CURRENT AFFAIRS | MAY 14, 2026
India’s 8.8 million Alzheimer’s patients — a number projected to nearly double to 16.9 million by 2036 — finally have access to a drug that does more than mask symptoms. On May 13, 2026, Eli Lilly India launched Lormalzi (international generic name donanemab), the country’s first disease-modifying therapy for early symptomatic Alzheimer’s disease. A single 350-mg intravenous vial is priced at Rs 91,688, putting the all-in monthly cost at roughly Rs 1 lakh per infusion.
Donanemab is a monoclonal antibody that targets and clears the toxic amyloid-beta plaques believed to drive Alzheimer’s pathology. In the global Phase-3 TRAILBLAZER-ALZ 2 trial of 1,736 patients, donanemab slowed cognitive decline by 35.1% over 76 weeks compared to placebo. The drug was approved by the US FDA in July 2024 as Kisunla, and the Drugs Controller General of India (DCGI) fast-tracked the Indian launch with marketing authorisation issued by CDSCO.
1. Article 21 — Right to Health, derived as part of Right to Life [Bandhua Mukti Morcha v. UoI, 1984; Paschim Banga Khet Mazdoor Samity v. State of WB, 1996].
2. Article 47 (DPSP) — State’s duty to raise level of nutrition and public health.
3. Article 39(e) (DPSP) — Health and strength of workers.
4. Drugs & Cosmetics Act, 1940 + Rules, 1945 — Import, manufacture, distribution and sale of drugs; New Drugs and Clinical Trials Rules, 2019.
5. Patents Act, 1970 as amended in 2005 — Product patents; Section 3(d) bars ‘evergreening’; Section 84 enables compulsory licensing.
6. Pharmacy Act, 1948 & National Medical Commission Act, 2019 — Professional regulation.
7. Mental Healthcare Act, 2017 — Special protections for persons with mental illness (Alzheimer’s is included in scope).
The trial also flagged a serious side-effect — Amyloid-Related Imaging Abnormalities (ARIA), including microhemorrhages and brain swelling, in around 19.7% of patients (mostly asymptomatic). Donanemab is therefore prescribed only after MRI screening and is contraindicated in patients with certain genetic risk factors (ApoE4 homozygotes have higher ARIA risk).
1. Access to medicines + Section 3(d) jurisprudence — Novartis v. Union of India (2013): SC denied patent for Glivec, upholding Section 3(d).
2. Compulsory Licensing — Natco v. Bayer (2012), India’s first CL for cancer drug Nexavar under Section 84 of the Patents Act.
3. Article 21 + WHO Alma-Ata (1978) — Health as a global human right; UDHR Art. 25.
4. Doctrine of Informed Consent — Samira Kohli v. Dr. Prabha Manchanda (2008): SC laid down ‘real consent’ for medical procedures.
5. Consumer Protection Act, 2019 — Medical negligence as a ‘deficiency in service’; Indian Medical Assn v. VP Shantha (1995).
6. Pradhan Mantri Jan Aushadhi Pariyojana & Ayushman Bharat PMJAY — Pharmaceutical access policies.
Cost remains the central question. At Rs 1 lakh per dose, monthly, the 18-month standard course would set patients back over Rs 18 lakh. Eli Lilly has announced an alternative access program, but advocacy groups point out that without inclusion in PMJAY or state insurance, donanemab will remain a drug for the wealthy. The pricing decision also revives India’s familiar tension between incentivising innovation (the TRIPS bargain) and guaranteeing affordable access (Article 21).
– Indian brand: Lormalzi (Eli Lilly India).
– Global brand: Kisunla (US FDA approval, July 2024).
– Mechanism: Anti-amyloid monoclonal antibody.
– Indication: Early symptomatic Alzheimer’s (MCI + mild dementia).
– Dose: 350mg IV infusion, once monthly.
– Price: Rs 91,688 per vial (~Rs 1 lakh all-in).
– Duration: Up to 18 months (not lifelong).
– Trial: TRAILBLAZER-ALZ 2 (1,736 patients).
– Efficacy: 35.1% slowdown of cognitive decline over 76 weeks.
– ARIA side effect: 19.7% (mostly asymptomatic).
– India patient pool: 8.8M (2025), 16.9M by 2036.
– Regulator: CDSCO/DCGI under Drugs & Cosmetics Act, 1940.
For aspirants, the larger thread is this: every blockbuster pharma launch in India is also a story about patent law, price control, federal health policy, and the Right to Health under Article 21. Lormalzi adds two new chapters — disease-modifying therapy for a chronic neurodegenerative condition, and the testing of India’s regulatory ability to fast-track without compromising patient safety.
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