Why precision medicine in India can’t advance without biobank laws

(Source – The Hindu, International Edition – Page No. – 7)

Introduction to Precision Medicine

• Precision medicine is transforming healthcare by offering personalised treatments, especially in fields such as cancer, chronic diseases, and genetic disorders.
• The Human Genome Project laid the groundwork for advancements in genomics, which have enhanced diagnostics and therapies for multiple health conditions.
• Emerging technologies like gene editing, mRNA therapeutics, and organ-on-chips are contributing to the progress of precision medicine.

Technological Advancements in Precision Medicine

• Gene editing and mRNA therapeutics are two key emerging technologies.
• Success stories include restoring vision through gene therapy and reversing diabetes with reengineered stem cells.
• During the COVID-19 pandemic, the mRNA platform played a critical role in the development of vaccines, which led to a Nobel Prize.
• Organ-on-chips offer promising solutions by replicating human organs in laboratories, aiding in more accurate drug testing.

Role of Biobanks in Precision Medicine

• Biobanks store biological samples (e.g., blood, DNA, tissues) and are crucial for the success of precision medicine.
• Large and diverse biobanks ensure that research benefits a broad section of society.
• Recent research using biobank data has led to the discovery of rare genetic disorders and the identification of potential sarcoma therapies through organoid-based studies.

Biobanks in India

• India currently has 19 registered biobanks storing various biological specimens, including cancer cell lines.
• Key initiatives like the ‘Genome India’ project, which sequenced 10,000 genomes from 99 ethnic groups, and the ‘Phenome India’ project, focused on cardio-metabolic diseases, are aiding precision medicine research.
• The Paediatric Rare Genetic Disorders (PRaGeD) mission aims to develop therapies for genetic disorders affecting children.
• Despite progress, India’s biobanking regulations are fragmented and hinder the full potential of precision medicine.

Challenges in Biobanking Regulations

• Unlike other countries such as the U.S. and the U.K., India lacks comprehensive regulations on biobanking, leaving gaps in informed consent, data protection, and privacy.
• Current guidelines from the Indian Council for Medical Research and the Department of Biotechnology are inadequate and do not protect individual rights effectively.
• Issues like mishandling of samples, data misuse, and non-consensual sharing pose ethical challenges.
• Without robust laws, Indian citizens risk losing control over their biological samples and the resulting research profits.

The Need for Regulatory Reform

• Stronger regulations, overseen by an expert committee, would encourage public participation in biobanks and ensure ethical practices.
• Proper biobanking laws aligned with global standards would position India as a leader in next-generation therapeutics, enhance trust, and facilitate international collaborations.
• India’s involvement in international organisations like the Quad and BRICS, as well as its leadership in pharmaceuticals, underscores the importance of aligning its biobanking policies with international standards.

Conclusion

• To harness the full potential of precision medicine, India must strengthen its biobanking regulations, ensuring ethical practices, data protection, and public trust.
• These reforms will not only benefit domestic healthcare but also enhance India’s position in global medical research and pharmaceutical diplomacy.