Russia’s loss can be India’s gain in clinical trial shift

Source: The post is based on the article “Russia’s loss can be India’s gain in clinical trial shift” published in “Business standard” on 10th October 2023.

Syllabus: GS2- Governance- Issues relating to development and management of Social Sector/Services relating to Health.

News: The article discusses how geopolitical issues in Russia and Ukraine are halting clinical trials, and suggests that these could be moved to India. Although India has potential and has made regulatory improvements, challenges like delayed site start-ups and historical regulatory concerns are hurdles to be addressed to attract global pharma companies for conducting more clinical trials.

What have been India’s challenges in hosting clinical trials?

Slow Site Initiation: Starting trial sites in India takes a long time, typically about 5-6 months. This delay reduces India’s appeal for global clinical trials.

Regulatory Hurdles: Even after the introduction of the New Drugs and Clinical Trial (NDCT) Rules in 2019, there’s uncertainty among pharmaceutical companies. They need to see how these new rules are implemented on the ground.

Delayed Approvals: Some government sites in India don’t begin their review in the Ethics Committee until the Central Drugs Standard Control Organisation (CDSCO) gives approval. If CDSCO’s approval comes within its 90 working day timeframe (4.5 calendar months), some sites still can’t join the trial because it’s already over globally.

Past Concerns: Around 2014, Biocon had to move its clinical trials to Europe, which was 10-20 times costlier than conducting them in India.

What changes have been made in India’s clinical trial regulations?

Introduction of NDCT Rules: In 2019, the New Drugs and Clinical Trial (NDCT) Rules were introduced to enhance the regulatory framework around clinical trials in India.

Improvement in Site Numbers: Since the establishment of the NDCT Rules, and up until 2022, the number of sites for conducting trials in India has increased by 40%.

Streamlining Approvals: Efforts have been made to smooth the approval processes, including developing online platforms and easing some approval processes, thereby promoting growth in trials.

How can India become the new hub for clinical trials?

Leverage Current Opportunities: With clinical trials halting in Russia and Ukraine, big companies are looking for alternatives. India, having a high disease burden, is a potential candidate for these relocations.

Increase Contribution: Despite being populous, India’s contribution to global trials has been around 4%. There’s scope to amplify this number significantly.

Optimize Regulatory Processes: Although the NDCT Rules of 2019 have brought improvements, India must ensure quicker and predictable site initiation and regulatory approvals to attract global trials.

Promote the R&D Ecosystem: A clinical trial ecosystem can generate high-end jobs and promote research and development in the nation, making it attractive for international companies.

Showcase Stability: Emphasizing India’s stable and consistent regulatory systems can attract global pharma giants.