Don't eat "Vitamin C Yinqiao Tablets" when you have a cold?

The Hong Kong Department of Health announced on June 18 that some citizens had purchased an oral product labeled as "Vitamin C Yinqiao Tablets" in the mainland, and they had serious adverse reactions after taking them. The drug was found to contain two unlabeled and banned western medicine ingredients "phenacetin" and "aminopyrine", and the public was urged to stop buying and using the product immediately. Shenzhen Tongan Pharmaceutical Co., Ltd. was accused of being the manufacturer of the drug, but the drug regulatory department showed that the company's 8 batches of products were qualified. The company said it was wronged and asked the Hong Kong Department of Health to clarify and apologize. The State Food and Drug Administration agreed to resume sales of Tongan Pharmaceutical, and determined that its products had nothing to do with the drugs tested by the Hong Kong Department of Health.

According to the explanation of the spokesman of the Hong Kong Department of Health: "Phenacetin" and "Aminopyrine" have been used for pain relief, but because of their serious side effects, they were introduced in Hong Kong in 1983 and 1984 respectively. Banned. "Phenacetin" can cause hemolytic anemia, metahemoglobinemia and thioheme, while "aminopyrine" can cause agranulocytosis. This is another incident that questioned the quality of Chinese patent medicines in mainland China after the vitamin C Yinqiao tablets produced by Guangzhou Pharmaceuticals were exposed to contain highly toxic ingredients in March this year.

As soon as this incident came out, the sales of the product of the same name on the market were greatly affected. Discussions on drug regulation and the storage and disposal of Chinese and Western compound medicines have once again become the focus.

According to a report by People's Daily Online on the 19th, Vitamin C Yinqiao Tablets Problems don't happen by accident. This is the fourth time that vitamin C Yinqiao tablets have exposed safety issues in the past 5 years.

From 2004 to 2010, there were a total of 1,885 case reports about Vitamin C Yinqiao Tablets in the official database, and 48 serious cases were reported.

As early as the end of 2008, Fang Zhouzi, a "fighting fighter", publicly wrote an article questioning the ingredients of Vitamin C Yinqiao Tablets; by September 2010, the State Food and Drug Administration had questioned the safety of Vitamin C Yinqiao Tablets. and adverse reactions were notified, reminding medical workers, drug production and operation enterprises and the public to pay attention to the safety of vitamin C Yinqiao Tablets, a compound preparation of traditional Chinese and western medicines.

In March this year, the vitamin C Yinqiao tablets produced by Guangxi Yingkang Pharmaceutical, a subsidiary of GPHL, were disqualified by the State Food and Drug Administration due to the use of industrial sulfur fumigation raw materials and the ingredients did not meet the actual requirements.

Some comments pointed out that the Hong Kong Department of Health's public warning on the safety of vitamin C Yinqiao tablets this time has brought people's attention to the controversial mainland Chinese patent medicine market. The frequent exposure of quality problems is not unrelated to the weak and slow market supervision.

As for the "error" of vitamin C Yinqiao tablets, we need to analyze specific problems in detail, but this time, vitamin C Yinqiao tablets are banned in Hong Kong, which once again reflects the "short board" of my country's traditional Chinese medicine management system. The matter was exposed in Hong Kong, and there are already many differences in the supervision of the drug market between the mainland and Hong Kong.

In terms of testing institutions, the Food and Health Bureau is one of the 12 decision-making bureaus in Hong Kong, responsible for food safety, environmental hygiene and health matters, and can centrally supervise food, medicine and health care institutions. The Hong Kong government has also unified various inspection agencies into a government laboratory, which is responsible for government-related health inspections and has statutory effect. Food (including health food), cosmetics, medicines, and medical devices in the Mainland belong to different regulatory authorities, resulting in multiple supervision and repeated sampling.

In terms of supervision methods, the Hong Kong Pharmacy and Poisons Board also issues licenses and supervises the wholesale, retail, import and export, manufacture and distribution, use, classification and registration of drugs, which is basically similar to the mainland. However, Hong Kong pays more attention to and emphasizes the management of pharmacists (persons), and requires pharmacists to conscientiously implement the laws and regulations on drugs, otherwise they will be severely investigated and punished, or even removed from their names. Since 2007, the mainland has implemented the quality authorized person system for pharmaceutical production enterprises, which is also an attempt to play the role of pharmaceutical quality management personnel. However, there are still many weak links in the requirements and supervision of pharmacists in the field of pharmaceutical distribution.

In terms of legal system, Hong Kong's legal system on pharmaceuticals is based on the Pharmacy and Poisons Ordinance and Regulation (Chapter 138), as well as special regulations on antibiotics, dangerous drugs, drug advertisements, and Chinese medicine management. the legal group. The basic requirements and lists in the Pharmacy and Poisons Ordinance and Regulations, Chapter 138, are further specified and explained through its five subsidiary legislations. This horizontal supplementation and vertical refinement of the legislative model is conducive to maintaining the unity of drug legislation and avoiding legislative blanks, maintaining the same legal effect among all regulations and avoiding self-contradictory provisions. The Mainland’s Drug Administration Law was enacted earlier and has been revised, but the supporting measures and implementation rules of the Drug Administration Law are dazzling, too many and too messy. First, the legal rank is too low. The second is frequent revisions, which makes the implementation at a loss; the third is that the specific regulations conflict and restrict each other.

Drugs are a very special commodity. Anyone must produce and sell drugs in accordance with the strict regulations of the law, otherwise it is illegal. Therefore, in terms of investigation and punishment of illegal acts, the Hong Kong Pharmacy and Poisons Ordinance and Regulation stipulates that it is a crime to hold or sell poisons without authorization, or sell poisons without the conditions. And the suspect bears the burden of proof that he or she has the right to possess or sell poison. Through laws, Hong Kong protects the initiative of law enforcement officers to investigate and investigate illegal persons and illegal acts, and can make presumptions against illegal persons and acts, which greatly improves the efficiency and effectiveness of law enforcement. On the other hand, after the drug regulatory authorities in the Mainland have grasped the phenomenon that the counterparty violated the Drug Administration Law, law enforcement officers have to further determine the circumstances and results of the illegal act, the subjective state of the parties, etc., while the legal evidence for determining these elements is in the party's hands. but the onus of collecting evidence falls on law enforcement officials. If the parties do not actively cooperate with the investigation, or take the form of denial, the administrative organs often know that the other party has violated the law but cannot find the other party's evidence and have no choice.

In addition, Hong Kong law adopts the principle of the highest level of punishment for illegal acts, which enables the law enforcement authorities to punish all kinds of illegal acts according to the circumstances at the highest level, avoiding the legislation that is too detailed and unreliable. Hong Kong also maintains a relatively reasonable proportion of penalties for drug violations. For example, the most severe punishment for violations of the Dangerous Drugs Ordinance and Regulations can be sentenced to life imprisonment. The strictest regulation of dangerous drugs such as The Antibiotics Ordinance and Regulations and the Undesirable Medical Advertisements Ordinance are supplements to the Pharmacy and Poisons Ordinance and Regulations. Penalties for breaches of the former are relatively lighter than those for breaches of the latter.

As for the domestic cold medicine market, due to the widespread use of vitamin C Yinqiao tablets, it often occupies the top three in the cold medicine market in various places, with a market size of more than one billion, and its production status is just as good as A microcosm of Chinese pharmaceutical companies - a variety is produced by hundreds of companies, with low prices, low threshold and fierce competition. In this case, in order to occupy the market and gain profits, market defects are more likely to lead to the emergence of disorderly competition, which in turn harms the interests of ordinary consumers.

Therefore, the national food and drug regulatory authorities need to step up their precautions to take the first step for consumers. The State Food and Drug Administration notified the requirements after the incident. Manufacturers should improve product instructions, packaging, and labels, add relevant safety information, and strengthen post-market safety research to ensure that product safety information is communicated to doctors and patients in a timely manner.

So, is Vitamin C Yinqiao Tablet a "compound of Chinese and Western medicine" or a "Chinese medicine"? Since it is a "compound preparation of Chinese and Western medicine", why is it sold in the Chinese pharmacy of the hospital? Since it is "Chinese medicine", how can we add western medicine ingredients?

Drugs in the National Essential Medicines List include chemicals, biological products, and proprietary Chinese medicines. Chemical drugs and biological products are mainly classified according to clinical pharmacology, and Chinese patent medicines are mainly classified according to function.

It is this management system that leads to the unclear positioning of Chinese and Western medicine compound preparations such as Vitamin C Yinqiao Tablets. However, it must be noted that Chinese and Western medicines are quite different in terms of pharmacology and toxicology, indications, usage and dosage, and the quality of medicinal materials. Therefore, just like traditional Chinese medicine, which is difficult to standardize, this management system not only creates obstacles for drug promotion, but also exposes the public to the risk of repeated drug use.

An expert from the former State Pharmacopoeia said that it is not easy to get approval for mixed preparations of traditional Chinese medicine and western medicines like Vitamin C Yinqiao Tablets. Before approval, to apply for this type of Chinese and Western medicine mixture, enough clinical trial cases must be done to verify 1+1>2. That is to say, it is necessary to do the test of the traditional Chinese medicine part first, then do the test of the western medicine part, and then do the test of the traditional Chinese medicine and the western medicine. The result must also be better than the effect of taking both traditional Chinese medicine and western medicine at the same time.

When the drug approval authority was in the provincial drug administrations, drugs like Vitamin C Yinqiao Tablets were particularly popular at that time. At that time, Guangdong, Jilin, Guizhou and other places approved many similar mixtures of Chinese and Western medicines. This work has not been done solidly enough in the past. However, after the approval was obtained, the pharmaceutical companies did not conduct enough tests, and in the process of raising the national standard of landmarks, these drugs became "national medicines" and eventually became the products of a specific period.

If it is said that safety and effectiveness are the body of the drug, then the vitamin C Yinqiao tablet with questionable safety is itself a "cold". And seamless supervision should be the "system prescription" for drug quality to cure diseases.

If this incident is not handled properly, it will not only be affected by the vitamin C Yinqiao tablet market, but the entire Chinese and Western compound preparation cold medicine market. But it is worth affirming that the State Food and Drug Administration responded immediately and responded to public concerns in a timely manner, which is progress. What people want to see more is that relevant departments make more active efforts in system construction, approval and supervision and other links.