Explainer: The Centre's medical devices policy 2023

May 09, 2023 03:20 PM IST

The Cabinet approved the Medical Devices Policy, aimed at increasing the production capacity of Indian manufacturers to reduce imports. HT explains the details

The Union cabinet recently approved the first-of-its-kind Medical Devices Policy 2023 which aims to enhance the production capacity of domestic manufacturers.

Medical devices are divided into five broad categories based on the type of risk. (Representative Image) PREMIUM
Medical devices are divided into five broad categories based on the type of risk. (Representative Image)

At present, India imports 75-80% of the medical devices sector in the market, according to Central government data. The market for medical devices in India was an estimated $11 billion (approximately, 90,000 crore) in 2020, and accounted for 1.5% of the global market. The Centre plans to increase this share significantly by 2048 to promote local manufacturing and broaden the market in the country.

“The government’s target is to take it to around 12% in the next 25 years,” said Anurag Thakur, I&B minister, about the Cabinet decision.

Medical devices are divided into five broad categories based on the type of risk: A refers to electronic equipment; B refers to implants; C refers to consumables and disposables; D refers to surgical instruments and E to in-vitro diagnostic reagents. Articles, software or accessories necessary for the diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder also count as medical devices. Thus, these could range from simple things like thermometers and disposable gloves to X-Ray, CT and MRI machines and implantable devices like stents and artificial joints.

Some of the popular foreign brands in India include Novartis, Medtronic, Johnson & Johnson, GE (general electric), Abbott, and Baxter. Some of the Indian brands include Poly Medicure, Opto Circuits, and Transasia Bio-Medicals.

The Centre started a production-linked incentive (PLI) scheme in 2020, which currently covers 13 sectors, to incentivise companies to manufacture locally. Since 2020, it has helped set up four medical devices parks, under this PLI scheme, in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.

26 projects in these four parks have been approved under the PLI scheme for medical devices — in all, the ministry of chemicals and fertilisers has committed 1206 crore. So far, an investment of 714 crore has been made in 14 projects in which 37 high-end medical devices will be manufactured. These include linear accelerators, MRI scans, CT scans, mammograms, C-Arm, MRI coils, and high-end X-ray tubes among others.

Five projects have been approved recently, under category B for the manufacture of 87 products or product components.

“While various departments of the government have undertaken programmatic interventions to encourage the sector, the current policy aims to put in place a comprehensive set of focus areas for growth of the sector in a coordinated manner. Secondly, in view of the diversity and multi-disciplinary nature of the sector, the regulations, skilling trade promotion of medical device industry are spread over several departments in the government both at the Centre and State levels,” read a government statement on the policy.

“We are more than hopeful that the policy details will help boost local manufacturing, help traders and importers to start investing in putting up factories and end the 70-80% import dependency forced upon India and the ever-rising import bill which last year shot up by a steep 41% to over 63000 Cr and make quality healthcare accessible and affordable for common masses worldwide,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD).

Government’s strategy

The medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions:

Regulatory streamlining: A single window clearance system for licensing medical devices to enhance ease of doing research and business.

Push for infrastructure: Establish large medical device parks/ clusters that are equipped with world-class facilities and are in proximity to economic zones with requisite logistics connectivity.

Facilitate R&D: Establish centres of excellence in academic and research institutions, innovation hubs, and support start-ups.

Attract investment: Encourage private investors, venture capitalists, and also enable public-private partnerships besides interventions like Make in India, Ayushman Bharat programme, Heal-in-India, and Start-Up mission.

Human resources development: Skill, reskill and upskill professionals across the value chain, including scientists, regulators, health experts, managers, technicians, etc.

The policy also supports dedicated multidisciplinary courses for medical devices in existing institutions for futuristic medical technologies, high-end manufacturing and research. It also aims to develop partnerships with foreign academic or industry organisations to develop medical technologies in order to be at an equal pace with the world market.

Brand positioning and awareness creation: Set up an export promotion council for the sector to help deal with various market access issues such as initiating studies and projects for learning from best global practices of manufacturing and skilling.

Industry needs

According to Sunil Khurana, CEO and MD, of BPL Medical Technologies, a dedicated body that understands medical devices not just from the pharmacological lens, but from the perspective of electronics and usage is key to building the medical devices sector. Regulatory simplification and skilling are also vital.

Khurana added that two points particularly will boost make in India rapidly. “While MNCs have their own technology, for almost all local companies in the med tech electronics space, a technology partnership with foreign academic institutes and med tech organisations with the support of the government offers the best route. Else reinventing the wheel will delay progress by three to four years. We also need the state and Central governments’ support in exporting Indian-made products to countries.”

Nath pointed out that policy implementation should ensure that the consumer also benefits.

“So far there is no restriction or capping on the MRP prices of medical devices. Some private hospitals are less concerned about the affordability needs of the patient and more worried about their profit. They consume high MRP goods instead of low-cost options. Because of this, the manufacturer or importer of India is tied up in a system of market operating with artificially inflated MRP labelled on the device. We have been seeking a system whereby ethical manufacturers and importers can offer low-priced MRP products and are still able to sell. We have been seeking MRP of imports to be monitored and compared with imports landed prices and steps taken to control when found irrationally excessive,” he said.

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    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

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