The Kerala High Court has asked the National Cancer Institute, Chittaranjan National Cancer Institute, the Regional Cancer Centre in Thiruvananthapuram, and the Drug Controller General of India to submit reports on whether ribociclib and palbociclib can be interchanged. The move aims to address soaring drug prices and improve access to life‑saving therapies.

Key Takeaways

  • Kerala High Court seeks reports on substitutability of ribociclib and palbociclib.
  • Amicus curiae highlights price disparity and patent concerns.
  • Findings to be reviewed on August 21.

In a decisive step, the Kerala High Court directed the National Cancer Institute (NCI) in Jhajjar, the Chittaranjan National Cancer Institute in Kolkata, the Regional Cancer Centre (RCC) in Thiruvananthapuram, and the Drug Controller General of India (DCGI) to prepare detailed reports on whether the patented breast‑cancer drugs ribociclib and palbociclib can serve as interchangeable alternatives.

Legal Context and Origin of the Petition

Justice Harishankar V. Menon issued the order while entertaining a suo motu petition that questioned the exorbitant prices of life‑saving medicines. The petition originated from a writ filed by a breast‑cancer patient who succumbed to the disease after being denied access to an expensive prescribed drug, while her challenge to the drug’s unaffordability was pending before the court.

Cost, Patent Issues and Industry Responses

The amicus curiae reported that ribociclib, manufactured by Novartis AG, cost roughly ₹58,000 per month at the time the petition was filed in 2022. It urged the government either to take over the patent for “government purposes” under the Patents Act, 1970, or to declare the drug an essential medicine, thereby preventing a monopoly. Pharmaceutical giants Eli Lilly and Novartis, however, argued that the central government had already decided there was no need to declare ribociclib essential, and highlighted that palbociclib is produced by several Indian firms at a considerably lower price.

Scientific Divergence and Court’s Request

The amicus further contended that the two drugs possess distinct clinical and toxicological profiles, making them non‑interchangeable. Novartis countered, stating that while the molecules differ, they target the same subtype of breast cancer. The court therefore requested comprehensive insights from the two cancer institutes, the RCC, and the DCGI, with the reports slated for review on August 21.

Potential Implications for Public Health

Should the findings support palbociclib as a viable, cheaper alternative, India could witness a substantial reduction in out‑of‑pocket expenses for cancer patients. Moreover, a precedent of re‑examining patent claims for essential medicines may stimulate broader reforms, encouraging a more equitable balance between pharmaceutical innovation and public health imperatives.