Published Sep 07, 2026 | 7:05 AM ⚊ Updated Sep 07, 2026 | 7:05 AM
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Synopsis: A four-year legal battle over access to an unaffordable life-saving breast cancer drug is finally approaching its decisive moment in the Kerala High Court—but not without fresh controversy. As the case heads for a final hearing on 9 September, a potentially crucial contradiction in an affidavit filed by India’s drug regulator, CDSCO, has raised serious questions. While the regulator claims that Ribociclib and the cheaper alternative Palbociclib are approved for the same indications, its own records show that Ribociclib has an additional approval for certain high-risk early-stage breast cancer patients—an indication not shown for Palbociclib.
The final chapter of a case that outlived the woman who brought it before the Kerala High Court may finally be near.
When the retired bank employee from Ernakulam moved the court in June 2022, she knew time was not on her side. Diagnosed a year earlier with HER2-negative metastatic breast cancer, she was seeking access to Ribociclib, the drug prescribed by her doctors but priced far beyond her reach.
She died within two months. Her petition, however, remained pending before the court.
The Supreme Court, which took suo motu cognisance of the delay in July, subsequently asked the High Court to dispose of the matter expeditiously.
More than four years later, the case is now headed for a final hearing on 9 September.
But as the proceedings move towards a conclusion, a contradiction in an affidavit filed by the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority for pharmaceuticals, has added a fresh and potentially significant question to the case—whether the court has been presented with an accurate picture of the indications for two crucial breast cancer medicines, Ribociclib and Palbociclib.
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Even as the hearing nears its conclusion, a contradiction in CDSCO’s affidavit filed on 14 August has brought the regulatory status of two widely used breast cancer medicines — Palbociclib and Ribociclib — under scrutiny.
The tables placed before the court by CDSCO show that both medicines are approved for hormone receptor-positive (HR-positive), HER2-negative advanced or metastatic breast cancer.
However, the same affidavit records a separate approval granted in January 2026 for Ribociclib in early-stage breast cancer among patients at a high risk of recurrence.
No corresponding early-stage indication has been shown for palbociclib.
Yet, paragraph 7 of the affidavit states that palbociclib and ribociclib have been approved for the “same indications”.
The discrepancy has assumed significance in the ongoing case over access to affordable breast cancer medicines. The concern is that the statement could create the impression that the less expensive palbociclib can be used in place of ribociclib across all stages of the disease — a proposition not supported by the regulatory information submitted by CDSCO itself.
The Drug Controller General of India (DCGI), the 14th respondent in the case, had earlier submitted that records available with CDSCO showed Palbociclib and Ribociclib had been approved for the same indications.
At the same time, the DCGI distinguished regulatory approval and clinical decision-making.
“However, the question as to whether Palbociclib can be considered therapeutically interchangeable with Ribociclib in the case of a particular patient is a matter for Doctors/Oncologists to decide,” the submission said.
CDSCO, it added, was not in a position to offer an opinion on therapeutic interchangeability between the two molecules merely based on its regulatory approval records.
For patient groups, however, the apparent contradiction in the affidavit is too significant to be brushed aside.
Gargeya Telakapalli, co-ordinator of the Working Group on Access to Medicines and Treatments — a collective of patient advocates, doctors, legal experts and civil society organisations seeking speedy completion of the case — said CDSCO’s records showed an additional indication for ribociclib.
“CDSCO’s own data shows an additional early-stage breast cancer indication for Ribociclib that is not shown for Palbociclib. Yet the affidavit then says the two medicines have been approved for the same indications. This is a serious contradiction,” Telakapalli said.
“A drug regulator has a responsibility to place clear and accurate information before the court, particularly when women’s access to life-saving treatment is at stake. The government must correct the record and act urgently to make Ribociclib and Abemaciclib affordable, including through compulsory licensing where monopoly pricing continues to block access,” he said.
The Regional Cancer Centre (RCC), in its submission on 20 August, presented a more nuanced picture, particularly regarding advanced disease.
It pointed out that CDK4/6 inhibitors used in combination with endocrine therapy form the standard first-line approach for stage IV hormone receptor-positive breast cancer. Palbociclib, Ribociclib and Abemaciclib are the three available medicines in this class.
RCC said clinical trial evidence shows broadly similar progression-free survival among the three drugs, although their toxicity profiles differ. All three, therefore, can be reasonable treatment options, with the final choice depending on individual patient and treatment-related factors.
But the argument took a sharper turn during the hearing on Thursday, 3 September.
Maitreyi Sachidananda Hegde, the amicus curiae in the case, told the court that Palbociclib could be used only in advanced cases of breast cancer. At the same time, Ribociclib and Abemaciclib were being administered across stages of the disease.
According to her submission, the difference in the scope of their use means Palbociclib cannot simply be treated as interchangeable with the other two medicines.
The competing submissions have now placed the controversy squarely before the court. While doctors may choose among the three CDK4/6 inhibitors in certain cases of advanced breast cancer, the regulatory record itself points to a wider approved use for Ribociclib.
That distinction, subject experts point out, could prove crucial in a case centred on affordability and access.
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Meanwhile, the Kerala High Court on Thursday directed the Central Government Counsel to ensure that two premier cancer institutions — the National Cancer Institute, Jhajjar, and the Chittaranjan National Cancer Institute, Kolkata — submit their opinions in an ongoing case concerning the treatment of HER2-negative metastatic breast cancer.
The court has been examining a key dispute over whether Ribociclib and Palbociclib, two medicines used in the treatment of certain forms of advanced breast cancer, can be considered alternatives to each other.
The issue arose from submissions made by the amicus curiae, who pointed out that Ribociclib, manufactured by Novartis AG, was an expensive medicine, costing patients around ₹58,000 or more per month when the writ petition was filed in 2022.
However, it was submitted on the other side that Palbociclib, originally manufactured under patent by M/s Pfizer Products India Pvt Ltd, had subsequently gone off patent. Several companies now manufacture the drug in India, and it is available at a considerably lower price.
The crucial question before the court, however, was whether Palbociclib could be used for treating the condition that forms the subject of the writ petition — HER2-negative metastatic breast cancer.
The amicus curiae said the molecules in the two medicines are different and their clinical and toxicological profiles also vary, making them non-interchangeable. Novartis AG, however, disputed this contention, maintaining that Ribociclib and Palbociclib are different molecules used for treating the same category of breast cancer.
Against this backdrop, the High Court, in its order dated 15 July, sought the views of the National Cancer Institute, Jhajjar; Chittaranjan National Cancer Institute, Kolkata; Regional Cancer Centre, Thiruvananthapuram; and the Drug Controller General of India.
While the RCC has submitted a report dated 20 August, the court took note of the affidavit of the Drug Controller General of India in its 21 August order.
The opinions of the National Cancer Institute and the Chittaranjan National Cancer Institute are still awaited.
When the matter came up on Thursday, the court asked the Central Government Counsel to liaise with the two institutions and ensure that their affidavits or reports are placed before the court ahead of the next hearing on 9 September.
The views of the two premier cancer institutions are expected to carry weight as the court considers whether the less expensive Palbociclib can serve as an alternative to Ribociclib.
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With the Supreme Court ordering an expeditious hearing, the Kerala High Court on Thursday rejected requests to adjourn the matter.
The development came as the case moved closer to final hearing, even as two institutions are yet to place their opinions before the court.
The High Court was considering adjournment requests made by parties to the case.
P Sreekumar, Additional Solicitor General of India, sought time citing a medical consultation.
Another request was made on behalf of the additional eighth respondent, Eli Lilly Company (India) Pvt Ltd, the manufacturer of the cancer medicine, with counsel P Arun Kumar submitting that he hails from Delhi and is not fit to travel.
But the court refused to grant further time.
Taking note of the urgency of the matter and the Supreme Court’s order of 24 August, the High Court said it was not in a position to accept the adjournment requests.
The matter has now been posted for final hearing and disposal on 9 September.
The adjournment requests came against the backdrop of mounting concern over the extraordinary delay in deciding the petition.
Earlier, the Collective Working Group on Access to Medicines and Treatment has urged Kerala Chief Justice Soumen Sen to ensure an early conclusion of the proceedings, pointing out that patients in urgent need of the medicine could not afford to wait indefinitely.
According to data compiled by the group, the case has been listed 58 times since the petition was filed. On 40 occasions, it was adjourned without a final hearing. During this period, the matter has come before eight different High Court judges.
Days before the 15 July hearing, the Working Group had submitted a representation to the Chief Justice, highlighting the prolonged pendency. The representation said the writ petition had been listed for final hearing 57 times since January 21, 2023, but had never been conclusively heard.
The Supreme Court took suo motu cognisance of the issue on 16 July and called for a speedy hearing. The apex court subsequently issued an order on 24 August, adding further urgency to the proceedings.
The question is whether the final hearing will finally bring the curtain down on a case that has travelled through dozens of listings and eight judges — while patients waiting for access to the medicine continue to watch from the sidelines.
(Edited by Majnu Babu).
