Why India urgently needs a legal framework for genomics

Subject: Science and tech

Section: Biotech

Advances in Genomics:

The past two decades have witnessed remarkable progress in genomics, highlighted by the ability to sequence, analyze, and interpret genomes on an unprecedented scale.
The dropping costs of sequencing forecast a surge in clinical genome sequencing applications. Population-scale genome programs worldwide are laying the groundwork for a significant shift in healthcare and research.

India’s Progress:

India‘s journey in human genomics began with its first genome sequencing in 2009, reaching 1,000 genomes by 2019, and recently completing 10,000 genomes.
These milestones have provided valuable insights into population-specific diseases, prevalence rates, and have underpinned decision-making and research acceleration.
Challenges and Opportunities:
- Given India’s vast, diverse population of over 1.4 billion, there is a critical need for ambitious and practical strategies to ensure genomics benefits reach everyone. This requires large-scale sequencing efforts, a robust legal and policy framework, and active industry participation.

Establishing a legal framework for data protection is urgent. While the Health Ministry Steering committee clearances are required for research collaborations, the Director General of Foreign Trade notificationenables samples to cross borders for commercial purposes, leading to foreign entities conducting research on Indian samples without significant local oversight.
Genetic testing services in India operate in silos, creating fragmented genetic data pools. Aggregating test results could enhance public health decisions but lacks a system for collection and analysis, hindering accessibility for health policy-making.
The potential for genetic information discrimination exists without laws to prevent it, affecting insurance and societal treatment. Moreover, market forces may exacerbate healthcare access disparities, particularly affecting the poor and ethnic minorities. Ensuring diversity in genetic data is essential to avoid exacerbating healthcare inequalities.
Ethical usage of genomics is crucial. This includes evidence-based application, ensuring test quality, and preventing misuse. Countries have developed guidelines and policies for ethical genomics use, a model India needs to adopt supported by legal measures.

The Role of Policies:

Effective regulations and clear policies are vital for advancing human genomics ethically and equitably. They foster trust, encourage collaboration, and support innovation, aligning with societal needs to maximize healthcare benefits from genomics.
India has the potential to lead in making genomics accessible on a massive scale, offering significant health and quality of life improvements. Achieving this requires proactive efforts in policy-making, regulation, and ensuring ethical and equitable use of genomics technologies.

Source: TH