Analgin, the popular pain-relief drug, which is banned in countries like the US, Australia, Japan and Canada, is again back on the chemist shelf after its sale was suspended in India by the Government in June last year.
The medicine sale was suspended following criticism from a Parliamentary Standing Committee, which had observed that its usage for human use was likely to involve risk to human beings and safer alternatives to it are available in the market.
However, the ten-month-old suspension has now been revoked after the Drug Technical Advisory Board, the highest decision-making body on the technical matters in the Ministry gave it a green signal.
The DTAB members said that since the duration of Analgin treatment was only a few days and, therefore, its usage might be continued according to the approved indication.As per recent notification issued by the Health Ministry, the medicine can be sold with a specific warning indication.
The DTAB has recommended the sale of the drug only for severe pain, pain due to tumours and also for bringing down temperature in refractory cases when other antipyretics fail to do so, a warning to be mentioned by the manufacturers on the package insert and promotional literature of the drug.
This is not the first time that the Ministry has revoked its suspension order on sale of a drug.last year, the Ministry had banned Analgin in India, along with two other drugs - anti-diabetic pioglitazone and anti-depressant deanxit following criticism from a parliamentary panel.
However, within less than two months, it revoked the ban on pioglitazone, in the absence of substantial scientific evidence showing the adverse effect of the drug on Indian patients. The Government allowed companies to resume the sale of the anti-diabetes drug, with a box warning.