India Waives Local Clinical Trials for Approved Foreign Drugs to Expedite Access

The Indian government has waived local clinical trials for drugs already approved in select countries to hasten the availability of innovative medicines. Experts praised the move as it will reduce drug development time and costs, making critical therapies more affordable and accessible to Indian patients.

The Indian government's decision to waive clinical trials for drugs already approved in select foreign countries has been met with approval from industry experts. The move aims to accelerate the availability of new and innovative medicines in India, reducing both the time and cost associated with clinical trials.

Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, said, 'IPA welcomes the move to waive clinical trials for several drugs that have already received approval in major Western markets. This will facilitate faster access to medicines and is a step towards regulatory simplification for better patient care.'

According to Raj Prakash Vyas, President of Corporate Affairs at Cadila Pharmaceuticals Limited, the waiver is a 'visionary step'. The Central Drugs Standard Control Organisation (CDSCO) emphasized that the move targets speeding up drug availability, especially for rare diseases, pandemics, and special defense needs. Dr. Anup Kumar noted that the new rule would decrease waiting periods for critical life-saving drugs, allowing them to be available sooner for Indian patients in life-threatening conditions.

'This landmark decision is a significant step forward in expediting the availability of life-saving medications to Indian patients suffering from the identified categories of diseases,' said Vyas. Rajeev Juneja, Managing Director of Mankind Pharma, added, 'The step will reduce the cost involved in clinical trials and time for drugs, which will benefit patients.'

The government's decision also has economic benefits. Official sources stated that by aligning regulatory standards with leading global drug regulators, India could emerge as a more attractive destination for pharmaceutical research and development. With costs of local clinical trials reduced, public procurement costs for government schemes like CGHS and Ayushman Bharat are expected to see savings passed on to patients.

(With inputs from agencies.)