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Four Rare Disease Medicines Witness Price Drop Amidst Domestic Production

Union Health Ministry officials said on Friday that because Indian pharmaceutical businesses are now developing medicines for four rare diseases instead of relying on pricey import formulations, these medicines are now available at substantially lower costs.

The price cuts come as the government prioritizes work on 13 uncommon illnesses, including sickle cell anaemia. Drugs for four of these disorders, including Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, as well as sickle cell anemia, have been authorized and are being produced in the United States.

Four more drugs for three diseases – Tablet Sapropterin for Phenylketonuria, tab Sodium Phenyl Butyrate and tablet Carglumic Acid for Hyperammonemia and Capsule Miglustat for Gaucher’s disease – are under process for approval and are likely to be available by April 2024, official sources said.

Because these pharmaceuticals will be made in the country, the yearly cost of Nitisinone capsules, which are used to treat Tyrosinemia Type 1, will be one-hundredth of the price of the imported medicine.

“For example, while the annual cost of the imported capsule comes at Rs 2.2 crore, the domestically manufactured capsules will now be available for just Rs 2.5 lakh,” a person familiar with the matter said.

Similarly, while imported Eliglustat capsules cost Rs 1.8-3.6 crore per year, domestically made capsules would now cost Rs 3-6 lakh per year, according to the source.

The cost of the imported Trientine capsules used in the treatment of Wilson’s disease comes to Rs 2.2 crore per annum but with the drug being manufactured indigenously, it will be available for Rs 2.2 lakh.

The cost of imported Cannabidiol (oral solution) used in the treatment of Dravet-Lennox Gastaut Syndrome is Rs 7-34 lakh per year, however it would be accessible for 1-5 lakh per year owing to local manufacture.
The commercial supply of Hydroxyurea Syrup, which is used to treat sickle cell anemia, is expected to commence in March 2024, with an estimated price of Rs 405 per bottle.

From abroad, this oral suspension costs 840 USD (Rs 70,000) for 100 ml.

All these drugs were not manufactured in the country till now.

“The exercise began in July 2022, and discussions were held with academia, pharmaceutical industries, organizations, CDSCO, and the Department of Pharmaceuticals, after which 13 rare diseases, including sickle cell anaemia, were prioritized.”

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Source: Business Standard

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