Kerala’s controversy over supplying a lower-cost generic spinal muscular atrophy drug to children has escalated, with three former health ministers of the LDF government demanding scrutiny of the decision and the state hospital administration rejecting an alleged link between a pharmaceutical company’s contribution and the medicine issue.
P K Sreemathy, K K Shailaja and Veena George questioned the state government’s decision to provide Natco Pharma’s generic version of risdiplam to children with spinal muscular atrophy, or SMA. Sreemathy demanded an investigation into what she described as alleged links between Health Minister K Muraleedharan and pharmaceutical companies.
The former ministers’ objections focus on the circumstances in which Natco’s medicine was selected and supplied, as well as the company representatives’ meeting with the health minister in the presence of the superintendent of SAT Hospital. They said the circumstances warranted scrutiny and questioned whether established procedures governing interactions between ministers and pharmaceutical companies had been followed.
The dispute also includes concerns over reports that medicines supplied to some patients carried the label “For Clinical Trials Only”. The former ministers said the labelling raised questions about the medicine’s safety and regulatory status. The supplied report does not establish whether the medicines were approved for routine treatment or clarify the regulatory basis for the label.
Risdiplam is used to treat SMA, a serious neuromuscular condition affecting children. The state government’s decision to provide an Indian-made generic version was intended to offer an alternative to an expensive imported medicine. The controversy therefore involves both the affordability of treatment and the procedures used to assess, procure and distribute it through the public health system.
Sreemathy also criticised the functioning of the Kerala Medical Services Corporation Ltd, which handles the procurement of medicines for the state. She said tender-based procurement was conducted by officials, including the health department’s principal secretary, and that ministers did not have a direct role in the process. Her comments sought to distinguish routine procurement responsibilities from the minister’s interactions with pharmaceutical representatives.
The hospital administration has rejected allegations that Natco’s assistance to SAT Hospital was connected to the SMA drug controversy. Hospital superintendent R S Riyas said the company’s contribution of Rs 25 lakh was intended to renovate Ward 14, an isolation ward for children with infectious diseases.
According to Riyas, the previous superintendent had requested corporate social responsibility assistance from Natco on March 25. The company released the first instalment after its representatives visited the hospital and assessed its facilities. Riyas said the representatives met the health minister in the first week of August to hand over a certificate related to the assistance.
He said a photograph from that interaction was being circulated to suggest that the meeting was connected to the SMA drug controversy. SATHHES, a society functioning under the hospital, receives corporate social responsibility contributions for improving patient facilities and supporting healthcare-related development activities, he said. Riyas added that such contributions were routinely handed over in the presence of ministers or the chief minister.
The immediate questions now concern the state’s approval and supply process for the generic risdiplam, the regulatory status of medicines carrying the clinical-trial label, and whether the pharmaceutical company’s hospital contribution was administratively separate from the drug decision. The former ministers have called for an investigation, while the hospital administration has maintained that the CSR contribution was meant for ward renovation.
