NEW DELHI: Days after a controversy erupted in Kerala over Natco Pharma’s generic drug for spinal muscular atrophy (SMA), regulatory clarifications suggest the row stemmed from labels on bottles supplied free of cost. The words “Physician Sample/Clinical Trial” raised fears among parents that their children were being given medicines meant for clinical trials rather than an authorised drug for routine treatment.In response to queries from TOI, Central Drugs Standard Control Organisation (CDSCO) officials said Natco’s risdiplam powder for oral solution (0.75 mg/ml) had been approved by the Telangana State Food and Drug Administration under the applicable regulations. The bulk drug had received CDSCO approval on April 7, 2025.The officials said bioequivalence studies were not required for the oral solution under the regulator’s draft guidance and that additional clinical trials were not necessary before patients could be switched to the generic formulation.Natco said it emerged as the lowest bidder in Kerala’s tender and supplies one free bottle for every three purchased under its Patient Assistance Programme, bringing the effective cost to around ₹8,500 per bottle against ₹1.5 lakh earlier for Roche’s drug. The company acknowledged that the free bottles carry the label “Physician Sample/Clinical trials only”, but said they were supplied as samples under the rate contract and not for clinical trials. It said its generic risdiplam, priced at an MRP of ₹15,900 against ₹6 lakh for Roche’s product, had met regulatory requirements.The issue became a political controversy after Leader of the Opposition Pinarayi Vijayan said parents of children with SMA had flagged the labels on medicines distributed through SAT Hospital in Thiruvananthapuram. He alleged violations of the Drugs and Cosmetics Rules and procurement norms and demanded an inquiry.SAT Hospital authorities have maintained that the medicine distributed was the approved generic formulation, not an experimental drug.Risdiplam is used to treat SMA, a rare genetic disorder that causes progressive muscle weakness. Kerala had been supplying Roche’s branded medicine free to eligible children at a negotiated price. The shift to Natco’s generic version could substantially reduce treatment costs and potentially allow the state to extend support to more patients.The controversy comes amid opposition from parents and the Cure SMA Foundation of India to Kerala’s decision to replace Roche’s medicine with Natco’s generic version. Parents have sought assurances about the safety and efficacy of switching children who have improved on the existing treatment.
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While the regulatory clarification addresses the generic drug’s approval status, the episode raises a separate question: whether labelling that combines “Physician Sample” and “Clinical Trial” can cause confusion when medicines are supplied for patient use.
