Risdiplam is used to treat SMA, a rare genetic disorder that progressively weakens muscles and can, in severe cases, be fatal. Swiss pharma major Rocheโs branded medicine, Evrysdi, is prohibitively expensive. Natco Pharmaโs Indian generic, Natsmart, contains the same active pharmaceutical ingredient and has received regulatory approval.
Keralaโs SMA technical committee estimates that switching to the generic could reduce the stateโs annual expenditure for 129 children from around Rs 25 crore to Rs 25 lakh. The move can be replicated in other states.
State health minister K. Muraleedharan has defended the decision, emphasising that it followed expert recommendations and regulatory clearance. The Central Drugs Standard Control Organisation clarified that separate bio-equivalence studies and additional clinical trials were not required for this oral solution under the applicable regulatory guidance. Delhi High Court rejected Rocheโs challenge to manufacturing the generic and the Supreme Court declined to overturn that outcome.
The scientific and regulatory position is therefore clear on a crucial point: Natsmart is an approved generic formulation, not an experimental drug awaiting clinical trials. The Indian Medical Association has also weighed in, with its Kerala president, Dr N. Sulphi, describing the controversy as a fallout of competition between pharmaceutical companies rather than evidence that the generic is unsafe.
While the head of Keralaโs SMA technical committee, Dr K.V. Viswanathan, has defended the medicineโs regulatory status and suitability, interventions by Dr B. Iqbal and Dr V. Ramankutty have given the debate an additional political dimension.
Iqbal, a public health activist associated with the Left, has welcomed the move towards affordable generic treatment. Ramankutty, a paediatrician, epidemiologist and former professor at the Achutha Menon Centre for Health Science Studies in Thiruvananthapuram, recalled his participation in Left-led campaigns for cheaper generic medicines in the 1980s. He expressed surprise at the Left questioning a regulator-approved generic.
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