Why recognising a generic drug for Spinal Muscular Atrophy is significant

Spinal Muscular Atrophy (SMA) is a rare, life-threatening genetic disorder that progressively weakens muscles, severely impairing both mobility and respiratory function. Although a complete cure remains elusive, Risdiplam is currently available as a pharmaceutical intervention capable of significantly decelerating disease progression. Timely administration of this medication is critical for enhancing patients’ quality of life and longevity. In this context, the Department of Health's decision to use a low-cost generic version of the drug produced by the Indian pharmaceutical company Natco for SMA treatment is an exemplary and entirely commendable measure. Nevertheless, certain media outlets and vested interests have continued to propagate unfounded allegations against this judicious decision.

The Struggle for the Right to Treatment and Market Realities

We possess numerous historical precedents in the ongoing struggle against exorbitant pharmaceutical pricing. A notable instance occurred in 2012 when the late Controller General of Patents, Shri P. H. Kurien, granted Natco a compulsory license for the cancer medication Sorafenib (Nexavar), reducing its cost considerably. Natco made history by marketing this generic alternative at ₹8,800 for monthly treatment, contrasting sharply with the German manufacturer Bayer’s monthly treatment cost of ₹280,428.

A remarkably similar situation characterises the SMA treatment landscape today. Roche’s branded therapeutic equivalent, Evrysdi (Risdiplam), costs about ₹6.2 lakh per bottle. Conversely, Natco’s generic version costs only ₹15,900 per bottle. Since a single bottle typically lasts 12 days, Natco’s monthly expenditure is about ₹30,000 (though actual costs may vary based on the patient’s age, dosage, and volume used). Compared with the branded pharmaceutical, the generic version is priced at approximately 97 per cent lower.

Although Roche initiated legal proceedings in the Delhi High Court to obstruct the commercial distribution of Natco’s generic Risdiplam, the court delivered a verdict in October 2025 authorising the production of the generic formulation, thereby enabling Natco to introduce it to the market. This Delhi High Court ruling was a historic victory for patients’ rights to treatment and the fundamental public health principle of affordable pharmaceuticals.

Unfounded Assertions Versus Empirical Realities

Arguments challenging the efficacy of the generic formulation and alleging a lack of “bioavailability” are entirely unscientific and baseless. Bioavailability denotes the rate and extent to which an administered pharmaceutical substance enters systemic circulation through the digestive tract. When authorised enterprises such as Natco introduce generic formulations, they must legally and scientifically demonstrate bioequivalence, proving that the drug enters the bloodstream in a manner comparable to the branded original. Under the Drugs and Cosmetics Act, regulatory approval for any generic pharmaceutical is granted only after successful completion of rigorous bioequivalence studies.

The Drugs Controller General of India (DCGI), the principal national regulatory authority, formally sanctioned this medication for market introduction. Natco is a highly credible pharmaceutical manufacturing enterprise that routinely exports medications to various regulated international markets. These empirical evaluations demonstrate that the generic pharmaceutical offers the same therapeutic efficacy and safety profile as its branded counterpart. In essence, these fallacious campaigns are fabrications orchestrated by vested interests seeking to preserve monopolies over excessively priced medications.

Public Health and Social Justice

The fundamental dilemma before us transcends a simplistic choice between a branded and a generic medication. Rather, it raises a pivotal public health policy question: whether finite public resources should treat a broader cohort of patients, or whether exorbitant expenditures should benefit an extremely limited demographic, thereby precipitating crises for impoverished populations.

Public health advocates have consistently argued that the tangible benefits of the Delhi High Court’s ruling can be realised only if stakeholders shift toward the economical generic formulation of Risdiplam. This decision goes beyond fiscal optimisation; it reflects a profound humanitarian and social obligation to ensure life-saving interventions for more SMA patients with equivalent financial allocations.

The availability of scientifically validated, universally recognised generic pharmaceuticals at lower cost is a major benefit for SMA patients and their families. Consequently, the Department of Health must disregard these unfounded media campaigns and steadfastly advance this decisive, patient-centric initiative.

Dr B Ekbal is a former professor of neurosurgery and a public health activist.

The opinions expressed in this article are those of the author and do not purport to reflect the opinions or views of THE WEEK.