Kerala’s SMA Drug Controversy: Branded vs Generic Treatment

A bold public health initiative in Kerala to provide free treatment for Spinal Muscular Atrophy (SMA) has triggered an intense political and medical debate. SMA is a rare, life-threatening genetic condition that gradually weakens muscles, severely impairing movement and breathing. While a complete cure remains out of reach, targeted therapies have completely changed the outlook for affected families, offering hope where few options once existed.

The core dispute kicked off after the state government decided to transition its publicly funded SMA care program from the expensive, branded medication Evrysdi (Risdiplam)—made by Roche Pharmaceuticals—to a much cheaper generic alternative called Natsmart. Public health officials defend the switch as a necessary financial move to keep free treatment alive for a growing pool of patients. However, families, advocacy groups, and political opposition parties have raised urgent concerns over drug safety, effectiveness, and a clumsy labeling error that surfaced during distribution at a state-run rare diseases center.

The Financial Strain of Treating Spinal Muscular Atrophy

Spinal Muscular Atrophy requires lifelong medical intervention. Risdiplam acts as a critical oral treatment that slows motor degeneration, helps physical milestones, and stabilizes breathing. When launched in India in July 2021, its steep price kept it far out of reach for average families. Kerala stepped in during 2022 as a pioneering welfare state, providing the drug for free through facilities like the SMA clinic at SAT Hospital in Thiruvananthapuram.

Initially restricted to children under 12, the program expanded in 2026 to cover genetically confirmed SMA Type 2 patients up to age 25, backed by a ₹30 crore budget. Yet, the economics of the program quickly strained state resources. Roche’s Evrysdi historically cost up to ₹6.3 lakh per bottle (later negotiated down to ₹5.4 lakh), requiring an annual state commitment of roughly ₹25 crore for 2,500 bottles. Because a single bottle lasts only about 12 days, maintaining a single patient on the branded drug runs to a staggering ₹60 to ₹70 lakh annually.

Following a landmark Delhi High Court verdict supporting generic drug manufacturing and subsequent approval by the Central Drugs Standard Control Organisation (CDSCO), Natco Pharma introduced Natsmart at a dramatically reduced price of ₹15,900 per bottle. A technical experts committee evaluated the alternative, leading the Kerala government to approve the procurement switch in February 2026 to keep the life-saving program financially afloat.

Understanding the Science: Branded vs. Generic Risdiplam

Moving from a patented medication to a generic equivalent comes down to established pharmaceutical standards and regulatory oversight. Bioavailability measures how quickly and fully an active pharmaceutical ingredient enters the bloodstream. Usually, introducing a generic requires running human bioequivalence studies to prove it works identically to the reference branded product.

However, public health experts emphasize that the World Health Organization (WHO) and international regulators allow formal in-vivo bioequivalence studies to be waived under specific conditions. These biowaivers apply when generic and reference options are pharmaceutical equivalents—meaning oral solutions containing the exact same active ingredient at identical molar concentrations, mixed with compliant ingredients that do not alter how the body absorbs the drug. Both Evrysdi and Natsmart contain Risdiplam, which works by modifying the splicing of survival motor neuron 2 (SMN2) pre-mRNA to boost functional protein production.

The CDSCO approved Natsmart after determining that a standalone bioequivalence study was unnecessary for this specific oral solution format. Public health authorities argue that regulatory approval is the benchmark for safety in public procurement, especially since premier teaching institutions across the country have adopted the generic formulation without seeing adverse clinical drops in patient serum levels.

The Real-World Impact on Families and Advocacy Groups

For families managing chronic childhood illnesses, drug costs represent an existential crisis. The tension in Kerala highlights the difficult balancing act public health administrators face between keeping budgets sustainable and giving patients peace of mind. Advocacy groups, including the Cure SMA Foundation of India, argue that a sudden shift to an alternative formulation could risk hard-won motor progress achieved by children stable on the original regimen.

At the same time, medical professionals point out that public health systems must maximize access for the broader population. Without concrete scientific evidence showing inferior safety or effectiveness, denying lower-cost generics could bankrupt state health budgets, ultimately forcing cutbacks in patient enrollment. Competitors and pharmaceutical manufacturers watch these state-level tenders closely, as bulk government purchases threaten high-margin branded monopolies.

Milestones and the Road Ahead

The rollout of Kerala’s SMA management program highlights how rapid policy scaling can run into operational hiccups. Key milestones include:

• July 2021: Roche’s branded Risdiplam (Evrysdi) launches in the Indian commercial market, remaining unaffordable for average households.
• 2022: Kerala becomes the first Indian state to offer free SMA medication, starting distributions for children under 12 at SAT Hospital.
• Early 2026: The state expands eligibility to cover genetically confirmed SMA Type 2 patients up to age 25, backed by an increased ₹30 crore budget.
• February 2026: Following CDSCO clearance and technical review, the government approves the procurement switch to Natco Pharma’s generic Natsmart.
• October 2026: The first batch of generic medicine is dispensed, sparking controversy over packaging labels and prompting immediate administrative clarifications.

Looking ahead, state health authorities plan to build an independent pharmacovigilance registry. This registry will track long-term clinical outcomes, motor milestone retention, and side effects for patients switched to Natsmart, aiming to set a benchmark for other Indian states considering similar generic programs.

Frequently Asked Questions

Why did Kerala switch from the branded SMA drug to a generic?

The state government shifted to Natsmart to manage escalating financial costs. While branded Evrysdi requires up to ₹70 lakh per patient annually, the generic alternative cuts medicine costs to under ₹5 lakh per year, ensuring the state can sustain free treatment for all eligible children.

Are generic SMA drugs safe and legally approved?

Yes. Natsmart received full regulatory approval from the Central Drugs Standard Control Organisation (CDSCO). Public health experts confirm the drug meets pharmaceutical equivalence standards and does not require a new bioequivalence study under established WHO guidelines for identical oral solutions.

Why did the dispensed medicine bottles have a clinical trial label?

Hospital authorities explained that due to temporary delays in regular government supply chains, they sourced sample bottles directly from Natco. Officials stressed these were standard medication samples rather than active human subjects for experimental clinical trials.

How can families ensure the quality of generic drugs in public hospitals?

Generic drugs procured for public health programs must pass strict quality checks, including batch-testing certificates of analysis (CoA), Good Manufacturing Practice (GMP) compliance audits, and post-market surveillance overseen by drug inspectors.

Sources and further reading

For more detailed coverage and background, read the original report on The Hindu.