George Clinical, a contract research organization (CRO) operating in the Asia-Pacific region, including India, said it welcomes the ongoing efforts of the Central Drugs Standard Control Organization (CSDCO) of India to improve timelines and submission approval rates.
Vanaja Krishnan, managing director of George Clinical, India, said “ambiguity and uncertainty” surrounding regulatory procedures and “growing ethical concerns” led to a major slowdown in the number of clinical trials approved in 2013.
“Approvals for new clinical trial applications were stopped following a public interest litigation filed against alleged trial-related deaths and serious adverse events,” she told us.
Since this time, Krishnan said the Union Health Ministry has been actively working to amend new rules related to clinical trials on a priority basis. “Significant strides” have been taken “to bring clinical research in India back on track,” she added.
According to the CRO, 2017-2018 saw a “significant rise” in the number of clinical trial approvals, from 178 in 2017 compared to 84 in 2016.
Additionally, the average time for clinical trial application approval decreased from about 6-7 months in 2016 to an average of 4 months in 2017-2018.
“The Indian clinical trials industry has begun seeing an upward trend since 2014,” Krishnan said. “India has now the potential of becoming one of the largest clinical trial hubs with the expected market growth at a CAGR of [approximately] 12%.”
“This positive trend has been primarily supported by several regulatory enhancements introduced by the Indian government making it amenable and reliable environment once again to run efficient clinical trials in India,” she added.
The changes have been focused on transparency “with clear specific guidelines on various aspects like medical and compensation management” and efficiency, by reducing timelines for regulatory approvals, Krishnan explained.
