Supreme Court Stays Kerala High Court’s Order on Procurement of Spinal Muscular Atrophy Treatment Drugs

Background of the Case: On February 24, 2025, the Supreme Court of India stayed the order of the Kerala High Court, which had directed the Union of India to procure life-saving medicines worth ₹18 lakh for the treatment of Spinal Muscular Atrophy (SMA) as a one-time measure. The Kerala High Court’s decision had been in response to a petition from a 24-year-old patient suffering from SMA, challenging the overpricing of the medicine Risdiplam, which is essential for the treatment of the rare disease.

The Supreme Court bench, led by Chief Justice of India (CJI) Sanjiv Khanna and Justice Sanjay Kumar, stayed the Kerala High Court’s order while issuing notice to the Union of India. The Court also asked the Union to explore alternative measures to potentially subsidize the cost of the drugs to make them more affordable.

Kerala High Court’s Initial Order

The Kerala High Court, in its ruling, had directed the Union of India to procure Risdiplam, an expensive medicine used to treat Spinal Muscular Atrophy (SMA) for a patient as a one-time exception. However, the court clarified that the ruling should not serve as a binding precedent for other patients suffering from similar conditions.

The petitioner, a 24-year-old individual suffering from SMA, had approached the High Court, challenging the excessive cost of the life-saving drug, which costs approximately ₹18 lakh. SMA is a genetic disorder that leads to the progressive loss of motor neurons, resulting in muscle weakness and atrophy. Risdiplam is one of the few approved treatments for SMA but is significantly overpriced, making it out of reach for many patients.

Supreme Court’s Ruling

The Supreme Court has now stayed the Kerala High Court's order and has asked the Union of India to explore possible measures to reduce the cost of the medicines. The Court also expressed interest in facilitating international negotiations to bring down the price of such drugs.

The CJI noted that the government should negotiate with the manufacturers of Risdiplam and other medicines for rare diseases in a manner that would make them affordable to patients. He remarked, “Find something out, there are 900 people suffering from this disease, the government can also negotiate... maybe the government has to negotiate and say please do it, we keep on paying you so much money, but you take 50 lakhs for the entire dose, for a lifetime.”

Union’s Response

The counsel representing the Union of India pointed out that the drugs required for treatment are custom-made and administered monthly or bi-annually based on individual patient requirements. As a result, it may not be as simple as negotiating a one-time price for the drug, as these treatments are tailored to each patient’s specific needs.

Exploring Alternative Solutions

The Supreme Court bench also encouraged the Union of India and the petitioners to directly engage with the drug manufacturing company to negotiate better pricing for the medicines used to treat Spinal Muscular Atrophy and other rare diseases. The Court suggested that discussions should also explore subsidizing the costs for a larger group of patients suffering from SMA.

It was further informed to the Court that approximately 900 individuals are suffering from Spinal Muscular Atrophy in India. This highlights the broader issue of the high cost of treatment for rare diseases and the need for affordable, sustainable solutions for patients in need.

The Supreme Court has allowed the respondents to place on record information about how other countries have managed to get the prices of rare disease medications subsidized. This could provide valuable insight for India to negotiate similar deals for its citizens.

Future Proceedings

The Supreme Court has issued notice to the Union of India and set a hearing date for the week starting April 17, 2025. Until the next hearing, the Court has maintained a stay on the Kerala High Court’s order.

Context and Broader Implications

The case is part of a broader conversation about the high cost of medicines for rare diseases in India. The Supreme Court is currently seized of a batch of petitions filed by parents of children suffering from Muscular Dystrophy, another rare disease, who are demanding free treatment for their children. This ongoing dialogue has the potential to reshape the way rare diseases are treated in India, particularly in terms of accessibility and affordability.

This case also reflects the global issue of high drug prices for rare diseases and the need for governments and pharmaceutical companies to find ways to make life-saving treatments more affordable for patients.

Case Title: UNION OF INDIA vs. SEBA P.A., SLP(C) No. 004684/2025