SC stays order asking govt to procure drugs for patient with rare disorder

The Supreme Court has stayed in the interim a Kerala High Court order directing the Centre to provide an additional Rs 18 lakh worth of medicines to a patient suffering from spinal muscular atrophy, beyond its Rs 50 lakh cap.

A bench comprising Chief Justice Sanjiv Khanna and Justice Sanjay Kumar on February 24 issued notice to the respondents on Centre's plea.

"Issue notice returnable in the week commencing April 17, 2025... till the next date of hearing, there will be a stay of the order of the impugned judgment."  Spinal muscular atrophy (SMA) is a rare genetic disorder characterised by progressive muscle weakness and wasting, affecting the nerve cells responsible for controlling voluntary muscle movement.

Under the policy, Centre can provide Rs 50 lakh for treatment to a needy patient.

The high court on February 6 instructed that the SMA drug Risdiplam should be provided as a one-time measure to ensure continued treatment for 24-year-old Seba PA till the matter over its high pricing was addressed by a single-judge bench -- a process expected to take at least a month.

Seba's plea before the high court highlighted the exorbitant cost of Risdiplam, priced at Rs 6.2 lakh a bottle.

Patients weighing up to 20 kilogram require one bottle a month whereas heavier patients may need up to three bottles, making long-term treatment financially unfeasible.

The Centre argued while the high court had clarified its ruling was not a binding precedent, granting individual exceptions could set one by default.

"There are more than 3,000 patients across India with varying facts and circumstances and if each case were considered unique, it could create an unsustainable financial burden," it added.

The Centre's counsel said the government policy set a firm cap at Rs 50 lakh for all patients, regardless of available resources.

Senior advocate Anand Grover, appearing for Seba, said the government could have taken steps to reduce the cost of SMA treatment by either negotiating with the drug manufacturer or invoking provisions under the Patents Act, 1970.

Grover said countries like China and Pakistan had successfully negotiated with the manufacturer to lower the price of SMA treatment and questioned why India had not taken similar steps.

The bench, however, suggested that the Indian government might be refraining from such measures due to "international ramifications".

"Why would the Indian government not be interested? They will be very much interested. It's easy to be critical on that. They would have tried their level best to get the prices down," the bench said.

The bench asked the Centre to explore the possibility of approving expenditures beyond Rs 50 lakh on a case-by-case basis.