Safety Concerns Over Indian Cough Syrups

16.05.2025

Safety Concerns Over Indian Cough Syrups

Context:     

Recent reports have highlighted serious health risks associated with certain cough syrups used for children in India. The issue has raised national and international alarm regarding drug regulation standards in India, especially since such syrups are also exported to other countries.

About the Issue:

• Fixed Dose Combinations (FDCs):
   The syrups in question contain Fixed Dose Combinations—two or more active drugs combined in a fixed ratio. These are often not clinically tested in combination for safety or efficacy in young children.
• Target Group:
   Commonly administered to children under 4 years of age, who are especially vulnerable to adverse drug reactions.
   
• Harmful Ingredients Identified:
  • Chlorpheniramine Maleate (an antihistamine)
  • Phenylephrine (a decongestant)
     These can lead to respiratory distress, drowsiness, irregular heart rate, and in extreme cases, sudden death, particularly in infants and toddlers.
     
• Unregulated Sale:
   These syrups are freely available over the counter in pharmacies, many of which are run by untrained staff, violating norms under the Drugs and Cosmetics Act, 1940.
   
• International Repercussions:
   Several of these syrups are part of India’s pharmaceutical exports, risking India’s reputation as a global pharma hub, especially after past incidents in Gambia and Uzbekistan where Indian syrups were linked to child deaths.
   

Recent Government Action:

• On April 15, 2025, the Government of India directed a halt in manufacturing of these harmful FDC-based cough syrups.
   
• However, the Delhi High Court allowed the sale of already manufactured stocks, raising concerns over enforcement and public safety.
   

Way Forward:

1. Parental Vigilance:
   • Parents should carefully read labels and verify ingredients before giving any syrup to children.
   • Avoid syrups with harmful FDCs and prefer safer alternatives such as:
     • Cetirizine (for allergy-related cough)
     • Fexofenadine (a non-sedating antihistamine)
2. Public Awareness:
   • Launch nationwide information campaigns about the risks of over-the-counter syrups.
   • Disseminate guidelines on safe home remedies for mild coughs and colds (e.g., warm water, honey).
3. Regulatory Reforms:
   • Strengthen drug regulation by:
     • Closing legal loopholes exploited by manufacturers.
     • Strictly enforcing bans on unsafe drug combinations.
     • Ensuring proper licensing and training of pharmacy operators.
4. Infrastructure and Manpower:
   • Increase the number of qualified drug inspectors.
   • Train existing pharmacy staff on basic pharmacology and drug safety protocols.
5. Encourage Safe Alternatives:
   • Promote natural and evidence-based remedies in mild cases.
   • Encourage pediatric consultations before administering any medicine to children.
      

Conclusion:

The issue of unsafe pediatric cough syrups in India is symptomatic of larger structural weaknesses in pharmaceutical regulation. While the recent government action is a step in the right direction, more robust and preventive measures are needed. From public education and regulatory tightening to improving pharmacy practices, a multi-pronged approach is essential to protect child health and safeguard India’s global pharmaceutical credibility.