xix. Clinical Trials in India

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens, and ensuring advancement in medical practice that is evidence-based. Through several key drivers, India is emerging as a favorable destination to conduct clinical trials.

India is establishing itself as a desirable location to conduct clinical trials because to several major reasons, as per a joint report by PwC India & USAIC (US-India Chamber of Commerce) titled, “Clinical Trial opportunities in India”.

Due to many significant legislative improvements that enabled free access to clinical trials in India and were aimed at achieving global harmonization, clinical trial activity has been gradually expanding in India since 2014.

The population of the nation is diversified, and its quickly developing healthcare system creates an ideal environment for clinical trials to flourish.

Top biopharma firms have the chance to create a long-term plan that concentrates on India’s major drivers of innovation and collaborative relationships.

Clinical trials	Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to participate in clinical trials to test medical interventions including drugs, cells, and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care. Clinical trials are carefully designed, reviewed, and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children. There are 4 phases of biomedical clinical trials: Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects. Phase II studies test treatments that are safe in Phase I but now need a larger group of human subjects to monitor for any adverse effects. Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved. Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
Clinical Trials in India	Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens, and ensuring advancement in medical practice that is evidence-based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials are abandoned or are not published due to “negative” or equivocal results. However, this tendency for the availability of only selective information from the innumerable clinical trials conducted is not proportionate with the practice of “evidence-based medicine”. Today, the world over, a need has been felt the imperative for transparency, accountability, and accessibility to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability, and accessibility of clinical trials.
Clinical Trials Registry- India (CTRI)	The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics (NIMS), is a free and online public record system for registration of clinical trials being conducted in India that was launched in 2007. Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population, etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which has been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size, and date of enrolment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display. Mission The mission of the CTRI is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of the PG thesis are also expected to be registered in the CTRI. Vision The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept the registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. Through several key drivers, India is emerging as a favorable destination to conduct clinical trials, per a joint report by PwC India & USAIC (US-India Chamber of Commerce) titled, “Clinical Trial opportunities in India”. Important details from the report: The private sector is a well-suited channel for 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 faster access to patients, sites, and investigators. The 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 specializations. 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 overall clinical trial participation of ~3% but contributes upwards of 15% to the global burden of most highly 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.
Regulatory Mechanism in India	Regulations have been set to ensure the integrity of the data collected from clinical trials which assure the safety, right,s and welfare of the subject. Law: Drugs and Cosmetics Act 1940 and Rules 1945 Regulation: Schedule Y for clinical research by CDSCO Guidelines: ICMR guidelines and ICH-GCP guidelines The main steps to go through for conducting clinical trials in India are- Step 1: Approval from the Drugs Controller General, India. Step 2: Permission from the particular Ethics Committee where the clinical study is designed. Step 3: Compulsory registration on the ICMR website. To advance clinical research in the nation, the Union Ministry for Health and Family Welfare has published the Drugs and Clinical Trials Rules, 2019. The new regulations will alter the country’s regulatory environment for the licensing of new pharmaceuticals and the conduct of clinical studies. All new medications, experimental pharmaceuticals intended for human use, bioequivalence research, and clinical trials in India will be subject to these regulations.
Challenges for performing clinical trials in India	There have also been ethical concerns due to non-transparency and consent processes, which have been addressed through stricter and more monitored processes. Quality of the trial, data protection, improper documentation, data quality, and GCP issues, are some of the considerations that need more attention. Delays for approval of clinical trials due to shortage of technical staff or trained staff.
Way forward	The patient benefits from the 2019 new drug development regulations since they are thorough, well-balanced and have greater ethical balance. Clinical trial approval in India within 30 days can expedite the trial procedure and support Indian drug development. New regulations that guarantee adherence to moral standards and the preservation of patients’ rights provide a chance for early access to revolutionary medical products. These modifications raise the sponsor’s obligations and demand a higher degree of management oversight to guarantee compliance. Biopharma may profit from the vital innovation-enabling components of India’s private healthcare system and use the country’s rapidly developing healthcare infrastructure. Private biopharma businesses have a great chance to take advantage of India’s diverse population and advanced healthcare system because of the country’s rising interest in clinical trials. India provides a good environment for biopharma businesses to perform successful and affordable clinical trials because of its big and diversified patient pool, streamlined regulatory procedures, and highly qualified workforce. By taking advantage of this chance, businesses may hasten the process of developing new drugs, boost the effectiveness of their research, and provide patients with cutting-edge therapies, thereby enhancing global healthcare.