Resource • White Paper

Spotlight on India: Regulatory Enhancements, Modernization, and Robust Data Collection Define India as a Potential Clinical Trial Hub

Article Snapshot

India has emerged as a rapidly developing investment hub, particularly in the healthcare sector, attracting major international pharmaceutical companies.
Recent reforms have streamlined the approval process, reducing timelines by at least 30-40 percent, and promoting high-quality clinical trials.
Regulatory reforms post-2019 by the Union Ministry for Health and Family Welfare have established a robust regulatory and clinical research ecosystem in India, promoting high-quality clinical trials.
Analysis of USFDA’s inspection data from 2015 to 2023 reveals comparable quality of data from Indian sites with that of the rest of the world. No findings classified as Official Action Needed (OAI) were identified since 2021, indicating high-quality standards.
India’s data renaissance fueled by modern digitalization and AI has improved data quality and management, further strengthening India’s position in the global clinical trial landscape.

Setting the Stage: Perception versus Reality

Today’s India is a vibrant and burgeoning global economic power, a country that has transformed into a worthy asset and vital partner for clinical research. Leading biopharma innovators have already tapped into modern India, giving them a head start in one of the world’s most promising scientific research landscapes.

With the largest population on earth at 1.4 billion people, and rich ethnic diversity, India is rife with untapped potential. Where some economies continue to struggle post pandemic, India is seeing abundant growth estimates of 7.3 percent for the 2024 fiscal year.[i] India is rapidly transitioning economically, demographically, and epidemiologically[ii] This includes:

A vastly improved education system that further contributes to a favorable atmosphere for conducting clinical trials in India.
A highly skilled work force, giving India a sizable talent pool of individuals in every field related to trial success – doctors, nurses, and research staff.
The Indian healthcare system, which has also made significant progressive strides in recent years, expanding access to healthcare services and improving overall general health outcomes.[iii]

However, historically, India has been seen through the lens of outdated observations concerning the efficiency and reliability of clinical trial execution. A 2023 report spelled out the actual success stories hidden behind some of these preconceptions.[iv]

In the last decade, India has become an important prospective venue for conducting clinical trials. Since 2004, the number of new trials has increased 31 percent (CAGR). Additionally, India has witnessed growth in the clinical trial market by almost 30 percent, which is almost double the global average. The promise of faster and cheaper trials initially attracted the attention of many major international pharmaceutical companies to India. However, recent enhancements taken have shifted the primary focus to one of data quality. Major reforms in regulatory, ethical supervision, and mandatory accreditation of all stakeholders – investigator sites, ECs, research institutions, sponsors, and CROs – are building vital credibility in gaining global trust in the outcomes of clinical research in India.[v]

Regulatory Reforms Create Positive Change

In truth, while some Asian-Pacific countries (APAC) countries continue to struggle in the post-pandemic clinical trial landscape, India has proactively implemented change. Since 2013, regulatory reforms, and the “New Drugs and Clinical Trial Rules of 2019,” have streamlined approval processes, reducing timelines by 30-40 percent. This has made India a more favorable destination for clinical trials.[vii]

When the Union Ministry for Health and Family Welfare in India published the new rules in 2019, they sought to establish a more robust regulatory and clinical research ecosystem for India. Mandates were put in place to promote high-quality clinical trials in India; with the added benefit of providing early access to new medications for the currently unmet needs of many Indian patients. The new regulations emphasized the significance of oversight in clinical trial activities by stakeholders, including pharmaceutical companies, study sponsors, investigators, academic research institutions, and ethics committees. These initiatives placed a collective responsibility on these parties to ensure patient safety and, most importantly, data integrity.[viii]

The new directives are viewed as comprehensive and well-balanced, with an aim toward improving the ethical and quality standards of clinical trials across the country. As a result, clinical trials in India since 2019, have seen benefits for patients and the overall industry, as they encourage drug development and aim to speed up the clinical trial process. While there have been some challenges and inconsistencies in the application of these new rules, particularly concerning post-trial access to new drugs, the overall impact of the newly implemented policies has been positive. Especially of note are the provisions added to promote enhancements to the predictability, transparency of the regulatory pathway, and the integrity of data in clinical research in India.[ix]

Key Regulatory Reforms Since 2019:

- 2019: Introduction of the “New Drugs and Clinical Trials Rules”, which streamlined and clarified the approval process for new drugs and clinical trials, aiming to make India a more attractive destination for clinical research.[x]
- 2020: Implementation of the “Digital Personal Data Protection Act”, which provided a framework for the protection of personal data in clinical trials.[xi]
- 2021: Further amendments to the “Drugs and Cosmetics Rules” to enhance ethical considerations and patient safety in clinical trials.[xii]
- 2022: Expansion of the “Central Drugs Standard Control Organization (CDSCO)” including increased oversight and faster processing of clinical trial applications.[xiii]

India has also enacted the Digital Personal Data Protection Act of 2023, which amends certain provisions of the Information Technology Act of 2000, to ensure the protection of individual personal data in clinical trials. These recent codifications demonstrate India’s commitment to maintaining high standards in clinical trials, ensuring they are conducted ethically and in accordance with global best practices.[xiv]

Modernization Leads to Growth in Clinical Trials

While clinical trials being conducted in India remain disproportionally low when compared to the overall population of the country, the number of trials taking place over the last decade is steadily growing. In top pharma sponsored trials, the number of clinical trial sites increased by 40 percent between 2014-2022, and the number of investigators has doubled since 2015. Moreover, this rise in conducted clinical trials, bolstered by recent regulatory changes, has led to a noteworthy expansion in high-quality trial outcomes and appreciably robust data collection.[xv]

Further support of this growth is revealed in the applications received by Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices, similar in function the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The CDSCO website provides information regarding the various number of applications that were approved in a particular year; this includes Global Clinical Trials (GCT). Referencing this vetted source reveals that the number of GCT approved applications has steadily increased since 2017. The graph below details the total number of approvals received across different applications along with the approvals received specifically for GCT.[xvi]

As presented in in the graph above, there has been an increase in the number of GCT applications approved from 2021 on, which is indicative of an exponential increase in the number of clinical trials that have been conducted in India. This paints a positive picture of growth and sponsor confidence for trials in India.

The graph below further substantiates the surge in approved GCT applications in India for various therapeutic areas in 2023, notably Oncology, Gastrointestinal Disorders, Metabolic Disorders, and Respiratory Disorders.

Innovations in Analytics and Oversight Drive Advances in Data

Key components to ensuring quality in clinical research are the reliability and credibility of information and data collected. The goal of such information is to provide an answer to the scientific question posed. Additionally, the clinical trial process must be in compliance with the pre-defined scientific and regulatory requirements.

Advancements in data management, the leveraging of technology, quality reporting, and patient-centric approaches to healthcare delivery have led to extensively improved analytics that have transformed the Indian healthcare industry while also attracting the attention of CRO site selectors. In addition, regulatory reforms established in 2013 and the New Drugs and Clinical Trial Rules of 2019 have streamlined the approval processes, leading to an increase in the volume and diversity of data generated from these trials.[xvii]

A recent study titled, “Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India with Acute Myocardial Infarction,” demonstrates the positive impact that quality improvement measures have had on clinical outcomes in India. This study analyses the USFDA inspection data for India over an eight-year period (2015-2023) compared this USFDA inspection data for India with other countries.[xviii]

Table 1. USFDA Inspection Data for India (2015-2023)

Table 2. USFDA Inspection Data across multiple countries (Summary from 2015-2023)

Good Clinical Practice (GCP), the international standard of quality, rests on assuring protection of the rights, safety, and well-being of trial participants and ensuring that data and reported results are credible and accurate. This compliance to the GCP standard is a top priority and can be evaluated by audits and regulatory inspection.

As seen in Table 1 above, the total OAI reported in India has been zero since 2021. This dramatic improvement directly correlates to the high-quality standards now defined for Indian clinical trials.

Studies such as this demonstrate a renewed confidence for trials in India. Since 2021, India has accounted for approximately 8.3% of global clinical trial activity, with several top global pharmaceutical companies establishing Global Capability Centers (GCCs) in India for efficient data processing. In this same period, India has seen Phase II and Phase III clinical trials grow by 15-18 percent.[xix]

A Data Renaissance in India

The growth in confidence in clinical trials in India has sparked a data renaissance in the country. Several factors have contributed to this growth, including a large and diverse patient population, a pool of skilled researchers, and a cost-effective research environment. Advancements in digitalization and artificial intelligence (AI) have further fueled this data renaissance. Digital platforms have streamlined data collection, management, and analysis, enhancing data quality and efficiency. AI-powered tools assist in patient recruitment by analyzing vast datasets to identify suitable candidates and improve trial matching.[xx]

Other advancements include:

Integration of Technology: India’s clinical trials have seen remarkable progress in the quality of the data produced. One of the key contributing factors has been the adoption of technology. The increased prevalence of applications, digital data tracking and an improved focus on patient convenience have led to the rapid adoption of decentralized clinical trials (DCTs). DCTs have become more prevalent, allowing for remote participation, and reducing the need for site-based visits. This has led to more efficient data collection and faster insights.[xxi]

Around the Clock Work Cycle and 24/7 Audit Readiness: Clinical trials in India are increasingly adopting global best practices. Around-the-clock work cycles and 24/7 audit readiness is becoming common practice. This is part of a broader trend towards maintaining high standards of Good Clinical Practice (GCP) and ensuring that trial conduct and data quality meet protocol specified, GCP, and applicable regulatory requirements.[xxii]

India’s commitment to maintaining a robust work cycle and audit readiness for clinical trials is commendable. The country’s large domestic market, product development expertise, and scientific workforce position it as an attractive location for conducting 24/7 work cycle trials. These combined advantages have led to a significant increase in the number of Indian trials in recent years. Audit readiness is essential in clinical research to ensure adherence to established protocols and regulatory requirements. Every step, from patient recruitment to data collection and reporting, must align with Good Clinical Practice (GCP) guidelines. India’s pivotal role in contributing trial data for numerous drugs currently on the market underscores its unwavering commitment to maintaining audit readiness. Clinical investigator site audits are a key component of clinical research in India, serving as quality assurance to protect the rights, safety, and well-being of patients, and accuracy, reliability, and verifiable outcomes of India’s data. [xxiii]

Seeing India in a New Light

India’s transformation to a fast-developing research hub and APAC clinical trial leader, has begun to make global biopharma companies take notice and expand operations accordingly. India’s mandate going forward is to continue to build upon a growing reputation for compliance, modernization, and data quality. Solidifying this new identity and promoting the advantages of India as a clinical trial venue means tearing down the misperceptions and replacing them with robust data, that allows all clinical industry stakeholders to see India in a new light.