ICMR seeks to provide oral formulation of hydroxyurea to treat sickle cell disease

• ICMR has invited Expressions of Interest for the joint development of a low dose or pediatric oral formulation of hydroxyurea to treat sickle cell disease in India.

Highlights:

• Sickle cell disease is one of the most common monogenic disorders of haemoglobin.
• Hydroxyurea, a myelosuppressive agent, is an effective drug for treating patients of sickle cell disease, and thalassemia.
• India has the highest prevalence of sickle cell disease in South Asia.
  • Over 20 million people with the disease live in the country.
• While most pharmaceutical companies in India market 500-mg capsules or 200-mg tablets of hydroxyurea, the biggest challenge in treatment is that it is not available in the suspension form for effective use in the case of pediatric patients
• Thus, there is a need for pediatric formulation of HU (hydroxyurea), considering the number of SCD cases in India and in view of the launch of the National Mission to eliminate Sickle Cell Anaemia by 2047
• The ICMR, also said that in India, according to the National Health Mission’s guidelines, healthcare providers initiate hydroxyurea therapy to only symptomatic sickle cell disease patients among children both because of the lack of availability of paediatric doses as well as the fear of toxicity.
• In children, the prescribed dose is 10 mg to 15 mg per kilogram of body weight after two years of age.
• This titration of dose is difficult, and currently, it is carried out by using a fraction of the broken capsules, which is not an appropriate method because it can lead to less accurate administration of the drug, which has five dose-related side-effects.

Prelims Takeaway

• Sickle Cell Disease
• Hydroxyurea