Paracetamol overdose a major clinical problem

CDSCO to restrict Paracetamol prescription

By U Sudhakar Reddy

The Central Drugs Standard Control Organisation has decided to curtail the prescription of paracetamol, which causes liver failure. The state drug control authorities have been directed by the Centre to reduce the paracetamol content in the prescription of drugs with a rider that it could be phased out in a period of next three years. Paracetamol overdose is a major clinical problem, causing a sudden hepatic failure. In its directive, the CDSCO has stated that the state licensing authorities may permit the lowering of the contents of paracetamol to 325 mg in the already approved formulations. A warning will be provided on the label of all products containing paracetamol.

However, Dr G.N. Singh, Drug Controller-General of India, said the renewals of product permission on the existing formulations mi-ght continue to be granted while ensuring that the manufacturers complied with the requirements. R. Uday Bhaskar, All India Drug Controllers Fe-deration secretary-general, explained: “The paracetamol tablets sold separately are up to limit of 650mg and in combination it is up to 400mg. In the circular issued, it is mentioned that the limiting of contents of paracetamol to 325mg can be done over the next three years. The irony here is why is so much time being given to the pharmaceutical companies to limit the contents?”

The Centre has exempted the fixed-dose combination containing paracetamol manufactured for export. Dr Ramesh Reddy, ex-vice-chairman of AP Medical Council, said a prolonged usage would cause liver damage. He said: “It is generally taken to relieve pain.”