DCGI Issues Warning on Chlorpheniramine Maleate and Phenylephrine Syrup, Prohibits Use in Children Below 4 Years

The Drugs Controller General of India (DCGI) has flagged as risky the cough syrup containing a combination of Chlorpheniramine Maleate and Phenylephrine for children under 4 years old. DCGI has advised against administering this syrup to children under 4 years of age for the past 4 years. The combination syrup, which includes Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL 5mg, is commonly used for the treatment of cold, congestion, and flu.

DCGI issued a Fixed Dose Combination (FDC) notice to all states on December 18th, which specifies that caution should be exercised in labeling cough syrups made from the combination of Chlorpheniramine Maleate and Phenylephrine. It emphasizes that such syrups should not be given to children under 4 years of age.

Concerns Over the Use of Over-the-Counter Drugs for Children by WHO and DCGI

The Drugs Controller General of India (DCGI) has expressed concerns over the use of cough syrups containing Chlorpheniramine Maleate and Phenylephrine in children under the age of 4. DCGI has been advising against the use of such formulations for children under 4 years old for the past 4 years. The combination syrup is commonly used to address issues like cold, congestion, and flu symptoms.

WHO also recommends avoiding the use of over-the-counter drugs for children under 5 years of age. Over-the-counter drugs are those that can be purchased directly by consumers without a doctor’s prescription. These drugs are readily available in medical stores.

DCGI recently issued a notice to all states regarding Fixed Dose Combinations (FDC), emphasizing caution in labeling cough syrups made from the combination of Chlorpheniramine Maleate and Phenylephrine. The directive underscores that such syrups should not be administered to children under 4 years of age.

The concern over the use of cough syrups is based on reported cases where 12 children died and 4 suffered serious health issues in India in 2019 after consuming locally manufactured cough syrups. Post this incident, India imposed stringent testing requirements for cough syrups, aiming to ensure the safety standards of these medications.

In light of these concerns, WHO and DCGI advise parents and caregivers to exercise caution and seek medical advice before administering any over-the-counter drugs to young children. The health and well-being of children are of paramount importance, and ensuring the safety of medications is crucial for their overall health.

High Mortality Among Children Linked to Indian Medications in Several Countries

In 2022, 70 children in Gambia reportedly lost their lives due to the consumption of four syrups manufactured by the Indian company Medman Pharma. All the deceased children were under the age of 5, and the cause of death was identified as kidney failure. The investigation by the Gambian government revealed that symptoms leading to these deaths were consistent across all cases.

Gambia is not the only country facing such tragic incidents. Uzbekistan’s government accused Indian-made cough syrups of causing the deaths of 18 children in their country. Uzbek health authorities specifically pointed to the cough syrup DOK-1 MAX produced by Merian Biotech in Noida, India.

The accusations have raised concerns globally about the safety and quality standards of medications manufactured in India. These incidents highlight the need for rigorous testing, quality control, and international collaboration to ensure the safety of pharmaceutical products, especially those intended for children.

The accusations and subsequent investigations underscore the importance of stringent regulatory measures and transparency in the pharmaceutical industry. It is crucial for countries to collaborate and share information to prevent such tragedies and protect the health and well-being of children worldwide.