Indian medical devices industry, one of the top 20 markets in the world, is the 4^th largest market in Asia. Large multinationals and small and medium enterprises (SMEs) comprise the medical devices industry in India. This industry is growing at an unprecedented scale. Amongst the emerging markets, India is the fastest growing medical devices market. There is immense scope for Indian medical device manufacturing companies to meet the demands of medical devices in India. This blog highlights why it is high time to tap into the potential of Indian medical devices manufacturing industry.

Overview of the medical devices industry in India

Double digit growth rates of the Indian medical devices industry indicate its importance in the health care sector. Infrastructural upgrades and increased demand for high quality medical devices have made the Indian medical devices manufacturing industry lucrative. Industry leaders, academia, healthcare practitioners, and policymakers are fostering innovation in this sector. The government has been taking steps to create a conducive regulatory environment, promote R&D initiatives, and support infrastructure and skill development to nurture a robust ecosystem for the medical device industry. The medical devices manufacturing industry is transitioning form a cost-based to a value- and innovation-based industry.

India has approximately 750 to 800 domestic medical device manufacturers that account for 65% of the market. The start-up ecosystem of the Indian medical devices sector is evolving. More than 250+ enterprises are focusing on medical device-based innovations for addressing important health issues. Furthermore, India’s role in domestic and global intervention against COVID-19 pandemic has placed Indian medical devices industry in the limelight. India manufactured and distributed medical devices and diagnostic kits, such as ventilators, RT-PCR kits, thermometers, PPE kits, and N-95 masks. This highlighted the contribution and potential of the Indian medical devices industry.

Dedicated medical device manufacturing parks and clusters are being setup across the country. This infrastructural development will support Indian medical device manufacturing companies. For efficient domestic medical device manufacturing, states are focusing on developing easy to access standard testing and infrastructure facilities. Four medical device parks located in Madhya Pradesh, Himachal Pradesh, Uttar Pradesh, and Tamil Nadu are being developed. These parks are expected to have common labs and testing facilities. The parks are expected to be completed by June 2024. This will also drive medical device manufacturing jobs in India. Additionally, this will also support medical equipment manufacturers in India.

The major segments in the Indian medical devices industry are as follows:

1. Consumables and disposables, such as needle, syringe, lab reagent, suture, cardiac catheter, etc.
2. Diagnostic imaging equipment and instruments, such as X ray machines, ultrasonography machines, MRI machines, patient monitoring machines, optical diagnostic equipment, etc.
3. Dental products, such as braces, dentures, etc.
4. Orthopaedics and prosthetics, such as artificial joints and knee implants
5. Patient aids, such as hearing aids, defibrillators, and pacemakers

Government support for the Indian medical devices manufacturing industry

Government regulations and policies play a pivotal role in creating a supportive environment for any industry. The Government of India has taken several steps to support the Indian medical devices industry. Initiatives have been taken to boost foreign direct investments, production, and improve the efficiency and effectiveness of medical devices. India, an emerging hub for medical device manufacturing, has a promising future in this sector.

Government support and initiatives are as follows:

• Production Linked Incentive (PLI): To boost domestic medical devices manufacturing, the government has launched the PLI Scheme. Under this scheme for Medical Devices, till date, 26 projects have been approved. An investment of INR 1206 Cr (approximately $147 Mn) to enable growth and innovation in this sector has been committed. This scheme is aimed at making India the global hub for medical device manufacturing and innovation in the near future.
• Tax exemption: A 15-year income tax exemption for locally created medical technology products has been offered.
• Foreign direct investments: The government has allowed 100% foreign direct investments. This will increase the inflow of investment and boost the market.
• Supportive policies: The government has proposed various supportive policies to boost innovation and research in the medical devices manufacturing industry.

10 key factors propelling the boom of Indian medical devices industry are as follows:

1. Increased private investment in healthcare
2. Increased public investment in the healthcare sector
3. Increased innovation and research fostering the development of the medical devices industry
4. Increased health awareness and understanding of the importance of preventive healthcare, thus driving the need for medical devices
5. Government schemes supporting the medical devices industry
6. Population growth and increase in life expectancy
7. Growing middle class with increased purchasing power for high quality medical devices
8. Increased number of individuals investing in healthcare insurance schemes
9. Increase in disposable income
10. Rise of the medical tourism industry, which has accelerated the demand for high-end medical equipment, technological devices, and appliances

All these factors are driving the growth of the medical devices industry in India. This in turn has made India one of the major medical devices industry market.

Why should you focus on the Indian medical devices industry?

• The medical devices industry in India has been growing at a compound annual growth rate (CAGR) of 15% over the last 3 years.
• The current market size of this sector is $11 bn. 
• The market size of this sector is expected to touch $50 Bn by the year 2025.
• Indian medical devices market is the fastest growing amongst the emerging markets.
• Make in India Campaign of 2014 designated this market as the Sunrise Sector of India.

Unlock the potential of Indian medical devices industry

Indian medical devices manufacturing industry is a dynamic and growing market. With increase in government support and increasing demand, the medical devices industry has immense potential. The Indian government is aimed at establishing India as a hub for manufacturing affordable, high-quality, and innovative medical devices. The current development trends of the Indian medical devices industry indicate a promising future. Low labour costs and government support for development of medical devices have made India a popular outsourcing manufacturing destination. Under updated laws, medical devices, equipment, consumables, and diagnostic equipment will be recognised as distinct from medications. This will empower local firms to expand and compete globally.

The government is trying to foster a robust medical device manufacturing ecosystem. Tapping into the Indian medical devices industry, the fastest growing market, can reap high returns. However, establishing a medical device manufacturing industry in India requires manufacturer licenses. Obtaining a medical device manufacturing license can be a daunting task.

Pharmadocx Consultants: Your trusted partner

We at Pharmadocx Consultants simplify the medical devices registration and licensing process.

From determining regulatory requirements, identifying medical device class, and assisting in documentation to obtaining medical device manufacturing licenses, Pharmadocx Consultants is your go-to-partner. Our team of experts will ensure a seamless registration and licensing process for your manufacturing company as per CDSCO guidelines. Additionally, as an authorized agent service, we assist foreign companies aiming to enter the Indian medical devices market. Our specialization is simplifying the complex process of registration and licensing of a medical devices business in India. Let us help you deal with the hassle of obtaining medical devices manufacturing license for starting a business in India. Call/Whatsapp us at 9996859227 or drop an email at [email protected].