Incentives for phase 1 clinical trials, cost advantage will help India to tap global opportunity: Parexel India MD Sanjay Vyas

There’s great potential and a lot of scope for optimism. Recent regulatory changes have helped increase the number of Clinical Trial Authorisation (CTA) applications, with over 150 approved in the last 18 months alone. While the number of trials is growing, it is not increasing at the expected rate. Most are Phase 2 and Phase 3 trials, conducted as part of global studies and their growthhas been slow. That said, I remain hopeful because global sponsors frequently express interest in including India in their studies. However, misconceptions about India’s regulatory environment persist. Some sponsors struggle to understand the commercialisation process, patient compensation policies and regulatory timelines. While the implementation of structured timelines for approvals is effective, challenges remain.

One major challenge is the repeated scrutiny that sponsors face from India’s Subject Expert Committees (SEC), even after obtaining approvals from regulatory bodies like the USFDA or EMA. This redundancy slows down the process and creates frustration. The industry must strike a balance between patient safety and efficiency. If a drug has already been proven safe and effective in the US or Europe, India should be able to leverage that data rather than duplicating efforts. 

Another challenge is patient recruitment. While Tier 1 cities have excellent infrastructure and high standards of care —sometimes even better than the NHS in the UK — recruitment in Tier 2 and Tier 3 cities remains difficult. Nearly 48 per cent  of investigative sites struggle to recruit the right patient profiles. 

We also need greater adherence to international standards, such as the ICH-GCP (International Council for Harmonisation – Good Clinical Practice) guidelines. China, Korea, and Taiwan have successfully aligned with these standards, which led to increased clinical trials in their countries. India should also follow suit. Standardisation across States and hospitals is also crucial.

Despite these challenges, I remain optimistic. With a population of 1.4 billion and initiatives like the Ayushman Bharat Digital Mission (ABDM), we have the potential to integrate hospitals and streamline patient data. This would allow us to create centralised patient registries, which are critical for real-world data collection and clinical trial planning.

Yes, the costs associated with clinical research in India are nearly half as those incurred in the US and Europe. However, cost should not be the primary narrative. Instead, we should focus on the speed of regulatory approvals, the diversity of our patient population, and the opportunity for patients to access medications earlier. Countries like Malaysia and Korea are offering incentives to attract clinical trials. For example, Australia provides a 43.5 per cent tax rebate for Phase 1 trials. Such incentives help offset costs and make Australia a preferred destination for early-stage trials. India needs similar incentives — not just for patients but also for investigators and private hospitals—to position itself as a global hub for clinical research.

We’re still gung-ho and expanding aggressively. Our new CEO, Peyton Howell, took over the baton from Jamie Macdonald. The first country she decided to visit as the CEO is India as India accounts for 26 per cent of Parexel’s global workforce, and we recently reached 6,000 employees. Over the next two years, we aim to grow to 8,000 employees. Moreover, we will continue to invest in terms of the resources, the skill sets that we are looking at.