(Health Times reporter Wang Zhenya)
On December 13, the State Drug Administration issued an announcement that 210 drug registration certificates were cancelled, including the "antipyretic miracle drug" metamizole, and this time 9 metamizole tablets were cancelled. The Health Times reporter found that the cancellation of the approval of the onnamol tablets were all small pharmaceutical enterprises in Inner Mongolia. Some companies have never produced metamizole tablets after receiving approval.
The relevant staff of Inner Mongolia Mongolian Pharmaceutical Co., Ltd. told the Health Times reporter, "Although we have approvals, we have never produced metamizole tablets, there is no production line of metamizole tablets, and we will not produce them in the future, so we cancelled the approval." ”
"At present, we mainly produce sea buckthorn health food and health care products, and do not produce metamizole tablets." The staff of Inner Mongolia Aerospace Pharmaceutical, who applied for the cancellation of the approval of the onionic film, also told the Health Times reporter.
In the impression of many Chinese people, metamizole tablets are the antipyretic medicines that were often prepared at home in the past. This "antipyretic drug", which was once a national best-selling drug, has been banned from sale, withdrawn or restricted from use in nearly 30 countries such as the United States, Australia, Norway and the Philippines due to serious side effects, even fatal.
On March 17, 2020, the State Food and Drug Administration issued the Announcement on Amending the Specifications of Metamizole-related Varieties (No. 34 [2020]), requiring the revision of the specifications of metamizole tablets. The revised specification of analgin tablets requires the addition of a warning: This product is forbidden for adolescents and children under 18 years of age.
"For the sake of patient safety, metamizole tablets are rare in clinical practice in large hospitals." Kang Zhen, deputy director of the National Licensed Pharmacist Development Research Center of China Pharmaceutical University, told the Health Times reporter that there is no market, and the original approval documents applied by pharmaceutical companies will also take the initiative to apply for cancellation when the time comes.
According to the Chinese Pharmaceutical Association's "Catalogue of Excessive duplicate varieties with more than 20 approved enterprises for the same drug (sixth batch)", as of September 2020, there are still 1275 approvals of metamizole and 838 production enterprises nationwide.
"In the past, many enterprises gathered to register Annai, in fact, many did not produce", Shi Lichen, founder of Beijing Dingchen Pharmaceutical Consulting Center, believes that the same variety of drugs are produced by hundreds of pharmaceutical companies, which brings great challenges to drug supervision, and has also become an important reason for the redundancy and unevenness of the entire drug market.
