Investigation into "Global Shopping" imported medicines: Why are Indian generic drugs of unknown origin able to be sold openly on e-commerce platforms?

(Source: Shanghai Observer News)

“Imported drugs” labeled as “overseas direct mail” are everywhere on e-commerce platforms’ “Global Shopping” section. An investigation found that many so-called imported drugs are actually generic medicines from India and other countries. These drugs are inexpensive but have unclear sources and questionable efficacy, leading to numerous complaints. The deeper issue is that regulatory gaps in cross-border e-commerce allow merchants to easily bypass national drug regulations, enabling these unverified drugs to reach consumers.

Mr. Wu from Zhejiang has been taking a medication called “Tolvaptan Tablets” long-term to treat “polycystic kidney disease.” Since polycystic kidney disease is not the primary indication for Tolvaptan, he cannot use medical insurance and must pay out of pocket. This medication is relatively expensive; even domestic generics cost between 15 and 30 yuan per tablet. Last year, he saw on a certain e-commerce platform that many sellers with names like “Overseas Specialty Store” were selling Tolvaptan Tablets at only 5 yuan per tablet. Between June and September last year, he bought two different types of Tolvaptan from two sellers but experienced no effect after taking them. “Tolvaptan is a diuretic, and you should feel a strong diuretic effect quickly after taking it,” Mr. Wu told reporters.

He suspected he had bought fake medicine. In October last year, he filed a complaint with Liberation Daily·Shanghai Observer News’ “Public Voice Express.” Over the past few months, reporters investigated all aspects of his purchase process and tested the medicines he received, revealing chaotic drug sales in cross-border e-commerce.

Is this really medicine sent from Hong Kong?

Mr. Wu’s “Tolvaptan Tablets” were purchased from “Aijiale Medical Overseas Store” and “Tianfu Medical Overseas Store” on a certain platform. Both are listed as international stores in the cross-border e-commerce section, with “Global Shopping” tags. He provided purchase and logistics records: on June 11 last year, he bought “Original Tolvaptan 100 tablets” from “Aijiale Medical” for 637.08 yuan; on September 17, he bought “Suma Cardipine substitute Tolvaptan 100 tablets” from “Tianfu Medical” for 538.2 yuan. Logistics records show both boxes were shipped from Hong Kong, cleared customs via “Yunda International” cross-border logistics, and delivered to Mr. Wu.

The logistics records show both boxes were shipped from Hong Kong, cleared customs through “Yunda International” cross-border logistics, and delivered to Mr. Wu.

Public information on the platform indicates both stores are registered as companies in Hong Kong, consistent with cross-border e-commerce logic. To verify authenticity, the first step is to check whether these two companies are real. “Aijiale Medical” is registered at “29A, Ningjin Center, Kwun Tong, Kowloon,” and “Tianfu Medical” at “S239, 2nd Floor, Capital Square, Tsim Sha Tsui.” Both companies registered between 2023 and 2024. On a weekday in January, reporters visited these addresses: the 29th floor of Ningjin Center has eight large compartments labeled A to H, with smaller partitions inside. The “A” door is closed, with no response to the doorbell, and no one is working inside; the second address at Capital Square has a row of small rooms, each only three to four square meters, with signs displaying company names. Room S239 is empty, with a password lock on the retractable door. From the scene, both addresses are physical locations, not virtual addresses, but the fact that they are rented but unused is unusual.

Public registration information for the two stores.

Kwun Tong, Kowloon, Ningjin Center, 29th Floor, Room A.

Tsim Sha Tsui, Capital Square, 2nd Floor, Room S239.

The reporter ordered a box of “Tolvaptan Tablets” from “Tianfu Medical,” which was delivered on March 4. The courier label shows a different Hong Kong address: “Shop 8A1, 2nd Floor, Long Fung Garden, Sheung Shui, New Territories.” “Long Fung Garden” is well-known in the cross-border e-commerce circle, with many shipping labels showing this address. The reporter visited Long Fung Garden and found a sign for a “School” outside “Shop 8A1.” Calling the sender “Mr. Chen,” the phone always prompts “Cannot connect.” The reporter noticed that the courier label not only says “Standard Express” but also has sorting info like “Shanghainese Area Package,” matching ordinary domestic courier labels. Previously, media reports exposed that some cross-border e-commerce stores are actually “pseudo-direct mail,” where packages are first sent to Guangzhou or Shenzhen, then forwarded by courier companies, with forged logistics records for the Hong Kong-to-Guangzhou/Shenzhen segment. Given the false sender address, could the package I received also be a “pseudo-direct mail”?

The courier label not only says “Standard Express” but also has sorting info like “Shanghainese Area Package,” matching ordinary domestic courier labels.

To verify whether it is a “pseudo-direct mail” package, checking customs clearance info is crucial. Both Mr. Wu and the reporter were asked to provide ID numbers and upload photos for customs declaration when ordering. A courier company told us that most cross-border e-commerce parcels enter China via the “CC Postal” declaration mode, using individual declarations by consumers through logistics companies. Shenzhen and Guangzhou ports conduct random inspections; if a parcel is not inspected, it can go through simplified customs procedures quickly. Regardless of the process, consumers can check their customs clearance data through multiple channels. Using the “China International Trade Single Window” website’s “Cross-border E-commerce Public Service” section, the “Personal Customs Data Inquiry” function was used, but despite logistics records showing customs clearance, no clearance info was found for the three orders from Mr. Wu and the reporter.

The “Cross-border E-commerce Public Service” section on the “China International Trade Single Window” website shows no customs clearance info for these orders, despite records indicating clearance.

The reporter also contacted Yunda Express. A relevant manager explained that Yunda only handles cross-border transportation, and customs clearance is self-declared by merchants. When asked why no clearance info was available, they did not respond, only emphasizing that logistics records appeared normal.

Additionally, Mr. Wu told us that, with the platform’s coordination, “Tianfu Medical” allowed him to return unused medicine to a station in Xuzhou Boai Community. The station owner said that the phone number used for deliveries receives over 20 parcels monthly, using aliases like “Fengze” and “Merchant CELE.”

Testing shows missing “key excipients”

The inability to trace the source of medicines through cross-border channels raises concerns about whether the drugs are truly “imported.” More importantly, consumers like Mr. Wu worry about whether the medicines are genuine, effective, or fake.

Both stores sell so-called “original imported” drugs, mostly using photos of original or European-produced medicines, but the actual products differ: “Aijiale Medical” sells drugs from “Zydus,” while “Tianfu Medical” sells products from “Healing Pharma,” both in 15 mg doses. Online searches reveal that these two companies are actually Indian generic drug manufacturers.

Both stores use images of original or European-produced medicines when selling “original imported” drugs.

But the actual products received are Indian generics.

“Healing Pharma” has an official website where the “Tolvaptan Tablets” are listed. The reporter contacted customer service through the website and provided photos of the two boxes purchased. After identification, the customer service confirmed that the codes “TT-1220026” and “TT-1220028” on the boxes can be found in their product database, but the authenticity of the medicines cannot be confirmed from photos alone.

“Healing Pharma” official website customer service confirmed that the codes “TT-1220026” and “TT-1220028” can be checked in their product database.

Opening the two boxes and squeezing out one tablet each: both are light blue with some black specks, with a score line in the middle. Photos of the tablets were sent to industry insiders for identification; they believe that, visually, these two tablets are somewhat uneven in quality.

The left tablet (lighter color) is “Zydus” brand “Tolvaptan,” the right is “Healing Pharma” brand. Visually, both are roughly made, with unevenness.

The two tablets were sent to “Shimadzu Shanghai Application Laboratory” for component testing. As a comparison, the same 15 mg “Tolvaptan” from domestic manufacturer “Guilin Nanyao” was also tested, which Mr. Wu has been taking and claims to be effective. The lab ground and dissolved the three medicines, filtered them, and analyzed with a mass spectrometer. Results showed that the main component “Tolvaptan” was similar across all three, but excipients differed significantly.

The mass spectrometry results show the main component “Tolvaptan” peaks, with differences mainly in the small “bump” on the left, indicating that the two Indian generics lack certain polymer excipients present in the domestic product.

A pharmaceutical company expert explained that the main active ingredient in a tablet is present in very small amounts; most of the tablet is excipients. Excipients are as important as the active ingredient because they control disintegration, release, and absorption in the body. For a drug to be absorbed by specific organs and over specific durations, excipients are used to precisely control these processes.

The mass spectrometry graph shows that the Guilin Nanyao “Tolvaptan” has a small “bump” indicating the presence of polymer excipients. These polymers, like hydroxypropyl methylcellulose, help improve solubility and prevent crystallization, aiding absorption. The two Indian generics lack this “bump,” indicating missing polymer excipients.

The responsible person from the pharmaceutical company explained that missing solubilizing polymers could affect dissolution and bioavailability. Other formulation methods, like micronization, might be used to improve solubility, but further testing is needed. The quality of Indian generics varies greatly, which may explain why patients do not see expected effects.

Therefore, the government enforces strict regulation on imported medicines. Regulations specify that imported drugs must have a “Drug Import Registration Certificate” (for foreign drugs) or a “Medical Product Registration Certificate” (for Hong Kong, Macau, Taiwan drugs) issued by the National Medical Products Administration before they can be imported and sold domestically. Imported medicines must meet Chinese quality standards and pass customs inspection.

The responsible person from the drug manufacturer stated that the two “Tolvaptan” products purchased by Mr. Wu clearly lack the necessary import registration certificates, making them illegal and effectively fake drugs; despite containing active ingredients, missing key excipients render them ineffective, classifying them as “substandard drugs.”

How can unverified “imported drugs” circulate so openly?

In the two stores where Mr. Wu bought medicines, besides “Tolvaptan Tablets,” there are many other drugs. For example, “Tianfu Medical” sells over 60 types, including metformin, atorvastatin, febuxostat, telmisartan, with over 25,000 reviews. I also found many “overseas specialty stores” selling medicines in the “Global Shopping” section of major platforms.

Are cross-border e-commerce platforms allowed to sell medicines? Currently, domestic cross-border e-commerce sales of medicines are still in a pilot stage. According to a reply from the State Food and Drug Administration’s Department of Comprehensive Supervision (Document: YJZ [2021] 266), medicines sold in cross-border e-commerce pilot programs must be approved for market listing in China or listed in the “2019 Cross-border E-commerce Retail Import Goods List.” The list includes very few medicines and medical devices, mainly traditional Chinese medicine wines, cooling oils, plasters, adhesive dressings, cotton, gauze, bandages, etc.

An express company official also told us that personal medicines entering China via courier are strictly regulated. Non-prescription health products and some OTC drugs can be imported for personal use, with customs almost always inspecting packages. Prescription medicines require invoices, instructions, buyer ID, and doctor’s prescriptions.

Given this, why can cross-border e-commerce platforms openly sell Indian generics? Last October, Mr. Wu filed a complaint with Liberation Daily·Shanghai Observer News, alleging “selling fake medicines.” The case was transferred to market regulation authorities, which responded that cross-border e-commerce imports are outside their jurisdiction. This indicates regulatory blind spots. Since medicines are not among the permitted categories for cross-border e-commerce sales, products listed on these platforms are treated as ordinary goods, and no prescriptions are required when ordering.

This creates a gray sales channel for unverified Indian generics: merchants can open stores on platforms by providing “Drug Business Licenses” and “Internet Drug Information Service Qualifications,” or, if using “international stores,” only need to provide foreign company registration certificates. Since platforms only support direct overseas shipping, merchants can register a company in Hong Kong, open an international store, and with courier help, either bypass customs or forge logistics records to sell unverified Indian generics openly.

There are many social media posts claiming to offer virtual logistics tracking for sellers.

Over the past year, due to significant price hikes of many original imported medicines, patients have turned to e-commerce for cheaper options. The Shanghai citizen hotline and other channels report a rise in complaints about fake medicines bought via cross-border e-commerce. Previously, counterfeit issues were mainly in health supplements, but now the chaos is spreading to medicines.

Industry experts say that medicines and medical devices are special and cannot be freely bought and sold like regular goods. The chaos in cross-border e-commerce drug sales exposes patients to high risks. This issue should attract regulatory attention. “Promoting cross-border e-commerce with overseas warehouses” was included in this year’s government work report. Experts suggest that regulatory systems should be improved quickly, with strengthened government oversight and platform self-discipline, to further standardize cross-border e-commerce operations and protect consumers.

Original Title: “‘Global Shopping’ Imported Drugs Investigation: Why Are Unverified Indian Generics Allowed to Be Sold Openly on E-commerce Platforms?”

Source: Author: Mao Jinwei, Liberation Daily