A Streamlined and Simplified Policy Framework: Paving the Way for India Emergence as a Global Hub for Medical Devices

Nov 09,2023

India's $11 billion medical device industry is set for exponential growth at a CAGRof 10-12 per cent. This growth is driven by increased healthcare spending, rising demand for quality care and the growing prevalence of chronic illnesses. While traditionally reliant on imports (comprising over 75 per cent of the market), India is now experiencing a surge in domestic production. Local companies are diversifying their production, including implants, surgical instruments and diagnostic equipments. However, this industry also faces challenges such as infrastructure limitations, high import duties on raw materials, and intricate regulatory requirements.

To unlock India's potential as a global medical device hub, streamlined regulations are crucial. These regulations can simplify and harmonise processes, reduce regulatory burdens, foster innovation, attract foreign investment, strengthen domestic manufacturing and enhance global competitiveness. The transformative New Drugs, Medical Devices and Cosmetics Billof 2023 has the potential to reshape the pharmaceutical and medical device landscape. Balancing the interests of all stakeholders and harnessing India's full potential as a global hub for medical devices is essential.

Reconsidering the New Regulatory Bill, the 2023 Drugs, Medical Devices and Cosmetics Bill aims to revolutionise India's pharmaceutical and medical device sectors. It introduces innovative components, including a risk-based classification system for medical devices, a dedicated regulatory framework for in vitro diagnostic medical devices, the establishment of Central Drugs and Central Medical Devices Authorities, online licensing processes, and stringent penalties for compliance. The bill has received acclaim for its forward-thinking regulation, offering benefits such as enhanced patient safety, innovation in vitro diagnostic medical devices and economic growth.

Proposed solutions include requiring MNCs to undergo equal clinical testing for new devices, implementing stricter import license criteria, offering financial incentives for local research and development and establishing a dedicated support fund for domestic manufacturers.

The Parliamentary Committee's 146th report recommends redrafting the 2023 New Drugs, Medical Devices and Cosmetics Bill with a focus on a dedicated Medical Devices Act. This stems from the complexity of the current bill, which covers drugs, medical devices and cosmetics, making regulation challenging. Rapid technological advancements in medical devices further necessitate a specialised approach. Benefits of such specialisation include improved device safety and quality, fostering innovation and gaining support from industry stakeholders.

Source: HealthWorld