The Drug Controller General of India (DCGI) has asked the state licensing authorities not to grant fresh licenses or renewals of the combination products of paracetamol, containing more than 325 mg per tablet or capsule.
The DCGI, in a notice to the zonal and sub-zonal officers of Central Drugs Standard Control Organisation (CDSCO), asked them to covey it to the respective State authorities. “The manufacturers marketing combination products having more than 325 mg of paracetamol should be asked to limit the paracetamol contents to 325 mg only in a period of three years,” it said.
The manufacturers of paracetamol combination products may also be asked to provide box warning on the label of such FDCs indicating that 'taking more than daily dose may cause serious liver damage or allergic reactions such as swelling of the face, mouth and throat, difficulty in breathing, itching or rash,' according to the order.
The order was issued based on the decision of the Drug Technical Advisory Board (DTAB) which agreed that as the paracetamol is known to have liver toxicity in the light of the decision taken by the US FDA, India also should limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination products in a phased manner in three years.
The proposal of limiting acetaminophen (paracetamol) was considered by the DTAB in the wake of US FDA issuing a note in January last year. The US agency asked the manufacturers of prescription combination products in USA to limit the amount of acetaminophen to 325 mg per table, citing the toxicity complications and with a view to ensuring patients safety.
The US FDA had also mentioned in the note that there was no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by the healthcare providers. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within 24 hours. The elimination of higher dose prescription combination acetaminophen products will be phased out in three years and would not create shortage of pain medication,” according to the US FDA note.