For nearly a year, 49-year-old Kerala lawyer Majida MA has started her mornings with a phone call from a friend - a reminder to take the medicine that keeps her alive. After breakfast, she takes three tablets of palbociclib, sold as Kryxana in India and Kisqali globally, and then works from home because she cannot sit at her desk for long. The drug's side-effects are brutal - bone pain that makes it air-conditioned, nausea, mood swings, sometimes hair fall, body ache and some discolouration.
The tablets come with a cost that is harder to ignore. Each strip of seven costs about Rs 25,000. She needs three strips a month, around Rs 75,000-80,000 - a large part of her income as a practising lawyer. "How can I manage to spend Rs 80,000 every month just for the medicine?" she asks. Hospitalisation, chemotherapy, tests and doctor consultations are extra.
Majida's case was first filed in 2022 by a 30-year-old milk bank employee who has since died. The Kerala High Court, which has since converted it into a Public Interest Litigation, registered a suo motu petition and directed the High Court to resolve the matter expeditiously. At the heart of the case is that both legal and medical: How can patients gain access to an effective cancer treatment when the patented drug is prohibitively expensive?
The petition seeks provisions under the Patents Act that allow government to grant a compulsory licence or authorize a generic manufacturer to make the drug accessible as a national emergency.
Dr Arathi PM, faculty at the School of Indian Legal Thought of Mahatma Gandhi University, says after her friend Majida joined it, “While looking into medicines for breast cancer, we saw that even after developing new therapies, if you look at the turnover of companies holding the patent for such drugs, they are making huge profits while patients are unable to access them.”
The medical question: The current debate before the court is whether palbociclib could instead be treated with another drug in the same class - abemaciclib. Both are CDK4/6 inhibitors. They block proteins called cyclin-dependent kinases 4 and 6, which play an important role in growth and division of cancer cells. But being in same class doesn't make them interchangeable, doctors say.
Dr Rajiv Sarin, former director of Advanced Centre for Treatment, Research and Education in Cancer, says the choice is made in the interest of the individual patient. "Ribociclib and palbociclib are both the same CDK4/6 inhibitor... but they should not be considered automatically interchangeable," he says. Different clinical trials, different toxicity, different dose.
The distinction matters because breast cancer is not one disease. With 2.27 lakh cases and more than 96,000 reported in GLOBOCAN, HR-positive/HER2-negative - fuelled by hormones such as estrogen or progesterone but not have unusually high levels of the HER2 protein - is the most common. But oncologists point out that does not mean every patient with HR-positive HER2-negative disease requires a CDK4/6 inhibitor. Roughly 70% of breast cancers, this does not mean every patient needs it - only carefully defined high-risk early-stage cases, particularly those with advanced stage at diagnosis.
For patients who do need these medicines, availability of cheaper alternatives matters. Patents have improved substantially, particularly after availability of generic palbociclib, which has significantly brought down price to less than innovative product, says Dr Shankar.
But even a lower price remains unaffordable for months and years. "Long-term monthly treatment is simply not possible with the existing cost for many Indian families, especially when treatment is predominantly out of pocket," he says.
That is the reality Majida is confronting. She says her life scope for her is simply to survive - trying to maintain her legal practice while undergoing treatment and taking three tablets every morning. "I don't want to give up," she says. The question is not just medical. It is whether privilege, not prescription, decides who lives.