Kounteya Sinha TNN
New Delhi: Now Analgin, a popular painkiller, is in the eye of a storm. The drug is approved in India for “severe pain or pain due to tumor and also for bringing down the temperature in refractory cases when other anti-pyretics fail to do so.”
However, the Parliamentary Standing Committee on health has found that the product insert of Baralgan-M and Novalgin — the two top selling brands of Analgin — recommend its use in “severe or resistant pain and fever” but the words “when other anti-pyretics fail to do so” have been omitted, thus leading to over promotion.
According to the Committee, the drug is banned in several countries across the world, including the US, France, Armenia, Morocco, Syria, Yemen, Zimbabwe, Lithuania, Nigeria, Serbia, the Philippines, Nepal, Vietnam, Canada, Australia, New Zealand, Japan and Iran.
It says that Analgin crosses the placenta and should not be used during pregnancy. Similarly women, who are breast feeding, must not use the drug.
“How many people know this? As per documents submitted by the Union health ministry, the issue of withdrawing Analgin has not been seriously considered,” said the Committee report placed in the Rajya Sabha on Tuesday.
Dr C M Gulhati, a drug expert said, “Analgin was found in 1920s in Germany. Presently, it has been discontinued in most parts of the world. So it makes no sense for India to continue using it. Since 1920, several painkillers have come in which are less dangerous and more effective.”
The Committee noted that there are a large number of alternative analgesics, antipyretics in the Indian market. “With so many countries banning Analgin, not to mention unlawful over promotion by manufacturers, the CDSCO should be directed to re-examine the rationality of continued marketing of Analgin,” the panel said.
Experts say a drug becomes a candidate for withdrawal not only due to serious side-effects but also when safer, more efficacious drugs are launched.
“Unfortunately, no attention is being paid to this issue. This principle should apply to all cases and all drugs need to be evaluated periodically,” it added.
Analgin, virtually sold as Over the Counter (OTC) drug without prescription, isn’t part of the National List of Essential Medicines (NLEM).
The report says, “There has been lot of public concern on the continued availability of potentially harmful drugs in India years after such products were banned and/or withdrawn abroad, more particularly in highly developed countries like United States, Canada, Britain, the European Union, Australia.”
Analgin remained in the market worldwide until the 1970s, when it was found that it carried risk of causing severe fall of white cells (agranulocytosis), which is a potentially fatal condition.
The US had banned the drug on June 27, 1977. Analgin was also banned for use in animals in 1995 in the US. Sweden banned the drug in 1997, while France had stopped sale of the drug nine years later due to negative benefit/risk evaluation.
IN THE
EYE OF A
STORM
• Analgin recommends its use in ‘severe or resistant pain and fever’
• But the words “when other antipyretics fail to do so” have been omitted, thus leading to over promotion
• found in 1920s in Germany, the drug has now been discontinued in most parts of the world. It makes no sense for India to continue using it
• This drug is banned in many countries including the US, France & Japan
• CDSCO should be directed to reexamine the rationality of continued marketing of Analgin, says House panel
• The issue of withdrawing Analgin has not been seriously considered as per data of health ministry, says the panel
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