Kerala High Court seeks reports on whether cheaper alternative can replace patented cancer drug

The Kerala High Court ordered the National Cancer Institute, Jhajjar; Chittaranjan National Cancer Institute, Calcutta; Regional Cancer Center (RCC), Thiruvananthapuram; and the Drug Controller General of India (DCGI) to report on whether Ribociclib and Palbociclib, drugs used in the treatment of breast cancer, can be substituted for each other.

Justice Harishankar V. Menon issued the directive while considering a suo motu petition challenging exorbitant prices of life-saving drugs. The lawsuit arose out of a lawsuit filed by a breast cancer patient who succumbed to the disease while her lawsuit challenging the unavailability of a prescribed expensive drug was pending in court.

The amicus curiae informed the court that Ribociclib, used to treat breast cancer and manufactured by Novartis AG, cost around ₹58,000 a month when the petition was first filed in 2022. The amicus curiae said the government should either take over the patent on the drug for “government purposes” as provided for in the Basic Product and Patents Act, 1970. it.

Pharmaceutical companies Eli Lilly and Company and Novartis AG said there was no need to invoke the provisions of the Patent Act because the central government had not previously found it necessary to declare Ribociclib as an essential product. They also claimed that the alternative medicine Palbociclib was manufactured by various companies in India and was available at a more affordable price.

In response, the amicus curiae argued that the two drugs have different clinical and toxicological profiles and are not interchangeable. But Novartis AG said they were just two different molecules used to treat the same type of breast cancer.

The court said the opinions of two cancer institutes, RCC and DCGI, are required. Their reports will be considered on August 21 when the matter will be heard again.

Published – 15 Jul 2026 23:46 IST