The row over medicines given to children with spinal muscular atrophy in Kerala took a sharp political turn on Tuesday, with former chief minister Pinarayi Vijayan demanding strict action over reports that experimental drugs were administered without the knowledge of their parents.
Vijayan, who now leads the opposition in the state, said in a statement that he was shocked by what had come to light and called for a full investigation into who was responsible. He accused the state health department of a blatant violation of the Drugs and Cosmetics Act and its storage rules.
Parents allege trial-marked medicines
The controversy began with complaints from parents of children being treated at the Sree Avittom Thirunal (SAT) Hospital in Thiruvananthapuram. According to news reports cited by Vijayan, the medicines distributed to the children carried markings such as “Physician Sample” and “For Clinical Trials Only”.
For parents already living with the daily strain of a rare, degenerative disease in their children, the discovery raised an immediate and frightening question: were the drugs being given to their children part of an experiment rather than a proven treatment?
Vijayan put the same question directly to the government. He asked whether children suffering from serious diseases were being turned into test subjects, and whether the medicines had been distributed without the informed consent of parents, something he said could not be taken lightly.
Minister points to old circular
Health Minister K Muraleedharan, responding to reporters earlier in the day, said the distribution had been carried out according to a circular issued by the previous government. He suggested that more details could be obtained from Dr Mini at SAT Hospital, who he described as the expert on the matter.
“The minister may not know about every medicine,” Muraleedharan added, a remark that did little to calm the storm.
The larger battle: patented drug vs generic
Behind Tuesday’s allegations sits a larger dispute over how Kerala treats its SMA patients. Since 2021, the state has been distributing Risdiplam, a patented medicine made by Roche Pharma, free of cost to children with the disease. The drug is expensive: a single bottle costs around Rs 5.4 lakh. The previous Left Democratic Front government negotiated the procurement price down to roughly Rs 1 to 1.25 lakh a bottle, and about 118 children have received the medicine under the scheme, which covers patients up to the age of 12 until they turn 25.
The current state government recently ordered the purchase of a generic version of the drug, manufactured by Natco Pharma, at a price said to be 97 percent lower than the patented version. Officials say the move is meant to widen access to the medicine for more patients.
Parents and the Cure SMA Foundation of India, an advocacy body for those affected by the condition, are not convinced. They argue that the safety and effectiveness of the generic version have not been properly established. Human bioequivalence studies and long-term efficacy data in SMA patients are not yet available, they say, and for a progressive disease where lost motor function cannot be regained, a switch in medication carries the real risk of a child’s condition slipping backwards.
Vijayan’s earlier letter to the health minister had also asked the government to reconsider its decision to reduce a Rs 30 crore fund sanctioned during the previous government’s tenure for the free drug distribution scheme. Parents, in a separate push, recently met both Vijayan and Industries Minister P K Kunhalikutty to seek political support for their demand that the current treatment continue until the generic’s safety is proven.
FAQs
- What is SMA? Spinal muscular atrophy is a rare genetic disorder that weakens muscles over time by damaging motor neurons in the spinal cord. In its severe forms it can be fatal, and treatment needs to begin and continue consistently.
- What have the parents alleged? Parents of children treated at Thiruvananthapuram’s SAT Hospital say the medicines given to their children were marked “Physician Sample” and “For Clinical Trials Only”, raising fears the drugs were experimental.
- What is the government’s position? Health Minister K Muraleedharan has said the distribution followed a circular issued by the previous government and pointed to experts at SAT Hospital for details.
- Why is the generic drug an issue? The state is switching from patented Risdiplam, costing about Rs 5.4 lakh a bottle, to a Natco Pharma generic that is 97 percent cheaper. Parents and advocacy groups say bioequivalence and long-term safety data for the generic are not yet available.
- What happens next? The opposition has demanded an investigation and strict action against those responsible. The government has not yet announced any inquiry.
For the families at the centre of this row, the politics matters less than the medicine. What they want is an assurance that the drug their children take is safe, tested and working, and they are unlikely to be satisfied until that question is answered in full.
