The Indian Drug Technical Advisory Board (DTAB) has recommended that the strength of paracetamol in prescription combination products be limited

The Indian Drug Technical Advisory Board (DTAB) has recommended that the strength of paracetamol in prescription combination products be limited to no more than 325mg, and a boxed warning regarding liver toxicity be added to the labelling of all paracetamol-containing products. Following a similar strategy to that implemented in the US,* the Drugs Controller General (India), FDA Bhawan New Delhi, is requiring that these changes be completed over a period of three years. Indian State Licensing Authorities may permit the lowering of paracetamol content in already approved formulations. Paracetamol-containing formulations manufactured for export are not subject to this mandate.