Pinarayi Vijayan questions SMA drug distribution; SAT Hospital says only CDSCO-approved drugs used

Even as the Leader of the Opposition, Pinarayi Vijayan, cried foul that “experimental drugs” meant for “clinical trials” were being distributed to SMA patients, SAT Hospital authorities have clarified that only drugs ratified by the Central Drugs Standards Control Organisation (CDSCO) are being distributed to SMA patients.

Mr. Vijayan, in a statement in Thiruvananthapuram on Tuesday (October 20, 2026), said the negligent stance of the Health Minister was criminal and demanded that the Government conduct an enquiry into the incident.

He said that the parents of SMA patients themselves had pointed out that the medicines distributed through SAT Hospital, Thiruvananthapuram, are marked “Physician Sample” and “For Clinical Trials Only.” and that this is a blatant violation of the Drugs and Cosmetics rules and of all procurement norms. The Health Department cannot evade responsibility for this, Mr. Vijayan said in his statement

However, the SAT Superintendent clarified that the drug distributed in SAT Hospital on Monday was the very same drug that is being given to SMA patients.

“The only difference was that it was the generic version of the patented original formula by Roche, manufactured by 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 statement issued by the SAT hospital said.

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

Kerala 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 Roche’s Risdiplam expired, that the Indian pharma firm, Natco obtained the licence of the Drugs Control General of India to manufacture the generic version of the Risdiplam. The generic drug — Risdinat — 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

“In fact, it was during the time of the previous Left Government that the decision was taken to procure the generic version so that we can ensure uninterrupted supply of the drug . The purchase processes were initiated in February 2026.The drug 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

“We had a shortfall in supply and on Monday, we procured some samples of the generic version from Natco so that the drug supply is uninterrupted. Government supply is expected in a day or two. The drug is the same as always and this is unnecessary scaremongering that “experimental samples” were given to patients,” sources at SAT hospital said.