Bioethics vis-a-vis Biosimilars

With India moving from strength to strength in establishment of biosimilars as the current and next step of affordable healthcare, the need of the hour is to understand the regulatory guidelines and their implementation as per current requirements.

The term “bioethics” was first coined in 1971 to signify the combination of biological sciences with humanistic knowledge. However, now it can be annotated as the application of ethics to the field of medicine and healthcare. The area of bioethics entails a vast span of concerns ranging from difficult private decisions in respect to clinical settings to the much talked about controversies surrounding stem cell research to implications of reproductive technologies and further broader concerns which include international human subject research, public policy in healthcare and allocation of scarce resources. Bioethics is thus the resultant controversy that results from the advancement of medicine or technology thus rendering the term to hold a fluid connotation. Bioethics brings to the fore fundamental issues and values arising from basic human rights such as the right to life and health, bodily integrity etc.

Usually bioethics as a notion entails discussion amongst experts from a wide range of disciplines – legal, philosophical, theological, nursing, medicine etc. However, the whole world woke up to discussions on bioethics in medicine in 1997 as the sheep Dolly took her first breath. The ethical issues with reproductive cloning included genetic modification and damage, health risks to the mother and the foetus, putting at risk the life contained within the embryo and the commodification of human life countered with the benefits and advancement of medical technology resulting from ‘Somatic Cell Nuclear Transfer’ thus resulting in a veritable plethora of debates.