Context: Precision medicines is setting up a new era of personalized healthcare, evolving significantly since its foundations were laid by the scientists during the completion of the Human Genome Project.
Introduction:
- Genomics has become pivotal in revolutionising the diagnosis and treatment of various conditions, including cancers, chronic illnesses and diseases affecting the immune, cardiovascular and liver systems.
- Other emerging technologies, such as gene-editing and mRNA therapeutics, also contribute to precision medicine.
- Examples:
- Using gene therapy, researchers were able to restore vision in people who had lost it due to a genetic mutation.
- Researchers in the U.K. reversed an individual’s diabetes by transplanting reengineered stem cells.
- COVID-19 pandemic: Researchers were able to use the mRNA platform to develop new vaccines in record time, winning the technology a Nobel Prize in 2023.
- Organ-on-chips is a promising precision Medical-Solutions.
- These small microfluidic devices containing human cells can replicate the microenvironment of a tumor or an organ in a laboratory setting.
- Researchers can now test drugs in settings more similar to the drugs’ eventual user.
Advancements in precision medicine in India:
- The Indian precision medicine market is estimated to be growing at a CAGR of 16% and will be worth more than $5 billion by 2030.
- It contributes 36% of the national bioeconomy.
- The New ‘BioE3’ ((Biotechnology for Economy, Environment and Employment) policy also includes the development of precision therapeutics.
- The policy aims to harness the power of biotechnology and develop new manufacturing methods that replicate or mimic processes found in natural biological systems.
- The BioE3 policy emphasizes innovation in research and development (R&D) and entrepreneurship, establishing Biomanufacturing, Bio-AI hubs and bio-foundries to expand India's skilled biotechnology workforce.
- This aligns with 'Lifestyle for Environment' programs, and targets the development of regenerative bioeconomy models.
- In 2023, the Central Drugs Standard Control Organization approved NexCAR19, India’s domestically developed CAR-T cell therapy.
- The Siemens Healthineers, in collaboration with the Indian Institute of Science, Bengaluru, launched new AI-driven facilities for precision medicine.
The role of Biobanks in advancing Precision medicine:
- A biobank is a repository of biological samples, such as blood, DNA, cells, tissues, and/or organs, alongside their genetic data.
- These samples are collected from consenting individuals and intended for use in research.
- For precision medicine to succeed, biobanks must be extensive and diverse, ensuring that their research benefits a wide range of individuals rather than just a limited population segment.
- Recently, health researchers created the largest biobank of sarcoma patient-derived organoids. This biobank is used to understand sarcoma and identify potential therapies using high-throughput drug screening.
- Organoids are miniaturized, synthetic versions of organs that can replicate tumors.
- The growth of Biobanks in India:
- There are 19 registered biobanks in India, hosting many biological specimens, including cancer cell lines and tissues.
- In 2024, the ‘Genome India‘ program finished sequencing 10,000 genomes from 99 ethnic groups to identify treatments for rare genetic diseases.
- The pan-India ‘Phenome India’ project has collected 10,000 samples to create better prediction models for cardio-metabolic diseases.
- The Paediatric Rare Genetic Disorders (PRaGeD) mission could help identify new genes or variants to develop targeted therapies for genetic diseases that affect children.
Despite potential, stringent regulations around biobanks in India pose a significant challenge to fully harnessing the benefits of precision medicine.
Challenges in regulating Biobanks in India:
1. Global standards vs. India's regulatory gaps:
- The U.K., the U.S., Japan, China, and many European countries have laws or comprehensive regulations addressing several biobanking issues, including informed consent, withdrawal rights, privacy, and data protection.
- India’s regulation of biobanks is inconsistent, with gaps that could undermine public trust and limit the potential of precision medicine.
- There is a lack of regulations to protect the rights of individuals.
2. Inadequacies in ethical guidelines and data practices:
- The Indian Council for Medical Research’s guidelines for biomedical and health research involving human participants, as well as the Department of Biotechnology’s (DBT) practices for data storage and analysis, have many gaps.
- Example: Participants are expected to consent to providing samples without knowing how their data will be used and for how long they will be stored.
- Genetic information can reveal insights about an individual and their family, potentially leading to discrimination.
3. Lack of Central regulation and penalties:
- Without a single authority to regulate biobanks and no penalty for misconduct, there is a considerable risk of inconsistencies arising from sample mishandling and ethical violations like data sharing for non-consenting purposes.
4. Risks of unregulated access to biological samples:
- Many pharmaceutical companies, including those abroad, will have access to samples from India, as many research projects often require researchers and pharmaceutical companies to collaborate with biobanks during drug discovery and development.
5. Impact of regulatory gaps on Data ownership and profits:
- Indians could be deprived of the ownership of biological samples, the data and the profits from the resulting research findings.
Seizing the opportunity for leadership in Biobanking:
1. Enhancing public trust through strong protections:
- Vital data, privacy protections and regulatory oversight by an expert committee will encourage more people to share samples and participate without worry.
- It will also allow research to happen on the right foundations.
2. India's pharmaceutical diplomacy and global aspirations:
- India is a part of international groups like the Quad and BRICS, with pharmaceuticals as a critical component of its soft diplomatic initiatives.
- It is a major supplier of generic drugs and a hub of vaccine manufacturing, and it plans to expand its leadership to include next-generation therapeutics.
- For this, India will have to align its biobanking laws with global standards, which will encourage public participation and trust.
Fostering greater public confidence in biobanking practices will encourage participation in precision medicine research, which in turn will enhance healthcare outcomes for India’s population and solidify its role in the global biopharmaceutical landscape.