The ethical and governance deficit in emerging biotechnologies

In the beginning of this year, the Union Department of Biotechnology formulated the National Biotechnology Development Strategy-2014 (Biotech Strategy-II) in continuation of National Biotechnology Development Strategy-2007 with the aim to fulfillment of Biotechnology Vision 2020.

Apart from other necessary strategy to take advantage from underlying promises of biotechnology in areas such as, but not limited to, agriculture and animal husbandry, there is a greater emphasis in harnessing genomics, synthetic biology and stem cells to address health needs.

The Union government has taken major initiatives in recent years in order to harness underlying promises of emerging biotechnologies for the benefit of the society at large. However, there are serious concerns with respect to ethics and governance associated with these technologies.

This aspect is also acknowledged in the current biotech strategy as it is pointed out that the issue of biotechnology regulation is a major challenge.

It appears, however, that this acknowledgment is just a ritual exercise given that since long, India has only guidelines for most of the areas and the government has never taken a serious step to address potential ethical and social implications of emerging biotechnologies.

Genomics: The Biotech Strategy-II has given prime importance to use genomics knowledge in addressing local health needs. It aims to provide genomics services such as pharmacogenomics and genetic testing to 50 per cent  of the hospitals by 2025.

India has initiated medical genetics programmes in the 1990s with the mandate to diagnosis, prevention and therapy of genetic disorders. Genomics in India is advancing with the emergence of many firms and hospitals that are providing genetic services. 

Many private genomics companies  are providing a number of genetics services to the public via direct-to-consumer (DTC) services for a wide range of DNA testing, paternity testing, genetic testing and DNA ancestry services, to name a few.

The websites of these companies are flooded with promises and they charge a substantial amount to public for genetic services. For instance, a genomics company based at Hyderabad is offering a genomic service by charging Rs 25,000. 

Similarly, a  company based in New Delhi offers peace of mind DNA testing by charging close to Rs. 15,000 to establish the parental link between a child and an alleged father. These kinds of information might have potential social and family implications. However, biomedical agencies in India, to date, have not taken any step to regulate/monitor these kinds of services.

In contrast, the United States Food and Drugs Administration forced a genomics firm to suspend its DTC services as these have potential to do more harm than good, given that the potential misuse of genetic data is an important issue worldwide.

These services are, at present, not regulated by any government agencies which raise concerns with respect to quality control and standardisation including economic exploitation of the public.  The clinical utility of these services are yet to be established.

Synthetic biology     
Synthetic biology is an emerging field that combines the knowledge of biology and engineering. By using engineering principles, synthetic biology aims to design/re-design and constructs new/existing biological parts, device and systems for useful purposes. Compared to developed nations, synthetic biology in India is at nascent stage. However, te Government of India appears to be highly supportive of promoting synthetic biology in the country.

The Task Force on Synthetic and System Biology Resource Network (SSBRN) has highlighted many potential applications of synthetic biology in the production of bio-fuels and medicines. The task force also paid attention to ethical and social implications of synthetic biology.

It appears, however, to be a procedural exercise as SSBRN has not allocated any funds in the recommended total budget of Rs 1850 crore to examine ethical and social implications of synthetic biology.  There is no mention of any accreditation body for monitoring activities in this promising area and its implications for the society at large.

For instance, it is noted that the synthesis of anti-malaria compound has potential to impact farmers’ livelihoods.  In India, given that a majority of the population is vulnerable and poor, there is a greater need to have a monitoring body that can assess the socio-economic impact of synthetic biology.

Stem cell: The activities in stem cell, especially its clinical application, are largely unregulated. A large numbers of clinics and hospitals in India are offering stem cell based experimental therapies for many degenerative and chronic diseases.

Stem cell clinicians are using both embryonic and adult stem cell including stem cell derived from child cord blood for treatment procedures. However, there is not enough evidence in the form of basic research to ensure safety and efficacy of treatment modalities. 

In a recent study conducted by All Indian Institute of Medical Sciences, it has been found that stem cell therapy is not useful for stroke.  Despite having concerns expressed by biomedical agencies such as the Indian Council of Medical Research and Central Drugs Standard Control Organisation, the Medical Council of India has never taken any action against those clinicians who are offering an experimental therapy.

In sum, there are many ethical and social issues associated with the proliferation of emerging biotechnologies which needs to be address to protect the citizen from possible health risks and economic exploitation.

There are clear indications that Indian biomedical sector is plagued with ethical and governance deficit. There is an urgent need to address this deficit for the benefit of society at large.

(The writer is a scholar of science and technology studies based in the USA)

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