India is now in the limelight for its expertise in some segments of the Medical Devices sector. Owing to its high growth potential in terms of domestic manufacturing and global exports, the Medical Devices, Surgical Equipments and Pharmaceutical Machineries sector has emerged as the ‘Sunrise Sector’ of India. EEPC India, under the aegis of Ministry of Commerce and Industry, Government of India, has identified Medical Devices as one of the four focus sectors under ‘Brand India Engineering.’

‘Brand India Engineering’ is an initiative being implemented by EEPC India under the aegis of the Ministry of Commerce and Industry, Government of India, in close cooperation with Industry to enhance India engineering exports, by highlighting and showcasing Made in India products and their capabilities in the global market. The initiative involves a 360-degree approach in promoting branding of Indian engineering products.

EEPC India is the largest and premier trade and investment promotion organisation in India. It is sponsored by the Ministry of Commerce and Industry, Government of India, and caters to the Indian Engineering Sector. As an advisory body it actively contributes to the policies of Government of India and acts as an interface between the engineering industry and the Government.

EEPC India draws its strength from its membership of around 13,000, which includes PSUs, Corporates, SMEs, Chambers, Associations, State Trade Promotion Bodies, etc and of which over 70% belong to MSMEs. The main objective is to promote trade, joint ventures, strategic partnerships and investments and act as a catalyst in the promotion of trade, investment and strategic partnerships.

EEPC India has a dedicated panel for ‘Surgical Equipments, Medical Devices and Pharmaceutical Machineries.’ Through this panel it extends benefits of various Government schemes such as MDA and MAI for trade promotion globally. Annually, EEPC participates in global trade shows and exhibitions, and through this panel, acts as a dedicated interface for policy advocacy with the Government and Industry stakeholders.

Advancements in medical technologies have allowed healthcare practitioners to improve their diagnosis and treatment of patients. Thanks to the continuous development of technology in the medical field, medical devices, electronics and related products of the healthcare industry are increasingly taking on enhanced roles in sustaining health in hospitals, clinics or in our lives at home.

The merger of manufacturing technologies with healthcare is responsible for improving the standards of living in various countries. From ‘small’ innovations such as adhesive bandages and ankle braces, to larger, more complex technologies like MRI machines, artificial organs, and robotic prosthetic limbs, technology has undoubtedly made an incredible impact on medicine.

The adoption of healthcare and medical devices technology innovations is the key enabler for effective transition from a developing economy to a developed one. The nation’s spending on healthcare has a direct impact on improving economic growth prospects. It improves labour productivity, and in turn improves general income levels of the society.

India is growing as the key market for medical devices and diagnostics. Given the large unmet healthcare needs and the current thrust of the Indian government, this sector has naturally lent itself as a priority for ‘Make in India.’

Indigenous manufacturing is expected to improve product quality control prices, making healthcare more accessible and affordable. Today Indian engineering has acquired relative strengths in the manufacturing and exports of the Medical Devices, Pharmaceutical Machineries and Surgical Equipments sector. Today, in the wake of the global economic slowdown, global majors are looking for emerging markets to tap manufacturing and market opportunities.

Some of the major strengths of India are as follows:

1. India is well placed in some segments of the sector such as outsourced contract design, development, and manufacturing.
2. Manufacturers in India have significant focus on the ‘designing-to-cost’ factor owing to the price sensitivity in the Indian market. This in turn has led Indian products gain competitive positions in majority of the global markets.
3. Indian manufactures range from predominantly low value to high-end medical equipment catering to one of the most diverse set of consumers.
4. India has steadily built capabilities in designing and development of vast range of electro--mechanical diagnostic and therapeutic devices. Besides, implantable devices and active implantables like pacemakers are also developed under the most stringent quality norms.
5. Today, all segments of medical devices are being developed in India and they also include high-precision components, subassemblies, printed circuit boards assembling, implantable grade materials and sterile packaging, biodegradable implantable materials, noble metals and biomaterials like nitinol, polymers, silicones, epoxy, micro electronics, polymers, laser welding-hermetic sealing, etc.
6. Recently, National R&D labs and the DRDO (Defence Research and Development Organisation) have increased their focus on the technologies for the sector. Some of them were recently developed and commercialised. They involved some of the most complex implantable devices made of titanium alloys for diverse engineering applications including osteo-integration for integrating with surrounding tissues with implanted devices. These technologies are now extensively used in the private sector.
7. India has steadily widened the ambit of markets and now exports to more than 150 countries. There is a growing awareness about the sunrise sector and Government of India extends full support in promoting exports of the sector.

1. The Government has launched a voluntary scheme ‘ICMED’ or Indian Certification of Medical Devices to bring international respect to medical devices which are made in India.
2. With effect from 1 January 2016 the Government has scrapped the requirements of obtaining a ‘No Objection Certificate’ from the Health Ministry for exports meant for developed countries. This is because these nations have scrutiny mechanisms before importing from India, and since our exporters take due approvals from importing countries, this additional information is not required.
3. FDI has been allowed 100% in order to promote world-class manufacturing and enhance competencies in the local manufacturing. Existing companies or setting up of new companies are allowed to bring FDI under automatic route in the medical devices sector. FDI inflow will spur R&D and manufacturing innovations, in turn increasing the efficiency and effectiveness of medical electronic products. Advancement of medical electronic product quality and associated successful diagnostic rates are expected to create a spurt in adoption.
4. National Medical Device Policy 2015 focuses on R&D, testing and quality for domestic manufacturing.
5. The Government of India unveiled a start-up policy aiming to encourage entrepreneurs in overall manufacture of goods and services. The policy in itself has covered significant benefits – such as barriers to entry have been diluted, a large corpus of seed funds has been earmarked, tax benefits have been extended and regulatory requirements have been significantly done away with.
6. To stimulate domestic manufacturing, the Government of India announced (on 19 January 2016) the withdrawal of earlier concessional import duty. Notification on Chapter 90 items and restricting this Concessional Duty to only 12 Medical Devices of this notification whereby the custom duties have been increased from 5% (0%) to 7.5% as earlier and SAD of 4% have been reimposed on 67 items of the 117 items identified as Medical Devices.
7. In order to boost self-sustaining industry-oriented R&D mechanisms, the Ministry of Commerce and Industry has undertaken an Initiative for Technological Upgradation for Boosting Engineering Exports, wherein 34 products at 8-digit HS Code tariff lines in Medical Devices have been identified, having significant global export potential. These products are mainly related to Chapter 90, i.e. Optical, Photographic Cinematographic Measuring, Checking Precision, Medical or Surgical Instruments and Apparatus Parts and Accessories.
8. The Government has announced that it would open three medical devices parks. The 200-acre park is being established in Vishakhapatnam, by the Government of Andhra Pradesh. Similarly, the Maharashtra government is considering a 200-acre park in Mihan, Nagpur, Maharashtra.
9. The Department of Commerce and EEPC India have organised a series of Technology Meets across major engineering exports clusters in the year 2016-17. Some of the major medical devices manufacturing clusters such as Ahmedabad, Rajkot, Bangalore, Delhi NCR, etc were also covered in the planned calendar of meets. The engineering enterprises of these clusters are being provided a platform to connect with the leading R&D Labs and strengthen their manufacturing and export capabilities.

The Indian medical devices industry is currently valued at around USD5 billion which is 2% of the USD250 billion industry. The overall healthcare industry in India is valued at USD90 billion which is expected to reach USD220 billion by the year 2020. Thus India’s Medical Devices, Surgical Equipment and Pharmaceuticals industry is poised to grow significantly in the coming years and emerge as cost-effective suppliers of the products to the whole world.

The Indian Surgical Equipment, Medical Devices and Pharmaceutical Machinery industry is fragmented with close to 1800 domestic firms who are predominantly MSMEs, primarily competing in the range of low- to medium-technology products. However, in recent years there has been a paradigm shift in the manufacturing landscape which has now expanded for the production of more cost-effective to high-end products including hi-tech R&D and testing in the sector.

The domestic market caters to low-value disposables and supplies space, whereas importers dominate the costly and high-end medical equipments with extensive service networks.

The Indian Medical Devices industry is a sunrise segment in the healthcare space. With focus on technology, innovation and conducive regulatory framework, this sector will attract investments from the private sector. This would help Indian companies to become originators rather than traders.

International companies in this field are also using India as a manufacturing base by either setting up facilities of their own or by acquiring domestic manufacturers. Some examples include 3M’s manufacturing plant in Pune, Becton Dickinson’s manufacturing facility in Haryana, Hollister’s setting up a manufacturing facility in India and Philips Medical Systems’ acquisition of Medtronics and Alpha X-Ray Technologies.

The Indian Medical device industry is the 4th largest in Asia; The market is primarily dominated by MNC products while the indigenous products form 20-25% of the market share. Majority of the products in the categories of Medical Electronics, Implants and other high- to medium-end technologies are catered through imports and foreign technologies.