Delhi High Court paves way for generics of spinal muscle atrophy drug

Innovator drug price is Rs 22-72 lakh per year; Analysts forecast Natco to price generic drug at Rs 3,000 per year

The annual treatment cost of spinal muscular atrophy (SMA) in India is expected to come down to just ₹3,000 annually against the current ₹22 lakh-72 lakh after the Delhi High Court’s Monday verdict opened the door for domestic firm Natco Pharma to manufacture generic version of Risdiplam.

 

The court nixed an interim injunction plea of Swiss pharmaceutical giant F Hoffmann-La Roche AG which had sought temporary restriction on Natco Pharma from infringing its patent.

 

Industry experts expect Natco to price the generic version of Risdiplam at around ₹3000 annually.

 

While delivering the verdict, Justice Mini Pushkarna said, “A drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a Court will consider at the time of dealing with an application for interim injunction.”

 

For patients like Seba PA and Purva Mittal, who led the legal battle, this ruling represents a lifeline.

 

Currently, the patented drug costs between ₹22 lakh and ₹72 lakh per year depending on the patient weight and dosage, well beyond the reach of most families, even with government support capped at ₹50 lakh under the National Policy for Rare Diseases.

 

Nirali Shah, pharma analyst at Ashika Group says, “The Delhi High Court’s ruling on Risdiplam shifts the risk-reward equation in favour of affordability, challenging Roche’s IP moat. While Roche cites high R&D costs to justify pricing, this verdict sets a precedent for generic entry in orphan drugs. A potential price reset from the current ₹ 72 lakh to potential ₹3,000 annually signals a shift toward volume-driven market expansion in SMA treatment. For Natco, this presents a new opportunity, though execution and regulatory clarity will be key.”

 

Speaking on the court decision, Roche Pharma India spokesperson said, “We are also supporting patients through our patient assistance program which makes Evrysdi (brand name of the drug) more affordable. IP protection is a cornerstone for any pharmaceutical innovation. Roche is committed to protecting its innovation. We believe that strong IP protection, including patents, is essential for medical innovation, patient well-being, and for access to new and innovative treatment to address the healthcare challenges we face today.”

 

Roche is considering its options within the scope of Indian Patent law. The company said since the launch of Evrysdi in 2021 (the first and still the only approved solution for SMA in India), it has been actively collaborating with local authorities in India to implement tailored pricing, similar to what we have been able to do in collaboration with payers in other parts of the world.

 

Seba, one of the petitioners, expressed hope that Natco Pharma will quickly supply the affordable alternative and called on the government to ensure its widespread availability.

 

Her lawyer, Anand Grover, emphasised that the ruling could prevent many unnecessary SMA-related deaths by making treatment accessible.

 

The court ruling comes at a time when the high cost of treatment is exacerbated by the Indian government’s limited funding under the National Policy for Rare Diseases, which provides up to ₹50 lakh per patient.

 

For example, Seba’s treatment cost reached ₹61,15,200 annually, far exceeding the funding cap, after the Center of Excellence procured risdiplam at ₹2,03,840 per bottle for 24 bottles, while 30 bottles are needed per year. 

Game Changer for SMA care

>Analysts expect Natco Pharma to price Risdiplam at ₹3,000 annually

>Innovator drug price is ₹22 lakh-₹72 lakh per year