Snapshot

Fostering innovation for improved health

The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale.

The current market size of the medical devices industry in India is estimated to be nearly $11 bn.

The Medical device sector has been growing steadily at a CAGR of 15% over the last 3 years

India’s medical devices industry is poised for significant growth in the coming years with the market size expected to reach $50 bn by 2025.

100% FDI is allowed under the automatic route for both brownfield and greenfield setups. Strong FDI inflows reflect the confidence of global players in the Indian market

  • Since April 2000, ~$2.2 bn in FDI
    • Of this, $600 mn was received in the last 5 years
    • Singapore, United States, Europe, and Japan are key investors
  • Equipment & Instruments, Consumables and Implants have attracted most FDI
  • For further details, please refer FDI Policy

Imports: $5.6 bn, Exports: $2.51 bn (2019-20) India’s expected export of medical devices will reach ~ $10 bn by 2025.

The Government of India has taken several steps to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India over the past 5 years:

  • Designated as a sunrise sector under the Make in India campaign, 2014
    • India is among the top 20 markets for medical devices worldwide
  • The Medical Devices Rule of 2017
    • The Ministry of Health & Family Welfare in line with global best practices adopted a risk-based classification system for medical devices based on the Global Harmonisation Task Force (GHTF)
    • Increased number of regulated medical devices in India to ensure quality
    • Introduction of post-market surveillance for imported and manufactured devices
    • Manufacturing licenses made perpetual to promote ease of doing business in the sector
    • Increased notified devices, clinical investigations, quality certifications, and post-market surveillance
  • Under the Medical Devices Amendment Rules 2020, all medical devices intended for use in human beings or animals are regulated as drugs w.e.f April 1st, 2020
  • A Productions Linked Incentives Scheme for Medical Devices, 2020
    • Incentive on 5% on incremental sales over the base year of good manufactured in India covered under target segments
    • Production Linked incentives of up to INR 3,420 Cr (~$456 Mn) will be awarded during the scheme tenure
    • Tenure of the scheme is from FY 2020-21 to FY 2027-28, with Base Year as FY 2019-20
    • The Department of Pharmaceuticals is reinviting applications under the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices. The last date of receipt of applications is July 28th, 2021. For more details, please visit this link
    • Production Linked Incentive Scheme (PLI 2.0) is inviting applications to enhance India's manufacturing capabilities in the in-vitro diagnostic sector (IVDs). The scheme shall be open for applications till July 31st, 2021. Applications to be made online here  
  • Funding for Medical Devices Parks in the country, 2020
    • Medical Device Parks with financial implications of INR 400 crores
    • A maximum grant-in-aid of Rs.100 crore per park will be provided to the States
    • Expected to reduce the manufacturing cost of medical devices in the country
    • The Schemes (Parks & PLI) will lead to a generation of additional employment of 33,750 jobs over a period of 5 years
  • %

    Pvt. sector's share in hospitals

  • %

    Market growth rate (2019-20)

  • Number of pvt. players in India

  • +

    Number of health-tech startups in India

2nd largest PPE Kits manufacturer with production capacity 10 lakh+ PPE coveralls per day

Market size expected to reach $ 50 bn by 2025

India is the 4th largest market for medical devices in Asia

Industry Scenario

The medical devices market has the potential to increase at a 37% CAGR and reach $50 bn by 2025

Medical devices are segregated into five major segments:

  • Consumables & Disposables include needles and syringes, etc
  • Diagnostic Imaging includes MRI, X-Ray, Ultrasounds, etc
  • Dental Products includes dentures, braces, etc
  • Orthopaedics & Prosthetics include knee implants, artificial joints
  • Patient Aids include hearing aids and pacemakers, etc

Around 65% of the manufacturers in India are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market with extensive service networks.

There are 750–800 domestic Medical Devices manufacturers in India, with an average investment of $2.3–2.7 mn and an average turnover of $6.2-6.9 mn.

The manufacturing is developing in its scale and geography: there are six Medical devices manufacturing “clusters” in the country (Refer to 'Data on Map' section below).

Clusters have “Medical Device Parks” developing around them: states have committed to set-up dedicated industrial parks where efficient domestic manufacturing at lower costs. The State Government of Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh have been given “in-principle” approval to develop Medical Devices Parks & create a robust ecosystem for medical device manufacturing in the country.

GROWTH DRIVERS

  • Growing Population

    India’s population is set to touch 1.45 billion by 2028, making it the world’s most populous nation

  • Life Expectancy

    From the current 67.5 years, life expectancy in India is expected to increase to 70 years by 2025

  • Shifting Disease Burden

    Non-Communicable Diseases (NCDs) account for 50% of the disease burden and 60% of all deaths in India

  • Changing Preferences

    Growing health awareness, changing attitude towards preventive healthcare, increasing lifestyle diseases

  • Growing Middle Class

    A rapidly growing middle class has contributed to the growth of private players in healthcare

  • Increasing disposable income

    8% Indians will earn more than $ 12,000 p.a. by 2026

  • Health Insurance

    Approx. 20% of Indians have health insurance cover. This number is expected to increase with rising incomes and growing urbanization

  • Rise in Medical Tourism

    Due to the relatively low cost of medical care in India, it is experiencing a 22-25% growth. It contributes over $2Bn to the healthcare market in India. Increased demand for healthcare and medical devices from rise in medical tourism.

  • Nascent industry

    Importing more than 90% of sophisticated devices, the domestic industry has a huge scope for R&D capacity

  • Infrastructural Development

    4 medical devices parks in India are in pipeline

  • Policy Support & Incentives

    100% FDI allowed in Greenfield & Brownfield projects, measures to correct unfavorable duty structure are being undertaken, single-window clearance e-portal to improve EoDB

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Production Linked Incentive (PLI) Scheme

The Indian Government has identified medical devices as a priority sector for the flagship 'Make in India' program and is committed to strengthening the manufacturing ecosystem. The Production Linked Incentive Scheme (PLI) Promoting Domestic Manufacturing of Medical Devices and Production Linked Incentive Scheme for Pharmaceuticals (PLI 2.0) have been introduced to provide an impetus to India’s vision of becoming a global manufacturing hub for medical devices.

  • 18420

    Schemes Outlay

Products

Industrial Land Bank Portal

GIS - based map displaying available infrastructure for setting up business operations in the state.

Major Investors

Data On Map

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FAQs

Frequently
Asked Questions

What is the regulatory environment for medical devices in India as per 'New Medical Devices Rules'?

The Ministry of Health and Family Welfare on Thursday notified Medical Devices Rules, 2017, which are in conformity with Global Harmonisation Task Force (GHTF) framework. The rules have come into effect from 1 January 2018.
The rules have been drafted with the intention to distinguish medical devices from pharmaceuticals for improved and well-defined regulation. The key highlights of the rules are:
1) Redefining ‘medical devices’, making it more comprehensive and easy to comprehend.
2) Introduction of risk-based classification system for class-wise regulation.
3) Single window clearance (online portal) for applications for import, manufacture, sale or distribution and clinical investigation.
4) Establishment of product standards for medical devices for being conformed.
5) Rationalization of timelines for obtaining licenses required to market medical devices.
6) Consolidation of registration certificate and import license into a single license.
7) New regulatory framework for clinical investigation of medical device.

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What are the requirements to be a registered Notified body?

The requirements are laid down in Part I of Third Schedule of Medical Devices Rules, 2017.

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What is the process for classification verification with CDSCO or notified body prior to submission?

The Central Licensing Authority shall, classify medical devices referred to in Rule 2, based on their intended use and other parameters specified in the First Schedule.
Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organization (CDSCO): Provided that the Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. CDSCO has already displayed the list of medical devices with classification, which is dynamic in nature.

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What are the changes that require an applicant to make afresh Registration?

The following changes require a fresh registration:
1) Any change with respect to manufacturer (legal/actual) like change in constitution,change in name, change in address, etc.
2) Any change with respect to importer/Indian Agent like change in constitution, change in name, etc.

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How are IVDs classified in India under Medical Device Rules, 2017? Who will have the responsibility of doing Classification of IVD as per Class A/B/C/D?

IVDs are classified under Chapter II, Rule 4, Sub-rule (2) of Medical Device Rules, 2017 on the basis of parameters specified in Part II of the First Schedule, in the following
classes, namely:
i) Low risk - Class A,
ii) Low moderate risk- Class B.
iii) Moderate high risk- Class C.
iv) High risk- Class D.                                                                       
Reference Rule 4 (3): This rule specifies that Central Licensing Authority shall classify the Medical Devices.

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