Pinarayi Vijayan questions distribution of SMA drugs; SAT Hospital says only CDSCO approved drugs are used

Kerala Assembly LoP Pinarayi Vijayan. File | Photo credit: PTI

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

In a statement on Tuesday (October 20, 2026) in Thiruvananthapuram, Mr. Vijayan said the health minister’s careless attitude was criminal and demanded that the government conduct an inquiry into the incident.

He said that parents of SMA patients themselves have pointed out that drugs distributed through SAT Hospital, Thiruvananthapuram are marked as “Doctor’s Sample” and “For Clinical Trials Only”. and that it is a clear violation of the rules for drugs and cosmetics and all public procurement standards. The Health Ministry cannot escape responsibility for this, Mr. Vijayan said in a statement

However, the SAT Superintendent clarified that the medicine distributed at the SAT Hospital on Monday was exactly the same medicine given to SMA patients.

“The only difference was that it was a generic version of Roche’s patented original formula, which is manufactured by Natco pharma and has been approved by the country’s drug regulatory authorities. The price of the drug is 97% lower than its patented version, enabling the government to provide the drug for free to more patients,” the SAT hospital said in a statement.

SAT Hospital has been running an SMA clinic since 2022. At that time, Roche Pharma was the only company licensed to manufacture and sell the SMA drug Risdiplam. The price of one 60 ml bottle was Rs. 6.3 million.

Kerala is the only state that uses public funds to provide free SMA treatment to children. As more children identified with the disease and were registered for free treatment, it became a challenge to maintain the free supply of medicine.

It was in 2025, after the patent term of Roche’s Risdiplam expired, that Indian pharmaceutical firm Natco obtained a license from the Drugs Control General of India to manufacture a generic version of Risdiplam. The generic drug – Risdinat – is priced at ₹15,900 per bottle.

According to the National Policy for Rare Diseases (2021), manufacturing and licensing of rare disease drugs by Indian pharmaceutical firms is an important objective so that rare drugs can be made available 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 could ensure uninterrupted supply of the drug. The procurement processes were initiated in February 2026. The drug has all regulatory approvals and is being used by all the leading healthcare institutions in the country to treat SMA patients. Keralam cannot continue to get the approved fraction at an affordable price for the original molecule.”

“We were short of supply and on Monday we procured a few samples of the generic version from Natco to ensure uninterrupted supply of the drug. The government supply is expected in a day or two. The drug is the same as always and it is an unnecessary scare that patients were given ‘experimental samples’,” sources at SAT Hospital said.

Published – 20 October 2026 22:09 IST