Why Keytruda and other cancer drugs are missing from NLEM

Summary

Pembrolizumab, sold under the brand name Keytruda, is one of the world’s best-selling cancer therapies that has transformed care in 22 different types of malignancies and ibrutinib, a drug launched first in the US in 2013 – has revolutionised treatment of certain aggressive forms of blood cancers. The group argues that India's current list, notified in 2022, has not kept pace with two subsequent revisions made by the WHO in 2023 and 2025. The WHO's 2025 Model List now includes 523 medicines, while India's 2022 NLEM contains 384 medicines, leaving a substantial gap between global recommendations and the country's current list. In its representation, the Working Group has argued that the prolonged delay in revising the NLEM has far-reaching consequences beyond public health policy. At the same time, patients seeking treatment in the private sector continue to face high out-of-pocket expenses for medicines that are considered essential globally but remain outside India's list. The group stressed that although the NLEM must reflect India's own public health priorities, the latest WHO recommendations include medicines that have become indispensable in treating major non-communicable diseases such as cancer and diabetes. It cites repeated Supreme Court rulings affirming that the right to life under Article 21 of the Constitution encompasses the right to health and access to medical treatment. In that context, the experts contend that the continued failure to update the NLEM is more than an administrative delay and could amount to a denial of a fundamental right. The Working Group has also linked the revision to India's international commitments, particularly Sustainable Development Goal 3, which seeks to ensure healthy lives and promote well-being for all. They have urged that the updated list should be based on the latest scientific evidence, India's disease burden and the WHO Model List, ensuring that patients are not left behind as newer, more effective therapies become global standards of care.