Same Drug Ingredient Doesn’t Mean Equal Efficacy

Same Drug Ingredient Doesn’t Mean Equal Efficacy


Drug manufacturing is a matter of conscience. Whether the drug is effective or not is the first thing the patient knows. Effective medicines can relieve the patient's pain. The non-effective medicine not only delays the treatment of patients and even affects life. Therefore, the manufacture of drugs should first effectively treat diseases as a prerequisite, and then consider the cost of drug manufacturing. Pharmaceutical specifications in various countries pharmacopeia have recorded the minimum eligibility standards for each drug. With the development of scientific and technological research and the progress of instruments, the quality requirements of drugs are becoming more and more stringent. The effectiveness of drug can be basically predicted by in vitro instrumentation. Therefore, the pharmacopeia of the advanced countries will be based on academic research and constantly update the inspection standards to improve the therapeutic efficacy and safety of drugs. For example, the American Pharmacopeia (USP) is updated every year with a new edition and an update of the Taiwan Chinese Pharmacopoeia every five years. At present, Taiwan's latest Chinese Pharmacopeia is published in the eighth edition in 2016.

 

Drug manufacturing is not as the general imagination, simply directly mixed with active principal ingredient (API) powder and excipients to make capsules or tablets. The bioavailability of drugs is often the key to drug effectiveness. In general, that the effect of injections will be better than oral preparations is the truth, but not all the injections of drug companies are safe. Injections that do not meet the latest pharmacopeia specifications are more dangerous. The same ingredient and the same dose of oral drugs made by different pharmaceutical companies may not have the same therapeutic effect. The key is the dissolution or absorption of the drug, i.e. the body availability (Bioavailability). Basically, medicines will have a certain degree of efficacy as long as they meet the latest pharmacopeia dissolution specification. The real drug bioavailability analysis must be carried out in practice by animal study. If pharmaceutical companies produce every batch of drugs to carry out animal testing, in addition to time-consuming and resource-intensive, there are also a large number of humane considerations at the animals. Therefore, pharmacopeia has simulated the gastrointestinal absorption environment for the prediction of bioavailability of drugs, and designed methods and procedures for the in vitro execution of drug dissolution rate and set the minimum qualify criteria. That is to say, the higher the pharmacopeia dissolution of drug, the better the drug efficacy. Pharmacopoeia in advanced countries regularly update the test specifications of medicines to ensure that commercially available drugs can achieve the purpose of effective treatment of diseases.

 

Sometimes, however, the health of patients is neglected when it comes to commercial interests or mismanagement by authorities. The Taiwan drug manufacturing license is valid for a period of five years and must be extended within six months of its expiration. The competent authorities of advanced countries in general have stipulated that "the extension of drug licenses must be accompanied by inspection specifications of the Pharmacopeia for the last five years". However, article 73 of the “Guidelines for the drug inspection and registration” published by Taiwan government in 2020.06.12. The "Extension of the period of validity of a drug license" allows the old medicines to be not required to meet the test specifications of the Pharmacopeia within the latest five years. As long as the extension application of drug license can be extended. This law is contrary to the requirement that advanced countries must be checked to meet the test specifications of the Pharmacopeia for the latest five years. This has led to the fact that some of Taiwanese old drugs, which were decades ago and did not meet the minimum standards of the latest pharmacopeia, can continuously provide physicians and pharmacists to treat patients without the need for research and improvement. Make the same ingredient of drugs with effective, less effective and ineffective entities sell at the same time in the Taiwan pharmaceutical market. Therefore, doctors question the efficacy of the drug and the patient's feeling that "the same components but different pharmaceutical manufacturers of drugs, the efficacy is not the same or even ineffective." is real. Although Taiwan and other advanced countries' pharmaceutical companies’ hardware and software requirements are all Pic/s GMP specifications, but Taiwan drug management is not synchronized with the world's advanced countries, which is a problem and even doctors and pharmacists do not know the situation, only pharmaceutical companies realize the fact. Behind the pursuit of cheap health-care drugs lies the sacrifice of patients' health and unfair competition between old and new drug companies. Because new drug companies and new licenses are required to be approved for manufacturing with the latest pharmacopeia specifications, older drugs that do not meet the latest pharmacopeia specifications are allowed to be used by physicians and pharmacists to treat patients. Thus, Taiwan government should phase out medicines that do not meet the specifications of the Pharmacopeia within the latest five years, so as to safeguard the health of the whole population.

2020-09-02