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 to take to increase this share?

 

India should expedite its journey to become a full member of the International Council for Harmonisation (ICH). This would be a step towards more acceptability of data generated from Indian participants and eliminate redundant requirements. We urgently need all stakeholders to work together to ensure we deliver on our late phase trials and further enable first-in-human trials for internationally discovered molecules in India. This restriction significantly limits our participation in early-phase research, forcing many Indian companies to conduct their early clinical development studies outside India.

 

Policymakers should establish dedicated clinical research units within premier institutions like Aiims and NIPERs, coupled with substantial tax incentives for research and development (R&D) investments. Regulatory authorities too would need support in developing their domain expertise and are also in need of resources for ensuring they can work together with the stakeholders to enhance approval timelines further. We're also lacking in specialised workforce development within the industry and a national mission to train clinical research professionals across the ecosystem would address this gap.

 

India’s diverse population is an asset for clinical trials, offering researchers access to rich datasets. Why is the Indian demographic not adequately represented in global clinical trials?

 

India is a significant player in global clinical trials today for all multinational companies with a footprint in the country. Most of these companies have an Indian entity and strive to collaborate with their global counterparts to place global clinical trials in India. However, many myths persist among global clinical researchers who are unfamiliar with India's capabilities and have not updated themselves on the country's advancements. Local affiliates work to dispel these myths, but concerns about regulatory pathways and the predictability of approval timelines often remain for global sponsors. While the 2019 NDCT Rules improved processes, the socialisation may not have reached all global decision-makers. When planning global trials where synchronised starts are critical, sponsors may hesitate to include Indian sites if they perceive potential delays.

 

What kind of discussions are you having with the Indian regulator and what are the key demands of the clinical trial industry?

 

We're advocating for more predictable regulatory timelines through streamlined review processes and enhanced digital infrastructure. Our engagement with the Central Drugs Standard Control Organisation (CDSCO) has been positive and the collaboration has improved over time. The interactions are also leading to further deliberations on enabling early clinical development in India for all new discoveries (in India and outside).

 

Another focus area is capacity building within regulatory bodies. We've proposed collaborative training programmes between ISCR, global regulatory experts, and Indian authorities to share best practices in reviewing complex trial designs and new therapeutic modalities. The clinical research industry's primary demands include acceptance of global data standards (CDISC), mutual recognition of inspection outcomes, and India's full membership in ICH and PIC/S to eliminate duplication of efforts.

 

What kind of policy changes are required in the patient recruitment phase in India?

 

For patient recruitment, India needs a paradigm shift in how clinical research and clinical trials are perceived. Policy changes should include clear guidelines permitting ethical recruitment advertisements and patient registries for those who need information on clinical research participation. Currently, it is challenging for patients to find a trial relevant to their disease condition despite having the information on the clinical trial registry. Limited awareness of clinical trials as a care option deprives patients from getting a chance for disease cure or sometimes some more years added to their lives.

 

India must also leverage our digital health initiatives to identify eligible patients while maintaining privacy. The Ayushman Bharat Digital Mission framework could potentially support anonymous patient identification for relevant studies.

 

Typically, CDSCO approval takes 90 working days or 4.5 calendar months, vis-a-vis countries like Malaysia and Korea where sites can start within 2-3 months. Are we losing trials to these countries as a result?

 

In the competitive global landscape of clinical trial placement, time is often the deciding factor even more than cost considerations. Sponsors designing global studies, particularly in fast-moving therapeutic areas like oncology, cannot afford to delay their overall development timelines. When faced with a choice between countries with similar capabilities but different approval and start up timelines, sponsors understandably select regions where they can initiate studies more quickly.

 

This challenge is particularly acute for studies with rapid enrolment targets or competitive indications where multiple companies are racing to be first-to-market. Thus, it is important that we get the opportunity to enrol maximum patients in global trials by ensuring sponsors provide accurate packages and the regulator provides approval within 4.5 calendar months so that we can serve patients who need these newer therapies. There is a concerning trend where even Indian pharmaceutical companies are choosing to conduct their early-phase studies in countries like Australia, Singapore, or Malaysia due to more predictable timelines. The regulatory authorities have surely taken a serious note of the same and are working with all stakeholders on ensuring this will change.

 

Cost of conducting clinical trials in India is 35 per cent cheaper than global sites. Do you feel that cost is not the major determining factor in bringing a trial to India, while speed is?

 

The cost of trial conduct in India is not the only factor for placement of global trials in India. India's cost advantage remains relevant when combined with other strengths – our highly qualified medical professionals, large patient populations, disease burden, and diversity of population, high-quality medical infrastructure, and English-speaking workforce. The challenge is to enhance our speed and predictability while maintaining these inherent advantages.

 

A delay of even a few months can have profound commercial implications. Consequently, sponsors frequently prioritise regulatory predictability, rapid start-up times, and efficient recruitment over pure cost considerations. 

 

India should take a page from the playbook of countries such as China and Australia if it wants a larger share of the global clinical trials market, experts feel. Do you agree and why?

 

I agree that India could learn valuable lessons from both China and Australia's approaches to clinical trials. However, we have to acknowledge that India has our own country-specific unmet medical needs and thus it is important that while we look at these examples, we adapt them to our unique context and look at the utility from a national interest perspective.

 

China's regulatory reforms, particularly their joining ICH as a full member and establishing clear review timelines, catalysed their dramatic growth in clinical trials. Their emphasis on building clinical research units within academic medical centres created sustainable infrastructure. India could similarly commit to develop centres of excellence with dedicated research units in our premier institutions.

 

Australia's model offers different insights. Their tax rebate for R&D activities has attracted early-phase studies and their streamlined ethics approval process, where a single review can suffice for multiple sites, significantly reduces start-up times. India could look at implementation of tax incentives specifically for clinical research activities and adopt a centralised ethics committee model for multicentre trials for scientific review.

 

On their part, CROs are engaging with the government to allow more phase-1 clinical trials in India. Why are phase-1 trials important to happen in India?

 

Phase-1 trials represent the critical first step in bringing innovative therapies to patients, and their limited presence in India creates a significant gap in our clinical research ecosystem for several compelling reasons.

 

Early-phase trials build essential expertise and infrastructure that benefit later-phase studies. The specialised capabilities developed for phase-1 trials, including pharmacokinetic sampling, biomarker development, and intensive safety monitoring, elevate overall research standards. Countries with robust phase-1 capabilities naturally attract more phase 2-4 studies due to this established expertise.

 

For Indian pharmaceutical companies developing novel molecules, the current restriction necessitates conducting early-phase studies abroad, increasing costs and complexity. This policy contradicts our national aspiration to become a pharmaceutical innovation hub.

 

With thoughtful policy changes and capacity building, India could develop a thriving phase-1 ecosystem that would benefit our patients, researchers, and pharmaceutical innovation landscape.

 

Did India benefit from the Russia-Ukraine crisis in terms of new sites starting here? What role is geopolitics playing in bringing trials to India?

 

There was an initial expectation surge of the trials potentially moving to India, but over time the existing sites across different countries across the world brought back the balance and there is no more a surge of trials due to the crisis.

 

Geopolitics should not be the rationale for conduct of trials anywhere, which is against the basic ethics. Indian Ethics Committees, regulator and all other involved stakeholders, including sponsors, investigators and researchers, are very cautious of ensuring this aspect of trials and do not endorse unethical trial conduct in India and would not endorse any geopolitics for trial placement. 

  What kind of hiring plans are there by the CT industry in India?

  In recent years, particularly after Covid, ISCR and the clinical research industry in India have significantly strengthened their public-private partnerships with government bodies. This progress has led to a surge in global capability centres, which employ a large number of Indian clinical researchers, technology experts, and various ancillary functional experts, embodying the "India for the globe" principle. Almost every major and medium-sized multinational pharmaceutical company and CRO, along with Indian multinationals, have established a presence in India, particularly in Hyderabad, Bengaluru, and Chennai, leveraging the talent in these hubs and employing thousands of individuals.

 

On the other hand, the clinical operations, data management, pharmacovigilance, quality, medical writing, data management, regulatory professionals are leveraging the hybrid models of working and providing employment in Tier-2 and 3 cities, thus leveraging the capability of individuals in smaller towns and cities, creating more employment in these areas.

 

As methodologies like artificial intelligence (AI), machine learning, decentralised trials, adaptive designs, and patient-centric approaches rapidly evolve, how are clinical trials changing?

 

Clinical trials are rapidly transforming with advancements in artificial intelligence (AI), machine learning (ML), decentralised trials, adaptive designs, and patient-centric approaches. These innovations are enhancing efficiency, speed, and global trust, positioning India as a key player in clinical research.

 

AI & ML: Advanced data analysis is optimising patient selection, protocol design, and investigator site selection. In the drug discovery space, speed, accuracy and quality of the targets chosen are improving with the use of AI & ML. Remote monitoring, telemedicine, and site digitisation are enhancing accessibility, improving the tracking of data in real time and helping swifter analysis to bring medicines to patients faster. These minimise the patient burden for travel to the site and also site burden helping them to concentrate on patient care.

 

What are the key changes the Indian CT industry needs to make to adapt to changing times?

 

The Indian clinical trials industry is at a pivotal moment, requiring strategic adaptations to remain globally competitive. Firstly, hospital sites need to clearly understand the innovations being introduced so they can effectively explain them to patients. Clinicians (investigators for clinical trials) must embrace digital innovations and ensure they have the necessary training, understanding, and tools to deliver these advancements to patients. Embracing digital innovations, such as decentralised trials, telemedicine, and AI-driven solutions is essential, building on pandemic-era advancements like remote patient monitoring, home health services, and direct-to-patient shipments. The industry must focus on providing complete and detailed information to all stakeholders to ensure appropriate approvals, understanding, and delivery of these innovations to end users.

 

Regulatory predictability remains crucial. While the New Drugs and Clinical Trials Rules (2019) were a step forward, we applaud the regulator for further strengthening communication with all stakeholders for consultation. However, we urge more consistent implementation of approval timelines to boost global confidence. Coordination and approvals from different government departments will be important as we look at e-innovations, ensuring that patients and investigators can use these advancements in a timely manner.

 

Capacity building across the clinical research ecosystem is equally vital. Beyond investigators, we must invest in skilled clinical research professionals, ethics committees, and support staff. ISCR is working with academic institutions to integrate clinical research into healthcare curricula, strengthening the talent pipeline within the academia via the Academic Research Consortium which has several academic partnerships and luminaries in the field working under ISCR flagship to foster upcoming talent within our medical colleges.

 

Additionally, ISCR also looks at positioning India as an early-phase research hub where we are building partnerships with different government departments and working on what are the required policy changes to permit studies for non-Indian discovered molecules so as to develop bench to bedside capabilities over the longer run in India to ensure our global contribution to the field of drug development at large.

 

Finally, prioritising data quality and attention to completeness of data from India will be crucial to gain global trust. By implementing robust quality management systems and leveraging our IT strengths, we can establish ourselves as a trusted global clinical research partner.