Article / Observer Wang Kaiwen Editor / Zhang Yaqi, Feng Xue
"Regular channels, 100% fidelity!"
"The green box is reported to be fake, so if you are not sure, buy the blue box."
"Customs can not pass, personal reasons are not refunded or replaced."
Last December, with the arrival of the peak of infection around the country, the demand for new crown oral medication is rapidly climbing, Pfizer Paxlovid (Nematrevir / Ritonavir tablets, commonly known as the "P drug") black market price was once speculated to tens of thousands of dollars.
Tension between supply and demand has brought Indian generics back into the national picture. However, over the past month, a number of testing organizations have revealed that a significant number of so-called "generic drugs" do not contain any active ingredients.
Recently, in the process of exchanging information with several buyers, the Observer found that the Indian generic drugs currently flowing into the Chinese market are mixed, and the generic drug Primovir (commonly known as the green box) is still on sale, which has been exposed to a long time ago as discontinued, and is mostly fake. And the pricing of these generic drugs is confusing, some of the offer and the domestic formal channels of sales of the original drug compared to not much advantage.
Over the past few days, many experts and industry insiders have warned that it is difficult to ensure the quality of foreign generic drugs from the source, and that there is a greater risk of health risks when purchasing on their own. And in the absence of legal qualification procedures, the import and sale of generic drugs is still illegal.
"If it is not impossible to buy, who will go to buy Indian drugs?" Xiao Liu, a netizen who bought an Indian green box in early December, told the Observer.
Observers noted that in the social platform, in the past few days, many netizens reflected that online formal channels to buy Pfizer Paxlovid has become easier, and even "do not need to grab".
The new crown oral drug Monoravir (Molnupiravir) of Merck Sharp & Dohme is also available for sale on the online platform from January 19th, and the price of the domestic new crown drug Azivudine is expected to be reduced to 175 yuan. At the same time, the domestic new crown oral drug field progress frequently, a variety of drugs are expected to be approved in the first half of this year.
Counterfeiting storm
From the netizen's sharing point of view, in the past period of time on the market circulation of new crown of India-made generic drugs are mainly Primovir, Paxista, Molnunat, Molnatris, Movfor and so on. The most "hot" time, some large e-commerce platform also openly on the shelves of such goods.
Primovir is commonly known as the "green box", Paxista is commonly known as the "blue box", these two are Pfizer Paxlovid's generic drugs, but also at the end of last year in the e-commerce platforms, Xiaohongshu, WeChat friends circle, etc. The "photogenicity" of the highest Indian new crown generic drugs. three drugs beginning with the letter "M", is the Merck Sharp and Dohme Monoravir generic drugs.
Green box Primovir and blue box Paxista
With the increase in the number of drug buyers, since December, the social platforms are also increasingly questionable.
According to the Surfing News English product "Sixth Tone" reported on January 6, last December 14, Zhihu blogger "Tianzhu ten years" posted an article on the new crown generic drug counterfeiting warned that it found Astrica production of generic Primovir. The new crown generic drug Primovir (green box) appeared to be evidence of counterfeiting.
"Ten Years in the Dharma" contacted a person in charge of Astrica via WhatsApp, based on the contact information on the box, and was told that Primovir had long been discontinued. According to the screenshot of the conversation, the person in charge of the company said bluntly, "Now there are people who fake it."
On January 8, UW Group CEO Yin Ye said on Weibo that as of 22:00 that night, UWG had recently tested 249 copies of the new crown copycat drug sent for testing, and only 19 copies of the active ingredient Nematrevir were detectable, while 230 copies were not detected (92.4% of the total). Nematrevir was not detected in 97.7% of all Green Box (Primovir) samples.
On January 10th, science science blogger @DrCash, Dr. Kaixi, posted that only 9 out of 155 Primovir (green box) samples he tested were detected as containing nematrevir. Even the generics containing nematrevir contained less than 30% of the original.
On January 16th, the WeChat public number "Shanghai Network Disinformation" posted an article saying that, according to a Shanghai-based testing organization "Xinpodi", the lab had been receiving samples from all over the country since early December last year, with a peak of nearly 200 samples a day. At the peak of the day, nearly 200 samples were sent for testing, and in the early days, most of the samples were sent by trading companies, and the test results showed that the generic drugs sent for testing basically contained Nematrevir. But since then, as individuals send more and more generics for testing, there are more and more test results that do not contain the active ingredient.
"At present, basically 90% of the Paxlovid generics sent for testing do not test for Nematrevir, which is a fake generic," said the head of NewPodi.
From the results of a number of testing organizations, the Indian version of the green box Primovir has become a fake drug "disaster area". As for the blue box Paxista and generic Monoravir, according to Dr. Kathy's data as of January 18, 53 samples of Paxista and 45 samples of generic Monoravir tested by Dr. Kathy contained Nematrevir or Monoravir.
However, questions about the authenticity of the generic monoravir drug Movfor have also already surfaced recently on social media platforms such as Little Red Book. No testing organization has yet publicly confirmed this.
"Shanghai Network Rumor" revealed in a report on the 16th that some platform merchants and drug dealers are not unaware of the abundance of fakes in the Pfizer Paxlovid Indian generics. An idle fish (second-hand goods trading platform) Indian buyers, said the green box drug Primovir in India has long been discontinued, and Nematrex is more difficult to obtain raw materials, there are claims that the green box of the factory to see the growth in demand for a batch of raw materials do not contain the Nematrex produced a batch of drugs is the source of this batch of fake generic drugs.
According to the article in the "Ten Years in the Dzongs", the head of Astrica said that he was also a distributor of India's Hyderabad Pharmaceuticals Ltd. and that he had asked one of Hyderabad's managers to help him produce the green box of Primovir in Hyderabad's subsidiary, and that now Hyderabad's subsidiary, Azista, had gotten the green box in Bhutan. Azista got Pfizer's approval in Bhutan, so Hydro no longer produces under license for Astrica, and asked Astrica to stop selling the green box, and must sell Paxista produced by Azista, a subsidiary of Hydro.
The Observer tried to call the "China Office" phone number on the back of Primovir's green box package several times, and was prompted to call the "China Office" phone number. office" on the back of Primovir's green box, but the phone was turned off.
The e-commerce platform is off the shelves, but can still be purchased through "hidden channels"
On January 16th, the State Drug Administration (SDA) said that, in response to the recent emergence of the illegal sale of drugs of unknown origin for the treatment of neocoronaviral infections in the market, the drug regulatory authorities of many places have taken a combination of online monitoring and offline mapping to find out how the drugs are used. online monitoring and offline mapping, in conjunction with the local public security departments of joint law enforcement, has dismantled some of the criminal gangs and dens, and seized a number of counterfeit Paxlovid (Nematrevir tablets / ritonavir tablets combination package) and unauthorized imported drugs on the spot during the net closing operation.
Upon inspection, some of the seized products did not contain effective pharmaceutical ingredients or illegally added other pharmaceutical ingredients, and were suspected of violating Article 141 of the Criminal Law of the People's Republic of China (PRC), which stipulates the crime of selling counterfeit medicines. At present, the case is being handled by the public security departments in accordance with the law.
The Observer noted that as of January 19th, several e-commerce platforms have been unable to directly search for Indian generic drugs, but can still be contacted through the "India purchase" keywords, such as purchasing. The company's website has been updated with the latest information about the company's website, including a list of its products and services, as well as a list of its products and services.
Through WeChat, buyer A provided the Observer with three Indian generic drugs, namely the green box Primovir (quoted at 1,400 yuan / box), the blue box Paxista (quoted at 1,600 yuan / box), and Azista's generic Monoravir Molaz (quoted at 500 yuan / box)
buyer A declared. "Regular channels, 100% fidelity", but added that "the green box is reported to be fake, if you are not sure, buy the blue box". When asked, "What is the difference between the green box and the blue box", he said: "The efficacy is the same, different manufacturers."
The Observer also added the buyer B, asked if you can buy the green box Primovir, the other took the initiative to remind: "Primovir is not recommended, the quality may be a little problem."
The buyer B then sent the blue box Paxista (quoted at 1800 yuan / box) and "Pfizer genuine" Paxovid (quoted at 5000 yuan / box) pictures, said that these two kinds of drugs "fidelity".
Generic C recommended two Indian generics to the Observer, Paxista (quoted at $1,000/box) in a blue box, and Movfor (quoted at $350/box), a generic version of monoravir.
The surrogate also offered the Japanese version of Merck Sharp & Dohme's monoravir, quoted at up to $9,150/box.
"Our goods are 100 percent genuine, and the green box appears fake because of a problem with the import channel." Generation purchase C claimed that their company will sign a contract with the patient, the sale of drugs "guarantee authenticity", is "a formal channel to purchase drugs, there are foreign pharmacy invoices, and the drugs are through the national customs inspection."
The buyer said, it provides generic drugs for "India direct mail", freight 200, service charge 100, "7-8 days out of the single number, out of the single number after the mail about more than 20 days, the specific time limit to postal transportation shall prevail."
However, he also said that the customs "can not be approved", you need to "call and ask", "Customs can not pass, personal reasons are not refundable or exchangeable, resulting in tariffs borne by the patient.
The drugs are not only for the sake of the patient, but also for the sake of the patient.
Drugs have always been sensitive items in international transportation, not to mention drugs that have not been approved by the State Drug Administration for listing. How did these Indian generic drugs get into mainland China?
Qianjiang Evening News WeChat public number reported a few days ago, there are domestic related industry, said the purchase of generic drugs is not a recent rise, some of the long-term businessmen between China and India, have their own channels to privately bring generic cancer drugs to Hong Kong, Macao, or from India directly mailed to the mainland, although there is a certain risk of customs clearance, but the overall are able to "safe! Although there are certain risks in customs clearance, they are generally able to bring them "safely". There is also a portion of generic drugs that are purchased directly from India by pharmacies in Hong Kong and Macau, and sold on local shelves, and then purchased on behalf of the Mainland.
Recently, Hong Kong and Macao have been cracking down on illegal drug imports. The Hong Kong Customs and Excise Department seized about three hundred and eighty boxes of suspected smuggled new crown oral medicines on January 11th and 14th, and arrested two people. The Macau Drug Administration has also recently found eight places in the Guanzha District Trade Center that are suspected of illegally supplying drugs and illegally importing drugs, including Indian-made Primovir, which has been followed up by the Macau Drug Administration according to the law.
It is worth mentioning that the Indian Pfizer generics currently on sale were once sold for 3,000 to 4,000 yuan a box in December last year, but have recently fallen to less than 2,000 yuan. As for monoravir generics, the current price is generally below 1,000 yuan.
The prices quoted by different buyers varied widely, with buyer C offering $350 per box of generic moinoravir, Movfor, with a "buy six, get one free, buy ten, get two free" offer, while buyer B quoted $900 for a box. Asked why it's so expensive, buyer B said, "Maybe it's because the channels are different."
Risks?
In 2018, a "I am not the God of Medicine" made the Indian generic drug industry enter the national vision.
India is the world's largest exporter of generic drugs. According to Invest India, the government's investment promotion agency, it has 20% of the world's generic exports, with 60,000 generic brands across 60 therapeutic categories, supplying more than 50% of Africa's and about 40% of the U.S.'s generic demand.
As of August 2021, India accounted for seven of the top 20 generic companies globally, as reported by the Pharmaceutical Exports Promotion Council of India (Pharmexcil) for the year 2021/22 (April 1 to March 31 of the following year).
The report also states that in 2021/22, the Indian pharma industry reached $49.5 billion with exports of $24.62 billion. During the same period, the Indian pharma industry produced finished generic drugs worth $43.91 billion and exported $19.02 billion.
Screenshot from the Pharmaceutical Export Promotion Council of India's Annual Report 2021/22
"India's pharmaceutical industry has emerged as a punching bag amongst all its export earning industries." Liu Zongyi, secretary-general of the Center for China and South Asia Studies at the Shanghai Institute for International Studies, recently told the Observer.
Liu Zongyi said that back in the 1970s, the patent law enacted by the Indira Gandhi government for food and pharmaceuticals granted only process patents, not product patents.
"That is to say, India's patent law only protects the entire production process of food and pharmaceuticals, but if the process is changed, the corresponding product does not have to be subject to the constraints of the original patent, which provides an avenue for India to imitate various types of drugs internationally."
By 1984, there were about 150 commonly used drugs in the U.S. whose patents had expired, and in order to promote the development of the pharmaceutical industry, the U.S. Congress enacted the Drug Price Competition and Patent Term Compensation Act (DPCA), which allowed generic drug companies to conduct trials to genericize a drug without filing a declaration of patent infringement prior to the expiration of the relevant drug's patent.
"This law facilitated that for India, and then generics developed in India. So now we see the most generic drugs imported into the US are made in India." Liu Zongyi said.
In the 90s, after India pushed forward the reform of economic liberalization, introduced a series of policies to introduce foreign investment in the field of pharmaceuticals, and later took advantage of the 10-year buffer period for joining the WTO, while taking advantage of generic drugs to expand the international market, while continuing to take advantage of some of the provisions of the patent law in terms of a large number of imitation of Western drugs, to support the development of the local pharmaceutical enterprises.
Since the new crown epidemic, Indian generic drugs have once again become the focus of attention.
On January 20, 2022, the Medicines Patent Pool (MPP) announced that it had signed agreements with 27 pharmaceutical companies (including 10 Indian pharmaceutical companies) to authorize them to manufacture and supply generic versions of Merck Sharp & Dohme's monoravir for 105 low- and middle-income countries or territories around the world.
On March 17, MPP also announced that it had signed agreements with 35 drug companies (including 19 Indian drug companies) authorizing it to manufacture nematrevir APIs or finished drugs, one of the components of Pfizer's new oral crown therapy drug Paxlovid, and to supply them in 95 low- and middle-income countries or territories.
Fitch Solutions 2022 bluntly stated in a report in January that India will be the epicenter of new crown generics.
It is worth mentioning that there is no shortage of Chinese pharmaceutical companies among those authorized to produce generic drugs. Fosun Pharmaceuticals, Borealis Pharmaceuticals, Via Bio's Longhua Pharmaceuticals (only authorized to produce APIs), Shijiazhuang Longze Pharmaceuticals, and Shanghai Diceno were authorized to generic Merck Sharp & Dohme's New Crown Oral Drugs; and Shanghai Diceno, Huahai Pharmaceuticals, Pulo Pharmaceuticals, Fosun Pharmaceuticals, and Jiuzhou Pharmaceuticals (only authorized to produce APIs) were authorized to generic Pfizer's New Crown Oral Drugs.
However, according to the agreement, both Pfizer and Merck Sharp & Dohme, the licensed area of its new crown generic drugs do not include China, which means that the generic drugs produced by Chinese pharmaceutical companies can only be used for export, and can not be listed on the market circulation in China.
Although India has a "global pharmacy", but official data show that the scale of its exports of Chinese drugs is not large. The annual report of the Pharmaceutical Export Promotion Council of India 2021/22 shows that India's top five drug exporters are the United States (28.85%), the United Kingdom (2.86%), South Africa (2.49%), Russia (2.43%) and Nigeria (2.39%), and its pharmaceutical exports to China accounted for only 1.4% of the overall exports, ranked 13th.
"Sixth Tone noted that in recent years, China has eased restrictions on the import of unapproved drugs. He Xiaobing, head of Beijing-based Minyan Pharmaceutical Research Co., told Sixth Tone that the policy changes have reduced legal risks for buyers and paved the way for an "unprecedented flow" of new Indian-made generic drugs into China.
"India is a major producer of generics, and it is the only country where we can source reliable, reasonably priced new crowns with guaranteed efficacy." Ho said, "But the strong demand is being exploited by illegal groups producing counterfeit drugs, which will seriously affect patient care."
Pharmacies selling generic drugs in New Delhi, India, Jan. 28, 2016, local time Photo: visual China
On the other hand, even though many Indian new crown generics have been authorized by the original manufacturers, both Paxlovid and Monoravir are prescription drugs, which need to be purchased with a prescription from a doctor with prescriptive authority at a hospital, and their private use carries a significant The company's website is a great source of information about Paxlovid and Monoravir.
CNN previously reported that Zhang Jiming, deputy director of the National Center for Infectious Diseases and chief physician, professor, and doctoral tutor at Huashan Hospital affiliated with Fudan University, said that it is difficult to ensure the quality of generic drugs from the source when buying them from abroad, and that it is difficult to guarantee the preservation conditions of the drugs.
In addition, "Shanghai Network Rumor," citing drug industry insiders, said that imported drugs in the domestic sales need to obtain a license approval, in the absence of legal qualification procedures, the import and sale of generic drugs is still illegal.
The report pointed out that although the newly revised Drug Administration Law in 2019 no longer simply recognizes drugs that have been listed abroad and not approved domestically as fake drugs, and makes it clear that "importing a small amount of drugs that have been legally listed outside the country without authorization can be mitigated or exempted from punishment according to the law if the circumstances are less serious," this does not The first step is to make sure that you have a good idea of what you're getting into and what you're getting into.
How much room is left for generic versions of India's New Crown in China?
"Who would buy Indian drugs if they weren't unavailable?" A netizen, Xiao Liu, who bought a green box of Primovir through a surrogate in early December, told the Observer.
This also reflects the mindset of many who sought to buy Indian generics some time ago. Since December last year, Pfizer Paxlovid has been put into use in Beijing, Shanghai and other places of community health centers, but for most of the people who want to buy the country still belongs to the sought-after goods, want to buy through the regular channels is not easy.
Pfizer Paxlovid is also available on online platforms such as Jingdong Pharmacy, Ali Health Internet Hospital, and Meituan Self-supporting Medical Consultation, where users are required to obtain a prescription with a positive nucleic acid/antigen result, after being consulted by an Internet doctor.
Observers noted that in social platforms such as Xiaohongshu, many users have recently reflected that it has become easier to buy Paxlovid online, and that they can even buy it without having to grab it. Xiaoliu also successfully purchased Paxlovid on an online treatment platform in mid-January.
Screenshot from social media
The other two new coronary therapeutic drugs, azulfidine and monoravir, which are included in the "Diagnostic and Treatment Program for Novel Coronary Virus Infections (Trial 10th Edition)," are also on the market.
Merck Sharp & Dohme has granted the distribution and exclusive import rights of monoravir to Sinopharm in China. The relevant person in charge of Sinopharm said recently that it is expected that monoravir will arrive in large quantities in batches around the Spring Festival.
On January 19, platforms such as Jingdong Pharmacy and Ali Health Internet Hospital have begun to supply a limited amount of monoravir.
On January 11, Fosun Pharmaceuticals CEO Wen Deyong said, azivudine has been in the country's 31 provinces, autonomous regions and municipalities directly under the Central Government to complete the health insurance network, the network price of 270 yuan / bottle (35 tablets per bottle, 1mg per tablet), has been covered by the main health care institutions around the country, including hospitals above the second level and primary health care institutions and so on. At the same time, Azulfidine has opened the Internet hospital asking prescription platform channel, to facilitate the people's access to medicine.
In terms of price, the flow of Indian generic drugs to the Chinese market pricing confusion, and the current price of many generic drugs and the domestic regular channels to buy the original drug compared with not much advantage, for example, the blue box Paxista offer is generally in the 1000-1800 yuan / box.
At present, the listed price of Paxlovid, Monoravir capsules and Azulfidine tablets are RMB 1,890/box and RMB 1,500/bottle, respectively, and have been temporarily included in the scope of reimbursement of medical insurance before March 31 this year.Paxlovid is less than RMB 200 out-of-pocket expenses after reimbursement of medical insurance at community hospitals in Beijing and Shanghai, and is sold for RMB 2,170 at e-commerce platforms such as Jingdong Pharmacy and Meituan. 2,170 yuan. And Azivudine tablets have been officially included in the national health insurance catalog, health insurance payment price is expected to fall from 270 yuan / bottle to about 175 yuan / bottle.
Azivudine is China's first small molecule oral drug with fully independent intellectual property rights for the treatment of new coronavirus infections. Recently, there have been a lot of reports of domestic neocoronavirus drugs.
On January 16th, the NDA of Sinocin, an innovative anti-coronavirus drug, was accepted by the State Drug Administration (SDA) under the Special Drug Approval (SDAP) procedure. On January 18th, Junshi Bio announced that the SDA had accepted the NDA of its oral anti-coronavirus drug, rimidivir hydrobromide tablets, on January 17th.
The Health Times reported on the 19th that more than a dozen new crown oral drugs in the research and development stage are now queuing up for review, and the first half of 2023 is expected to usher in the approval of a number of drugs on the market.
Also according to the National Health Commission on the 19th, the medical treatment of people infected with the new coronavirus is smooth and orderly, and the daily diagnosis and treatment services are gradually restored. The provinces have already passed three peaks, which are the peak of fever clinic, the peak of emergency room and the peak of serious patients.
It is believed that with the passing of the peak of new crown infections, the easing of the supply of new crown oral medicines from regular channels, and the accelerated advancement of domestically produced new crown medicines, the domestic demand for Indian new crown generic medicines will further decline.
(Xiao Liu is a pseudonym. The drug information in the pictures in this article is for reference only)