Medical Plastics Data Service Magazine May - June 2019 by Medical Plastics Data Service

Table of

Contents Vol. 27

34 35

38 38 16 31 38

May-June 2019

No. 3

May-June 2019

COVER STORY Drug Device Combination Products : Market Overview And Opportunities - Dr. Atul Sardana - Combination products offer several advantages and have emerged as innovative medical products due to their contribution in advancing medical care and thus expected to have major impact on overall medical device market.

COVER STORY Low Risk, Patient Friendly Microneedle Arrays: An Emerging Medical Device for Enhanced Local/Systemic, Transdermal Drug Delivery - Dr. Manish Nivsarkar & Dr. Viral Shah - An emerging medical device for enhanced local / systemic transdermal drug delivery, the system has been recognized as potential alternative to conventional injection meyhods because ………….

GLOBAL TRENDS • Global Super Absorbent Polymer Market Poised To Cross US$12 bln By 2025 • Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations

AiMeD & REGULATORY UPDATES • New AiMED Website On A New And Advanced Platform : Members Request To Update Online Registration Form • DCGI Asks Medical Device & IVD Manufacturing Associations To Give Feedback On New Online Portal • CDSCO Issues Alert On Pacemakers

INDUSTRY NEWS • Telangana Govt Allocates 250 Acres Of Land For Medical Device Park At Sultanpur • Phillips-Medisize Showcases Drug Delivery Innovations For Indian Market • CII, AMTZ Join Hands To Help Usher In Business Opportunities For MSMEs Towards Indigenous Manufacturing • Meril’s Myval Transcatheter Heart Valve Receives CE Approval • Tekni-Plex Completes Acquisition Of Amcor Flexible Packaging Units Serving Medical Device OEMs

PRODUCT GALLERY • ISO 80369-7 Compliant Components

CORPORATE • Qosina Launches European Operations

DID YOU KNOW? • About Needs for Medical Devices for Ageing Populations

EVENT • National Seminar On Advances And Developments Of Plastics In Medical Sector • Medical Plastics Pavilion @ Plastivision 2020

EVENT CALENDER • Seminar on “Advances and Developments of Plastics in Medical Sector” : 24 July, 2019, Pune • Medicall 2019 - Chennai : 26-28 July, 2019, Chennai • K 2019 : 16 - 23, October, 2019, Germany

• Medica 2019 : 18 - 21 November, 2019, Germany • Compamed 2019 : 18 - 21 November, 2019, Germany • PLASTIVISION INDIA 2020 : 16 - 20, January 2020, Mumbai • Medical Fair India 2020 : 5 - 7 March, 2020, Mumbai

Did You Know ?

Flashback Select Article Index

Mar 2011 to Sept 2011 • Quality : CE Marking and MDD 2007/47/EC Amendment (March - April 2011) Mr. Harshit Thakkar, Project Manager, DEKRA Certification B.V. • Global Trends : Trends and segments for Medical Devices in the EU market (March - April 2011) • Did You Know ? : About Healthcare Plastics Recycling (March - April 2011) • Learning Zone (Basic-Discoveries-Innovations) : Double J Stent (March - April 2011) • Cover Story : Medical Device Packaging (May – June 2011) • Quality : Significance Of 13485 Certification In Product Certification (CE Marking) (May – June 2011) Mr. Arul Manickam, Product Manager, SGS India Pvt. Ltd. • Quality : Packaging Used To Pack Medical Devices (May – June 2011) Mr. Pradeep Rao, Pradeep Surgipack • Global Trends : A CBI Medical Programme Concludes With A 95 Percent Success Rate (May – June 2011) • Learning Zone (Basic-Discoveries-Innovations) : First Biodegradable Antimicrobial Polymer Nanoparticles (May – June 2011) • Did You Know ? : About Sterilization Packaging Manufacturers Council (May – June 2011) • Cover Story : Medical Polymers: How Are They Different? (July – August 2011) • Cover Story : Polymers In Healthcare (July – August 2011) • Technology : Silicone Solutions for Lubrica tion in Medical Applications (July – August 2011) Nathan Wolfe, Technical Sales, NuSil Technology

About Needs for Medical Devices for Ageing Populations

As part of a project funded by the World Health Organization (WHO), a report on the, “Systematic Review of needs for Medical Devices for Ageing Population” was prepared under primary authorship of the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical group of the Royal Australasian College of Surgeons. As per the report, across the World Health Organization (WHO) Western Pacific Region, as in most parts of the world, the population is rapidly ageing. This is likely to place additional burdens on the provision of health care services to this demographic. Many medical devices are available that may benefit elderly people, although these devices may be expensive or may not be available in all countries. These factors impede equitable access to medical devices. The clinical focus of this report has been defined as the five health conditions that cause the greatest loss of disability-adjusted life-years (DALYs) for older people (defined as people aged 60–79 years) in the Western Pacific Region. Five main health conditions, with 19 associated sub-topics, were identified: • Cardiovascular diseases; • Malignant neoplasms; • Respiratory diseases; • Sense organ diseases; • Neuropsychiatric conditions. This report provides a literature-based review of medical devices needed by older people. The results have been used to create lists of devices categorized in terms of whether they are preventive, diagnostic or therapeutic. Broad clinical safety and effectiveness information has also been provided when available, although the volume and quality of this information vary widely between each device. Detailed information on the safety, efficacy and cost–effectiveness of each device was beyond the scope of this report. Where possible, all identified medical devices were categorized according to the definitions presented by the Global Harmonization Task Force. It is intended that this report ( as available at the following web link ) will inform future research, with the aim of determining the need for medical devices and thus improving access of elderly people to needed devices. While the report focuses on the Western Pacific Region, it is relevant for most parts of the world. https://www.who.int/medical_devices/systematic_Review_needs.pdf

• Global Trends : Brazilian Health Devices : The New Industry Brand To Be Launched (July – August 2011) • Bits & Pieces : Looking Beyond Customer Imagination (July – August 2011) • Did You Know ? : About Sterilization of Plastics (July – August 2011) • Learning Zone (Basic-Discoveries-Innovations) : Synthetic Windpipe (July – August 2011) • Cover Story : Manufacturing Injection Molded Medical Components (September – October 2011)

It is possible to fly without motors, but not without knowledge and skill. -Wilbur Wright

May-June 2019

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

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. 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. 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

Editor’s Desk

From the

Combination Products Show Way For the Convergence in the Life Science Industry The merger of Pharmaceuticals and Medical Devices opens a wide range of new opportunities for therapeutic treatments while at the same time facing regulatory challenges. Drugs are commonly defined as chemical in nature and are intended to interact with metabolic processes within the human body. While very complex in development, their production and application follows well-established procedures. In contrast, medical devices rely by-and-large on physical interaction with the human body. Their design and way of application usually is determined by its intended use. Traditionally, the Medical Devices and Pharmaceutical sectors have represented two different facets of the life science Industry. The need for new growth avenues and an more alertness of consumers, Medical Device, Pharma and Diagnostics companies are coming together to deliver innovative solution. However, this area is still in very early stages. There are challenges to be overcome to ensure that the products are innovative and safe. Regulatory authorities play crucial role in the growth of the Drug / Device combination products segment. Innovative combination products play significant role in advancing medical care and thus are expected to have impact in the coming years. The advantages are many – reduced adverse / side effects, improved patient compliance, controlled release of drugs and targeted drug delivery, overall reduction in healthcare expenses and augmented performance. This issue covers two very well researched articles on the subject. Dr Atul Sardana, Managing Director, Alpha Corpuscles Pvt Ltd, through his detailed article covering Market Overview And Opportunities for Drug Device Combination Products, shows how Indian Medical Device Manufacturers may find this as an opportunity to collaborate with well-established Pharma Industry to expand their product portfolio and revenues. Another analytical article by Dr Manish Nivsarkar and Dr Viral Shah from B.V.Patel PERD Centre has given an indepth analysis of how ‘Low Risk, Patient Friendly Micro needle Arrays as and emerging Medical Device for Enhanced Local / Systemic Transdermal Drug Delivery. Needs For Medical Devices For Ageing Population: As per a recent publication by the World Health Organisation, in most parts of the world, the population is rapidly ageing. This is likely to place additional burdens on the provision of health care services to the demographic. As detailed in the “Did You Know “column in this issue, the report provides a literature-based review of medical devices needed by older people. The objective is to help future research, with the aim of determining the need for medical devices and thus improving access of elderly people to needed devices. This issue also covers our regular columns including Global Trends, Regulatory and Industry News, Events, “Did You Know” etc.

Notice: Every precaution is taken to ensure accuracy of content.

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

May-June 2019

Cover Story

Drug Device Combination Products : Market Overview And Opportunities

Dr. Atul Sardana Director Alfa Corpuscles Pvt. Ltd., New Delhi

Drug device combination products are defined as the individual products comprising of two regulated components, an active pharmaceutical ingredient and medical device that are chemically or physically combined to produce a “single product”. Some examples are drug eluting stents, prefilled syringes, bone graft implants, drug coated catheters, photodynamic / ionotophoretic therapy, wound care combination devices, inhalers, transdermal patches and drug eluting beads. These products offer several advantages which include reduced adverse side effects, dose sparing, improved patient compliance, controlled release administration of drug, and also provide targeted drug delivery. Combination products have emerged as innovative medical products due to their contribution in advancing medical care and are thus expected to have major impact on the overall medical devices market. The global drug device combination products market was valued at USD 66 billion in 2012 and USD 96.3 billion in 2016, showing a growth at a CAGR of 7.9%, to reach an estimated value of USD 115 billion in 2019. Going further the market is expected to grow to about USD 140 billion by 2025.

The market is primarily driven by growing patient and physician preference for minimally invasive procedures and consistent-dosing treatment alternatives. The growth of the Global Drug-device Combination Products Market is driven by rise in incidence of chronic diseases such as diabetes, cancer, and respiratory problems, increase in casualties owing to accidents and trauma, rise in geriatric population, growth in homebased healthcare market, and technological advancements such as development of prefilled syringes. However, factors, such as unnoticed complications of drug-device combination products, number of product recalls, and stringent government regulations, hamper the market growth. Conversely, rise in healthcare infrastructure and high market potential in untapped emerging economies are expected to provide lucrative growth opportunities for the market. The Subsequent increase in adoption of these products can be credited to associated benefits such as reduced pain levels, better patient outcome, reduced hospitals stay, and overall healthcare cost efficiency. Other advantages include synergistic effects facilitating multitarget treatment, improved tolerance levels, simplification of dosage regime, and improved symptomatic and pharmacokinetic profiles. These benefits are expected to propel demand for these systems and present the market with numerous growth opportunities. In addition, frequent intervention by government health organizations to ensure high patient safety is also a predominant market driver. Moreover, unprecedented growth in the development of clinical drugs and devices by large pharmaceutical companies is believed to meet the demand for advanced medication delivery technologies. This has resulted in extensive product pipelines and maximized commercial returns on already established products, thereby serving as a significant driving factor for the industry. The global drug-device combination products market is segmented based on product, application, end user, and region. On the basis of product, the market is segmented into drug-eluting stent, infusion pump, photodynamic therapy, antimicrobial wound dressing, prefilled syringe, drug-eluting balloon, nebulizer, inhaler, transdermal delivery system, and others. Drug-eluting stents are further sub-segmented into coronary stents and peripheral vascular stents. The infusion pumps segment is further divided into implantable infusion pump, insulin infusion pump, patient-controlled analgesia pump, and ambulatory infusion pump. Similarly, prefilled syringes are further categorized into single-chamber prefilled syringes, dual-chamber prefilled syringes, and customized prefilled syringes. The drug-eluting balloon segment is bifurcated into coronary drug-eluting balloon and peripheral drug-eluting balloon. The inhaler segment is further segmented into drug powder inhaler (DPI), metered dose inhaler (MDI), and soft mist inhaler (SMI). Lastly, the transdermal delivery system segment is bifurcated into passive delivery system and active delivery system. May-June 2019

Cover Story The transdermal delivery system segment accounted for the largest market share in 2017 and is expected to continue this trend throughout the forecast period. Advantages associated with adoption of transdermal patches include better patient compliance and reduced risk of needlestick injuries and infections, which further accelerates demand for these patches. Moreover, rising patient preference for pain-free drug delivery has led to a significant surge in adoption of adhesive skin patches to administer drugs. This is expected to present the market with tremendous growth potential over the forecast period. On the other hand, the prefilled syringe segment is anticipated to grow at a significant CAGR of 9.9% during the forecast period. This can be attributed to increasing demand for selfadministration of drugs in cases of diseases requiring long-term treatment. For instance, in diabetes, insulin is needed to be frequently administered intravenously into the patient’s body. This repeated use of injections to deliver insulin causes pain and increases risk of infection transmission, thus leading to heightened growth prospects for alternative drug delivery modes. The inhalers segment is anticipated to exhibit a lucrative growth rate over the forecast period owing to rising prevalence of chronic diseases such as tuberculosis, diabetes mellitus, and chronic obstructive pulmonary disease, which require more rigorous treatment. Technological advancements such as particle engineering, agglomerated vesicle technology, incorporation of MDI technology, and supercritical fluid technology are expected to boost segment growth.

On the basis of application, the market is categorized into cardiovascular treatment, diabetes, respiratory problem, cancer treatment, antimicrobial application, and other applications. The respiratory problem segment accounted for the largest market share in 2017, whereas the antimicrobial application segment is expected to register the highest growth rate during the forecast period. May-June 2019

Depending on end user, the market is fragmented into hospital & clinic, ambulatory surgery center (ASC), home care setting, and other end users. The hospital & clinic segment held the largest share of the market in 2017, whereas the ambulatory surgical center segment is expected to register the highest growth rate during the forecast period.

Based on region, the global market is studied across North America, Europe, Asia-Pacific, and LAMEA. North America held the largest share of the market in 2017, followed by Europe. On the other hand, the Asia-Pacific is anticipated to dominate the market during the forecast period, owing to large population base, increase in disposable income, and improvement in patient awareness about combination devices. Moreover, Asia is a large continent, and is a home to some of the world’s highly populous countries. This region has emerged as an epicenter of numerous chronic disorders.

Cover Story Development of advanced but low cost drug device combination Products will pave the road for new entrants. The upcoming research and development activities will open a new avenue and extraordinary opportunities for drug device combination products manufacturing companies. The cost of Drug Device Combination Products is currently high owing to incorporation of advanced technologies and complex consumer’s requirements. However, many manufacturers in the developing markets are now coming up with the low cost devices. Thus, the price of these devices is expected to decrease as compared to the branded products in coming years. The Indian Medical Device Manufacturers may seek this as an opportunity to collaborate with the well established Indian Pharmaceutical Industry to expand their product portfolio and revenues by lateral insight into beneficial effects of drug coatings on existing and new devices and providing the Pharmaceutical industry with an opportunity to convert decades of their drug research and investment into a sustainable and successful pharmaceutical product with safe and effective delivery devices with a brand differentiation.

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Cover Story

Low Risk, Patient Friendly Microneedle Arrays: An Emerging Medical Device for Enhanced Local/Systemic, Transdermal Drug Delivery Dr. Manish Nivsarkar Dept. of Pharmacology and Toxicology, B.V.Patel, Pharmaceutical Education and Research Centre, Ahmedabad. Dr. Viral Shah Dept. of Pharmaceutics, B.V.Patel, Pharmaceutical Education and Research Centre, Ahmedabad

ABSTRACT : There exist distinct pathways for drug delivery to body to achieve maximum therapeutic effects. Transdermal drug delivery system has been recognized as one of the potential alternative to conventional injection methods because, skin is easily accessible for drug administration. The Stratum corneum acts as a major barrier in systemic or topical delivery of the drug via skin. Transdermal administration of drugs is feasible only for low molecular weight and moderately lipophilic drugs. The biomolecules-based bio-therapeutics market is expanding with the development of genetic engineering and proteomics. Delivery of biomolecules-based bio-therapeutics by achieving controlled disruption of the skin without losing protective function of the skin is the current need. Microneedles (MNs) based transdermal drug delivery system can enhance the skin permeability of hydrophilic drug substances and bio-therapeutics by temporarily rupturing the skin barrier layer physically. Various types of MNs have been designed and evolved. The present review article would focus on the application of low risk, patient friendly microneedle arrays as an emerging medical device for enhanced local /systemic, transdermal drug delivery.

INTRODUCTION : Background The pathway for drugs to achieve therapeutic effects comprises distinct phases of delivery in the body. Currently, most biopharmaceuticals are administered by parenteral route using hypodermic needle based injection systems. However, treatment by injection requires a visit to the hospital or clinic for the administration. In addition, hypodermic needles should be disposed of under specific protocols because reuse can be another path for disease infection. Also the injection based systems have not received patient acceptability till date. To resolve these problems, pharmaceutical companies are currently focused on the design of biopharmaceutical delivery by non-conventional routes such as transdermal drug delivery systems.1-5 Development of a transdermal drug delivery system has been of interest as one of the alternatives to conventional injection methods because skin is the most easily accessible site for drug administration, transdermal formulations are easy and convenient to use and they would likely have better patient compliance than hypodermic needles. The role of the integumentary system which is composed of the skin is the regulation of interactions between the body and the external environment for the purpose of protecting the body. The protective function of the integumentary system composed of skin resides in the outer layer of the skin, the stratum corneum. StraMay-June 2019

tum corneum prevents entry of noxious chemicals, dangerous microorganism and dehydration of the body by controlling water loss. Thus Stratum corneum acts as a major barrier in systemic or topical delivery of the drug via skin. It is observed that transdermal administration of drugs is feasible only for low molecular weight and moderately lipophilic drugs. It is difficult to deliver high molecular weight and hydrophilic biomolecules drugs into the body without using hypodermic needles.

The barrier properties of skin Transdermal drug delivery systems have been investigated for a long time due to the advantages described above. However, the skin is exposed to external environments and has become evolved into an efficient barrier to prevent entry of harmful chemicals and microorganisms. These barrier properties of the skin result from the histological layers: the subcutaneous tissue, the dermis layer, and the epidermis layer as shown in Figure 1. The skin consists of two main parts; the outermost layer, epidermis, and the inner connective tissue layer, dermis, as shown in Figure 1. The dermis layer is 3-5 mm thick and the major component of skin. It is composed of mostly collagen fibrous protein providing the mechanical properties of skin. The vascular structures, such as blood or lymphatic vessels, nerve endings, and various glands, are in this layer to perform nutrient/waste exchange, create sensation, and regulate body temperature controlling, and so forth. From the standpoint of transdermal drug delivery, the vasculature elements in the dermis layer are the absorption sink causing the concentration gradient of drug diffusion from the exterior into skin and are the driving force for drug permeation.

Figure 1 Schematic illustrations of skin, stratum corneum and viable layer of skin

Cover Story The epidermis layer creates the barrier function against transdermal drug delivery. It has complex multiple layers of cells in the differentiation processes with the changes of structure and the lipid content of skin. While cells in the lower layers of epidermis, the viable epidermis, contain typical organelles like mitochondria, the outermost epidermis layer, the stratum corneum, is a horny layer with approximately 10-15 µm thickness and composed of dead cells, which are the final product of the differentiation process. A typical horny cell has an amorphous structure, created by dead keratinized cells with approximately 30-40 µm of diameter encompassed by multiple lipid bilayers. This envelope structure, in which keratinized cell and lipids are continuously overlapped with each other. Because of this ‘brick and mortar‘ structure of stratum corneum , stratum corneum is the key layer of the skin barrier for regulating the flux of molecules from the inside to the outside of the body and vice versa. Due to the stratum corneum barrier, only small molecular weight and moderately lipophilic drugs are able to diffuse through the skin at a therapeutic rate. Consequently, various transdermal methods have been designed for enhanced transdermal delivery of hydrophilic or large molecular weight drugs by modulating the barrier properties of stratum corneum or disrupting it or breaking it or removing.

Transdermal drug delivery systems Historically, a primitive type of transdermal drug delivery patch was used in the form of a medicated plaster several hundred years ago. This prototype of a transdermal drug patch simply contained herb extracts composed of small molecules such as menthol and methyl salicylate used to soothe inflammation in muscle or to help healing of bone fractures by inducing a local analgesic effect. While the barrier properties of skin have been a subject of scientific debate since the early 1900’s, it was shown that these properties reside in stratum corneum and drugs can or cannot permeate stratum corneum depending on their water/oil partition coefficient around 1950’s. These scientific findings triggered development of transdermal drug delivery systems for systemic therapy. In early 1970’s, the first transdermal drug delivery system for 3 days of systemic effect of scopolamine against motion sickness, Transderm-Scop® was developed by Alza and approved for the USA market in 1979. Since then, various types of transdermal drug patches have been designed for systemic effect at controlled rates. For patch types of drug formulations, it has been suggested that transdermal administration for systemic effects might be limited to small and moderately lipophilic drugs because patches are based on the passive diffusion of drugs from the reservoir of a patch to skin. Thus, an active transdermal drug delivery system has been sought to deliver hydrophilic or large size drugs which are bio-therapeutics that cannot permeate through intact stratum corneum. These active delivery systems should bring an integrity change of stratum corneum or the physical removal and breakage of stratum corneum to increase the permeability of the skin. To create an integrity change in stratum corneum, chemical treatment of the skin surface or the use of energy application was studied such as chemical enhancement. with various chemicals, sonophoresis with ultrasound, and Iontophoresis or electroporation with electrical energy. For the removal or breakage of stratum corneum, minimally invasive methods were

designed, such as the jet injector, microneedle and skin ablation treatment. However, the use of chemical enhancers has been limited due to skin irritation and the inability to deliver large size drugs. Sonophoresis uses ultrasonic energy to increase the permeation of drugs through skin. Iontophoresis uses an electrical gradient for the transport of charged drugs. Electroporation applies a relatively higher voltage (~100 V) pulse to skin than iontophoresis does, but the electric field lasts for a shorter time, usually 10 µs –10 ms.

Transdermal drug delivery by the breakage of stratum corneum MNs were conceptualized in the early 1970’s as a simple idea to enhance the skin permeability of hydrophilic and large size molecules therapeutics by breaking the skin barrier layer physically. Since the first generation of MNs was fabricated out of silicon using micro-electro mechanical systems (MEMS) in 1998 shown in Figure 2 , various types of MNs have been designed and evolved with improved features; such as solid metal MNs, hollow metal MNs, hollow glass MNs, solid biodegradable polymer, and so forth. These MNs enabled various types of transdermal drug delivery. Transdermal drug delivery with MNs has been extensively investigated with various drugs, most of which have hydrophilic properties that are not applicable to passive diffusion based transdermal patch systems. Alza Corp. designed the drug coated micro-projection array system, Macroflux® as shown in Figure 3. They fabricated a titanium micro-projection array which is inserted with coated drug into skin. Zosano Pharma™, Inc. developed a parathyroid hormone (PTH) transdermal delivery system with Macroflux® technology for osteoporosis and Phase II clinical trials have been completed.

Figure 3 Transdermal drug delivery with Macroflux® technology using drug coated MNs For hollow microneedle applications, Nanopass Technologies LTD developed MicronJet, an intradermal system for proteins and vaccines requiring minimal expertise for administration. The device consists of MicroPyramids made of pure silicon crystals which are mounted on a standard syringe for the replacement of a conventional hypodermic needle. Currently, two pilot clinical studies have been completed to assess the safety and efficacy of MicronJet as shown in Figure 4. May-June 2019

Cover Story typically less than 1 mg for small microneedle arrays.

Hollow microneedle Hollow MNs provide a defined conduit for drug delivery into the skin or other tissue. Similar to hypodermic injection, hollow MNs enable pressure-driven flow of a liquid formulation (Figure 5, hollow MNs). Pressure, and thereby flow rate, can be modulated for a rapid bolus injection, a slow infusion or a time varying delivery rate. The liquid formulation may simplify use of existing injectable formulations for delivery using MNs, but misses the opportunity of solid microneedle delivery methods to administer dry-state drug formulations without reconstitution to improve drug stability and the patient convenience of a patch-based delivery method.

Figure 4 MicronJet intradermal self-administration system

Types of microneedle 1. Solid microneedle 2. Coated MNs

3. Hollow microneedle 4. Dissolvable microneedle

Solid microneedle MNs can be used as a pretreatment for pore formation in the skin (Figure 5, skin pretreatment). Sharp MNs penetrate into or scrape the skin in order to make holes through which drugs can transport, either for local effect in the skin or for systemic delivery after uptake by skin capillaries. The drug can be applied to the skin surface over the pores using a drug-loaded patch, as is commonly used in conventional transdermal drug delivery, or using a semisolid topical formulation, such as an ointment, cream, gel or lotion, as is commonly used for other skin treatments.

Hollow MNs have also been used as a conduit for drug diffusion into the skin from a non-pressurized drug reservoir.

Dissolvable microneedle In contrast to coated MNs, polymer MNs have been developed to completely dissolve in the skin and thereby leave behind no bio-hazardous sharps waste after use (Figure 5, drug-loaded MNs). These MNs are typically made solely of safe, inert, water-soluble materials, such as polymers and sugars that will dissolve in the skin after insertion. While dissolving MNs can be used as a skin pretreatment to increase permeability, drugs are often encapsulated inside the microneedle for release into the skin similarly to coated MNs. All these types of microneedle mostly suitable for delivery of biomolecule and fabricated via different technique like solvent casting, photolithography, ion etching etc. The most usable technique is solvent casting technique by means of centrifugation, pressure or vacuum as driving force to fabricate MNs.

Application of microneedle based transdermal patch system :

Figure 5 Methods of drug delivery to the skin using MNs (MN). MNs are first applied to the skin (A) and then used for drug delivery (B). Solid MNs are used as a pretreatment, after which drug can diffuse through residual holes in skin from a topical formulation (solid MN). After insertion of drug-coated MNs into the skin, the drug coating dissolves off the MNs in the aqueous environment of the skin (coated MN). Drug-loaded MNs are made of water-soluble or biodegradable materials encapsulating drug that is released in the skin upon microneedle dissolution (dissolving MN). Hollow MNs are used to inject liquid formulations into the skin (hollow MN).

Coated MNs Solid MNs can be used not only as piercing structures, but also as vehicles to carry and deposit drug within the skin or other tissue (Figure 5, drug-coated MNs). This can be done by coating MNs with a drug in a formulation suitable for coating and subsequent dissolution. In this way, the desired dose of the drug is delivered into tissue quickly upon insertion of the MNs. The drug dose that can be administered this way is limited to the amount that can be coated onto the tip and shaft of the MNs, which is May-June 2019

Microneedles have been explored for varied applications ranging from systemic and local drug delivery to cosmetic applications. Owing to benefit of minimal skin invasion and pain free delivery, MNs serve as an alternative to conventional hypodermic therapy and have been employed for ocular, systemic and intracellular drug delivery. Varied applications are MNs are briefly summarized below : 1. Delivery of immunobiologicals: Microneedles have an edge over conventional vaccination delivery systems with associated needle phobia and the pain associated with insertion of needle into the skin and chances of occurrence of infectious diseases. MNs can be used for the administration of immunobiologicals via the subcutaneous, intramuscular or intradermal route. 2. Delivery of biopharmaceuticals: Owing to the harsh gastric environmental conditions including acidic pH, proteolytic degradation and hindered absorption, bioactive macromolecules such as heparin, insulin, growth hormones are not administered orally. The majority of biopharmaceuticals are administered via the parenteral route. Microneedles can be used for systemic delivery of biopharmaceuticals via skin with no associated pain or chances of infection. 3. Delivery of small molecule synthetic drug substance: It is essential for a drug molecule to possess necessary physico-

Cover Story chemical properties like lipophilicity and low molecular weight to cross the skin barrier. Transport of a drug molecule through the skin and also the rate of transportation are governed by these physico-chemical properties like hydrophilic-lipophilic balance, solubility, molecular weight, etc. These challenges posed in transdermal drug delivery can be overcome by use of microneedles based drug delivery. 4. Diagnosis: The use of microneedles along with quantum dots can be employed in the field of diagnosis. Hollow microneedles acts as channels for delivery of nano scale crystals with a light-emitting property which in turn would help in medical diagnosis. 5. Cosmeceuticals: Treatment of skin conditions like ageing (wrinkles, lax skin), scarring (acne, surgical), photo damage, hyperpigmentation (age/ brown spots) and hair loss (alopecia) can be easily and effectively done with the aid microneedle technology. CONCLUSION: Microneedle patch based transdermal systems have evolved as an alternative to conventional hypodermic injections for a number of clinical applications. MNs based technology can offer pain-free drug delivery also eradicating the chances of infection. Microneedle based technology would be beneficial particularly in paediatric vaccinations where it can help dispel anxiety and actually enhance participation. Microneedle based patch systems are emerging as promising technology and can be foreseen as a complete replacement of injectables.

MACHINERY FOR SALE 1. Machine for Assembly opf Disposable ESR Pipettes with Dies & Moulds. 2. Machine to make Velcro Tourniquet. 3. Ultrasonic Plastic Welding Machine. 4. 32 Cavity Mould for RIA tube/Test tube(PS/PP).

Contact : Sushil Kumar Soni +91-9789966873

May-June 2019

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com

May-June 2019

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 : 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

0434

May-June 2019

Event NATIONAL SEMINAR ON

ADVANCES AND DEVELOPMENTS OF PLASTICS IN MEDICAL SECTOR Wednesday, 24th July, 2019, Pune (India) About INDIAN PLASTICS INSTITUTE – IPI AND MEDICAL PLASTICS DATA SERVICE The Indian Plastics Institute has been a leading Institute for education and technology training for the plastics industry in India for over 3 decades. The Insti tute has 15 active Chapters at major centers in India. It has on roll over 2750 professional members from the industry and Research and Academic Institutions. IPI Pune Chapter is one of the active chapters and has hosted many seminars and conferences. The co-host of the Conference is "Medical Plastics Data Service", a company providing informat ion resources for Medical Technology and Markets through Publications, Internet Portals, Exhibitions, Conferences and Market Research sinc last 23 years.

Invited Speakers Profile & Abstracts : Dr. Ajay Passalgikar, Senior Principal Scientist, DSM Biomedical in Exton, Pennsylvania, USA Introduction : Dr. Ajay Padsalgikar, USA, a Well-Known Personality in this versatile field has agreed to be the Keynote Speaker. He is working as a Senior Principal Scientist at the Innovation Center of DSM Biomedical in Exton, Pennsylvania, USA. He has more than 30 published scientific papers and 10 patents. In 2017, he wrote a book titled “Plastics in Medical devices for Cardiovascular Applications” that was published by Elsevier. Abstract Health care is expanding worldwide with the industry showing double digit growths in emerging economies. The use of polymers within this sector is increasing with the growth of the industry as well as with new approaches in medical treatment. This talk will focus on the suitability of plastics for medical applications, the manufacturing processes for medical device production, emerging applications and opportunities for the Indian industry. Dr. Suneel Bandi, PhD, Technology Leader Medical High Performance Polymers, Americas Introduction : Sunil Bandi Holds a Doctoral Degree in Macromolecular Science and Engineering from Case Western Reserve University, with a broad polymer industrial experience. Presently Global Technology Leader - Medical (implant and non-implant) for EVONIK's High performance polymers group. Prior to joining Evonik, Lead product development at Solvay and has Management consulting experience in the domain of technology based market and strategy assessment at Newrycorp. Lead startup Aeroclay Inc. a novel platform technology for lightweight applications. Dr. Suneel Bandi is well connected to global network of medical customers, and actively support technical programming. High Performance Polymers for Medical Device Applications Abstract: EVONIK is a technology leader for high-performance polyamides, EVONIK’s current portfolio of specialty polyamides include PA12, PEBA (flexible polyamide), bio-based polyamides, and transparent polyamides for the medical devices. From catheters and balloons to diagnostic equipment and surgical instrumentation, VESTAMID® Care and TROGAMID® Care are well established. EVONIK offers flexibility in the design and manufacturing through May-June 2019

our new Bonding VESTAMID® Care and TROGAMID® Care grade polymers. EVONIK’s VESTAKEEP® Care PEEK materials are used in temporary contact and instrument applications, while VESTAKEEP® PEEK i-Grades are used for permanent implant applications. From spine and sports medicine, to drug delivery devices and heart valve applications, new compounds of VESTAKEEP® PEEK are designed to meet the specific application needs and performance demands of medical-device industry. Mr. Umang Shah, National Sales & Marketing Manager Masterbatch & Compounds for Medical & Pharma Segment, CLARIANT Chemicals India Ltd, Mumbai Introduction : CLARIANT is one of the world’s leading Specialty Chemicals company. Mr. Umang Shah is a National Sales & Marketing Manager for Masterbatch & Compounds for Medical & Pharma Segment (HPS) since Dec, 2015 and based at head quarter in Navi Mumbai. He is helping Indian manufacturers to develop various Medical devices & Pharma packaging applications meeting the regulatory requirements for the domestic & export markets. Mr. Umang Shah is a Polymer Technologist, MBA – Marketing with over 25 years of experience in reputed MNCs. Earlier, he worked with SABIC Innovative Plastics & GE Plastics for more than 22 years. He has rich Techno- Commercial experience and handled various key responsibilities as a • Key Accounts Manager – Sales & Marketing. • Application Development Specialist. • Technical Services Manager at Mumbai. He has worked on various segments like Automotive, Electrical, Appliances, Medical and Industrial projects. Successfully developed several Metal to Plastics, Themoset / Glass to Thermo-plastics applications. Also, worked at Engineering Plastics compounding plant at GE Plastics (now SABIC), Vadodara, Application Development Centre at Gurgaon, GE’s Global R&D Centre at Bangalore on various innovative and Patent projects. Mr. Umang Shah is Immediate past Chairman of Indian Plastics Institute (IPI) – Mumbai Chapter. With this, He is helping Plastics industry and students to organize, seminars, conferences for the latest updates. Polymer Compounds & Masterbatch from CLARIANT - Helping You Deliver Safe Treatments Globally Abstract 1. Clariant at a glance. 2. Healthcare Products & Process for

Event new developments. 3. What is Important/ Interesting for Customers ? 4. PROTECTION of healthcare products:- end to end solutions from API to patient. 5. Focus on Regulatory changes: USP 661.1, ICH Q3D 6.Why CLARIANT ? Mr. Aditya Kumar, Managing Director, Marco Polo Use of additive manufacturing technologies for development of medical devices Amol Chaudhari, Director, Research and Development, SynThera Biomedical Pvt. Ltd. Introduction : Education : pH.D. in Biomedical Science Professional Career : 1. SynThera Biomedical Pvt. Ltd., Pune, India - Director, Research and Development 2. Savitribai Phule Pune University, Pune, India - Postdoctoral Fellow 3. University of California, Davis, USA - Postdoctoral Fellow Honors / Awards : 1. Dr. D. S. Kothari Postdoctoral Fellowship (Postdoctoral Position at Savitribai Phule Pune University) 2. Katholieke Universiteit Research Fund (PhD Research at Katholeieke Universiteit Leuven) Publications : 1. Research Papers, Reports: 20 2. Others: 1 PhD Thesis, 6 Conference Presentations Glass Foam as Bone Graft Material Abstract : There is a clinical demand for artificial bone graft materials which has interconnected pores and resorbable structure that stimulate bone regeneration. Bone graft materials of bio-active glasses are very efficient in bone regeneration due to the virtue of bonestimulating resorption. If porosity can be included in such glasses, then their functionality can be further enhanced due to their possible use as integrated scaffold. One of the commonly used glass manufacturing processes is in-situ polymerization with added glass powder wherein gas-forming (or foaming) agents are used to form bubbles in the solid mass which resembles foam. Glass particles are incorporated in the bulk of such foam. Thus formed foam is then heated to a temperature at which the glass particles fuse together and the foam structure is retained made only of glass. There are many parameters that are required for obtaining suitable foam. In the presentations following points will be discussed: • Specific applications of glass foam in biomedical field • Controlling the bioactivity of such glass foams • Different foaming agents and their effect on the bioactivity of foam Dr. Sachin Jain, Founder Director, SKYi Composites Pvt. Ltd. Introduction : Dr. Sachin Jain is a founder Director of SKYi Composites Pvt Ltd and SKYI Innovation LLP. Sachin studied Polymer Engineering from University of Pune, India, and Masters from University of Akron, OH, USA. He worked on a sponsored project at NASA on nano-composites and bio-degradable polymers. Subsequently, he worked at Dainippon Ink and chemicals Inc. Japan on nanostructured blends of UV-curable polymers for flexible displays and artificial heart transplants. He then continued his studies at Eindhoven University of Technology, Eindhoven The Netherlands. His PhD thesis challenged long perceived theory of Einstein on

filled polymers. His research was cited as ”HOT paper“ in 2005 in Scientific journal “SOFT MATTER” and awarded with the Golden Thesis Award for his PhD thesis. He started his professional career at BASF-SE, Ludwigshafen, Germany as a Research Scientist, and later became Director of Research and technology at DSM. In 2015, he founded SKYi as a part of a larger objective of being a global leader providing sustainable solutions in the field of polymer technology. Sachin has accrued more than 27 international patents and has published more than 14 papers; some of his papers have been cited as “HOT” papers by scientific journals. He has also been invited to deliver over 40 high-level academic lectures and presentations around the world. He can be reached at sachin.jain@skyi.com Bio-absorbable composites for supporting medical implants Abstract : The paper presents biodegradable composites which be process as conventional glass fiber reinforced polymers, where polymer matrix is chosen from commercially available environmental friendly bioplastics such as PLA, PBS etc. The reinforcing glass fiber degrades in controlled environment. Bio-absorbable composites using long fiber reinforcement technology gives high strength and stiffness to material which can replace conventionally used metal supports specially used for orthopedic surgeries. Earlier attempts to use absorbable composites lacked the strength and life for such applications and importantly also the cost. Advances in the medical grade glass fibers combined with SKYi’s proprietary long fiber composites manufacturing technology is expected to provide successful alternative. The challenge remains on availability and cost of medical grade glass fibers. Most importantly, these bio-degradable composites can be processed on conventional injection molding machines. Lokesh Upadhye, Leister India Abstract : Plastics are part of our everyday life. It has transcended in to all aspects of our life including necessities in addition to desires. From diapers to clothing to gadgets to cars to medical devices, plastics is everywhere. As the parts are getting complex, the need to join the moulded components is getting more demanding. The weld must be strong, hermetic with a process that is consistent, repetitive, CLEAN and ECONOMICAL TO RUN. Laser technology is the cleanest method to assemble plastic parts. There is no particle dust formation. Moreover, it leaves minimal or zero stress behind making it the most suited technique for medical devices. Laser being a focused source of energy can melt plastic in quick time. As it is one of the latest technical advancements, it is expensive than the more established techniques. However, concentrated energy of laser means that we can use fraction of energy of other techniques to melt plastics. Again, laser can be used in different source formats to get the most out of available energy. Leister, a renowned name worldwide in plastic welding and process heat, is a Swiss origin company that has added Laser and Infra-red technologies to meet customer demands. Leister provides 6 configurations of laser source to suit the part to be joined making it possible to provide an economical, energy efficient, assured technique to weld plastic medical devices. With a pan India footprint of 10 sales, service offices, Leister is committed to be with customers from pre-sales consultancy to post-sales support. May-June 2019

Event Mr. Rajesh K. Gera Asst. Vice President, Business Development Reliance Industries Limited, PET Division, Mumbai PET Plastics Applications in Pharma Industry Introduction : Mr. R. K. Gera is working with Reliance Industries Ltd. PET Division based in Mumbai in India since Dec’97. He worked in Marketing Technical Services and Market Development and is currently General Manager Marketing of Western region. He work comprised of Trouble-shooting, Technical Services with current focus on PET Application development for bottels, sheets and strapping. He is B. Tech in Plastics Technology from H.B.T.I. Kanpur of 1985 batch. His work experience includes L. G. Polymers Vishakhapatnam and FGF Hyderabad in their Technical Services and Market Development Depts prior to joining RIL. He has over 20 years of experience in plastics industry including PET, Polystyrene and FRP. In L. G. Polymers, he worked on Polystyrene developments, commissioning of EPS processing plants & developing new grades. The major developments in FRP were FRP Underground Petroleum Storage Tanks and uses in automobiles and Railways. In PET developments, focus is on niche bottle applications including Hot-fill and FMCG sector & non-bottle uses like APET blisters and cartons among others. Today he is going to share with us his views on ‘APET Developments’ with focus on possibillites in Pharma and Heakthcare sector.

May-June 2019

Mr. Aditya Kumar Managing Director, Marco Polo Introduction : Company founded in 1999 and began with offering 3D printing services to the industry using FDM technology. Gradually started services using SLA AND SLS techniques and also offering a range of parts using Vacuum Casting and RIM. Over the last 5 years the company has been actively engaged in manufacturing tools and supporting supplies for Injection Moulding. Personal : Polymer Engineering from Pune University and masters in Plastics Engineering from USA. Have been associated with 3D printing technology technologies for last 20 years primarily in the field of automotive applications and development of medical devices. Overview of presentation 1. Brief history of 3D printing 2. Applications for prototyping 3. Various industry verticals using 3D printing 4. Use of 3D printing for medical applications 5. Specific applications in detail including - pre surgery models - dental applications - hearing aids - other medical devices 6. Future expectations from the technology

Global Trends Global Super Absorbent Polymer Market Poised To Cross US$12 bln By 2025 The global super absorbent polymer market size is poised to reach US$12.13 bln by 2025, according to a new study by Grand View Research, Inc., posting a CAGR of 6.2% during the forecast period. Growing demand from various application sectors such as baby diapers, adult incontinence products, agriculture, and female hygiene products is expected to drive the market during the forecast period. Super absorbent polymer is a key component of baby diapers. SAPs are used to absorb and retain fluids under moderately high pressure. In terms of revenue, Europe dominated the global super absorbent polymer market. It is anticipated to expand at a CAGR of 6.1% during the forecast period. Baby diapers were the largest application segment in the market in 2017 and are projected to maintain their dominance through 2025. Agriculture is poised to be the most promising application segment, rising at a CAGR of 7.3% over the forecast period. The growth of the segment can be attributed to ongoing extensive research conducted by governments and agricultural agencies in countries such as the U.S., China, and India to pave way for novel applications of super absorbent polymers. Asia Pacific is likely to exhibit the fastest CAGR of 7.2% during the forecast period. Increasing demand from various application

Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations China’s National Medicinal Products Administration (NMPA) has reported a 25% year-on-year drop in initial registrations of medical devices. The fall dragged the overall level of registration activity down to its lowest level since China began publishing data on the topic in 2013. Last year, NMPA approved 1,128 initial medical device registrations. When renewals and changes are factored in, the overall number of registration approvals for the year totals 5,528. In 2017, NMPA approved 1,507 initial registrations and 8,579 filings overall. Since the start of records in 2013, China had never previously approved fewer than 7,530 registrations in a year. NMPA provided no explanation for the sharp fall in registrations. The trend was driven by declining activity in multiple areas. The number of renewals approved was down 59% on the prior period. There were similarly significant declines in the numbers of approvals of filings to import and register Class III medical devices. Registrations by provincial drug regulatory authorities fell sharply, too. The number of registration changes approved by NMPA was the exception to the downward trend. NMPA signed off on 21% more changes in 2018 than the previous year, potentially reflecting growth in the number of medical devices already registered for use in China. Those efforts have continued into 2019. This week, NMPA published technical guidelines on the electronic submission of medical device registration applications and an accompanying document on its electronic declaration information system. NMPA published the documents as part of its work to implement a 2017 government order about the reform of the medical device

segments in the region, particularly in China and India, is projected to supplement the growth of the market. Emerging regions such as Asia Pacific and Central & South America are likely to witness a sharp rise in the demand for baby diapers owing to growing population, rising disposable income, and increasing awareness regarding benefits of synthetic baby diapers, which are estimated to play a key role in the development of the overall market. Factors such as constantly developing medical infrastructure, technological advancements, and growing accessibility to medical treatments have resulted in an increase in life expectancy rates. Growing life expectancy is expected to further supplement the growth of the adult incontinence product market and, in turn, boost the growth of the SAP market. Super absorbent polymers find application in the agriculture industry owing to their water retention and water absorbing properties, which makes them perfectly suitable for agricultural applications, particularly in water-scarce regions. These super absorbent polymers increase crop yield and water use efficiency. http://www.plastemart.com/news-plastics-information/globalsuper-absorbent-polymer-market-poised-to-cross-us$12-blnby-2025/51886 approval system. https://www.raps.org/news-and-articles/news-articles/2019/6/ asia-regulatory-roundup-china-reports-25-fall-in

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May-June 2019

NEW AiMED WEBSITE ON A NEW AND ADVANCED PLATFORM : MEMBERS REQUESTED TO UPDATE ONLINE REGISTRATION FORM AiMeD India has launched its New Website www.aimedindia.com on a New and Advanced Platform with some Additional Features like every Registered Member has been allotted a User Name & Password so that they can change / edit / modify their Company information e.g. Contact Details, Product Details etc. in the New Members Directory in the New Website. It is required to update our Members Directory also as many of the information / details of the Member Companies mentioned in the Members Directory are obsolete and which needs updating e.g. Contact Details etc. and also many of the Member Companies mentioned in the Members Directory are also not active also and which needs to be removed / deleted or modified.

Therefore, "Aimed" appeals concerned team / person to fill the online registration form again by clicking www.aimedindia.com (https://aimedindia.com/register) website and submit so that the New Members Directory in our New Website and also allot you the User Name & Password to enable you to update your details as and when required. Members are also requested to drop a one liner email informing about their Primary / Associate / UdaiMeD / IMDRRG Membership and whether they have submitted the online registration form to enable to track the same and send them the confirmation of the same without seeking any clarification or asking any details.

DCGI Asks Medical Device & IVD Manufacturing Associations To Give Feedback On New Online Portal In order to enhance public confidence in quality, safety and efficacy of medical devices marketed in India, the Drugs Controller General of India (DCGI) has asked all medical device and IVD manufacturing associations to give feedback on separate "Medical Device" online portal. A separate Medical Device online portal has also been started in line with new Medical Device Rules-2017 recently for applications related to medical devices and IVDs. Central Drugs Standard control Organisation (CDSCO) has also recently devised an action plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act to ensure safety, quality and performance of medical devices.

2016 for Import & Registration purpose and subsequently for cosmetics, GCT, biological and other divisions. Keeping in line with Government of India's vision to promote digital India and ease of doing business, CDSCO aims to strengthen this online medical device portal to enhance public confidence in quality, safety and efficacy of devices and drugs marketed in India, as per the notice sent to the stakeholders. It says, as the "Medical Device" online system (www.cdscomdonline.gov.in) has already been rolled out, it is desired to obtain feedback from the stakeholder to improve the system. A detailed feedback form has been circulated.

As per the plan, all manufacturers and importers of all non-regulated medical devices will register the details of the devices manufactured and imported by them in the special SUGAM portal developed for the purpose and a notification will be issued under the D&C Act in this regard.

All stakeholders are requested to provide their valuable feedback as per the form with suggestions about short term, medium term and long term measures to be taken to improve the system. The feedback should be forwarded to feedback@cdsco.nic.in within two weeks of this notice in scanned pdf format as well as excel document format.

The central drug regulator under eGovernance had rolled out online services for filing of applications through SUGAM portal in

http://pharmabiz.com/NewsDetails.aspx?aid=115736&sid=1

CDSCO Issues Alert On Pacemakers A nationwide alert will be announced by the Central Drugs Standard Control Organisation (CDSCO) on Monday on some faulty pacemakers models sold by the world’s largest medical device manufacturer, Medtronic. Confirming this, the Drug Controller General of India (DCGI) Dr. S. Eswara Reddy, said on Sunday, “The alert was approved on May 17 and will be issued this Monday.” Medtronic’s Astra, Serena and Solara CRT-Ps (Cardiac May-June 2019

Resynchronisation Therapy Pacemakers) have been covered under the Indian medical device alert. The two-page alert, a copy of which The Hindu has accessed, states that, according to the company, healthcare providers were unable to communicate with the device due to battery depletion, resulting in loss of pacemaker function. https://www.thehindu.com/sci-tech/health/cdsco-issues-alerton-pacemakers/article27180571.ece

Industry News Telangana Govt Allocates 250 Acres Of Land For Medical Device Park At Sultanpur An exclusive Medical Devices Manufacturing Park is coming up at Sultanpur in Telangana. The state government of Telangana has already allocated 250 acres of land to set up the project. And the state government has just signed a Memorandum of Understanding (MoU) with 21 medical equipment manufacturing and allied services companies and is expecting an investment of more than Rs. 500 crore in the next 5 years. Particularly, as Hyderabad is a hub for more than nearly around 5000 small and big hospitals, the demand for medical devices and various equipments need by doctors and patients is increasing many folds. “Keeping this in view we have decided to set up a new medical devices park on a plot of 250 acres of land. We have already signed MoU with 21 companies and 3 companies have already started their operations from the Medical devices park,” Narasimha Reddy, managing director of Telangana State Industrial Infrastructure Development Corporation (TSIIDC). So far, as many as 14 companies out of 21 have already been allocated 51.7 acres of land and the state government is expecting that these companies will invest nearly Rs. 425 crore in the next 5 years in the Medical Devices Park and generate an employment to nearly 3900 persons in Telangana.

Cyient Limited and Sandor Medicaid’s Private Limited companies which are planning to invest Rs. 100 crore each. The company has already been allocated 10 acres of land in the Park by the government. “The pro-active industrial policy of Telangana state has attracted us to invest in the state. We are into Medical Technologies and Healthcare and have invested about Rs. 100 crore in the said area,” informed Balaji Rajagopalan, vice president of Cyient Limited. This apart other major investors include Transcath Medical Devices, which is investing Rs. 27.9 crore and is expected to manufacture catheter category of products. Another investor Healthware Private limited is investing Rs. 16.2 crore and the company is in the manufacturer of medical equipment like urolgoy, GI, respiratory care, advanced surgery, gynaecology and ENT related medical equipments. Another Rs. 12.5 crore of investment is in the planning by Man Machine Electronics, which is in the business of manufacturing Ultrasound Scanners. The state government has already allocated one acre of land to this company in the Medical devices park. http://pharmabiz.com/NewsDetails.aspx?aid=116237&sid=1

Major among the investors in the Medical Devices Park includes

Phillips-Medisize Showcases Drug Delivery Innovations For Indian Market Global healthcare company Phillips-Medisize has showcased its expertise in drug delivery and connected devices this week at the 8th Annual InnoPack Pharma Confex.

Speaking on the show’s first day, chief technology officer Bill Welch spoke to pharma companies on how to reach the market faster and expedite product development with proven technology accelerators for all types of infusion, injection and inhalation devices. His presentation – “Transforming Drug Delivery”, explained how to gain a competitive edge with human-centred design for customisable and user-friendly devices along with technology solutions that support global commercialisation. More so, a panel discussion moderated by Welch on day two (22 May) looked at how to address the role of connected drug delivery devices for patient use in healthcare settings.

The company has been discussing the latest breakthroughs in drug delivery and demonstrating how its connected health solutions and powerful analytics are helping to improve patient engagement and adherence.

“Our primary business focus is on complex, regulated drug delivery devices and connected health solutions,” Welch said. “Together with our customers, we challenge and push the limits of product design and development to help transform the diagnosis and delivery of healthcare.” https://www.medicalplasticsnews.com/news/phillips-medisizeshowcases-drug-delivery-innovations-for-in/

CII, AMTZ Join Hands To Help Usher In Business Opportunities For MSMEs Towards Indigenous Manufacturing The Confederation of Indian Industry (CII) in association with Andhra Pradesh MedTech Zone Ltd (AMTZ) helped over 80 Indian MSMEs related to healthcare and medical devices to understand best manufacturing practices and local supply chain management towards the central government’s Make in India initiative. Medical device manufacturers and other MSMEs recently congregated at AMTZ Visakhaptnam campus to understand the mutual need for supporting operations towards possible business

opportunities as part of the session titled “Business Opportunities for Healthcare and Medical Devices for MSMEs”. Over the years, CII has worked closely with government and industry to raise the competitiveness of Indian MSMEs and escalate the productivity levels of each sub-sector through adoption and dissemination of best practices, knowledge management systems and appropriate technologies. http://pharmabiz.com/NewsDetails.aspx?aid=115889&sid=1 May-June 2019

Industry News Meril’s Myval Transcatheter Heart Valve Receives CE Approval Meril Life Sciences becomes the first and currently only Indian company to market and distribute its patented Transcatheter Heart Valve (THV): MyvalTM -THV System to Europe and other countries. Recently, MyvalTM received the coveted CE approval. Meril now becomes the first Indian company to market and distribute its indigenously designed and patented TAVR technology, MyvalTM -THV system, to European Union and other countries. The CE certification is a conformity mark indicating the product to be compliant with the European Union (EU) health standards. The CE certification would enable MyvalTM -THV to reach over 60 countries in Europe and outside of India which accept CE mark document for their own regulatory approvals. TAVR is an established treatment modality for patients who are at a risk or unwilling to undergo open heart valve replacement surgery. TAVR is a minimally invasive procedure that repairs the aortic heart valve without removing the old, damaged valve. Instead, it places a replacement valve through a catheter or tube inserted through the femoral artery (the large artery in the groin). The TAVR procedure is also beneficial for treating patients with previous failed bioprosthetic valve, hence preventing an additional surgical intervention. The MyvalTM THV System has a Hybrid honey comb design, on crimping it has a distinct alternating dark-light banding pattern visible under fluoroscopy. This unique pattern helps in precise placement of the valve and ensures orthotopic deployment.

MyvalTM THV gets crimped on a Navigator delivery system which comes with a dual-stopper system ensuring valve crimping is precise and snug. The MyvalTM System includes Mammoth balloon dilatation catheter, 9F low profile, for valvuloplasty. The kit also includes atraumatic and lubricious coated Python introducer sheath, 14F low Profile which allows for percutaneous access of the crimped MyvalTM THV. Meril Life Sciences got CE and Central Drugs Standard Control Organization (CDSCO) approval for MyvalTM technology basis the results of MyVal-1 Study. One-year clinical outcomes from the MyVal-1 study demonstrated 100% acute procedural success and no device-related mortality as reported at EuroPCR 2019 (21-24 May). The data were presented in a Late-breaking trial session at EuroPCR’2019 Conference at Paris by the trial’s Principal investigator, Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute, New Delhi, India. Dr Seth explained that in addition to the procedural success and zero device-related mortality rate, there were also no new pacemaker implantations, no strokes and no paravalvular leaks observed in the trial patients. Furthermore, Echo parameters were maintained at 12-month follow-up and there was a significant improvement in Quality of Life of the patients as demonstrated by tests including NYHA functional class.1 https://health.economictimes.indiatimes.com/news/medicaldevices/merils-myval-transcatheter-heart-valve-receives-ceapproval/69690049

Tekni-Plex Completes Acquisition Of Amcor Flexible Packaging Units Serving Medical Device OEMs Tekni-Plex (Wayne, PA) announced today that it has completed the acquisition of three manufacturing facilities from Amcor Flexible Packaging that serve medical device OEMs. Located in Madison and Milwaukee, WI, and Ashland, MA, the facilities provide a broad portfolio of sterilizable medical device packaging substrates, including coated and uncoated Tyvek, heat-seal and cold-seal coated paper and films, medical-grade laminates, and die-cut lids and labels, said Tekni-Plex. “The acquisition expands our complex packaging solution portfolio for medical device manufacturers, many of whom have been supplied by our Colorite, Natvar and Dunn medical products businesses for decades,” said Paul Young, President and CEO of Tekni-Plex. “The acquisition of these three plants also brings us 150 highly qualified and experienced employees who form the backbone of the business. We are happy to welcome them to the Tekni team of 3,000 strong across the world.” This is the eleventh acquisition Tekni-Plex has made in the past five years, supporting its strategy to grow its business though transformative acquisitions and strategic add-ons, the company said. “Genstar is excited to be sponsoring Tekni-Plex’s acquisition of the Amcor plants, as we continue to focus efforts on expanding our healthcare-related packaging capabilities,” added David Golde, Managing Director, Genstar Capital. https://www.plasticstoday.com/medical/tekni-plex-completesacquisition-amcor-flexible-packaging-units-serving-medicaldevice-oems/141439573360995 May-June 2019

ISO : 13485 : 2012

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 Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 37

Product Gallery Qosina Expands Offering of ISO 80369-7 Compliant Components Ronkonkoma, NY, USA, May 1, 2019— Qosina stocks a number of components that comply with the ISO 80369-7 standard, which specifies dimensions and requirements for the design and performance of small-bore connectors intended to be used in intravascular or hypodermic applications. This standard replaces ISO 594-1 and ISO 594-2. As a medical component supplier, Qosina stays abreast of regulatory changes and safety standards in the industry, and provides customers with solutions to achieve compliance, minimize patient risk and be innovative when designing devices. Qosina will be showcasing its ISO 80369-7 products, in addition to its thousands of stock components, at booth 1529 during MD&M East at the Jacob K. Javits Convention Center in New York, June 11-13.

to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 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) 2423000. 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.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need

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

Qosina Launches European Operations Ronkonkoma, NY, USA, May 8, 2019—Qosina Corp. is pleased to announce the establishment of operations in Europe. Qosina Europe is located in Milan, Italy, and is managed by Giampaolo Meana. “The decision to expand into Europe was a logical step in our business growth strategy,” said Scott Herskovitz, President and CEO of Qosina. “Our European market has grown considerably, and more companies look to Qosina to support their medical device development and production requirements. It’s critical that we have visibility where our customers live in order to serve them effectively.” With over 30 years of experience and a strong presence in the medical device industry, Mr. Meana has a proven track record of success and in-depth technical knowledge related to medical device development and manufacturing. “We expect Giampaolo will have a significant impact on strengthening our existing customer relationships and is well positioned to support our new customer and project inquiries,” said Jeff Cushner, Qosina’s Director of Sales. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical in-

dustries. The Qosina 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 9001, ISO 13485 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. Rachelle Morrow - Marketing Communications Manager Qosina Corp. 2002-Q Orville Drive North, Ronkonkoma, NY 11779 USA T: +1 (631) 242-3000, ext. 281 Email: rmorrow@qosina.com • www.qosina.com

Events Calender Seminar on “Advances and Developments of Plastics in Medical Sector” 24 July, 2019, Venue : Pune Medicall 2019 - Chennai India’s Largest & No. 1 Medical Equipment Exhibition 26-28 July, 2019, Chennai Trade Centre, Chennai, India K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber 16 - 23, October, 2019, Venue : Dusseldofr, Germany PLASTIVISION INDIA 2020 16 - 20, January 2020, Venue : Mumbai

Medical Fair India 2020 26th International Exhibition and Conference 5 - 7 March, 2020 Bombay Convention & Exhibition Centre, Mumbai Medica 2019 Leading International Trade Fair 18 - 21 November, 2019, Dusseldort, Germany Compamed 2019 Leading International Trade Fair 18 - 21 November, 2019, Dusseldort, Germany

May-June 2019

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

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

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

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

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

: 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 May-June 2019

National Healthcare An ISO 9001 : 2008 Company

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

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

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in 40

May-June 2019

GMP ISO - 9001-2008 Certified Company

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

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

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 PRODUCTS

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 May-June 2019

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 41

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 Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901

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.

May-June 2019

Medical Plastics Data Service Magazine May - June 2019

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