Draft for renaming traditional Chinese medicine： thousands of drugs may need to be renamed
Xiaoer Kechuanling, Qiangli Pipa Dew and Quick-acting Jiuxin Pill … … These familiar drug names may be changed. On January 11, the State Food and Drug Administration publicly solicited opinions on the new naming rules for Chinese patent medicines, requesting that they be sent to the designated mailbox of the General Administration by e-mail, and officially closed on February 15.
The reporter found that according to the new regulations, thousands of drugs may need to be renamed. China food and drug administration said that the following principles should be adhered to in this work: First, it should be strictly regulated. In the listed Chinese patent medicines, if there are exaggerated curative effects, superstitions and vulgar terms in the names, the enterprises are required to rename them. The second is classified implementation. Distinguish between listed products and newly declared products. For listed traditional Chinese medicines, it is planned to distinguish between exaggeration, implied curative effect or nonstandard naming, and the nonstandard problems will be dealt with step by step. The third is a reasonable transition. Considering the actual situation of the enterprise, take appropriate transitional measures after the product is renamed.
Renaming involves a number of pharmaceutical companies and brands, which will generate new registration costs.
The Technical Guiding Principles for Naming General Names of Chinese Patent Medicines (Draft for Comment) proposes that the naming of Chinese patent medicines should avoid using the names of drugs related to pharmacology, anatomy, physiology, pathology or therapeutics, such as "hypoglycemic, antihypertensive, lipid-lowering, anti-inflammatory and cancer"; Exaggerated, boastful and unrealistic words, such as "treasure", "spirit", "essence", "strength", "quick effect" or "imperial system" and "secret system" should not be used. In addition, Chinese patent medicines should generally not be named after names of people, places and enterprises, and feudal superstitions or vulgar and indecent terms should not be used.
For the existing proprietary Chinese medicines in the market, the opinion draft proposes that the guiding principle is not only applicable to the naming of new Chinese medicines, but also applicable to standardizing the irregular naming of the original proprietary Chinese medicines. For the drug names that have been used for a long time, if it is necessary to change them, the former names can be listed as a transition.
How wide is the old medicine involved? In the column of domestic drugs in the drug database of the Food and Drug Administration, the reporter entered some keywords related to changes, and thousands of drug approvals can be retrieved, including more than 2,000 drugs with the word "Ling" in their names. The medicines of many listed pharmaceutical companies may be renamed, including Tongrentang, Guizhou Bailing, Zhongxin Pharmaceutical, China Resources Sanjiu, Tianmu Pharmaceutical and Shenwei Pharmaceutical.
Li Jin, technical quality director of Yunnan Baiyao Group Co., Ltd. said that if the name cannot be used, seven dosage forms and seven products of Yunnan Baiyao series will be affected. In addition to the dosage forms and products containing the word "Yunnan Baiyao", the Yunnan Baiyao series may include: Compound Niuhuang Xiaoyan Capsule, Pudilan Xiaoyan Tablet, Xiaoyan Zhike Tablet, Xiaoyan Antipyretic Granule, Xiaoyan Analgesic Plaster (all of which contain the word "Xiaoyan"), Xiaoer Baotaikang Granule, Baibaodan, Gengnianling Capsule and Xiaokeling Tablet (all of which contain "Xiaoyan")
Li Jin believes that if the current opinion draft is implemented, many well-known time-honored brands will be greatly affected. "If Yunnan Baiyao needs to be renamed, the brand, reputation and public awareness established by Yunnan Baiyao in 115 years will collapse, and the estimated loss will exceed 10 billion yuan."
Fu Lijia, executive vice president of Beijing Pharmaceutical Industry Association, said: "Renaming means that all packaging materials, brochures, small boxes, cartons and labels need to be changed, and the cost of production and packaging can be calculated and borne. However, for old brands, the intangible loss caused by renaming is very large, and it takes a lot of manpower and financial resources to carry out secondary market cultivation, so that consumers can know that the renamed products are the old drugs they used to."
An industry insider told reporters that for pharmaceutical companies, they need to re-register with the local food and drug administration after renaming. For enterprises with a large number of renaming, the registration fee will be a big expense. "The charging prices vary from place to place. A few provinces do not charge, and most provinces charge. A product in Beijing will cost 6600 yuan. " The person said that his company has 35 products or will be renamed, and the registration fee alone will be more than 230,000 yuan.
Renamed to control the chaos of "Don’t stop until the name is amazing"
The reporter’s investigation found that as early as the 1990s, the national authorities had proposed to standardize the naming of Chinese patent medicines. In 1997, the General Names of Drugs in China compiled by the Pharmacopoeia Committee of the Ministry of Health clearly put forward the naming principles of traditional Chinese medicine, chemical drugs, biological drugs, radioactive drugs and diagnostic drugs.
The reporter noted that the new naming rules of this opinion draft are based on the principles put forward in the common name.
Fu Lijia believes that it is necessary to standardize the naming of Chinese patent medicines. "This is a problem formed by history. In the past, many drug names were approved by local authorities, and there was no unified naming rule. In addition, although many Chinese medicines are a name, they are actually not a prescription. "
Especially in recent years, the people’s demand for drugs and health care drugs has become increasingly strong, and the exaggerated naming of Chinese patent medicines under the banner of health care products is frequent. According to industry insiders, the quality of proprietary Chinese medicines produced by individual pharmaceutical companies is mixed, but in naming, "the name is not surprising, and the curative effect is boasted at will, which leads many elderly consumers to be deceived. It is imperative to standardize the naming of proprietary Chinese medicines.
Experts call for both cultural inheritance and supervision in naming traditional Chinese medicines.
It is difficult for many consumers to understand that all existing Chinese medicines must be renamed. Liu Yue, a primary school teacher in Kunming, said: "Yunnan Baiyao aerosol, Ma Yinglong hemorrhoid cream and essential balm are all standing medicines at home. People recognize these brands. If these names don’t exist overnight, they will feel very uncomfortable."
Wang Ying, vice president of china association of traditional chinese medicine, told the reporter that the association had recently held a forum to organize member enterprises to discuss seriously and submit their opinions to the Food and Drug Administration.
Li Jin believes that some well-known old brands and brands are outstanding representatives and symbols of Chinese medicine culture, which have world influence and need to be treated differently. For example, Barron’s Weekly listed Yunnan Baiyao as "10 China brands that Americans must know". Once Yunnan Baiyao is renamed, its brand image representing China will be out of the question.
"Traditional Chinese medicine can’t be managed with the thinking of western medicine, especially in naming." Chen Qiguang, head of the National Research Group of Traditional Chinese Medicine of China Academy of Social Sciences, said that when naming traditional Chinese medicines in China, the inventor, place of production, name of monarch medicine and other factors should always be taken into account, such as "Ji Desheng Snake Medicine", "Ma Yinglong Hemorrhoid Ointment" and "Zhao Nanshan Dutong Pill", which is a recognition of the inventor’s contribution.
In addition, Chinese medicine pays attention to "authenticity", and place names are the best embodiment. "For example, Yunnan Baiyao, not only Yunnan has Baiyao in the country, but only Yunnan Baiyao has the best efficacy." Chen Qiguang said that if people’s names and place names can’t be used as medicine names, traditional Chinese medicine will completely lose its traditional cultural heritage.
Zheng Jin, deputy director of the Yunnan Provincial Health Planning Commission and director of the Administration of Traditional Chinese Medicine, believes that the names of proprietary Chinese medicines need to be standardized, but old brands should also be respected. "Standardized management of drug names can indeed reduce the misleading of drugs that exaggerate their efficacy to consumers, but it is not appropriate to make a one-size-fits-all approach for a few old drugs that have historical origins, are established by convention, are recognized by the people, and have a reputation and a market." Zheng Jin suggested that new drugs with no historical origin can be bound by new naming methods, and drug names of time-honored brands should not be forcibly renamed.
Xinhua News Agency, Beijing, February 15th