In 2006, Biocon launched BIOMAb EGFR - India's first indigenously developed novel biologic monoclonal antibody used as treatment for certain kinds of cancer - after completing clinical trials entirely in India. At the time, an Indian biotech could discover a molecule, develop it domestically, and work with the regulator to bring it to patients without navigating today's layers of complexity. Replicating that journey today would be far harder, as the regulatory pathway has become increasingly challenging.
Following legitimate concerns over clinical trial practices, India rightly tightened oversight. In 2013, Supreme Court intervention led to stronger safeguards and scrutiny of clinical trial approvals. While the resulting framework strengthened oversight, its regulatory interpretation over the past decade has also added procedural complexity and multiple layers of review.
