India’s Risdiplam Launch Cuts SMA Drug Cost to ₹15K
A major breakthrough has just made waves in India’s healthcare scene — a new treatment for spinal muscular atrophy (SMA) is finally here. This isn’t just medical news; it’s life-changing for hundreds of families across the country who’ve been waiting for hope, access, and affordability.
For years, SMA patients in India have faced two tough choices: either import an expensive treatment or go without. Now, with the launch of a cost-effective oral medication by Natco Pharma, things are finally looking up.
In this blog, we’ll walk you through everything you need to know — what SMA is, why this launch matters, how it’s stirring legal debates between Natco and Roche, and most importantly, what this means for Indian families. We've also included expert opinions, current pricing updates, and answers to common questions. Let’s break it all down.
What’s all the buzz about this new drug launch in India?
Known globally for its effectiveness, the drug has now entered the Indian market in a more accessible form. The credit goes to Natco Pharma, which introduced a generic version of the original molecule developed by Swiss giant Roche.
Until now, Indian patients were largely cut off from this life-saving medication because of high costs and limited availability. Natco’s move is being called a “ray of hope” by several health experts. In fact, Dr. Sheffali Gulati, Head of Child Neurology at AIIMS, New Delhi, told ET Healthworld, “This launch is a significant step forward for SMA patients in India, especially for early-stage cases where timely treatment can transform outcomes”
How serious is spinal muscular atrophy, and why is this drug a big deal?
SMA is a progressive genetic disorder that affects nerve cells in the spinal cord, leading to muscle wasting and weakness. It’s among the top genetic causes of infant mortality worldwide.
In India, access to SMA therapies has been particularly grim. The injectable alternatives required hospitalisation and cost crores annually. This new oral solution brings a massive shift, not just in how it's administered but also in who can afford it. It can be taken at home, sparing families from endless hospital visits and medical procedures.
Who’s behind the launch, and why is there legal drama?
The excitement comes with some courtroom tension. Natco Pharma launched its version of the drug amidst a high-profile patent dispute with Roche. Natco claims its move is protected under India’s compulsory licensing provisions, which allow the production of generics for public health needs.
The Natco Pharma vs Roche patent battle has been playing out in Indian courts and is now one of the most significant pharmaceutical IP cases in recent memory. On the other side, Roche is holding firm on its patent rights, arguing that the launch undermines years of research investment.
But, according to Dr. Melissa Barber from Yale University, India has every reason to make this move. In a presentation cited by the Times of India, she noted, “If India chooses to manufacture locally, the same drug could cost as little as ₹3,000 per year”
How much does the treatment cost in India now?
Let’s talk numbers. Before this launch, families paid an astronomical ₹6 - 8 lakh every month or over ₹70 lakh a year. That’s not something the average household could even dream of affording.
This significant price drop is a major relief for patients and advocacy groups who have long campaigned for more affordable rare disease treatments in India.
Is it approved and safe to use?
Yes, this isn’t a grey-market drug. The Risdiplam approval in India followed a rigorous evaluation by national regulatory bodies. Authorities reviewed international clinical trial data along with Indian studies to ensure the generic was up to the mark.
The drug is already approved in over 80 countries and has shown strong safety and efficacy profiles, especially in early-stage SMA cases. Its oral form is particularly beneficial for children and patients with mobility issues.
What’s next for the SMA community in India?
This isn’t just about one medicine. The ripple effects of this launch could be felt across the rare disease landscape in India. More pharmaceutical companies may now consider pursuing compulsory licenses for other high-cost treatments, especially for rare and orphan diseases.
It also puts pressure on the government to formalise frameworks for rare disease management and funding. Financial aid schemes have started rolling out, but families still report bureaucratic delays.
Still, hope is in the air—and it's not just because of a single drug. It's because of a shift in mindset. Accessibility is becoming a priority, and that could lead to real, long-term change.
Frequently Asked Questions (FAQs)
Q.1) What is the name of the new SMA drug launched in India?
The new SMA drug launched in India is a generic version of risdiplam, recently introduced by Natco Pharma. It offers a more affordable alternative to the brand-name drug Evrysdi. This launch marks a significant step toward making SMA treatment more accessible in India.
Q.2) How much is a bottle of risdiplam?
The price of a bottle of risdiplam in India varies significantly depending on the manufacturer. Roche's brand-name version, marketed as Evrysdi, is priced at approximately ₹6.2 lakh per bottle. In contrast, Natco Pharma has introduced a generic version of risdiplam at a much lower cost of ₹15,900 per bottle. This stark price difference highlights ongoing efforts to improve accessibility and affordability for patients who rely on this essential medication.
Q.3) Who can use Risdiplam?
Risdiplam is prescribed for individuals diagnosed with Spinal Muscular Atrophy (SMA) Types 1, 2, and 3. A healthcare professional will determine eligibility based on the patient’s condition and medical history. It is important to undergo proper evaluation before starting the treatment.
Q.4) What about side effects?
Common side effects of risdiplam may include diarrhea, rash, and fever. Some patients might experience other symptoms, which should be reported to a doctor immediately. Always consult a healthcare provider before starting the medication to assess potential risks and benefits.
Q.5) Can we get financial help for this treatment?
Yes, financial assistance is available through various avenues in India. The National Policy for Rare Diseases (NPRD) 2021 provides up to ₹50 lakh per patient for treatment at designated Centers of Excellence. Additionally, NGOs like the Care and Protection of Children Trust (CPCT) have partnered with pharmaceutical companies to offer lifelong free access to Risdiplam for eligible children. Some state governments, such as Karnataka, have also initiated programs to support SMA patients. It's advisable to consult with local SMA support groups and healthcare providers to explore these options.
Parting words
This launch represents more than just a new drug; it signifies a shift in India's approach to treating rare diseases. The introduction of an affordable, effective treatment for SMA sets a precedent for future developments in the healthcare sector.
The ongoing patent case between Natco Pharma and Roche underscores the importance of balancing intellectual property rights with public health needs. As the situation evolves, it may pave the way for increased accessibility to essential medications for rare diseases in India.
Stay informed as this story continues to develop, potentially reshaping the landscape of rare disease treatment in the country.
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References
- https://health.economictimes.indiatimes.com/news/policy/sc-to-hear-pleas-over-rs-50-lakh-cap-on-centre-aid-for-rare-diseases/120115704
- https://timesofindia.indiatimes.com/india/rs-72-lakh/year-rare-disease-drug-can-be-made-for-rs-3000/year-hc-told/articleshow/114666406.cms
- https://www.pharmabiz.com/NewsDetails.aspx?aid=177199&sid=2
- https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/health-groups-raise-concerns-over-patents-for-rare-disease-drugs/articleshow/114991405.cms
- https://pubmed.ncbi.nlm.nih.gov/35284988/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10977425/
