"Cancel the entrusted processing of traditional Chinese medicine" is the most controversial

The reporter learned from the 70th national drug trade fair that many Chinese patent medicine enterprises had a great controversy over the notice on strengthening the supervision and administration of extraction and extract of traditional Chinese medicine (Draft for comments) issued recently The pharmaceutical and chemical supervision department of the State Food and Drug Administration held a seminar on strengthening the supervision and administration of extraction and extract of traditional Chinese medicine in Beijing on the 5th Relevant personnel of the State Food and Drug Administration told the reporter of the economic reference newspaper that in order to further regulate the production and use of Chinese herbal medicine extraction and extract and ensure the quality and safety of Chinese patent medicine, the administration drafted the notice on strengthening the supervision and management of Chinese herbal medicine extraction and extract (draft for comments) (hereinafter referred to as the notice) "The notice strengthens the regulatory requirements for the extraction of traditional Chinese medicine, clarifies the filing requirements for the extraction of traditional Chinese medicine, strengthens the management of the pre-treatment and residue of traditional Chinese medicine, defines the scope of the extraction of traditional Chinese medicine with national drug standards, and clarifies the qualitative and processing requirements for the illegal activities of the extraction." He pointed out that the promulgation of the notice can further regulate the production order of traditional Chinese medicine extraction and extraction, severely punish all kinds of illegal behaviors, encourage the healthy development of advantageous enterprises, strengthen the quality responsibility of Chinese patent medicine production enterprises, and ensure the quality of Chinese patent medicine However, the reporter learned from the national drug trade fair that the most intolerable thing for some traditional Chinese medicine enterprises is the clause of "cancel the entrusted processing" in the notice According to the notice, Chinese patent medicine manufacturers must have the ability to extract traditional Chinese medicine in line with the variety and scale of production Since January 1, 2016, the entrusted processing of extraction of traditional Chinese medicine has been completely cancelled It is allowed to share one extraction workshop among enterprises within the group, and qualified enterprises are allowed to establish extraction workshops in their own province and other provinces, but they must be strictly managed An industry association told reporters that due to the limitations of extraction equipment and technology, many Chinese patent medicine enterprises are outsourcing Chinese herbal extracts, and then processing them by themselves after returning to the factory, "Chinese herbal extracts are raw materials, not drugs, as long as the quality is controllable and qualified, why not allow entrusted processing?" "We have our own extraction workshop, and this notice has no impact on us." A vice president of a listed company pointed out But a small traditional Chinese medicine enterprise manager told reporters that the listed traditional Chinese medicine enterprises generally have their own extraction workshop, but most of the other traditional Chinese medicine enterprises are not large-scale, many enterprises are limited by capital and other aspects, and have been adopting the way of outsourcing traditional Chinese medicine extracts for many years "Therefore, if the notice is followed, none of these enterprises can survive, only to seek cooperation from others." However, the relevant personnel of China Association of traditional Chinese medicine believe that the notice emphasizes that the purpose of Self Extraction and elimination of entrusted processing is to curb the counterfeiting and inferior quality of Chinese patent medicines from the source, which is conducive to regulating the development of the whole industry in the long run It is reported that at present, there are 2595 Chinese patent medicine manufacturers in China, and listed Chinese medicine companies such as Kangenbei (600572, Guba), Yabao Pharmaceutical (600351, Guba), Yunnan Baiyao (000538, Guba), Tongrentang (600085, Guba) have their own TCM extraction workshops.