Listed 57 times, still no verdict: Letter to CJI flags Kerala HC delay in cancer drug case

A cancer patient died while her writ petition to access life-saving Ribociclib was pending, but the Kerala high court continued hearing the case in the public interest. Now, two-and-a-half years later, a ‘working group on access to medicine’ has requested the Supreme Court to do something about it: The case has been listed 57 times since January 2023 and yet a final hearing has not materialised.In a letter to Chief Justice of India Surya Kant, the group’s co-convenors, Jyotsna Singh and K.M. Gopakumar write that “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 working group comrpises lawyers, doctors and patient advocates pushing for affordable cancer care. The parties that have appeared in the case include expert witnesses to drug manufacturers and government bodies, from the Department of Trade Promotion and Policy to the Controller General of Patents, the drugmakers Eli Lilly and Novartis, the Union of India itself, the Department of Pharmaceuticals and the Indian Council for Medical Research (ICMR).Yet the patient died in September 2022, a week after the petitioners informed the high court that she was critically ill, and without the assistance she sought. A brief case history, also shared by the working group with the CJI, shows that a first order in the case was passed on June 14, 2026, and in it the government was asked to consider the matter within four weeks.The second order said that the patient’s files were being “pushed from one department to another”. Thereafter, delays resulted from “incomplete orders posted” (a claim of the respondent government) and a failure – again of the government – to file a statement (affidavit) from July 18, 2022 to weeks after the woman had died.Still, the hearings continued and the matter was posted for a “final” hearing on November 30, 2022. That hearing has yet to take place.A snail's pace in courtSingh and Gopakumar share with their letter the long journey of the petition since it was filed on February 6, 2022. Its status remains “pending” since then.Some of the hearings after the patient’s death were limited in scope: such as the high court having to ask the government to provide the addressess of the manufacuturers of these drugs. In one hearing (March 2023), the local unit of Novartis informed the court that the international (parent) company needed to be impleaded.In another, the counsel for Novartis India Ltd. was asked to furnish the email id of Novartis AG, Switzerland and the registry was directed to serve notice, narrates the timeline shared by the working group.As per news reports on the case, the companies told the high court that sales of their drugs were high despite their prices.Ribociclib, for which Novartis holds the licence in India, and a very few other drugs are known to be beneficial in the treatment of women with breast cancer detected in early stages. The disease is one of the most common causes of deaths in female cancer patients.In April 2023, the “Ministry of Health and Family Welfare [was directed] to collect the details of different types of breast cancer in India from Indian Council of Medical Research, New Delhi”.In May 24, 2025, “both the companies had not appeared and there was no objection for the matter to be posted for hearing”, as per the working group’s timeline. The other company is Eli Lilly, which holds the licence for another breat-cancer drug, Abemaciclib.As per a September 2023 report in The Print, in its affidavit in the high court, Novartis argued that Ribociclib was priced at Rs 23,625 for 21 tablets, among the “lowest in the world”.The working group informs the CJI that the monthly cost of Ribociclib treatment was Rs 78,468.75 and for Abemaciclib it was Rs 47,752 to Rs 95,504 per month.On June 16, 2023, Novartis AG appeared and sought to be impleaded in the case. The company said it saw the notice sent by the court’s registry late because “the mail was in the spam box”.Later that year, the companies offered using their Corporate Social Responsibility targets to fulfil the needs of Indian patients. The court asked for the Union government’s response to the offer.A month and a half later, the Union government told the court in a written statement that the patent of one of the three medicines [Palbociclib, maufactured by Pfizer] related to the writ petition had expired, thus generics were available and no further steps were required to make the other two medicines affordable.To this, the amicus curaie appointed by the court said scientific papers did not accept the notion of “interchangability” of these drugs. That is, “the expiry of the patent of one medicine [Palbociclib] does not have any significant impact on the access to medicines for the citizens,” says the working group.Cancer incidence, government response“Gynaecologic cancers, including breast cancer (51%), accounted for over half of all cancers in females,” said a report that analysed hospital cancer registries, published in 2021 by the National Cancer Registry Programme, an ICMR body.The National Academy of Medical Sciences (NAMS), another government-run body, delivered a task force report on breast cancer in India in 2024 that said, “Breast cancer is the most common malignancy among women globally and in India. Approximately 2,00,000 new cases were reported in 2020, and it is expected that 232,832 cases will be diagnosed in 2025.”Yet, in their letter to the chief justice, the group points out that the Union government declined to use Section 100 of the Indian Patents Act, 1970 to make Ribociclib accessible at lower costs to the patient. “While the government acknowledged the medicine’s effectiveness, it refused to issue a government use licence, stating that breast cancer did not constitute a matter of national urgency,” says the report.Section 100 empowers the Union government to ensure public access to critical health inventions. It allows “domestic production”, meaning that generic versions of a drug can be produced on the government’s orders, be they patented or those for which patent is pending. The patent-holder may be compensated if the government decides to make a drug accessible.According to the letter, generic production can reduce the price of a drug by 90-95%, yet the government declined to intervene, and the woman whose primary plea in the Kerala high court was for the government to use Section 100 to help those combatting the disease, has 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. 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 courts, it says.The letter says the top court – the chief justice himself – should intervene to ensure the matter is finally heard and disposed of: “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,” it says.The next hearing – the 58th in the case – is next week, on July 15. The matter has been adjourned 40 times.This article was republished from The Wire. Read the original article here.