Medical Device

Manufacturing Facility
Pharmaceuticals
Government of Gujarat
Contents

Project Concept 3
Market Potential 5
Growth Drivers 6
Gujarat – Competitive Advantage 7
Project Information 8
- Location
- Infrastructure Availability/ Connectivity
- Key Players
- Potential Collaboration Opportunities
Project Financials 11
Approvals & Incentives 15
Key Department Contacts 16

Page 2
Project Concept

Role of Healthcare Devices

Healthcare devices play an increasingly important role across the healthcare consortium

Screening Diagnosis Treatment Monitoring

30-40% 20-25%

Share of medical
Cost of medical
technology cost
technology in
in setting up a
total healthcare
tertiary care
cost for a patient
hospital
Source: Medical Devices. Making in India – A Leap for Indian Healthcare. 2016

Objective
The medical device industry is one of the biggest industries in healthcare, driven by innovation and
new technologies. The last decade has seen an unprecedented the development of state-of-the-art
medical devices and has acted as a growth enabler of the healthcare industry.

The objective of the proposed facility is to reduce import dependency and make India self-sufficient
to meet the needs of the domestic industry.

Import Dependency of Medical Devices Market Share of Indian Medical Device Industry by
Segments (2014)

Patient Aids 20% 80%

Equipment and
Instruments
7% 13%
Implants 25% 75%
Consumables and
Disposables
Equipment 10% 90% 53% Implants
27%

Consumables 60% 40% Patient aids

0% 20% 40% 60% 80% 100%

Indigenous Sale Import

Source: SKP business consulting – The medical device industry in India. 2016.

Page 3
Project Concept

The proposed facility will focus on manufacturing:

 Orthopedic implants  Catheters
 Cardiac stents  Disposable syringes
 Cannulae

Orthopaedic Implants
The proposed facility will use Electron Beam Melting (EBM) technology for
manufacturing of orthopedic implants
Key differentiators of EBM technology
 The obtained part has metallurgic characteristics similar to heat treated material that allows to
avoid heat treatment phases, saving cost and time
 The process of removing gating and feeding as well as chemical milling are not necessary since
the part production does not occur in a ceramic shell
 The time to market of the product goes down from months (for traditional technologies) to a few
days (6-10)

Cardiac Stents
The proposed facility will use Ultra Short Pulse Lasers for manufacturing
Cardiac Stents
Key differentiators of Ultra Short Pulse Lasers technology
 Potential to process stents and other sensitive and delicate materials with minimum thermal
effects and high accuracy
 Use of a special amplification technique enables the pulse duration to be compressed to less than
picosecond time regime. For instance, the chirped pulse amplification (CPA) is a technique where
the laser pulse is stretched before the amplification step

Infrastructure at the Proposed Facility

 Production block– Main area for manufacturing of the medical devices

 Quality assurance block – This area in the facility will ensure that the medical devices
produced are as per the industry standards
 Research and development (R&D) block – The proposed facility will have a dedicated
area for R&D so that the research work could be carried out for the development of
further evolved technology
 Training block –The production of the medical devices requires technical skills.
Therefore, the proposed facility will have a training area for the development of technical
skills

Page 4
 Market Potential

Global Medical Device Industry

Trends
Global medical device industry – Market size (USD b)
 With 50% of the global population slated
600 to be over 65 years in 2039, the medical
500 477.5 devices industry in developed nations is
undergoing a strategic change, with the
375.2
USD b

400 focus of the industry shifting from

300 diagnosis to prevention

200  With a large aging population and the

100 increased incidence of lifestyle and
chronic diseases, innovations that
0 reduce or eliminate hospital stays will be
2014 2020F
critical: remote healthcare, wireless
enablement, minimally-invasive
Source: Evaluate MedTech - World Preview 2015, Outlook to treatments
2020

Indian Medical Device Industry

 India is one of the top 20 markets for medical devices in the world and is the fourth largest market
in Asia after Japan, China and South Korea

 The Indian medical device industry, valued at USD3.35 b, is relatively small but has seen sharp
growth in the last few years. It is expected to grow at a CAGR of 7.3% from 2014 to 2019

 From both the regulatory and domestic innovation perspective, recent changes in this industry,
especially with the government’s focus on the Make in India campaign, will cause a shift in the
industry’s structure, conduct and performance
Source: Espicom

Medical device industry in India – Market size (USD b)

6.0
4.8
4.4
3.8 4.1
3.5
USD b

4.0 3.4

2.0

0.0
2014 2015 2016 2017 2018 2019
Source: Espicom – India Medical Devices report, 2Q 2016

Page 5
Growth Drivers

Untapped Potential and Growth Drivers

Rising income levels, ageing population, increased prevalence of lifestyle-related diseases, and the
government’s commitment to provide healthcare services at a reasonable cost to both rural and
urban population are some of the factors attracting domestic and global players to the Indian medical
device market
India: 0.7 doctors India: 1.4 beds
Global: 3 doctors Global: 5 beds
Doctor density per Hospital beds per
1000 population Drivers 1000 population

India: 25% India: 7.3% (2014-19)

Global: 80-90% Global: 4.1% (2014-20)

India: 4% India: USD 3.5 b

Global: 9.9% Global: USD 391 b
Healthcare spending Medical device
as % of GDP market size (2015)
Source: SKP business consulting, Evaluate MedTech and Espicom

Initiatives of Government of India

In September 2014, the Indian government launched the ‘Make in India’ campaign, with the
objective of making India a global manufacturing hub. Accordingly, a task force was formed to
address industry issues and make recommendations on ways to assist the industry

Department of Pharmaceutical A draft bill released, which proposes to expand the

constitutes a task force to identify issues scope of Drugs & Cosmetics act to cover new areas
relating to the promotion of domestic and regulate the import, manufacture, distribution
production of high end medical devices and sales of drugs and medical devices

Sep 2014 Oct 2014 Dec 2014 Jan 2015 April 2015

Honourable PM announces Medical device sector was Recently a draft National Medical
the Make in India campaign carved out from the pharma Device Policy 2015 has been
sector thereby allowing 100% issued, which sets out the
FDI under automatic route regulatory structure

Page 6
Gujarat - Competitive
Advantage
Registered Medical Device Manufacturers in Gujarat

 Gujarat is already a manufacturing hub for

medical devices in India as out of 253
registered medical device manufacturers in
India, 135 (53%) are present in Gujarat
47% Gujarat
 Almost 30 to 40 per cent of medical
53% Rest of India devices that are manufactured in India
originate from Gujarat

Surat in Gujarat specializes in Stent

manufacturing. The laser-cutting
technology used in diamond cutting was
Source: CDSCO - Medical Device licensed manufacturing modified in India to manufacture stents
units in various stats of India

Setting up centre of excellence to boost skill development in medical

device manufacturing industry at Ahmedabad
 The government of India has mandated National Institute for Pharmaceutical Education and
Research (NIPER) Ahmedabad to initiate a National Centre for Medical Devices (NCMD) for
development of skilled manpower in the medical device industry. This would involve collaborative
inputs from the industry to help build an innovation ecosystem and develop human resources for
the industry along with a testing infrastructure at NIPER

 This would also complement the first upcoming medical device testing lab of the country at
Vadodara in Gujarat by the end of 2016

 Key players involved in manufacturing medical devices in Gujarat include Meril Lifesciences Pvt.
Ltd, Polymer Technology International (Care Group), Sahajanand, ATL Therapeutics among
others

Other Advantages

 Gujarat is the one of the power surplus states in the country as a result this helps
bring in huge amount of investment from the industries

Flourishing Economy
 Gujarat contributes 7.2% to India’s GDP and shows leadership in many areas of
manufacturing and infrastructure sectors
 Gujarat’s SDP (State Domestic Product) at current price registered a growth of 11%
during the year 2014-15
Source: DNA India and Statisticstimes

Page 7
Project Information

Suggested Locations

Suggested locations

Following sites are proposed for the development of the

medical device manufacturing park: Sanand
 Sanand
Ahmedabad
 Ahmedabad
 Vadodara
 Rajkot Rajkot Vadodara
(Baroda)

Key Highlights for Disposable Syringes Manufacturing Unit

Area 600 sq meter

Built-up area 400 sq meter

Overall project cost INR 3.2 crore

Key Highlights for Orthopedic Implant Manufacturing Unit

Area 1,000 sq meter

Built-up area 500 sq meter

Overall project cost INR 13.9 crore

The proposed facility will be designed in a cluster-based approach consisting of five

manufacturing units. These units will focus on manufacturing of cardiac stents, catheters, IV
cannulae, orthopaedic implants and disposable syringes. Details of manufacturing facilities
have been provided in the following pages.

Page 8
 Project Information

Logistics & Connectivity

Gujarat has an extensive outlay of robust physical, social and industrial infrastructure,
which makes it an excellent investment destination.

Rail Road

 Gujarat has a total railway length of 5,257 km  Gujarat has a wide road network of around
(8.25% of India) 77,030 km. Of these, 95% roads are
 Mumbai-Ahmedabad bullet train project surfaced, all-weather roads.
planned with investment of USD16.58b  In 2015-16 budget, the state government
 Ahmedabad metro rail project construction to further plans to invest USD8.3m in a four-
begin in 2015-2016 with USD101.3m budget lane road joining Vadodara-
 Govt of Gujarat further plans to invest Ankleshwar,USD2.7m in construction of
USD1.65m in regional rail projects expressways and USD81.4m in resurfacing
roads

Air Port

 The state has 18 domestic airports (the highest  The state has one of the strongest port
in any state) and one international airport infrastructures in India, with 42 ports(21% of
 During 2014-15, the Ahmedabad airport India’s ports are in Gujarat), including one
handled 59,313 thousand tonnes of freight. major port at Kandla and 41 non-major
Freight traffic at Vadodara and Rajkot ports, along a 1,600 km coastline
measured 966 tonnes and 79 tonnes  It is the first state in India to take up port
respectively during April-September, 2015 privatisation. Gujarat Maritime Board, has
developed port privatisation models such as
private/joint sector ports, private/captive
jetties

Utility

Water Power

 Gujarat has a state-wide “water supply grid”  Gujarat has 24-hour 3-phase uninterrupted
spread across 1,20,769 km that aims to serve power supply throughout the state, with
75% of Gujarat’s population. installed power capacity of 29,293
 In the state budget for 2015-16, USD83m was MW(10.38% of India’s overall power
allocated for bulk water supply schemes and capacity)
USD 574m was allocated for improving the  The state has surplus power to the tune of
infrastructure of existing water supply systems 2000 MW

Page 9

Source: Vibrant Gujarat Summit, 2015 and Gujarat The Growth Engine of India – IBEF, Nov 2015
Project Information

Key Players
Key players in Gujarat involved in manufacturing of orthopedic implants, disposable surgical
syringes and cardiac stents

Manufacturer Category

Merril Healthcare Ltd. Orthopedic Implants

Merril Lifesciences Cardiac Stents

M/s. Smit Medimed Pvt. Ltd Orthopaedic Implants, (New Medical Devices) Bone
Screws, Plates, Pins & wires, Nuds, Spine Implants etc.

M/s. Sky Surgicals Orthopaedic Implants & Surgicals Instruments

M/s. Sharma Surgicals & Engg. Pvt.

Non Sterile Orthopaedic Implants
Ltd

M/s. Unisys Ortho, 51, 52, 53,

Orthopaedic Implants (Plantes/Screws)
Bhagirath

M/s. Greens Surgicals (P) Ltd Orthopaedic Implants

M/s. Nebula Surgical Pvt. Ltd Non-sterile Orthopaedic Implants

Shree Umiya Surgical Pvt. Ltd. Disposable Surgical Syringes

Tiger Surgical Disposable Private

Disposable Surgical Syringes
Limited

Multimedics Cardiac Stent

Sahajanand Medical Technologies Pvt.

Cardiac Stent
Ltd

Source: Govt of Gujarat, FDCA-Gujarat, Times of India and Trade India

Potential Collaboration Opportunities

 The manufacturing units can collaborate with education institutes (like NIPER Ahmedabad,
Maharaja Sayajirao University of Baroda) for R&D as well as providing training to students

 The manufacturing units can also collaborate with the foreign players to bring in advanced
technology to the country
Page 10
Project Financials

Cost of Setting-up an Orthopaedic Implants Plant

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,
drainage, landscaping, street lighting)
0.1
(Area: 1000 sq meter,
Average rate: INR 1,200 per sq meter)

Building and construction

(Built-up area: 500 sq meter, 1.3
Average rate: INR 25,000 per sq meter)

Machinery and equipment 10.0

Miscellaneous fixed assets

0.03
(Furniture and fixtures)

Sub-total 11.4

Contingency (@10%) 1.1

Sub-total 1.1

Indicative Project Cost 12.5

Benchmark project: Based on Engineers India Research Institute project profile on orthopaedic implants and
instrument (INR 13.06 crore facility in 1000 sq meter area)

Page 11
Project Financials

Cost of Setting-up a Disposable Syringe Plant

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,
drainage, landscaping, street lighting)
0.10
(Area: 600 sq meter,
Average rate: INR 1,200 per sq meter)

Building and construction

(Built-up area: 400 sq meter, 1.00
Average rate: INR 25,000 per sq meter)

Machinery and equipment 1.80

Miscellaneous fixed assets

0.01
(Furniture and fixtures)

Environmental protection measures 0.01

Sub-total 2.9

Contingency (@10%) 0.3

Indicative Project Cost 3.2

Assumptions:

 Benchmark project: Micro Small Medium Enterprises Development Institute report project profile on
disposable syringes manufacturing facility (INR1.25 crore facility set up in 2011)

 Average inflation used for the calculation purpose is 7.8% for the period 2011 to 2016

Page 12
Project Financials

Cost of Setting-up a Cannula Manufacturing Plant

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,
drainage, landscaping, street lighting)
0.07
(Area: 600 sq meter,
Average rate: INR 1,200 per sq meter)

Building and construction

(Built-up area: 400 sq meter, 1.00
Average rate: INR 25,000 per sq meter)

Machinery and equipment 1.45

Miscellaneous fixed assets

0.10
(Furniture and fixtures)

Sub-total 2.62

Contingency (@10%) 0.26

Indicative Project Cost 2.88

Cost of Setting-up a Catheter Manufacturing Plant

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,
drainage, landscaping, street lighting)
0.12
(Area: 1,000 sq meter,
Average rate: INR 1,200 per sq meter)

Building and construction

(Built-up area: 600 sq meter, 1.50
Average rate: INR 25,000 per sq meter)

Machinery and equipment 4.20

Miscellaneous fixed assets

0.15
(Furniture and fixtures)

Sub-total 5.97

Contingency (@10%) 0.59

Indicative Project Cost 6.56

Page 13
Project Financials

Cost of Setting-up a Cardiac Stents Manufacturing Plant

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,
drainage, landscaping, street lighting)
0.14
(Area: 1,200 sq meter,
Average rate: INR 1,200 per sq meter)

Building and construction

(Built-up area: 720 sq meter, 1.80
Average rate: INR 25,000 per sq meter)

Machinery and equipment 5.60

Miscellaneous fixed assets

0.20
(Furniture and fixtures)

Sub-total 7.74

Contingency (@10%) 0.77

Indicative Project Cost 8.51

Note : Indicative Project Cost may vary subject to the scale and requirement of the Project

Page 14
Approvals & Incentives

Clearances Required*

 Regulatory approval from Drug Controller General of India (DCGI) under the Central Drugs
Standard Control Organization (CDSCO).
 Regulatory approval for medical diagnostic X-ray equipment from Atomic Energy Regulatory
Board
 Clearance from Foreign Investment Promotion Board (FIPB) in case of foreign direct investment
 Infrastructure related: Approval / NOC required from civic bodies like Gujarat Water Supply and
Sewerage Board, Gujarat Electricity Board, etc.
 Environment-related clearances:
 Approval from Gujarat Pollution Control Board

 Approval from Ministry of Environment and Forests, Government of India

 Rapid Environment Impact Assessment (REIA) studies

*List of clearances required is not exhaustive

Proposed Offerings by the Government of India

Type Details
Proposed Government Government has recommended the implementation of the
policies** following policies to foster the development of the medical device
industry in India:
 The import of second hand diagnostic equipment to be
banned or to be made stringent
 Zero or minimal duty to be levied on the import of raw
materials for production of medical devices
 Creation of a separate department for medical devices, which
should be a part of an umbrella ministry dedicated to
pharmaceuticals
Financial  R&D should be supported/ coordinated by agencies like
ICMR, DBT, CSIR, DIETY & DoP through a single facilitating
body
 Low cost funding like interest subsidy to MSME
 Concessional power tariff for up to 5-10 years

**Recommendations of the task force on the medical devices sector in India – 2015 (Recommendations yet to be implemented)

Page 15
 Food and Drugs Control Administration

https://gujhealth.gujarat.gov.in/food-and-drug-control-administration.htm

BIRAC

www.birac.nic.in

GITA, Global Innovation & Technology Alliance

www.gita.org.in

SERB, Science and Engineering Research Board

www.serb.gov.in

Indian Council for Medical Research

www.icmr.nic.in

Note: This project profile is based on preliminary study to facilitate prospective entrepreneurs to assess a
prima facie scope. It is, however, advisable to get a detailed feasibility study prepared before taking a final
investment decision.

Food & Drug Control Administration,

Gandhinagar
Old Sachivalya, Block No.8, 1st Floor,
Dr. Jivraj Mehta Bhavan,
Gandhi Nagar-382010
Phone: 079-23253400, 9825049232,
26851817(R)
Fax:079-23252417