The Union government on Wednesday approved the National Medical Devices Policy, 2023, with an aim to boost the production of medical devices in the country, as well as to promote an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation.
The policy is expected to help the medical devices sector grow from present $11 billion to $50 billion in the next five years.
“Currently about 75-80% of medical devices are imported in India and with this scheme the government will enhance India’s manufacturing capacity. It is also essential to enhance indigenous capacity as there is a growing demand for affordable quality medical devices” said Mansukh Mandaviya, Union minister for health and family welfare during the media-briefing.
“The Union government’s vision is emerge as a global leader in manufacturing and innovation of medical devices by achieving a 10%-12% share in the expanding global market over the next 25 years”, said the minister.
Mandaviya further said there is a need for systemic development and expansion of medical devices industry in the country. “Medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions, including regulatory streamlining, enabling infrastructure, facilitating research and development and innovation, attracting investment and human resource development,’’ he said.
According to a release issued by the government, the policy is expected to provide the necessary support and directions to strengthen the medical devices industry into a competitive, self-reliant, resilient and innovative industry that caters to the healthcare needs of not only India but also the world.
“The Indian medical devices sector's contribution has become even more prominent as India supported the domestic and global battle against the COVID-19 pandemic”, mentioned the release.
Describing the medical devices sector in India as a “sunrise sector which is growing at a fast pace”, the release said that the National Medical Devices Policy, 2023 aims to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients.
The Government of India has already initiated the implementation of the Production Linked Incentive (PLI) Scheme for medical devices and support for the setting up of 4 Medical device Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
Till now, a total of 26 projects have been approved under the Production Linked Incentive (PLI) scheme for medical devices, with a committed investment of Rs 1,206 crore. Out of this, an investment of Rs 714 crore has been achieved so far.
"Under the PLI scheme, a total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high-end X-ray tubes, etc," said the release. "The remaining 12 products will be commissioned in the near future. Five projects out of a total of 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products/product components,” it read further.
Stressing on the need for a holistic policy framework, the release mentioned that various Government departments have undertaken programmatic interventions to encourage the sector.
"In view of the diversity and multi-disciplinary nature of the sector, the regulations, skilling trade promotion of the medical device industry are spread over several departments in the Government both at the Centre and State levels. There is a need to bring together the range of interventions in a coherent manner that would facilitate focused and efficient support and facilitation for the sector by the respective agencies," added the release.
The release said that the building and enabling of the ecosystem for manufacturing will go along with a focus on innovation as well as creating a robust and streamlined regulatory framework. It further said that the Government will provide support in training and capacity building programs and in promoting higher education to foster talent and skilled resources in line with the industry requirements.
Adding further, the release mentioned that the domestic investments and production of medical devices complement the Government’s 'Atmanirbhar Bharat' and 'Make in India' programs.