The government has lifted the ban on painkiller and anti-pyretic drug Analgin and all formulations containing the drug, allowing pharmaceutical companies such as Sanofi and Alkem to re-launch their popular brands of the medicine in the market. However, companies selling the product will have to carry a warning on their package and promotional literature of the drug specifying its usage, a gazette notification published by the Ministry of Health and Family Welfare said.
The product was available under various popular brands such as Novalgin and Baralgan, which are now likely to gain from the lifting of the ban.
"On the basis of the recommendations of the Drugs Technical Advisory Board, the Central government hereby revokes the notification G.S.R 378(E) 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 notification said specifying the content as : "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."
Analgin is banned in most parts of the world including in the US, Australia, Japan, Canada, Sweden and France. It was also barred in a few developing countries such as Nigeria and Nepal.
India had decided to suspend sale and distribution of the drug in June last year after it received representation from various forums, mainly criticism from Parliamentary Standing Committee, suggesting side-effects from the medicine and the fact that it is restricted in most parts of the world.
However, soon after the suspension the matter was taken up by the Drug Technical Advisory Board (DTAB) during November last year. The advisory board said that the duration of Analgin treatment was only a few days and, therefore, the use of the drug might be continued according to the approved indication.
According to the notification, the ban on Analgin has been revoked based on DTAB?s recommendations.
Though the total market for Analgin is estimated to be smaller at around Rs 100 crore annually, market analyst say few established brands hold majority of this market while there are many other small and unorganized players also selling the drug, sales data for which may not be generated or available. There are also alternatives of the drug available in the market.
Analgin is not the only drug coming back to market soon after facing a suspension order. Along with Analgin, the government had also suspended sale of an anti-diabetic drug pioglitazone in June last year. 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.
Experts point out that the current move of the government to revoke the ban on Analgin could be motivated as drug, which does not appear in the National List of Essential Medicines (NLEM), is not under price control.
?Analgin is very cheap to manufacture and many Indian companies may, therefore, like to sell the product,? says Amit Sengupta, a medical practitioner and also the co-convenor of Jan Swasthya Abhiyan, a public health advocacy movement.
According to Sengupta, the problem with the regulatory system in India is that there is no framework to generate data related to adverse drug reactions.
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