Medical Plastics Data Service Magazine May - June 2016

Table of

Contents Vol. 24

No. 3

May. - Jun. 2016

22 Cover Story

• Effective Vendor Management For Medical Device Industry Companies serving other markets are shifting their focus to medical technology due to the stability of the marketplace. While many of them have good intentions, they often don’t understand the complexities of medtech manufacturing. Although manufacturers are ultimately responsible for complying with regulations and standards, their vendors should…........

• Supplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance - Ms. Preeti Vani, Plant Head, Sahajanand Laser Technology, Gandhinagar Global regulatory compliance is important because in today’s world of globalized supply and demand networks, companies need to efficiently optimize the supply base given a broad set of requirements that go well beyond cost. To effectively do this, companies should……….

• Medtech Companies Need Collaboration With External Partners For Innovation And Growth

36 Technology • Innovative Computer-Aided Catheter Reprocessing System (CRS) for Cleaning Catheters De veloped By Chandigarh Biomedical Engineer CRS machine intends to replace the conventional method for cleaning of catheters. The machine is ……

• India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector The med-tech industry, both domestic and international, has generally welcomed India’s new intellectual property rights (IPR) policy, in large part due to…...

35 Product Gallery • Qosina Adds 40 Enteral Feeding Connectors that Meet the ISO 80369-3 Standard

25 Global Trends • Medical Adhesives : Fastest growing Segment

31 Industry News • • • • • •

Andhra Med Tech Zone Gets Formal Registration To Set Up Asia’s First Dedicated Medical Devices Park Gujarat Govt Allocates Land For Setting Up Medical Device Park At Sanand Industry Wants ICMED Certification Mandatory For All Medical Devices Marketed In India India And Japan To Seek Regulatory Collaboration For Medical Products Separate Rules To Spur Medical Devices Sector Soon Centre To Notify Revised Schedule M III For Medical Devices By June End

20 Did You Know?

• About Best Practices to Ensure Good Supplier Management

38 Events • • • • • • • May-June 2016

Medicall 2016, 15th Edition: July 22 – 24, 2016, Chennai. / 16th Edition: Sept. 09 – 11, 2016, Delhi.

ICMD Autumn 2016: 30st August - 1st September 2016. China.

Medical Manufacturing Asia: Aug. 31st – Sept. 2nd, 2016.

K 2016: Oct. 19 – 26, 2016.

CMEF 2016: 29 October - 1st November 2016. China MEDICA and COMPAMED 2016: 14-17 November 2016. Germany.

Medical Fair India 2017: April 06 - 08, 2017

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Flashback Jan. - Feb. 2004 From Editor’s Desk Dear Readers, First of all, I am pleased to inform our readers that, the Seminar on “Medical Plastics: Materials, Applications And Processing For Medical Devices And Pharmaceuticals Industries” organized by “MEDICAL PLASTICS DATA SERVICE” was a big success .More than 150 participants attended the Seminar which was first of its kind in India. Presentations were made by leading Companies and professionals from the Medical Plastics / Devices Industries as well as research institutions.

Participants represented Medical Product Manufacturers, Machinery Manufacturers, Raw Materials Manufacturers, Consultants, Marketing Companies, Research & Academic Institutions, Publications from all most all parts of the country including Chennai, Trivandrum, Mumbai, Hyderabad, Gujarat, New Delhi, Kanpur, Gwalior, Chandigarh etc.

On behalf of “MEDICAL PLASTICS DATA SERVICE” and the Indian Medical Devices/Plastics industry, we thank Dr Sushil Verma, Director General, Central Institute Of Plastics Engineering & Technology, (CIPET), Chennai for not only accepting our invitation to inaugurate the Seminar but also deliver a thought provoking presentation on “ Plastics - A Front Runner In Medical & Healthcare Applications”. We are happy to reproduce the presentation in the issue.

We also acknowledge with most sincere gratitude, the contributions by all the following learned speakers and the leaders of the industry for sharing their valuable experience with the participants of the Seminar.

CONTENTS • Cover Story Plastics - A Front Runner in Medical & Healthcare Applications • Seminar Report : Seminar on "Medical Plastics : Materials, Applications And Processing For Medical Devices And Pharmaceuticals Industries" • Global Trends Innovative Miniature Plastic Parts : Microtechnology Is Becoming Established In Medicine • Industry News - Medical part cos to benefit from expansion in health sector - Budget Impact on Pharma - Hindustan Latex, Chinese co in JV for contraceptives - Pharmaexcil action plan to be in by April • Did You Know ?

About Coatings For Blood-Contacting Devices • Events - HOSPIMedica ASIA 2004 • Events Calendar

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Did You Know ?

?

About Best Practices to Ensure Good Supplier Management.

Companies that manage their suppliers well, do so through a number of best practices. They carefully select and contract with their suppliers, often with deep involvement from the internal quality organization, and they identify vendors that deal with the most critical aspects of their product and invest heavily in training and monitoring them. Finally, they are highly disciplined about cutting off even preferred suppliers once it is clear that quality performance has dropped. They also recognize that resources for supplier management often do not reduce with improved quality, unlike in manufacturing, for example.

Communication with vendors has to be purely professional and confidential. Vendors should be allowed to place their suggestions in front of top bosses in a well managed forum. The vendor’s suggestion is the most valuable piece of advice, as regards consumer satisfaction. In case a product is not achieving good sales, suggestion from vendors can be used to rectify the mistakes.

A close watch needs to be kept on the performance of vendors. The contract signed should ensure good profit margin to the company as well as the vendors.

The company and vendors can help each other by advertising in television media or via brochures, by sharing the costs. On monthly basis, vendors should be encouraged to have open discussions with vendors selling similar products. This will promote exchange of ideas, sharing of needs of consumers, different approaches and strategies to maximise sales.

In addition, multiple interviewees suggested establishing an industry certification and shared auditing program for suppliers to drive quality and standardization.

(Ref.: https://doctors.practo.com/best-practices-medical-vendor-management/ http://www.fda.gov/downloads/aboutfda/centersoffices/ officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm277323.pdf)

In a Nutshell....

“Beware of false knowledge; it is more dangerous than ignorance.”

- George Bernard Shaw

May-June 2016

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

ASSOCIATE EDITOR Ms. Bishuna Singh, B.E. (Biomedical Eng.)

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. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, 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 Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India.

Dr. J. V. Tyagi Consultant, Medical Device Certification 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 :

Editor’s Desk

From the

A strong supply chain is essential to support Indian Medical Device Industry in order to accelerate the “Make-in-India” process. However, it is also essential that the companies select potential suppliers, contractors and service providers with due care. After all, Medical Device Company not the supplier – is responsible for complying with regulations and standards. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency in terms of time, cost and quality.

This issue highlights critical issues related to effective Vendor Management for Medical Device Industry. We highly appreciate Ms Priti Vani, Plant Head, Sahajanand Laser Technology Ltd for contributing an article on “Supplier Quality Management” and sharing her knowledge and experience with our readers. We appeal all the Executives of Indian Medical Device Industry to come forward and contributes articles related to their areas of specialization.

Strengthening the Ecosystem for Innovations, Growth and sustainability is the need of the hour for Indian Medical Device Industry. Creation of Medical Device Parks in the country is an important requirement for strengthening the ecosystem. Governments of Andhra Pradesh and Gujarat have taken active steps in the direction. “Andhra Med Tech Zone, ( AMTZ )” will be Asia’s first dedicated Medical Device Park to be established in an area of 226 acres at Vishakhapatnam in Andhra Pradesh. AMTZ is the brain child of Dr Jitendar Sharma, Head, Health Technology Dept., National Health Systems Resource Centre and advisor to Chief Minister of Andhra Pradesh for Health and Medical Technology. Government of Gujarat has also allocated land for setting up Medical Device Park at Sanand. As per Dr H G Koshia, Commissioner, FDCA Gujarat State, “Medical Device Park is very relevant for Gujarat as the state has 135 licensed Medical Device Companies as against 240 in the entire country”. As per Dr Koshia, “setting up of this park will bring about quality, compliance and cost effectiveness”.

On the regulatory front also, there are many developments. After the development of ICMED, the country’s first indigenously developed quality assurance system, a joint initiative of AIMED and Quality Council of India, the Industry now wants ICMED Certification mandatory for all Medical Devices marketed in India. The Government of India has also agreed to align Schedule M III with ISO 13485 by delinking it from Schedule M for Pharmaceuticals industry. The revised Schedule M III is expected to be notified by end June 2016. The recently announced new IPR Policy is also expected to spur Innovation in Med – Tech Sector.

Image Virtual Creation, Ahmedabad-58 •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.

May-June 2016

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Cover Story Effective Vendor Management For Medical Device Industry Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency — in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

There are a lot of contract manufacturers that are shifting their focus to medical technology due to the stability of the marketplace as compared with the automotive or aerospace industry. While many of them have good intentions, they often don’t understand the complexities of medtech manufacturing.

However, for Medical Device Manufacturers, their suppliers are their partners.

Although they are ultimately responsible for complying with regulations and standards, their vendors should provide support by being compliant themselves.

The manufacturer of the finished device — not the supplier — is responsible for compliance. However, the regulations also specify that device manufacturers should select only suppliers with the capability to provide quality products. It is said that, “Quality cannot be inspected or tested into Products and Services.

It must be built into device.”

Medical Device Manufacturers should identify suppliers that have a successful track record in the device industry.

They should be competent to satisfy quality and regulatory needs.

Purchasing Controls: It is necessary to establish and maintain quality requirements for suppliers, vendors, and contractors.

Medical Device manufacturers should evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.

The major issues that impact a device manufacturer’s Compliance efforts are: 1 Vague Quality Requirements: Not having quality requirements for suppliers is one of the major problems.

Working closely and collaboratively with suppliers in creating and documenting the criteria is very essential.

This result in making suppliers part of quality process which in turn results in better quality for your materials/ components. It will also help manufacturing to produce high quality products at reasonable cost.

2 Participation in Validation: It is god to prefer suppliers that implement meaningful validation program.

This along with strict change control is very essential. It is also necessary to ensure that suppliers are notifying us of any changes that take place in material and/or processes.

For, effective Vendor Management, some of the important considerations are: • Getting the right references from the suppliers.

• Installing good software system to have a robust audit program.

• Use of latest technology to incorporate purchasing controls in the Quality Management Systems (QMS) • Ensuring that the suppliers and their suppliers/subcontractors are in harmony and the suppliers have control over their outsourcing process.

Medtech Companies Need Collaboration With External Partners For Innovation And Growth As per a recent global study by “PwC Health Research Institute”, Medtech executives are beginning to appreciate that innovation must occur outside of traditional research and development units, they cocreate — that is, they involve customers or external partners from idea generation to execution — on onethird or less of their products and services. Most Medtech companies identify “open innovation” — external and internal people generating and commercializing ideas together — as one of the top two approaches that will generate the most growth. Nearly 81% of executives have plans to collaborate with strategic partners during the next three years, but more than half said a major challenge is finding the right partners. How they collaborate with these partners will be key.

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May-June 2016

Cover Story Supplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance

Preeti Vani Plant Head (Medical Division) Sahajanand Laser Technology Ltd.

The quality of supplier’s product or service plays a vital role for the quality of final product manufactured by Medical Device Manufacturer. Hence, supplier quality management is a critical part of the quality management system. Supplier Quality Management is a confidence in supplier’s ability to deliver a good product or service that will satisfy the customer’s needs. It can be achieved through interactive relationship between the customer and the supplier; it aims to ensure that product is ‘fit’ to the customer’s requirements with little or no adjustment or inspection.

Every manufacturer in the healthcare industry is required to document the qualification of suppliers and the ongoing evaluation of those suppliers. Supplier qualification and evaluation activities should be strategic. There are no specific rules and regulations on how supplier qualification and evaluation is done. The only requirement is that company shall have a procedure, do it and keep records. Now the recently updated quality management standard ISO 13485:2016 has enhance supplier qualification requirement. The standard suggested to use risk based approach for it.

Thus, risk based approach for supplier management includes following phases and activities.

1. Planning Planning phase includes various activities like Identification of Product or services to be obtained from the supplier, Technical and process information of the product or service to be purchased, Identification of potential suppliers, Identification of risk and Identification of controls to reduce the associated risk.

Identify what type of service or product need to be purchased from the external source. It can be critical raw material, consumables used into the manufacturing process, packaging material. Services to be obtained from supplier include sterilization, calibration, validation, design, manufacture, transport, external quality testing of product or consultant etc. Finished medical device may also become supplier’s product for own brand labelers.

After identification, define the technical requirement of to be purchased product. Technical requirement can be product specifications, part requirements, some detail about its manufacturing process or work instructions. This can be comparable to your existing supplier or other potential suppliers.

Later, prepare a list of potential supplier who can provide you the product or service you want. Collect and make a list of name and contact information of all potential supplier. Now identify the risk May-June 2016

associated with it. Also, identify the controls associated with the product for both of manufacturer and supplier. Controls can be auditing the supplier facility, supplier’s quality management system certificate and other required regulatory certificate, certificate of analysis with each supplied batch, batch size and lot size required at each order time, Inventory control, traceability, change control and quality system records. These are the important controls; require following for the supplier. Assess the supplier based on this controls. These controls can address and control the identified risks associated with product.

2. Supplier Evaluation And Qualification Potential suppliers for proposed product or service shall be selected. Their contact details are saved into database. Selection of supplier from the database is done based upon its business capability and operational capability. A potential supplier’s business conduct, practices, reputation and financial viability may provide useful information about the business capabilities of that supplier.

A potential supplier’s business capability could have an important effect on a manufacturer’s ability to deliver safe and effective devices. The financial viability of the potential supplier is particularly important especially when a manufacturer intends to enter into a long-term partnership. Investigation of the supplier’s technological capability should include the assessment of the supplier’s ability to meet the manufacturer’s product and/or service specifications.

Things to consider may include the adequacy of manufacturing processes or equipment, information technology, system infrastructure, engineering resources, etc.

The scope of the investigation may include the supplier’s past performance, experience, expertise, and human resources. Based on that, supplier evaluation criteria are fixed and all potential suppliers are evaluated based on that. Communicate with supplier and evaluate its ability to fulfill the requirements for manufacturers.

Thus, evaluate and qualify the supplier.

It Should Be Supported By Following Documents.

• The manufacturer’s assessment of the supplier’s resources (e.g. facilities, personnel, infrastructure), current product/ service portfolio • Documentation and records provided by the supplier, such as environmental control records, equipment maintenance programs, calibration records, qualification records of appropriate personnel, process validation records, capacity planning, certificates, etc.

Based on the evaluation and acceptance criteria, supplier qualification should be done and shall be supported by necessary documentation.

On selection of supplier for particular product or process, manufacturer and supplier should sign a quality agreement with agreed terms and conditions. It should mention the time period of the contract, other business and quality requirements. It should be thorough enough to be used as a reference for any violation that may occur in future.

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Cover Story 3. Verification Of Purchased Product And Purchasing Information Supplier performance assessment is a continuous process. It is done by verifying the purchased product. Establish inspection plan for each batch or lot of supplied product to verify it against the product requirements. The extent of these verification activities is based on the supplier evaluation results and proportionate to the risks associated with the purchased product.

When any changes occur to the purchased product, the manufacturer should determine whether these changes affect the final product quality or not. Certificate of analysis must be included into the purchasing information for each supplied batch or lot. It mentions the product specification, acceptance criteria, procedures or equipment used, whenever necessary. This purchasing information shall be maintained for the purpose of traceability. Any changes occurred in the processing or specification of product that may affect the final product quality, supplier should notify to manufacturer in this regard by written communication. Change control should be maintained by both supplier and manufacturer.

4. Supplier Monitoring And Re-Evaluation After selecting supplier for any particular product or services, Supplier monitoring and re-evaluation is a continuous process. It is required to be done in a timely manner. Make a qualification plan for monitoring and re-evaluation of suppliers. It should be separate for each supplier. Assess the supplier performance during this period and give the ranking to it. Performance is checked based on supplier’s ability to deliver good products, delivery time, supplier initiated issues, supplier- initiated change requests, supplier facility audit, change control etc. Monitor the Phase-1: Planning Activities: a. Identification of Product or services to be obtained from the supplier b. Technical and process information c. Identification of potential suppliers a. Identification of risk associated and its impact on quality of final product b. Identification of control

Phase- 2: Supplier evaluation and qualification Activities: a. b. c. d. e. f.

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Supplier’s business capability Supplier’s technical capability Planning for evaluation and qualification of supplier Communication with supplier and supplier facility audit Supplier acceptability Quality agreement with supplier

Phase-3: Verification of purchased product and purchasing information Activities: a. Purchased product inspection plan b. Verification of purchased product against requirements c. change control maintenance for both supplier and manufacturer

Phase-4: Supplier monitoring and re-evaluation Activities: a. Supplier monitoring and re-evaluation plan b. Supplier performance assessment c. Supplier facility audit plan performance of supplier for meeting the requirements of the purchased product. These results of the monitoring provide an input into the supplier re-evaluation process. Non-fulfillment of purchasing requirements shall be addressed with the supplier; discuss the risk associated with the purchased product and its failure to comply with applicable regulatory requirements.

Figure 1 summarizes The Supplier Qualification And Evaluation Process In Brief.

Figure-1: Flow Chart Of Supplier Qualification And Evaluation Process • Supplier Facility Audit: Supplier audit constitute major part of the supplier qualification programme. It should also be conducted on regular bases as continuous evaluation of supplier. Make audit strategy and prioritize the audit based on risk. One manufacturer may have number of suppliers. Each supplier facility cannot be audited. Hence, decide it based upon quantifying supplier risk, accounting for both performance and criticality; we can effectively prioritize issues that require the most attention. It is advisable to treat these external risks similar to internal insufficiencies or gaps. Employing CAPA or deviation management techniques, as you would in-house, will mitigate supplier risk while also avoiding the same issues from arising in the future. Supplier audit frequency is also to be decided in audit plan.

These all requirement fulfills the supplier quality management requirement and allows medical device manufacturer for global regulatory compliance. Global regulatory compliance is important because in today’s world of globalized supply and demand networks, companies need to efficiently optimize the supply base given a broad set of requirements that go well beyond cost. To effectively do this, companies should begin to use a risk based approach that looks at both the criticality of a supplier and the likelihood of failure of a supplier. By applying standardized risk and audit tools, the long term successes of initiatives around supplier quality are much more likely to succeed.

May-June 2016

Global Trends Medical Adhesives : Fastest Growing Segment Adhesives are critical components in the design and manufacture of the majority of medical devices. As medical devices become smaller and more complex, greater demands are being made on the materials and components used in them. New advances are widening the performance envelope for medical adhesives.

Variations in polymer compositions, coupled with compounding differences, are allowing properties to be tailored to meet specific application requirements, including biostability, sterilization effects, and mechanical properties. Perhaps even more exiting are estimates that only about one-half of the applications that could be served by adhesives are actually using adhesives in assembly, leaving significant growth opportunity. By all measures, growth potential is very attractive and this market segment generates a lot of interest among adhesive suppliers.

Markets The market for adhesives used for medical applications is one of the exciting segments in the specialty chemicals industry.

As per a recent report by the Business Communications Company the 2001 US market for specialty adhesives was about $5.7 billion, and is forecast to grow at 4.3% per year, with medical and dental applications being the fastest-growing sector at 5.9% per year.

Frost and Sullivan report the size of the European PSA market (medical and non-medical) to be $620 million in 2000, and $796 million in 2007.

Zion Research has published a new report titled “Medical Adhesives and Sealants (Synthetic and Natural) Market for Internal, External and Dental Applications: Global Industry Perspective, Comprehensive Analysis and Forecast, 2014 – 2020.” According to the report, global demand for medical adhesives and sealants market was valued at USD 6.0 billion in 2014, and is expected to reach USD 10.50 billion in 2020, growing at a CAGR of 8.5% between 2015 and 2020.

North America is the largest market, both in terms of volume and value, followed by Europe. China, U.S., Japan, India, and Germany

are expected to persist as successful medical adhesives markets.

The key players in the medical adhesives market are Bostik Ltd. (France), Henkel AG & Company (Germany), B. Braun Melsungen AG (Germany), 3M Company (U.S.), CryoLife, Inc. (U.S.), Chemence Ltd. (U.K.), Cyberbond LLC (U.S.), Itac Ltd. (U.S.), Ethicon Inc. (U.S.), Covidien Ltd. (Ireland), GluStitch Inc. (Canada), Adhezion Biomedical (U.S.), Cohera Medical, Inc. (U.S.), Baxter International Inc. (U.S.), Gem S.r.l (Italy), Meyer-Haake Gmbh (Germany), and Biocoral, Inc. (France) , and others.

The medical adhesives demand, in terms of value and volume, depicts the current and future projections according to the parallel economic and industrial outlook. This analysis covers important developments, investments & expansions, partnerships & agreements, and mergers & acquisitions of the leading global companies.

Cost cutting in the healthcare industry is a reality and likely here to stay. Hospitals and other large healthcare providers have formed very successful buying groups who are pressuring suppliers for lower prices and additional services, which, in turn, create cost pressures on all suppliers throughout the value chain. In some instances, high-end devices that were manufactured for single use are being cleaned via sophisticated on-site processes to stretch the healthcare dollar even further. There has also been significant consolidation via merger and acquisition of participants at all levels of the value chain. In recent years, large distributors have emerged and everyone is aware of the consolidation of hospital and other large healthcare providers. As a result, the industry screams for lower total costs, and adhesives offer the potential for ever-increasing production speeds.

(Ref: http://www.dolcera.com/wiki/ index.php?title=Pressure_sensitive_adhesives https://globenewswire.com/news-release/2016/04/20/830668/0/ en/Global-Medical-Adhesives-and-Sealants-Market-Poised-toSurge-from-USD-6-0-Billion-in-2014-to-USD-10-50-Billion-by2020-MarketResearchStore-Com.html )

Pressure-Sensitive Adhesive Some of the applications of Pressure – Sensitive Adhesive are plaster and pads, transdermal drug delivery systems (TDDS), Tapes, biomedical electrodes, self-adhesive hydrogels and surgical drapes. Pressure Sensitive Adhesive tapes are most widely used.

Pressure-sensitive adhesive tapes (PSAs) are easily adapted to a range of medical applications from joining components like panels in medical equipment, to joining and sealing parts in handheld diagnostic devices, to joining and sealing surgical drapes and wound care dressings to skin.

PSA tapes require pressure to adhere to a surface. These tapes can be formulated to form high strength bonds when used in medical equipment or to join different dressing and drape substrates together, or to provide gentle adhesion when used in a stick-to-skin application. PSA tapes can be acrylics, silicones, or styrene block co-polymers.

May-June 2016

Stick-to-skin PSAs have the following general properties: • • • • • • •

Nontoxicity; Adhesion to organic and inorganic surfaces; 100% solid; Optimized for wetting and gap filling; Working characteristics suitable for high-volume production Compatibility with different forms of sterilization; Sterilizable;

Hydrocolloids and silicone PSAs are increasingly popular for their low skin trauma characteristics. These medical tapes are often required to provide secure adhesion for a device or dressing long enough for a therapeutic effect to occur. When adhesion is too low, the device won’t stay in place long enough; too high and the skin and wound may suffer trauma upon removal of the device or dressing.

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

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High Concentration Mask

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

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount

May-June 2016

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

May-June 2016

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®

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

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SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •

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May-June 2016

Industry News Andhra Med Tech Zone Gets Formal Registration To Set Up Asia’s First Dedicated Medical Devices Park Andhra Med Tech Zone (AMTZ)- company established under government of Andhra Pradesh has finally received formal registration which will kick start establishing Asia’s first dedicated medical device park in an area of 226 acres at Visakhapatnam in Andhra Pradesh.

AMTZ has cleared a major milestone- with the release of RFP for selection project consultancy firm for preparing a Detailed Project Report (DPR).

Andhra Med Tech Zone Ltd. (AMTZ) in its marathon target to be the first of its kind medical equipment manufacturing hub, has cleared another major milestone- with the release of RFP for selection project consultancy firm for preparing a Detailed Project Report (DPR). The RFP for DPR agency was released on 3rd of June and a pre-bid meeting with Industrial Partners was held on 17th June at Visakhapatnam.

While champions in industrial designing and infra-tech development are expected to

participate in the preparation of DRP for the prestigious project, no effort would be spared in getting technical excellence to design and implement the project- said Dr. Jitendar Sharma, the Chief Executive Office of AMTZ Ltd. Andhra Pradesh health department has formally taken over 226 acres of land to set up Asia’s first dedicated medical device park at Visakhapatnam. AMTZ is proposed to have in-house high investment scientific facilities that would help manufacturers reduce the cost of manufacturing and is first of its kind in Asia as it aims to flourish as a hub of medical device manufacturing, putting India on the global map of high end medical equipment production.

The park will provide for modern state of art common facilities such as specialized laboratories, warehousing, testing centre apart from 100 to 150 independent manufacturing units, each in a built-in ready to use area of 0.5 to 1 acre each.

A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent.

Indian medical device industry is worth over Rs. 60,000 crore and country’s humongous import bill for this segment amounts to over Rs. 23,000 crore while export amounts to only over Rs. 7,000 crore. India’s import dependency on high-end medical devices is over 80 per cent and 60 per cent to 70 per cent for other devices. And this is where the dedicated medical device park would be of great value - reducing humongous import dependency, increasing export while generating wealth and employment within.

(Ref.: http://www.pharmabiz.com/ NewsDetails.aspx?aid=94934&sid=1 http://ealth.economictimes.indiatimes. com/news/medical-devices/amtz-opensdetailed-project-report-opportunity-forglobal-cos-/52815286)

Gujarat Govt Allocates Land For Setting Up Medical Device Park At Sanand Subsequent to Union minister of chemicals and fertilisers Ananth Kumar announcement for setting up medical devices and pharma parks in Gujarat, Gujarat government has finally identified and allocated the land for the same at Sanand near Ahmedabad.

Detailed Project Report (DPR) has also been submitted and a favourable response has been awaited on the same from the Centre, informed an official associated with the development.

Gujarat Food and Drug Control Administration (FDCA) commissioner Dr H G Koshia said, “A medical device park is also very much relevant for Gujarat as the

state has the largest number of 135 licensed medical device companies as against 240 in the entire country which are nurtured by Gujarat FDCA with an exemplary approach and has received recognition in the country.”

He explained government’s plan to set up medical device parks will bring about quality, compliance and provide cost effectiveness in the industry by providing infrastructure to boost medical device manufacturing in India.

The creation of manufacturing park for medical devices is the need of the hour as medical devices manufacturing requires certain high investment facilities which are

too capital intensive for individual manufacturers to invest upon.

Currently, due to lack of such centrally located common facilities, manufacturers do not undertake production of technologies and therefore send their products abroad for process up-gradation and value addition.

This will also help facilitate to create an ecosystem for manufacturing of high end medical device manufacturing aimed at import substitution and export opportunities and would be a major boost to SMEs. (Ref.: http://www.pharmabiz.com/ NewsDetails.aspx?aid=95558&sid=1)

Industry Wants ICMED Certification Mandatory For All Medical Devices Marketed In India Experts have urged the Centre to make Indian Certification of Medical Devices Scheme (ICMED), country’s first indigenously developed quality assurance system for medical devices mandatory for all medical devices marketed in the country.

This was proposed in recently concluded meeting called to draft (separate) rules for May-June 2016

medical devices with the top government officials with special focus on drafting regulatory framework for granting manufacturing licenses for medical devices.

The meeting stressed upon the need for registration of low risk and moderate risk devices on basis of 3rd Party (CAB) certification and grant of manufacturing

license to high risk device manufacturers and importers on basis of defined criteria and inspection. This according to sources will be done by CDSCO medical devices officers with a predefined competency or through 3rd party certification bodies.

Association of Indian Medical Devices

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Industry News Industry (AIMED) strongly advocated that ICMED certification should be made mandatory as the scheme will be able to fill big regulatory vacuum in quality certification space for medical devices in the country and will enhance the competitiveness and profitability of Indian medical device industry. Currently, there is no India-specific official quality assurance system, due to which Indian medical device manufacturers encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits, ICMED also fills a big regulatory void.

Launched in March, ICMED has two certification options, ICMED 9000 certification (an ISO 9001 plus additional

requirements) for low risk medical devices and ICMED 13485 (An ISO 13485 plus additional requirements) for medium and higher risk devices. A third level, to additionally prescribe medical device specifications developed by health ministries NHSRC is still under development and would be launched later this year.

and injurious phenomenon in the Indian market. Most importantly, it will bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies, thereby ensuring substantial savings, enhanced credibility,” stressed Rajiv Nath, forum coordinator, AIMED and chairman, technical committee, QCI-AIMED.

“Why not make ICMED certification mandatory, as it is aimed at enhancing patient safety, provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. This Scheme is intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread

ICMED is the first home developed international class certification scheme for the medical devices in the country. It is a joint initiative of AIMED, Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB).

(Ref.: http://www.pharmabiz.com/ NewsDetails.aspx?aid=95101&sid=1)

India And Japan To Seek Regulatory Collaboration For Medical Products The Japan has extended support to Government of India for Indian regulators’ skill enhancement through its Asia Training Centre India and Japan are looking to accelerate collaboration for medical products through increased collaboration between the regulators of the two countries. Against this background, the first ever joint symposium between India and Japan to facilitate regulatory collaboration for medical products was organised by FICCI from May 18-19, 2016 in New Delhi.

As India is scaling up its healthcare systems and in parallel streamlining the pharmaceutical and medical devices regulatory guidelines, it is envisaged that

harmonisation of regulatory frameworks will benefit trade exchange & technology exchange for larger good. Japan is the third largest medical devices manufacturer and consumer in the world. It is a pioneer for development of several pharmaceutical and medical devices.

Japan and India are strong cultural and trade partners, with Japan being the fourth largest FDI contributor to India. Under the agreement held in 2015 between PM Narendra Modi and Japanese PM Shinzo Abe, FDIs from Japan are likely to be doubled by 2019.

During the two day symposium, participants from both countries agreed to collaborate more comprehensively in future. The

Japanese side has extended support to Government of India for Indian regulators’ skill enhancement through its Asia Training Centre.

This is a great start. We have achieved much needed momentum for our regulators to meet and collaborate. From this point onwards, we collectively commit ourselves to greater partnership and bilateral relationship”, said Probir Das, chairman, FICCI Medical Devices Forum.

(Ref.: http://www.businessstandard.com/content/b2b-pharma/indiaand-japan-to-seek-regulatorycollaboration-for-medical-products116052100319_1.html)

Separate Rules To Spur Medical Devices Sector Soon In lines with the prime ministers ‘Make in India Campaign’, the department of industrial policy and promotion (DIPP) has identified medical devices as one among the top five sectors having good investment potential in the domestic as well as export market. The government has approached the industry, to gauge the market dynamics and understand their demands and challenges.

In a bid to encourage investments in domestic manufacturing, the government has also recently allowed 100 per cent foreign direct investment (FDI) under automatic route in the medical devices sector. Such investments would also be

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exempted from other caveats such as the ‘non-compete clause’, which is applicable for FDI in existing pharmaceutical manufacturing units. Easing of norms for medical devices industry by creating a special carve-out in the existing FDI policy in the pharma sector will encourage FDI inflows.

This comes at a time when manufacturers in the country are facing challenges like import and export related issues, inverted duty status, Free Trade Agreement (FTA) etc.More than Rs 20,000 crore medical device market in India is highly unregulated and unorganised. Besides this, 10 per cent standard duty and 12 per cent excise or

countervailing duty add to the cost which has posed a major burden on the manufacturers. There are 10 major international players and around eight local players in the highly unorganised and unregulated market.

Quality has also taken a beating as manufacturers from outside India might dump sub-standard products as there is no regulation in place. Products are often being labeled with a high price due to lack of any regulation in terms of pricing as most of the medical devices have not been notified by the government under a separate set of rules.

May-June 2016

Industry News Admits an official from the Union Health Ministry, “There is an urgent need for separate rules for medical devices which is therefore being proposed in the new amended draft bill on Drugs and Cosmetics Act to be tabled in the budget session of the parliament to give the much required boost to the sector.

Alarmed by unusual spikes in prices of medical devices like cardiac stents and drug-eluting stents, the pricing regulator National Pharmaceutical Pricing Authority (NPPA) has also sought pricing data from manufacturers, importers and distributors of these devices. For monitoring of price movement of notified medical devices as drugs under DPCO, 2013, NPPA has asked the manufacturers and importers of medical devices in the country to urgently produce a slew of documents to examine the extend of price variations of medical devices in the domestic market. It has also been reminded the companies that since such medical devices are under non-scheduled drug category, their prices can be increased only up to 10 per cent of MRP annually.

Those who have charged beyond this have to reduce it to the level of 10 per cent of MRP for the next 12 months.

“In this regard it has been decided to seek the following information/documents in order to examine price variation, if any, in respect of notified medical device manufactured/imported/marketed by the company”, the NPPA said.

The NPPA has issued letters to all concerned manufacturers/importers including Abbott Healthcare, Boston Scientific India, Zimmer India, Edwards Life Sciences, Johnson & Johnson, India Medtronic Corporate, B Braun Medical India, 3M India, Harsoria Healthcare and Roche Products India.

Further, Para 25 of DPCO, 2013 provides that every manufacturer /importer shall issue a price list and supplementary price list in Form V to the dealer, State Drugs Controller and the Government from time to time.

Industry perspective The MedTech industry has welcomed the proposed Drugs and Cosmetics (Amendment) Bill especially as it recognizes medical devices as distinct from drugs/ pharmaceuticals. Further, it is important that the Bill and the subsequent Rules to be framed incorporate regulations that are harmonised with international best practices such as the International Organization for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF).

This effort would help medical device manufacturers achieve the highest standards of safety and efficacy, and also allow indigenous industry to prosper and become globally competitive.

Some category of products need more focus in terms of regulations and quality assurance. A case in point being that Drug Eluting Stent (DES) meant for cardiac disorder is notified but Cerebral Shunt meant for neurological disorders is not notified.

Says Sanjay Banerjee, Regional Managing Director, South Asia, Zimmer, “Risk management is a process for identifying, evaluating and mitigating risk. For medical devices, this means product safety, including risks associated with harm to people and damage to property or the environment. Risk management is an integral part of medical device design and development, production processes and evaluation of field experience.

The Indian regulatory system needs to adopt a risk-based approach to the

regulation of medical devices, to ensure that Indian patients have timely access to the safest medical technology.”

The current regulatory practices for medical devices in India are ad-hoc and were issued in a knee-jerk manner in response to the Honourable Supreme Court judgement in 2005. While several efforts have been made to streamline the registration process, the genesis of the list of fourteen notified medical devices remains questionable. A risk-based classification for medical devices, along the lines of harmonized international best practices is the need of the hour.

“There is a need for incremental innovation in the medical device segment to differentiate them in terms of pricing and to meet varied demands of the Indian healthcare system. Medical device innovation need not only restrict to the invention of new devices but also to adjustments to, or incremental improvements of, existing devices and clinical practices. It can also denote efforts to adapt devices designed for use in one setting, such as a modern high-tech hospital, to be used in another setting, such as a patient’s home or at a mobile clinic or primary health centre,” Banerjee added.

Typically, medical devices are developed through continuous innovation and iterative improvements and have short product life cycles. In the Indian setting, MedTech Industry and Academia need to participate in active collaborative research and development, which encourages businesses and researchers to work together on innovative projects in select areas of therapy–from which successful incremental innovative products and services can emerge, contributing to societal welfare and also economic gain.

Centre To Notify Revised Schedule M III For Medical Devices By June End Following strong representation from the medical devices industry, the Centre has agreed to align Schedule MIII with IS/ISO 13485 by delinking it from Schedule M for Pharma. The revised Schedule MIII will be notified by end of this month and is expected to attract huge investments into R&D which will enable India to emerge as a world class manufacturing hub for medical devices.

governs the Indian medical device sector, which has very different R&D, technologies, investment, production and taxation requirements from that of pharma sector.

This, the industry pointed out had a detrimental impact on medical device sector Making India import dependent, leading to unfavorable business environment especially for the domestic manufacturers.

Drugs & Cosmetics Act, 1940, currently

The government has been very favorable

May-June 2016

in understanding and addressing the issues of the industry, which is evident by the ground breaking decisions taken by the Centre in the last few days. Apart from this industry friendly decision, the government also recently conceded to set up separate Medical Devices regulatory framework and law for the industry with separate rules. It also agreed on the utilization of NABCB accredited third party conformity assessment bodies for QMS quality audit.

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May-June 2016

Product Gallery Qosina Adds 40 Enteral Feeding Connectors That Meet The ISO 80369-3 Standard

Ronkonkoma, NY – May 25, 2016 – Qosina is pleased to announce the addition of 40 enteral feeding connectors that meet the ISO 80369-3 standard and will not mate with the ISO 594-1 and ISO 594-2 luers. Qosina is offering ENFit™ male and female connectors, caps, stepped adapters, Y connectors, stopcocks and syringes, as well as the ENFit to ENLock adapters, ENPlus cross spikes and universal bottle adapters for the ENPlus cross spike. All of these parts have been added in various sizes and materials. Qosina will continue to add more ENFit connectors to meet the needs of your enteral project. Please visit our ENFit section at www.qosina/ ENFit.Qosina can modify any existing component to meet your needs or build new tooling to meet your exact requirements.

Enteral is the first clinical application to make the transition to new, safer connectors. The New Enteral Feeding Connectors have been designed to improve patient safety and reduce the risk of enteral feeding misconnections. The new standard has changed the configuration of the male and female connectors.

These enteral connectors are larger and will not allow connectivity with the male luer or female luer connectors that meet the ISO 594 standards or any other connectors for any other clinical use.

Administration sets and syringes have a female connector end that fit into a male patient-access feeding tube port.

The Global Enteral Device Suppliers Association (GEDSA.org) was formed to facilitate the transition to the new type of connectors and has created the brand ENFit to represent the new ISO 803693 standard.Qosina is actively researching the upcoming changes and is a member of GEDSA. Qosina will be adding compliant components to its extensive line as the standards become approved. To learn more about the ISO 80369 standard, please visit www.qosina.com/iso-80369.

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Technology Innovative Computer-Aided Catheter Reprocessing System (CRS) For Cleaning Catheters Developed By Chandigarh Biomedical Engineer Having developed an innovative computer-aided Catheter Reprocessing System (CRS) for cleaning catheters, 27-year-old citybased biomedical engineer Vikram Goel has won the DST-Lockheed Martin India Innovation Growth Programme (IIGP) 2016, which was recently conducted in collaboration with the Department of Science and Technology, Government of India, in New Delhi.

Talking about the CRS machine developed by him, which intends to replace the conventional method for cleaning of catheters, Goel told Chandigarh Newsline, “The machine is fully automatic, and also adopts a stringent cleaning process for removal of microbes and antigen for each catheter. The CRS also takes care of everything. Using this machine, catheters can be attached with the press of a single button, thus eliminating the need for any human intervention.”

The CRS machine developed by Goel had also won the award for the Best Medical Innovative Product for 2016 at the 22nd International Medical Fair held in Mumbai earlier this year. Not only this, Goel was also awarded the Young Innovator Award 2016

by PGIMER for his project. Having developed the fully automatic catheter reprocessor, Goel has now also applied to patent the system under his name. Prior to this, he has also worked on several projects for making healthcare more accessible and

cheaper. His other achievements include developing a helium compressor and coldhead monitoring device for MRI systems, advanced in-house repair of medical devices and a digital safety cane for visually impaired people.

Goel now intends to start a company for production of the CRS machine, in line with the Make In India campaign. “At the investor meet in US, I will now be convincing potential investors to fund my project so that I can start production for this machine. The idea is to facilitate healthcare and make it more affordable.”

With an intention to make healthcare more accessible, Goel, who currently works as a senior biomedical engineer at Fortis Hospital, Mohali, developed the CRS machine which is likely to reduce the treatment cost for cardiovascular diseases by up to 55 per cent. Saving Rs 526 per catheter and reducing the catheter replacement process by 80 per cent, the CRS was awarded with the Innovation Award at IIGP 2016, along with 30 other innovators from across India.

Having won the project, which is also along the lines of PM Narendra Modi’s Make In India campaign and Swach Bharat Abhiyaan, Goel will now be participating in a leadership programme for innovative business development methods sponsored by Stanford University in the Silicon Valley in the USA. This year, the Indian delegation will be led by PM Modi.

(Ref: http://indianexpress.com/article/cities/chandigarh/fordeveloping-machine-to-clean-catheters-chandigarh-biomedicalengineer-wins-award-iigp-2836731/)

India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector The med-tech industry, both domestic and international, has generally welcomed India’s new intellectual property rights (IPR) policy, in large part due to the fact that it has something for everybody, from industry to public health policy makers. However, IPR policy experts have expressed reservations over what they see as an over-emphasis on IPR creation.

The policy, released last month, makes it clear that India will strictly comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) but will not adopt anything beyond that.

Rajiv Nath, founder and forum coordinator of Association of Indian Medical Device Industry (AIMED) welcomed the new policy, which he signals that India is evolving to be in accordance to the U.S. and EU’s standard in terms of protecting intellectual property.

“This will bring more investors to India, especially to medical device sector,” he said.

Lacking IP protection was the one of the biggest blocks that keep foreign capital flowing into India’s med-tech sector, according to the founder of the association.

“Multinational companies lack confidence in protecting their intellectual property if they move manufacturing facilities to India.

The new policy addresses the criticism from companies,” Nath told Medical Device Daily. “I am not sure how much this fills the

36

IP gap as the implementation and other details have yet to be seen. However, I think that things are headed in the right direction.”

At the same time, the new rules will give more incentive to domestic medical device manufacturers in terms of research and development.

New Policy Objectives The new policy has seven objectives, including stimulating the generation of IPRs, developing strong and effective IPR laws that balance the interests of rights owners and the larger public interest and broader commercialization of IP. Another key objective is to modernize and strengthen service-oriented IPR administration by setting up a special “Cell for IPR Promotion and Management’ (CIPAM) to facilitate more effective and synergistic work between various IP offices, as well as help promote, create and commercialize IP assets.

The policy also aims to strengthen the enforcement and adjudicatory mechanisms to combat IPR infringements.

Other objectives include improving IPR outreach and promotion by creating public awareness about the economic, social and cultural benefits of IPRs among all sections of society and to strengthen and expand human resources, institutions and capacities to teach, train, research and build skills related to IPR. Some See Flaws In New Policy May-June 2016

Technology India’s leading patent policy expert Shamnad Basheer, a former professor at the National University for Juridical Sciences in Kolkata, said “a fundamental flaw” with the new policy is “the assumption that IP is an end in itself and we must notch up more IP registrations for the mere sake of it. Given this fundamental flaw, the policy makes a number of empiricallyunsound assertions, such as a near compulsion for publicly funded scientists to register all their new discoveries as IP,” he said.

Basheer said that the policy’s positive features include expedited examination, an open IP exchange, and the infusion of corporate social responsibility (CSR) funds into open innovation.

There is still uncertainty on IPR issues including compulsory licensing, section 3(d). Global innovation hubs have a strong IPR policy and mechanisms for patent litigation in cases of IP infringement. Given the current negligible contribution of Indian med-tech companies to global IPR in terms of product patents, it is unclear how the new IPR policy will bridge the demands of the global IPR community including multinational companies and investors vis -a -vis the public health realties in India.

“India’s new national IPR policy strikes a balance between protecting the rights of patients and promoting innovation within the pharmaceutical industry,” said Kiran MazumdarShaw, executive director of Bangalore-based Biocon Ltd. “It unambiguously states that India will strictly comply with patent rules within the TRIPS framework, but will not go beyond those obligations as required in a TRIPS-Plus regime.”

May-June 2016

India has also refused to dilute Section 3(d) of the Indian Patent Act that essentially prevents ‘evergreening,’ where pharmaceutical companies patent frivolous changes to their drugs in order to extend IP protection, thereby preventing generic companies from manufacturing cheaper drugs the poor can better afford,” she said.

“The new IPR policy, which aims to protect inventors and innovators in their quest to create new knowledge but deters frivolous patenting that hinders equitable knowledge creation,” is at the heart of the Indian Prime Minister Narendra Modi-led government’s mission to generate more innovation in India, she added.

What’s more, the new policy also “demonstrates the seriousness of the Indian government in putting in place a well-defined IPR policy and creating the infrastructure for streamlining the filing and disposal of IP applications. The policy seeks to not only fasttrack patent application and processing procedures but also reduce patent approval timelines,” Mazumdar-Shaw said.

Job Opportunity A LEADING MULTINATIONAL COMPANY IS LOOKING FOR SALES / MARKETING EXECUTIVE FOR MEDICAL GRADE PLASTIC COMPOUNDS AND TUBINGS IN INDIA. Interested persons may please send personal details to medicalplastics@gmail.com

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Events From Challenges To Opportunities: Favourable Climate For The Plastics Industry The plastics industry in ASEAN remains unperturbed by global developments that impacts the growth path of key industries. With K 2016, the world’s largest trade fair for plastics and rubber, coming up in Düsseldorf, Germany, from 19-26 October.

The new norm of economic growths and trends such as oil prices, variable supply and demand, and weakening of most Asian currencies against the US dollar, have allowed the region’s countries to rediscover their strengths to sustain growth either individually or as a part of the collective grouping of the 10-member ASEAN, which comprises Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei, Vietnam, Laos, Myanmar and Cambodia.

One of ASEAN’s top export sectors by value is plastics & plastic products earning US$ 39.3 billion in export revenues in 2013.

The sector’s production rates have witnessed a steady average growth over the recent years, especially in the ASEAN-6: Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam, which account for more than 95 % of regional GDP, according to McKinsey & Company.

Vietnam’s relatively nascent plastics industry had an average annual growth of 16-18 % between 2010 and 2015. It relies on imported raw materials, like polypropylene & polyethylene resins, importing an average of 4 million tonnes of raw materials while domestic production totals 1 million tonnes.

One of ASEAN’s top exporters of plastic products, Malaysia has over 1,500 plastic production companies that export to Europe, China, Singapore, Japan, and Thailand.

Thailand’s plastic consumption is led by packaging (48 %), electronics (15 %), construction (14 %), and automotive (8 %).

Its automotive sector attracts manufacturing opportunities, although itsoverall cost index is 20 to 25 % higher than Indonesia, Vietnam and the Philippines, largely because of a high quality and mature automotive manufacturing ecosystem, including tiered suppliers of automotive components.

Around 95 companies are represented on Singapore’s Jurong Island, attracting investments in excess of S$ 35 billion, according to the Economic Development Board. Presently, companies like BASF, ExxonMobil Chemical, Lanxess, Mitsui Chemicals, Shell & Sumitomo Chemicals have plants. However, BMI Research expects Singapore to face an uphill climb in 2016, in the face of a Chinese downturn & regional oversupply.

Pushing further the region’s plastics industry, initiatives are being laid out by plastics trade associations, including the ASEAN Federation of Plastics Industries, the Malaysian Plastics Manufacturers Association, the Thai Plastic industries Association, and the Philippines Plastics Industry Association.

The associations are working in tandem with international-scale trade agreement blocs, including the ASEAN Economic Community (AEC), the US-led Trans Pacific Partnership Agreement (TPPA), and the China-backed Regional Comprehensive Economic Partnership (RCEP).

The RCEP, made up of ASEAN members, China, Japan, South

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Korea, India, Australia and New Zealand, aims to consolidate the existing ASEAN FTAs and tie-ups with the other six partner economies. It will impose a 65 % tariff cut, with the percentage likely to increase to 80 % within a decade.

With these optimistic developments taking place, the ASEAN plastics industry will witness an expansion. In the ASEAN Business Outlook Survey 2014, by the American Chamber of Commerce Singapore & US Chamber of Commerce, Indonesia ranked as the most attractive country for new business expansion, followed

by Vietnam, Thailand & Myanmar. Availability of low-cost labour in countries such as Cambodia, Indonesia, Laos, Myanmar, and Vietnam, renders a competitive advantage. Overall, ASEAN’s growing consumer bases, broadening of plastic import & export markets, and expanding foreign trading powers offers foreign investors significant opportunities.

Contact: Tel.+49-211-4560240/F:+49-211-4560 8548 RugensteinE@messe-duesseldorf.de / AngelovaD@messeduesseldorf.de/ GiewaldS@messe-duesseldorf.de

Events Calender • Medicall 2016 15th Edition 16th Edition Date: 22-24 July, 2016 Date: 09-11 Sep, 2016 Venue: Chennai.

Venue: Delhi.

• ICMD Autumn 2016 The 23rd International Component Manufacturing & Design Show Date : 30st August - 1st September 2016.

Venue : Shenzhen Convention & Exhibition Center, China.

• Medical Manufacturing Asia 3rd Manufacturing Processes for Medical Technology Exhibition and Conference Date : 31st August - 2nd September 2016.

Venue : Marina Bay Sands, Singapore • K - 2016 The World’s No.1 Trade Fair for Plastics and Rubber Date : 19-26 October 2016.

Venue : Dusseldorf, Germany.

• CMEF 2016 The 76th China International Medical Equipment Fair (CMEF Autumn 2016) Date : 29 October - 1st November 2016 .

Venue : Shenzhen Convention and Exhi. Center, China.

• MEDICA and COMPAMED 2016 The World’s No.1 Trade Fair for Plastics and Rubber Date : 14-17 November 2016.

Venue : Dusseldorf, Germany.

• Medical Fair India 2017 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi.

May-June 2016

Available For Sale Auto Disable Syringes Manufacturing Unit (Or Only Machineries) With European Technology / Machineries A syringe factory in Nigeria with state-of-art facility (factory) to manufacture Auto Disable Syringes is for sale on As-itIs condition basis located inside an Export Processing Zone in one of the most safest city to live in Nigeria with many location benefits .Built on 3 acre land with 99 years lease, the Unit was installed by a European Company in 2005 using all European machines & equipment which are still in good condition.

Auto Disable Syringes Manufacturing Unit The Promoters, a well reputed group, is interested to dispose off his syringe plant with immediate effect with following two options.

1 Full plant with 3 acre land, complete machinery & laboratory and 40,000 sq. ft building on As-it-Is condition basis (includes 1.5 Acre land is still empty for any new project set up). OR 2 Only all machinery with laboratory equipment without (new investor can relocate all the machines/equipment to his desired country)

Manufacturing Plant Overview

• Total production capacity is 90 million pieces per annum • Requires 125 total staff for full utilization in 3 shifts.

• Sizes : Auto Disable Syringes of K1 design from UK : • New investor can continue to produce&market K1 design 2ml and 5ml AD syringes either at Nigeria location or any other country • Total sales turn over @ 100% plant utilization is USD6.0 across the globe by relocating all production+QC million per annum lab+utility equipment.

• Plant can be inspected for production for 1 or 2 days.

Full details of the Plant and Equipment with specifications can be provided to seriously interested companies on request.

Write to : MEDICAL PLASTICS DATA SERVICE / C/O Classic Computer Services B-4, Mandir Apartment, Opp. Jodhpur Char Rasta BRTS Bus Stop, Satellite Road, Ahmedabad - 380015, Gujarat, India.Phone : 0091-79-26740611, Telefax: 0091-79-26754867 Mobile: 0091-9825457563, EMAIL : medicalplastics@gmail.com May-June 2016

39

GMP ISO - 9001-2008 Certified Company

Surgical Industry For

SALE In Hyderabad, R. R. District, Telangana.

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

An ISO 9001:2008, 13485:2012 & GMP Certified Company Address

Contact through:

surgicalindustrysale@gmail.com BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance.

BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc.

• DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.

BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014.

Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com 40

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

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

May-June 2016

AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

GMP. & ISO 9001 – 2000 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 / URINE BAGS / MEASURE VOLUME SETS ETC.

Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.)

(DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products

Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch

Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699

Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com May-June 2016

• 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

41

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 :

PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

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

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 42

May-June 2016