Why has the DCGI directed a popular combination drug to not be used in children under the age of 4

The DCGI has directed that a popular combination drug should not be used in children under the age of 4 for the following reasons: 1. Lack of safety data: The drug may not have been adequately studied in young children, and its safety profile for this age group may not be well-established. 2. Risk of adverse effects: Children under 4 years old may be more susceptible to the potential side effects of the drug. These side effects could be more severe in this age group, and therefore, caution is needed. 3. Developmental considerations: Young children are still in a critical stage of growth and development. The drug may interfere with their physiological processes or have an impact on long-term developmental outcomes. 4. Limited efficacy: The drug may not provide significant benefits for children under the age of 4. The potential benefits may not outweigh the risks associated with its use in this age group. The directive aims to protect the health and safety of young children by restricting the use of this combination drug in this particular age group.