Despite having 8% of the global clinical trials share, India is often overlooked during the early phases of international studies due to regulatory concerns and lingering misconceptions. Seema Pai, President of the Indian Society for Clinical Research (ISCR), highlights in a recent interview that while India offers a diverse population and rich datasets, outdated perceptions and unpredictable approval timelines deter global sponsors.

She emphasizes the need for streamlined regulatory reviews, digital infrastructure enhancement, and more predictable timelines to position India as a preferred destination for early-stage clinical development.

Compared to China’s 29% participation, India’s limited presence in early-phase trials is largely due to regulatory hurdles. Expediting full membership in the International Council for Harmonization (ICH) would boost global data acceptance and reduce redundant trial processes.

To strengthen the ecosystem, Seema Pai recommends:

• Establishing clinical research units at AIIMS and NIPER’s
• Offering tax incentives for R&D
• Investing in capacity building of regulatory authorities
• Launching a national mission to train skilled professionals in clinical research

The industry’s demands also include the adoption of global standards (like CDISC), mutual recognition of inspections, and participation in global regulatory forums such as ICH and PIC/S.

Continued dialogue with regulators such as CDSCO is already yielding improvements. Collaborative training between Indian and international regulatory experts will further elevate India’s status in the global clinical research landscape.

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