ADMI welcomes the government’s decision to maintain stringent clinical trial requirements for In-Vitro Diagnostics (IVDs), reinforcing the commitment to safety and efficacy in India’s healthcare sector. By refusing to waive clinical trials for IVDs approved in other developed countries, the government ensures that these devices are rigorously evaluated based on India’s unique biological, genetic, and environmental factors. This move safeguards patient well-being, enhances trust in diagnostic tools, and encourages global manufacturers to meet Indian standards, fostering innovation tailored to the country’s needs. With India’s IVD market projected to grow to $3.24 billion by 2029, this policy supports the development of reliable, high-quality diagnostics and strengthens healthcare infrastructure. ADMI fully supports this initiative and believes it will benefit the industry while promoting patient safety and trust