Kerala at Crossroads: Generic vs Patented SMA Drug Sparks Debate on Public Health Policy

Kerala, the only Indian state providing free treatment for Spinal Muscular Atrophy (SMA) through public funds, is facing a contentious policy decision: whether to continue procuring the expensive patented drug Risdiplam or switch to a far cheaper generic version approved by national regulators.

SMA is a rare genetic disorder that destroys motor neurons, leading to muscle weakness, severe disability, and often premature death. Since 2021, Kerala has been purchasing Risdiplam, manufactured by Roche, at a negotiated price of about ₹1–1.25 lakh per bottle—a significant reduction from its market price of ₹5.4 lakh. The drug is provided free to patients in the state.

However, a generic version of Risdiplam, named Risdinat and produced by Natco Pharma, has received marketing approval from Indian drug regulatory authorities. Priced at ₹15,900 per bottle—roughly 97% less than the patented version—it offers the potential to dramatically expand access. The state government is now considering procuring the generic to treat more SMA patients and redirect savings to other rare diseases.

Patient advocacy groups, such as Cure SMA, have raised concerns. They argue that the generic has not undergone separate clinical trials and question its efficacy. They urge the government to continue supplying the patented molecule until the generic's effectiveness is proven.

Public health experts and doctors counter that regulatory approval should guide procurement. “Generic medicines do not need to repeat clinical trials; they just need to demonstrate bioequivalence,” said a prominent neurologist in Thiruvananthapuram. “The generic drug can make SMA treatment accessible to many more patients.”

A senior health official noted that generics are what make expensive drugs affordable. “The government would be able to procure the generic at even lower prices to sustain treatment for many more SMA patients. We also have other rare diseases to care for with limited resources.”

The debate is unique to Kerala. In the rest of the country, the complaint is that SMA patients lack access to the generic drug. “Kerala cannot continue to procure the original molecule at high prices when an approved generic is available at a fraction of the cost,” said public health expert B. Ekbal. He pointed out that an adult patient weighing over 20 kg requires about 2.5 bottles per month. The cost of one patented bottle could cover nearly three months of generic treatment for an adult.

Ekbal added that newly approved generics accumulate long-term data only after widespread use. “Public procurement policy cannot be based on speculative concerns. In the absence of evidence demonstrating deficiency, continuing to purchase a product costing eight times more is unjustifiable.”

The decision now rests with the Kerala government, which must balance patient anxiety, fiscal responsibility, and the imperative to maximize access to life-saving treatment.