As recommended by the US/FDA, India has decided to limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination products within the next three years.
With an aim to ensure that manufacturers comply with the advisory of restricting content of paracetamol in combination products, the Drug Controller General of India (DCGI) has asked the state drug controllers to allow renewal of licence of the manufacturers only after ensuring that manufacturers comply with the requirements in a specified period.
“The state drug controllers have been alerted to renew the licenses of manufacturers for three years only. After three years, the manufacturers will have no option but to limit the content of the drug,” said a senior official.
“The limiting of paracetamol in prescription combination is required to be completed in a period of three years,” said the DCGI’s recent letter to the state drug controllers.
The Drug Technical Advisory Board (DTAB) — the highest technical body, had earlier suggested to limit the content after the US/FDA recommended for the same as the drug was found to be causing liver toxicity.
In his recent communication with the state drug controllers, the DCGI has also recommended the state drug controllers to ensure that “box warning” be printed on the label of such FDCs indicating that “taking more than daily dose may cause serious liver damage or allergic reactions”.
The decision by the DCGI was taken earlier 2012 following the news release by the US FDA.