India: To meet the evolving healthcare needs of the country, the Union Cabinet on April 26th, 2023, approved the much-awaited medical device policy of India. The India Medical Device market has always been an import driven market with majority of imports being done from countries like United States, Germany, China, Brazil, among others. The medical device market in India is fourth largest in the Asia Pacific region and is expected to reach USD50 billion by 2030. In order to reduce the dependency on imports and boost the status of indigenously produced medical devices, the National Medical Device Policy was formulated. This policy aims at providing 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 the Indian population but the world as well. The policy aims at placing the medical devices sector on an accelerated path of growth with a patient centric approach to meet the healthcare needs of the population.

A single window clearance system for licensing of medical devices will be created by the government under this policy. This would help companies in doing business by getting faster market approvals. The policy will also focus on helping brands in improving their positioning by creation of a dedicated export promotion council which will help the companies increase their market access. This policy will also strengthen the role of agencies such as Bureau of Indian Standards (BIS)in product manufacturing, processing, and even looking at its performance. Furthermore, the policy will focus on the development of skilled professionals in order to have an adequate supply of skilled workforce in the medical device sector, including scientists, regulators, health experts, managers, technicians, among others. Developing collaborations and partnerships with international organizations in order to facilitate research & development and growth in the medical device industry is also a key focus area of the policy. The policy will also focus on strengthening the medical device infrastructure in India and will support the already initiated implementation of PLI Scheme for medical devices and support for setting up of 4 Medical devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh by the Government of India. Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs.1206 Cr and out of this, so far, an investment of Rs.714 Cr 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.

According to the government officials, “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. They also stated that the medical device industry is expected to realise its full potential, with strategies viz, “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 programmes and promoting higher education to foster talent and skilled resources in line with the industry requirements. Further, encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programmes.”

According to TechSci Research, the positioning of India in the global medical device market has significantly increased over the years. The support that India provided in battling the pandemic through the large-scale production of medical devices and diagnostic kits like ventilators, rapid antigen test kits, RT-PCR kits, PPE Kits and N-95 masks has not gone unnoticed. However, reliance on imports had always remain a serious concern. Implementation of PLI scheme for medical devices was the first step in boosting the domestic production of medical devices in India. The formulation of National Medical Device Policy will further give a boost to the Atmanirbhar Bharat scheme and generate employment besides reducing import dependency. The domestic manufacturing of various medical devices such as linear accelerators, MRI machines, CT Scanners, Mammography devices, C-Arm, among others has already started, this policy will help in putting into place a comprehensive set of focus areas for the growth of the sector in a coordinated manner.

The medical devices sector in India was regulated by the Drugs and Cosmetics Act of 1940 and the industry was asking for a specific policy since years. 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 actually necessitated after revelations about faulty hip implants marketed by Johnson & Johnson, exposing the lack of regulations when it came to medical devices in India. This new policy will not only help in regulating the industry but will also stringently monitor any kind of faulty devices in the industry, thereby boosting the status of India medical device market.