A generic version of Risdiplam, a medicine used to treat spinal muscular atrophy (SMA), could soon be available in India at $183.47 dollars per bottle, a sharp 97% drop from the current rate of $7,150 dollars. The news has been welcomed by healthcare activists and patients as a significant development.
Government intervention at this juncture is critical, says K.M. Gopakumar, a legal researcher who works in the area of access to medicines.
“Even with this possible cost cut, the drug will remain expensive and out of reach for a large proportion of patients. The Central government can intervene, procure these medicines and reduce the price in a manner that is more affordable. They can also invoke Section 100 of the Patents Act, 1970 that would allow the manufacture of the generic version of the drug and ensure procurement of medicine for all SMA patients,’’ he said.
Legal battle
Indian generic manufacturer Natco Pharma announced that it could commercialise a generic version of Risdiplam at ₹15,900, equivalent to $183.47. Natco released this information within the context of its legal battle with Roche Pharma, the current patent holder for the drug. The Delhi High Court has rejected Roche’s plea for an interim injunction against Natco for alleged infringement of its patent.
Patients and their families are all waiting for an affordable treatment option, says Saifullah Khalidi, an SMA patient representative and disability rights advocate.
“SMA is a lifelong condition and Roche’s drug improves quality of life. Currently, the drug costs upwards of ₹70 lakh annually for an adult patient. This makes sustained access to the drug an impossible task. As of now, we don’t have any idea about when production would start or when the generic medicines would be available for patients. However, we welcome the possibility of having multiple companies making the generic version of the medicines and bringing down the cost to a point that it becomes affordable for all SMA patients,’’ he said.
Mr. Khalidi added that, without treatment, SMA patients struggle with reduced mobility, encounter respiratory challenges, and typically have a shortened lifespan. “This medicine is critical for ensuring quality of life for SMA patients,’’ he emphasised.
No cure
SMA is a genetic disorder that causes weakness and wasting, or atrophy, of the muscles used for movement. It is caused by a loss of motor neurons, the specialised nerve cells in the spinal cord that control muscle movement.
Symptoms vary depending on the type of SMA, but can include muscle weakness, difficulty with movement, breathing problems, swallowing difficulties, and scoliosis. There is currently no cure for SMA, but treatments can help manage symptoms and improve quality of life, with some therapies.
Evrysdi (Risdiplam), a small molecule oral medication, is the first and only approved treatment for SMA in India, manufactured by Roche. Additionally, Nusinersen (Spinraza), another disease-modifying therapy, is available in India through a special program for select children.
“Access to medicines means improved quality of life. I was able to raise ₹61 lakh through crowd-funding in 2022 which gave me access to Roche’s medicine for close to a year. However, I have been without this medicine due to the high cost ever since. An easily accessible generic medicine would ensure a better life for people living with SMA,’’ said writer and SMA patient Sarmista, who hails from Assam.
Published – April 12, 2025 03:01 am IST
