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Indian Pharma: Are Regulatory Gaps From Generics Following Biosimilars?

Transparency, Trust, and the Problem of “Invisible Evidence” in Cancer Care

India’s pharmaceutical success has long rested on speed, scale, and affordability. For decades, regulatory frameworks and patent exceptions were designed to enable rapid entry of generics once exclusivity ended. In the small-molecule era, this approach was defensible—and often beneficial.

But as India moves deeper into the world of biologics and biosimilars, particularly in oncology, an uncomfortable question demands attention:

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