Initiatives By Government Of India & EEPC For Development Of The Indian Medical Devices Sector

(Cortsey : EEPCINDIA )

Market

Medical devices is a sunrise sector of the Indian economy. The size of the Indian medical devices market is estimated at USD 11 Billion in year 2020, expected to grow to USD 50 Billion by year 2030 with CAGR of 16.4%.

Industry

India being an emerging market is also evolving as a potential manufacturing hub for the key global medical device companies. It has huge market potential and is witnessing a double-digit growth rate. As per “Invest India”, there are 750 -800 domestic medical devices manufacturers in India with an average investment of USD 2.3 – 2.7 mn and an average turnover of USD 6.2 – 6.9 mn. Since 1989, the regulations for Medical Devices including IVD in India has been growing consistently under Drugs & Cosmetics Act 1940.

The government issued Medical Device Rules 2017. Two more notifications in February 2020 expanded the coverage of medical devices, advising on the phase wise actions to be taken by the Industry until August 2023. As a result, the number of medical device companies in India is likely to be multiplied manyfold. New rules shall ensure availability of quality medical devices across the country. The new rules also aim to promote a culture of self compliance by manufacturers of medical devices.

Exports of medical devices from India

India exported USD 2.9 Billion worth of medical devices in financial year 2021-22. There has been a growth of 15.47% over the year 2020-21. The top 5 destinations of India’s exports of medical devices were USA (21.6%), China (5%), Germany (4.4%), France (3.1%) and Singapore (2.8%). In the exports of medical devices category wise, the disposable and consumables sectors constituted around 47.14% share in India’s total exports from the sector followed by equipment and electronics (31.79%) share, IDV reagents (6.01%), implants 4.63% and surgical instruments 2.44%.

Imports of medical devices by India

India is a net importer of medical devices with total imports of USD 8.5 Billion in year 2021-22. A growth of 36.8% over the previous year. The top sources of India’s imports of medical devices are China (19.4%), USA (17.2%), Germany (9.2%), Singapore (8.5%) and Japan (4%). In the category wise imports of medical devices by India, the share of equipment’s and electronics is the highest at 63.7%, followed by disposable and consumables at 19%, IVD reagents at 10.3%, implants at 5% and surgical equipment’s at 2%.

Clusters and Parks

In India, 10 medical device clusters are present in Andhra Pradesh, Haryana, Gujarat, Karnataka, Tamil Nadu, Telangana, Maharashtra and West Bengal. The Ahmedabad and Vadodara clusters in Gujarat manufacturers a wide variety of implants, equipment and disposables with Surat cluster having most implant manufacturers. Faridabad cluster in Haryana produces an array of consumables and disposables. Bengaluru cluster in Karnataka majorly focuses on medical electronics. The Baruipur cluster in West Bengal specializes in manufacturing of surgical equipment. Implant and medical electronics manufacturers are clustered both in Chennai and Mumbai with Mumbai cluster also having IVD and disposable production units.

Despite recent experiences in accelerating domestic production of medical devices, most imports of medical devices are largely high-value and low-volume devices while the domestic production are largely low-value and high-volume diagnostic tools. However, in recent years, Indian medical devices manufacturing industry is improving its coverage even among sophisticated and high-end segment. Indian industry has begun manufacturing more sophisticated devices like electro diagnostic apparatus, used in medical, surgical, dental or veterinary sciences, orthopedic appliances, splints and other fracture appliances, artificial parts of the body etc.

Some of the initiatives by Government of India for development of the Medical Devices Sector

• Announcement of National Medical Device Policy - The Government of India announced the National Medical Device Policy on 3rd May, 2023 with a vision to place the Indian Medical Device sector at an accelerated growth path with a patient centric approach and to ensure cost effective, innovative and affordable healthcare products of excellent quality. The aim is to position India as a global leader in manufacturers and innovation of medical devices by achieving 10-12% share in expanding global market over the next 25 years.

• 100% FDI in medical device sector under automatic route - Almost all the lead global firms have their Indian subsidiary. The lead 50 medical devices leaders of the world have their Indian subsidiaries. 50 per cent of those are from USA, 20 per cent from Japan, 4 each from France and Switzerland, 3 from Germany and the remaining from UK, China etc.

• Scheme of promotion for Medical Devices Parks - The Government of India has announced a total financial outlay of INR 400 crores for 4 medical device parks. These parks will be setup in Uttar Pradesh, Himachal Pradesh, Madhya Pradesh and Tamil Nadu.

• Launch of production linked incentive schemes for the medical device sector - The Government of India has launched the PLI Scheme to boost domestic manufacturing in medical device sector. Under the PLI Schemes of medical devices till now 26 projects have been approved with a committed investment of INR Rs. 1206 crores.

• Price monitoring - The Government of India has also announced the public procurement order 2017 which is related to the procurement of goods and services in medical device. This order aims to encourage Make in India and promote manufacturing and production of medical devices goods and services.

• The Government of India also aims to ease the registration of medical device manufacturers on Gem portal. The medical device manufacturers and OEMs are exempted from vendor assessment process after producing and submitting certified copy of verified manufacturer/import license from the concerned issuing drug license authority.

• The Government also aims to extend an assistance to medical device clusters for Common Facility Centres CFCs where it is proposed to support minimum of 12 clusters and maximum support of INR Rs. 20 crores per cluster. The Government is also aiming to launch a phased manufacturing program for identifying medical devices where India has an inherent competence and strength.

• A separate Export Promotion Council for Medical Devices was setup by Department of Pharmaceuticals, Government of India on 22nd May, 2023. The major objective of the Council is to make India and international medical devices export hub effectively developing and promoting its exports.

EEPC India initiatives for the medical device sector - Under the mandate of Department of Commerce, EEPC India has been the central agency to promote the growth of exports of medical devices and allied sectors. A few of the major initiatives undertaken by EEPC India for the medical devices are as follows

a) Creation of separate product panel for medical device sector - EEPC India has setup a separate panel for medical device sector. The panel is engaged in developing strategies for the promotion of the sector as well as involved in policy advocacy for the sector.

b) Creation on E-product catalogue for the sector - EEPC India has developed an E-product catalogue for the medical device sector which acts as a ready reckoner for the industry. The catalogue facilitates product wise, country wise search options as well as maintains the details of the various standards and certificates followed by the industry which is very important keeping in view the mandate for the medical device sector to capture international markets.

c) Participation in international fairs and exhibitions - EEPC India has over the years been participating in international fairs and exhibitions of repute like Arab Health, Nepal Medical Show & Bangla Med Expo etc. The aim is to help Indian companies to explore the overseas markets and gain higher market share.

d) Creation of Brand India engineering for the medical device sector - EEPC India is engaged in a Brand India engineering initiatives with IBEF and aims to promote India as a quality and affordable supplier of medical device goods and services. The promotional campaign for these initiatives was launched and carried widely across various countries across the globe.