 items in HS Codes 90.27, 38.22 and 30.06, (where there is no indigenous manufacturing or insufficient capacity, items having export turnover less than Rs. 5 crore). This has to be done with a predictable policy of increasing this to 7.5% in 2 years and 10% in 3 years or on establishment of a manufacturing unit whichever is earlier.

India is 80% to 90% import dependent in medical device sector even after 70 years of independence and imports have grown last year at an alarming rates of 24% and crossed Rs. 38,800 crore in 2018-19, crushing the already beleaguered and battered manufacturers who are mostly MSME with labor intensive employment.

On this, Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD) said, “Though Prime Minister has given a clarion call for “Make In India” and in the Budget Speech, Point (d) of the vision statement of the Finance Minister mentions Medical Device w.r.t. MSME and Make in India. However regretfully, there was nothing substantial in the budget to support this. On ground the reverse is happening.”

Many of the Indian manufacturers have reconciled to the fact that Government is seemingly unwilling to correct the low tariff structure prevalent since 2010 and they have adapted business strategy and started importing rather than manufacturing in India as it is convenient and cheaper, he further added.

Even overseas MNC’s are not bothered to put factories in India if they have no market access barriers and have free access with negligible custom duties of zero to 7.5%.

“We are facing further loss of competitiveness post GST as now cost of imports is down by 11% as importers can avail GST input credit which they were not availing earlier. With 6% CVD and 4% SAD no such credit to a trader was earlier available.

India was already Import dependent earlier and unless this is

urgently neutralized, we are killing what little industry is there, as even existing manufacturers are resorting to imports rather than manufacturing in India or focusing on exports which has gone up by a healthy 29% to US$ 1.2 billion,” Nath explained.

In January, 2016, prior to GST introduction, duty had risen by 2.5% for some devices from 5% level to 7.5% but even this was too less to be majorly impactful. Imports not only steals Indian employment generation but also drains valuable foreign exchange and slows down the economy.

The industry has recommended to increase basic duty to minimum 7.5% for 3 items in HS Codes 90.18 and 90.27 (no change in Custom duty for 21 items, where the duty is already 7.5%), where manufacturing is established for items having export turnover between Rs. 5 crore to Rs. 10 crore. Though export turnover in HS Code 90.22 (X-Ray Tubes) exceeds Rs. 100 crore, being a component for finished medical devices, the duty may be maintained at 7.5% as currently being imposed.

The recommendations also includes to revert basic duty to minimum 15% for 36 items in HS Codes 90.18, 90.21, 90.22, 90.27, 30.02, 30.05, 30.06 & 38.22, having export turnover of more than Rs. 100 crore, i.e., proven international competitiveness and undisputed production capabilities so no distress to consumers in availability as per list enclosed.

Items having 0% basic duty as per ITA-1 list/ where trade agreements renegotiation is not possible to disallow GST Input Credit of 12% to importers of these items.

It is also recommended to encourage a phased manufacturing plan of components by increasing duty to 5% basic duty on import of part or accessories for medical devices, up from 2.5% done in January 19, 2016 and then increase to 7.5% in 2nd year under heading HS Code 90.18, 90.19, 90.20, 90.21, 90.22.

It has also been asked to consider 2.5% basic duty on import of medical grade raw materials for medical devices under heading also for HS Code 90.27, 30.06 & 38.22 on actual user condition, as had been done earlier for 90.18, etc. (http://pharmabiz.com/NewsDetails.aspx?aid=120553&sid=1)

Health Ministry Seeks Stakeholders Suggestions On Framing Recruitment Rules For Medical Device Regulators The Union health ministry has sought stakeholders suggestions on framing recruitment rules for medical device regulators in Central Drugs Standard Control Organisation (CDSCO) for implementing new Medical Device Rules, 2017.

In this regard, a draft recruitment rules have been prepared, a copy of which has been shared for stakeholders recommendations and feedback.

CDSCO has been facing acute manpower crunch as the workload has been increasing at an average of 20% to 25% over the past few years.

Considering the increase in work load, the regulatory infrastructure including manpower need to be strengthened proportionJan.-Feb. 2020

ately for licensing as well as enforcement activities, as per the Drugs Technical Advisory Board (DTAB) report which recommends for creation of a new team under CDSCO. Meanwhile, the Union health ministry is examining a proposal for framing of recruitment rules for the post of Drug Inspector (Medical Devices), Assistant Drugs Controller (India) (Medical Devices) and Deputy Drugs Controller (India) (Medical Devices) in CDSCO. As per a notice, the ministry stated, “Before taking up the proposal for framing of Recruitment Rules with the Department of Personnel and Training (DoPT), Union Public Service Commission (UPSC) and other agencies for finalising the same, comments, if any, are invited from all stakeholders in the matter

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within a period of thirty days from the date of this notification on the website of the Union health ministry.”

The team under drugs controller general of India (DCGI) would be led by an additional drugs controller (ADC-India).

The comments/objections/suggestions received from the stakeholders within the specified period shall be considered by the ministry as per rules/requirement before finalising the recruitment rules.

As per the DTAB recommendation, there should be four Joint Drug Controllers (JDC-India) to assist the ADC-India, one each for specific function like invasive medical devices, non-invasive medical devices, in-vitro diagnostic medical devices, Materiovigilance Programme of India (MvPI), enforcement, legal and training.

With centre’s move to bring all medical devices under regulatory control leading to increase in work load, a total of 754 CDSCO regulatory officers and laboratories staff is being planned to be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO. As per the road map outlined for 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training.

There should be 12 deputy drugs controllers (DDC -India), 48 ADCs, 192 each of drugs inspectors (DI-Medical Device) and assistant drugs inspectors (ADI-Medical Device).

It is also envisaged to recruit 71 data entry operators (3 for office of ADC (I), 2 each for JDC(I), 1 for each for DDC(I), ADC(I) and 71 office assistants which may be hired through outside agency. (http://pharmabiz.com/NewsDetails.aspx?aid=120752&sid=1)

www.medicalplasticsindia.com

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

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Jan.-Feb. 2020

Industry News Trivitron Healthcare Eyes Over Rs 1,000-Crore Revenue In FY'22 Trivitron Healthcare currently has nine manufacturing facilities across five locations - Chennai, Mumbai, Pune, Ankara and Helsinki -- and is in the process of constructing the tenth facility in Patalganga in Maharashtra.

New Delhi: Domestic medical devices maker Trivitron Healthcare is looking to clock revenue of over Rs 1,000 crore in fiscal year 2022 as it expands the number of manufacturing facilities and also eyes inorganic growth, a top company official has said. Trivitron Healthcare currently has nine manufacturing facilities across five locations - Chennai, Mumbai, Pune, Ankara and Helsinki -- and is in the process of constructing the tenth facility in Patalganga in Maharashtra.

globally, Velu said.

Mostly, it would be through joint ventures with existing companies there, he said adding that the company already has a presence in these markets through trading infrastructure.

At present the company is mainly in-vitro diagnostics, imaging, intensive care, operation theatres and renal dialysis segments, he added.

"Out of these, in-vitro diagnostics and imaging contribute more than 85 per cent of our total revenues currently," Velu said.

The company is expecting to close the current fiscal year with a revenue of around Rs 700 crore.

But going forward, the company is focusing on the areas like radiation protection and newborn screening, he said and added that it is also investing in research and development in mass spectrometry and radiation shielding.

"We are looking at a revenue of over Rs 1,000 crore for the fiscal year 2022. It will be achieved through organic and inorganic growth," Trivitron Healthcare Chairman and MD GSK Velu told.

"The company is focusing on manufacturing and at present around 70 per cent of our revenues are coming from manufacturing," Velu said.

At present, 60 per cent of the company's revenue come from India and 40 per cent is international, he added.

The company also has plans to list in FY23, but it would depend on many factors, he said.

"Going forward, Africa is going to be one of the biggest areas of growth for the company. We are also looking at both the US and China as key markets for growth this year and plan to have some kind of manufacturing presence in both the countries in the current calender year," he added.

On being asked about the state of medical devices sector in India, Velu said, as the sector is different from the pharma sector, it should have separate regulator and separate department of medical devices to promote the segment.

Manufacturing presence in the US and China would strengthen company's presence in the two of the most important markets

https://health.economictimes.indiatimes.com/news/medicaldevices/trivitron-healthcare-eyes-over-rs-1000-crore-revenuein-fy22/73371525

Nagpur : Research Will Make Cochlear Implants 50% Cheaper Says Nitin Gadkari NAGPUR: Union minister Nitin Gadkari, on Thursday, revealed that the Defence Research and Development Organisation (DRDO) has developed an indigenous multi-electrode cochlear prothesis for the benefit of profoundly deaf people which will cut the cost of cochlear implants surgeries in India by 50%. The existing cost is more than Rs6.50 lakh.

“The DRDO team gave a presentation on the subject two days ago in New Delhi. This Made in India implants will bring a revolution in the field of cochlear implant surgeries and thousands of kids born deaf will be benefited,” he said.

Gadkari was addressing the inaugural function of the 72nd annual conference of the Association of Otolaryngologists of India (AOICON 2020) at Chitnavis Centre. Former chief minister of Madhya Pradesh Shivraj Singh Chouhan was the guest of honour.

About medical devices park project under MSME ministry, Gadkari said, “Medical devices parks will be opened to work on reducing costs of manufacturing goods. MRI machines costing Rs5 crore are being made available in such parks at only Rs98 lakh.”

Jan.-Feb. 2020

The national convention of ENT surgeons AOICON will showcase vast expanse of otolaryngology field. Organizing chairman Dr Madan Kapre said that the conference will lay special emphasis on prevention of oral cancers along with advances in management. More than 1,800 delegates from all over India and abroad are attending the conference. Around 480 scientific research papers will be presented.

National president of AOICON Dr Satyaprakash Dubey appealed that Maharashtra Government should start a statewide mission to facilitate cochlear implant surgeries of poor patients on the lines of Madhya Pradesh. Replying to his appeal, Gadkari said that proposal has already been sent to the state government and chief minister will take final decision on it soon.

During the function, AOI felicitated veteran ENT surgeons Dr Krishnakant Bhargava, Dr KP Morwani and Dr Mohan Kameshwaran with lifetime achievement awards. https://health.economictimes.indiatimes.com/news/medicaldevices/nagpur-research-will-make-cochlear-implants-50cheaper-says-nitin-gadkari/73187603

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Industry News Medtech Firm Axio Biosolutions Lands $5.2M Funding Led By Omidyar The company plans to use the funds raised to expand its footprint, especially in the United States and Western Europe, while continuing to develop novel surgical and wound care products for the global market.

Bengaluru-based Axio Biosolutions has raised $5.2 million funding led by Omidyar Network India, with participation from existing investors Accel, University of California and Ratan Tata’s UC-RNT Fund and Chiratae Ventures.

The company plans to use the funds raised to expand its footprint, especially in the United States and Western Europe, while continuing to develop novel surgical and wound care products for the global market.

“As the first global wound care brand from India, we have plans to explore new markets and introduce more products in the wound care and drug delivery space. With Axiostat receiving USFDA clearance, we are all set to enter the US market this

year. Soon, we also will be launching our products direct to consumers for emergency trauma use" said Leo Mavely, founder and CEO, Axio Biosolutions.

Founded in 2008, Axio Biosolutions had raised $2.1 million in Series A funding from Accel Partners and Chiratae Ventures in 2016, followed by a $7.4 million funding round led by Ratan Tata’s UC- RNT Fund in 2018.

Among its products include Axiostat that stops massive bleeding within just two-three minutes of its application and MaxioCel for patients suffering from chronic wounds.

The market of novel surgical and wound care products globally is expected to touch $24.8 billion by 2024 from $19.8 billion in 2019. https://health.economictimes.indiatimes.com/news/medicaldevices/medtech-firm-axio-biosolutions-lands-5-2m-fundingled-by-omidyar/73170387

Medical Devices Trade Margins Likely To Be Capped At 30% The government seems to have found a middle ground between demands of the domestic industry and global MNCs investment. While it has decided to abandon the price cap regime for medical devices (as in the case of stents and knee implants), a limit of 30% trade margin on medical devices is likely to be approved soon, the same people said.

NEW DELHI: A cap on trade margins at 30% for medical devices is being considered, as India and US move ahead to sign a mutually acceptable trade deal this month, people in the know said.

A series of meetings were held between drug pricing regulator National Pharmaceutical Pricing Authority (NPPA), Niti Aayog, Department of Pharmaceuticals (DoP) and the ministry of commerce over the last few days and “the government is likely to replicate the formula it applied for reducing cancer drug prices, which means capping trade margins at 30%,” said one of the persons.

The government had, in February 2019, slashed cancer drug prices, indicating the move is a pilot for more drugs and medical devices. “This is being rolled out as a pilot for the proof of concept, which means that it will be upscaled," NPPA chairperson Shubhra Singh had said then. The issue of first point of sale for domestic producers and multinationals is a concern, and is yet to be decided upon, said the person quoted above, requesting anonymity.

The government is of the view that the maximum retail price (MRP) of a device should be decided by adding the trade margin to the price at the first point of sale (stockist). However, “The work is in progress. We have to take a balanced view and seen that the formula used for cancer drugs have slashed prices tremendously without hurting the industry. The first point of sale

is yet to be decided”, added another person. The trade margin is the difference between the price at which the manufacturer/ importers sell to stockists and the price charged to consumers.

With this, the government seeks to abandon the current price control mechanism, as it allays the concerns of device makers, particularly importers of stents and knee implants, who have complained that price caps hurt innovation.

Currently, only 23 medical devices have been notified as drugs and are regulated under the Drugs and Cosmetics Act. Of these, only four—cardiac stents, drug-eluting stents, condoms and intra-uterine devices—are included in the National List of Essential Medicines and are, therefore, subject to notified price caps. Stents and knee implants were the latest to be brought under the price control under para 19 of the Drugs (Price Control) Order, 2013. The remaining medical devices are not under any form of price regulation.

Sources said India’s price control regime on medical devices was a key obstacle in trade deal pegged above $10 billion (more than Rs 70,000 crore). The government’s earlier move of price control on stents had become a contentious issue between the two countries. It led to a price cut of up to 85% resulting in many MNCs withdrawing their products from the country.

The US has since then been pressing India not to extend price caps on other medical devices.

US trade representative Robert E Lighthizer will be in India in the second week of February to finalise the trade deal. https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/medical-devices-trade-margins-likely-tobe-capped-at-30/articleshow/74020350.cms

NGOs Ask Govt To Reject US’ Demand To Adopt “TRIPS-Plus” IP Provisions And To Do Away With Price Caps On Medical Devices A large number of NGOs working in the health and related fields

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in the country have demanded to the Indian government to Jan.-Feb. 2020

Industry News reject the United States’ demands for India to adopt “TRIPSplus” intellectual property provisions and to do away with the price caps on medical devices.

In a letter to Prime Minister Narendra Modi, these NGOs have stated that they are concerned with demands of the United States to do away with the price controls on medical devices as part of the ongoing negotiations on US-India trade deal.

“We are also apprehensive of the US pressure on India, which has been exerted continuously and will surely intensify following the deal, for increased intellectual property (IP) protections through amendments to the IP Acts. In this regard, we note that the Department for Promotion of Industry And Internal Trade (DPIIT), Ministry of commerce and industry, recently held a meeting with stakeholders to review India’s existing IP Acts. During the meeting participants from law firms representing their foreign multinational pharmaceutical companies have insisted on removing public interest safeguards in the patents Act such as provisions restricting the scope of patentability, local working as a ground for granting of a compulsory license, pre-grant oppositions etc,” the NGOs said.

The recently announced US-China economic and trade agreement requires China to provide for measures that will result in extending the IP protections for medicines and confer longer monopolies, which exceed international obligations under the agreement on Trade-Related Aspects of Intellectual Property Right (TRIPS) such as patent term extensions (i.e., extending the duration of a patent beyond 20 years to compensate for delays in granting marketing approval or patents), patent linkage (i.e., linking the marketing approval of generic medicines to the patent status of the drug and denying marketing approval to generics), and heightened enforcement provisions. Similar demands may be placed on India. Because India does not provide for data exclusivity in its laws, the US could even ask for data exclusivity to be adopted.

News reports have suggested that the mini trade deal is a precursor to an FTA between the US and India. The United States has been the biggest critique of the public-health friendly provisions enshrined in the Indian IP laws and had, in the past, threatened India with serious consequences for the Government’s act of granting a compulsory license for sorafenib, a kidney cancer drug. We urge that if India accepts the “TRIPSplus” demands of the USA, it would seriously undermine the availability of affordable generic medicines in India and result in pushing more people below the poverty line due to out-ofpocket expenditure on medicines and increased costs of healthcare. Conceding to US demands for “TRIPS-plus” provisions would have a devastating impact on all the national health programs, they said.

Another demand of the US is to do away with the price controls on medical devices and regulate only trade margins. Such a move will allow the companies to fix very high introductory prices and compromise access to medical devices. Your much welcome steps to cap ceiling prices of medical devices like cardiac stents and knee implants made them affordable to the common man, and also checked exploitation of patients by hospitals.

The regulation of trade margins in the absence of ceiling price Jan.-Feb. 2020

caps will only shift the exploitation of patients from the hospital to the manufacturer.

In fact, trade margin rationalisation is a much weaker form of regulation that if applied in the absence of price caps will leave retail prices unchecked, will not correct serious market distortion in medical devices and exclude manufacturers and importers from the ambit of regulation. The attempt to secure trade margin rationalisation is a backdoor attempt to neutralize the price caps, which remain simply the most effective way to make critical medical devices accessible to patients.

Even under the current regime of ceiling price caps on cardiac stents, the United States, representing the interests of US-based medical devices companies, has been demanding higher prices for foreign-made stents on the basis of claims of ‘incremental innovation’.

In fact it has repeatedly been held by the Government’s Expert committees that there is no evidence of any superiority linked to better clinical outcomes for any of these stents. There is no precedent of India negotiating price control policies in trade and it is critical that policies meant to protect public health are kept outside the purview of trade agreements.

Therefore, we call upon you to consider the concerns of teeming millions of ordinary people in India, as you did in the case of RCEP and reject the United States’ demands for India to adopt “TRIPS-plus” intellectual property provisions and to do away with the price caps on medical devices, the NGOs stated. http://pharmabiz.com/NewsDetails.aspx?aid=121067&sid=1

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Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount (Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

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High Concentration Mask

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

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount Jan.-Feb. 2020

Product Gallery Qosina Unveils New Line of Adhesives for Bonding Components

Ronkonkoma, NY, USA, February 3, 2020— Qosina recently rolled out Build-It-Yourself Assemblies, a resource to help customers easily find and order components for their next design project.

Qosina is pleased to announce that it has teamed up with H.B. Fuller, a premier medical adhesive manufacturer, to offer a variety of reliable and durable solutions for bonding assemblies together. If customers require an adhesive that has a low, medium or high viscosity, or are working with different types of materials, H.B. Fuller’s instant and light-cured adhesives deliver hassle-free bonding.

Qosina will be showcasing its Build-It-Yourself Assemblies and new adhesive product line at booth 2021 during the MD&M West trade show, February 11-13, in Anaheim. H.B. Fuller will be joining Qosina at the booth to present live componentbonding demonstrations throughout the show. Attendees who are present for the live demos will receive a free adhesive sample.

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 supplies to the cosmetic, skincare, spa and salon industries.

Contact : Qosina Corporation, Rachelle Morrow +1 (631) 242-3000 rmorrow@qosina.com

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

Events Calender ISO : 13485 : 2012

Medical Fair India 2020

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

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

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA

26th International Exhibition and Conference 5 - 7 March, 2020 Venue : Bombay Convention & Exhibition Centre, Mumbai

Medicall India’s Largest & No. 1 Medical Equipment Exhibition 3-5 April, 2020 Venue : Hyderabad, Telangana

Medicall India’s Largest & No. 1 Medical Equipment Exhibition 24-26 July, 2020 Venue : Chennai Trade Centre, Chennai Tamilnadu

The 16th National Conference and Technology Exhibition on Indian Medical Devices & Plastics Disposables/Implants Industry 2020 October 2020 Venue : Ahmedabad Management Association, Ahmedabad, Gujarat

Tele : +91-79-25835567, +91-79-25834850

E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Jan.-Feb. 2020

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Management Consultants, Trainers, Customer Compliance • • • • • • • • •

Management Consulting & ISO Consulting Measure Employee Engagement Level Training – Design and Delivery Process Design and Process Mapping ISO 9001 | ISO 14001 | ISO 45001 MDR 2017 | CE | ISO 13485 | EU MDR HACCP | FSSC 22000 | ISO 31000 | ISO 50001 SA 8000 | Sedex | BSCI Management Audit | Audit | Process Audit | Safety Audit

Mr. Bhupesh Sood – COO SEC Global Consulting & Initiatives LLP Contact :

F6, Parth Apartment, Ramdevnagar, Satellite, Ahmedabad – 380015 (India) Mobile : +91 997 480 3399 / +91 95121 00909, Email : info@complianceforgrowth.com, Website : www.complianceforgrowth.com

Jan.-Feb. 2020

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

ISO 9001-2000

Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform PhysicoChemical, Sterility, Micro-Biological Tests.

Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc...

The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing.

– Supply of Components for Medical Devices.

ANGIPLAST Private Limited

REGISTERED FIRM Wide Range Of Products :

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

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India.

Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009

E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India.

Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com 42

Jan.-Feb. 2020

National Healthcare

GMP ISO - 9001-2008 Certified Company

An ISO 13485 : 2016 Company

S. Nath & Co.

Manufacturing & Exports of Medical Disposables :

Excellence in Quality

I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL®

Injection Moulded Medical Components and Extended Tubes :

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

I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel

Address

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India.

Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

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

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

ISO 9001:2008 CERTIFIED COMPANY

•

I.V. Infusion Sets

•

Blood Administration Sets

•

Scalp Vein Set

•

Urine Collection Bags

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE P R O D U C T S

Address : Apex Medical Devices Plot No. 10/B, Shyam Ujjawal Indurstrial Estate, Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, Ahmedabad-382445. Gujarat, India.

Phone No. : +91-79 - 29701333 E-mail : apexmedical@live.in Website : www.apexmedicaldevice.com Jan.-Feb. 2020

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079-25733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com

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ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products • 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

• • • • • • • • • • •

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

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Mr. Uday Sinha B-305, Yogeshwar Residency, Nr. Krishnkunj Society, Moti Canal, Vastral, Ahmedabad-382418 Mobile : 09898162576

An ISO & CE certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.

Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.

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Jan.-Feb. 2020