Experts support India's move to waive clinical trials for pre-approved drugs

India's decision to waive local clinical trials for drugs already approved in select countries has received widespread approval from industry experts. The move aims to accelerate the availability of innovative medicines, cut costs, and reduce the time required to bring new drugs to market.

Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, praised the government's decision, noting that it will facilitate faster access to medicines and simplify regulatory processes. "This is a step towards regulatory simplification for better patient care," Jain said.

Raj Prakash Vyas, President of Corporate Affairs at Cadila Pharmaceuticals, described the waiver as a "visionary step." He highlighted that this policy change will expedite the availability of life-saving medications, particularly for patients with rare diseases, those affected by pandemics, and special defence needs.

The Central Drugs Standard Control Organisation (CDSCO) announced that the waiver applies to drugs approved in countries such as the US, UK, Japan, Australia, Canada, and the EU. These drugs, which offer significant therapeutic advances, can now be made available in India without the need for local trials.

Rajeev Juneja, Managing Director of Mankind Pharma, noted that aligning India's drug regulations with those of leading global authorities will reduce the cost and time involved in bringing critical therapies to Indian patients. "This new regulation will decrease the waiting period for life-saving drugs in India," he added.

Dr Anup Kumar, Head of Urology Robotics and Renal Transplant at a major Indian hospital, also supported the decision. He emphasised that drugs approved in developed countries undergo rigorous testing before being cleared for clinical use, making the waiver a safe and effective measure for India.

The waiver covers drugs used in treating rare diseases, gene and cellular therapies, new drugs required during pandemics, and those with significant therapeutic advances. However, the government will still require final phase four clinical trials for these drugs to ensure ongoing safety and efficacy.

Reportedly, the decision will not only benefit patients by making critical drugs available sooner but also reduce costs for public health programs like CGHS and Ayushman Bharat. Pharmaceutical companies are expected to pass on the savings from reduced trial costs to patients, further improving access to essential medicines. (With inputs from ANI)