Government lifting ban from Analgin

 

Indian health ministry revoked the ban from Analgin, potent analgesic and antipyretic. Last year in June 2013, government issued a ban on manufacturing and selling of analgin in country because it is involved in risk to human beings and whereas safer alternatives of analgin are available. After revoking ban from pioglitazone, this is the second time when ministry has lifted ban from a drug.

The ministry has issued 'GSR 86 (E)' notification on 13.2.2014 which is revoking the ban from Analgin. In 65th meeting of Drugs Technical Advisory Board (DTAB), it has examined the issue of suspension of manufacture and sale of the said drug on 25th November, 2013  and recommended that the suspension of the drug should be revoked and allowed to be marketed subject to certain conditions which the manufacturers shall mention on their package insert and promotional literature of the drug.

In 65th meeting, The DTAB members were informed that Analgin is used as analgesic for short period as and when necessary. It is  not indicated for long term use. There are no adequate reports of agranulocytosis  at present associated with the use of the drug which may warrant suspension / prohibition the drug in the country. The recommendations were forwarded to the Ministry of Health and Family Welfare for their consideration and taking further action in the matter. 

On the basis of the recommendations of DTAB, the Central Government revoked the notification G.S.R. 378(H) dated 18th June, 2013 subject to the condition that manufacturers shall mention the following on their package insert and promotional literature of the drug: “The drug is indicated for Severe pain or pain due to tumor and also for bringing down temperature in refractory cases when other antipyretics fail to do so.”


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