A place to work, A place to grow

Facilitated by

Department of Pharmaceutical Ministry of Chemical and Fertilizer Govt. of India Shastri Bhawan, New Delhi

mdp medical device

ark

balancing

business with lifestyle...

index Need and Governments Initiative

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Why Gujarat

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- Phenomenon of convergence - Trained Human Resources and R&D culture Aim of the proposed medical device park

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Project Description

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- Introduction - Park Components Location Analysis

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- Advantages Dahej, Bharuch - Proximity to major cities Salient features

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Preferred development model for the medical and device park

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- Existing Manufacturing economy - Evolving R&D interest - Diverse Scale of Operation Methodology

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Need Analysis

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Service Arcade

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Role of various stakeholders

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- Vintron Infrastructure and Projects Pvt. Ltd. and its associates stakeholders

- Government of India - Government of Gujarat Conclusion

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1

need and governments initiative Medical devices industry is a multi product industry producing wide range of medical devices. Considering all the medical devices in the product category together, India is importing around 69% of its total requirements from different countries. The import of high-end medical devices are much higher, going up to around 87% for the category of medical electronics, hospital equipments and surgical equipment. At present only 30% of countries total requirements of medical devices are met through the indigenous production and that too the low end category devices. In view of the prevailing scenario the task force on “promotion of domestic production of high end medical devices and pharmaceutical manufacturing equipment” was set up by the Department of Pharmaceutical as per the government's initiative under “Make in India” concept which was headed by the Secretary of Pharmaceutical Department consisted of representatives from Planning Commission, Department of Health and Family Welfare, Department of Health Research, Department of Commerce, DCGI, Department of Industrial Policy and Promotion, Department of Electronics and IT as also various industry association including CII, AIMED, FICCI, ASSOCHAM and FOPE etc. The task force has given recommendations to address concerns and constraints facing the sector and suggested the measures that would augment domestic production of high end medical devices. The measures recommended are to enhance policy and institutional support, suggested strengthening of infrastructural support and recommended fiscal and financial support to the sector. In addition, the task force has also recommended measures for creating institutional setup for efficacy and safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D capability of the sector and pricing strategy for the sector and conducive regulatory environment. To promote local manufacturing, the task force has suggested change in duty structure including discount on import duty, restrictions on import of second hand diagnostic equipments or tools for pricing regulation. The committee suggested to formulate the medical devices regulatory act which suggests separate price control order for medical devices and empowering of National Pricing Policy Authority (NPPA) for fixation and monitoring of pricing under a separate vertical. While accepting the recommendations of the task force, the government of India decided to initiate several steps to boost the domestic production of high end medical devices and pharmaceutical equipments. Accordingly, the government has declared that the first such medical devices park in the country shall come up in Gujarat.

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why gujarat With the convergence of enabling factors such as well established pharmaceutical, chemical and agro industries, trained technical and administrative staff, state of art infrastructure, Government support and enhanced investment has been rapidly evolving in the state of Gujarat. The scenario prevailing in Gujarat for further specialized development of clusters has been found to be favoring considering the availability of rail, road air, and port routes, least IR problems, peaceful work environment, quality life and proactive governmental support. The proposed medical device park project has been conceived by Government of India as a commercially and financially viable venture, which shall aim at facilitating the development of medical units in the country as a cluster of manufacturing units. This would not only benefit the promoters of the company but also create new job opportunities both direct and indirect, bring more investment into the country which ultimately serves the society at large. The proposed medical device park would be a geographic cluster of surgical & medical device manufacturing companies both local and global, surgical component manufacturers under SME Park, readymade shed of 10000 to 20000 square feet , research and R& D testing laboratories and for general well being. This will be spread over more than 350 acres of land and will endeavor to : Accelerate commercialization of new technologies and commercialization Enable surgical start up to collaborate with industries. Create world class infrastructure for medical devices manufacturing and development. Foster and mentor investment Promote exports.

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Phenomenon of convergence : Gujarat can be unarguably be associated with the provenance of industrial revolution in the country, with its established base of traditional industry that provides the necessary technical and financial support to foray into the medical industry. Gujarat accounts for almost 3267 registered pharmaceutical industrial units and 50% of the country's total pharmaceutical production, involving a capital investment of Rs. 75 Billion mainly in small and medium scale sector. These companies have gradually developed considerable process in niche segments. The investor friendly policies of the state government have also encouraged the business community to foray into new ventures.

Trained Human Resources and R&D culture : Gujarat has fairly large scale of world class educational institutions and universities, the universities have further been promoting entrepreneurship culture in the state. The human resource manpower both technical and non technical are available in plenty and found to be less problematic compared to the manpower as found in other states. Negligible IR issues between the company management and employees are one of the examples for the steady growth of industrialization in the state. Even the human resource from other states and countries do not hesitate in migrating to Gujarat for this being safe, developed, good quality life and good environment for the employees and their families.

aim

aim of the proposed medical device park

To create world class medical device park at Dahej, Bharuch that promotes a competitive edge. Create the cluster based specialized industrial zone to include SME park and component manufacture units. To promote technology transfers and investment in the field of medical devices and manufacturing. To create efficient operating environment by developing a cluster wherein the issues of common interest are addressed at a common platform. Recognizing the benefits of adopting cluster based approach and in accordance with the global outlook and theme, Vintron Infrastructure and Projects Pvt. Ltd. and its associate stakeholders proposes to develop a state of the art medical device park at Dahej distt. Bharuch, Gujarat based on mutual cooperation with Government of India. The park endeavors to create geographic concentration of medical units both from India and global companies, R&D companies with modular laboratories, manufacturing facilities with all other support of infra companies.

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project description 1. Introduction : The medical device park has been conceptualized as a commercially and economically feasible venture which aims at facilitating the development of surgical & medical equipment industries in the country thereby attract global players to setup their plant which not only adds to development but also creates employment opportunities, investment opportunities and aids to the socio economic development. The proposed medical device park at Dahej shall have global concentration of medical companies, research, institutions, and other related equipments / parts/ service providers.

2. Park Components Spread over an area of 350 acres in the first phase the medical device park will endeavor to : Create world class infrastructure to medical device industry, research and manufacture. Help in collaboration with plastic and related manufacturing industries. R&D: The proposed medical device park shall be commissioned complying USFDA and WHO norms for the industry. It is proposed to hire consultants' and experts for the implementation of Indian FDA and WHO norms. R& D – In house R&D will be promoted. Build to suit plots: Build to suit plots would be independent developed plots which will be customized.

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Ahmedabad

Surendranagar

Nadiad

LOCATION Vadodara Dholera

Dahej ONGC Petro

Bhavnagar Dahej

DMIC Alignment DMIC Influence Area Cities

Investment Region Investment Area Industrial Area

DMIC : Proposed Modules in Gujarat 6

Bharuch

location analysis The location of the proposed park is one of the major deciding factors that offer significant bearing to the success of medical device park. The location identified and selected depends on diverse range of parameters based on the specific needs of the large companies and the general business requirements of the country. For a well defined medical device park apart from analyzing the basic infrastructure requirements and parameters, the city connectivity transport linkages, dry port availability or connectivity, proximity to leading research institutions, availability of homogeneous environment for trained labor forces, negligible IR problems, Government support, flexibility to scale up the activities, urban infrastructure, rail road, port and air connectivity etc. are the prerequisite and important considerations. Location thus is one of the determining factors that offer significant value for the success of the medical device park. Presence of all the above parameters to be in place, and scope for creating SME Park, Plastic Park with ready built sheds of 10000-20000 sq feet for raw materials / component suppliers to the medical device park and warehousing clusters add to the attraction for the said venture. Dahej in Bharuch district has been offered for the proposed medical device park considering large scale industrial development taking place in that area and also as DMIC corridor is passing very close to the proposed medical device park, the units shall have natural advantage of connectivity. The location offers diverse range of parameters as per the specific needs of the target companies and general business requirement of the industry. For such a cluster apart from analyzing the basic parameters such as city infrastructure major surrounding cities, transport linkages, etc., several other important parameters such as proximity to leading research organizations, pharmaceutical units in the vicinity, availability of trained manpower, government support, flexibility to scale up operation, to expand the quality urban infrastructure etc. are of paramount importance.

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advantage

dahej, bharuch

Dahej in Bharuch District is seen to be flavors for most of the established and upcoming companies and manufacturing units, as this falls on the DMIC corridor and also for the closeness to the finance capital of the country i.e. Mumbai. Well knit, road, rail, port and air connectivity with major highways being nearby adds to its attraction. For companies targeting their products for exports, would always count on transportation and logistics expenses. As dry port is also being planned, the connectivity further improves and gets systemized.

Proximity to major cities : Baroda and Surat both major cities of the Gujarat are at close distance of 2 hrs journey. These cities offer much infrastructural, administrative and operational support. While Ahmedabad and Mumbai are approximately 187 kms and 292 kms respectively from Bharuch.

features

Some of the salient features of the proposed surgical device park are

Vertical 40 meter and 60meter road connects to Horizontal 120 & 250 meter roads which leads to SH-6 (Existing Bharuch-Dahej 6 lane road)

Dahej has well laid railway line from Dahej to Bharuch junction and from Bharuch the logistic industries get the PAN India connectivity.

Domestic Airports: Vadodara-Surat at equal distance from Bharuch. Int’l. Airports: Ahmedabad-Mumbai

At present Dahej has 66 KV, 220 KV and 400 KV substations in the near vicinity.

PCPIR ZONE The land parcel belongs to PCPIR Zone having ETP line very near by & with connecting existing roads

Dahej port is just at 15 kms & Nava shiva port is at 396 kms.

It has been planned to create dry port facility at the park.

ETP. CHANNEL Water Availability for both domestic use and industrial supply as per Guj. industrial development norms.

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Available just at approximately 1 km from the proposed creation.

development

Preferred development model for the medical device park

An analysis of development models of some of the leading parks globally suggests that several factors such as overall industrial scenario, business interest of the stake holders, prevailing socio economic conditions, profile of prospective companies, availability of sound industrial relation, availability of every required resources, creation of solid infrastructure significantly impacts the development of such a theme based medical device park. Following could be the reason for developing the model for such a park at Dahej, Bharuch. 1. Existing Manufacturing economy The manufacturing activity in the state is the mainstay of the economy with the availability and sound operation of diverse set of manufacturing companies, operating without any obstructions of any nature. 2. Evolving R&D interest Presence of competitive academic organization ad pursuit of high end R&D activity by the pharma companies in the state has been driving the growth of pharma companies. 3. Diverse Scale of Operation Gujarat state has presence of well established pharmaceutical companies, chemical companies and equipments manufacturing companies and is home to several large and medium scale players, who have over periods of time, diversified into different manufacturing units. The development model for the medical device park has been accordingly defined, to create an integrated multifaceted medical cluster with companies from global platform setup their units having diverse scale of operation across the globe.

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basic view

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methodology The proposed medical device park to be developed in a phased manner. 1.

Phase one is analyzing development models adopted by leading medical device park globally and the needs of prospective companies setting up of their plants to define an appropriate development model.

2.

Phase Two will focus on conceptualizing the development model for the proposed medical device park at Bharuch incorporating the inputs designed from various on ground studies based on phase one.

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Phase three will be incorporating the inputs of probable stake holders and Government guidelines for the proposed park to refine the proposed development model.

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Fourth phase In this the activity shall be to define the concept plan for the proposed medical device park.

need analysis Creation of medical device park which essentially offers specialized and customized infrastructure backed by very strong organization linkages between, corporate, Government, R&D companies and investors, has channelized the thought for the creation of a specialized medical device park which will be first of its kind in India. The shared facilities at the medical device park not only provide economies of scale to the resident companies but also play an important role in incubating novel ideas into commercial production. In accordance with the above and to harness the potential of medical equipment with the aim to emerge as the one point destination in this sector, the Government has thought apt on the creation of such a specialized park. The need for a dedicated medical device park stems from the aspiration of the Government to enhance competitiveness and strengthen its position to meet the diverse requirement of the medical device industry and also be self reliant in this segment. Following factors play important role in driving the need for a medical device park :a. To encourage and promote entrepreneurship in the country. b. To increase the flow of FDI in this sector. c. Attract global companies to setup their unit in an organized park with all infrastructural facilities. d. To enable optimum utilization of the available resources within the country. e. To facilitate access to large pool of skilled labor. f. To facilitate socio-economic growth in the country. g. To develop necessary industry based research academia linkages and facilities commercialization to normal technologies. h. To position Gujarat as the first state in the country to set up the first medical device park with all necessary infrastructure facilities.

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service arcade Service Arcade : To have blocks which shall cater to the following: Landscape garden Office building for excise/FDA/Bank/Post office/ Courier and information center Laboratory / Material testing & ETP plant

Food court/Canteen/ cafeteria

Rest rooms for staff of the medical device park.

Telecom, Wi-Fi and communication setup

Well laid out manual and electronic surveillance system for security. Fire safety as per global norms and a fire station. Medical support shall have medical room, ambulance and nursing assistants at the park. On need basis create Helipad for the visit of top officials from global companies-connectivity from Mumbai and Surat Airport to be established for the same. Creation of warehousing facilities to cater to the needs of various companies. Dry port connectivity for export business to be commissioned. ATMs.

Eating joint.

Mini Vehicle repair centers.

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various stakeholders Role of various stakeholders : The proposed medical device park would serve as a catalyst for the development of a cluster of innovative and technology oriented research enterprises in the medical industry. This requires a clear definition of the roles of various stake holders. These stakeholders would act as the facilitators for the growth of proposed medical device park and set a guiding principle for the emerging medical industry in the country. The key stakeholders could be identified as under : a)

Vintron Infrastructure and Projects Pvt. Ltd. & Its Associate Stakeholders

b)

Government of India

c)

Government of Gujarat

Vintron Infrastructure and Projects Pvt. Ltd. & Its Associate Stakeholders : Vintron Infrastructure and Projects Pvt. Ltd. and its associates stakeholders Plays the most crucial role in providing land, create all the infrastructural facilities for the growth of medical device park. Roughly the role of Vintron Infrastructure and Projects Pvt. Ltd. and its associates stakeholders could be as under : Conceiving the idea for the creation of medical device park. Allocate sufficient land for creating the cluster. Designing the medical device park. Developing the comprehensive business plan for the park. Procuring all clearances from all the authorities for starting the project implementation. Construction of the common facilities within the stipulated time frame. Implementing environmental management plan required for the project. Liaison with all authorities from inception to finishing of the project and after commissioning, implementation stage liaison. Maintenance and operation of the park. Bringing best support companies into the park for complete synergy among different companies/ owners. Attracting national and international investments into the proposed park. Creating linkages to encourage knowledge sharing.

Role of Government of India : The Government of India is expected to play a major role in the proposed medical device park in terms of : Providing incentives / benefits to the companies setup their units. Providing the development of the required infrastructure. Creating a suitable regulatory and fiscal environment marked by incentives such as tax holidays, rebate in customs duties and income tax, liberal investment policies etc. Creating hastle free single window clearance mechanism. Swift approval for the establishment of custom and FDA clearance at the park. Provide financial assistance. Assist in collaborations. Motivating the industrial and pharma related companies to setup their units by availing the support through incentive provided by the Government.

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Government of Gujarat : Gujarat Government would act as a facilitator by playing an active role, by nurturing the existing local industry and attracting new investments from outside industries into the new knowledge based industries and function as a catalyst to spur the growth of medical device park. The State Government would devise an investor friendly framework which would essentially enable speedy clearances, simplification of procedures thereby providing a single window mechanism. The State Government would further establish dedicated agencies to provide Venture Capital funding and marketing support. The State Government would provide an appropriate blend of hard and soft infrastructure that would facilitate in creating a conducive business environment in the proposed medical device park The State Government may also partner with any Private party to create specialized infrastructure for R&D to enable optimization of resources and bring down the cost of innovation for the Park tenants. The State Government would introduce several fiscal and tariff incentives such as tax holidays, capital subsidies and energy concessions to attract private sector investments in the Park. To reinforce the commitment of the Government towards investors by creating a hassle free clearance / approval mechanism. To organize global conferences/training programs within the State to create networking and learning opportunities.

conclusion This document has been prepared with a view to providing information and place before the major stake holders to decide on how, given adequate resources inflow, world class infrastructures and Governmental support, will facilitate in creating the first specialized medical device park in the country which shall attract both local and global players who could avail the benefits of cluster based manufacturing unit that will be responsive to industrial needs which shall have strong national, regional and global showcasing platform. Also, this document shall give an insight to company promoters who shall be keen to start their manufacturing units (Both from Domestic & Global Platforms) under “Make-In-India” concept to avail long term benefits.

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VINTRON INFRASTRUCTURE & PROJECTS PVT. LTD. (A divion of Vworldwide group)

: Corporate Office : 409, Sarthik-II, Opp. Rajpath Club, S.G. Road, Ahmedabad-380054. Gujarat, INDIA. Phone : +91 79 26870952/54, Fax : +91 79 40032655. Website : www.vintroninfratructure.com Email : [email protected]