A joint report by PwC India & US-India Chamber of Commerce (USAIC) has revealed that India is emerging as a favourable destination to conduct clinical trials. The report was released at the USAIC BioPharma & Healthcare Summit held virtually on May 3.
“Clinical trial activity in India has been increasing steadily since 2014 due to several key regulatory reforms aimed towards global harmonisation, enabling open access to clinical trials in India. The country’s diverse population, combined with its rapidly advancing healthcare infrastructure, provides a fertile ground for clinical trials to flourish. This is an opportunity for top biopharma companies to develop a long-term strategy that focuses on the key enablers of innovation and strategic partnerships in India,” Sujay Shetty, Partner & Global Health Industries Leader, PwC, said in a statement.
According to the report, Biopharma can benefit from the critical enablers of innovation in the private healthcare system in India and leverage the rapidly expanding healthcare infrastructure in the country.
Key takeaways from the report:
- The private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients.
- Indian states with high disease prevalence (e.g., cancer) also have the most number of tier-1 cities, with advanced medical infrastructure and availability of investigators. Targeting these states can provide biopharma companies with faster access to patients, sites, and investigators
- Total number of investigators has increased by 2x between 2015 and 2020, with the majority of the increase occurring in the internal medicine and oncology specialisations. However, the growth in the number of investigators is largely restricted to tier-1 and 2 cities.
- While the top 20 pharma activity for the major therapy classes in India has remained largely constant in the last decade, growth opportunities exist across key diseases (e.g., pain, epilepsy, cervical cancer) and orphan diseases (β-thalassemia, Duchenne Muscular Dystrophy)
- India has an overall clinical trial participation of ~3% but contributes upwards of 15% to the global burden of most high prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, cervical cancer), representing an untapped potential for top pharma
- Top biopharma should align their strategy towards tier-1 cities (e.g., Mumbai, Delhi, Bengaluru, Chennai) where the higher bed capacity, number of doctors, and presence of tertiary care multi-city hospitals can support enablement efforts of running faster and more efficient clinical trials.
However, Industry experts point out that there is still a lot to do for India in order to become the innovation hub as well as the clinal trial destination.
Sanish Davis, President, Indian Society for Clinical Research told Financial Express.com that currently, India is not part of early clinical development work from any of the big innovators due to the turnaround that is required from regulatory, and ethics committees as well as the lack of dedicated sites which can do these complex studies.
“Providing enabling and predictable regulations to ensure that India has review and approval timelines in line with some of the advanced economies/regions/countries (USA, EU, SG, AUS, KOREA etc.). While the NDCT Rules states 90 working days, in reality the timeline overshoots the 90 working days timeline in majority of the cases making India unattractive for clinical development work (Phase I, Phase II etc. which require very quick review and approval),” Davis said.
Davis also pointed out that Clinical Trial needs to be encouraged as a care option in the therapeutic armamentarium of all clinicians. This will bring in the demand for innovation and also clinical trials to India, benefitting patients with unmet medical needs (Rare diseases, oncology, immunology, neurology etc.)
“Adequate staffing (multidisciplinary teams) as well as Building expertise in review of innovative clinical research protocols within CDSCO: biologicals (CAR-T, mRNA, snRNA, BCMA products), adaptive clinical trials, decentralized clinical trials etc. Currently, CDSCO has to rely on Clinician experts from govt. institutions for the review process (SEC). While the Clinicians bring in a wealth of experience what they lack is the understanding and exposure to Regulatory Science which is important for providing inputs for the clinical trial proposals,” he added.
He also informed that India currently allows only early phase studies for compounds that are discovered in India which leads us to lose out on this expertise. This also then stymies the development of expertise/talent/capacity building of Phase I sites as there are only a few studies, he added.
“There needs to be more participation and ownership from Medical Institutional heads, Ethics committees, Patient advocacy groups etc. to enable the conduct of clinical trials for Rare Diseases, communicable diseases of relevance to India, Neurosciences, Opthalmology etc.,” he said.
