Known for causing liver toxicity, India has decided to limit the content of Paracetamol in the combination products.
In a recent order of the Drug Controller General of India (DCGI) sent to state drug controllers, the DCGI — based on deliberations of the Drug Technical Advisory Board (DTAB) — the highest technical body, has said that India should limit the content of Paracetamol to not more than 325 mg per tablet or capsule in the combination products in phase-wise manner over three years.
To start with, the DCGI has asked to limit paracetamol in prescription combination products and giving box warning about its liver toxicity.
The decision has been taken following the news release earlier this year by the US FDA where it had directed the manufacturers of prescription combination products in the US containing Peracetamol (Acetaminophen) to limit its amount to not more than 325 mg in each tablet or capsule. In addition to this, the US FDA also asked for a box warning highlighting the potential for severe liver injury and “a warning of potential for allergic reaction eg: swelling of face, mouth and throat, difficulty breathing, itching or rash”. The DCGI in his recent communication to the state drug controllers has also asked manufacturers marketing fixed dose combinations of para-cetamol to limit its content to 325 mg and a box warning to be printed on the label of such FDCs indicating that “taking more than daily dose may cause serious liver damage or allergic reactions,” it said.
The DCGI has also directed that state licensing authorities should not grant fresh licenses or renewals of the combination products of paracetamol containing more than 325 mg per tablet or capsule. Experts however say that this is a half hearted step to reduce liver injury. “The situation in India is far worse because Paracetamol is allowed to be combined not only with opioids but also with Non-Steroidal Anti-Inflamm-atory Drugs which include ibuprofen, nimesulide, piroxicam, naproxen, etoricoxib etc. It is known that the adverse effect of NSAIDs is far more serious on liver compared to options,” said Dr Chandra M. (CM) Gulhati, editor, Monthly Index of Medical Specialities (MIMS).