What are drugs and how do they differ from other products?

Currently on the market there are a lot of different medicines, as well as products, which at first glance can be classified into this category. This raises questions: what is a pharmaceutical agent? What is the difference between a therapeutic agent and a drug? Как отличить лекарственное средство от медицинского изделия? From cosmetic products? From the dietary supplement?  This article will discuss some of the key differences between these product categories.

  1. What is a pharmaceutical agent?

According to Federal Law No. 61, medicines pharmaceutical agents are substances or combinations thereof that come into contact with the human or animal body, penetrate the organs, tissues of the human or animal body, used for prevention, diagnosis (with the exception of substances or combinations thereof which are not in contact with the human or animal body), treatment of the disease, rehabilitation, preservation,  prevention or termination of pregnancy and obtained from blood, blood plasma, organs, tissues of human or animal body, plants, minerals by synthesis or by application of biotechnological methods.  Pharmaceutical agents include pharmaceutical substances and drugs.

  1. What is the difference between a pharmaceutical agent and a drug?

It is important that pharmaceutical agents include pharmaceutical substances and drugs.  However, only drugs are subject to registration (more details here), and pharmaceutical substances are subject register in the GRLS (more details here)

According to the same Federal Law, drugs are medicines in the form of dosage forms used for the prevention, diagnosis, treatment, rehabilitation, preservation, prevention or termination of pregnancy.

From this definition it is important to understand that drugs on the market are presented in the form of ready-made and easy-to-use dosage forms (tablets, capsules, solutions, ointments, etc.) that provide the necessary biopharmaceutical properties of the drug. This is their key difference from pharmaceutical substances, which are essentially raw materials.

  1. How to distinguish drugs from MD?

Differences of drugs from MD can be traced in the analysis of the definition of MD:

According to article of the 323 Federal Law, Medical devices are any instruments, apparatus, equipment, materials and other devices […] whose functional purpose is not implemented by pharmacological,  immunological, genetic or metabolic effects on the human body. 

For example, a patch containing a pharmaceutical agent can be considered as a drug and as a medical device.

If we consider the plaster as a drug, we mean that the intended use is provided by the delivery of the pharmaceutical substance to the human body, i.e. the plaster is a dosage form.

If we talk about the patch as about MD, its purpose is ensured by the creation of a protective barrier, and the drug only supports the main purpose.

  1. How to distinguish drugs from cosmetics?

According to the Customs Regulation of the Customs Union 009/2011 (TR CU 009/2011), perfumery and cosmetic products is a substance or mixtures of substances intended for application directly on the the outer cover of a person […] or on the teeth and the mucous membrane of the oral cavity with the sole or primary purpose of cleansing them, changing their appearance, giving them a pleasant odor and/or correcting the odor of the body and /  or protect and/or maintain in good condition and/or care.  (more about PKP here).

In addition, another difference of drugs from cosmetics is the method of application — cosmetics is intended exclusively for external application on certain parts of the human body.

Accordingly, cosmetics is not intended for the purposes of treatment, prevention, diagnosis and other purposes specific to the intended use of drugs.

  1. How to distinguish drugs from dietary supplements?

Biologically active food supplements are natural and/or identical to natural biologically active substances, as well as probiotic microorganisms intended for use at the same time as food or introduction into food products.  (more about dietary supplements here ).

Supplements are specialized food products, not intended for the purpose of diagnosis and treatment of any diseases. As a rule, dietary supplements are used for the purpose of enriching the diet by separate food and biologically active substances or their complexes.

It should be noted that despite the rather clear criteria for classifying the product to a particular groups, there are still some border cases. The good example is a patch containing medicinal substances described above.

Sources:

  1. FZ-61 (Федеральный закон “Об обращении лекарственных средств” от 12.04.2010 N 61-ФЗ (последняя редакция))
  2. FZ-323 (Федеральный закон “Об основах охраны здоровья граждан в Российской Федерации” от 21.11.2011 N 323-ФЗ)
  3. CU TR 009/2011 (ТР ТС 009/2011)
  4. CU TR 021/2011 (ТР ТС 021/2011)
  5. http://www.roszdravnadzor.ru/i/upload/images/2016/2/5/1454664599.12275-1-778.pdf

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©Beawire –  April 2019.