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ICMR Invites EoI for Paediatric Hydroxyurea Formulation for Sickle Cell Disease

  • The Indian Council of Medical Research (ICMR) seeks Expressions of Interest (EOI) for the joint development and commercialization of a low-dose or paediatric oral formulation of hydroxyurea to treat sickle cell disease (SCD) in India.
  • India has the highest prevalence of SCD in South Asia, with over 20 million affected individuals.
  • Current pharmaceutical options in India include 500-mg capsules or 200-mg tablets of hydroxyurea.
  • There is no suspension form available for effective paediatric use.
  • Hydroxyurea is a medication used to treat various conditions such as chronic myelogenous leukaemia (CML), sickle cell anaemia, and certain types of skin cancers.
  • It works by inhibiting DNA synthesis, which helps to slow the growth of cancer cells and reduces the frequency of sickle cell crises.

ICMR’s Statement

  • A paediatric formulation is essential due to the high number of SCD cases and the National Mission to eliminate SCD by 2047.
  • Hydroxyurea therapy for symptomatic children is challenging due to the lack of paediatric doses and toxicity concerns.
  • The prescribed dose for children is 10-15 mg per kilogram of body weight after two years of age, but current methods are inaccurate and pose risks.

Dig Deeper: Read about the increased burden of Noncommunicable diseases in India.

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