Kerala will treat children with a cheaper copy of a costly rare-disease drug. The move has sparked a debate on price, safety and trust.
- The disease: spinal muscular atrophy (SMA), a rare genetic illness that weakens muscles.
- The drug: risdiplam. Roche sells it as Evrysdi. Natco sells a generic called Natsmart.
- The price gap: about Rs 5.2 lakh a bottle against Rs 15,900.
- The row: a bottle label and the lack of a separate safety study.
What Happened in Kerala?
The decision
- On 5 July 2026 Kerala decided to buy Natco’s generic risdiplam for its KARE programme. KARE treats 109 children with SMA. (Source: Onmanorama)
- Roche’s Evrysdi costs about Rs 5.2 lakh a bottle. Natsmart was launched at Rs 15,900. (Source: Onmanorama)
- The Kerala High Court let the tender go ahead on 30 September. (Source: Onmanorama)
- The state’s technical committee said no separate safety or efficacy study was needed. A bioequivalence study could still be done. (Source: Onmanorama)
The court background
Roche holds the patent on Evrysdi. Natco argued that the patent lacked novelty. On 9 October 2025 a Delhi High Court bench refused to stop Natco. It weighed the credible challenge and the public need for an affordable drug. (Source: KEI)
This was a court order. It was not a compulsory licence, which is a Government grant under the Patents Act.
Why Is It Being Questioned?
The label row
- According to the hospital superintendent, bottles marked “Physician’s sample/Clinical trials only” had reached six patients at a state hospital. They were taken back after parents objected. (Source: The News Minute) (Source: Onmanorama)
- The superintendent said the labelled bottles were free samples supplied by Natco. (Source: The News Minute)
- On 22 October 2026 former health ministers questioned the switch. Health Minister K Muraleedharan said the drug is safe. (Source: Onmanorama) (Source: The News Minute)
The bioequivalence point
Bioequivalence checks that a generic enters the blood at the same speed and in the same amount as the brand. Natco argues that a plain oral solution with the same ingredient and strength is exempt under WHO guidelines. (Source: Onmanorama)
Why Does It Matter for Exams?
Four ideas to link
- Patents and access: a patent gives the maker a sole right for a time. Courts and the Government can balance it with public need.
- Bioequivalence: the usual proof that a generic works like the brand.
- Compulsory licensing: a Government grant that lets another firm make a patented drug. It is different from a court refusing an injunction.
- DPCO: the Drugs (Prices Control) Order, 2013, which caps the price of scheduled medicines.
The static background is in Essential Medicines in India: NLEM, DPCO and Drug Price Control. It covers generics, patents and price caps in detail.
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