In a major development, a leading Indian pharmaceutical company, Natco Pharma, has been given approval to produce Risdiplam. This is a groundbreaking therapeutic drug for the treatment of Spinal Muscular Atrophy (SMA). This decision made by the Delhi High Court is expected to dramatically lower treatment costs. Because of the decision, this life-saving drug is accessible to more patients in India and globally.
What is Spinal Muscular Atrophy (SMA)?
SMA is a rare and life-threatening genetic disorder. It causes progressive muscle weakness and atrophy because of the loss of motor neurons. It primarily affects infants and young children. It is one of the leading causes of death in this age group. Approximately 1 in 10,000 live births are affected by SMA. This makes it a critical condition that need effective treatments.
The Role of Risdiplam in SMA Treatment:
Risdiplam is marketed as Evrysdi. It works by increasing the production of the SMN protein that is important for motor neuron survival. This therapeutic drug can slow the progression of the disease and improve motor function. This offers hope to SMA patients.
Impact on Patients:
Risdiplam was inaccessible to many due to its steep price of nearly ₹6.2 lakh per bottle. Nonetheless, the financial burden on families will be alleviated as Natco Pharma’s generic version will be priced at only ₹15,900 per bottle.
This landmark decision is aligned with India’s National Policy for Rare Diseases, which seeks to encourage domestic manufacturing of essential medicines and subsequently increase their affordability for patients.
References:
https://indianexpress.com/article/cities/delhi/delhi-hc-sma-drug-risdiplam-natco-swiss-pharma-roche-9905857/
https://finshots.in/archive/is-pharma-playing-fair-risdiplam-the-cost-of-survival-evrysdi-la-roche-natco-pharma/
Why is Risdiplam so expensive in India?
Risdiplam, sold as Evrysdi by Roche. It costs between ₹20-70 lakhs annually in India. This makes Risdiplam inaccessible for most patient populations. The high price is because of the company’s patent rights and the drug’s limited market.
What did Natco Pharma do regarding Risdiplam?
Natco Pharma sought to manufacture a generic version of Risdiplam at a significantly lower price. Once the manufacturing of Risdiplam starts from Natco, the medicine will be more affordable and accessible to SMA patients in India.
Why did Roche challenge Natco's generic version of Risdiplam?
Roche challenged Natco’s generic production, citing patent infringement. Roche’s patent for Risdiplam is valid until 2035. This gives it exclusive rights to manufacture and sell the medicine.
What did the Delhi High Court decide in this case?
The Delhi High Court ruled in favor of Natco. This allows the company to manufacture Risdiplam. The court emphasized the public interest and affordability of the therapeutic drug for SMA patients in India.
How does India’s patent law affect generic drug production?
India’s patent law allows generic drug production under certain conditions, including compulsory licensing if a patented drug is too expensive or not meeting public demand. This ensures medicines are affordable.
What is 'evergreening' in the pharmaceutical industry?
A company practices evergreening when it modifies a drug’s patent by making slight alterations that do not improve its effectiveness. This strategy blocks generic alternatives and maintains high prices for the drug.
