China Busts Counterfeit Plavix Ring In Ongoing Crackdown

BEIJING – When a resident in China’s central Hubei province surnamed Li found out that Plavix (clopidogrel) tablets, a best-selling blood thinner made by French firm Sanofi, purchased the day earlier for his ailing father soon became strange and “soggy”, he realized something was not right.

Li's father, who recently underwent heart surgery, needed the antiplatelet agent to prevent blood coagulation. When Li came across a drug store where the widely prescribed medicine was sold at CNY120 ($18.50) for a box of seven tablets of 75mg, instead of the CNY140 he usually paid at hospitals, he immediately bought several boxes.

After discovering the problem, Li sent the remaining tablets to the Shiyan Municipal Food and Drug Administration office. After testing, the product was found to contain no active pharmaceutical ingredients and was deemed to be counterfeit.

The bogus Plavix was therefore not only ineffective but could actually cause harm to the cardiovascular system if taken long term, Li told local media. Months of investigations and a multi-provincial crackdown by Shiyan police then started to unearth a deep-rooted and hard-to-trace drug counterfeiting ring.

According to details now released by the investigators, all documents presented to the drug stores where the fakes were discovered seemed to be genuine; the only catch was the price. Compared to the normal wholesale price of CNY110 per box, the fake Plavix prices were just CNY90 a box.

Tracking Ghosts

When the police tracked the drugs back to their supplier, a person surnamed Feng then claimed to know nothing about the counterfeits, since he bought them from someone else with whom he communicated only via social media, including QQ and Wechat, two popular instant messaging tools in China. So not only was identification hard, but the mobile phone numbers belonged to someone else.

A promising lead suddenly seemed to go nowhere, but the investigators didn't give up.

They traced the logistics of the counterfeits and nailed a person called Xin, later found to be a false name for Han Libo, a professional “drug collector” in Beijing. This means he buys unused drugs a penny to a dime from patients who have medical insurance coverage, and also from online chatroom acquaintances.

Meanwhile, through tracing bank transactions, the police also identified another key person, Liu Chenglong from the Northeastern province of Helongjiang who spent most of the time in Tianjin, a coastal city south of Beijing.

Through Liu, the investigators further discovered Jiang Tao, a Tianjin-based ring leader who was in charge of manufacturing, collecting and distributing the counterfeits.

According to the investigation, Jiang and his ring members used corn starch and peanut powder to make “Plavix”, and injectable sodium chloride to produce fake insulin products.

In total, over 200,000 bogus Plavix tablets were discovered, and authorities in over 20 provinces and cities launched a concerted crackdown on the counterfeits, resulting in the detention of 201 suspects and a total haul with an estimated value of CNY100m.

As counterfeit medicine rings in China increasingly turn to social media to conduct activities from recruiting and soliciting to marketing, manufacturing and distribution, authorities are scrambling to find new ways to clamp down on them amid explosive growth in smartphones and instant messaging tools.

In Shiyan's case, due to the use of social media, many transactions including money transfers and product delivery could be done without knowing the identity of the other person. Taking advantage of people's desire to buy brand drugs for less, the ring members commonly posted product images to targeted patient groups to fish for customers, and after receiving orders, would start buying orders in bulk from eager sellers or to manufacture the items themselves.

One year after the counterfeits ring was first broken in May 2015, no details of punishments have been disclosed.

Countering The Counterfeits

China's multilayered pharma distribution network only complicated matters when it came to tracing products through the system.

In one move to counter the counterfeits, the China FDA launched a digital monitoring system using a scanned 20-digit code printed on the outer package, through which an end user can use a smartphone and get find out the drug's supply route, expiry date and manufacturing time.

However, many patients simply purchase drugs based on brands and prices, and only scan the code after suspecting something wrong, like what happened in Li’s case.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) reports a growing threat from counterfeit medicines, which may account for around 1% of global medicine sales, according to the group’s statistics.

In response to a PharmAsia News request for comment on the Plavix case, Sanofi said the company supports and collaborates with the government to crack down on counterfeits. "Patients’ health is the core of our work. Counterfeit drugs are a big threat to patients’ health and even their lives," said the company in a written statement.

"Sanofi will continue to support and actively cooperate with government institutions to carry out the fight against the manufacture and sale of counterfeit drugs. Sanofi has been proactively adopting methods such as using tamper-resistant packaging and will spare no effort to ensure drug safety for the benefit of all patients."

An Old Problem

Counterfeits are not new in China, where bogus versions of erectile dysfunction drug Viagra (sildenafil) have long been found to be prevalent. The country was ranked top in terms of number of fake Pfizer Inc. drugs, according to a report by the US manufacturer.

Pfizer’s global security regional director for Asia Pacific, Harry Waskiewicz, told PharmAsia News in a previous interview that "proliferation of internet pharmacies…and relatively small risk and penalty faced by counterfeiters" have contributed to the spike in counterfeits.

"And what was once thought to be a Viagra problem has spread to every therapeutic category, with counterfeiters targeting more than 60 Pfizer medicines," he said (Also see "Pfizer Global Security Regional Director Harry Waskiewicz On Busting Counterfeit Drugs: An Interview With PharmAsia News (Part 1 of 2)" - Scrip, 26 Feb, 2013.).

The cost markup system at Chinese hospitals may also potentially contribute to the issue. Hospitals traditionally add 15% or more to drug costs, and that easily adds up for patients who take regular treatments for chronic diseases. To cut cost, some patients actively look for cheaper drugs.

High-cost oncology products are among the targets of a CFDA crackdown on high-profile counterfeits. In 2014, the agency teamed up with the China Public Security Ministry to establish a dedicated branch investigating drug and food violations (Also see "China Steps Up War On Counterfeit Drugs With Cancer Products In Focus" - Scrip, 1 Apr, 2014.).

Meanwhile, in addition to the packaging codes, new technologies such as microchips and smart tags are helping drug makers track and prevent products from adulteration. An on-dose edible authentication tagging system developed jointly by WuXi AppTec Inc. and TruTag has shown promising results (Also see "WuXi and TruTag’s Smart Tags To Help Fight Counterfeits" - Scrip, 21 Aug, 2015.).