Wednesday, November 6, 2024
The Telegraph India, Swiss firm Roche bid to prevent India’s Natco Pharma from introducing cheap spinal drug
Roche’s action in Delhi High Court seeking an injunction against Natco Pharma to prevent the introduction of a generic version of the drug called risdiplam will jeopardise public interest by compelling patients to rely on the Roche product that costs ₹6 lakh a month, they said. … The network called Working Group on Access to Medicines and Treatments has cited an analysis by Melissa Barber, a public health researcher at Yale University in the US, which estimated that generic risdiplam could be priced at ₹3,024 per patient per year. “This includes the cost of production with a 20 per cent markup and 25 per cent tax,” the Working Group said in a statement released on Tuesday. “Risdiplam is less complex to manufacture than other treatments for SMA. Production in small volumes is feasible and cost-effective.” Provisions in Indian laws on patents allow the Centre to enforce a so-called compulsory licence to enable generic versions of patented molecules if there is a large unmet need, experts say. And generic drug makers could also challenge already-granted patents seeking invalidation, said Chetali Rao, a member of the Third World Network, a think tank that engages in healthcare and other issues that impact developing countries. “There is a huge unmet need in the case of risdiplam — the vast majority of patients in India will have no access to a medicine that costs ₹72 lakh a year and that needs to be taken throughout life,” said Rao.
Knowledge Ecology International, Proposal for Addition Of Risdiplam to WHO Model List Of Essential Medicines, for the treatment of Spinal Muscular Atrophy (SMA)
On November 1, 2024, Knowledge Ecology International (KEI) submitted a proposal for the addition of risdiplam to the World Health Organization’s (WHO) Model List of Essential Medicine (EML). You can access the full proposal here: risdiplam2WHOEML1Nov2024. … In addition to our strong recommendation for the inclusion of risdiplam on the core EML, KEI additionally recommends that the World Health Organization (WHO) consider a new category for essential yet expensive medicines alongside the recommendation for the government to take measures to obtain an affordable version of the medicine.