Recently, CCTV "Weekly Quality Report" reported that Fujian Sanming Rubber Co., Ltd. (hereinafter referred to as Fujian Sanming) and other plastics companies use raw materials such as sulfuric acid and alkali to process raw materials to make edible gelatin and medicinal gelatin.
After the incident was exposed, Fujian Sanming insisted on the official website that the product was qualified. However, the reporter learned from the Food and Drug Administration of Ningde City, where Sanming is located in Fujian, that relevant companies involved have stopped production and are currently conducting on-site investigations. At the same time, many pharmaceutical companies such as Cologne Pharmaceuticals also urgently cleared up the relationship.
Liu Zhongtang, a medical researcher at Anbang Consulting Group, told the Daily Economic News reporter that for the pharmaceutical excipients, there is no unified registration document issued by the country and the standard system is relatively confusing. Currently, the standard is based on local standards and regulations, and the standards are very different.
Two kinds of raw materials cost about one million tons of gelatin
In 2012, CCTV revealed that some gelatin companies used lime to treat leather waste and made industrial gelatin that exceeded the limit of heavy metal chromium. The capsules were finally made into the belly of patients. The "toxic capsule" incident exploded.
Two years later, the turmoil in the gelatin began again. CCTV reported that Fujian Sanming, Sishui Hengyuan Plastics, Shandong Yixin Biotechnology, Hunan Jinlong Gelatin, Hebei Chengda Gelatin and other large-scale gelatin plants use the tannery industrial trash skin as the main raw material, and then Industrial salts, sulfates, etc. are processed to produce medicinal gelatin or edible gelatin.
An industry source told the reporter of “Daily Economic News†that medicinal gelatin must control the quality from the source, but many manufacturers are trying to reduce costs, lower prices each other, use unqualified raw materials, because the cost is low, they can be sold at a very low price. Going out, there is room for profit. The regular manufacturers may instead be unable to sell because of high prices.
According to CCTV reports, the price of industrial waste leather used by Fujian Sanming is only RMB 2,000 per ton, but it can be sold to food factories and capsule factories at a price of RMB 30,000 to 60,000 per ton after being finished. The price of fresh skin from slaughterhouses is as high as 4,000 yuan per ton, and 1 ton of gelatin is produced from 7 tons of raw hides. The cost of gelatin produced from animal skins will only increase by more than 10,000 yuan.
In the report of CCTV, there was no specific disclosure of the specific list of gelatin flowing to pharmaceutical companies. However, in 2012, the National Food and Drug Administration had asked the provincial food and drug administrations for the pharmaceutical capsules and medicines of local capsule manufacturers. Using the source of gelatin to publicize, from the publicity in 2012, "Daily Economic News" reporter found the traces of Fujian Sanming capsule flow.
Listed company subsidiary or involved
The official website of the Food and Drug Administration of Lishui City, Ningbo City, Jieyang City and other places showed publicly available sources of gelatin, and Sanming’s medicinal gelatin mainly went to Zhejiang Jingning Minjiang Capsule Co., Ltd. and Puning Lvzhou Capsule Co., Ltd. , Ningbo Yinzhou Rubber Pill Factory, Ningbo Yinzhou Shiqi Lighthouse Plastic Pill Factory, Ningbo Yinzhou Youth Pharmaceutical Capsule Factory, Zhejiang Pujiang County Enerkan Capsule Co., Ltd. and other companies, the reporter used these capsule companies as keywords to find out These capsules mainly flow to companies with small scales, and also have subsidiaries of listed companies.
The Lishui City Food and Drug Administration announced that it was on display on May 15, 2012. Zhejiang Pujiang County Ercang Capsule Co., Ltd. is the source of capsules for Zhejiang Guojing Pharmaceutical Co., Ltd., a subsidiary of Kelun Pharmaceutical (002422, SH). Enterprise; Shanghai Food and Drug Administration publicity shows that Ningbo Yinzhou Lighthouse Plastic Capsule Factory is a pharmaceutical capsule of Shanghai Great Wall Pharmaceutical Co., Ltd. jointly invested by Shanghai Industrial Group Co., Ltd. and Shanghai New Asia (Group) Co., Ltd. supplier.
CCTV reports that half of Fujian Sanming's gelatin has flowed into Xinchang County in Zhejiang Province. Kangping Capsule Factory is one of them. The Jinhua City Food and Drug Administration publicly disclosed that Kangping Capsule Factory is a listed company, Luoyang Pharmaceutical (000739, SZ) holds 90 shares. % of its subsidiary, Zhejiang Prolocomal Natural Medicine Co., Ltd. suppliers.
The Columbine Pharmaceuticals Securities Department sent an e-mail to the reporter of “Daily Economic Newsâ€, saying that Sichuan Kelun Pharmaceutical Co., Ltd. currently only subordinate Zhejiang Guojing Pharmaceutical Co., Ltd. purchases medicine from Urqang Capsule Co., Ltd., Pujiang County, Zhejiang Province. Hollow capsules are used. The latter's "Notes on Hollow Capsules" stated that since the 2012 May, Enkang has not purchased and used gelatin produced by Fujian Sanming as a raw material for capsules.
According to a public announcement issued by the Qingdao Municipal Food and Drug Administration in May 2012, Fujian Sanming is one of the sources of gelatin for Double Whale Pharmaceuticals, and Double Whale Pharmaceuticals issued a statement on its official website a few days ago that it has not purchased Fujian Sanming in the past two years. Gelatin produced by the plastics industry.
Sanming, Fujian issued a statement in the official website, said that the production and sale of gelatin in Fujian Sanming (pharmaceutical accessories) and gelatin capsules in line with national regulations, is willing to accept and cooperate with the food and drug supervision and management supervision and inspection.
On March 18, a reporter of “Daily Economic News†learned from the Food and Drug Administration of Ningde City, where Sanming is located in Fujian, that relevant companies involved have stopped production. The relevant personnel are currently conducting on-site investigations. Whether the violation is pending after on-site investigation It can be concluded that the tracking and recall of Fujian Sanming gelatin flow needs to be investigated.
Medicinal capsules are of different standards
Two years later, why was the capsule once again caught in a "toxic" vortex?
Liu Zhongtang stated that the State Administration of Food and Drug Administration assigned pharmaceutical excipients to drugs in the management category. However, in practical implementation, medicinal excipients were separately identified. The registration and examination and approval were carried out according to local standards and regulations, and the standards were different.
It is understood that the domestic original drug standards are divided into two levels, which are divided into national standards and local standards; the examination and approval also implement two levels of approval, and the approval document numbers are in the form of “national drug approval word†and local approval document number. At the end of 2001, the national drug regulatory authority carried out rectification and re-evaluation of local standards, standardized and recertified the approval numbers, but did not rectify and re-evaluate the excipient standards contained in local standards. The problem of non-uniform quality standards for excipients. In the publicity of the drug regulatory agencies on the status of medicinal capsules and pharmaceutical gelatin sources, Daily Economic News reporter found that the medicinal capsules have the national drug approval number, and there are also different approval numbers for the official drug name and the official identification number. .
In the previous report of the "Pharmaceutical Economic News", an expert from the Pharmaceutical Packaging Association stated that the "Code for the Quality Control of Pharmaceutical Excipients Production" issued in 2006 was not enforced, and the "Regulations for the Registration of Pharmaceutical Excipients" had not been introduced to make local supervision. There is no relevant basis for supervision and management of pharmaceutical gelatin in the department.
Liu Zhongtang told the reporter that in 2005, the former State Food and Drug Administration Registration Department issued a solicitation draft for the "Administrative Measures for Registration of Pharmaceutical Excipients." After the outbreak of capsule chromium violations, in 2012, the former State Food and Drug Administration issued the "Relevant Regulations on Strengthening the Supervision and Administration of Pharmaceutical Excipients," which regulates and regulates the use of pharmaceutical excipients, but the national standard for the registration of excipients has so far been Not formally introduced.
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