Clearly, the CPM is not satisfied with the clarification the Health Minister, K Muraleedharan, has offered in connection with the procurement of the generic version of Risdiplam for the treatment of children with Spinal Muscular Atrophy (SMA).

On Friday, a couple of hours after the health minister's press conference, CPM state secretary M V Govindan held another one and hurled six questions at the government, the answers to at least some of which were provided during the minister's media interaction.

Question # 1: How did the label 'For Clinical Trials Only' appear on the medicines that were procured by Kerala Medical Services Corporation Limited (KMSCL)? "The government should answer how such medicines reached the hospital (SAT Hospital, Thiruvananthapuram)," Govindan told reporters.

(Geneticist Dr Sankar V H, the chairman of the Technical Committee, said during the health minister's press briefing that no clinical trials were being conducted for the medicine. "It is a proven drug," he said. "The patients and their caregivers were told about the change in medicine by the paediatric neurologist at the time of consultation. Moreover, four or five meetings were held with parents to give them awareness about this medicine," he added. Another thing to be noted is that the label also says 'physician's sample'. "When it is stated 'physician's sample', it means it is a tested molecule. The content and dosage are the same. It means it is the same medicine," the doctor said.)

Q#2: If, as the minister claims, the medicine is safe, why was it withdrawn? "Why was the health Department desperate to take back the medicines from the parents of affected children? Were parents told beforehand about the decision to change the medicine," Govindan said.

("It was taken back to avoid confusion," the health minister said. "It would have caused no problem even if the medicines were not returned. No one doubts the efficacy of the new medicine," he said. To allay concerns, the minister said that doctors had already talked to patients and their caregivers. The minister also suspected that the concerns around the new medicine were stoked by the foreign pharmaceutical company, Roche. "There is someone behind the curtain," he said.)

Q#3: Has the bioequivalence study of the medicine been completed?

(Experts with the health minister said that there was no need for a bioequivalence test for generic drugs. Further, Natco's formulation has been approved by the Central Drugs Standard Control Organisation. On the other hand, it is also a fact that the State Mission director wrote to the additional chief secretary (health) on May 23, after the UDF assumed office, that "bioequivalence studies can be conducted and they are doing the studies at present at National level".)

Q#4: Has the KMSCL conducted quality tests on this drug? "The quality control team of the KMSCL was disbanded right when the UDF assumed power. Fact is, no quality tests have been conducted," Govindan said.

(The government's stand is that the Central Drugs Controller itself had approved the drug and, therefore, no such quality tests are required.)

Q#5: Why was there a two-month delay in floating a tender after deciding to procure the medicine? Why were tender guidelines revised for the benefit of one company?

("Natco is the only company that manufactures the generic version of Risdiplam," the minister said. "We placed orders only after the Supreme Court also gave its sanction," the minister noted. Natco owns Natsmart, the generic version of Roche's patented Risdiplam brand Evrysdi.)

Q#6: Who will take responsibility if side effects are found in children to whom the new medicine is administered?

(Government experts said that Natsmart is a proven drug with the same contents as Evrysdi.)