With 17 per cent of world population and a GDP growth rate of 7.2 per cent, India is amongst the fastest growing economies of the world. The Indian healthcare sector grew at a rate of 18 per cent from 2010 till 2016 and is expected to advance at a rate of 15 per cent during 2016-20 to reach $280 billion by 2020.

With one-sixth of world’s population and a growing demand for healthcare services, India is also likely to witness a spur in the demand for allied technologies, medical devices, medical equipment and medical consumables which will aid in delivery of affordable healthcare. Medical technology can be instrumental in shaping healthcare for all in India as it provides the opportunity to leapfrog over India’s longstanding healthcare challenges — accessibility, affordability and quality.

Initiatives

The Indian government has encouraged many positive initiatives for the healthcare industry, especially the medical devices sector in the last three years. 

Medical devices were included in the “Make in India” initiative which is driving indigenous manufacturing

Medical devices were opened up for 100 per cent FDI through automatic route, which attracts further investment

Correction in inverted duty structure to help local manufacturing

Export incentives (MEIS) increased from 2 per cent to 4 per cent

Development of clusters to support growth and innovations through medical devices parks in Andra Pradesh, Gujrat and Tamilnadu

The recent notified “Medical Devices Rules 2017” which will be implemented from January 1, have eased norms for obtaining license and conducting clinical trials, and also reduced manufacturer-regulator interface by prompting digital platform. These harmonised policies and rules for the medical devices will also encourage local manufacturing and move towards improving affordability for patients.

The new “National Health Policy 2017” aiming to provide healthcare in an assured manner to all. The policy will strive to address current and emerging challenges arising from the ever-changing socio-economic, technological and medical specialty scenarios.

Challenges

Though the Indian healthcare industry has been growing at double digit rate and has matured significantly in the last three years, it still faces a number of challenges.

Too many governing bodies with diverse requirements and standards

Delay in bringing in the New Medical Devices Act 2016

No arbitrary price control mechanisms should be applied to med tech products as they become hindrance to innovation and promotion of new technology and create a push back for “Make in India”

Phasing out of chlorinated plastic bags, gloves and blood bags within two years by Ministry of Environment and Forest without looking into alternatives

Accessibility

Limited Access: Tier 2/3 cities and rural areas do not get sufficient care

India has only 0.7/0.8 beds per 1,000 people which is well behind 3.5 beds per 1,000 people recommended by WHO.

Healthcare delivery system will need additional 3.6 million beds to reach recommended capacity. ($36 billion new investments are needs to ramp up)

Affordability

Major concern:  One in every five citizens is still below the poverty line in India. Unplanned health expenditure can put significant burden on families. Around 60 million people are pushed below the poverty line per year

Low insurance coverage and weak public healthcare system are driving up the average cost of healthcare to families and creating a burden for those with limited resources

Out of pocket expenditure is 62.4 per cent of the total health care expenditure in the country as compared to the world average of 18.2 per cent. (China 32 per cent, Brazil 25 per cent and South Africa 6 per cent)

The government should look at implementing universal h coverage for BPL patients all across the country. (Some states like Andra Pradesh and Tamilnadu already have this scheme).

Utilise buying power of the government to develop a low cost buying platform: If the government uses centralise purchasing and simplifies its supply chain, it will lead to tremendous cost savings to the patients. 

Consumer rights

Consumer should have the right to choose appropriate technology based on requirements

Procedure costs should be capped rather than capping cost of devices

Suggestions

Some key suggestions from the medical devices industry

Rather than focusing on Make in India for India, the shift should be towards make in India for the world

Announce export incentives for manufacturing in India for the rest of the world.

Should align our regulation towards internationally harmonised standards

Financial incentives: Reduce import duty to 2.5 per cent on all inputs needed to manufacture medical devices in India. (Currently it is applicable on only selected inputs)

Include medical devices in ‘Interest subvention schemes’ for exports. (Include medical devices falling under chapter 9018)

For quality medical devices: Adhere to Global-best norms, align completely to ISO 13485

Device certification has to be in line with the certification with respect to CE marking (used all over Europe) and USFDA

Alongside, significantly improve CDSCO medical device regulator staff strength and train them with support from reputed global regulator from GHTF countries

Bureau of Indian Standards (BIS) can adopt globally accepted standards & align them with Indian requirements

Single window clearance: implement a single nodal agency – Medical Device Promotion Council or a window clearance system to coordinate across various ministries to initiate local manufacturing / research and development/ regulatory for a fast track approval process

Industry need to customise business models in line with requirement for the Indian markets

Products with low to medium technology could be immediate focus areas — will reduce import significantly. 

Focus on innovation to design products appropriate for India

Use frugal innovation techniques to create affordable devices

Create compact, energy efficient and easy to operate devices which can be deployed in remote areas without skilled technicians

The removal of existing barriers for growth and  innovative initiatives from government will ultimately lead to increased investment in the Indian medical devices industry by domestic and global players alike, whether in the form of local manufacturing, fostering research & development and innovation, partnerships for skill development, among other things.
(The writer is managing director of Poly Medicure)