Reduction in Spinal Muscular Atrophy (SMA) Treatment Costs in India
The Delhi High Court's recent verdict significantly impacts the cost of SMA treatment in India, facilitating domestic production of a generic drug.
Key Judgement Details
- The court allowed Natco Pharma to manufacture a generic version of Risdiplam.
- The decision followed the denial of an interim injunction plea by Roche to prevent patent infringement.
Impact on Drug Pricing
- Current drug costs range from ₹22 lakh to ₹72 lakh annually, depending on dosage and patient weight.
- Natco's generic pricing is expected to be around ₹3,000 annually.
- The ruling is a potential lifesaver for patients struggling with high costs.
Legal and Industry Perspectives
- The court prioritized drug accessibility for rare diseases over patent protection.
- Nirali Shah, a pharma analyst, noted the ruling challenges Roche's IP rights and could reset the price structure for orphan drugs.
Pharmaceutical Company Responses
- Roche stresses the importance of IP protection for innovation and patient access.
- Roche has been working on tailored pricing models and patient assistance programs to make the drug more accessible.
Public and Legal Advocacy
- Petitioners like Seba PA and Purva Mittal view the ruling as critical to making SMA treatment affordable.
- The ruling challenges the current funding limits of the National Policy for Rare Diseases, which caps government support at ₹50 lakh.
- Seba's lawyer highlighted how the decision could reduce unnecessary deaths from SMA.
Conclusion
This landmark decision is expected to lead to a drastic reduction in SMA treatment costs, potentially increasing accessibility and saving lives by making the treatment affordable for more patients.
