Supreme Court Questions Pharma Giant Over Sky-High Drug Price for Rare Disease Treatment in India:

In an important development which may be a respite for the thousands of families grappling with rare diseases in India, the Supreme Court has questioned F. Hoffman-La Roche Limited for the unreasonable cost of the life-saving drug Risdiplam, which is used for treating Spinal Muscular Atrophy (SMA).

This action came after a sympathetic plea from the lawyer of a 24-year-old woman suffering from SMA who disclosed the fact that the drug in question is available for much lower prices in countries like Pakistan and China and is priced exorbitantly in India at ₹72 lakh per year.

SMA Gets Supreme Court Attention

Along with Chief Justice Sanjeev Khanna, Judge of the Court Sanjay Kumar and Judge KV Vishwanathan also shared their concern over the imbalance in prices. In a stern move, the bench served a notice to the manufacturer of the drug asking the company to provide cost substantiation documents and explain why the cost to an Indian patient is so much higher than the price on other countries’ patients for the exact same treatment.

“The question still remains, is Risdiplam is available on other countries in considerably more affordable prices, and if yes, does it mean the same condition will be applied for the Indian patients?” was the remark made by the bench.

The court added that when it comes to people’s lives, especially those with life-threatening rare diseases, there must be access and not barriers created by pricing. The next hearing for this case is set for April 8, 2025.

Is There Scope for Intervention from the Indian Government?

There is another important question that came out during the court discussions: why does the Indian government not step in to negotiate with international manufacturers for reasonable pricing, especially when young and middle-aged lives are at stake?

Senior Advocate Anand Grover, representing the patient, noted that other countries such as Pakistan and China have stepped in and negotiated drastically lower prices for the same drugs. “Why not the Indian government?” he challenged. He pointed out that citizens of this nation are entitled to equal treatment—especially when the disparity in cost and rationale is so outlandish.

This argument seemed to resonate with the court's understanding, which suggested that if these pharmaceutical companies continue to be unreasonable with their prices, there is a strong possibility that government-level talks will have to be initiated.

What Is Spinal Muscular Atrophy (SMA)?

SMA or Spinal Muscular Atrophy is a hereditary disorder that affects the muscles and weakens them progressively due to the damage of motor neurons located in the spinal cord. SMA is regarded as a rare condition, but unfortunately, it is quite prevalent in India, especially considering infants and toddlers.

In its most severe form, this condition is life-threatening. Type 1 SMA, or the most severe form, tends to result in death before a person reaches 18-24 months if there are no treatments available. There are older patients as well, such as a 24-year-old woman who’s case is currently in court, and with time the disease makes them progressively disabled, making losing the ability to perform the simplest daily tasks.

Despite not being a cure, Risdiplam improves quality of life and slows the disease down significantly. The drug is unfortunately out of reach for most patients as in India it is priced at ₹72 lakh annually, which leads to family crises.

A Larger Debate on Drug Pricing

The situation presents a strong case for discussing the affordability of medicines in India, particularly in the scope of life threatening diseases and rare disorders. There is broad condemnation of multinational pharmaceutical corporations for pricing their goods as per the locality’s purchasing power and considering prospects of low- and middle-income countries. India, being one of the populated markets, suffers the brunt of exorbitant costs owing to a treatment culture in which millions languish.

There is considerable pressure on the government to act more vigorously, whether in the form of price negotiation, fostering generics, or allowing compulsory licensing in severe circumstances to make basic medicines accessible to all.

The Supreme Court’s intervention may indeed shift things in the direction of a more compassionate healthcare system. As the April 8 hearing gets closer, patients, families, and healthcare advocates across the nation are anxiously wondering if affordable healthcare will get the upper hand over corporate control.