India Needs a Legal framework for Genomics

In Context of Genomics Information
In the last two decades, unprecedented advancements have come in our ability to sequence,
analyze, and interpret genomes at an unprecedented scale, along with an emerging and
expanding corpus of evidence to act upon the genomic Information for healthcare
decision-making.
The population-scale genome programs currently underway in many large and small
countries encompassing millions of genomes would form the foundation and fuel this
paradigm shift.

India’s Genomic Programmes
India has not been too far behind in human genomics, with the announcement of the first
genome sequencing in 2009, 1,000 genomes in 2019, and recently concluded 10,000
genomes last week. These contributed to significant insights into diseases in the population,
estimates of the prevalence of many conditions, and more importantly served as baseline
data for decision-making, apart from their utility in accelerating research.

Equity and Diversity
Data protection is one of the important components that urgently require a legal framework.
While the Health Ministry Steering Committee clearances are required for research
collaboration, the Director General of Foreign Trade notification enables samples to cross
borders for commercial purposes.
This has been widely exploited by large pharma and research organizations abroad to
perform research on Indian Samples. Despite Significant established capacity and expertise
in India, a significant number of samples from India are sequenced/analyzed by companies
abroad with little oversight and regulation.

Challenges Regarding Genomics
Other issues that India is facing in Genomics are:
1. Fragmentation of genetic data, with many organizations providing genetic testing
services, the data remains in silos.
2. Discrimination based on genetic information.
3. Equity and Diversity in genetic data also is a concern that needs to be addressed.
4. Lack of equity can result in less research and less insight/ evidence for clinical
decision-making.

What can be done?
To counter these challenges some measures can be taken:
1. Formulation of Non-discrimination Act which prevents discrimination based on
genetic information.
2. Ensuring ethical use of the technology is paramount to both advance it and ensure
that people benefit from its use.
3. Evidence-based use of genomics and mechanisms to ensure the quality and validity
of genomic tests.

Way forward
India has the potential to be a leader by enabling genomics for the masses, at an
unprecedented scale opening up unprecedented opportunities and heralding a better and
healthier future for its people, but only if it puts the best foot forward.