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

Why is it in the news?

  • The Indian Council of Medical Research (ICMR) has invited Expressions of Interest (EoI) from eligible organizations for the “joint development and commercialization” of low dose or pediatric oral formulation of hydroxyurea to treat sickle cell disease in India.
Indian Council of Medical Research (ICMR):

·       ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research.

·       Its mandate is to conduct, coordinate and implement medical research for the benefit of the Society; translating medical innovations into products/processes and introducing them into the public health system.

·       It is funded by the Government of India through the Department of Health Research, Ministry of Health & Family Welfare.

 More about the news:

  • India has the highest prevalence of sickle cell disease in South Asia, and over 20 million sickle cell affected individuals reside 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’s not available in the suspension form for effective use in the case of pediatric patients, the ICMR said.

About Sickle Cell Anemia (SCA):

  • SCA is a type of sickle cell disease (SCD), first identified by physician James Herrick.
  • It distorts red blood cell shape, impacting oxygen distribution throughout the body.
  • In individuals with SCD, abnormal haemoglobin causes red blood cells to become rigid and look like a C-shaped farm tool called a sickle.
  • Healthy red blood cells, containing haemoglobin, are normally round and flexible.
  • This alteration hampers blood flow, affecting oxygen delivery to tissues and organs.
  • The premature death of sickle cells causes a shortage of red blood cells, exacerbating oxygen deficiency.
  • These obstructions and shortages may cause chronic anaemia, pain, fatigue, acute chest syndrome, stroke, and a host of other serious health complications.

SCA in India:

  • India is the second-worst affected country globally in predicted births with Sickle Cell Anemia (SCA).
  • Approximately 18 million individuals in India carry sickle cell traits, with 1.4 million affected by SCA.
  • SCA prevalence is notably high among tribal communities, with around 1 in 86 births among Scheduled Tribes (STs) affected.
  • Certain states, including Chhattisgarh, West Bengal, Uttar Pradesh, Maharashtra, Madhya Pradesh, Jharkhand, Gujarat, Odisha, Kerala, and Rajasthan, exhibit significantly elevated SCA rates.
  • These states collectively form the “sickle cell belt” in India.

Efforts to Combat Sickle Cell Anaemia in India:

  • Ministry of Tribal Affairs’ Initiative: Sickle Cell Disease Support Corner inaugurated to facilitate healthcare access in tribal regions.
  • This portal offers web-based patient registration, consolidating SCD data among India’s tribal communities.
  • In the Budget 2023-24, the government announced its plans to distribute “special cards” across tribal areas to people below the age of 40.
  • The cards will be divided into different categories based on the screening results.
  • The mission will receive funding under the National Health Mission.
  • In July 2023, PM Modi launched National Sickle Cell Anaemia Eradication Mission (NSCAEM) 2047.
  • The mission aims to address the pressing health challenges posed by sickle cell disease, particularly among the tribal population.
  • It was announced in the Union Budget 2023.
  • Through this mission, the government aims to eradicate sickle cell anaemia from India in a mission mode by 2047.
  • The The National Council on Sickle Cell Disease has also been constituted for timely and effective action.

About Hydroxyurea: 

  • Hydroxyurea, an oral chemotherapy medication, aids individuals with sickle cell disease by maintaining blood cell flexibility, improving oxygen delivery.
  • As a myelosuppressive agent, it inhibits bone marrow blood cell production, used effectively in sickle cell disease and thalassemia treatment.
  • Working: Sickle cell blood cells clump and form polymers when deoxygenated, increasing stickiness and blockage risks. Hydroxyurea boosts fetal haemoglobin (HbF), preventing polymer formation, thus averting complications in sickle cell disease.
  • Hydroxyurea for Children
  • Most pharmaceutical companies in India offer hydroxyurea in 500 mg capsules or 200 mg tablets.
  • The main challenge in treating paediatric patients is the lack of a suspension form, making low-dose treatment difficult.
  • Service providers must break down high-dose tablets, risking dose accuracy and efficacy.
  • There is a need for a paediatric formulation of hydroxyurea, especially considering the number of sickle cell disease cases and the goal of eliminating the disease in India by 2047.

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