On October 22, the National Drug Procurement Office officially announced the relevant information of the 11th batch of drug collection. This drug collection included a total of 55 varieties, covering major disease areas such as anti-infectives, anti-tumor drugs, diabetes, and cardiovascular drugs.
After the results of the tenth batch of drug collection were announced last year, the discussion about “3 cents per aspirin, 22 cents per injection of phloroglucinol” is believed to be still fresh in everyone’s memory. At that time, the official statement was that although the collected drugs were low-priced, their efficacy was guaranteed, and some positive energy bloggers said that 3 cents was enough to produce aspirin, and 22 cents for phloroglucinol was also reasonable.
Now a year has passed, are these drugs still okay?
The 22-cent phloroglucinol doesn’t seem to be doing well.
In March of this year, the drug regulatory authorities found during an inspection that Sichuan Taiji Pharmaceutical, which produces the collected phloroglucinol injection, had deviations in key production processes and did not handle the deviations in accordance with the specifications, which did not meet the GMP requirements.
This batch of phloroglucinol injection was produced by Taiji Pharmaceutical after Sichuan Haimeng Zhisen Company won the bid for collection. The official announcement said “deviations in key production processes”, I will translate it into plain language for everyone, which is “the winning manufacturer just takes a look, and the producing manufacturer just does it”, just to get the job done.
How much do you guess the price of Sichuan Haimeng Zhisen Company’s winning bid for phloroglucinol is? It is 22 cents per injection, which topped the trending searches. Is this a coincidence or a coincidence?
After finding that the production process did not meet the specifications, the drug regulatory authorities suspended the production and sales of Sichuan Taiji Pharmaceutical’s phloroglucinol injection and revoked its qualification for the collection.
Pramipexole injection is also not very good.
In April of this year, the pramipexole injection produced by Shanxi Guorun Pharmaceutical was found to be inconsistent with the requirements of the pharmaceutical production quality management规范, and its production and sales were suspended, and its qualification for collection was also revoked.
Pramipexole injection is a drug used to treat severe influenza. In the tenth batch of collection, Shanxi Yanghe Pharmaceutical won the bid with a price of 7.19 yuan per injection and entrusted Shanxi Guorun Pharmaceutical to produce it.
The first batch of drugs was produced before it was launched, and it was found that the production quality management was not standardized. Please note that this is the first batch that failed after winning the bid, and the attitude of the manufacturer is already very clear:
I’m not pretending anymore, I’m coming clean, this medicine is produced like this, anyway, there is no profit, whether you want it or not.
So, for such completely irresponsible collection-winning enterprises, in addition to revoking the qualification for this bid, what other penalties are there?
Yes! The National Drug Collection Office will include these two companies in the list of violations and suspend their application qualifications for collection in the next 18 months.
After 18 months, they will be a good man again. Are you afraid of this punishment?
Sodium bicarbonate Ringer’s injection is also not very good.
In August of this year, Jiangxi Jingrui Pharmaceutical, which won the bid for sodium bicarbonate Ringer’s injection, was found to have defects in confirmation and verification and was ordered by the drug regulatory authorities to suspend production and sales. Subsequently, the National Collection Office canceled Jiangxi Jingrui Pharmaceutical’s qualification for the sodium bicarbonate Ringer’s injection.
Sodium bicarbonate Ringer’s injection is used to treat metabolic acidosis and supplement electrolytes. Some diabetic patients with poor blood sugar control develop ketoacidosis, or patients with renal insufficiency develop acidosis, which requires this drug to save their lives. If this drug is of poor quality, it will really kill people.
The “defects in confirmation and verification” mentioned in the announcement are not easy to understand, I will translate it for everyone:
Ensuring the quality of drug production requires both hardware (factory buildings, facilities, equipment) and software (production process, operating procedures or methods, systems). If both the software and hardware are very reliable and can ensure that the expected results of drug quality are achieved, it is called “confirmation and verification qualified”.
“Defects in confirmation and verification” means that there are defects in key hardware and software, and it cannot be guaranteed that the produced drugs meet the quality requirements.
Then why not directly point out which link is unqualified? This is the most intriguing place: one possibility is that the problem is not serious, so it is handled vaguely, and the other possibility is that the loopholes of this pharmaceutical company are as many as a sieve, and it is really impossible to know where to start.
Which one do you believe, you who are smart?
Similarly, Jiangxi Jingrui Pharmaceutical was also included in the “violation list” and suspended its application qualification for the national drug collection for 18 months.
The chemotherapy drug fluorouracil injection is also not very good.
Last week, the fluorouracil injection, a chemotherapy drug produced by Zhejiang Dahongying Pharmaceutical, a winning bidder in the tenth batch of collection, and entrusted by Heilongjiang Fuhe Pharmaceutical, was found to be a “substandard drug” by Zhejiang Drug Administration.
Different from the previous few companies with process violations, this was found to be unqualified in the results of drug sampling.
According to the definition of the “Drug Administration Law”, substandard drugs refer to drugs whose ingredients do not meet the national drug standards, drugs that are contaminated, drugs that have not been marked or have changed their expiration date, have exceeded their expiration date, have not been marked or have changed their product batch number, and drugs that have been added with preservatives and excipients without authorization.
For patients who need chemotherapy, any of the above situations of substandard drugs are life-threatening.
So, what kind of punishment did the collection-winning enterprise that was found to produce substandard drugs receive?
The Zhejiang Provincial Drug Administration imposed a penalty on the enterprise, confiscating its illegal gains and imposing a fine.
The National Drug Collection Office is relatively strict and will include these two companies in the list of violations and suspend their application qualifications for collection in the next 18 months.
These two high-quality pharmaceutical companies, just because they produced a little substandard drugs, were deprived of their winning bid qualifications and have to wait until 2027 to participate in the national drug collection again. It is really too miserable and pitiful, it is simply heartbreaking and tearful.
Of course, friends in Beijing may cry even louder.
According to the winning results of the tenth batch of drug collection, the fluorouracil injection won by Zhejiang Dahongying Pharmaceutical includes Beijing, Zhejiang, Anhui, Guizhou, and Xinjiang.
Is it a little unexpected?
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