IORD welcomes the landmark judgment by the Delhi High Court clearing Natco Pharma to launch its generic Risdiplam (Natsmart) for Spinal Muscular Atrophy.
In a landmark judgment, the appellate Delhi High Court two-judge bench has cleared Natco Pharma to launch its generic version of Risdiplam for Spinal Muscular Atrophy (SMA), bringing an end to a prolonged legal battle with Swiss multinational Roche. The ruling, delivered by Justices Hari Shankar and Ajay Digpaul, underscores a powerful message: public health takes precedence over patent protection.
Under this decision, Natco is now permitted to sell generic version of Risdiplam under the new brand name Natsmart at a dramatically reduced price of ₹15,900 per bottle — nearly a 97% reduction from Roche’s imported Evrysdi, which had been priced as high as ₹6.2 lakh per bottle in India.
The court held that Roche held a patent in India only for the specific chemical compound of Risdiplam (#9969754) but failed to file for the broader product patent (#9586955), thus providing a technical gap that went in favour of Natco, reported Economic Times while quoting an Intellectual Property Law expert.
Initially, Natco had won the patent dispute when a single judge bench had ordered in its favour in March, 2025, prompting Roche to file an appeal before the present two-judge bench. During the hearing, Natco was restrained with status quo order from releasing the drug in the market till the disposal of the appeal. It is possible Roche may further appeal this case in the Supreme Court. Senior counsel J. Sai Deepak had represented Natco in this case.
Public Health Over Profit: The Court’s Rationale
The verdict follows years of advocacy and legal debate over the stark disparity in drug pricing between India and its neighboring countries. In the past, it was reported in the media how the pharmaceutical company had been making available Risdiplam for around ₹41,000 in Pakistan and ₹44,692 in China, while Indian SMA patients faced steeper prices many times.
In fact, in her landmark judgment by Justice Prathiba M Singh of Delhi High Court on October 4, 2024, the single judge bench explicitly cited these comparisons. While appearing for one of the petitioners Cure SMA Foundation, senior counsel Anand Grover argued that Roche’s “prohibitively high” pricing imposed unbearable financial strain on Indian families, urging the government to ensure fairer access to essential rare disease treatments.
In that case, it was argued that the Drug Controller General of India (DCGI) approved Risdiplam in October 2020, and Roche commercially launched the medicine in July 2021. Under its Patient Support Program, Roche offers the drug at approximately ₹72 lakh per year for the first two years and ₹56 lakh annually from the third year onward. “However, the same treatment is available at significantly lower prices in countries such as China and Pakistan,” the court was told. Please check page 162 of the judgment here.
A Victory for Patients and Affordable Care
The Delhi High Court two-judge bench verdict has been widely hailed by both the media and the rare disease patients’ community including rare disease organisations. This ruling is being viewed as a watershed moment for Indian families affected by SMA. Experts and patient advocates agree that local manufacturing—backed by robust orphan drug manufacturing and proactive government backed bulk procurement policy —is key to closing the treatment access gap, as demonstrated in countries like China and Pakistan.With this milestone, SMA treatment is expected to become more accessible and affordable nationwide.
Welcoming the judgment, Dr. Krishnaji Rao, Secretary of the Indian Organisation for Rare Diseases (IORD), stated: “We welcome the Delhi High Court’s decision allowing Natco Pharma to continue marketing its generic version of Risdiplam for Spinal Muscular Atrophy. This judgment reinforces the importance of balancing innovation with equitable access to life-saving therapies. Ensuring affordable treatment options for patients with rare diseases remains at the heart of IORD’s mission.”
Meanwhile, Natco has announced additional patient access programs and discount schemes for poor families most in need, reinforcing the social impact of this legal win. SMA patients can order the drug here.
💡 Read more in our three-part series on Justice Pratibha Singh’s 2024 landmark rulings that reshaped India’s rare disease policy: Standard Treatment Protocol • NRDC Extension • National Fund Allocation
“The Delhi High Court’s ruling in the Roche–NATCO case sends a strong message that public health and innovation must coexist within a just ecosystem. For India’s rare disease community, this is more than a legal outcome — it is a reaffirmation of our nation’s commitment to accessible, sustainable, and patient-centric healthcare. IORD will continue to advocate for policies that foster innovation while ensuring equitable access to life-saving therapies for all who need them.” — Dr. Ramaiah Muthyala, President & CEO, Indian Organisation for Rare Diseases (IORD)
