November 25, 2024

Government approves 4 home-grown, cheaper drugs for rare diseases

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NEW DELHI: In a major relief for rare disease patients, the government said on Friday it has approved the marketing of four drugs manufactured by Indian pharmaceutical firms that are drastically cheaper than their imported versions.
For example, while the annual cost of the imported Nitisinonecapsule that is used in the treatment of Tyrosinemia Type 1 comes to Rs 2.2 crore, the domestically manufactured capsules will now be available for just Rs 2.5 lakh.Tyrosinemia Type 1 is a rare disease that affects one in a lakh population.
Similarly, while the cost of the imported Eliglustat capsules that is used in the treatment of Gaucher’s disease comes at Rs 1.8-3.6 crore per annum, the domestically manufactured capsules will now be available for just Rs 3-6 lakh per annum.

While the annual cost of the imported Nitisinone capsule used in the treatment of Tyrosinemia Type 1 comes to Rs 2.2 crore, the domestically manufactured capsules will now be available for just Rs 2.5 lakh.

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The cost of the imported Trientine capsules used in treatment of Wilson’s disease comes to Rs 2.2 crore per annum but with it being manufactured indigenously it will be available Rs 2.2 lakh.
The cost of the imported Cannabidiol (oral solution) used in treatment of Dravet-Lennox Gastaut Syndrome comes to Rs 7-34 lakh per annum but with it being manufactured indigenously it will be available for Rs 1-5 lakh per annum, officials said.The commercial supply of Hydroxyurea Syrup used in the treatment of sickle cell anemia is likely to begin by March 2024 and the tentative price would be Rs 405 per bottle. The cost of this oral suspension is $840 (Rs 70,000) per 100 ml. All these drugs were not manufactured in the country till now.
“The exercise to encourage Indian companies to manufacture generic versions of drugs used in treatment of the rare diseases, also referred to as the orphan drugs, started in July 2022 and discussions were held with academia, pharma industries, organisations, CDSCO, Department of Pharmaceuticals after which 13 rare diseases were prioritised along with sickle cell anaemia. After which interactions were held with drug manufacturers and the Drugs Controller General of India after which these drugs were approved and prices were slashed,” said an official.



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