Medical Plastics Data Service Magazine September - October 2019 by Medical Plastics Data Service

Table of

Contents Vol. 27

No. 5

Sept.-Oct. 2019

COVER STORY Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead - Dr. V. G. Somani, Drugs Controller General (India), Ministry of Health & Family Welfare, Govt. of India Comprehensive regulation of Medical Devices is important for ensuring safety and well beings of patient’s using such Medical Devices. Ministry of Health and Family welfare, had constituted a committee to work out a roadmap on regulation of all Medical Devices.

COVER STORY Excessive MRP’s Stiffling India’s Mfg Growth - Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) The practice of Excessive MRP on the finished product labels has been a bottleneck for the growth of manufacturing sector in India…

Waste Management Healthcare Plastics Waste Recycling: Improves Environment & Job Creation - V R Patel, CEO, Vir Enviro Management & Former, Deputy Chief Engineer, Gujarat Pollution Control Board - D L Pandya - Editor & CEO, MEDICAL PLASTICS DATA SERVICE and www.medisourceasia.com Recycling PVC diverts waste and useful resources from landfill and reduces the consumption of energy feedstock in the production of new products. It can also lead to positive environmental outcomes…

GLOBAL TRENDS Export Opportunities for Medical Devices in Africa - S.Abidi, Research Advisor, Govt. of Guj.-AMA Centre of International Trade With close to one billion people and a GDP of approximately $1.7 Trillion, Africa presents a sizeable investment opportunity. African countries have united together to establish Regional Economic Communities (RECs)…

33 36

39 18 39 Sept.-Oct. 2019

AiMeD & REGULATORY UPDATES • Conference on Comprehensive Regulation of Medical Devices • AiMeD & BCIL Seek Regulatory Framework On Medical Devices • Govt Issues Draft Notification To Bring All Medical Devices Under Single Regulatory Framework

INDUSTRY NEWS • Niti Aayog proposes separate regulator for medical devices The ministry had issued a draft notification saying that all medical devices would come under the category of drugs from December 1 and would be regulated under the Drugs & Cosmetics Act. Oct 29, 2019 • India Wooing Japanese Medical Device Firms to Cut Reliance on US • TSIIC Allocates 20 Acres Land To Set Up Cardiac Stent Mfg. Unit At Medical Devices Park In Telangana • Medical Devices Exporter Poly Medicure Eyes 17-18% Revenue Growth

PRODUCT GALLERY • Tuohy Borst Adapters

DID YOU KNOW? • About Healthcare Waste Management : Reasons For Failure

EVENT CALENDER • Medica 2019, • Compamed 2019, • Medicall 2019, • PLASTIVISION INDIA 2020, • Medical Fair India 2020

Did You Know ?

Flashback Select Article Index

May 2012 to Nov. 2012 • Cover Story : Medical Device Development (May - June 2012) • Cover Story : Development Of Critical Use Medical Devices (May - June 2012) Mr. D.S.Nagesh, Scientist/Engineer-G, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology • Global Trends : Antimicrobial Plastics Used In Medical Devices Prevent Hospital Related Preventions (May - June 2012) • Global Trends : PolyOne & Microspec Collaborate To Develop Antimicrobial Solutions For Medical Devices (May - June 2012) • Did You Know : About Medical Devices : Managing The Mismatch (May - June 2012) • Learning Zone : Colostomy & Colostomy Bags (May - June 2012) • Cover Story : Jugaad Innovation And Medical Technology In India (July - August 2012) • Cover Story : Jugaad Innovators: West In Search of Indian Might (July - August 2012) • Cover Story : Lead User Process For Developing Breakthroughs Products : The 3M Experience For Surgical Drapes (July - August 2012) • Global Trends : West European Market for Medical Plastics (July - August 2012) • Global Trends : Medical Technology Emerging Markets : Changing Outsourcing Drivers (July - August 2012) • Did You Know : About High Impact Frugal Innovations In India (July - August 2012) • Cover Story : Indian Medical Device Industry 360º View (September - October 2012) • Global Trends : World Medical Disposable Market (September - October 2012)

About Healthcare Waste Management : Reasons For Failure

Lack of awareness about the health hazards related to health-care waste, inadequate training in proper waste management, absence of waste management and disposal systems, insufficient financial and human resources and the low priority given to the topic are the most common problems connected with health-care waste. Many countries either do not have appropriate regulations, or do not enforce them.

The Way Forward The management of health-care waste requires increased attention and diligence to avoid adverse health outcomes associated with poor practice, including exposure to infectious agents and toxic substances. Key elements in improving health-care waste management are: • promoting practices that reduce the volume of wastes generated and ensure proposer waste segregation; • developing strategies and systems along with strong oversight and regulation to incrementally improve waste segregation, destruction and disposal practices with the ultimate aim of meeting national and international standards; • where feasible, favouring the safe and environmentally sound treatment of hazardous health care wastes (e,g, by autoclaving, microwaving, steam treatment integrated with internal mixing, and chemical treatment) over medical waste incineration; • building a comprehensive system, addressing responsibilities, resource allocation, handling and disposal. This is a long-term process, sustained by gradual improvements; • raising awareness of the risks related to health-care waste, and of safe practices; and • selecting safe and environmentally-friendly management options, to protect people from hazards when collecting, handling, storing, trans porting, treating or disposing of waste. Government commitment and support is needed for universal, long-term improvement, although immediate action can be taken locally. ( Ref : https://www.who.int/en/news-room/fact-sheets/detail/health-care-waste )

• Did You Know : About Health Technology Assessment (HTA) (September - October 2012) • Manufacturing : “Involving the Future of Healthcare in India through Medical Device Manufacturing” (November - December 2012) Mr. Manoj Bhardwaj - Managing Director, SMC Manufacturing Pvt. Ltd., Bangalore • Management : “Medical Device Start Ups / New Projects” (November - December 2012) Mr. Nitin Mahajan - Managing Director, Mitra Industries ( P ) Ltd., Haryana

Let’s go invent tomorrow insted of worrying about what happeneed yesterday

- Steven Jobs

Sept.-Oct. 2019

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 expressed herein.

Sept.-Oct. 2019

Editor’s Desk

From the

This issue highlights four different but critical issues of relevance to the Indian Medical Device Industry, namely Regulatory transformation taking place, the effect of Minimum Retail Prices (MRP) on the growth of medical device manufacturing industry in India, Export Opportunities and lastly importance of healthcare plastics recycling in hospitals on Environment, Public Health, Economy and Job creation. First of all, on behalf of the Indian Industry and “MEDICAL PLASTICS DATA SERVICE”, WE WELCOME AND WELCOME OUR NEW YOUNG AND DYNAMIC DRUGS CONTROLLER GENERAL OF INDIA \, DR . V.G.SOMANI and look forward to his support and guidance to achieve our Hon. Prime Minister’s Vision of “Make-In-India” very fast. In a recently held Conference jointly organized by AiMeD and BCIL , Dr Somani very elaborately shared the updates on Medical Device Regulations in India along with the Key Features of Roadmap ahead. The highlights of his presentations including achievements by CDSCO for the benefit of Industry starting from Classification of Medical Devices and IVDs to introduction of Materio-Vigilance Programme as well as actions taken to support exporters are included in this issue. In the road map ahead, Dr. Somani explained the action plan on how the new revised Medical Device Rules will be implemented. Mr Rajiv Nath, Forum Co-ordinator, “AiMeD” explained how the practice of Excessive MRP on the finished product labels has been a bottleneck for the growth of manufacturing sector in India. Through a detailed analysis as reproduced in this issue, Mr Rajiv Nath has explained that while the ex-factory prices are going down, creating artificial inflation by using high MRP as selling tool, the manufacturing growth is stifled. Mr S. Abidi, Research Advisor, Ahmedabad Management Association, in his article on “Export Opportunities For Medical Devices In Africa” has given a very informative analysis for the features of the African market and the opportunities for Indian Manufacturers / Exporters of Medical Devices. Apart from the growth, the Medical Device Industry as part of the Health-Care ecosystem has also to be responsible towards various issues of concern to the society like Environment, adverse effect on Public Health, support to the economy and also Job Creation. As a part of our research activities, we carried out desk research on how recycling of Healthcare Plastics Waste in Hospitals can contribute to the above objectives while satisfying the current Biomedical Waste Treatment Regulations. As explained in the article in this issue, it was also found that there is also very good commercial potential in recycling healthcare / medical plastics waste particularly commonly used materials like PVC. We acknowledge the support and contribution of Mr V R Patel, CEO, Vir Enviro Management & Former Deputy Chief Environmental Engineer, Gujarat Pollution Control Board. Under the column “Did You Know”, various reasons for the Healthcare Waste Management Failure are explained along with how it can be improved as given by WHO. This issue also covers our regular columns like Industry & Regulatory News, Product Gallery etc.

Cover Story

Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead Dr. V. G. Somani Drugs Controller General (India) Ministry of Health & Family Welfare, Government of India

Achievements New online system for medical devices is functional for uploading the applications for Import License and Manufacturing License of Medical devices and IVDs, for post approval changes, registration of medical devices testing laboratories, clinical investigation etc. Classification of Medical Devices and IVDs has been finalized in consultation with the stakeholders and uploaded in the CDSCO website. New online system for Medical devices is functional for the registration of Notified Bodies. Six notified bodies have been registered and information is available on the CDSCO website. Grouping of Medical Devices and IVDs along with essential principle checklist has been finalized in consultation with the stakeholders and uploaded in the CDSCO website. Notification of Medical Device Officer and Medical Device Testing Laboratories have been published. CDSCO organised workshops to impart trainings various stakeholders including State Licensing Authorities for the effective implementation of Medical Devices Rules, 2017. For addressing various questions on regulatory practices in medical devices, Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is uploaded on CDSCO website. Also regular interactions are taking place with all the stakeholders to resolve their regulatory practices issues. Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices have been published on the website. Guidance document for stability study and post marketing surveillance of In Vitro Diagnostics is prepared and shared with the stakeholders for their comments. Setting up of Public Relation Office at CDSCO (HQ), New Delhi will act as single window to guide, assist and providing information to the innovators regarding regulatory requirements. Function from 10:00 am to 5.30pm in all working days Launch of Support Cells for WHO PQS for IVDs in India for providing guidance to the Indian manufacturers for the WHO Prequalification of In Vitro Diagnostics Programme in India 1) National Institute of Biologicals in North India

Sept.-Oct. 2019

Cover Story

Materio-vigilance Programme •

Materiovigilance programme of India was launched on 6th July 2015 at Indian Pharmacopoeia Commission, Ghaziabad. Indian Pharmacopoeia Commission functions as National Coordination Centre (NCC). Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram act as National Collaborating Centre,

• •

National Health System Resource Centre (NHSRC), New Delhi, act as Technical support partner Central Drugs Standards Control Organisation (CDSCO), New Delhi, support MvPI with experience of functioning as National regulator.

Medical Device Testing Laboratory Serial Number

Name of Laboratory

Category of medical device

The National Institute of Biologicals, Noida

In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent

The Central Drugs Testing laboratory, Chennai

Condoms

The Central Drugs Laboratory, Kolkata

Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant

The Regional Drugs Testing Laboratory (RDTL), Guwahati

Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. Cannulae

The Central Drugs Testing Laboratory, Mumbai

Intra Uterine Devices (IUD) and Falope Rings

SIPRA LABS LIMITED Sanathnagar, Hyderabad, Telangana-500018.

Copper-T, Condoms ,Sterile Hypodermic Needles, Tubal Rings ,Hypodermic Syringes and Blood Bags

M/s, Star Imaging & Path Lab Pvt. Ltd. situated at 4B/4, TILAK NAGAR, West Delhi Delhi, Delhi - 110018

Bilirubin (Total and Direct), Creatinine test reagent / kit, Aspartate Amino Transferase, Alanine Amino Transferase, Uric Acid Test reagents / kits, Total Protein test reagents /kits , Activated partial, PT (Prothrombin Time) Test

M/s Alcatec Research Laboratories India Pvt Ltd. situated at 1652 MIE Part B, Bahadurgarh, Haryana – 124507

Sterilized Surgical Ligatures, Sterilized Disposable Device, Sterilised Surgical Sutures

Sree Chitra Tirunal Institute For Medical Sciences & Technology Medical College Thiruvananthapuram (India) - 695011

Cardio Vascular Devices, Neuroprosthesis, Orthopedic Implants, All medical devices and Materials, Dental Implants

Initiative taken by NIB, Noida

Specifications of Notified IVDs Analyte

NIB, Noida also evaluate the following IVDs

• Syphilis test kit • Blood glucose test strips • Dengue IgM ELISA • Chikungunya IgM ELISA • Blood grouping sera

ELISA / CLIA /ELFA etc.

Rapid Kit

Sensitivity

Specificity

Sensitivity

Specificity

Anti HIV 1 / 2

100%

> 98%

100%

> 98%

HBsAg

100%

> 98%

100%

> 98%

Anti-HCV

100%

> 98%

99%

> 98%

Export • As per the notification G.S.R.318 (E) dated 18.04.2019, the FSC for class A and B shall be issued by SLA and for Class C and D by CLA with the fees as per category and not for distinct device (Rs.1000 per category as per Second Schedule). • The labels on packages of devices for export shall be adopted to meet the specific requirements of the importing country. If consignee does not want to label the name and address of manufacturer then code number or special code number should be mentioned as per the approval of CLA Sept.-Oct. 2019

Cover Story

Medical Devices Roadmap in India • Many of the Medical Devices like equipments, analyzers, instruments etc. used in various healthcare facilities for diagnosis, treatment, mitigation are currently out of scope of regulation under Drugs and Cosmetics Act. Concerns have been raised from time to time in different fora regarding safety, quality and performance of non notified medical devices. • Comprehensive regulation of Medical Devices is important for ensuring safety and well beings of patient’s using such Medical Devices. • Keeping in view the need for such comprehensive regulation of all medical devices, Ministry of Health and Family welfare, had constituted a committee vide order No.11035/61/2019-DR dated 04.02.2019 to work out a roadmap on regulation of all Medical Devices.

Terms of References (TORs) of the committee • To work out a roadmap for notification of all Medical Devices under the Drugs &Cosmetics Act, 1940. • To work out a roadmap for Medical Devices vertical in CDSCO.

Key features of Roadmap • Inclusion of Medical device definition “All Medical Devices including an instrument, appara tus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assisted in its intended function by such means for one or more of the specific purposes of,a) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; b) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; c) Investigation, replacement or modification or support of the anatomy or of a physiological process; d) supporting or sustaining life; e) disinfection of Medical Devices; f) control of conception;’’

First Phase

Second Phase

Third Phase

• Issue of notification for including all medical devices by their technical definition and provisions for exemptions to obtain import / manufacturing license and permission for clinical investigation till 30 month (class A and B) and 42 month (class C and D).

• Registration (by number) of Class A & B devices shall be followed by mandatory licensing within 12 months after 18 months of voluntary registration period.

• Registration (by number) of Class C & D devices shall be followed by mandatory licensing within 24 months after 18 months of voluntary registration.

• After 12 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class A & Class B Medical Devices without prior license under the Medical Devices Rules, 2017.

• After the 24 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class C & Class D Medical Devices without prior license under the Medical Devices Rules, 2017.

• Registration of all non-regulated Medical Devices on SUGAM portal i.e. obtaining voluntary registration (in the form of registration number) up to 18 months from date of notification. Thereafter compulsory registration for 12 months (class A and B) and for 24 months (class C and D).

Separate Vertical for Medical Device

Action Plan

754 posts of

• MDTAG (Medical Devices Technical Advisory Board) has been constituted including experts from various Govt. Departments & various Associations in order to discuss the various issues/ concerns related to medical devices and In Vitro Diagnostics Kits.

• Regulatory • Laboratory and • Medical specialist officials in various disciplines of medical devices are proposed for recruitment and are under active consideration for incorporation at advanced stage as per procedures.

• As per the request of various manufacturers the issue related to put the old license no. and old name on the label for export purpose and during transition period as per choice of applicant was deliberated in DTAB and is under consideration for adoption. Sept.-Oct. 2019

Cover Story

Excessive MRP’s Stiffling India’s Mfg Growth Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD)

THE PROBLEM • • • • •

Excessive Competition Import duties down Ex-Fcy Prices Down MRP up High MRP as a selling tool - huge disparity

Ex Factory Price 3.50 Rs to 9.50 Rs + 12% GST MRP comparision of different brands of IV Set

MRP comparision of different brands of IV Cannula 20G Ex Factory Price 4.60 Rs to 25 Rs + 12% GST

MRP comparision of Disposable Syirnge 5ml with Needle Ex Factory Price Ranges 1.40 Rs to 1.80 Rs + 12% GST

Sept.-Oct. 2019

Brand : RMS (Romsons) MRP : Rs 115

Brand : Venflon (B.D.) MRP Rs 132

Brand Life Long MRP : Rs 23

• • • • •

Artificial Inflation Consumer No choice Skewed Market place Unethical Collusion Lack of Trust in Medical Profession

Brand : Polymed MRP Rs 108 (Pack size 25)

Brand Ideal MRP : Rs 80

Brand Ultra (Polymed) MRP : Rs 120

Brand : Nipro MRP : Rs 18

Brand : JMS MRP : Rs 35

Brand Romsons MRP : Rs 115

Brand BD Emerald (Blister) MRP : Rs 15.50

Brand Kit Kath+ (HMD) MRP : Rs : 102.50

Brand Dispovan (HMD) MRP : Rs 6.50

Cover Story Why Indian Medical Devices With Lower Ex-Fcy Prices Are Not Competitive ? ATTEMPTING RATIONALITY

SHsH....... When Their MRP Is Too Low! MRP : Rs. 285/-

FOR MEDICAL DEVICES NOT NOTIFIED AS DRUGS • Tax Based Disincentive • 1% GST Cess on MRP • Discourage Artificial Inflation

MRP : Rs. 5,400/- MRP : Rs. 8,000/FOR MEDICAL DEVICES NOTIFIED AS DRUGS RATIONALIZE TRADE MARKUPs Over 1st POINT OF SALE & The MRP (When GST Applied 1st Time When Overseas or Indian Manufactured Goods Enter Supply Chain)

IOL Vast Disparity even in Basic lens

What’s Difference between Trade Mark Up & Margin ? Mark Up: is % Profit over buying value (MRP - Ex-Factory Sale Value) X 100

MRP : Rs. 4,500/- MRP : Rs. 7,400/- MRP : Rs. 8,500/-

Ex-Factory Sale Value Margin: is % Profit on Selling Price (MRP-Ex-Factory Sale Value) X 100 MRP

Capping Markup between Ex fcy / Landed & MRP List Of Notified Medical Devices No.

Name of Device

Transcation

< 1000

1000-1.00 Lac 1.00 Lac Plus

Disposable Hypodermic Syringes

B2C

Disposable Hypodermic Needles

B2C

Disposable Perfusion sets

B2C

IV Cannula

B2C

Scalp Vein Set

B2C

Intra Ocular Lenses

B2C

Surgical Dessing

B2C

Umbilical Tapes / Ligatures / Sutures and Staplers

B2B2C

Catheters

B2C

Internal Prosthetic Replacements

B2C

Orthopaedic Implants

B2C

Bone Cement

B2C

Heart Valves

B2C

Blood / Blood Components

B2B

Blood Grouping Sera

B2B

X4(?)

In Vitro Diagnostic Devices for HIV HBsAg and HCV B2B

X4(?)

Cardiac Stents

B2C

Capped

Drug Eluting Stents

B2C

Capped

Intra Uterine Devices (Cu-T)

B2C

Capped

Condoms

B2C

Capped

Tubal Rings

B2C

Ablation Devices

Sept.-Oct. 2019

Cover Story Trade Margin Rationalization Formula (1) Imported

Use PRICE CAPPING For Devices with identical speces & innovation BUT with excessive price disparity

Trade Margin Rationalization

Formula (1) Imported Cost of Manufacturing

Add Duty 7.5% + GST

Total

100

Add Margin

30 (25%)

Indian Manufacturer

Price to Distributor

130

Cost of Manufacturing

Add Reseller Margin – 66%

170 (56%)

Add Duty 7.5% + GST

MRP

300

Total

Add Margin

20 (20%)

Price to Distributor

100

Add Reseller Margin – 66%

200 (66%)

MRP

300

Trade Margin Rationalization Formula (2) Imported

You will notice that Reseller will have slightly less margin in Formula 1 so may prefer to sell Indian Devices unless Consumer has strong Brand pull and insists for imported.

Trade Margin Rationalization Consumer gets same price for imported or Indian in formula 1 but pays 3 times Indian prices in formula 2 but he will not have choice to buy Indian as Trade / Hospital will push him imported as they make more money in Formula 2.

Formula (2) Imported

Indian Formula (2) Manufacturer Imported

Formula (1) Imported

Cost of Manufacturing

Add Duty 7.5% + GST

Total

100

Total

100

Add Margin

200 (67%)

Add Margin

20 (20%)

200 (67%)

30 (25%)

Price to Distributor

300

Price to Distributor

100

300

130

Add Reseller Margin – 66%

600 (66%)

Add Reseller Margin – 66% 200 (66%)

600 (66%)

170 (56%)

MRP

900

MRP

900

300

You will notice that Reseller (Dealer / Hospital / Retailer) will have highest Margin in Formula 2 so they will prefer to sell imported devices

So, Formula 1 gives a minor strategic competitive advantage to Indian Products & Formula 2 gives major strategic competitive advantage to importers.

From Table 1, the percentage of tender deviation is approximately 38% accounting to 80 tenders which are asking exclusively for foreign regulatory approvals in India. Of these deviations the GoI or Central government organizations have shown overall 26% deviation while Haryana state government alone has shown about 20% deviation as shown in graph 1 below.

Considering the high value and importance of medical device equipments in the field of Radiology and Cardiology, NMDPC has further assessed deviation of tenders into three categories, namely – 1. Radiology, 2. Cardiology, and 3. Others. It is found that of the total deviations 36% of tender deviations fall under Radiology and Cardiology categories.

Graph 1: Tender Deviations amongst State and Central organizations

Sept.-Oct. 2019

Way Forward: Transparent procurement practices with adherence to Public Procurement Order 2017 can open a lot of avenues for Indian manufacturers, provided payments are also settled with the manufactures in a timebound manner. Secondly, National Medical Devices Promotion Council realizes that there is a distinct ecosystem advantage which can be provided to the medical device stakeholders while operating out of a cluster, considering Andhra Pradesh MedTech Zone (AMTZ) as a model cluster where common resources like infrastructure, scientific facility, testing facility, sterilization facility, regulatory enablement and market access are in complete synchrony with manufacturing. Replicating such clusters and linking them with each other or linking them to the existing clusters for enabling smooth flow of services can go a long way as far as import substitution is concerned, and thus making the best use of the capabilities which already exists.

Waste Management Hospitals generate various kinds of wastes from wards, operation theatres and outpatient areas. Plastics are a significant share of hospital general waste. 85 percent of the plastic waste generated is non-hazardous, meaning free from patient contact and contamination.

Healthcare Plastics Waste Recycling: Improves Environment & Job Creation There is very good potential in recycling healthcare / medical plastics particularly commonly used materials like PVC.

V R Patel

D L Pandya

CEO, Vir Enviro Management & Former, Deputy Chief Engineer, Gujarat Pollution Control Board

Editor & CEO, MEDICAL PLASTICS DATA SERVICE and www.medisourceasia.com

Recycling PVC diverts waste and useful resources from landfill and reduces the consumption of energy feedstock in the production of new products. It can also lead to positive environmental outcomes like Reduced Energy and Reduced Carbon Footprint along with Reducing Waste Management Costs as well as Supporting Jobs and Manufacturing.

Medical care is vital for our life, health and well-being. But the waste generated from medical activities can be hazardous, toxic and even lethal because of their high potential for diseases transmission. The management of Health-care waste is an integral part of a national health-care system. Hospitals generate various kinds of wastes from wards, operation theatres and outpatient areas. These wastes include bandages, cotton, soiled linen, body parts, sharps (needle, syringes etc), medicines (discarded or expired), laboratory wastes etc which carry infection and should be properly collected, segregated, stored, transported, treated and disposed.

Sept.-Oct. 2019

Waste Management Environmental Concerns The main environmental concerns with respect to improper disposal of bio-medical waste management are spread of infection and disease among medical / non-medical personnel, unauthorized recycling and increased toxic emissions.

Plastics: Significant Share of Hospital General Waste Plastics are a significant share of hospital general waste. There is an almost endless supply of disposable plastic materials in a typical health care facility. 85 percent of the plastic waste generated is non-hazardous, meaning free from patient contact and contamination. It is estimated that between 20 and 25 percent of such waste could be attributed to plastic packaging and products.

Global Scenario Healthcare facilities across America generate around 14 000 tons of waste per day. Up to 25% of this is made up of plastic products such as packaging. The US Healthcare Plastics Recycling Council has created a detailed guidance document to help boost recycling rates of commonly binned medical waste. By weight, almost 5 million pounds (or 40%) of plastic scrap generated at US hospitals is sterilisation wrap. Another 25% comprises other types of flexible non-woven and film packaging, while 19% represents paper, roughly 10% are rigid plastics. Around 5% is a mix of glass, metal, and foil.

Common Recyclable Plastics Some of the most common recyclable medical plastics include the following : • Tyvek, made from high-density polyethylene, is a common material used in sterile barrier packaging. • Sterilization wrap, often referred to as blue wrap, is a sterile material made from polypropylene (PP) that protects surgical instruments and other items from contamination. • Saline bottles are a common operating room product, typically made from PP. • Water pitchers, basins and trays are common patient care products, typically made from polyethylene terephthalate.

The fact is that a lot of materials are incinerated or landfilled without reason. It is estimated that the ‘vast majority’ of that medical plastic waste – up to 85% – is non-infectious. Overall, it is believed that 1 million tons of clean, non-infectious healthcare plastics is generated at healthcare facilities nation-wide every year.

As per an international expert, environmentally minded staff in hospitals have been the primary driving force in the successful implementation of recycling systems. However, the entire supply chain has a role to play. That begins with the medical device manufacturer, who should keep end-of-life issues in mind when designing devices, and extends to hospital purchasers and healthcare professionals, who are doing the actual sorting, and to the recycler and converter, who are going to buy the recyclate and make new products. While there is no organized information about the healthcare waste scenario in India, it is also likely to be similar.

Good Potential for Recycling There is very good potential in recycling healthcare / medical plastics particularly commonly used materials like PVC. It is found that PVC medical products can be separated relatively easily by hospital staff. Recycling PVC diverts waste and useful resources from landfill and reduces the consumption of energy feedstock in the production of new products and hence, there is a very good case to take-up PVC Recovery programs in line with successful global models, of course after ascertaining the Indian scenario. Sept.-Oct. 2019

Medical grade PVC is a high quality compound that can be recycled into many new soft PVC applications. It is estimated that of all plastics waste generated by a hospital, PVC medical products are about 25 per cent. Recycling PVC can be cheaper than disposing to regular waste.

International Bench-Mark Activities Estimates indicate that there are about 1 million tons of clean, non-infectious healthcare plastics generated in U.S. healthcare facilities each year. While the potential of this largely untapped waste stream is obvious; how to access this waste stream is less clear. The Healthcare Plastics Recycling Council (HPRC) - a private, technical consortium of industry peers across the healthcare, recycling, and waste management industries , recently launched the Healthcare Plastics Guide for Recyclers to help inform and educate plastics recyclers and processors about the common streams of plastic waste generated in clinical settings.

This guide includes: • •

The most commonly generated healthcare plastic waste streams. How to partner with hospitals for a successful recycling program.

Waste Management • • •

Recycling options, including common steps in mechanically processing healthcare plastics. Case studies and other helpful resources. Technical specifications for common healthcare plastics.

2. Reduced Carbon Footprint : A life cycle assessment conducted by the University of NSW showed that PVC fluid bags instead of disposing of them in either clinical or general waste resulted in a carbon footprint reduction. Also recycling PVC in comparison to incineration result in a 77 percent reduction in carbon dioxide emissions, while in comparison to land fill, there is an 18 percent reduction in carbon dioxide emissions.

One more initiative of the consortium include its flexibles projects, which will determine viable strategies for recycling multi-material flexible plastic packaging currently being discarded as hospital waste. After learning from Western Health, many Australian and also New Zealand hospitals have implemented similar programmes. Today, around 170 hospitals in Australia and New Zealand recycle non-infectious PVC-based IV bags, face masks and oxygen tubing. Every month, 20 tonnes of PVC waste is collected and recycled. The implementation of PVC recycling in hospitals is mainly driven by staff. Due to the success of the programme, PVC recycling is now part of the nursing training in Australia.

Environmental Outcomes Recycling clean PVC instead of putting it into waste bins can also lead to positive environmental outcomes like: 1. Reduced Energy: It saves energy and conserves valuable raw material resources. A recycled plastic product (including PVC) has approximately one quarter of the embodied energy compared to an equivalent product made with virgin resin.

Waste Management Savings 1. Reduce Waste Management Costs : PVC recovery in hospitals reduce waste management costs against more expensive disposal options of clinical / general waste. 2. Support Jobs And Manufacturing: Preventing quality reusable materials going to landfill, supports local jobs and manufacturing as it gets new life like hose, safety mats and many more.

Biomedical Waste Categories and their segregation & collection (As per Bio-Medical Waste Management Rules, 2016) Category Types of Waste

Type of Bag or Container to be used

Yellow

(a) Human Anatomical Waste (b) Animal Anatomical Waste

Yellow coloured non-chlorinated plastic bags

Yellow coloured non-chlorinated plastic bags or containers

(e) Chemical Waste

Yellow coloured containers or non-chlorinated plastic bags

(f) Chemical Liquid Waste

Separate collection system leading to effluent treatment system

(g) Discarded linen, mattresses, beddings contaminated with blood or body fluid

Non-chlorinated yellow plastic bags or suitable packing materials

(h) Microbiology, Biotechnology and other clinical laboratory waste

Autoclave safe plastic bags or containers

Red

Contaminated Waste (Recyclable)

Red Coloured non-chlorinated plastic bags or containers

White

Waste sharps including metals

Puncture proof, Leak proof, tamper proof containers

(a) Glassware (b) Metallic Body Implants

Cardboard boxes with blue colored marking Cardboard boxes with blue colored Marking

(Translucent)

Blue

Sept.-Oct. 2019

Waste Management Recyclable Biomedical Waste Treatment and Disposal Options Type of Bag or Container to be used

Category Types of Waste Red

Contaminated Waste (Recyclable) (a) Waste generated from disposable items such as tubing, bottles, intravenous tubes and sets, Catheters, urine bags, syringes (without needles and fixed needle syringes) and vaccutainers with their needles cut) and gloves.

Red coloured nonchlorinated plastic bags or containers

Treatment and Disposal Options Autoclaving or micro-waving / hydroclaving followed by shredding or mutilation or combination or sterilization and shredding. Treated waste to be sent to registered or authorized recyclers or for energy recovery or plastic to diesel or fuel oil or for road making, whichever is possible. Plastic waste should not be sent to landfill sites.

Amendments in Bio-Medical Waste Management Rules, 2016 Rules Bio-Medical Waste Management Rules, 2016 Rules have been amended to improve compliance and strengthen the implementation of environmentally sound management of biomedical waste in India. The amended rules stipulate that generators of bio-medical waste such as hospitals, nursing homes, clinics, and dispensaries etc will not use chlorinated plastic bags and gloves beyond March 27, 2019 in medical applications to save the environment. Blood bags have been exempted for phase-out, as per the amended BMW rules, 2018.

Salient features of Bio-Medical Waste Management (Amendment) Rules, 2018 are as follows: 1. Bio-medical waste generators including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, health care facilities, and clinical establishments will have to phase out chlorinated plastic bags (excluding blood bags) and gloves by March 27, 2019. 2. All healthcare facilities shall make available the annual report on its website within a period of two years from the date of publication of the Bio-Medical Waste Management (Amendment) Rules, 2018. 3. Operators of common bio-medical waste treatment and disposal facilities shall establish bar coding and global positioning system for handling of bio-medical waste in accordance with guidelines issued by the Central Pollution Control Board by March 27, 2019. 4. The State Pollution Control Boards/ Pollution Control Committees have to compile, review and analyze the information received and send this information to the Central Pollution Control Board in a new Form (Form IV A), which seeks detailed information regarding district-wise bio-medical waste generation, information on Health Care Facilities having captive treatment facilities, information on common bio-medical waste treatment and disposal facilities. 5. Every occupier, i.e. a person having administrative control over the institution and the premises generating biomedical waste shall pre-treat the laboratory waste, microbiological waste, blood samples, and blood bags through disinfection or sterilization on-site in the manner as prescribed by the World Health Organization (WHO) or guidelines on safe management of wastes from health care activities and WHO Blue Book 2014 and then sent to the Common bio-medical waste treatment facility for final disposal. These amendments have been made vide Notification G.S.R. 234(E) dated March 16, 2018.

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Alpha Medicare and Devices Ltd.

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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

Sept.-Oct. 2019

Global Trends

Export Opportunities for Medical Devices in Africa S.Abidi Research Advisor Govt.of Guj.-AMA Centre of International Trade

Medical Device & Equipment sector is the next sunrise sector in India, which has high growth potential. The global medical device market is consistently shifting to adopt new treatment, budgets and increase in demands.

The global medical device market is consistently shifting to adopt new treatment, budgets and increase in demands.

With close to one billion people and a GDP of approximately $1.7 Trillion, Africa presents a sizeable investment opportunity. Today, 26 of Africa’s 54 countries have achieved middle-income status. Africa has a larger portion of its population entering the workforce than any other region in the world. There are 720 million African mobile users, more than in Europe or North America. Five of the 12 fast est-growing economies in the world are in Africa. At the country-level, however, the story is less enticing. If one considers that 3 countries (South Africa, Nigeria and Egypt) account for over half of Africa’s economic activity, it is quite clear that the remaining 51 countries suffer from a lack of scale. To address these challenges, African countries have united together to establish Regional Economic Communities (RECs). These RECs aim to boost regional integration and economic development and, thereby, improve the profile and competitiveness of its member nations. The most prominent RECs in Africa include: Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), Common Market for Eastern and Southern Africa (COMESA), and East African Community (EAC). Sept.-Oct. 2019

African countries have united together to establish Regional Economic Communities (RECs). These RECs aim to boost regional integration and economic development and, thereby, improve the profile and competitiveness of its member nations. 31

Global Trends

With the signing of African Continental Free Trade Area by 44 out of 54 countries, within 2-3 years, this will become a single market. The Africa Medical Devices Market is growing with a steady pace; mainly due to the rapidly growing middle-income group, increasing healthcare expenditure, increasing number of medical tourists, proliferation of hospitals, government programs and support, and increasing incidence of life style diseases. Moreover, rising economic growth also drive the market in this region. We expect the Africa Medical Devices Market to reach around $ 7069.61 million by 2025 from $ 4900 million in 2017, by the end of the forecast period at a CAGR of 6.3 %. However, the major markets are in the mid-income countries such as South Africa, Kenya, Nigeria, Egypt and Morocco. Economies of countries like Ethiopia, Ghana and Ivory Coast are rapidly expanding to reach middle income status. The market of medical devices is growing rapidly in Africa region owing to upgrade of hospitals, introduction of health insurance policy, and rapidly growing middle-income group. Government is focussing more to improve the life of their citizens, thus they are more focusing on the establishment of best hospitals in the region. There is a large base of NGO hospitals and new private hospitals are opening at a rapid rate. Ethiopia alone will open 50 new hospitals. These are the factors which are fuelling the growth of the market of medical devices with the significant rates in this region.

However there exists huge barriers too. The most formidable barrier is the low per capita income and the poor connectivity and infrastructure of Africa. Although Africa has a large middle-class consumer base there exists the reality that approx. 60% of population survives on less than USD 2 a day. Thus, two things should be noted: African medical devices market is very price sensitive and opportunities lie at the lower end with devices with lower cost and features to dominate the segment. This presents a huge opportunity for Indian companies with frugal engineering skills. Traditionally, our exporters have concentrated their efforts on the larger markets such as South Africa, Egypt and Nigeria. African Continental Free Trade Area under implementation will create larger markets. To get entrenched in the African market, it is very important that products must be visible to the decision makers and influencers on a regular basis through regional trade fairs, both on East & West coasts. At present, our Export Promotion bodies can only cover a fraction of the markets. Exporters, especially SME should join hands and cooperatively book smaller stalls which can be manned by one or two representatives on behalf of all exhibitors. They can also distribute composite directories of their products to the visitors which can act a reminder when they go to their work places. In this manner, small exhibitors can participate in more exhibitions and create greater visibility for their products.

Sept.-Oct. 2019

Conference Highlights

Sept.-Oct. 2019

AiMeD & BCIL Seek Regulatory Framework On Medical Devices New Delhi, Oct 5 (IANS) A joint conference was organised in New Delhi on Saturday by Association of Indian Medical Device Industry (AiMeD) and Biotech Consortium India Limited (BCIL) supported by Department of Pharmaceuticals (DoP) on comprehensive regulation of medical devices.

"They seek a comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as they get discouraged to be regulated as Drugs," said Chugh. GST on medical devices is in favour of imports and is detrimental to Make in India, he added.

The discussion highlighted the current state of the beleaguered domestic industry of Indian medical devices. The private sector urged the government to expedite steps to end the 80-90 per cent import dependence forced on the industry, which results into an import bill of over Rs 38,837 Crore.

"MSME sector has been worst hit with huge job losses...MSME dominated medical domestic manufacturing which took a hit post GST as imports became 11 per cent cheaper. Imports of medical devices are up by record 24 per cent, from 31,386 crore in 20172018 to 38,837 crore in 2018-2019", said the private sector statement.

"Expedite steps for patients'' protection, stronger quality &amp; safety regulations, price control, to make medical devices and quality treatment accessible and affordable and ethical indigenous manufacturing viable", said a statement. Dr. Vinod Paul, Member, NITI Aayog, emphasized on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical devices to the patients is incorporated in government policies. Gurmit Chugh, Joint Coordinator (AiMeD) said that the manufacturers have been confused with informally choosing of products and notifying them as drugs.

The private sector sought a pro-active policy formulation to regulate medical devices differently than drugs, as it will lead to free market dynamics and keep regulations simple, consumer friendly and incentivise ''Make in India''. "The Indian Medical Device Industry is very hopeful that right from trade margin rationalization to ensuring a separate set of legislation and regulatory framework to govern the medical device sector and everything in between will be looked afresh and hastened up by Modi Government to galvanise the domestic medical device manufacturing sector." said Rajiv Nath, Forum Coordinator, AiMeD. https://www.outlookindia.com/newsscroll/aimed-amp-bcil-seekregulatory-framework-on-medical-devices/1634729

Govt Issues Draft Notification To Bring All Medical Devices Under Single Regulatory Framework The union health ministry has come out with the draft notification, making it mandatory for all the devices to get certified by the Central Drugs Standard Control organisation, India’s drug regulatory authority. According to the draft notification, while certification by the regulatory authority will be on voluntary basis up to 18 months from date of notification, thereafter it will be made mandatory. To ensure that all imported as well locally made medical devices meet certain quality standards, the health ministry has proposed to regulate all such equipment used on human beings or animals. The union health ministry has come out with the draft notification, making it mandatory for all the devices to get certified by the Central Drugs Standard Control organisation (CDSCO), India’s drug regulatory authority. According to the draft notification dated Oct 18, "In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs

with effect from the 1st day of December, 2019," the draft notification reads. According to the draft notification, while certification by the regulatory authority will be on voluntary basis up to 18 months from date of notification, thereafter it will be made mandatory. The country's top advisory body on drugs, the Drugs Technical Advisory Board (DTAB), had in April recommended that all medical devices should be notified as drugs under the existing Drugs and Cosmetics Act. ET had first reported about the government’s agenda to bring medical devices under regulation. The government decided to update its review process in the wake of recent case of Johnson & Johnson (J&J) hip implants which left many people permanently disabled due to the faulty device. As part of the draft notification, “all devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others”, will be regulated under the legislation. Such medical Sept.-Oct. 2019

devices also include those which are used for the purpose of supporting or sustaining life, disinfection of medical devices. Rajiv Nath, Forum Coordinator, AiMeD “What’s missing in covering note is assured road map to a separate medical devices law with a defined transition period and in a phased manner, in addition to the voluntary registration as a temporary measure under the current Drugs Act”. The stakeholders have been given a month to respond to the draft notification. The manufacturers, importers will have to upload information about their devices on the “Online System for Medical Devices” established by CDSCO for this purpose. Once the information is uploaded a registration number will be generated which the manufacturers will have to put on the label of the medical device. The manufacturers will also have to have certificate of compliance

with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of their medical device. The importers will also have to also obtain free sale certificate from country of origin before they enter the Indian market. Once notification comes into effect, the Central Drugs Standard Control organisation (CDSCO) will be the nodal authority to investigate quality, safety related failure, complaints and can suspend the registration based on the outcome of investigation. Currently there is no mechanism for reporting the malfunctioning of non-notified medical devices. Once notified, there will be an effective product recall system, inspection of manufacturing sites by CDSCO. (Ref : The Economic Times , Octo.18, 2019)

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

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Industry News Niti Aayog proposes separate regulator for medical devices

The ministry had issued a draft notification saying that all medical devices would come under the category of drugs from December 1 and would be regulated under the Drugs & Cosmetics Act. Oct 29, 2019 NEW DELHI: Government think tank Niti Aayog has rejected the health ministry’s proposal to bring medical devices under the Central Drugs Standard Control Organisation (CDSCO), saying the body does not have the required expertise. People aware of the matter said the Aayog has instead moved a draft Bill proposing that medical devices be governed by a separate regulator. Earlier this month, the ministry had issued a draft notification saying that all medical devices would come under the category of drugs from December 1 and would be regulated under the Drugs & Cosmetics Act. A senior official confirmed to ET that there is some support for Niti Aayog’s view in the government that it is inappropriate to allow CDSCO to regulate medical devices as they have expertise in pharmacy/chemicals and not in devices. People familiar with the development told ET that the Aayog has floated a draft Bill to regulate over 6,000 bio medical devices in the country. “The Bill proposes a separate regulator for medical devices on the lines of the Food Safety and Standards Authority of India (FSSAI), an autonomous body under the health ministry,” one of the persons cited earlier said, requesting not to be named. In India, only 23 categories of medical devices are regulated under the Drugs and Cosmetics (D&C) Act. The ministry’s notification said all medical devices will be brought under regulation in a phased manner. It has proposed seven categories of devices intended for use in human beings or animals as drugs with effect from December 1, 2019, while ultrasound equipment would be treated as drugs from November 1, 2020. “Ministry of health should clearly define that its current regulations to define devices as drugs and their regulation by CDSCO is a temporary measure till a separate medical devices law and a competent regulatory authority is formed as devices are not drugs,” Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry said. 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. https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/niti-aayog-proposes-separate-regulatorfor-medical-devices/articleshow/71798635.cms

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Sept.-Oct. 2019

Industry News India Wooing Japanese Medical Device Firms to Cut Reliance on US The government is exploring all possibilities to attract Japanese investment in India’s medical devices sector, a move which is likely to reduce the country’s dependence on US manufacturers. Price curbs imposed on medical devices have irked US companies and become a key trade issue between Washington and New Delhi. Even as the US is sparring with India over this, the focus is now on fast-tracking investments from other countries, especially Japan, said people who are part of the discuss .. PD Vaghela, the secretary at the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers, held a high-level meeting with industry executives and government officials to discuss the current status of investments in medical devices, how to maximise Japanese investments and the regulatory issues. Representatives of Japanese companies like Omron Healthcare, Teremo Corp, Shimadzu Corp, Sysmex Corp, Horiba India, HitachiNSE -1.18 % India, Toshiba, CuraNSE 0.00 % Healthcare and the Japan Federation of Medical Devices Association, and the first secretary at the Embassy of Japan in India attended the November 8 meeting. Officials from the Ministry of Health, Department of Promotion of Industry and Internal Trade, Drug Controller General of India, and representatives from the CII, Ficci, Andhra Pradesh Medtech Zone and the Association of Indian Medical Device Industry (AiMed) were also present. “Top government and industry representatives from Japanese companies and India deliberated various ways of strengthening the partnership between both countries,” said a person.

While Japanese brands have been household names in India for cameras, TVs and automobiles, the US remains the largest exporter of medical devices to India, followed by Germany, China, Singapore and the Netherlands. The government is now looking at enhanced cooperation from Japanese investors to strengthen the domestic capacity of medical devices. “Economic relations between India and Japan have vast potential for growth, given the similarities that exist between the two countries. Vision 2025 outlined by both countries aims to strengthen Indo-Japan relations by synergising business partnerships, facilitating investments and creating an empowering environment in India for Japanese investments. The meeting was held in view of that,” said a senior government official. India’s medical device market is projected to grow to $50 billion by 2025 from $10 billion now. It is the fourth largest in Asia, after Japan, China and South Korea. 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. While India allows 100% foreign direct investment in medical devices on the automatic route, investors have been wary due to the current regulatory environment. India’s decision to slash prices of coronary stents by 85% in 2017 and then capping the prices of knee implants affected US exports, US trade representative had said in 2018. economictimes.indiatimes.com/articleshow/ 72016205.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

TSIIC Allocates 20 Acres Land To Set Up Cardiac Stent Manufacturing Unit At Medical Devices Park In Telangana The Telangana State Industrial and Infrastructure Corporation (TSIIC) has allocated 20 acres of land to set up Asia’s largest cardiac stent manufacturing plant at medical devices park located at Sultanpur in Sangareddy district of Telangana. As part of this programme, Indian medical device company, Sahajanand Medical Technologies (SMT) has come forward to invest Rs. 250 crore to set up the unit. SMT is India’s second leading provider of cardiac stents in the country and abroad. During the inaugural ceremony of the programme, Telangana health minister said, Telangana state government is committed

to make the state a hub for pharma, biotechnology and medical devices sectors in the country. “Already Telangana is known for its bulk drugs, formulations and vaccine manufacturing industries in the country. Now we have decided to make Telangana the medical devices manufacturing hub and had long back established a special economic zone (SEZ) for the same. With this new investment, SMT will set up its state of the art southern regional manufacturing campus which is expected to manufacture 1.25 million cardiac stents per annum from this unit. http://pharmabiz.com/NewsDetails.aspx?aid=117952&sid=1

Medical Devices Exporter Poly Medicure Eyes 17-18% Revenue Growth The New Delhi-based Poly Medicure Limited, one of the leading manufacturer and exporter of medical devices, is eyeing 17-18% revenue growth for the next financial year 2019-20.

with a sharper focus on innovation. We will also focus on US and European markets in near future and will be expanding our reach in Africa”.

The company is expanding its manufacturing footprint by investing in capacity expansion to meet new demand over the next few years.

The company is also planning to launch new products in core therapy areas in vascular access, infusion therapy accessories, dialysis, blood management and diagnostic in near future. With its strong research and development (R&D) initiatives, the company has been granted 230 plus product and process patents globally and has also filed for grant of an additional 210 plus patents.

On expansion, Himanshu Baid, MD, Poly Medicure said, "We are setting up a new plant at Mahindra Special Economic Zone (SEZ) in Jaipur and also doing phase 2 expansion of IMT Faridabad plant. Besides, we are doing further capacity expansion in the existing plants in Faridabad. We have registered growth in most of our key markets and hope to continue this momentum Sept.-Oct. 2019

http://pharmabiz.com/NewsDetails.aspx?aid=118074&sid=1

Nu-Vu Conair Pvt. Ltd. Opens A New Factory In Ahmedabad Nu-Vu Conair Pvt. Ltd., one of the leading manufacturers of Plastic Auxiliary Equipment in India inaugurated its new fabrication facility in Ahmedabad on 8th Aug 2019. This facility houses ultra-modern fabrication machinery such as Laser Cutting machine, CNC Press Brake, CNC Rolling Machine and Automatic Welding Machine. This new initiative is a part of our ‘Continuous Improvement’ program encompassing all business functions of the company and will enable us to meet stringent quality standards and tight delivery schedules. It will also help us provide customized solutions to our customers in fastest possible time frame.

The event was graced by Mr. Bill Hricsina, International Business Manager, Conair USA in the presence of management team of NVC and employees of the company. Nu-Vu Conair Pvt. Ltd. is a customer centric company that strives to deliver innovative solutions and high quality, reliable plastic auxiliary equipment backed by efficient service & support. This new factory is one more step towards achieving that goal.

About Nu-Vu Conair Pvt. Ltd. Nu-Vu Conair Pvt. Ltd., Ahmedabad, India is a joint venture company between Nu-Vu Engineers, Ahmedabad and The Conair Group, a leader in auxiliary equipment for plastic processors; headquartered in Cranberry Township, PA, U.S.A. Conair has manufacturing facilities in the USA in addition to India and manufactures 450 different products. The company also owns two world-class R & D (Research & Development) labs. We, Nu-Vu Conair Pvt. Ltd. are a leading manufacturer of plastic auxiliary equipment in India. We have state-of-the-art manufacturing facility in Ahmedabad to manufacture central vacuum conveying systems, drying systems, gravimetric blending systems, chillers and mould temperature control units, crystallizers, belt conveyors, granulators and more for polymer processors. We have a PAN India and global presence with highly trained sales and service engineers to serve our valued customers. Nu-Vu Conair has garnered a significant level of trust in the market by offering worldclass plastic auxiliary equipment, value added services and customized solutions.

Reach Us : Nu-Vu Conair Pvt. Ltd. Plot No. 147, 148 & 154, Devraj Industrial Park, Piplaj - Pirana Road, Piplaj, Ahmedabad - 382405 Phone: +91 79 2970 8147, +91 97129 28201 Email: marketingindia@conairgroup.com | Website: www.conairgroup.com/india

Sept.-Oct. 2019

Product Gallery Qosina Is the One-Stop Source for Tuohy Borst Adapters Ronkonkoma, NY, USA, October 3, 2019 Qosina is pleased to carry over 40 different configurations of tuohy borst adapters in sizes ranging from 0-18 FR. A tuohy borst adapter, which is a three-piece assembly comprised of a body, gasket and cap, is commonly used to prevent the backflow of fluid and facilitate catheter introduction. The silicone valve and cap torque around a tube or instrument to hold it in place. Tuohy borst adapters from Qosina are costeffective, durable and easy to build into a design. Because Qosina carries so many different styles available off-the-shelf, they can provide customers with a number of solutions. Qosina also carries build-it-yourself options for custom configurations based on customers’ applications. Qosina offers tuohy borst adapters with various connection types such as female luer lock, male luer lock, male luer with spin lock, barbed, threaded and tubing port. Qosina also stocks tuohy borsts with or without sideports, and in small or large-bore body types. Qosina will be showcasing its tuohy borst adapters, in addition to its thousands of stock components, at booth 1816 during MD&M Minneapolis at the Minneapolis Convention Center, October 23-24.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, justin-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

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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

Leading International Trade Fair 18 - 21 November, 2019 Dusseldort, Germany

Compamed 2019 Leading International Trade Fair 18 - 21 November, 2019 Dusseldort, Germany

Medicall 2019 India's Largest & No. 1 Medical Equipment Exhibition 13 – 15 December 2019 Mumbai

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

Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Sept.-Oct. 2019

Sept.-Oct. 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

Sept.-Oct. 2019

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 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

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

Sept.-Oct. 2019

National Healthcare

GMP ISO - 9001-2008 Certified Company

An ISO 9001 : 2008 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 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 Sept.-Oct. 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 43

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.

Sept.-Oct. 2019

Medical Plastics Data Service Magazine September - October 2019

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