A drug costing expert has estimated that the annual cost of treating Spinal Muscular Atrophy (SMA) in India, currently around Rs 72 lakh per patient due to patent restrictions and lack of local production, could be reduced to just Rs 3,000 if domestic manufacturing were allowed. This estimate was presented in an affidavit by a 24-year-old SMA patient in Kerala’s high court. Dr. Melissa Barber of Yale University, who conducted the analysis, explained that risdiplam, a preferred SMA treatment, could be produced cheaply in India. Despite its current high price in the U.S. ($11,170 per vial), she demonstrated that its local production is feasible at a significantly lower cost due to its simpler manufacturing process compared to other SMA treatments.
As reported by The Times of India, the petitioner highlighted that while the government has increased financial aid for rare diseases from Rs 20 lakh to Rs 50 lakh, this remains insufficient without local production of the drug. A crowdfunding platform launched to assist with the costs has also been ineffective, raising only Rs 3.5 lakh, despite 2,340 patients being registered.
Additionally, the affidavit criticized the government for not answering how it plans to secure continued access to medicines like risdiplam, beyond financial assistance. While the National Rare Diseases Committee, formed in 2023, has a mandate to indigenize drugs, there are no clear steps toward fostering domestic production at affordable rates, as outlined in the National Policy for Rare Diseases 2021. The case underscores the need for urgent action to make life-saving treatments like risdiplam more accessible and affordable through local manufacturing.