In an unusual move, three former health ministers of Kerala and Communist Party of India (Marxist) leaders - Veena George, KK Shailaja and PK Sreemati -convened a press meet on Thursday, October 22. All three raised their concerns over use of a generic medicine for patients of Spinal muscular atrophy (SMA), a genetic condition that causes progressive loss of muscle strength, coordination and mobility. Former Health Minister Veena alleged that children with SMA were subjected to clinical trials.
The ongoing controversy over replacing Switzerland-based Roche’s SMA drug Evrysdi (Risdiplam) with its generic version, Natsmart, manufactured by Indian firm Natco Pharma, is raising challenges for Kerala United Against Rare Diseases (KARE) scheme, state’s pioneering initiative under which Rs 30 crore is allocated annually for the free treatment of SMA patients.
While public health experts and organisations such as Indian Medical Associations are rallying behind the much affordable generic drug, a section of parents of SMA patients and opposition parties are demanding a proper study before distribution of the medicines to the patients. While the concerns are mostly raised by beneficiaries of KARE, SMA patients who are not in the beneficiary list press for affordable drugs.
Natsmart, the generic drug, costs only Rs 16000 per bottle against Rs 5.2 lakh of Evrysdi. As per Natco’s affidavit at Kerala High Court, the medicine will be available to Kerala government at a cost of Rs 9540 per bottle for the KARE scheme. Public health experts say affordability should be prioritised, as the drug does not cure SMA but can improve patients’ quality of life and life expectancy.
Question of ‘clinical trial’
The use of generic medicine for SMA patients was first questioned by Cure SMA Foundation of India, a support group of patients and families affected by SMA, which filed an interim application in April 2026 to its Writ Petition in Kerala High Court. It requested the court to direct the Kerala government to continue providing ‘innovator formulation’ to the beneficiaries, who are availing treatment under KARE programme. It added that substitution with generic formulation could be made only on the basis of appropriate scientific material. However, the court, on September 30, did not allow the application and permitted the state government to proceed with the tender process.
A controversy broke out this week when parents of some SMA patients raised concerns after they received bottles bearing the label ‘physician’s sample / for clinical trial’ from state-run Sree Avittom Thirunal Hospital in Thiruvananthapuram.
On October 22, superintendent of SAT Hospital, Dr I Riyas, issued a statement where he said that the decision to provide an Indian-manufactured drug as alternative to imported medicine was based on an expert committee recommendation. “Poor patients and their families should not be pushed into anxiety through the spread of misconceptions in the name of drug trials,” he said in the statement, without specifically mentioning the reason for giving medicines with the label of ‘clinical trial’.
In a separate interview to the media, Riyas said that the bottles which carried ‘physician's sample / clinical trial’ were supplied only to six patients after the hospital noticed a shortage of medicine on Friday. According to him, Natco was supposed to supply the drugs on Monday. When demand arose on Friday, the company provided free samples, carrying the label, which was given to six patients. He said the medicines were taken back after parents’ expressed concerns.
Parents demand transparency
Nine-year-old daughter of Fida (name changed), a Tirur-native, told TNM that the parents demand nothing but some clarity on the issue. “My daughter was diagnosed with SMA around 5 years ago and has been under treatment since then. She is a beneficiary of the KARE scheme and has seen a tremendous improvement in the last few years. She can stand and walk a little bit, which itself is a major change. The new drug was given without any prior intimation last week. Then this controversy followed. I have not given medicine to my daughter for the last 3 days and it is worrying. All I want is some clarity that this has undergone enough study,” she said. Fida said that the only time she could meet the doctors was during the review every three months at SAT Hospital in Thiruvananthapuram.
Thrissur resident Mohammed Shafeeq, whose toddler son is an SMA patient, said that a report clarifying efficacy of the medicine could be enough to convince parents like him and absences of a proper study was causing them the concern. “My son was showing good improvement, especially since his recurrent infections have gone down. The effect of these medicines is different on different patients such as Type 1, Type 2 etc. My son belongs to Type 2. Since this is not a regular drug, we demand a proper study before giving to our kids,” he said.
Kerala branch of Indian Medical Association said that availability of Natsmart was an opportunity to make treatment more affordable and said that efforts to make medicines at lower prices should be encouraged. It also asked the Health department to provide clear information regarding the source of medicine, quality assurance and the distribution process. “Transparent communication is essential to address parental concerns and maintain confidence in the treatment programme,” it added.
While it was mostly the beneficiaries under KARE who raised concerns, many who are out of the state’s beneficiary list and are purchasing the medicine on their own backed the generic drug. One notable voice in this regard was that of P A Seba, an SMA patient who has been taking Natsmart since April. “It has now been five months since my treatment was switched to Natsmart. I am experiencing the same effects with Natsmart as I did when I was taking Evrysdi. I have not experienced any problems because of the change in the brand of the medicine. All the bottles of medicine provided to me free of cost through Natco’s Patient Assistance Programme carry the label “Physicians Sample/Clinical Trials Only.” It is easy to understand that this label is intended to prevent anyone from selling these bottles for profit,” she wrote in a facebook post.
Chandrasekharan Nair, whose two sons are SMA patients, wrote on Facebook that there is little attention to the concerns of hundreds of families who don't have access to the medicine due to the high cost. “Because of the unaffordable cost of these medicines, I have not been able to provide this treatment to my elder son. As a father, that is a pain I carry silently every day. Fortunately, I have been able to obtain Natco’s Risdiplam for my younger son. He has now been taking this medicine for 11 months,” he wrote. Chandrasekharan added that the medicine that has made a positive difference to his son over 11 months should not be dismissed on the basis of unnecessary doubts and suspicions.
What experts say
Paediatric neurologist and neuromuscular specialist Dr Ann Agnes Mathew said generic medicines could help more patients access treatment for SMA. She said that the concerns of only a few are being highlighted when the number of SMA patients in India is estimated around 2-3 lakh.
“There could be 5,000 patients in Kerala alone. Those who raise concerns are people who know they have the condition. I have even had patients whose SMA was diagnosed posthumously. The problem with the imported drug is that it can reach only a few patients. I understand the concerns of parents, but the imported drug reaches only a little over 100 of the estimated 4,000–5,000 patients,” she said.
Dr Ann said she had recently presented cases involving 100 SMA patients who had switched to Natsmart at a conference in Japan. “Some patients were taking Natsmart, while others had switched from Roche’s to the Indian brand. They did not report any difference. That is why we are not hesitant to recommend it. We believe generic medicines can help more people access treatment,” she said.
She added that conducting a bioequivalence study would be beneficial. However, the estimated cost of around Rs 4 crore could ultimately be passed on to patients, she said.
Dr Ann also highlighted Kerala’s influence on SMA treatment policies in other states, noting that Rajasthan and Assam had begun offering free treatment to patients. “One small state is changing everything. This means more people are getting access to treatment. If Kerala starts using generic medicines for SMA, more states will follow suit,” she added.
According to Gargeya Telakapalli, coordinator of the Working Group on Access to Medicines, a network of patients, healthcare activists and civil society organisations working to make healthcare affordable, the assumption that every generic medicine must undergo clinical trials is unfounded. “The generic medicines are chemically the same compound. A medicine goes through clinical trials when it is a new chemical or biological entity. In this particular case, even bioequivalence is not necessary. What now happens is scaremongering, either intentionally or unintentionally,” he said.
In an affidavit submitted at the Kerala High Court, Natco Pharma said that in vivo bioequivalence study was not required as Natsmart was an oral solution with the same active substance, Risdiplam, in the same concentration.
Natco was allowed to manufacture Risdiplam after the Delhi High Court, in October 2025, declined Roche’s plea for an interim injunction. However, a legal fight over the patent claim of Roche is still going on.
Archana Vashist Panda, co-founder of Cure SMA India, said that they had met Natco CEO after the Delhi High Court order and the company had agreed to initiate an efficacy study, but it didn't happen. “We are absolutely not against the use of generic drugs. We are a group which is fighting for affordability. However, our request is to include safety along with affordability,” she said.