4hw.com.cn: in the afternoon of June 7, the official microblog of Hongmao Guoyao released a letter to consumers and national partners, responding to the questions raised by the public about the toxicity of formula and the legality of purchasing raw materials such as leopard bone.
In this open letter, we saw that the regulatory authorities conducted three flight inspections on enterprises, and conducted detailed investigations on the use of musk, leopard bone, drug toxicity and intangible cultural heritage identification and other issues of concern. The results are in line with the relevant laws and regulations of the state. The stone pressing on the heart of Hongmao national medicine and the question hanging in the heart of consumers finally came to the ground.
However, many problems exposed in Hongmao medicine and wine incident are worth thinking, such as how to treat traditional Chinese medicine correctly by the public, how to spread health knowledge scientifically by doctors, how to keep the media independent, objective and fair in front of public opinion, etc. Under the background of "healthy China" strategy, how to develop traditional Chinese medicine is more important.
According to the letter, from March to April 2018, Inner Mongolia food and Drug Administration conducted three flight inspections on the company, including workshop, quality control, personnel management, data integrity, supplier audit and finished product sales. Hongmao medicine wine said that the company strictly in accordance with national regulations production, product quality standards.
The letter also said that in 2018, Inner Mongolia food and Drug Administration inspected the company's leopard bone and Artificial Musk's value-added tax invoice, in and out account, batch production record and inventory quantity, the purchase, use and inventory quantity of leopard bone and artificial musk were consistent, and the purchase and use of leopard bone and artificial musk were in line with national regulations.
For the toxicity of aconite, tiannanxing and pinellia, Hongmao liquor said that the above raw materials used by the company are processed products, because they are not toxic traditional Chinese medicine varieties.
The letter also responded to the application for the world heritage of Hongmao liquor making technology and the identification of class a over-the-counter drugs.
The full text is as follows:
A letter to consumers and national partners
Respected consumers, national distributors and retail pharmacies:
Thanks for the trust and support to Hongmao pharmaceutical wine! Recently, due to the false and untrue reports on Hongmao pharmaceutical wine by some self media, many troubles and inconveniences have been caused to consumers, dealers and retail pharmacies all over the country. We apologize for this! Now we will make the following description of the actual situation:
1、 Implementation of drug production quality management specifications
Our company has been organizing production in strict accordance with the requirements of the pharmaceutical production quality management specifications. Over the years, the food and drug supervision and administration departments at all levels in Inner Mongolia Autonomous Region have carried out supervision and inspection and flight inspection on our company's implementation of relevant laws and regulations and the implementation of the pharmaceutical production quality management specifications. From March to April 2018, Inner Mongolia food and drug administration carried out pre-treatment and extraction workshop of traditional Chinese medicine, liquor production workshop, storage area, quality control and quality assurance room, process water and air conditioning purification system, staffing and training, material management, production management, quality control and quality assurance, document management, data integrity and material balance for our company Three flight inspections were carried out on condition, production process, supplier audit and finished product sales.
Over the years, Inner Mongolia pharmaceutical inspection and Research Institute has carried out multiple supervision and sampling tests on Hongmao liquor (specification: 500ml), all of which were carried out in accordance with ws3-b-2792-97 standard of pharmaceutical standard of the Ministry of Health (Volume 14), and the test results are in line with the regulations. In 2015, Wulanchabu food and Drug Administration conducted random inspection on Hongmao medicinal wine and its related original families, Chenxiang, Gentiana, asparagus, notopterygium root, Cuscuta chinensis, lotus seed, Ligusticum chuanxiong, angelica, Amomum villosum and fennel salt. In 2017, it conducted random inspection on Astragalus, liquorice and safflower, all of which met the requirements.
2、 The purchase and use of leopard bone and artificial musk of Hongmao medicinal wine comply with relevant laws and regulations
In 2018, Inner Mongolia food and Drug Administration verified on-site the value-added tax invoice, in and out account, batch production record and stock quantity of leopard bone and artificial musk, the purchase, use and stock quantity of leopard bone and artificial musk were consistent, and the purchase and use of leopard bone and artificial musk of Hongmao medicinal wine were in line with relevant laws and regulations.
3、 Aconite (prepared), Rhizoma Arisaema (prepared) and Pinellia (prepared) used in Hongmao liquor are not toxic traditional Chinese medicine
In the measures for the administration of toxic drugs for medical use (Order No. 23 of the State Council), there are three kinds of toxic traditional Chinese medicine: raw aconite, raw Nanxing and raw Pinellia. However, all the aconite (system), tiannanxing (system) and Pinellia (system) used in Hongmao liquor are processed products, which are not toxic traditional Chinese medicine.
4、 Hongmao liquor is a class a over-the-counter drug, and its approval results meet the requirements of relevant laws and regulations
Article 37 of the drug administration law of the people's Republic of China (implemented in 2001) stipulates that the State shall implement the classified management system for prescription drugs and over-the-counter drugs, and that the State Drug Administration shall be responsible for the selection, examination and approval, and issuance of the catalogue of over-the-counter drugs in accordance with article 4 of the classified management measures for prescription drugs and over-the-counter drugs (for Trial Implementation). On November 25, 2003, the former State Food and Drug Administration issued the notice on the publication of the Sixth Batch of OTC drug catalogue (gsyan [2003] No. 323), and announced Hongmao liquor as a class a OTC drug.
From 2004 to 2017, 137 ADR reports of Hongmao liquor were retrieved from the national ADR monitoring system. The ADRs were mainly manifested as dizziness, pruritus, rash, vomiting, abdominal pain, etc.
5、 The identification process of the intangible cultural heritage of Hongmao medicinal wine preparation technology conforms to the relevant provisions of the law of the people's Republic of China on intangible cultural heritage
On May 8, 2018, the reply of the Intangible Cultural Heritage Department of the Ministry of culture and tourism on the application for government information disclosure pointed out that in November 2014, in the "fourth batch of national intangible cultural heritage representative project list" published by the State Council, the application and recognition process of Hongmao liquor preparation technology conforms to the relevant provisions of the intangible cultural heritage law of the people's Republic of China.
To sum up, our company organizes production in strict accordance with the relevant national regulations and registration process in the process of drug production quality management, and the products meet the quality standards; the selection and approval process of Hongmao liquor as an over-the-counter drug meet the requirements of laws and regulations.
Hongmao liquor has been passed on for 279 years. As a pharmaceutical manufacturer, Hongmao Guoyao must take the main responsibility of the enterprise and be responsible for the safety and effectiveness of the whole life cycle of the product; As a time-honored enterprise of traditional Chinese medicine, Hongmao Guoyao should be more strict and self disciplined, continuously improve product quality and service guarantee, pay attention to brand image and social public welfare, and be more responsible to consumers.
We sincerely thank consumers, distributors and retail pharmacies all over the country for their concern and support for Hongmao medicinal wine as always. We believe that the regulatory authorities will make a fair conclusion on Hongmao medicinal wine based on facts and laws. We also invite people from all walks of life not to believe in or spread rumors, and work together to maintain a good social order and public opinion environment.
Thank you again for your consistent support to Hongmao Guoyao!
Inner Mongolia Hongmao Guoyao Co., Ltd
June 5, 2018