'A huge relief for us': SMA patients welcome Delhi HC verdict allowing generic Risdiplam  

The Delhi High Court’s recent order rejecting Swiss pharma major Roche’s appeal to restrain domestic drugmaker Natco Pharma from selling the generic version of the life-saving drug Risdiplam has brought immense relief and hope to Spinal Muscular Atrophy (SMA) patients across the country.

Risdiplam is the first and only home-administered oral medication for treating SMA in adults, children, and infants.

The division bench’s ruling upheld an earlier single-bench order from March, which had denied Roche’s request for an interim injunction—reaffirming that public health must take precedence over monopolistic practices and evergreening tactics.

The court’s decision has paved the way for the introduction of an affordable generic version of risdiplam by Natco Pharma, significantly improving access to this life-saving treatment for patients across India.

Expert views

“The decision is particularly significant given the striking price difference between the two versions of the drug. Roche’s Risdiplam currently costs around Rs 6.2 lakh (USD 6,982) per bottle. As it has to be taken lifelong, the cost makes it unaffordable for most families. In contrast, Natco’s generic version is expected to cost around ₹15,900 (USD 179) per bottle, reducing the price by nearly 97%,” noted representatives of the Working Group on Access to Medicines and Treatment.

The Working Group also observed that the verdict will ensure wider availability of this critical drug to SMA patients and enable greater government support under the National Policy for Rare Diseases.

Seba PK, a 26-year-old from Kerala and one of two SMA patients who intervened in the case opposing the injunction, had earlier written in THE WEEK that patent monopolies play a major role in keeping prices unaffordably high. “Life-saving drugs should not be treated as profit-generating commodities. If negotiations fail to bring prices down, the government should not hesitate to invoke the public interest safeguards under the Indian Patents Act,” she had noted.

Following the division bench’s verdict, Seba expressed immense relief. “We have all been eagerly waiting for the judgment. The court’s decision could make a significant difference in the affordability of Risdiplam. With the reduced price, the government will now be able to purchase and provide the medicine for several years using the Rs 50 lakh fund under the National Policy for Rare Diseases. This is a huge relief for me and my friends living with SMA.”

Collective victory

Purva Mittal, another intervener representing people living with SMA, stated: “This victory belongs to all the parents of SMA patients and the angels of the SMA community. It marks a pivotal moment in our collective journey. We are deeply grateful to the judiciary for delivering a verdict that prioritises life, compassion, and justice—a decision that will help save countless lives and offer hope where it is needed most.”

Meanwhile, the Working Group on Access to Medicines and Treatment emphasised that access to life-saving medicines should not depend on a person’s ability to pay and urged the Union Government to take proactive steps to procure the generic version of Risdiplam under the National Policy for Rare Diseases to ensure timely and equitable access to this essential medicine.

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