Advancing Precision Medicine in India: The Need for Biobank Regulations

Advancing Precision Medicine in India: The Need for Biobank Regulations

Sub : Sci

Sec : Health 

Why in News

India’s push for precision medicine is facing a significant hurdle due to the lack of comprehensive biobank regulations. While biobanks play a critical role in medical research, especially in advancing precision medicine, India’s inconsistent regulations may impede progress and limit the benefits for society.

About Precision/personalised Medicine:

Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.

Precision medicine, also known as personalized medicine, is a new frontier for healthcare combining genomics, big data analytics, and population health.

This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people.

It is in contrast to a one-size-fits-all approach, in which disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.

The field gained momentum following the Human Genome Project and has since played a pivotal role in diagnosing and treating cancers, chronic diseases, and cardiovascular and immunological disorders.

Emerging technologies like gene editing, mRNA therapeutics, and organ-on-chips are revolutionizing precision medicine, making it possible to target specific genetic mutations.

India’s precision medicine market is growing at a Compound Annual Growth Rate (CAGR) of 16% and is expected to exceed $5 billion by 2030.

Precision medicine accounts for 36% of the national bioeconomy, alongside cancer immunotherapy, gene editing, and other biotechnologies.

The Role of Biobanks in Precision Medicine

A biobank is a repository of biological samples, such as blood, DNA, cells, and tissues, along with their genetic data.

These samples are collected from consenting individuals and are crucial for research, particularly in precision medicine.

Biobanks must be large and diverse to ensure that the findings benefit all sections of society, not just a small group.

Biobanks aim to support studies on disease progression, treatment, and the development of new medical solutions. They play a vital role in understanding genetic predispositions and the impact of environmental factors on health.

Types:

• Population-based biobanks: Store samples from large groups, often for studying population health trends.
• Disease-specific biobanks: Focus on particular illnesses like cancer or cardiovascular diseases.

Relevance to SDGs: Biobanks contribute to SDG 3 (Good Health and Well-being) by supporting research that can lead to the discovery of new treatments and improved health outcomes globally​

Regulatory Challenges for Biobanks in India

Unlike countries like the U.K., U.S., Japan, and China, which have robust biobank regulations, India’s biobanking laws are inconsistent, with gaps in informed consent, privacy, and data protection.

Currently, there is no law in India that protects the rights of individuals donating biological samples to biobanks.

The Indian Council for Medical Research (ICMR) guidelines and Department of Biotechnology (DBT) protocols lack clarity on data storage, access rights, and long-term use of samples.

Individuals are often asked to provide consent without knowing how their genetic data will be used or who will access it.