Law

E-commerce platform 'Global Purchase' imports drugs with unknown origin, industry calls for improvement of regulatory system

2026-03-16   

Imported drugs that are labeled as "overseas direct mail" can be seen everywhere in the "Global Purchase" section of e-commerce platforms. The reporter's investigation found that many so-called imported drugs are generic drugs from countries such as India. These drugs are cheap, but their origin is unknown, their efficacy is questionable, and there are a large number of complaints. The deeper issue is that there are loopholes in the regulation of cross-border e-commerce, which allows merchants to easily bypass the country's supervision of drugs. Mr. Wu from Zhejiang suffers from polycystic kidney disease and has been diagnosed and treated by doctors for a long time, taking a medication called "Tofacitant Tablets". Due to polycystic kidney disease not being the main indication for atorvastatin tablets, Mr. Wu is unable to use medical insurance and needs to purchase them at his own expense. This is a relatively expensive drug, even if it is a domestic generic drug, the current price per tablet ranges from 15 yuan to 30 yuan. Last year, he saw on an e-commerce platform that a large number of merchants with the name of a certain overseas specialty store were selling "Tofacipatan tablets" for only 5 yuan per tablet. From June to September last year, he purchased two types of "Tofacitant Tablets" from two sellers, which were originally diuretics, but his body showed no response after taking them. Mr. Wu suspected that he had bought fake drugs. In October last year, he sought help from the "People's Voice Express" of Liberation Daily and Shangguan News. For several months, reporters have investigated various aspects of Mr. Wu's drug buying process and sent the drugs he purchased for testing, revealing the numerous irregularities in drug sales through cross-border e-commerce. Is it really sent by 'cross-border e-commerce'? Mr. Wu's "Tofacitant Tablets" were purchased from the "Aijiale Pharmaceutical Overseas Franchise Store" and "Tianfu Pharmaceutical Overseas Franchise Store" on a certain e-commerce platform. Both stores belong to the international cross-border e-commerce sector, with a "Global Shopping" label after the store name. His purchase records show that on June 11 last year, he purchased 100 imported tablets of "Tofacitant" from "Aijiale Pharmaceutical" at a cost of 637.08 yuan. On September 17 last year, he purchased 100 tablets of "Sumacapine for Tofacitant" from "Tianfu Pharmaceutical" at a cost of 538.2 yuan. Logistics display shows that both boxes of medicine were shipped from Hong Kong, cleared through cross-border logistics of "Yunda International", and delivered to Mr. Wu's hands. The platform's public information shows that both store operators are registered enterprises in Hong Kong. Do the two companies really exist? The registered address of "Aijiale Pharmaceutical" is "Room A17, 29th Floor, Ningjin Center, Kwun Tong, Kowloon", and the registered address of "Tianfu Pharmaceutical" is "Room S239, 2nd Floor, Capital Plaza, Tsim Sha Tsui". Both companies were registered between 2023 and 2024. On a working day in January this year, the reporter found someone to go to the two addresses mentioned above to check. There are 8 large compartments from Room A to Room H on the 29th floor of Ningjin Center, with even smaller compartments inside. But the white glass door of Room A was tightly closed, the doorbell rang but no one responded, and there was no one working inside; On the second floor of the Capital Square, there are rows of artificially separated small rooms, each measuring only three or four square meters, with light boxes at the top for businesses to post their names. S239 is completely empty indoors, with a password lock fastened to the retractable door. From the on-site perspective, both of these addresses are physical locations, not virtual registered addresses. It's somewhat unusual for a company to rent physical premises but not use them. The reporter placed an order for a box of "Tofacitant Tablets" at "Tianfu Medicine" and it was delivered by courier on March 4th. On the express waybill, the shipping address is another Hong Kong address "8A1 Shop, 2nd Floor, Lung Fung Garden, Sheung Shui, New Territories". Longfeng Garden is very well-known in the cross-border e-commerce circle, with a large number of shipping addresses written here on waybills. The reporter sent someone to Longfeng Garden again to verify, and found a sign of a certain "school" hanging outside the "2nd floor 8A1 shop"; When calling the sender 'Chen Sheng' again, the voice message keeps saying 'unable to connect'. The reporter noticed a detail that the express waybill not only has the words "Standard Express" written on it, but also includes the words "Shanghai Area Package" and other sorting information. The characteristics of the waybill are consistent with those of ordinary express waybills printed by domestic branches. Previously, it has been exposed by the media that some cross-border e-commerce platforms are actually "fake direct mail", which means that express packages are actually sent to Guangzhou or Shenzhen first, and then sent by courier companies on behalf of Guangzhou or Shenzhen, and the logistics records of the previous Hong Kong to Guangzhou or Shenzhen segment are forged. Based on the false mailing address, may the journalist have received a "fake direct mail" package? Checking the customs clearance information is a crucial step in determining whether the package is a "fake direct mail" package. When placing an order, the reporter and Mr. Wu were asked by the e-commerce platform to provide their ID card numbers and upload the front and back of their ID card photos for customs declaration and submission of information. A courier company told reporters that most cross-border e-commerce packages entering the country adopt the "CC Shipping" customs declaration mode, which means declaring through logistics companies in the name of the consumer. Shenzhen and Guangzhou ports adopt a sampling system for cross-border e-commerce packages. If the express package is not sampled, customs clearance only requires a simple customs declaration procedure, and the clearance time is very fast. But regardless of which clearance procedure, consumers can access their personal clearance data through multiple channels. The reporter used the "Personal Customs Clearance Data Query" function in the "Cross border E-commerce Public Services" section of the "China International Trade Single Window" website to find that although there are customs clearance records in the express logistics records, no customs clearance information for the three orders of the reporter and Mr. Wu can be found on the website. The reporter asked Yunda Express for verification, and the relevant person in charge of the other party defended that Yunda is only responsible for cross-border transportation, and customs clearance is declared by the merchant themselves. The other party did not respond to why the customs clearance information could not be found, only emphasizing that there was no problem from the logistics records. Mr. Wu also told reporters that under the coordination of the e-commerce platform, "Tianfu Medicine" allows him to return the medicine he has not eaten, and the provided return address is a post station located in Boai Community, Xuzhou. The reporter found the boss of the courier station, who claimed that this phone number receives more than 20 parcels on behalf of the courier station every month, and the recipients use pseudonyms such as "Fengze" and "Merchant CELE"... Testing shows that there is a lack of "key accessories" and cross-border e-commerce channels cannot be traced, and the origin of the drugs is unknown. Mr. Wu and other consumers are more concerned about whether the medicine they buy is genuine or fake. When selling so-called "original imported" drugs, the two stores mostly use photos of original research drugs or European produced drugs. But what consumers actually receive is different from the picture: what "Aijiale Pharmaceutical" sells comes from the pharmaceutical company "Zydus"; And the products sold by "Tianfu Pharmaceutical" are from the pharmaceutical company "Healing Pharma", with both "Tofacitant Tablets" having a specification of 15 milligrams. According to online searches, both of these companies are actually generic drug manufacturers in India. Healing Pharma has an official website where you can find the product "Tofacitant Tablets". Through the website, the reporter contacted customer service and provided photos of the two boxes of "Tofacitant Tablets" outer packaging boxes purchased by the reporter and provided by Mr. Wu. After identification by the customer service, they were informed that the codes "TT-1220026" and "TT-1220028" on the two drug boxes could be found in the product library, but the authenticity of the drugs themselves could not be confirmed through pictures. Open two boxes of medicine and squeeze out one tablet each: the two tablets are light blue in varying shades, and upon closer inspection, some black dots are found mixed in. There are indentations in the middle of the tablets that are easy to open. The reporter sent photos of the pills to industry insiders for identification. They believe that, based solely on the naked eye, the uniformity of these two pills is slightly inferior. The reporter sent two pills to the Shimadzu Shanghai Application Laboratory, which specializes in biopharmaceutical testing, for ingredient testing. As a comparison, the reporter also provided the "Tofacitant Tablets" produced by the domestic pharmaceutical company "Guilin Nanyao", which are also 15 milligrams in size. This is a drug that Mr. Wu has been taking, and it is said to have good efficacy. The laboratory staff crushed, dissolved, and filtered three drugs to make a solution, which was then analyzed using a mass spectrometer. The analysis results show that there is not much difference among the three drugs in terms of the main ingredient "tolvaptan", but there are significant differences in the excipients. The person in charge of a pharmaceutical manufacturing company explained to reporters that the main ingredient in a single pill is actually very low, with the vast majority being excipients. He told reporters that the importance of excipients is no less than that of the main ingredients, because excipients control the disintegration of drugs and their release and absorption in the body. For example, a drug needs to be absorbed by which organ of the human digestive system and for how long, all of which require precise control through excipients. On the analysis result chart of the mass spectrometer, there is a small bulge on the left side of the peak indicating the principal component for the "Tofacitant Tablets" produced by Guilin Nanyao. According to analysis by pharmaceutical industry professionals, this bulge may indicate some kind of polymer excipient. Tovaptan is a highly hydrophobic drug with low solubility, which cannot be absorbed by the human body when taken directly. It requires the use of polymer excipients such as hydroxypropyl methylcellulose to assist in solubilization, prevent drug crystallization, and allow it to be absorbed by the human body. The mass spectrometry analysis results of two Indian generic drugs do not show this bulge, indicating a lack of polymer excipients. The person in charge of the above-mentioned pharmaceutical production enterprise analyzed that the lack of solubilizing polymer excipients theoretically affects the dissolution performance and bioavailability. However, there are also other formulation routes in the industry to improve dissolution, such as ultrafine pulverization. Further testing and evaluation are needed to determine whether these two Indian generic drugs have adopted other formulation routes. But he pointed out that the quality of generic drugs in India varies greatly, which may explain why the effects are not significant after patients take them. Therefore, the country has strict regulatory procedures for imported drugs. According to relevant regulations, imported drugs must obtain an "Import Drug Registration Certificate" (for foreign drugs) or a "Pharmaceutical Product Registration Certificate" (for drugs from Hong Kong, Macao, and Taiwan) issued by the State Food and Drug Administration in order to handle import filing and port inspection procedures. Imported drugs must comply with Chinese drug quality standards and pass inspection by the port drug inspection office before they can be sold in the domestic market. The person in charge of the above-mentioned drug production enterprise believes that the two "Tofacitant Tablets" purchased by Mr. Wu obviously did not obtain the "Import Drug Registration Certificate" and are fake drugs in the legal sense; Although these two drugs have main ingredients, they lack key excipients and their therapeutic effects are not significant, making them a 'inferior drug'. Unknown "imported drugs" are circulating in the two stores where Mr. Wu bought drugs. In addition to "Tofacitant Tablets", there are also a large number of other drugs. Taking "Tianfu Medicine" as an example, there are more than 60 drugs commonly used by patients, such as metformin, atorvastatin, febuxostat, telmisartan, etc., on sale, and a total of 25000 reviews have been received. The reporter found that there are many "overseas specialty stores" that sell drugs in the "global purchase" section of major e-commerce platforms. Can cross-border e-commerce sell drugs? It is understood that the domestic cross-border e-commerce sales of pharmaceutical products are still in the small-scale pilot stage. According to the reply letter from the Comprehensive Department of the National Medical Products Administration on matters related to cross-border e-commerce sales of pharmaceutical products (Drug Administration Comprehensive Drug Administration Letter [2021] No. 266), the pharmaceutical products sold in cross-border e-commerce pilot projects should be products that have obtained market approval in accordance with the law in China, as well as drugs listed in the "List of Cross border E-commerce Retail Imported Goods (2019 Edition)" published by the Ministry of Finance and other departments. The list of imported goods for cross-border e-commerce retail (2019 edition) specifies very few varieties of drugs and medical devices, only including Chinese medicinal wine, cooling oil, adhesive plaster, other adhesive dressings and items with adhesive coatings, cotton swabs, gauze, bandages, etc. In addition, a person in charge of a courier company told reporters that drugs for personal use entering the country through courier channels are also subject to strict supervision. If it is health products and some over-the-counter drugs, they can be imported within the scope of personal use,

Edit:Chenjie Responsible editor:Jiajia

Source:https://www.jfdaily.com/

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