An appeal by Mr. Haris Beeran, member of Parliament from Rajya Sabha member to the Union Health and Family Welfare Ministry on Dec 20, 2024, sparked the debate to find the equilibrium between public health and the protection of Intellectual Property. Mr. Beeran appealed to the ministry “to invoke Section 100(1) of the Patents Act to facilitate local production of a drug called risdiplam”.
Spinal Muscular Atrophy (SMA) is a rare genetic disease caused by mutation in the SMN1 gene. Risdiplam, the only curative medicine for SMA is protected under the Indian Patent Law until year 2035. The medicine is available at an exorbitantly high price of INR 620,000/- per bottle. The cost of dosage required for children can go up to 72 lakhs (12 bottles) and 1.86 crores for adults (30 bottles).
Section 100 of the Indian Patents Act allows the Central Government to use the Patented invention for the purposes of the Government. Also, the National Policy of Rare Diseases (NPRD) 2021 emphasizes and provides framework to address the issues of reducing the cost of treatment and allow local manufacturing of the essential drugs.
India's Patenting system provides means and measures to balance the priority of public health vis-à-vis expensive drugs required for the treatment of rare diseases. However, Central Government while executing its powers should also take in consideration the rights of the Patent holders along with the improved quality of life which the SMA patients has to lead.
In context with the article: MP Haris Beeran calls for local production of generic drug variant for spinal muscular atrophy - Telegraph India
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