New Delhi: In a groundbreaking move, the Indian government has launched a special initiative to manufacture four types of homegrown “Made in India” drugs for rare diseases, addressing a crucial healthcare need in the country. This initiative, unveiled by the Central Government, marks a significant shift, as all drugs used for treating rare diseases were previously imported and expensive.
The Central Government has identified and prioritized 13 rare diseases, along with sickle cell disease, for the manufacturing of indigenous drugs. This strategic move, initiated in July 2022, followed extensive discussions with academia, pharmaceutical industries, organizations, and the CDSCO (Central Drugs Standard Control Organization) department of pharmaceuticals.
“After discussions with pharma companies, scientists, drug regulators, and academia, we decided to initiate manufacturing to deliver the drugs. We prioritized drugs for 13 rare diseases and for sickle cell disease as well,” stated official sources from the Union Health Ministry.
This initiative is expected to bring about a revolutionary change, significantly reducing costs. The sources mentioned, “If a drug is costing 2.5 crore, then in India, it will cost 2.5 lakh.” The new drugs are anticipated to bring down costs by up to 100-fold, making them more accessible to patients.
For instance, the Union Health Ministry highlighted that a 2 mg tablet costing 5 lakhs in Sweden will be available for 6500 in India. The move is crucial as rare diseases are health conditions with particularly low prevalence, affecting a small number of people. India has an estimated 8.4-10 crore cases of rare diseases, with 80% being genetic conditions.
Currently, there are eight types of generic drugs available in India for rare diseases, including Tyrosinemia Type, Gaucher’s Disease, Wilson’s Disease, and Dravet or Lennox Gastaut Syndrome-seizures. Another four types of drugs are expected to be available next year.
The priority drugs include Nitisinone (capsules) for Tyrosinemia Type 1, with a significant cost difference – 2.2 crore per annum if purchased from other countries but manufactured in India at 2.5 lakh per annum. Eliglustat, recommended for the treatment of Gaucher’s Disease, will cost India ₹3-6 lakhs per annum.
The initiative also aims to boost domestic production of Hydroxyurea syrup for sickle cell anemia, offering a low-cost alternative starting next year. India reports approximately 65 cases of Tyrosinemia Type 1, 235 cases of Gaucher’s disease, and a significant number of cases of Spinal Muscular Atrophy.
India’s move to initiate low-cost drugs for rare disease treatment follows a careful study of successful models from other countries and addresses a critical healthcare gap in the country.
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