- 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.