Health activists and public health experts in India are pushing for affordable breast cancer treatments as the Kerala High Court continues to hear a case originally filed in 2022. The case and the surrounding advocacy concern access to the medications ribociclib and abemaciclib – both of which have demonstrated significant benefits for patients with early-stage breast cancer but remain prohibitively expensive for a large part of the population.
Breast cancer represents a true public health crisis in India, noted the Working Group on Access to Medicines and Treatment. In 2024, of the 780,000 new cancer cases among women, breast cancer accounted for 237,000 diagnoses. India also has a notable survival gap compared to other countries: five-year survival stands at 65.7%, compared to 87.3% in high-income countries.
“The price of the treatment is one of the biggest barriers,” the Working Group noted. “Ribociclib costs around 75,000 rupees (approximately USD 786) a month. A three-year course can therefore cost close to 27 lakh rupees (approximately USD 28,300). Abemaciclib costs roughly 48,000–95,000 rupees (approximately USD 500-995) a month. Such prices put these medicines beyond the reach of most families.”
Members of the working group stress that the high cost stems from the treatments’ market positioning. “Ribociclib and abemaciclib remain available mainly as expensive branded medicines and are not routinely available through government support programs,” they point out, with a significant impact on rural and poor patients.
“Nearly 100,000 women are dying of breast cancer every year. If that is not a public health emergency, what is?” asked co-convener of the Working Group Jyotsna Singh. “The woman who first approached the Court died before she could get the medicine she needed. Many more women have died while this case has continued.”
Calls to invoke Patents Act safeguards to ensure treatment accessibility
Activists are urging the Indian government to trigger safeguards under the Indian Patents Act, including compulsory licensing, to expand access to ribociclib and abemaciclib. They say this should be done swiftly and decisively, especially after the Central Drugs Standard Control Organization (CDSCO) submitted a counter affidavit containing contradictory information, adding a new layer of complication.
At one point in the brief, the Working Group warns, CDSCO claims ribociclib is approved for the same indications as palbociclib, a generically available and thus cheaper medicine. While the two are both used in the treatment of advanced cases of cancer, ribociclib has additionally demonstrated notable benefits in early-stage cases. This means the treatment can help prevent cancer cells from returning and becoming metastatic, “when the disease is much harder to cure,” the Working Group pointed out.
The formulation in CDSCO’s submission risks implying the same benefits can be expected from palbociclib. “This is not a minor discrepancy,” the Working Group insists. “It risks misleading the Court into believing that the cheaper palbociclib can replace ribociclib for early-stage breast cancer, when the data placed before the court by CDSCO itself says otherwise.”
“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,” emphasized Gargeya Telakapalli, co-coordinator of the Working Group. “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.”
Read more: India’s newly amended patent rules threaten affordable medicines in the Global South
Renowned oncologist Dr. R. Ravi Kannan, Director of Cachar Cancer Hospital, submitted a court opinion echoing many of these observations and further clarifying the different profiles of palbociclib, ribociclib, and abemaciclib – calling for wider availability of the latter two. “Every advancement that safely reduces recurrence risk is vital,” he wrote, “because each relapse means additional financial burden on the family and risk of poverty, with the loss of cure and a return to only palliative options.”
“Generic entry has historically been the single most reliable lever for expanding access to targeted cancer therapies in resource-limited settings, and there is no clinical reason to expect abemaciclib and ribociclib to be an exception,” he added.
“The government cannot keep treating access to breast cancer medicines as an ordinary pricing dispute,” Singh concluded ahead of the next hearing, scheduled for September 3, 2026. “Women need the best available treatment when it can still save their lives.”
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