Row over SMA drug distribution in Keralam unwarranted, say experts

The row over the distribution of “experimental drug” meant for “clinical trials” to spinal muscular atrophy (SMA) patients assumed political dimensions in the State, with the Opposition quick to latch on to the issue, demanding that the government assuage the concerns of the parents.

All hell broke loose on Tuesday, with parents of SMA children claiming that the SMA drug given free of cost at the SMA clinic in SAT Hospital was an “experimental drug” as the marking on the carton said “physicians’ samples/ for clinical trials only.”

Leader of the Opposition Pinarayi Vijayan expressed concern whether “the sick children were being treated like mere guinea pigs” as well as shock at the Health Minister’s “criminal negligence.” On Wednesday, senior CPI(M) leader K.K. Shailaja too said the government cannot “change the drug just like that merely because it is cheaper.”

However, the fact remains that the decision to shift to the generic version of SMA drug had been taken during the previous government so that uninterrupted supply of the drug can be ensured. The purchase processes were initiated in February 2026 itself.

SAT Hospital authorities had clarified on Tuesday itself that no “experimental drug” was being given to children and that only the generic version of the original molecule, approved by the Central Drugs Standards Control Organisation (CDSCO) was given to the patients.

“We had a shortfall in the supply of the drug. On Monday, rather than send SMA patients away, we procured some samples of the generic version from Natco and distributed it. There is no change in the drug and the scaremongering about “experimental drugs” is unnecessary,” sources at SAT Hospital said.

“No experimental drug was given to SMA children. What was given was the generic version of Risdiplam, the patented original formula by Roche, now manufactured by the Indian firm Natco Pharma and which has been approved by drug regulatory bodies in the country. The drug is priced at 97% less cost than its patented version and makes it possible for the government to give the drug free of cost to more patients,” a hospital statement said.

On Wednesday, SAT Hospital authorities said they too back the physician samples. “We received the government supply on Tuesday evening and, hence, we opted to replace the drug,” Superintendent of SAT I. Riaz said.

SAT Hospital has been running an SMA clinic since 2022. At the time, Roche Pharma was the only firm licensed to produce and market the drug Risdiplam for SMA. The cost of one 60 ml bottle was ₹6.3 lakh.

Keralam is the only State to utilise public funds for providing free SMA treatment to children. With more children being identified with the disease and getting registered for free treatment, sustaining the free drug supply was becoming a problem.

It was in 2025, after the patent period of Risdiplam expired, Natco obtained the licence of the Drugs Control General of India to manufacture the generic version of Risdiplam. The generic drug is priced at ₹15,900 a bottle.

According to the National Policy for Rare Diseases (2021), manufacturing and licensing of drugs for rare diseases by Indian pharma firms is an important objective so that the precious medication can be accessible to more patients at a lower cost.

“The generic version has all regulatory approvals and is being used by all premier medical institutions in the country to treat SMA patients. Keralam cannot continue to procure the original molecule at high prices when an approved generic formulation is available at a fraction of the price. The government’s decision to embrace generics is a patient-centric move and it is highly commendable because it prioritises equitable access to life-saving drugs over vested commercial interests,” public health expert B. Ekbal said.

IMA representative N. Sulphi, too, pointed out that the controversy was nothing but a fallout of the rivalries between two pharma firms.

Health Minister K. Muraleedharan said the generic version of Risdiplam had been approved by an expert committee and that any concerns about the quality or efficacy of the drug were misplaced. The government’s only intention was to make the drug accessible to more patients, he said.