The drugs controller general of India (DCGI) has once again clarified that lowering of the paracetamol content to 325 mg is applicable to the combination of the paracetamol with other analgesic/anti-inflammatory drugs only.

The issue of permitting FDC formulations of paracetamol containing 500mg per tablets, which are being sold as OTC products for indication which are other than pain medication prescription based products, was discussed in the 46th meeting of the Drugs Consultative Committee (DCC) held on November 12-13, 2013.

Allaying the confusion of the DCC members, who are state drug controllers, DCGI Dr GN Singh, who is also the chairman of the DCC, once again clarified that lowering of the paracetamol content to 325 mg is applicable to the combination of the paracetamol with other analgesic/anti-inflammatory drugs only and the OTC products having indications other than pain medication based products will be permitted to contain paracetamol 500mg instead of 325mg as stated in the DCGI' s earlier circular.

In the DCC meeting, the state drug controllers said that there are several products available in the market which are sold as OTC products such as D-Cold tablets (containing paracetamol IP 500mg caffein anhydrous IP 32mg phenylephrine HCl IP 10mg), Vicks Action 500 (containing paracetamol IP 500mg phenylephrine HCl IP 10mg caffein anhydrous IP 32mg 40) and Crocin Cold & Flu Max (contains: paracetamol IP 500mg caffein anhydrous IP 32mg phenylephrine HCl IP 10mg) which are meant for indication other than pain medication prescription based products. They wanted clarification from the DCGI whether such OTC products having indications other than pain medication based products can be permitted to contain paracetamol 500mg.

Ever since 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, there has been confusion among the industry as well as among the state drug controllers, as an impression has been created that the concentration of paracetamol should be restricted to 325mg for all combination products containing paracetamol.