DCGI has directed all the state drug authorities to advise the manufacturers of all paracetamol formulators to carry a warning, "Overdose may be injurious to liver" on the labels of their products. The action follows a decision took by the DTAB recently in this regard.
The DTAB felt that the issue of overdosage of Paracetamol should be avoided in India also because of reports of toxicity of overdose of paracetamol in the USA.
Non-prescription Drug Advisory Committee of the Food and Drug Administration, USA, recommended that explicit warning about the possibility of liver toxicity with overdose of paracetamol should be added on all the packs of OTC products containing paracetamol.
There are hundreds of paracetamol single ingredient brands and generics sold in India mostly in 500 mg tablet form. The top paracetamol brand, Crocin, is the most widely used product and it belongs to GSK. There has been a notable increase in the sales of paracetamol brands in India during the last one year following the controversy over nimesulide use.