What Happened
- Pembrolizumab (brand name Keytruda), a first-in-class cancer immunotherapy drug made by US pharmaceutical company MSD (Merck Sharp & Dohme), has become a significant subject of public policy debate in India given its expanding clinical approvals and severe affordability gap
- The Drug Controller General of India (DCGI) has approved Keytruda for 14 indications across 8 types of cancers in India, including triple-negative breast cancer, renal cell carcinoma, cervical cancer, head and neck cancer, and non-small cell lung cancer
- A single dose (100 mg vial) of Keytruda costs approximately ₹2–4 lakh in India; full treatment courses run into tens of lakhs of rupees, making it inaccessible to the vast majority of Indian patients without insurance
- A WHO Medical Product Alert (November 2024) warned of falsified Keytruda products circulating globally, including in markets supplying India, raising additional safety concerns
- Indian pharmaceutical companies including Biocon, Dr. Reddy's Laboratories, and Cipla are developing biosimilar versions of pembrolizumab, with patents on the original molecule expected to expire between 2028 and 2030
- The Keytruda access question sits at the intersection of three major policy debates: cancer drug pricing, intellectual property under TRIPS, and India's capacity for compulsory licensing of life-saving medicines
Static Topic Bridges
PD-1/PD-L1 Checkpoint Inhibitors — How Immunotherapy Works
Traditional cancer treatments (surgery, chemotherapy, radiation) directly attack tumour cells. Immunotherapy works differently: it removes the "brakes" that cancer cells apply to the immune system. Cancer cells express a protein called PD-L1 (Programmed Death-Ligand 1) that binds to PD-1 receptors on T-cells (immune system's killer cells), signalling them to stand down. Pembrolizumab is a humanised monoclonal antibody that blocks the PD-1 receptor, preventing cancer cells from suppressing T-cells and allowing the immune system to identify and destroy tumours.
- Pembrolizumab is a PD-1 inhibitor; other checkpoint inhibitors include PD-L1 inhibitors (atezolizumab) and CTLA-4 inhibitors (ipilimumab)
- It is classified as a "biologic" — a large-molecule drug derived from living cells, not a small chemical molecule like aspirin
- First FDA approval: 2014, for advanced melanoma; now has 40+ FDA approvals across cancer types — the most of any cancer drug in history
- Works best in tumours with high "tumour mutational burden" (TMB) or high microsatellite instability (MSI-H), which can be tested via biomarkers
- Side effects include immune-related adverse events (irAEs) — the drug can inadvertently activate the immune system against healthy tissues
Connection to this news: Understanding the PD-1 mechanism is essential context for why Keytruda is called a "paradigm shift" in oncology and why it commands such high pricing — its mechanism of action is fundamentally different from (and often more effective and less toxic than) conventional chemotherapy.
TRIPS Agreement, Doha Declaration, and Compulsory Licensing
The WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS, 1994) requires member countries to grant 20-year product patents on pharmaceutical inventions. This gives drug companies monopoly pricing power. The 2001 Doha Declaration on TRIPS and Public Health reaffirmed that member states have the right to use TRIPS flexibilities — including compulsory licensing — to protect public health and ensure access to medicines for all. Under a compulsory licence, a government can authorise a domestic manufacturer to produce a patented drug without the patent holder's consent, subject to compensation.
- India used compulsory licensing for the first time in 2012: the Controller General of Patents granted Natco Pharma a compulsory licence to manufacture generic sorafenib (Nexavar) for liver and kidney cancer at 3% of the originator price
- Section 84 of the Indian Patents Act, 1970 allows compulsory licensing if: (a) reasonable requirements of the public are not met; (b) the drug is not available at a reasonably affordable price; or (c) the patented invention is not worked in India
- Section 3(d) of the Indian Patents Act prevents "evergreening" — the patenting of new forms of known substances without demonstrating enhanced efficacy; this is a uniquely Indian provision that has helped prevent some pharmaceutical monopoly extensions
- Keytruda's patents (covering the molecule, formulation, and manufacturing processes) are held by Merck until approximately 2028–2030; biosimilar entry post-patent expiry could reduce prices by 60–80%
Connection to this news: The affordability of Keytruda in India directly raises the question of whether Section 84 compulsory licensing grounds are met — a policy decision that would trigger significant diplomatic and commercial pressure from the US but could transform access to immunotherapy for Indian cancer patients.
India's Cancer Burden and Health Policy Gaps
India carries approximately 14 lakh (1.4 million) new cancer cases annually, with cervical, breast, oral cavity, lung, and colorectal cancers being the most common. The National Cancer Control Programme and the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) form the policy backbone, but public health spending on oncology remains severely inadequate. Out-of-pocket expenditure in India accounts for over 60% of total health spending, making catastrophic health expenditure from cancer treatment a major driver of poverty.
- India's cancer incidence expected to reach 15.7 lakh by 2026 (ICMR projection)
- Cervical cancer, largely preventable through HPV vaccination, remains the second most common cancer in Indian women; the national HPV vaccination programme was launched only in 2023
- Ayushman Bharat–Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) covers cancer treatment, but expensive immunotherapy drugs like Keytruda are generally not included in its package rates
- The National List of Essential Medicines (NLEM) does not currently include pembrolizumab; inclusion could trigger price regulation under the Drug Price Control Order
- The PM Rashtriya Swasthya Suraksha Mission aims to expand AIIMS-level oncology care but does not address drug pricing directly
Connection to this news: The Keytruda debate crystallises the structural failure of India's health financing and drug access policy to keep pace with oncological innovation — a Mains-relevant policy gap between what is medically possible and what is economically accessible to ordinary Indians.
Biosimilars and India's Pharmaceutical Sector
A biosimilar is a biological product that is highly similar to an already-approved biologic (the "reference product") and has no clinically meaningful differences in terms of safety and efficacy. Unlike generic small-molecule drugs (which are identical to the original), biosimilars require complex manufacturing and clinical data packages for regulatory approval. India is one of the world's largest biosimilar producers and exporters.
- India's biosimilars regulatory framework is governed by the "Guidelines on Similar Biologics" (2012, revised 2016) issued by CDSCO (Central Drugs Standard Control Organisation)
- Biocon's biosimilar trastuzumab (for breast cancer) — branded as Canmab — has been available in India since 2014 and globally; it reduced HER2+ breast cancer treatment costs by 80%
- Cipla, Dr. Reddy's Labs, and Biocon are all building pembrolizumab biosimilar pipelines for post-2028 market entry
- The global biosimilars market is expected to reach $100 billion by 2030; India aims to capture a significant share through its pharmaceutical manufacturing competitiveness
- WHO's prequalification of Indian biosimilars enhances their access in low-and-middle-income countries through procurement programmes
Connection to this news: India's wait for pembrolizumab biosimilars (2028–2030) represents the medium-term access pathway; the near-term policy debate is whether compulsory licensing or government procurement negotiations can bridge the gap for patients who cannot wait.
Key Facts & Data
- Pembrolizumab brand name: Keytruda; manufactured by MSD (Merck Sharp & Dohme, US)
- Mechanism: PD-1 inhibitor (monoclonal antibody blocking PD-1/PD-L1 pathway)
- First FDA approval: 2014 (advanced melanoma); now 40+ FDA approvals across cancer types
- DCGI approvals in India: 14 indications across 8 cancer types (as of 2025–26)
- Cost in India: ~₹2–4 lakh per dose (100 mg vial); full course costs tens of lakhs
- India's first compulsory licence: 2012 (Natco vs. Bayer for sorafenib/Nexavar)
- Section 84, Indian Patents Act 1970: compulsory licensing provision
- Section 3(d), Indian Patents Act: anti-evergreening provision (unique to India)
- Pembrolizumab patent expiry: approximately 2028–2030
- India's annual cancer incidence: ~14 lakh new cases (ICMR estimate)
- WHO alert on falsified Keytruda products: November 2024