India should expedite efforts to become full ICH member: ISCR president

Policymakers should establish dedicated clinical research units within premier institutions like Aiims and NIPERs, regulatory authorities too would need support in developing their domain expertise

India has an around 8 per cent share in global clinical trials, and several pharma companies take their early stage trials overseas due to regulatory bottlenecks here. Dr Seema Pai, president of the Indian Society for Clinical Research (ISCR), who has around two decades of experience in the field, in an email interview to Sohini Das, advocates for more predictable regulatory timelines through streamlined review processes and enhanced digital infrastructure to enable early clinical development in India. Edited excerpts:

 

India has an 8 per cent share in global clinical trials, as against China’s 29 per cent. What steps policymakers need