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.