Kerala HC flags high patented-drug prices, asks Centre to assess affordability

The Kerala High Court said exorbitant prices for patented medicines can warrant government intervention, directing the Centre to examine affordability of treatments including HR-positive, HER2-negative breast cancer drugs under Section 100.

— Source publishedTue, 29 Sept, 2026, 00:48 IST·First seen Tue, 29 Sept, 2026, 00:55 IST·Source ET Small Business

The development

Kerala High Court said on Monday that HR-positive, HER2-negative breast cancer accounts for around 55-60% of breast cancer cases in India and directed the Centre to assess patented-drug affordability, potentially enabling government intervention under Section 100.

The numbers

  • 55-60%
  • Rs 78,400
  • Rs 7,750
  • Section 100

Why it matters to operators and investors

Pharmacy operators should prepare for stronger demand for affordable oncology access programs if government intervention lowers prices of patented therapies.

The counter-case

The ruling is an early-stage judicial prompt, not a price-control order, compulsory licence, or Section 100 authorization. The Centre may conclude that existing patient-assistance programs, public procurement, insurance coverage, negotiated discounts, or generic alternatives sufficiently address access. Even if intervention follows, it may be limited to a narrow set of indications, patients, or public-sector supply channels rather than broadly impairing Eli Lilly's or Novartis's patented-drug pricing.