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Experts stress on predictable regulatory environment to create global trust in India as a stable clinical trial market

Experts in the clinical trial arena are of the view that there is an urgent need for a predictable regulatory environment in the country to create global trust in India as a stable clinical trial market. But, they rued that developments in the last few years have dented the confidence of sponsors in doing clinical research in India. 

India is on a slow recovery period and there is a need to ensure that it continues the growth trajectory.

"Various factors, including reports of alleged irregularities in clinical trials have also led to a lot of misinformation and negative perceptions of clinical trials in India. Besides this, some of the clauses of The Draft Clinical Trial Rules 2018 around compensation are regressive and, if implemented, could force sponsors  both domestic and foreign to reconsider doing clinical trials in India,"explains Naz Haji, Managing Director, IQVIA India. 

Formed through the merger of IMS Health and Quintiles, IQVIA is a leading global provider of information, innovative technology solutions and contract research services.

Echoing similar views, experts pointed out that India is still recovering from the setback of 2013 and any further setback will hurt country's image further and seriously impact ability to attract clinical research into the country, besides denying patients access to the latest treatment options. Regulators should have more consultative meetings with stakeholders to review these contentious clauses, while ensuring that patient safety, confidentiality and quality are not compromised. 


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