Exploring India's Increasing Role in Clinical Trials, Addressing Key Concerns

During the SARS-CoV-2 epidemic, the speedy approval of Covid-19 vaccinations demonstrated the value of clinical studies that it had a great deal of potential to aid patients, improve therapeutic regimens, and ensure the advancement of evidence-based medical practise.  

According to a joint report by PwC India and USAIC (US-India Chamber of Commerce), India is becoming a sought-after venue for conducting clinical trials for a number of key reasons. 

The regulatory reforms since 2013 and the New Drugs and Clinical Trial Rules of 2019 have streamlined the licencing processes, cutting timeframes by 30per cent to 40per cent, making India an attractive location for clinical trials, according to the above mentioned report. 

Despite having a huge population, India only contributed 4per cent on average annually to global clinical trials from 2010 to 2022, according to the report. It also noted that of all trial participants worldwide, India's contribution was only 3 per cent compared to 30 per cent for the US. 

Key drivers for clinical trials  

Commenting on factors weighing on clinical trials in India, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, conveyed that India is a desired destination for clinical trials because of its large and diverse patient pool, streamlined regulatory framework, and highly qualified workforce. "The key drivers for clinical trials in India include access to treatment-naïve patients (especially in Tier 2 and 3 cities), a high disease burden, lower cost, and good medical infrastructure (even in Tier 2/3 cities)," Jain added. 

Further expounding on the impetus from the amended rules, the Secretary General reflected, "The New Drugs and Clinical Trials Rules of 2019 aim to promote clinical research in India by providing a predictable, transparent, and effective regulation and ensuring faster accessibility of new drugs to the Indian population. The new rules have also reduced the time for approving applications. The positive impact of NDCTR is reflected in the approval of an increasing number of trials and the reduction in the time taken for the approvals by 30–40 per cent." 

Requisites for conducive clinical trials 

In conveying the requisites for leveraging clinical trials, Gayatri Saberwal, Professor, Policy Research, Institute of Bioinformatics and Applied Biotechnology, in an article for a science journal, mentioned that steps like bringing together all the documentation on every trial on one platform are in the interest of transparency. She further suggested that CDSCO should allow public access to regulatory documents, as it is well-known that there have been several inconsistencies between trial data in a registry and the publication of the study or U.S. Food and Drug Administration documents. 

"I think regulators should look more at final outcomes and not focus too much on intermediates. The industry should be able to self-regulate on the intermediate steps, while the final step, which is the interface between industry and patients, needs to be strictly regulated. This is the approach that is taken by most regulators in the West, and a mindset change is needed to allow that to happen. To give a specific example, for every substance produced, separate approval is needed, which takes time and money. This is unnecessary at this stage. Rather, policing needs to be done on how any substance, once manufactured, is ultimately utilised," said Dr. Jogin Desai, Founder and CEO, Eyestem. 

On exemptions to improve the efficiency of conducting clinical trials, Jain stated, "The NDCT Rules, 2019 have an elaborate framework that clearly lays down the process of approvals for clinical trials in India. The new rules provide for an exemption for clinical trial data in the Indian population for drugs already approved and marketed in any of the developed countries. Trials in discussion with DCGI can be conducted after the Marketing Authorization Application (MAA)." 

Technology as an enabler for clinical trials 

Speaking on deploying technology for leveraging clinical trials, Jain stated, "Clinical trials are increasingly leveraging digital tools for patient recruitment, retention, data collection and analytics, and remote monitoring of recruits. Companion diagnostics are being used to enrol patients with the best chances of success from particular therapies. Digital tools are also helping in streamlining inclusion-exclusion criteria and patient recruitment for clinical trials." 

"Just as it has done in the telecom industry, India has the potential to leapfrog in electronic health records (EHR), especially given that most of our hospitals do not have a first-generation system that is entrenched. Common standards for EHR, which are currently under consideration, would help provide an immensely valuable pool of information for patient recruitment and would instantly transform India’s potential as one of the most attractive destinations to do clinical trials in the world," Dr Desai defined future prospects with EHR. 

"In high-income countries, particularly the US, collaborative enterprises are prevalent to facilitate rapid progress. Large research programmes involve numerous collaborators across disciplines. India can greatly enhance its participation in such multidisciplinary, multi-centric collaborations. We need more collaboration between social science, biological science, and computer and data scientists," said Soumya Swaminathan, former Chief Scientist of the World Health Organisation (WHO), in a recent interview with the media. 

Addressing concerns and enhancing transparency: 

Despite the vaccine's success during covid, there have been concerns expressed about the transparency of the clinical trials as well as the safety and effectiveness of the vaccinations due to the haste with which some Covid-19 vaccine-related phases were certified in India. 

There have been instances where trial data and findings were not made available openly, raising questions about the validity and dependability of trials done in India. The Clinical Trials Registry of India (CTRI) mandates that every trial be registered before commencing. 

Saberwal, in the same article, enumerated practises that have kept CTRI from becoming "world class," such as not complying with WHO regulations for primary registration, undefined classification of type of study, internal consistencies, confusion over definitions, missing data, messy data, misleading information, a faulty search function, etc. 

Clinical trials carried out in India have occasionally involved ethical violations, such as a lack of informed consent, insufficient participant compensation, and the exploitation of vulnerable people. Large-scale clinical trial capability and India's healthcare infrastructure have both undergone scrutiny. Challenges have included a lack of facilities, qualified staff, and quality control procedures.   

Problems around funding resources  

Industry pundits have reiterated problems around securing funding for clinical trials, both domestically and internationally. Moreover, it's estimated that out of every 1000 molecules with potential as new drugs, only one successfully overcomes all barriers, which means that when you invest in 1000, only one succeeds. 

Furthermore, the scientist who discovers the molecule doesn’t assume responsibility for all subsequent steps. Subsequent steps need pharmacologists, organic chemists, biochemists, experts in animal and toxicology studies, facilities for conducting those studies, pharmacokinetics specialists, and experienced individuals for clinical trials. 

"The first thing is that R&D for new drugs, diagnostics, and vaccines is risky. Therefore, a company, especially a small to medium-sized one, would not want to take major risks. They prefer to use their money to ensure marketable products and returns for shareholders. In the US, the initial risky investment is typically made by the government, specifically the NIH, which has a budget of about 30 billion dollars. They invest in basic science and allow scientists to spin off companies or sell their intellectual property. Once a company knows that a product has been developed to a certain stage by scientists, they can upscale and manufacture it," Swaminathan mentioned. 

Way forward  

Clinical research in India is a sunrise sector and can provide satisfying employment to students not only from life science, pharmacy, medicine, and nursing, but also from statistics, IT, and supply chain backgrounds. As the world’s most populous country, India constitutes 18 per cent of the global population. But only 6-7 per cent of clinical trials happen in India. Leveraging the diverse population and digital prowess will help accelerate clinical trials in India.  

Experts have been advocating for creating a system where there is synergy and collaboration between these different groups. There are several initiatives by the government of India, the department of biotechnology, the Council for Scientific and Industrial Research (CSIR), and the ICMR focused on collaboration between academia, the public, and industry partnerships in order to actually move a product, whether it's a vaccine or a drug candidate. 

India's potential in clinical trials is immense, with the opportunity to contribute to medical advancements and improve patient outcomes. Addressing concerns regarding transparency, safety, and effectiveness is essential to build trust and credibility. By implementing reforms, improving registry systems, and fostering collaboration between stakeholders, India can emerge as a leading hub for transparent, efficient, and impactful clinical trials.