A Keralam patient dies, another joins legal battle as breast cancer drug case drags on

Majida Abdul Majeed, 49, a lawyer from Ponnani in Keralam’s Malappuram district, was diagnosed with breast cancer in August 2025. For the past year, she has been undergoing treatment, including regular Zoledronic Acid injections along with Ribociclib, the breast cancer medicine. The treatment costs her family around Rs 80,000 a month.

She has partial insurance coverage and a strong support system of friends and relatives. That has helped her continue treatment through the first year, with the treatment showing good results so far.

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Majida came to know about the litigation over the price and availability of the breast cancer medicine Ribociclib through her legal academic circles. When she learnt that an affected patient could seek impleadment in the case, she decided to join the proceedings.

‘Life-punishing medicine’

The Kerala High Court allowed her application on August 21, making her the second patient with the condition to become part of a case that began in 2022. The original petitioner, who had also been diagnosed with HR-positive, HER2-negative breast cancer and was taking Ribociclib, died while the case was pending. The court then decided to continue the proceedings, recognising that the issue extended beyond the individual petitioner.

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“The price is far beyond what an ordinary person can afford. The reason we have managed to continue with it for so long is because of the support we have received from the people around us. There are many people in this country who do not have that kind of support. For them, this must be an enormous difficulty,” Majida said.

“They call it a life-saving medicine, but for us it sometimes feels like a life-punishing medicine because of the financial burden. Every month is a source of tension. We have to take it for 21 days, then there is a one-week break. During that break, we have to somehow arrange the medicine for the next month. That is the difficulty we face,” she added.

Limited insurance coverage

Majida said the insurance coverage she had was limited but had helped her manage the cost of treatment. The support from friends and others had also made a difference.

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“But when we think about people who do not have the same kind of support, their situation is extremely difficult. When I came to know about the litigation and the work being done by the Third World Network’s International Working Group on Access to Medicines, I decided to do my bit. The organisation has taken care of the legal aspects of the case,” she said.

Ribociclib’s monthly cost

The medicine at the centre of the litigation is Ribociclib, manufactured by Swiss pharmaceutical major Novartis AG. When the original petition was filed in 2022, the monthly cost of the medicine was around Rs 58,000 or more. The price cited before the High Court in July this year was Rs 78,468.75 a month.

The original petition sought directions to the Union government to exercise its powers under Sections 92 and 100 of the Patents Act, 1970. The provisions provide for government intervention in the use of patented inventions under specified circumstances.

Palbociclib as alternative

The government has maintained that there was no necessity to invoke these provisions. It also pointed to Palbociclib as an alternative. Palbociclib, originally patented by Pfizer Products India, has gone off patent and is now manufactured by several companies in India at lower prices.

Whether Palbociclib can actually be used as a substitute for Ribociclib has become one of the key questions before the court.

During the proceedings, the amicus curiae appointed by the court argued that the two medicines were different molecules and had different clinical and toxicological profiles. Counsel for Novartis disputed this and submitted that both medicines were used for the same type of breast cancer.

The court subsequently sought the views of the National Cancer Institute at AIIMS, Jhajjar, Haryana, the Chittaranjan National Cancer Institute in Kolkata, the Regional Cancer Centre in Thiruvananthapuram and the Drug Controller General of India.

Not a minor discrepancy

The Drug Controller General, in an affidavit filed before the court, said that its records showed that Palbociclib and Ribociclib had been approved for the same indications. However, it said it was not in a position to state whether Palbociclib was therapeutically interchangeable with Ribociclib for a particular patient. That, it said, was a matter for doctors and oncologists to decide.

According to the Working Group on Access to Medicines and Treatments, this is not a minor discrepancy. 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 Central Drugs Standard Control Organisation (CDSCO) itself says otherwise.

Litigation since 2022

Gargeya Telakapalli, coordinator of the group, said this contradiction could mislead the court into treating the cheaper Palbociclib as a substitute for Ribociclib in early-stage breast cancer. “Central Drugs Standard Control Organisation’s own data shows an additional early-stage indication for Ribociclib that is not shown for Palbociclib. The government must correct the record and act urgently to make these medicines affordable,” she said.

The court has directed the cancer institutions to provide their specific views on the issue.

The litigation began in June 2022 when the original petitioner approached the High Court seeking access to Ribociclib at an affordable price. After her death, the court decided to continue the case as a matter concerning the pricing of life-saving patented medicines. The case was renamed “In Re Exorbitant Pricing of Life Saving Patented Medicines” and an amicus curiae was appointed.

With at least six government departments and agencies along with pharmaceutical companies, cancer institutions and the drug regulator named as respondents, the case has been adjourned time and again for various reasons, including procedural and bureaucratic delays, even as it concerns access to a life-saving medicine. The case was listed for a special sitting on January 21, 2023, for final hearing. That hearing did not take place following a change in roster and jurisdiction. The case was subsequently listed several times, including for disposal, without a final adjudication. The case has now been listed 59 times and will come up for its 60th listing on September 3.

Eli Lilly and Novartis were impleaded in the proceedings, while the National Cancer Institute, Chittaranjan National Cancer Institute, Regional Cancer Centre and Drug Controller General were later brought into the case for their views on the medical and regulatory questions.

Next hearing on Sept 3

The court's August 21 order also records that the Supreme Court had directed the High Court on July 17 to dispose of the matter expeditiously. The High Court cited that direction, along with the urgency of the matter and Majida's impleadment, while posting the case for September 3.

The case raises questions about the government's powers under patent law when the price of a patented medicine becomes a barrier to treatment. The petition has also brought into the proceedings the question of whether an off-patent medicine available at a lower price can be considered an adequate alternative to the patented drug.

For Majida, the issue is directly connected to her treatment. She has already completed a year of treatment and says the medicine has produced good results. But continuing with it means finding around Rs 80,000 every month. She now enters a case that was started by another woman with the same disease, who did not live long enough to see its outcome.