Approval for clinical trials back to pre-Covid days

Industry insiders say timeline delays often force sponsors such as pharmaceutical companies to look for other geographies to conduct their trials

- SOHINI DAS

Approval timelines for clinical trials in India have slipped back to the pre-pandemic days, industry insiders feel. During the pandemic, trial approval timelines had significantly improved by 30-40 per cent, they claim.

Speaking to Business Standard, Sanjay Vyas, Global SBU Head-Clinical Logistics and Global Safety Services, and Managing Director-India at Parexel, one of the largest clinical research organizations (CROS) in the world, says that in the last 12 months, around 110 clinical trial applications have been approved by the Indian regulator. Parexel is working on 30 clinical trials in India at the moment out of the 600-odd trials it is conducting worldwide. This is despite the fact that the CRO employs more than 6,000 people in India, or about 20 per cent of its global workforce.

Vyas says application timelines had seen a significant boost during the pandemic when real-time monitoring and a more decentralised approach was taken, including remote monitoring. Approvals for trials could then come in as fast as 30 days or so for Covid-19 studies and around 45 days for nonCovid-19 subjects.

Sanish Davis, President, Indian Society for Clinical Research (ISCR), agrees: "Regulatory timelines in India are long up to 90 working days, or 4.5 calendar months. On top of this, there are ethics committee approval timelines too, which in India is around two-three months as against the global average of one-two months."