Budget Expectations 2024-25: Unlocking India’s Potential In Med Tech With A Robust Regulatory Framework

The emphasis should be on ensuring safety, quality, and effectiveness of medical devices in India, thereby positively impacting public health and general well-being. Read on.

The Medical Technology (Med Tech) sector in India is poised for a transformative journey in 2024, buoyed by recent policy initiatives. With the recent unveiling of the 'National Single Window System' and the National Medical Devices Policy 2023, the sector is on the brink of a golden era. As expectations turn toward the Interim Budget 2024-25, the industry hopes for a conducive environment that fosters innovation, ensures quality healthcare, and propels the sector to its projected $50 billion mark by 2025.

An optimistic start to 2024

The Medical Technology sector is filled with optimism as the year 2024 commences, marked by an early policy initiative. In the inaugural week of the year, India introduced the 'National Single Window System' developed by TCS to facilitate the simplification of Medical Device Imports. Launched by India's CDSCO, the 'National Single Window System (NSWS)' streamlines the import process for medical devices, offering a comprehensive platform for approvals. This initiative strives to establish a centralized platform for investors, ultimately enhancing the overall ease of doing business. Notably, the NSWS became operational on January 1, heralding a promising start to the year. Earlier, the introduction of National Medical Devices Policy 2023 was a major leap forward. It got a robust response from all stakeholders and the industry chalked out a roadmap for the future.

A promise for affordable healthcare

In the Union Budget, the Med Tech Industry would be expecting a reformative push and the government's intervention to create a balanced ecosystem where both domestic and international companies can contribute significantly to providing quality and affordable healthcare to all. Quality and affordable healthcare can reach the last mile by leveraging and deploying medical technology.

Presently, the industry stands on the verge of a turning point. The market, which was nearly USD 8 billion in the pre-Covid Period (2019), is growing at a rate higher than the global growth rate. The pandemic proved the immense resilience of the sector and the industry is projected to grow to $50 billion by 2025 as per a Deloitte Report.

MedTech in India: Need for favourable policies

Budget allocations and policy adjustments must guarantee the industry's adherence to the most stringent standards of voluntary quality management systems, embracing a global perspective, and securing a significant share of global Capital Medical equipment. This marks the Golden Decade for MedTech in India, and a favorable policy environment is essential for an additional impetus.

Quality products equals good patient outcomes

With a broader perspective and to enable the desired growth of the industry, new regulatory capabilities are urgently needed and that will be a major boost for the development and progress of the medical Tech sector. There is no disagreement among stakeholders on the fact that regulatory requirements and expertise for the medical device are completely different from those of the pharma sector. For example, to combat the high rate of Hospital-acquired Infections in the country, a strict regulatory mechanism needs to be in place and the government should come out with a comprehensive regulatory mechanism that not only asks for adherence to proper guidelines but also incentivizes the players in the field for their contribution in this space. Overall, India needs to ensure quality products and good patient outcomes. It is also important to establish a level playing field for ensuring quality while encouraging local manufacturing.

Important to rationalise tax structure

To encourage industry to flourish, India needs to rationalize its complex tax structure, especially the EXIM duty structure. It is promising to note that India is trying hard to harmonize and ally the domestically developed quality standards and regulations with the best of global standards. India's Med Tech has been growing faster than the global industry which is growing at the rate of 4-6 per cent. While the market for medical devices is growing rapidly in the country with the increasing burden of non-communicable diseases and hospitalization cases, India is hugely dependent on imports for sourcing medical devices, particularly complex and high-end ones.

Transition from import-friendly to export-confident Med Tech country

There is a need for contemporary policy interventions and support to transform India from an import-friendly to an export-confident Indian MedTech country. Union Budget should focus on further boosting research and development infrastructure, gearing up for an aspirational $50 billion MedTech economy.

The last word

Collectively, the emphasis should be on ensuring the safety, quality, and effectiveness of pharmaceuticals and medical devices in India, thereby positively impacting public health and general well-being. We aspire to witness substantial growth in the upcoming years, striving to realize the vision of 2047 - India@100. As India stands at the threshold of the Golden Decade of MedTech, the Union Budget 2024-25 is expected to hold the key to unlocking the sector's vast potential.

(This article is authored by Mr Prashant Arer, India Head, Enbio Group AG)