Supreme Court Urges Government to Negotiate Cheaper Rare Disease Medicines

On February 24, 2025, the Supreme Court suspended a Kerala High Court order that had instructed the Union to buy medicines worth ₹18 lakh to treat Spinal Muscular Atrophy (SMA) on a one-time basis. The bench, headed by Chief Justice Sanjiv Khanna and Justice Sanjay Kumar, noted that the government should explore ways to make such high-priced drugs affordable by directly approaching drug manufacturers.

The case concerned a 24-year-old patient with SMA who protested against the exorbitant pricing of Risdiplam, a life-saving drug for the disease. This is part of a larger problem, as many patients throughout India are unable to afford the cost of orphan drugs—specifically developed for rare diseases.

Financial Implications of Rare Disease Treatments

One of the biggest challenges in treating rare diseases is the sky-high price of drugs. For example, the cost of Risdiplam for a year for a patient with SMA can amount to around ₹72 lakh. However, studies suggest that if the drug were manufactured locally in India, its cost could be reduced dramatically to as little as ₹3,000 a year.

On February 24, 2025, the Supreme Court suspended a Kerala High Court order which had instructed the Union to buy medicines worth ₹18 lakh to treat Spinal Muscular Atrophy (SMA) on a one-time basis. The bench, headed by Chief Justice Sanjiv Khanna and Justice Sanjay Kumar, noted that the government should look into ways of making such high-priced drugs affordable by directly approaching drug manufacturers.

The case concerned a 24-year-old patient with SMA who protested against the exorbitant pricing of Risdiplam, a life-saving drug for the disease. This is part of a larger problem, as many patients throughout India are unable to afford the cost of orphan drugs—specifically developed for rare diseases.

Financial Implications of Rare Disease Treatments

One of the biggest challenges of treating rare diseases is the sky-high price of drugs. For example, the cost of Risdiplam for a year for a patient with SMA can amount to around ₹72 lakh. But according to studies, if the drug were manufactured locally in India, its cost would bring down dramatically to as little as ₹3,000 a year.

The Supreme Court's order follows ongoing deliberations regarding petitions submitted by parents of children afflicted with muscular dystrophy. These petitions advocate for a national policy providing free treatment for rare diseases. In December 2024, the Court had also stayed a Delhi High Court directive seeking the elimination of the ₹50 lakh limit on rare disease treatment costs, highlighting the judiciary's positive initiative in addressing these healthcare issues.

Success with Domestic Production of Drugs

Positive developments in India's home-grown drug industry offer hope. Government efforts to initiate domestic manufacturing of some orphan drug medications have led to significant price reductions. For instance, the treatment price for Gaucher's disease, which used to cost anywhere between ₹1.8 crore and ₹3.6 crore per year, has dropped to a mere ₹3.6 lakh. Similarly, the cost of Trientine capsules for Wilson's disease, once a hefty ₹2.2 crore per year, has been significantly reduced. These initiatives underscore the potential for scaling up local production to drive down treatment costs further.

International Models for Affordable Drug Procurement

India can take inspiration from global best practices in making rare disease medications affordable. Nations such as China and Pakistan have successfully negotiated with pharmaceutical companies to lower drug prices, providing India with models to follow. By leveraging the size of its pharmaceutical market and bargaining power, the Indian government can secure beneficial contracts for the import of these crucial medicines.

(Input from various sources)

(Rehash/Pragati Sakhuja/MSM)