SMA drug trial controversy: Health Department examines circumstances; hospital says misinformation is being spread

THIRUVANANTHAPURAM: The SAT Hospital has alleged that attempts are being made to spread misinformation by portraying the supply of medicines for spinal muscular atrophy (SMA) patients as a drug trial. Hospital Superintendent Dr Riyas said such allegations were aimed at undermining the development initiatives of an institution that provides quality treatment to children and pregnant women in the government sector.

He said the government's decision to provide an Indian-made medicine to SMA patients instead of an expensive imported drug was based on the recommendation of an expert committee appointed by the government. The initiative was launched during the previous government's tenure and was completed within the stipulated time by the present government, enabling the medicine to be made available quickly.

The Supreme Court and the Drug Controller General of India had granted permission for the medicine's sale after assessing that the required procedures had been completed, he said. The hospital urged people not to create confusion and cause anxiety among patients through misleading claims. The medicine has been available in the open market for nearly a year and is being used by several SMA patients. The controversy arose when the government began distributing it free of cost, Dr Riyas said in a press release.

Meanwhile, the Health Department is examining the circumstances under which medicines labelled as samples or for clinical trials were supplied to patients.

The explanation given is that the Indian-made medicine supplied by Natco Pharma as an alternative to the foreign company's drug had run out of stock, prompting the hospital to issue medicines marked as samples. Doctors have informed Health Department officials that there was no compromise on quality and that the medicine was given to ensure that treatment was not interrupted for children with the condition.

The Indian Medical Association (IMA) welcomed the Health Department's steps to ensure continued treatment for children with SMA and reduce the financial burden on their families. IMA state president Dr M.N. Menon and secretary Dr Roy R. Chandran said the decision to provide Natco Pharma's low-cost Risdiplam as an alternative to Roche's medicine would make treatment more affordable.

Natco Pharma representatives met minister to hand over certificate

The meeting between Natco Pharma representatives and Health Minister K. Muraleedharan has also come under scrutiny after photographs of the meeting surfaced amid the controversy over the SMA medicine. The meeting took place on August 5.

The Minister's Office clarified that the company representatives had visited him to hand over a certificate acknowledging the CSR contribution made to the SAT Hospital Society.

On March 25, the then hospital superintendent had requested the company to provide CSR funds for the renovation of Ward 14, the isolation ward for children affected by infectious diseases. The company subsequently transferred the first instalment of Rs 25 lakh to the hospital society's account. The representatives met the Minister to hand over the certificate related to this contribution.