Medical Instrumentation Industry- Indian Scenario

 

L. Devasena¹, Nirmala Jegadeesan², Dr. R. Alamelu³, Dr. R. Amudha⁴, Dr. L. Cresenta Shakila Motha⁵

¹AP-II/EIE/SEEE, SASTRA University, Thanjavur, Tamil Nadu

²AP-II/EIE/SEEE, SASTRA University, Thanjavur, Tamil Nadu

³AP-III/SoM, SASTRA University, Thanjavur, Tamil Nadu

⁴SAP/SoM, SASTRA University, Thanjavur, Tamil Nadu

⁵AP-III/Training and Placement, SASTRA University, Thanjavur, Tamil Nadu

 

ABSTRACT:

Introduction: The healthcare sector constitutes medical devices and equipment industry which promotes only 6% of Indian contribution with a value of US$ 2.5 billion. As predicted, the Indian medical device industry, fourth largest in Asia is showing a higher momentum and growth from $4.4 billion to $7 billion in the recent past. Materials and methods: This study is based on a case approach focusing on various issues related to medical devices and instrumentation industry in Indian context. Results and discussion: With the aid of Electronics and Instrumentation technologies, the medical devices segment consists of various processes as processing, conversion, control, sensing, display and sharing of information etc.  This industry provides a wide range of 14,000 + products based on the Global Medical Device Nomenclature (GMDN) and it includes wound closure pads to stents and IVD machines. As per the PricewaterhouseCoopers (PwC), this sector forecasted to grow to US$17 billion in 2021.  The ensuring 100% FDI in medical devices boost the local companies with maximum capability. Nearly 1000 local firms primarily involved in medical device manufacturing that goes with technological intensive industry and producing high quality devices. These developments have given a high ray of hope for the growth of the sector in India. Conclusion: The benefit of demographic dividend of young Indian minds with talent and experience in innovation, the Prime Minister’s Make in India movement for creating a ecosystem for medical devices, the upskilling and implementation of disease management programs for medical device manufacturers has made the industry to go in for a rapid transformation in India. This will endorse the health insurance availability and provide better health care services Indian consumers.

 

 

 

INTRODUCTION:

The healthcare sector constitutes medical devices and equipment industry which promotes only 6% of Indian contribution with a value of US$ 2.5 billion. Comparatively, this medical devices sector grows at the annual rate of 15% than health care sector which normally grow at the rate of 10-12%.

 

As predicted, the Indian medical device industry, fourth largest in Asia is showing a higher momentum and growth from $4.4 billion to $7 billion in the recent past[1]. As the need for healthcare services increases proportionately the number of hospitals also gets increased in turn created a need for medical devices for better treatment. 

 

With the aid of Electronics and Instrumentation technologies, the medical devices segment consists of various processes as processing, conversion, control, sensing, display and sharing of information etc.  This industry provides a wide range of 14,000+products based on the Global Medical Device Nomenclature (GMDN) and it includes wound closure pads to stents and IVD machines.

 

The medical device industry is encouraged to provide innovative solutions for existing healthcare issues of Indian consumers and has significantly reduce the frequency of disease among Indian patients. But still, in India, the role of medical devices in healthcare is low and this industry is expecting a supportive role by government by way of implementing a regulatory framework.

 

Recently Indian Prime Minister has expressed that the government is working on a law to regulate and improve the affordability of generic medicines at the cheaper cost by sophisticated medical devices. The private and world players also using India as a hub for manufacturing medical devices and the government of India initiative of medical technological parks has proven the domestic manufacturing. This ensures the inflow of foreign direct investment to Indian economy and recuperating the advanced medical electronic devices.

 

Indian scenario:

The ‘Make in India’ movement has created a viable environment to the industry as all representatives have conferred to make it as the best event happen to the industry. The best decision makers had a chance to present their ideas in a very open has opened up a new way with the aid of government.

 

As the annual growth of medical device industry was 10-15% of USD 7 billon has turned the focus in to this specific industry and organizations like All India Medical Devices Association (AIMED), FCCI and CII focus Medical device industry [2]. As an initiative of government, under the department of Chemicals, medical device industry and IVD has been formed as a separate department and it is part of the Ministry of Health and Family Welfare. The state government and their hospitals and different schemes of healthcare are the buyers of Medical device and IVD Instruments. Under the department of Pharmaceuticals, the task force on Medical device industry was created to identify the core issues and for a consensus. Related to this issue, first fiscal policy was exposed to aid the Indian medical device manufacturing by withdrawing concessional duty for few devices in January has made a significant positive movement hence 60% of the devices got relief. Still the issues of inverted duty structure continued to be the big obstacles for local manufacturing [2].

 

Buy Indian Policy:

Based on the statistics, nearly 70% of the population live in rural and 73% of the qualified medical practitioners belongs to urban areas and the increase of chronic diseases in wide spread in rural areas too. This has made a high demand for the domestic medical devices industry specifically to serve to the needy rural population.

 

To promote Domestic Manufacturing many countries have a strategy. Even America has a “Buy American Policy” to supply medical devices to US companies for public healthcare. The Chinese government offer more incentive to their domestic medical devices has made the Indian industry to struggle in the overseas market. The domestic industry is expecting the 15% pricing for origin medical devices, it is the right time for the government to address the duty issues and provide a conducive duty structure for balancing raw material and finished products in the local devices market[3].

 

Present Scenario:

Creativity and innovation has played a major role in bringing up new medical devices to spot out the real life issues in healthcare sector. The medical device industry in India is a mixed of apparatus, appliances or even software is specially designed for the need of the health care system. The mediating role of technology advancement has made the healthcare affordable to public. The driving force for the flourishing of this sector is expected from better infrastructure, strong legislation, low cost medical devices etc. As per the PricewaterhouseCoopers (PwC), this sector forecasted to grow to US$17 billion in 2021.  The ensuring 100% FDI in medical devices boost the local companies with maximum capability[4]. Nearly 1000 local firms primarily involved in medical device manufacturing that go with technological intensive industry and producing high quality devices. These developments have given a high ray of hope for the growth of the sector in India.

 

Challenges in ahead:

The Medical Devices and Equipment industry development integrates many sciences, is technology intensive and capital intensive. The technological strengths contain these in electronics, mechanical fabrications, specific material, data processing, detectors, sources etc. A good infrastructure for R and D is needed for developing concepts. For this type of development scientific community and industry relation, a sound infrastructure for hardware development is very important. Here, the role of spin off and link companies may be essential.

 

Table No:1

Lack of growth in Instrumentation 1.       Commercialisation of medical devices is not go in hand as innovation has not taken place much with R and D. 2.       Lack of global vision industry in India. 3.       Lack of interaction between the stakeholders as industry, research institutions and the academic institutions. 4.       Lack of awareness, innovation and encouragement in component industry 5.       Utilization of biomedical devices in medical instrumentation and hospitals has enlarged in complication and in numbers also.

 

Table No:2

Key challenges faced by the Medical devices Sector 1.       Low Penetration 2.       Accessibility 3.       Affordability 4.       Awareness 5.       Nascent Regulatory Environment 6.       Low Indigenous Manufacturing 7.       No Distinct Status of the Industry 8.       Need for Quality Benchmark at par with the Global Standards 9.       Complex Rules and Guidelines 10.    High Capital requirement

 

Table No:3

Reforms required: 1.       Urgent Necessity for resource, funds allocation for training and skill up gradation. 2.       Evolve medical technology clusters with common facilities and developing an ecosystem for the benefit of SME’s focusing on medical technology. 3.       Increase public spending in healthcare from 1% of GDP to 3% of GDP to radically alter the provision of healthcare services. 4.       Encourage greater collaboration between medical centers and technology universities. 5.       Increase the quality and enhance consistency of training received by medical and paramedical staff 6.       Include medical technology education within the medical curriculum with assistance from agencies like NIPER. 7.       Increase the training for regulatory staff at domestic level 8.       Usher further reform in the insurance sector to stimulate health insurance thereby providing financial incentives for medical technology innovation. 9.       Set up a venture investment fund to address the lack of early stage venture capital Recommendations for Government to Improve Sector 1.       Move toward adoption of the Global Harmonization Task Force’s (GHTF) definition and specified classification of medical devices. 2.       Work towards making legislative amendments to enable comprehensive Medical Device

 

CONCLUSION:

"India has made considerable strides in developing innovative industries across a number of sectors and maintains strong potential to do the same in medical devices," Nanavaty, who chaired the delegation, said[1]. The benefit of demographic dividend of young Indian minds with talent and experience in innovation, the Prime Minister’s Make in India movement for creating a ecosystem for medical devices, the upskilling and implementation of disease management programs for medical device manufacturers has made the industry to go in for a rapid transformation in India[5]. This will endorse the health insurance availability and provide better health care services Indian consumers. 

 

REFERENCES:

1.        http://ficci.in/sector/76/Project_docs/Medical_Devices_and_Equipment_Sector_profile.pdf.[accessed on 02/06/2017]

2.        https://www.trivitron.com/blog/medical-device-industry-in-india-at-a-cross-road/.[accessed on 02/06/2017]

3.        http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/indian-medical-device-industry-can-grow-to-7-billion-by-2016.[accessed on 02/06/2017]

4.        http://health.economictimes.indiatimes.com/news/medical-devices/india-the-new-destination-for-healthcare-equipment-industry/46847343.[accessed on 02/06/2017]

5.        http://insaindia.res.in/pdf/Final_report_on_Instrumentation.pdf.[accessed on 02/06/2017]

 

 

 

 

Accepted on 14.09.2017           © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(6): 2618-2620.