Kerala High Court Seeks Expert Opinion on Affordable Cancer Drug Alternatives
The Kerala High Court has directed four medical institutions and the Drug Controller General of India (DCGI) to submit reports on whether two breast cancer drugs, Ribociclib and Palbociclib, can be substituted for each other. Justice Harishankar V. Menon issued the directive while hearing a suo motu petition concerning the high prices of life-saving medications.
The case stems from a writ petition filed by a breast cancer patient who passed away during the proceedings. The patient had challenged the unaffordability of the prescribed medicine. The amicus curiae informed the court that Ribociclib, manufactured by Novartis AG, costs about ₹58,000 per month as of 2022. The amicus suggested the government either take over the patent under Section 102 of the Patents Act, 1970, for 'purposes of the government', or declare the drug an essential product to prevent monopoly.
Pharmaceutical companies Eli Lilly and Company and Novartis AG argued against invoking the Patents Act, noting that the central government had already decided not to declare Ribociclib an essential product. They also pointed out that an alternative, Palbociclib, is manufactured by multiple Indian companies at a lower cost.
The amicus curiae countered that the two drugs have different clinical and toxicological profiles and are not interchangeable. However, Novartis maintained that both are molecules used to treat the same type of breast cancer. The court has now sought expert opinions from the National Cancer Institute, Jhajjar; Chittaranjan National Cancer Institute, Kolkata; the Regional Cancer Centre, Thiruvananthapuram; and the DCGI. The matter is scheduled for further hearing on August 21.
