Govt of India bans anti-cold drug combination in kids below four years

The Central Drugs Standard Control Organisation (CDSCO) has banned the use of the anti-cold drug combination.

New-Delhi: The Central Drugs Standard Control Organisation (CDSCO) has banned the use of the anti-cold drug combination.

The decision came after the death of atleast 141 children who lost their lives related to the cough syrups globally.

“FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on July 17, 2015, under the 18 months policy decision”, ANI reported quoting the letter.

The letter further stated, “Subsequently concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCL IP 5mg drop/ml was discussed before the committee.

“The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert,” the letter read.

As per the report released by the Central Drugs Standard Control Organisation (CDSCO), out of 1,105 samples tested, 59 samples were declared as ‘not of standard quality’.

The report was released by the CDSCO in November under a list of drugs, medical devices and cosmetics declared as ‘not of standard quality’ or ‘spurious’ or ‘adulterated’ or ‘misbranded’.

Also Read: New Rule For Cough Syrup Export To Kick Start From June 2023

 
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