CDSCO to ban common cold and flu syrups for children below 4 yrs; Pharma cos asked to insert warning

Subject : Science and Tech

Section::Health

In the news:

The Central Drugs Standard Control Organisation (CDSCO), the country’s apex health regulatory agency, has decided to ban the use of a popular anti-cold cocktail medicine combination among children below four years of age.

Expert Committee Recommendation:

In June, an expert committee discussed the matter and advised against using this drug combination for children under four.
The committee suggested adding a warning regarding this restriction on labels and package inserts.

Reason:

Some concerns have been raised over the use of a fixed drug combination of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCI IP 5mg drops. The formulation was an unapproved one for infants.
- The combination is used to treat cold and flu-like symptoms, which include coughing, sneezing, watery eyes, among others.
- Makers of these medicines have been asked to insert a ‘warning’.

About CDSCO:

Formed in 1961, operates under India’s Ministry of Health and Family Welfare.
Regulatory Scope and Functions:
- Oversees drugs, cosmetics, and medical devices’ safety, efficacy, and quality as per the Drugs and Cosmetics Act.
- Grants approvals for new drugs, licenses for manufacturing, and regulates clinical trials.
Organizational Structure:
- Comprises expert committees focusing on drug approvals, adverse event monitoring, and policy formulation.
Quality Control and Inspections:
- Manages a network of drug testing laboratories, conducts facility inspections to ensure compliance with regulations.
International Collaborations:
- Collaborates with global regulatory bodies and organizations to align with international standards and practices.