THE LEGAL LANDSCAPE OF BIOTECHNOLOGY: BETWEEN INNOVATION AND PROTECTION

Biotechnology is rapidly moving forward from the laboratory to encompass every domain of human life—healthcare, agriculture, pharmaceuticals, environmental management, and genetic research. But these innovations raise various legal and ethical issues that our conventional regulatory framework has yet to answer. In India, instead of a single statutory body, biotechnology is regulated by a framework including environmental legislation, patent law, biodiversity regulation, data-ownership law, pharmaceutical regulation, and many other constitutional principles. This article explores the primary legal tensions arising from biotechnology in India, with a main focus on genetically modified organisms, intellectual property, biodiversity, targeted gene editing, informed consent, and protection of human rights. It critically reviews the patent eligibility issues of the Patents Act, 1970, and the friction between the Patents Act and the Biological Diversity Act, 2002. There is a need for a comprehensive statutory framework that should be coherent, risk-based, and rights-oriented and will be capable of safeguarding the constitution, a sustainable environment, and a fair distributive justice.