The Union health ministry's notification on 'limiting of Acetaminophen (paracetamol) in prescription combination products' dated 23.9.2011 and the subsequent clarificatory' notification dated 4.4.2012 have created confusion among the industry, as an impression has been created that the concentration of paracetamol should be restricted to 325mg for all combination products containing paracetamol.

Following the footsteps of the US FDA, in which the US agency had issued a news release on January 13, 2011 directing that prescription combination pain medications containing Acetaminophen should be limited to 325mg per tablet/ capsule, the Drugs Technical Advisory Board (DTAB) also recommended to implement the same in India. The US FDA had expressed its concern over various pain medications containing paracetamol in combination with other analgesic or anti-inflammatory drugs and therefore coined the words 'prescription combination pain medication'.

Based on the recommendations of the DTAB, the Central Drugs Standard Control Organisation (CDSCO) issued a notification, asking the state drug authorities that “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.” 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, the CDSCO order further said.

Sources in the industry said that the ministry's notification on 23.9.2011 and the subsequent clarificatory' notification on 4.4.2012 have created confusion among the industry, as an impression has been created that the concentration of paracetamol should be restricted to 325mg for all combination products containing paracetamol. Besides box warning about liver toxicity, the 'clarificatory' notification reiterates limiting content of paracetamol to 325mg in prescription products and the words 'prescription combination pain medication' have been excluded in the notification.

There are several other indications where paracetamol is prescribed in combination with domperidone or flunarizine or metoclopramide, etc. where the role of paracetamol is completely different from the other drug in the combination, sources said and added that the industry has apprised the drug controller general of India (DCGI) that paracetamol may be limited to 325mg in combination pain medication products only.

The industry has urged DCGI Dr GN Singh to limit paracetamol at 325mg only when in combination with other analgesic or anti-inflammatory drugs and exclude all other paracetamol combinations from the notification.