KeytrudaJeffrey Hamilton

Missing key cancer drugs in national medicine list spark call for urgent overhaul

A coalition of health experts has asked the Union government to urgently revise the NLEM. They say the delay is restricting affordable access to newer essential cancer and biological therapies.

by · India Today

In Short

  • India's 2022 essential medicines list trails WHO revisions from 2023 and 2025
  • Seventeen cancer medicines, four supportive drugs and nine antibodies remain omitted
  • Included medicines face government price control and feature in public programmes

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.

Yet, these breakthrough cancer drugs and monoclonal antibody therapies are not included in India's National List of Essential Medicines (NLEM), prompting a fresh demand for an immediate revision of the country's essential drugs list, with public health experts warning that the delay is depriving millions of patients of affordable access to life-saving treatment.

A coalition of health experts under the Working Group on Access to Medicines and Treatments has written to the Union government, urging it to urgently update the NLEM to reflect the latest World Health Organization (WHO) Model List of Essential Medicines.

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 medicines included in the NLEM are also called scheduled drugs, are brought under direct price control by the government and are also included in several public-run health programmes.

Among the most glaring omissions, the group says, are 17 active cancer medicines, four supportive cancer drugs and nine monoclonal antibodies (mAbs) that have become standard treatments for several life-threatening diseases, particularly cancer.

The latest letter by public health specialists says that the missing cancer medicines include abiraterone, dasatinib, erlotinib, everolimus, vinorelbine, nilotinib apart from pembrolizumab and ibrutinib, among others.

Many of these cancer drugs are inhibitively expensive, costing several lakhs per treatment cycle.

A full course of treatment with pembrolizumab, often spanning 18 months, can cost as much as Rs 50 lakh. For some patients, the annual cost of treatment can be as high as Rs 1.2 crore annually.

Many of these drugs have transformed treatment outcomes in cancers such as prostate cancer, chronic myeloid leukaemia, lung cancer and blood cancers by improving survival and reducing disease progression.

Equally significant, experts point to the absence of monoclonal antibodies such as adalimumab, bevacizumab, blinatumomab, emicizumab, pembrolizumab and ustekinumab.

These targeted biological therapies have become integral to the management of cancers as well as autoimmune disorders and rare diseases, offering more precise treatment with better outcomes for many patients.

According to the Working Group, bringing these medicines under the NLEM would not only strengthen public health services but also improve affordability in the private sector, since inclusion in the essential medicines list often paves the way for wider procurement, improved availability and, where applicable, price regulation.

ACCESS AND AFFORDABILITY

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.

It noted that millions of patients have effectively been denied free access to newly recognised essential medicines within the public healthcare system.

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.

The representation also frames the issue as one of constitutional rights. 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. Keeping the NLEM aligned with evolving global evidence, it argues, is central to achieving universal health coverage and reducing inequities in access to treatment.

The experts have therefore called for the government to immediately initiate a transparent, time-bound and conflict-of-interest-free process to revise the NLEM.

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.

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