The Union Cabinet, chaired by the Minister Shri Narendra Modi, approved the National Medical Devices Policy, 2023. The medical devices sector in India is a sunrise industry. The market size of the medical devices sector in India is estimated to be $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
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. This sector is expected to realise its full potential, with the strategies for building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programs and promoting higher education to foster talent and skilled resources in line with the industry requirements.
This sector in India is an essential and integral constituent of the Indian healthcare services. It assumed greater significance during the COVID-19 pandemic through the large scale production of medical devices & diagnostic kits, such as Ventilators, Rapid Antigen Test kits, Real-Rime Reverse Transcription Polymerase Chain Reaction (RT-PCR) kits, Infrared (IR) Thermometers, Personal Protective Equipment(PPE) Kits & N-95 masks.
The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of four medical devices parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
Under the PLI scheme for medical devices, a total of 26 projects have been approved, with a committed investment of ₹1,206 crore and out of this, so far, an investment of ₹714 crore has been achieved. Under the PLI scheme, 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. Remaining 12 products will be commissioned in near future. Five projects out of total 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products / 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. 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.