India Waives Clinical Trials for Approved Drugs from US, UK, and EU

The Indian government has decided to waive clinical trials for drugs that have already been approved in select countries such as the US, UK, Japan, Australia, Canada, and the EU. This decision aims to accelerate the availability of new and innovative medicines in India, reducing the time and cost associated with conducting clinical trials.

Expert Opinions

Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, welcomed the move, stating, “This will facilitate faster access to medicines and is a step towards regulatory simplification for better patient care.”

Raj Prakash Vyas, President of Corporate Affairs at Cadila Pharmaceuticals Limited, called the waiver a “visionary step” and emphasized its potential to expedite the availability of life-saving medications for Indian patients.

Rajeev Juneja, Managing Director of Mankind Pharma, noted that the decision would reduce the cost and time involved in clinical trials, benefiting patients.

Dr. Anup Kumar, Head Unit of the Department of Urology Robotics and Renal Transplant, highlighted that the new rule would decrease the waiting period for critical life-saving drugs in India.

Government and Regulatory Insights

The Central Drugs Standard Control Organisation (CDSCO) stated that the waiver aims to speed up drug availability, especially for rare diseases, pandemics, and special defense needs. Official sources mentioned that medicines approved by other regulatory authorities like the US, UK, and EU, which are not immediately available in India, will no longer require local trials under certain conditions.

This decision is expected to reduce the costs of public procurement for the Indian government and state governments under various schemes like CGHS and Ayushman Bharat. However, final phase four clinical trials for the drugs will still be mandatory.