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India is undergoing a significant transformation, with pharmacoeconomics and real-world evidence (RWE) now taking centrestage in regulatory decision-making. India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), is increasingly integrating RWE into its approval and post-market surveillance processes, addressing global trends and India’s healthcare challenges, said Dr. Purav Gandhi, CEO and founder, Healthark Insights.
Our country has faced several systemic hurdles that have constrained the effectiveness of traditional pharmacoeconomic evaluation approaches. There has been a shortage of specialist health economists who can undertake rigorous economic evaluations. The country falls short of quality data on healthcare costs, patient resource use, and health-related quality of life. A standardized national cost database is still under development, and population-specific utility tariffs: EQ 5D 5L for QALYs are only now being generated, he added.
Healthcare system here is fragmented with state level variations and urban-rural divide. Consequently, Health Technology Assessment (HTA) findings often fail to translate into policy due to lack of legislative support. Being a developing country, 85% of total health expenditure in India is financed by house-hold, out-of-pocket expenditure. Since there is no comprehensive national reimbursement system, it means that pharmacoeconomic assessments have little impact on coverage decisions outside specific government programmes. In such a scenario, the integration of RWE can be a turning point in addressing these critical challenges that have long plagued India’s healthcare system, pointed out Dr Gandhi.
The shift towards RWE is an emerging trend. Traditionally, randomized controlled trials (RCTs) have been the gold standard for drug approvals. However, RCTs have often face limitations in India due to high costs, and controlled environments that do not fully reflect day-to-day clinical practice. This is problematic in India, as patient populations are highly heterogeneous and healthcare delivery varies widely, Dr Gandhi told Pharmabiz.
Globally, US FDA and European authorities increasingly rely on RWE for drug approvals and post-marketing safety monitoring. RWE supported new indications and safety data for pembrolizumab, palbociclib, avelumab, and blinatumomab, he said.
CDSCO updated its frameworks to encourage the use of RWE, particularly in post-marketing surveillance. For instance, local clinical trials may be waived for certain drugs if robust RWE and post-marketing commitments are provided, balancing timely access with patient safety. Programmes like the National Digital Health Mission, National Cancer Registry Programme, National Diabetes Registry, and Ayushman Bharat PM-JAY are also contributing to the development of high-quality datasets for large-scale analyses, he said.
New Drugs and Clinical Trials Rules, 2019, and CDSCO’s IT-enabled systems are streamlining approval processes, bringing in transparency, and faster, evidence-based approvals and post-marketing decisions. Indian clinical research organizations (CROs) are rapidly advancing in RWD collection and analysis to support regulatory submissions. The five regional pharmacovigilance centres strengthened for real-time data analysis and feedback. This led to an increase in adverse drug reaction (ADR) submissions, improving quality of safety data. Pharmacovigilance Programme of India (PvPI) has expanded to include 895 Adverse Drug Reaction Monitoring Centres (AMCs) with 209 AMCs enrolled in 2023-24, he said.
This shift signifies that effective healthcare decisions must be based on real-life experiences of patients. India’s implementing RWE is ushering in a new era of regulatory innovation and patient-centric healthcare, said Dr Gandhi.
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