On March 9, 2024, Dr Vinod Scaria wrote an article in science page of The Hindu urging for a strong regulatory crackdown to prevent Indian biological samples from being analyzed by foreign commercial entities. His chain of reasoning includes protection of privacy, anti-discrimination, and promotion of Indian biotech ventures to provide genomics access for the masses.
At the onset, let me clarify that I am completely in favor of data privacy and protection laws. No one should be discriminated against based on their genetic background and we must enact laws to protect our vulnerable segment.
However, this article goes over and beyond patient advocacy, and wants a gatekeeping layer to prevent international commercial offerings from accessing any Indian genomics data. We are already at a loss because international research collaborations require stringent approvals from the Health Ministry, and our academic institutions can’t provide novel genomic insights from our data due to uncompetitive scientific and monetary resources. Here, I posit that an additional crackdown on international commercial genomics offerings in India will cease our access to highly advanced and innovative Western technology, and result in poor health outcomes and lack of therapeutic options for our citizenry.
India is an extremely price sensitive market and people routinely tap foreign genomics organizations to get superior insights from their biological samples at a value bargain. We have several homegrown public and private sector entities, but they remain uncompetitive compared to superior Western offerings which have access to world-class scientific talent and significantly more research funding. This is the case for genomics offerings geared across the lifespan, from infancy to gerontocracy, for both health and disease (rare genetic disorders to cancer).
India is the biggest beneficiary of open science and virtually every insight on our genomics history and disease risk profiles has originated from world-class research in Western institutions. All our genomics tools, workflows, methods, algorithms are a product of Western generosity and their progressive shared belief in open science without borders. This walled garden approach is against our espoused One World, One Health, One Future vision, and will make the global scientific community suspicious of India’s interests, and likely prevent our access to Western technology and destroy the global scientific collaborative ecosystem.
Regulatory crackdown on foreign commercial genomics ventures will also cause severe conflict of interests because several large corporations are investing in genomics infrastructure. A rash decision might result in undue commercial advantages to a few conglomerates and reduce competition and innovation in the diagnostics, therapeutics, and personalized medicine space.
I am a firm believer in Make in India for the World project, and supporting our innovative genomics startups is a no-brainer. We have tremendous potential for disruptive innovation. However, preventing competition from ultra-innovative foreign startups, from gut health to precision live bio-therapeutics, cancer and genetic risk profiling and therapeutics, without any serious improvement in the Indian innovation index will hurt the interests of our population.
Surely, we do not want only the privileged elites, for example Late Honorable Finance Minister and ex-NAC chairperson, to access the best healthcare technology from New York but curtail this access for the masses.
(Varun Aggarwala, Assistant Professor, AI and Biomedical Sciences, Jio Institute, Navi Mumbai)
‘Misuse of loopholes is my major concern’
Vinod Scaria’s response to Dr Varun Aggarwala’s rebuttal
Protection of national interest and assets is well within the raison d’être of a nation. My article largely focussed on a legal framework for genetic material of individuals, which is a significant concern, much beyond the scope of laws already in place to protect biodiversity as it involves privacy and more importantly the potential for misuse, which can be detrimental to wellbeing of Indians in the future. I disagree with Dr Aggarwala’s statement that no novel genomic insights have come from India. In fact, the academic and industry enterprise in India caters to hundreds of thousands of genomic tests annually benefiting patients in India with affordable and accessible genetic diagnostics.
While I am not against international collaborations that follow the laws of the land, I would like to make it explicit that misuse of loopholes is what my major concern is as the effects can be very detrimental, such as the predatory practices aimed at data collection and monetisation rather than provision of high-end services. To give an example, a significant number of non-invasive prenatal testing (NIPT) which happens abroad are not covered under the PNDT act which prohibits sex determination in India. Enforcing Indian laws is therefore possible only for tests performed in India or by organsiations in India. Similar efforts for data localisation, for example, have now been legally implemented in India.
It would be at the best counterfactual to state that Indian entities are uncompetitive, or not at par with western offerings in quality. In fact, there are multiple organisations in India which have been accredited for their best-in-class services by College of American Pathologists (CAP) as well as the Clinical Laboratory Improvement Amendments (CLIA). To put facts on record, there are also Indian organisations providing end-to-end clinical reporting and analysis services to the best clinical and research centres across the world. To believe that this is not built on talent and hard work, but on generosity would be at the best derogatory to the entire field and people in India.
The regulatory framework proposed will in no way be detrimental to investments. There is ample evidence across different domains how right regulatory frameworks could accelerate investments as well as promote the field and also enable a more democratised environment and a level-playing field. Brighter future would be possible only if we build self-sufficiency in a stepwise and planned fashion. In fact, the COVID-19 pandemic is the best-case example where with the right policies, India could not only build self-sufficiency, but also contributed to the insights, products including early genomic insights and early warning for many new variants. We need to contribute to One World on an equal and confident footing.
(Vinod Scaria is a genomics scientist and senior consultant at Vishwanath Cancer Care Foundation and an Adjunct Professor at Indian Institute of Technology Kanpur)
