India’s Precision Medicine: A Vision Hindered by Biobank Regulations

Precision medicine, a transformative approach to healthcare, is redefining the landscape of disease diagnosis and treatment. From groundbreaking personalised healthcare solutions to innovations like mRNA vaccines and gene-editing technologies, the field promises a new era in medical science. Yet, as India stands on the cusp of this revolution, a significant hurdle looms: the lack of robust biobank regulations.

Biobanks, essential repositories of biological samples, are critical to the success of precision medicine. These collections of blood, DNA, and tissue samples, coupled with genetic data, form the backbone of research aimed at developing targeted therapies for diseases like cancer and diabetes. However, as highlighted in a recent analysis by The Hindu, India’s inconsistent biobank regulations threaten public trust and impede progress.

The Promise of Precision Medicine

In recent years, precision medicine has witnessed remarkable achievements. Through gene therapy, researchers have restored vision in individuals with genetic mutations, while in the U.K., scientists have reversed diabetes using reengineered stem cells. The rapid development of COVID-19 vaccines using the mRNA platform, which earned a Nobel Prize, further underscores the potential of precision medicine.

India’s Growing Market

The Indian precision medicine market is burgeoning, with projections estimating a value exceeding $5 billion by 2030. Initiatives like the BioE3 policy and the approval of NexCAR19, a domestically developed CAR-T cell therapy, mark significant strides. However, the true potential of these advancements lies in aligning biobank regulations with international standards.

The Biobank Conundrum

While countries like the U.K., U.S., and Japan have comprehensive biobank regulations ensuring data protection and privacy, India’s framework remains fragmented. The absence of a single authority to regulate biobanks and the lack of penalties for misconduct create risks of ethical violations and undermine public confidence. As the ICMR guidelines illustrate, participants often consent to provide samples without clarity on data usage, raising concerns about privacy and potential discrimination.

A Path Forward

To harness the full potential of precision medicine, India must establish stringent biobank regulations. Aligning with global standards will not only bolster public trust but also position India as a leader in next-generation therapeutics. As part of international groups like the Quad and BRICS, India has the opportunity to expand its pharmaceutical leadership and enhance its soft diplomatic efforts.

Manjeera Gowravaram, a PhD in RNA biochemistry, provides insightful analysis on the intersection of science and policy.