An In – Depth Exploration of the Recent Survey on Bulk Drug Procurement in China and the Responses to Public Concerns
In January of this year, concerns were raised by some experts about the potential quality risks of certain drugs under the centralized bulk procurement system in China, such as “ineffective blood pressure – lowering drugs, anesthesia – resistant anesthetics, and ineffective laxatives for intestinal preparation”. The relevant departments quickly took action and conducted a comprehensive survey. Recently, officials from the medical insurance and drug supervision departments involved in the survey answered reporters’ questions about the issues of public concern.
Survey Findings:
The survey team listened carefully to the opinions of relevant experts, as well as the heads of seven hospitals including Ruijin Hospital, Renji Hospital, and Zhongshan Hospital, and medical staff from departments such as surgery, internal medicine, anesthesiology, and pharmacy. While listening to the opinions, they also extracted relevant data from the relevant departments.
The survey team expressed their sincerity in “holding open – door bulk procurement and actively seeking opinions”, and introduced the specific practices of the national centralized bulk drug procurement, the measures to strengthen the quality supervision of bulk – purchased drugs, and the handling of individual selected drugs with quality risks. They also introduced the real – world research on bulk – purchased selected drugs carried out by more than 80 tertiary hospitals, covering over 300,000 patients.
The survey team focused on three main aspects of information from the experts: first, the feelings about the efficacy and quality of various bulk – purchased drugs in clinical practice; second, the specific situations of “ineffective blood pressure – lowering drugs, anesthesia – resistant anesthetics, and ineffective laxatives for intestinal preparation”; and third, the suggestions for improving the drug bulk procurement policy and strengthening drug quality supervision.
Response to Specific Concerns:
- Blood Pressure – Lowering Drugs : Some reflected that the efficacy of the generic drug “amlodipine besylate” was not as good as the original – research drug, which was due to personal medication experience. Ruijin Hospital provided the clinical real – world research results of the comparison between the selected generic drug and the original – research drug of Amlodipine besylate in their hospital, showing that “both the original – research and generic amlodipine besylate can achieve good effects in treating primary hypertension patients, effectively reduce blood pressure levels, and have equivalent safety”. This research result has been published.
- Anesthetics : The clinical doctors of the anesthesiology department of the hospitals surveyed introduced that “the hospital performs an average of more than 2,000 surgeries per month, and there has been no significant change in the usage and dosage of anesthetics before and after the bulk procurement. There was no significant difference in the average dosage of various types of anesthetics such as induction agents, sedatives, and muscle relaxants”. A hospital leader said, “There is no problem of ‘anesthesia – resistant anesthetics’ in our hospital”. After the face – to – face communication, Ruijin Hospital quickly conducted a retrospective comparison of the usage records of the ninth – batch bulk – purchased anesthetic “propofol emulsion injection” for patients in the hepatobiliary surgery ward who underwent laparoscopic cholecystectomy under general anesthesia in December 2023 and December 2024. From the whole process of anesthesia, there was no statistical difference in the average dosage of anesthetics between the original – research and bulk – purchased generic drugs. Looking specifically at the induction period of anesthesia, the average dosage of the bulk – purchased generic drug was 157mg, and the average dosage of the original – research drug was 146mg (both the bulk – purchased and original – research drugs have a content of 200mg per vial). In the absence of finding “anesthesia – resistant anesthetics” and no difference in the total dosage of propofol per person, the average dosage of the generic drug during the induction period increased slightly, and more data need to be collected for analysis and judgment.
- Laxatives for Intestinal Preparation : It was understood that the laxatives mainly used for intestinal preparation are compound polyethylene glycol electrolyte powder, which is a new variety included in the tenth – batch bulk procurement and was just announced on December 30, 2024. It is still in the preparation stage before implementation, which means that the relevant hospitals and medical staff have not yet used the “bulk – purchased laxatives”. Ruijin Hospital and several other hospitals reflected that they have not received any feedback from the front – line about “ineffective laxatives for intestinal preparation”. The director of the colorectal surgery department of a surveyed tertiary hospital said, “The two types of laxatives used for colonoscopy preparation for many years are domestic drugs, and there has been no change. I have never heard of the situation of ‘ineffective laxatives for intestinal preparation’.”
At the same time, for the individual adverse reactions collected in the clinic (including both original – research and generic drugs), the seven hospitals have reported drug adverse reactions as required, and the reporting channels are unblocked. Some hospitals also provided more detailed reports, and the adverse reactions of the bulk – purchased generic drugs and original – research drugs were all within the scope of the drug instructions and literature reports.
Consistency Evaluation of Generic Drugs:
Since 2015, China has been promoting the reform of drug review and approval system, changing the generic drugs from the original “imitating drugs with national standards” to “imitating drugs with the same quality and efficacy as the original – research drugs”. For the early – marketed generic drugs, consistency evaluation is carried out in batches according to the principle of being consistent in quality and efficacy with the original – research drugs.
Firstly, the selection of reference preparations for consistency evaluation is strictly carried out. Generally, the original – research drugs are chosen as the reference preparations, which means that the reference drugs for consistency evaluation are unique, and all generic drugs are compared with the reference preparations. The concern that “the first – to – market generic drug is based on the original – research drug, and the subsequent generic drugs are based on the first – to – market generic drug, leading to a decline in imitation standards” does not exist.
Secondly, China’s consistency evaluation method adopts internationally recognized strict standards. The technical requirements for China’s generic drug consistency evaluation have been aligned with the international standards, and the technical review of generic drugs is carried out in accordance with the international technical standards such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), including pharmacology, non – clinical, and clinical aspects, and all ICH technical guidance principles have been implemented. Developed countries such as Europe and America also use the above technical standards for review. Referring to the practices of European and American drug regulatory agencies, the review reports are made public on the basis of legally protecting the commercial secrets of enterprises.
Thirdly, drugs after passing the evaluation are still subject to strict supervision after being marketed. The drug supervision department not only adheres to strict standards in the review and approval of drugs when they are marketed, but also insists on strict supervision after the drugs pass the evaluation and are marketed. It requires enterprises to produce strictly according to the process applied for the consistency evaluation, and major changes must be re – approved. The review standards for post – marketing changes are also aligned with the international standards, and the holders need to continuously improve and optimize the quality of drugs in accordance with the technical and regulatory considerations of ICH Q8 (R2) Pharmaceutical Development, ICH Q9 (R1) Quality Risk Management, ICH Q10 Pharmaceutical Quality System, and ICH Q12 Pharmaceutical Lifecycle Management. Therefore, consistency evaluation is a complete set of quality evaluation and supervision system, not a “one – time evaluation”.
Use of Non – Selected Original – Research Drugs:
There is a claim that original – research drugs have completely withdrawn from China, but the fact is obviously not the case. China is one of the most important and most open original – research drug markets in the world. Since the national medical insurance directory negotiation in 2018, 212 imported drugs have been successfully negotiated, accounting for nearly 50% of the negotiated Western medicines. Even in the highly competitive centralized bulk drug procurement, more than 30 original – research drugs have been selected after competing with generic drugs on the same stage.
The drug bulk procurement policy has encouraged the competition between original – research drugs and generic drugs since its inception. Even if they are not selected, original – research drugs will not be banned. The agreed purchase volume of bulk – purchased drugs is 60% – 80% of the demand reported by medical institutions. When the actual purchase volume of hospitals reaches the corresponding scale, it is considered as completing the purchase agreement. The part outside the agreement is independently chosen by the medical institutions in terms of brands, and they can choose to purchase non – selected original – research drugs. This policy is clear and consistent. Ruijin Hospital has equipped both the bulk – purchased drugs and the corresponding non – selected original – research drugs. The materials provided show that “while introducing 24 bulk – purchased antihypertensive drugs, 18 corresponding original – research varieties of antihypertensive drugs are retained; in the aspect of antibacterial drugs, 48 bulk – purchased varieties are introduced, and 21 corresponding varieties of original – research drugs are retained; in the aspect of anesthetics and muscle relaxants, 6 bulk – purchased varieties are introduced, and 4 corresponding varieties of original – research drugs are retained”. In addition, it should be noted that not all original – research drugs of drugs have been produced and sold in the domestic market all the time, and some have never entered the domestic market.
Cost Coverage and Quality Risk Handling of Selected Drugs:
The selected enterprises feedback that the selected price of bulk – purchased drugs can cover the cost, mainly for three reasons: first, the selected drugs directly enter the hospital with guaranteed sales volume, which greatly saves marketing costs; second, the “volume – based” can form a scale effect, make full use of production capacity, reduce marginal production costs, and at the same time, use scale purchasing to improve the bargaining power with upstream suppliers and save raw material purchase costs; third, in the environment of scaled and stable production, enterprises carry out production line automation transformation to further reduce production costs and stabilize quality. Therefore, the selected enterprises can make a small profit but quick turnover on the premise of ensuring quality.
Drug quality and safety is not only the lifeline of enterprises, but also the bottom line of regulatory departments. The drug supervision department has always strictly supervised the quality of drugs, especially the quality of selected drugs in bulk procurement, adhering to “full coverage” and “zero tolerance”. Every year, the selected enterprises and selected varieties of national bulk – purchased drugs are subject to two “full coverages” of inspection and sampling inspection, which has covered all used national bulk – purchased varieties and more than 600 drug – producing enterprises involved. Overall, the situation of drug safety in China is generally stable, and the quality of drugs is continuously improving.
The drug supervision department immediately takes measures such as suspending production, import, and sales for individual products with quality risks found, whether they are original – research drugs or generic drugs, and deals with them seriously and exposes them to the public to ensure the safety of people’s medication. The medical insurance department and the drug supervision department have established a regular disposal mechanism, maintain close contact, and the medical insurance department promptly cancels the selected qualification of the bulk – purchased drugs with risks found by the drug supervision department according to the agreement of the purchase tender, to ensure the safety of people’s medication. In the past few years, among the more than 1,600 selected products used in the first 9 batches, 9 drugs have been canceled due to quality risks, including 6 imported drugs (including 3 original – research drugs) and 3 domestic drugs, and the relevant enterprises have been dealt with seriously.
Individual Differences in Drug Efficacy Perception:
Many real – world studies have shown that generic drugs are equivalent to original – research drugs in terms of efficacy and safety. However, some individuals and experts sometimes have different feelings about drug efficacy on the Internet and around us. For example, the published real – world research results of metformin hydrochloride show that the compliance rate of glycated hemoglobin (<7%) is 78.9% in the original – research group and 83.4% in the bulk – purchased generic group; the compliance rate of fasting blood glucose (<8mmol/L) is 87.6% in the original – research group and 83.8% in the bulk – purchased generic group. The two compliance rate indicators of the two groups are higher and lower, and according to the standardized statistical analysis, there is no difference between the generic drug group and the original – research drug group. Whether using original – research drugs or generic drugs, about 80% of patients can control blood sugar or glycated hemoglobin to reach the standard, and about 20% of patients have poor efficacy and need to adopt other treatment methods or drugs with other mechanisms of action. Selecting individual cases from the 20% of patients with poor efficacy to “prove” that generic drugs or original – research drugs have poor efficacy is inaccurate and unscientific.
The evaluation of drug efficacy in a scientific, fair, and accurate way requires a systematic and rigorous method and process, while individual feelings are easier to understand and have impact. Simple and “vivid” specific cases are often more communicable than scientific verification. Taking metformin as an example, more than 10 billion tablets of bulk – purchased metformin are used in China every year. Although the compliance rate of glycated hemoglobin and fasting blood glucose are consistent with the original – research drugs, both about 80%, it is not difficult to find individual cases with poor efficacy of generic drugs, and it is also not difficult to find examples of poor efficacy of original – research drugs.
Further Measures to Ensure Drug Quality:
Since 2018, the continuous practice has not only made the bulk – purchased drugs and policies withstand the clinical test, but also enabled the mainstream drugs used by Chinese patients to achieve a leap from “un – evaluated generic drugs” to “evaluated generic drugs”. However, compared with the expectations of the broad masses of people, there are still areas that need to be continuously improved in our work. For example, we can further urge the selected drug enterprises to actively disclose drug quality data to the society. We can also further use more down – to – earth ways to respond to the widespread concerns of the society, effectively clear up doubts and answer questions. Drug quality assurance requires unremitting efforts and a continuous “exam” spirit. In the next step, the relevant departments will continue to work hard in the following aspects to continuously ensure the quality of bulk – purchased drugs.
First, continue to strengthen the supervision and management of drug quality. Quality is the lifeline of drugs. The drug supervision department will continue to benchmark international technical standards, strictly manage technical review and post – marketing changes, continue to disclose review reports according to law, adhere to full – coverage inspection of selected enterprises and full – coverage sampling inspection of selected varieties, urge enterprises to produce in compliance continuously, deal with the problems found in a timely manner, and disclose regulatory information according to law. At the same time, the drug supervision department will promptly inform the medical insurance department of whether quality risks of bulk – purchased drugs are found in daily supervision.
Second, continue to encourage front – line doctors to make good use of the drug adverse reaction monitoring information platform and actively feedback clues of drug quality risks. The drug supervision, medical insurance and other departments encourage doctors to timely and accurately find and collect suspected drug adverse reactions, and report them to the “National Drug Adverse Reaction Monitoring System” in accordance with relevant laws and regulations. The drug supervision department will organize evaluation and deal with them according to law based on the relevant information, and will also further introduce to medical institutions and medical staff, fully protect the privacy of adverse reaction reporters, and eliminate the concerns of active reporting. At the same time, we also encourage people in the pharmaceutical industry and all sectors of society to continue to supervise the quality of drugs.
Third, continue to encourage and support front – line medical staff and medical institutions to give full play to their professional advantages and professional spirit, and carry out clinical research in a scientific and standardized manner. The medical insurance, drug supervision and other departments support relevant medical institutions and medical staff, especially authoritative medical institutions such as national medical centers and regional medical centers, to explore and carry out real – world research on original – research drugs, generic drugs that have passed consistency evaluation, etc., to examine the efficacy of drugs on a larger scale, prompt regulatory focuses, promote industrial development, and let high – quality drugs benefit more patients.
Improving the Bulk Procurement Policy:
- Strictly Adhere to Standards : Continue to insist on using reference preparations and high – quality generic drugs that have passed the quality and efficacy consistency evaluation as the “threshold”. Widely understand the situation of drugs under daily supervision, and exclude products with relatively high quality risks from bulk procurement.
- Refine the Organization and Implementation : For varieties with an expected number of bidding enterprises exceeding a certain scale and fierce competition, issue strong competition warnings in advance, reminding enterprises to make cautious decisions, scientific bidding, and rational pricing. Pay close attention to the lowest bids with high deviation, and ask enterprises to respond to relevant concerns in a timely and open manner. At the same time, comprehensively consider various factors such as the stability of market supply and the fairness of competition, and continuously improve the centralized bulk procurement policy to better ensure the quality and supply of bulk – purchased drugs with more refined work.
- Full – Process Transparency : During the bulk – procurement application period, bidding enterprises need to sign a quality commitment letter and actively disclose information such as the consistency evaluation research report and bioequivalence test data of the drugs, as well as the situation of previous quality supervision and inspection. After winning the bid, continue to disclose the situation of accepting quality inspections from domestic and foreign drug supervision departments, as well as the changes and approval of production processes, raw and auxiliary materials, etc. Require the selected enterprises to disclose contact persons to facilitate consultation and communication with medical institutions, medical staff, and relevant parties of the society, respond to quality concerns in a timely manner, and rectify supply problems in a timely manner. Encourage enterprises to organize open – day activities, invite media, medical staff, and representatives of the public to participate, and display the production process of the selected drugs in a way that does not affect production safety to increase transparency.
- Full – Chain Traceability : Starting from 2025, all drugs participating in bulk – procurement must have a drug traceability code to achieve “code – based procurement”. Medical insurance – designated medical institutions and pharmacies need to collect and upload the traceability code of relevant drugs throughout the process according to the designated agreement, and the medical insurance department will use the traceability code information as the basis for payment, and implement “code – based settlement”. At the same time, the medical insurance department will give full play to the data – related advantages of the traceability code, resolutely curb the backflow and exchange of drugs, resolutely crack down on fraud and insurance fraud, and use the traceability information to support drug quality supervision.-Fineline Info & Tech
