Is Biobanking legal in India? 

The rapid rise of health care technology and biobanking has created a new set of privacy issues and it is necessary to enact laws on such biobanks to protect the interest of citizens. Biobanking is going to give an opportunity for the research community and the industry to move health care services ahead in a big way by providing better patient-specific treatments. But it is also going to create a number of regulatory challenges.

Biobanking has a strong presence in India and coupled with our burgeoning healthcare industry, there’s no doubt this will continue to grow. However, as the article above highlights, it’s important to discuss the various ethical implications that come with biobanking and data collection. While consent will play an important part in anything currently happening or contemplated, having a comprehensive law on biobanks will help ensure we’re all on the same ethical page moving forward.

The regulators, therefore, will have their work cut out in deciding what should be allowed or not. While they do that they should keep these issues in mind.The law is unclear on the issue of biobanks in India. While data collection is abundant, it lacks mechanisms to protect these records. Current legislation needs to be updated to include procedures for data protection and identity fraud prevention.Whilst amendments to the current guidelines are being proposed, it is perhaps time that we did away with the concept of informed consent under the Biologicals Rules -1972 altogether an bring our policies in line with international norms. The current model has proved to be insufficient as biobanks continually strive to catch up with the ever-increasing speed at which research is conducted, and with advances in technology. Perhaps it is time for a more global approach to policy making on issues affecting biobanks, rather than relying on piecemeal attempts at regulation.

So where does that leave us in the present? If there is no law, what is our process? Should we just wait until something more definitive comes out? Or should we push ahead in the meantime? In my opinion, we need to work with the government and other bodies to get something passed. We don’t want to violate the law, so let’s take whatever steps necessary to ensure that our process is legal. Most importantly, we should actively promote the act of getting consent from donors ethically. One last thing while waiting for a comprehensive law on privacy, I think it would be safer to have guidelines that are applicable across India than have state-by-state variation. Let’s not forget that biobanking is growing fast around the world. While the reasons for establishing a genetic biobank are understandable, it would be naive to assume that such an endeavour would remain uncontroversial . Even though such an initiative could be extremely well intentioned and offer a real hope for scientific advancement, scholars have argued that it is important to first consider the issues of informed consent and privacy.

Reference:

https://pubmed.ncbi.nlm.nih.gov/27256123/#:~:text=Biobank%2Dbased%20research%20is%20not,level%20of%20identification%20of%20specimens.

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