No clinical trial waiver for in-vitro diagnostics in India: A balanced perspective

India’s in-vitro diagnostics (IVD) sector is an essential pillar of the healthcare system, providing diagnostic solutions that help in early detection, disease monitoring, and precise treatment. The Central Drugs Standard Control Organisation (CDSCO) has recently reinforced its commitment to patient safety by eliminating clinical trial waivers for IVDs, ensuring that only thoroughly evaluated products enter the market. This decision, while safeguarding public health, offers a significant opportunity for the Indian IVD market to align with global regulatory frameworks and foster innovation that caters to both domestic and global healthcare needs.

The CDSCO’s decision demonstrates an unwavering commitment to patient safety. By mandating clinical trials for IVDs, the regulatory body is ensuring that all diagnostic tools used in India are evaluated for their effectiveness and safety under local conditions. It reflects the robust efforts of the CDSCO to uphold the highest standards of healthcare product quality, which is vital as diagnostics directly impact patient outcomes.

Globally, leading regulatory frameworks like Europe’s CE-IVD Regulation require diagnostic kits to undergo evaluations such as Common Technical Specifications (CTS), which mandate that these kits be tested on local populations to ensure relevance and efficacy in specific regions. By adopting a similar rigorous approach, the CDSCO is aligning India with international best practices, emphasising that patient safety remains a top priority, irrespective of where the product was originally developed.

A critical consideration in this decision is the need for a risk-based regulatory approach. Imposing clinical trials uniformly across all risk classes of diagnostics may, at times, hinder the timely entry of low-risk, proven technologies into the Indian market. For example, many diagnostics with a low-risk profile have already established a strong safety and efficacy track record globally, having been approved by stringent regulatory bodies such as the U.S. FDA or European CE. Requiring such products to undergo full clinical trials in India may not provide additional patient safety benefits but could delay the introduction of life-saving innovations.

Instead, a differentiated regulatory model, as seen in the European CE framework under IVDR, allows for lower-risk products to follow streamlined approval processes, while higher-risk products undergo more comprehensive evaluations. By adopting such a tiered model, India could ensure that innovation continues to thrive while patient safety is upheld. Low-risk diagnostics, which have already passed rigorous international tests, could be brought to the Indian market faster, ensuring timely access to cutting-edge technologies for Indian patients.

One of the key advantages of this decision is that it encourages manufacturers to develop region-specific diagnostic solutions. India’s diverse population and unique healthcare challenges require diagnostics that cater specifically to local needs. By enforcing clinical trials locally, manufacturers are driven to refine and adapt their products for the Indian market, ensuring that the diagnostic tools are not only innovative but also highly relevant and effective for Indian patients. This emphasis on local trials will likely result in more accurate and tailored diagnostics that address region-specific health conditions and patient profiles. As a result, Indian healthcare providers will have access to technologies that are optimised for local conditions, leading to better patient outcomes.

The global IVD market is projected to reach $114.4 billion by 2028, with India’s domestic market expected to grow significantly as well. By maintaining rigorous evaluation standards, India bolsters confidence in the quality of the diagnostics available in its market. As we approach 2030, the Indian healthcare landscape will increasingly depend on high-quality diagnostics to meet the needs of a growing population. The CDSCO’s approach ensures that even internationally approved diagnostics are scrutinised to meet Indian regulatory requirements, further enhancing the quality and reliability of diagnostic tools available domestically.

This focus on high standards promotes not only patient safety but also innovation within the industry. It encourages manufacturers to continually innovate, ensuring that their products are both effective and compliant with the most stringent global standards. This strategy will ultimately position India as a leader in healthcare technology and a trusted hub for diagnostic innovation.

From the perspective of domestic manufacturers, including Innvolution Healthcare, which specialises in cardiac catheterisation labs and stents, we believe that balancing regulatory compliance with innovation is critical. As a company that adheres to international standards, the challenge lies in navigating local regulations that may not always align with global practices. For companies like ours, harmonisation with global regulatory norms can ensure smoother operations and help bring our products to market faster while ensuring safety standards are not compromised.

Furthermore, for Indian companies that aspire to be global players, harmonisation with international standards is crucial. At Innvolution Healthcare, we believe that collaboration with global regulatory bodies can help India adopt best practices that facilitate faster approval processes while ensuring safety standards are met. This collaborative approach would enable Indian manufacturers to not only cater to the domestic market but also expand into international markets with confidence.

The decision by the CDSCO to require clinical trials, even for internationally approved diagnostics, marks a positive step toward elevating the quality of healthcare in India. While it challenges manufacturers to navigate stricter requirements, it also presents an opportunity to develop more relevant, region-specific solutions that directly benefit Indian patients. This move fosters innovation while maintaining the highest safety standards, creating a win-win scenario where technological advancements are both cutting-edge and tailored to local needs.

In conclusion, CDSCO’s decision to eliminate clinical trial waivers for IVDs signals a commitment to rigorous evaluation, patient safety, and fostering innovation within the healthcare ecosystem. It ensures that only the highest-quality diagnostics reach Indian patients, providing them with the tools they need for better health outcomes. At Innvolution Healthcare, we remain committed to working within this regulatory framework to bring forward diagnostics that are safe, innovative, and tailored to meet the specific needs of India.