‘Clinical Trial’ or regular medicine? SMA drug controversy rocks Kerala

THIRUVANANTHAPURAM: The supply of an Indian-made generic medicine to children with spinal muscular atrophy (SMA), a rare genetic disorder, in place of an imported drug at SAT Hospital has triggered a controversy. The complaint alleges that the children were given medicines labelled “Doctors’ Sample” and “Clinical Trials”, prompting accusations that the government was conducting drug trials on children.

The Health Department said the medicine had central approval and that there was no difference between the products labelled as samples and the regular medicine. Hospital authorities said the bottles marked as samples had been mistakenly supplied in place of the regular medicine. Following mounting protests, steps were initiated to retrieve the medicines labelled “Sample/Clinical Trial” that had been given to the parents of five children.

The imported medicine, Evrysdi, manufactured by Roche, had been used for a long time. A bottle containing 80 ml costs more than Rs 5 lakh. It has now been replaced with a generic medicine manufactured by Hyderabad-based Natco Pharma, priced at Rs 15,000. Officials said the generic medicine was available at government hospitals for as little as Rs 8,000. The medicine is also provided free of cost under the CARE scheme.

Opposition leader Pinarayi Vijayan said in a statement that the supply of medicines bearing clinical trial labels to children could not be taken lightly. He alleged that the children were being turned into experimental subjects and called for an urgent investigation. Former Health Minister K. K. Shailaja also expressed concern.

Parents said their children's health had improved while they were taking the imported medicine. They fear that switching to the new medicine could adversely affect their children's health.

Decision taken by previous government: Minister Muraleedharan

Minister K. Muraleedharan said the current medicine was being supplied on the recommendation of a technical expert committee. The decision was taken, and the technical committee met, during the previous government's tenure, he said. The present government had issued the order, he added. The minister said the government was prepared to investigate if a complaint was made.

Health expert Dr B. Iqbal said the decision to use a lower-cost generic medicine manufactured by an Indian company was welcome and exemplary. He said the allegations being circulated had no basis.