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Dated: 12.06.2025
New Drug Safety Regulation Restricts Cold Medication for Young Children
The Ministry of Health and Family Welfare, Government of India, has issued Notification S.O. 1717(E) dated 15.04.2025, prohibiting the manufacture, sale, and distribution of pharmaceutical formulations containing the fixed-dose combination (FDC) of Chlorpheniramine Maleate + Phenylephrine for pediatric use in children below 4 years of age.
Key Highlights of the Notification
- Notification Date: 15th April 2025
- FDC Banned: Chlorpheniramine Maleate + Phenylephrine
- Target Group: Children aged below 4 years
- Legal Backing: Section 26A of the Drugs and Cosmetics Act, 1940
- Implication: Ban on manufacture, sale, and distribution of this FDC for pediatric use
Legal Context: Section 26A of the Drugs and Cosmetics Act, 1940
The Government exercised its power under Section 26A, which authorizes the Central Government to regulate or restrict drugs that may involve risk to human beings or where safer alternatives exist.
This section enables prohibition when:
- The drug is unsafe under normal use,
- There is no therapeutic justification, or
- It poses risk that outweighs benefit.
Scientific Reason Behind the Ban
Recent pharmacovigilance and expert studies highlighted:
- Increased risk of respiratory depression, sedation, and CNS side effects in children under 4
- Lack of sufficient data on the efficacy and safety of these FDCs in infants and toddlers
- Recommendations by the Drugs Technical Advisory Board (DTAB) to restrict pediatric use
Why This Matters to Consumers and Manufacturers
- Pharmaceutical Companies must immediately stop production and recall affected formulations.
- Retailers and Distributors must ensure such drugs are withdrawn from shelves.
- Parents and Pediatricians should avoid administering cold medications containing this combination to children below 4 years.
What Should Be Used Instead?
Doctors are advised to:
- Rely on symptomatic management (like nasal saline drops, hydration, steam)
- Prescribe safer alternatives, especially under pediatric consultation
Advisory for Healthcare Professionals
- Carefully check age-appropriate formulations
- Educate parents on the dangers of self-medication in infants
- Report adverse events to PvPI (Pharmacovigilance Programme of India)
Conclusion
The notification marks a proactive step in child safety regulation and aligns with global best practices to ensure that pediatric medication is evidence-based, safe, and age-appropriate. This move reinforces the government’s commitment to patient-centric drug policy, particularly for vulnerable populations like infants and toddlers.
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Source: MoHFW
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