Personalised medicine in India needs a systemic prescription

Personalised or precision medicine is often mistaken as a futuristic luxury, relevant only to rare diseases or niche therapies. But the underlying promise is much broader: optimising treatments based on specific patient profiles, medical histories, environmental and lifestyle factors, and response patterns. In countries with organised healthcare systems, it is already making a dent in healthcare outcomes and cost-efficiency. The real question for India is not whether we should adopt personalised medicine, but whether our legal and regulatory system can support it.

Global success, national silence

The US FDA, European Medicines Agency, and regulators in Japan and South Korea have issued detailed frameworks integrating personalised medicine into drug approvals, diagnostics, and treatment protocols. Their systems link hospitals, health records, trial registries, and pricing models, thereby creating end-to-end clarity. For example, the US FDA has worked with stakeholders in the healthcare industry, laboratories, academia, and patient and professional societies to develop a flexible regulatory approach to accommodate rapidly developing precision medicine technologies. India, however, lacks a defined legal or regulatory classification for personalised medicine. While the New Drugs and Clinical Trials Rules, 2019, account for “orphan drugs” and accelerated approvals, the current Indian regulatory regime does not envisage an ecosystem of precision medicine therapies requiring tailored diagnostics, real-time response tracking, or post-market personalisation.

Regulatory red-tape led delays

India’s regulatory gap may be attributed to multiple factors, including the nascent stage of precision medicine adoption in the country, limited infrastructure for genetic testing and data management and the absence of a unified health data policy. Furthermore, regulators have been slow in adapting to rapid technological advancements in genomics and biotechnology. Ethical concerns, data privacy issues and the need for co-ordination amongst multiple agencies such as the ICMR, CDSCO and Ministry of Health and Family Welfare also hinder efforts to establish regulations for new-age technologies. As a result, stakeholders engaged in precision medicine in India operate in a legal gray area, potentially impacting innovation, access and accountability in this emerging field of medicine.

A healthcare model not built for individualisation  

India’s healthcare system is not yet structured to support healthcare personalisation at scale. Public healthcare delivery is focused on primary care and mass treatment. Most government drug procurement policies prioritise cost-efficiency over outcome-based personalisation. Hospitals and pharmacies are not required to maintain treatment-response databases that personalised care depends on. Regulatory bodies have no framework for real-time tracking of therapy adjustments or treatment iteration. Furthermore, medical infrastructure is highly uneven. Urban tertiary centers may experiment with tailored approaches for oncology or metabolic disorders, but 70 per cent of the population depends on rural or semi-urban setups that follow standard protocols due to resource constraints.

Infrastructure, not innovation, is the bottleneck

Unlike developed nations, the challenge in India is not innovation—it is implementation. A surge in startups offering tech-led personalisation in wellness, diagnostics, and chronic care indicates demand. But these models operate in silos, unlinked to public health policy or insurance frameworks. There is no legal requirement for integration with the Ayushman Bharat Digital Mission or health registries.

Our laws are also not structured to evaluate outcomes or reward personalisation. Insurance contracts do not incentivise tailored treatments. National health schemes have not incorporated flexibility in protocols or pricing. The clinical establishment rules do not define how hospitals can legally deploy variable-dose or response-based therapies without falling foul of standard care norms.

So, is there even a need in India?

Yes-and the rationale is not futuristic, it is practical. India has one of the highest burdens of non-communicable diseases (NCDs) including diabetes, cardiovascular conditions, and cancer. These are precisely the diseases where personalisation improves compliance, reduces hospital stays, and cuts long-term costs. With an aging population and rising lifestyle diseases, standardised treatment is economically unsustainable. It is also relevant in multi-drug resistance, a growing challenge in India. It allows tailoring treatments based on what has failed for a patient before reducing trial and error prescriptions that increase resistance and costs.

The legal vacuum is the real roadblock

India has the scientific capacity, market size, and disease burden to benefit from personalised medicine. But legal and regulatory clarity is missing at every step. No official definition exists and the “one size fits all” approach remains prevalent. There are no approval guidelines, reimbursement frameworks, or institutional directives. Unless this gap is addressed, the promise of personalisation will remain limited without becoming a systemic option for broader public health impact.