Revitalizing Indian Healthcare Manufacturing: Can the New Strategic Medical Device Policy Unlock Growth?

The Union Cabinet has approved the National Medical Devices Policy to increase domestic production and reduce imports of medical equipment. The National Medical Devices Policy 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation. The government has planned six strategies to tap into the potential of the medical devices sector with the Implementation Action Plan.

Union Health Minister Mansukh Mandaviya said that the National Medical Devices Policy 2023 will promote the domestic production of medical devices. He added that encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programmes. Additionally, he said that six strategies had been planned to tap the potential of the medical devices sector with the Implementation Action Plan.

The National Medical Devices Policy aims to help the medical devices sector grow from the present $11 billion to $50 billion in the next five years. The policy's short-term goal is to achieve a $50 billion industry by 2030. Encouraging domestic investments and production of medical devices complements the Government's 'Atmanirbhar Bharat' and 'Make in India' programmes. The policy aims to achieve a 10-12 per cent global market share in the next 25 years.

Encouraging Domestic Investments

India's medical devices sector has one of the lowest per capita spending at $3 compared to the global average per capita consumption of $47, significantly lower than the per capita consumption of developed nations like the US at $415 and Germany at $313. Some 80-85 per cent of the medical devices currently sold in India, mostly high-end ones, are imported. The Indian players and manufacturers have centred their offerings in low-cost and low-tech products like consumables and disposables.

The policy aims to help promote domestic production of medical devices, which will reduce imports and boost the country's economy. The strategies planned to achieve this include building an enabling ecosystem for manufacturing with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity-building programmes and promoting higher education to foster talent and skilled resources in line with the industry requirements. The policy details will hopefully help traders and importers start investing in factories and end the 70-80% import dependency and the ever-rising import bill.

Promote domestic manufacturing 

One of the main challenges faced by the medical devices sector in India is the lack of a specific policy on medical devices. The industry has been asking for such a policy for years, and the National Medical Devices Policy 2023 aims to fill this gap. Another challenge is the dominance of imported medical devices in the Indian market. To address this, the government has initiated the PLI scheme. The Indian government has initiated the implementation of the PLI Scheme for medical devices and extended support for setting up four medical device parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.

Under the Production Linked Incentive (PLI) scheme for medical devices, till now, a total of 26 projects have been approved with a committed investment of Rs 1,206 crore, and out of this, so far, an investment of Rs 714 crore has been achieved. Five projects out of the total 26 projects have been approved recently under Category B, for domestic manufacturing of 87 products or product components. Fourteen products have been commissioned, and domestic manufacturing of high-end medical devices like Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high-end X-ray tubes, etc. has begun. The remaining 12 products will be commissioned in the near future.

Current regulatory framework 

India's medical devices sector is primarily regulated by the Drugs and Cosmetics Act of 1940. In February 2020, the Centre notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940. This was necessitated after revelations about faulty hip implants marketed by Johnson & Johnson, exposing the lack of regulatory teeth when it came to medical devices.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMeD) has been quoted by the Indian Express, saying, that the details of the National Medical Devices Policy will hopefully help traders and importers to start investing in putting up factories and end the 70-80% import dependency and the ever-rising import bill. Nath added that entrepreneurs had stepped up during the pandemic to follow the initiative of Make in India to address the lockdown crisis, and the need for a policy to align various ministries and departments was acutely felt.