Delhi High Court clears way for Natco to sell generic risdiplam, rejects Roche’s appeal

In a blow to Swiss drugmaker Roche, the Delhi High Court has upheld an earlier order allowing Hyderabad-based Natco Pharma to sell a generic version of Roche’s spinal muscular atrophy (SMA) drug, risdiplam, in India.

A division bench rejected Roche’s appeal against a March 2025 single-judge order that had refused an injunction on public interest grounds, noting that life-saving therapy must remain affordable and accessible.

Sold by Roche under the brand name Avarisdi, risdiplam is used to treat SMA – a rare genetic disorder that causes progressive muscle weakness and loss of motor function. The latest decision paves the way for Natco to launch its generic version immediately.

In a statement, Natco said it will release the product at a maximum retail price of ₹15,900 per bottle, which is significantly lower than the price of Roche’s imported version of around ₹6 lakh. The company said it plans to offer additional discounts through a patient access program to make the drug even more affordable for eligible patients.

Although there are no official statistics on the number of SMA patients in India, available studies estimate that the condition affects one in every 7,744 live births. According to an affidavit filed by the Central government in the Kerala High Court earlier this year, the annual cost of treating all SMA patients in the country could range between ₹6,400 crore to ₹34,000 crore.

While the decision marks a major win for patient access and India’s domestic generics industry, it also reignites the debate on the challenges faced by multinational drugmakers with respect to patent protection and innovation in India’s emerging IP landscape.