Game Changer for Rare Disease Treatment: Natco Launches Affordable SMA Drug

In a major relief for families grappling with spinal muscular atrophy (SMA), Indian pharmaceutical company Natco has announced the launch of a generic version of the life-saving drug risdiplam, drastically reducing its annual cost from ₹72 lakh to approximately ₹5 lakh.

The announcement has been welcomed by parents of SMA patients across the country. “Making this medicine available at a reduced price without compromising efficacy and safety will increase accessibility and be a game changer,” said one parent.

According to Natco’s legal update titled “Risdiplam Launch in India,” the drug will be priced at ₹15,900 per 60mg bottle. Adult SMA patients, who typically require about 30 to 36 bottles annually, would see their annual medication expense fall significantly under the new pricing.

However, the company’s ability to manufacture and supply risdiplam is subject to the outcome of an ongoing legal battle. Roche, the multinational that holds the original patent, has challenged a Delhi High Court ruling from March 24 that denied an injunction against Natco’s production. The matter is currently under appeal.

The price difference is stark. While Roche sells risdiplam in India at over ₹2 lakh per bottle through Centres of Excellence for Rare Diseases, the same drug is available at ₹44,700 in China and ₹41,000 in Pakistan. In her affidavit to the Supreme Court, SMA patient Seba PA pointed out the glaring disparity in international pricing.

A Yale University expert estimated that with local production, the cost of manufacturing risdiplam could be as low as ₹3,000 per year.

India’s Rare Disease Policy offers a one-time financial aid of up to ₹50 lakh per patient. However, at Roche’s current pricing, this amount doesn’t even cover a single year’s treatment. With Natco’s lower pricing, the same assistance could potentially provide a patient with medication for nearly a decade.

Despite over 750 SMA patients being listed on the government’s rare disease portal and 1,800 registered with the Cure SMA trust, very few have received any financial support. Cure SMA’s intervention in court highlighted that only two or three patients had benefitted from government assistance so far.

Public health experts argue that facilitating local production and bulk procurement is the only sustainable path forward. “At the current price, treating 1,800 SMA patients would cost ₹90,000 crore—equivalent to the entire Union Health Ministry budget for 2024,” said one activist. “Local manufacturing, as outlined in the National Rare Diseases Policy, is the only feasible way to make treatment affordable and assistance meaningful.”

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