The CPM’s objections to the Kerala government’s decision to procure a low-cost generic drug for spinal muscular atrophy (SMA) have triggered a row, with questions raised over its safety, labelling and regulatory clearance. Dr KV Viswanathan, chairman of the SMA Technical Committee and Director of Medical Education, explains the science and regulatory aspects of the drug, the patent dispute surrounding its launch and the potential savings for the State.

Was Natco Pharma legally entitled to develop a generic SMA drug?
The Swiss company Roche developed risdiplam, the molecule used in the drug and naturally, they secured a patent for it. The drug is marketed under the brand name Evrysdi. After the patent expired, Indian pharmaceutical company Natco Pharma developed a generic version called Natsmart. It also obtained approval from the Central Drugs Standard Control Organisation (CDSCO). When Natco was preparing to launch its version, Roche moved the Delhi High Court to protect its patent rights. The court rejected its plea. Roche then approached the Supreme Court, but that too proved unsuccessful. Natco’s generic drug eventually hit the market in October 2025.

When did the Technical Committee decide to make the generic drug available to SMA patients in Kerala?
The subject came up for discussion at a Technical Committee meeting on February 12 this year, with the Health Department being kept informed. The committee decided that the drug should be made available to patients only after its efficacy was officially established. Dr VH Shankar, a committee member and medical genetics specialist, subsequently wrote to the CDSCO seeking clarification on whether clinical trials and a bioequivalence study were necessary.

Was the response positive?
Certainly. If clinical trials and a bioequivalence study were required, changes would have to be made to the generic drug’s formulation, dosage or inactive ingredients in comparison with the patented version. Natco has manufactured its drug using the same formulation as Roche’s product. The CDSCO therefore clarified that clinical trials and a bioequivalence study were not required for the generic version.

Was the previous government in favour of procuring the generic drug?
Yes. Otherwise, the Technical Committee would not have taken up the issue. Before the present government assumed office, the committee approved the procurement of the generic drug at its meeting on May 8. Its recommendation was forwarded to Additional Chief Secretary Rajan Khobragade on May 25. The committee’s mandate is to assess whether the generic drug is suitable for patients and make a recommendation. We are not expected to concern ourselves with changes in government or the circumstances surrounding them.

Patients appear apprehensive about the generic drug?
There is no reason for such apprehension. Numerous generic medicines are available in the country, yet similar concerns are rarely raised about them. In Kerala, each patient is briefed about the generic drug before it is dispensed.

What are the benefits of procuring this generic drug?
Kerala pays ₹5.20 lakh for a bottle of Roche’s drug, whereas the generic version costs just ₹8,000. At present, 129 children below the age of 12 receive the medicine free of cost. Procuring Roche’s drug costs the State ₹25 crore a year. Switching to the generic version would bring the annual expenditure down to just ₹25 lakh.

Is the generic version of the SMA drug already available in Kerala?
Yes. Several private hospitals have been offering the generic drug for some time. It is also being used at government hospitals of national importance, among other institutions.