India's largely unregulated market for personalized medicine services desperately needs regulation and public accountability.
Biotechnology in India is now rapidly stepping up from laboratories to industry. The Association of Biotechnology Led Enterprises (ABLE) in its White Paper on “India’s biotech ecosystem” estimated that there were 1022 start-ups in the biotechnology sector by the end of 2016. The focus of majority biotech start-ups is the healthcare sector, which includes medical devices, drugs and diagnostics. In recent years, many companies have emerged that provide personalized medicine services, with the most notable examples being Mapmygenome, The GeneBox, DNA Labs India, Indian Biosciences, Xcode and EasyDNA. The types of tests biotech companies offer to the public include: personal genomics (drug response profile, nutritional needs, predisposition), diagnostics (preconception screening), nutrigenomics (DNA based dietary plans), fitness, sport, paternity, ancestry and pharmacogenomics (the role of genetics in a patient’s reaction to drugs).
Genetic tests are mostly offered online, either directly through the companies’ websites or through the e-commerce company Amazon by paying around INR 3,000 to INR 1,20,000 per test. Consumers order their DNA test kit online, send their DNA sample (saliva or cheek swab) and receive their results in a few days. This process is not physician-mediated and hence it is termed direct-to-consumer testing (DTC). Since these various tests are being largely offered without doctor's referral, there are concerns about their clinical validity and utility.
To date, in India, there is no mechanism to monitor the use of genetic tests and DTC marketing is proceeding without regulatory oversight. Companies are free to offer genetic tests at any price (see above) with exaggerated claims about benefits, using strategies similar to private cord blood banking companies. Unfortunately, publications on the issue in mainstream scientific journals such as Nature and articles in the popular press have largely tended to emphasize how biotech companies are driving innovation, rather than engage in a critical analysis of DTC marketing. There is an urgent need to address ethical and social concerns arising from unregulated genetic tests in India.
Companies’ websites are filled with case studies and testimonials from imminent industrial and political personalities about their services. For instance, the website of Mapmygenome features the following statement by a leading politician:
Dear Anu (CEO), thank YOU! I found the report hugely impressive, remarkably accurate about my overall health and very professionally and helpfully done. I would be happy to recommend your services to anyone interested.
This testimonial is clearly a marketing ploy, which has the potential to mislead the public. People will be more likely to seek genetic services if they are recommended by prominent public figures. The most worrisome is that these testimonials are published with the persons’ names and photos, which raises serious concerns about genetic privacy. There is no information on how companies store genetic data and protect consumers’ health information from potential leakage or sharing with third parties for commercial and research purposes. Personal health information is very sensitive and free access to it can have a harmful effect on peoples’ lives. Moreover, medical insurance companies can use personal health to limit medical coverage and increase insurance premiums.
Additionally, there are many legitimate health care and scientific issues with DTC genetic services. For instance, personal genetic tests are non-diagnostic in nature. This means that DTC genetic tests offered by for-profit companies cannot diagnose the presence or absence of a disease. Most tests identify the probability of a disease, similar to weather forecasting. Since there is often no involvement of clinicians in the whole process, there are greater chances that patients can misinterpret their test results. The matter is further complicated by the lack of qualified genetic counselors and skilled medical practitioners with expertise in genetics in India.
Another key issue with DTC genetic services is the lack of data on Indian population. It is worth noting that India did not participate in the first human genome project, which was completed in 2003. Although the country has taken its own initiatives to sequence the Indian genome in 2003, Indian commentators still believe that we do not have enough data to accurately predict many disease conditions. This is the major reason why companies in India are using data generated from Caucasian populations, which is clearly not an actual representation of Indian population.
Despite insufficient genomic data and unresolved social, ethical and regulatory issues, genomics companies in India are not subjected to scrutiny and continue to flourish in the name of biomedical innovation. India's biomedical agencies such as The Indian Council of Medical Research (ICMR) and The Central Drugs Standard Control Organization (the Indian equivalent of FDA), as well as health professionals, need to come forward with a regulatory framework to protect consumers from possible health risks and address concerns about economic exploitation given that companies often charge exorbitant fees for personalized medicine services. Unfortunately, to date, India has not developed guidelines/regulations for personalized medicine, although the ICMR Director General is completely aware of the situation, as highlighted in a recent media report.
Dr. Shashank Tiwari is a Research Fellow at the Canadian Institute for Genomics and Society. His research focuses on the social studies of life sciences, biomedicine and emerging biomedical technologies in India.