According to incomplete statistics from a reporter from Beijing Business Daily, as of yesterday, 100 pharmaceutical companies have had their GMP certificates (ie, "Good Manufacturing Practices for Drugs") withdrawn, far exceeding the 50 companies in the whole of last year. Among them, traditional Chinese medicine companies accounted for 63%. Industry insiders believe that with the approaching deadline of the new version of GMP certification, the reshuffle of the traditional Chinese medicine industry is also accelerating.

Pharmaceutical companies double the amount of deductions

A reporter from Beijing Business Daily found that, as of yesterday, 100 pharmaceutical companies in 19 provinces across the country had their GMP certificates revoked, and 63 of them produced GMP certificates. Traditional Chinese Medicine and Chinese Herbal Pieces. The reasons for the withdrawal of GMP certification include falsified production records, falsified inspection records, out-of-scope production of TCM decoction pieces, chaotic production management, illegal production of TCM decoction pieces, and major defects in the quality management system.

Last year, only 50 companies had their GMP certificates confiscated, but before the end of this year, the number of companies with confiscated certificates has doubled. In this regard, Shi Lichen, head of Beijing Dingchen Pharmaceutical Management Consulting Center, believes that the state has increased supervision this year. The intensity of investigation and punishment has also made many companies that "slipped through the net" last year to be invisible in this year's inspection, and the number has also increased accordingly.

Certificate renewal deadline is approaching

It is understood that the new version of GMP certification has two time points: enterprises that produce sterile drugs such as blood products, vaccines, and injections should meet the requirements of the new version of GMP before December 31, 2013; other types of drugs represented by traditional Chinese medicine and Chinese herbal decoction pieces All manufacturers should meet the requirements of the new version of GMP before December 31, 2015. Enterprises that fail to meet the requirements shall not continue to produce drugs after the above-mentioned prescribed period. This means that Chinese medicine companies must pass the above inspections before the end of this year if they do not want to face the dilemma of factory shutdowns.

According to the data, 63 of the 100 companies whose certificates have been withdrawn are Chinese medicine and Chinese medicine decoction pieces. According to industry insiders, the reason why traditional Chinese medicine enterprises have become the hardest hit areas for "receiving certificates" is that on the one hand, the State Food and Drug Administration listed traditional Chinese medicine enterprises as key inspection objects in the "unannounced inspection", and stepped up the inspection before "the deadline is approaching". On the other hand, although the production of traditional Chinese medicine is subject to GMP compulsory certification, compared with the preparation manufacturers, the production enterprises of traditional Chinese medicine and Chinese herbal decoction pieces generally have problems such as low level of production quality management. The phenomenon of sub-packaging or changing the label of purchased pieces, renting out the license and issuing false bills, etc. occurs frequently. Even some companies still commit crimes after their GMP certificates are confiscated.

On March 27 this year, the State Food and Drug Administration issued an announcement saying that during the "unannounced inspection", it was found that 10 manufacturers of Chinese herbal medicines such as Ren'an Medicine had violations of laws and regulations in production and operation. In this regard, the State Food and Drug Administration notified 10 pharmaceutical companies and took back their GMP certificates. One of the companies, Taiyuan Traditional Chinese Medicine, continued to organize production after the certificate was confiscated. Therefore, this year, the State Food and Drug Administration has also increased the frequency and intensity of "unannounced inspections".

De-deterioration of the market

With the advancement of the new version of GMP certification and the approaching deadline, the industry believes that the pharmaceutical industry, especially traditional Chinese medicine companies, may usher in an opportunity to reshuffle. Shi Lichen said that due to the bad phenomenon of "bad money drives out good money" in the traditional Chinese medicine industry, many small pharmaceutical companies have used counterfeiting and shoddy methods to lower low prices and seize the market, resulting in large companies in the face of bad competition. Helpless, but also caused the market chaos. Now, through high-intensity "unannounced inspections" and confiscation of GMP certificates, it helps to drive out these "black sheep".

In addition, Shi Lichen pointed out that while the GMP certificate was confiscated, more companies simply gave up and waited for "closing their doors". "Because of the fierce market competition, some small enterprises and small pharmaceutical factories cannot meet the requirements of the new GMP certificate. requirements, so simply wait for the certificate to expire at the end of this year, stop the product line, and transform to other fields.”

(Jilin Province Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)