TAG: GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: The Indian Council of Medical Research (ICMR), the apex biomedical research body in India, has invited Expressions of Interest (EoI) from eligible organizations, companies, and manufacturers to undertake the “Joint Development & Commercialization” of a low-dose or paediatric oral formulation of hydroxyurea to treat sickle cell disease (SCD) in India.
EXPLANATION:
Challenges with Current Hydroxyurea Formulations
- India has the highest prevalence of SCD in South Asia, with over 20 million affected individuals.
- Most pharmaceutical companies in India market hydroxyurea in 500 mg capsules or 200 mg tablets.
- The biggest challenge is the lack of availability of a hydroxyurea suspension formulation for effective use in paediatric SCD patients.
- Since only high-dose hydroxyurea tablets are available, initiating low-dose treatment becomes difficult for healthcare providers, as the capsule or tablet has to be broken down appropriately to be administered based on the child’s body weight, risking the efficacy of the measured doses.
Paediatric Hydroxyurea Formulation and its Need
- Hydroxyurea, a myelosuppressive agent, is an effective drug for treating SCD and thalassemia patients by inducing fetal haemoglobin (HbF).
- In India, according to the National Health Mission’s guidelines, healthcare providers initiate hydroxyurea therapy only for symptomatic SCD patients among children, due to the lack of availability of paediatric doses and the fear of toxicity.
- The prescribed dose for children is 10-15 mg per kilogram of body weight after two years of age.
- This titration of the dose is difficult, as it is currently done by using a fraction of the broken capsules, which can lead to less accurate administration of the drug and its dose-related side effects.
- With the availability of a paediatric formulation, the titration of the drug can be better, and its dose-related side effects can be reduced.
- The ICMR has stated that there is a need for a paediatric formulation of hydroxyurea, considering the number of SCD cases in India and the launch of the National Mission to eliminate Sickle Cell Anaemia/SCD by 2047.
ICMR’s Invitation for Collaboration
- The ICMR is inviting EoIs from eligible organizations, companies, and manufacturers for the “Joint Development & Commercialization” of a low-dose or paediatric oral formulation of hydroxyurea for SCD treatment in India.
- The ICMR is willing to collaborate with the selected organizations and provide technical support through its team of experienced scientists in study planning, product development, clinical studies, and other aspects.
- The ICMR may enter into exclusive or non-exclusive agreements with the eligible manufacturing companies for the joint development and commercialization of the paediatric oral formulations of hydroxyurea for SCD.
Indian Council of Medical Research (ICMR)
- The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
- The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health & Family Welfare.
- It aims to translate Research into Action for Improving the Health of the Population.
- Its objective are:
- Generate, manage and disseminate new knowledge.
- Increase focus on research on the health problems of the vulnerable, the disadvantaged and marginalized sections of the society.
- Harness and encourage the use of modern biology tools in addressing health concerns of the country.
- Encourage innovations and translation related to diagnostics, treatment, methods/ vaccines for prevention.
- Inculcate a culture of research in academia especially medical colleges and other health research institutions by strengthening infrastructure and human resource.