The National Medical Devices Policy,2023: Agame changer to create a $50 billion sector by2030

,Managing Director,Poly

India's medical device industry is a vital and crucial part of the country's healthcare system. Together with healthcare providers, pharmaceutical companies, and the healthcare insurance sector, it serves as a crucial pillar in the healthcare delivery system and aids in achieving the main goals of the National Health Policy (NHP), 2017. The multidisciplinary field of medical devices can be broadly divided into the following categories: (a) electronic equipment; (b) implants; (c) consumables and disposables; (d) surgical instruments; and (e) in vitro diagnostic agents. According to the CDSCO, there are additional device categories spread throughout 24+1 (IVD) sub-categories.

As India supported the domestic and international fight against the COVID-19 pandemic through the mass 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 contribution of the Indian medical devices sector has become even more notable.

The medical devices business in India is a rising star that is rapidly expanding. The medical devices business in India was $11 billion (roughly 90,000 crores) in 2020, with a 1.5 per cent share of the worldwide medical device market.

The Indian medical device industry is expanding and has huge potential to become selfsufficient and contribute to the aim of universal health care.

With the new policy in place, the government hopes to reduce India's import dependence to approximately 30 per cent in the next few years and to make India one of the top five global manufacturing hubs. The policy thrust is to look at export-driven manufacturing of high-end devices that are also affordable to Indian hospitals and laboratories, while dramatically reducing import dependence.

The initiative also aims to raise the amount spent on medical devices per person in India. Compared to the global average per capita consumption of $47 and the per capita consumption of wealthy countries

highlights that Poly Medicure restates its

Making Quality

ment: To have a steady supply of skilled work force across the value chain.

◆ Brand positioning and awareness creation: Dedicated Export Promotion Council enabling market access.

The National Medical Devices Policy also aims to establish an innovative and globally competitive industry in India, supported by world-class infrastructure in accordance with PM Gati Shakti, an enabling ecosystem, a streamlined regulatory framework, and qualified manpower, to meet the evolving healthcare needs of patients. This will make sure that everyone has access to high-quality healthcare goods that are patient-centric, innovative, and reasonably priced. This goal is to gain a 10-12 per cent market share in the expanding worldwide market over the next 25 years to become the world leader in the production and innovation of medical devices. The initiative is expected to boost the Medical Devices Sector from $11 billion to $50 billion by 2030.

like the US at $415 and Germany at $313, India has one of the lowest per capita expenditures on medical devices at $3.

In addition to reducing imports, the policy will help in lowering the costs and increasing the accessibility. This will guarantee greater use throughout the hospital, better healthcare, and more inexpensive therapy.

Strategies to promote medical device sector through National Medical Device Policy 2023:

◆ Regulatory streamlining: creation of a Single Window

Clearance System, enhancing the Role of BIS and designing a coherent pricing regulation.

◆ Enabling infrastructure: The establishment and strengthening of large medical device parks.

◆ Facilitating R&D and innovation: Department’s proposed National Policy on R&D and Innovation in the PharmaMedTech Sector.

◆ Attracting investments in the sector: encourages private investments, Venture Capitalists, and also Public-Private Partnership (PPP).

◆ Human resources develop-

The Policy establishes a road map for promoting safety and quality to increase Access & Universality, Affordability, Quality, Patient-centered & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower in a methodical manner.

I am pleased to commemorate the historic adoption of the National Medical Devices Policy, which will be a game changer for India's MedTech sector. The sector is now supported by a strong and consistent policy framework aimed at reducing regulatory processes, promoting Ease of Doing Business, embracing global standards, and boosting sector competitiveness.