This article sheds light on the biobank and its evolution for Precision medicine.
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- Precision medicine is revolutionising personalised healthcare, relying on advanced technologies like genomics, gene-editing, and mRNA therapeutics.
Evolution and Status of Precision Medicine in India
- Introduction: Precision medicine focuses on personalised healthcare, and it has rapidly grown since the Human Genome Project.
- Growth of Precision Medicine in India
- The precision medicine market in India is expected to grow at a rate of 16% CAGR and surpass $5 billion by 2030.
- It contributes to 36% of India’s bioeconomy, with advancements in cancer treatment, gene editing, and biologics.
- Key Developments in Precision Medicine
- NexCAR19: India’s first domestically developed CAR-T cell therapy was approved in 2023, marking a significant milestone.
- CAR-T cell therapy is used to treat cancer.
- AI Collaborations: Partnerships, such as those between Siemens Healthineers and the Indian Institute of Science, focus on using artificial intelligence for cancer treatments and advancing precision medicine.
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About Biobanks
- A biobank is a repository that stores biological samples, such as blood, DNA, cells, tissues, and organs, for research purposes.
- They play a vital role in precision medicine by providing valuable information for studying diseases and developing targeted treatments.
Importance of Biobanks
- Large-Scale Research: Biobanks provide researchers with access to a vast collection of samples, enabling them to conduct large-scale studies that would be difficult or impossible with smaller sample sizes.
- Genomics and Personalized Medicine: Biobanks are essential for genomics research, which aims to understand the genetic basis of diseases.
- This knowledge can lead to the development of personalised treatments tailored to individual patients’ genetic makeup.
- Disease Biomarkers: By analysing samples from large groups of people, researchers can identify genetic variations associated with specific diseases.
- These variations can serve as biomarkers for early diagnosis and targeted treatment.
- Genome India:
- It is a national project, funded by the Department of Biotechnology.
- Objective: It aims to sequence 10,000 genomes from healthy individuals across India.
- Phenome India:
- It is the initiative of the Council of Scientific and Industrial Research (CSIR).
- Launch date: 2023 (Dec)
- Objective: This project aims to develop India-specific risk prediction models for diseases like liver diseases, and cardiac conditions.
- The Paediatric Rare Genetic Disorders (PRaGeD) mission.
- It is a pan India initiative.
- Funded by: Department of Biotechnology (DBT), Ministry of Science and technology.
- Objective: Developing art facility to study Paediatric Rare Genetic Diseases.
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Biobank Regulations in India
- India currently has 19 biobanks, and initiatives like Genome India and Phenome India aim to improve disease prediction and treatment.
- Regulatory challenges
- However, India lacks comprehensive biobank regulations, creating issues related to:
- Informed consent: Participants are unsure how their data will be used.
- Privacy risks: Genetic data could lead to discrimination.
- Regulatory gaps: There is no single authority to regulate biobanks, and misconduct may occur.
- Ethical concerns: There is a need to resolve issues such as exploitation, stigma, and discrimination based on genetic information.
- Sample quality and integrity: Maintenance of quality and integrity of biological samples is necessary over time.
- It requires necessary protocols and optimal storage conditions for preventing it from degradation and contamination.
- Legal Framework Governing Biobanks in India
- Lack of Comprehensive Legislation
- India does not have specific laws for biobanks.
- Existing guidelines are not enforceable, leading to regulatory gaps.
- National Ethical Guidelines by ICMR
- The Indian Council for Medical Research (ICMR) has issued ethical guidelines for biomedical research involving humans.
- These guidelines are not legally binding and do not fully address long-term storage or data sharing for biobanks.
- Department of Biotechnology (DBT) Standards
- The DBT has set practices for data storage and analysis.
- However, these are not enforceable and do not adequately cover issues like informed consent and privacy.
- Absence of a Single Regulatory Authority
- India lacks a dedicated regulatory authority for biobanks.
- This results in inconsistencies and limited oversight in biobanking activities.
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Global Standards and India’s Path Forward
- Countries like the U.S., U.K., and Japan have stringent biobank laws covering data protection, consent, and privacy.
- India needs similar laws to protect participant rights and ensure ethical research practices.
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October 15, 2024
