SFDA to eliminate eleven Chinese herbal injections

Domestic products reach hundreds of billions of market scales

The State Food and Drug Administration issued an announcement saying that due to the insufficient clinical use, safety, and effectiveness of 11 clinical injections of traditional Chinese medicine such as Chasin Cold Injection, it is difficult to guarantee the homogeneity of quality of the products in the existing standards. Kinds of traditional Chinese medicine injections. According to experts, on the one hand, there are currently hundreds of varieties of traditional Chinese medicine injections, with a market size of 10 billion. On the other hand, the safety problems that have been exposed in recent years are numerous and there are many deadly cases. Therefore, if the industry wants to develop healthily, it will inevitably embark on a "modernization road" that strictly examines and approves strictly.

Elimination due to less use, insufficient safety

The types of vaccines to be phased out on the Internet this time are: Chaixin Cold Injection, Chuanshanlong Injection, Ganjing Injection, Ganxintai Injection, Tianjihuang Injection, Lemahui Injection, Hanmusong Injection, Tumuzi saponin injection, Tincanning injection, Aconitum injection, and Naoxinkang (lyophilized) for injection.

According to the State Food and Drug Administration's consultation letter, experts from the relevant technical units of the State Food and Drug Administration screened 11 clinical use cases such as Chasin Cold Injection, which had insufficient data on safety and efficacy, and the existing standards were difficult to guarantee. The list of Chinese medicine injections with homogeneous quality is to be eliminated.

The State Food and Drug Administration said that the opinions of the relevant pharmaceutical production, operation, and use units and all sectors of the society can submit opinions and suggestions to the Department of Drug Safety Supervision of the State Food and Drug Administration before December 15.

"This kind of sidestepping of inapplicable products and strict approval of the approval of new Chinese medicine injections is very good. Even if some patients go to the hospital in the early years, they will not be able to get a shot the same day, leaving many people to the emergency department. Do not take the initiative to ask for Chinese medicine products.” An industry source told this reporter.

Prospects for traditional Chinese medicine injection market are still very good

At present, there are more than 100 varieties of traditional Chinese medicine injections, and the market scale has reached 10 billion. The much-anticipated new round of basic drug list adjustments is due to be released at the end of the year. Many insiders are eager to see more TCM injections selected for the new base drug catalog.

"It's development prospects are still very good, especially for many domestic companies with exclusive products, annual sales are very impressive, and is expected to continue to grow." A pharmaceutical analyst told this reporter.

“Now the attitude of the Chinese government for Chinese medicine injections is to support the side of the inspection. Some traditional Chinese medicine injections have been selected as national 863 research projects. However, the safety issues that have arisen have also been concerned by the relevant departments.” Zhang Shijun, Department of Traditional Chinese Medicine, the First Affiliated Hospital of Sun Yat-sen University The professor told this reporter that the “Houttuynia” incident, the “Acanthopanax” incident, the “Yinhuanghuang” incident, and the “Qingkailing” incident that occurred before were still alerting the company to strictly control product quality and the doctors should be reasonable. use.

"As the State Food and Drug Administration continuously publicizes feedback on the adverse reactions of injections, pharmaceutical companies increase quality control and upgrade their processes, the quality of Chinese medicine injections has greatly improved, and the impurities contained in the products have been reduced much more than in the past. Injectables do have the effect of being incapable of being replaced by Western medicine.” Director of the Chinese Academy of Otolaryngology and Research Institute of the Armed Police Hospital told reporters that clinical doctors and patients must remain vigilant and that any adverse reactions, such as allergies, should be followed closely and promptly. deal with.