KOTTAYAM: Even as the Opposition continues to criticise the health department’s decision to replace the branded drug used to treat children with Spinal Muscular Atrophy (SMA), a rare and life-threatening genetic disorder, with a low-cost generic alternative, health experts and public health activities, including those owing allegiance to the Left, have thrown their weight behind the state government.
According to them, the decision to use the generic version of the drug, risdiplam, manufactured by Indian pharmaceutical company, Natco, as a major step towards challenging exorbitant drug prices and making treatment more affordable.
Dr B Ekbal, former professor of neurosurgery and a public health activist, said the move should be viewed in the context of efforts to counter the high cost of life-saving medicines. Citing an earlier instance involving a generic cancer drug in 2012, he said Natco had offered a treatment at Rs 8,800 a month, compared with Rs 2,80,428 for the corresponding drug manufactured by German pharmaceutical company Bayer.
“Roche’s branded drug Evrysdi (risdiplam) costs around Rs 6.2 lakh per bottle, while Natco’s generic version is priced at Rs 15,900. Since a bottle typically lasts 12 days, the monthly expenditure on Natco’s formulation comes to around Rs 30,000. This represents a price reduction of approximately 97% compared with the branded drug,” he said.
Ekbal also pointed out that Roche had initiated legal proceedings in the Delhi High Court seeking to restrain the commercial distribution of Natco’s generic risdiplam. However, the court ruled in October 2025 in favour of allowing the generic formulation to be manufactured, paving the way for its market introduction, he said.
He dismissed arguments questioning the efficacy of the generic formulation and alleging inadequate bioavailability as scientifically unfounded.
“Bioavailability refers to the rate and extent to which an administered drug enters systemic circulation. Generic manufacturers such as Natco are required to demonstrate bioequivalence, establishing that their formulations deliver the active ingredient into the bloodstream in a manner comparable to the branded drug. Under the Drugs and Cosmetics Act, regulatory approval for any generic pharmaceutical is granted only after successful completion of rigorous bioequivalence studies,” he said.
According to Dr K P Aravindan, pathologist and public health activist, criticism of an Indian pharmaceutical company that had challenged multinational drug patent monopolies and helped make essential cancer medicines more accessible could ultimately benefit the multinational giant that holds the patent until 2035.
“Bioequivalence involves three components. The first is verifying that the formulation contains an adequate quantity of the active drug, while the second is ensuring that the drug is sufficiently absorbed by the body. The third concerns whether the drug produces the intended therapeutic benefit in patients. The first two are preliminary assessments that must be completed to obtain approval from the Drug Controller. However, the drug’s actual clinical efficacy can be established only after it is administered to patients,” he said.