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The Medical Devices Sector in India; Task Force Recommendations


Medical devices’ industry is a multi-product industry, producing wide range of products. Manufacturing and trade in medical devices is also growing quite steadily. Double digit growth rates indicate its importance in health care. Medical devices’ industry mostly depends on imports. Most hi- tech innovative products and technology originate from a well developed eco-system and innovative cycle which needs to be developed in India to promote indigenous industry and to reduce our dependence on imports.

The ‘Make in India’ campaign of Hon’ble Prime Minister Narendra Modi’s government has a mandate to boost the medical device manufacturing sector in India for all types of medical devices and equipments used in manufacturing of Pharmaceuticals. To implement the initiative a Task Force was constituted under the chairmanship of the Secretary, Department of Pharmaceuticals (DoP) to address issues relating to the promotion of domestic production of high end medical devices and pharmaceutical manufacturing equipment in the country. The Terms of Reference (ToR) for the Task Force is given in the detailed report.

The need to address various basic concerns facing the industry including human resources, finance, market, ease of doing business, promotion of R&D and innovation etc was identified. Specific issues that have to be deliberated upon intensively were identified and more focused sub-groups were formed to address these issues including :

Sub-group 1: Sector overview
Sub-group 2: Policy & Infrastructure
Sub-group 3: Regulatory

All the recommendations from different sub-groups were reviewed, collated and a concise actionable set was created. However participation of the industry / stakeholders from manufacturing equipment used in pharmaceutical was lacking and the Task Force did not receive inputs from them despite all attempts.

.An overview of the device industry and the different elements required to build the envisioned harmonized ecosystem is given below.

Medical Devices Sector Overview

Medical devices sector in India is very small by size as compared to the rest of manufacturing industry, though India is one of the top twenty markets for medical devices in the world and is the 4th largest market in Asia after Japan, China and South Korea. Although accurate data is not available, an educated guess would place the retail market at Rs. 60,000-70,000 Crores.


The Medical Devices market can be classified into two major categories:

• Devices that do not require any external energy source.
• Devices that require external energy source to be operational (powered).

Powered devices are further divided into three product categories:

a. Equipments,
b. Implants, and
c. Disposables.

a. Equipments

Equipments account for the largest share of the total market followed by medical implants and disposable segments respectively. This segment is also the fastest growing and is largely dependent on imports currently.

This can be further segmented into the following categories -

• Surgical Equipments :

Prominent factors that drive demand are advancements in surgery and surgical device designs, availability of high skilled surgeons, growing breed of corporate hospitals and advanced surgical facilities like advanced robotics, minimally invasive
surgical techniques and imaging.

• Diagnostics:

Increase in the prevalence of diseases, their complexity and the need for quick diagnosis has created a high demand for diagnostic services and devices like Cardiac imaging, CT scans, X-ray, Molecular Imaging, MRI and Ultrasound-imaging including hand - held devices.

• Life Support:

As life support technologies evolve and improve, use of equipments like ventilator and automated external defibrillator outside of the hospital environment has increased. Also, as consumer spending power increases demand for such systems is expected to grow.

b. Implants

The market for implants is witnessing some amount of innovations in terms of catering to large unmet needs in certain disabilities e.g. blindness. A microchip retina implant is under trial which will allow blind patients to read letters & recognize foreign objects.

c. Disposables

Medical disposable products for medical electronic equipment are used by all hospitals and private nursing homes in the country, including diagnostic and pathological laboratories. The market is becoming increasingly competitive due to low entry barriers (for MNCs), increasing number of players and an expanding consumer base. Examples include disposable medical and electronic probe assemblies for minimally invasive applications, disposable catheter cables, disposable EEG sensors/lead wires, disposable SpO2 sensors, panel mount receptacles, etc.

Present status

During the period 2011-12 to 2014-15 both import and export of medical devices have grown at more than 10% rates.

Import as well as export of Medical Electronics and Hospital Equipment has been the highest amongst all the devices in terms of value. Along with surgical instruments they form more than 50% of total sales with majority being imported (87.4%)

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