Judicial Delay in Landmark Ribociclib Access Case: Petitioner Dies as Kerala High Court Lists Matter 57 Times Without Final Hearing
核心洞察
A writ petition seeking affordable access to breast cancer (搜索) drug Ribociclib has been listed 57 times since January 2023 without a final hearing, prompting a letter to the Chief Justice of India.
The original petitioner died in September 2022, a week after the Kerala High Court was informed of her critical illness, yet constitutional questions on access to medicines remain unaddressed.
The working group on access to medicines reports Ribociclib costs Rs 78,468.75 per month under Novartis's patent, while generic versions could reduce prices by 90-95% through a government use licence under Section 100.
A writ petition seeking affordable access to the life-saving breast cancer (搜索) drug Ribociclib has been listed for final hearing 57 times before the Kerala High Court since January 21, 2023, without the matter ever being heard. The original petitioner died in September 2022 — a week after the court was informed she was critically ill — and the case has since continued suo motu given its larger public interest. Now, a working group on access to medicines has written to Chief Justice of India Surya Kant, urging the Supreme Court to intervene and expedite a resolution.
The working group, comprising patient advocates, patient groups, civil society organisations, academics, and lawyers, detailed the case's protracted journey in their letter. "Every stakeholder has been heard. Every report sought by the court has been placed on record. Every scientific development has been brought before the court. The pleadings stand completed. Yet the constitutional questions on the obligations of the government under Article 21 with regard to access to medicines remain unaddressed," the letter states.
The Human Cost of Procedural Delay
The petition was originally filed on February 6, 2022, seeking a government use licence under Section 100 of the Indian Patents Act, 1970, which would have enabled domestic production of generic versions of Ribociclib at substantially lower prices. According to the working group, generic production can reduce drug prices by 90-95%. The monthly cost of Ribociclib treatment stands at Rs 78,468.75, while another targeted therapy, Abemaciclib (marketed by Eli Lilly), costs between Rs 47,752 and Rs 95,504 per month.
The patient died in September 2022, a week after the petitioners informed the high court that she was critically ill. A brief case history shared by the working group shows that a first order was passed on June 14, 2022, directing the government to consider the matter within four weeks. A subsequent order noted that the patient's files were being "pushed from one department to another." Delays continued due to what the respondent government claimed were "incomplete orders posted" and a failure to file an affidavit from July 18, 2022, until weeks after the woman had died.
"The untimely demise of the petitioner in this matter highlights the devastating human cost of judicial delays in cases involving access to lifesaving drugs," the working group wrote. "A swift resolution to this matter would not only honour the memory of the late petitioner but also provide hope to others who are suffering from the dreaded disease but do not have the means to approach the court."
Government and Industry Responses
The Union government, in its response, acknowledged the medicine's effectiveness but refused to issue a government use licence, stating that breast cancer (搜索) did not constitute a matter of national urgency. The working group noted that the government has not provided a reasoned response regarding access to life-saving medicines and the enjoyment of the right to health.
Novartis, which holds the licence for Ribociclib in India, argued in its affidavit that the drug was priced at Rs 23,625 for 21 tablets, among the "lowest in the world." Eli Lilly, the manufacturer of Abemaciclib, was also impleaded in the case. At one point, both companies offered to use their Corporate Social Responsibility targets to fulfil the needs of Indian patients, prompting the court to seek the Union government's response.
The Union government later informed the court in a written statement that the patent of Palbociclib (manufactured by Pfizer), one of three medicines related to the writ petition, had expired, and thus generics were available. The government argued that no further steps were required to make the other two medicines affordable. However, the amicus curiae appointed by the court countered that scientific papers did not accept the notion of "interchangeability" of these drugs, meaning the expiry of Palbociclib's patent "does not have any significant impact on the access to medicines for the citizens."
Breast Cancer (搜索) Burden in India
Breast cancer (搜索) represents a significant public health challenge in India. According to the Global Cancer Observatory report of 2022, India reported more than 1.9 lakh new cases and 98,300 deaths. Official data tabled in Parliament by the Ministry of Health and Family Welfare in early February 2026 made an estimated projection of 2.4 lakh cases. The National Academy of Medical Sciences (NAMS) task force report on breast cancer in India, published in 2024, stated that approximately 2,00,000 new cases were reported in 2020, with an expected 232,832 cases projected for 2025.
A 2021 report by the National Cancer Registry Programme, an ICMR body, noted that "gynaecologic cancers, including breast cancer (搜索) (51%), accounted for over half of all cancers in females." Among these, patients with Luminal A (HR+/HER2-) breast cancer (搜索), an invasive subtype that can spread to other parts of the body, require targeted medicines such as Ribociclib and Abemaciclib. These medicines are critical for HR+HER2- patients because they can be used to treat patients at an early stage.
Procedural Labyrinth
The case has traversed a complex procedural path. After the petitioner's death, the high court decided to continue the case suo motu and appointed an amicus curiae. Various respondents, including the Union of India, filed detailed responses. The manufacturers were impleaded and also filed their responses. Parties that have appeared include expert witnesses, drug manufacturers, the Department of Trade Promotion and Policy, the Controller General of Patents, the Department of Pharmaceuticals, and the Indian Council for Medical Research (ICMR).
Some hearings after the patient's death were limited in scope — such as the high court having to ask the government to provide the addresses of the drug manufacturers. In March 2023, the local unit of Novartis informed the court that the international parent company needed to be impleaded. On June 16, 2023, Novartis AG appeared and sought to be impleaded, stating it saw the court registry's notice late because "the mail was in the spam box."
The matter was posted for a final hearing on November 30, 2022. That hearing has yet to take place. The next hearing — the 58th in the case — is scheduled for July 15. The matter has been adjourned 40 times.
The working group's letter to the CJI underscores the constitutional stakes: "Delays in adjudicating cases involving access to essential medicines deprive patients of their fundamental right to health and life under Article 21 of the Constitution of India."