Oncologist and recipient of the Magseys Award, Dr. Ravi Kannan, expressed an opinion that diverges from the government's statement regarding the possibility of using generic palbociclib as an alternative to patented drugs in the same class for breast cancer treatment. Dr. Kannan explained that these medications are not interchangeable.
He noted that ribociclib is effective in early-stage breast cancer, helping to reduce relapses and improve overall survival. In contrast, trials of palbociclib showed that it plays no role in treating early-stage breast cancer.
Dr. Kannan, who is the director of the Chakar Hospital and Cancer Research Center in Silchar, a non-profit organization providing free cancer treatment, presented his conclusion in a case before the Kerala High Court. The case was initiated by a patient seeking access to expensive patented breast cancer drugs. After the patient's death, the court took up the matter ex officio in the public interest. The issue concerned the most common subtype of breast cancer—hormone receptor-positive tumors with negative HER2 status.
The petition required obtaining a license for state use under Section 100 of the Patent Act to ensure access to the patented drug ribociclib at affordable prices. However, the government refused to grant such a license, arguing that breast cancer is not a matter of national emergency, and citing statements from the National Institute of Cancer in Jajjar and the Chittaranjan National Cancer Institute in Kolkata that generic palbociclib could be used instead of ribociclib.
In Dr. Kannan's letter, it was pointed out that although palbociclib, abemaciclib, and ribociclib are CDK4/6 inhibitors, they 'cannot be interchanged in adjuvant treatment of early-stage breast cancer.' He referred to a study that demonstrated that adding abemaciclib to endocrine therapy significantly reduced relapses, and seven-year follow-up showed significant disease-free survival and improved overall survival. He also mentioned studies showing that taking ribociclib for three years along with a nonsteroidal aromatase inhibitor, a type of hormonal therapy used to treat hormone receptor-positive breast cancer, substantially improved outcomes. This study revealed a significant improvement in disease-free survival and a reduction in cancer recurrence in distant parts of the body.
Furthermore, he added that two large studies showed that palbociclib did not demonstrate similar benefits in early-stage breast cancer. Citing trial results, Dr. Kannan stated that approving the generic palbociclib in India should not be viewed as granting an equivalent adjuvant option. The letter emphasized: 'Clinicians must use evidence-based drugs—abemaciclib or ribociclib—when indicated for high-risk patients in the early stages, as palbociclib adjuvant trials have shown no benefit.'
He pointed out that the high cost of abemaciclib and ribociclib means that a huge number of high-risk patients who could benefit from these drugs simply cannot afford them. Ribociclib costs over 78,400 rupees per month, and Abemaciclib ranges from 47,700 to 95,500 rupees per month.
Dr. Kannan added that 'historically, generic availability has been the most reliable lever for expanding access to targeted cancer therapy in resource-constrained settings, and there is no clinical reason to expect abemaciclib and ribociclib to be an exception.' He concluded that only a substantial reduction in prices will allow the vital benefits of these drugs to reach a wide range of high-risk patients in India.
The latest affidavit submitted on August 14 by the Central Drugs Standard Control Organization (CDSCO), India's top pharmaceutical regulator, includes tables showing that palbociclib and ribociclib are approved for metastatic or advanced breast cancer with positive hormones and negative HER2. However, this affidavit also records a separate approval of ribociclib for early-stage breast cancer in January 2026 for high-risk relapse patients. Gwargeya Telakapalli, coordinator of the Working Group on Access to Medicines and Treatments, noted: 'The CDSCO data itself shows an additional indication for early-stage breast cancer for ribociclib, which is absent for palbociclib. Nevertheless, the affidavit states that both drugs are approved for the same indications. This is a serious contradiction. The drug regulator is responsible for presenting clear and accurate information to the court, especially when women's access to life-saving treatment is at stake.'
Jotsna Singh, co-chair of the Working Group, stated: 'Nearly one hundred thousand women die from breast cancer every year. If this is not a public health emergency, then what is it? This case has been ongoing since 2022. The woman who first approached the court died before she could receive the necessary medication. Many other women have died while this case was pending. The government cannot continue to treat access to breast cancer drugs as a routine price dispute. Women need the best available treatment when it can still save their lives.'