A combination of medicines and herbal preparations. Herbal medicines that have a sedative effect

The tradition of using medicinal plants has a long and successful history. Herbal preparations have gained great popularity among the population of different countries and continents. In the minds of the current technogenic society, the stereotype about the safety and usefulness of everything that is of natural origin is firmly entrenched, and herbal medicines are no exception. But, unfortunately, there is a risk of developing undesirable effects when using such drugs. Its source can be both improper application and inadequate product quality. It is in order to protect the population and protect the health of its citizens that the EU government has taken measures to tighten the regulation of the circulation of traditional herbal preparations.

Among the variety of pharmaceutical products, a prominent place is occupied by traditional herbal medicines - drugs marketed for at least 30 years, of which at least 15 years - in the EU, intended for OTC and oral or topical use, which include at least one substance of plant origin. They are represented by a wide range of dosage forms and have been popular with the population for many years. Until recently, their presence in the pharmaceutical markets of the EU countries did not require special registration and approval from the European Medicines Agency (EMA).

Previously it was believed that herbal medicines are completely safe for consumers and cannot harm health. But a large influx of various herbal preparations, in particular the widespread use of Chinese and Indian (Ayurvedic) traditional medicine, as well as cases of side effects in the use of herbal preparations, necessitated more careful regulation of this segment of the pharmaceutical business.

To this end, the Herbal Directive (2004/24/EC) was adopted in 2004, which regulates the use of traditional herbal medicines. It should be noted that this category is not limited to traditional European herbal preparations, but also includes Chinese traditional medicine and Ayurveda. Examples of plants used in the preparations of this group are calendula (Calendula officinalis); echinacea (Echinacea purpurea); eleutherococcus (Eleutherococcus senticosus); fennel (Foeniculum vulgare); witch hazel (Hamamelis virginiana); peppermint (Mentha x piperita) and anise (Pimpinella anisum).

Issue price

According to the data published on the website www.pr-inside.com, in 2009 the volume of the Western European market for traditional medicines - a group that includes traditional herbal preparations, was estimated at 4.15 billion dollars. United States, it is expected that by 2014 this figure will reach 4.19 billion dollars. Thus, the average annual increase can be 0.2%.

The leader in the market of traditional drugs is Boehringer Ingelheim GmbH, which accumulates 15.2% of the Western European market. The size of the market for traditional medicines in Eastern Europe is much smaller - 2.6 billion dollars. in 2009, however, it has great room for growth. Thus, the average annual increase by 2014 is estimated at 4.2%. Thus, by 2014 this figure will reach 3.2 billion dollars.

Global sales of herbal medicines in 2011 are estimated at $26 billion.

Worldwide sales of herbal medicines in 2011, according to information published by the Biotechnology Research Center (Development Center for Biotechnology) of the World Health Organization (WHO), is estimated at 26 billion dollars. For comparison, in 2006 this figure amounted to 19 billion dollars. It is also predicted that in the next few years the average annual increase in sales of drugs in this group will be at the level of 6.6%. It is expected that in the structure of sales of herbal preparations in 2011 the maximum share will be accumulated by medicines for the treatment of colds with a market share of 24% and medicines for the treatment of oncological pathology - 25%. Hsu Ya-fen, an analyst at the Biotechnology Research Center, noted that 45% of the world's population take herbal medicines to prevent or treat disease.

What was the matter

The Herbal Directive (2004/24/EC) is a revised version of an earlier document - Directive 2001/83/EC, which provides a simplified registration scheme for traditional herbal medicines. The directive covers traditional herbal medicines. At the same time, they may include vitamins and minerals, for which there is information on the safety profile. Homeopathic* and herbal medicines that are marketed on the basis of general approval from the EMA are not covered by the directive.

Under the Herbal Directive (2004/24/EC), pharmaceutical companies that produced traditional herbal preparations were given 7 years to register them. Following the expiration of this deadline on May 1, 2011, the marketing of unregistered traditional herbal medicines in the EU was prohibited. From now on, EU citizens who purchase traditional herbal medicines in pharmacies can be fully confident in their safety and effectiveness. It should be noted that those pharmaceutical companies that did not have time to register their products within the allotted time can do so after May 1, 2011 under the same conditions.

A simplified registration procedure for traditional herbal medicines was proposed due to the fact that they have been on the pharmaceutical market for a long time and are trusted by consumers. Thus, there is no need to conduct a large number of clinical studies. At the same time, the Herbal Directive puts forward certain requirements for product quality, and also requests data on safety and efficacy during the registration process.

According to John Dalli, Commissioner for Health and Consumer Protection of the EU, the 7-year transition period has given manufacturers sufficient time to demonstrate an acceptable level of efficacy and safety of their products, and patients can now have confidence in the herbal preparations they are taking. buy in the EU.

Registration procedure

In order to protect public health, all medicinal products, including traditional herbal preparations, must obtain marketing authorization in the EU. A simplified registration procedure for traditional herbal products allows obtaining marketing authorization without clinical trials of a medicinal product, as is required for other pharmaceutical products.

An applicant wishing to register a traditional herbal medicinal product must provide documents confirming the absence of adverse reactions, while following the instructions prescribed in the instructions for the drug. It is also necessary to provide evidence that the drug has been used for 30 years (of which 15 in the EU) without any problems. This simplified scheme should save applicants not only time, but also significant costs compared to the general requirements for drug registration introduced by the EMA.

However, even a long history of use of traditional medicines does not guarantee the safety of the product, therefore, if necessary, the regulatory authorities of the EU Member States have the right to request additional data in order to assess the safety of the medicinal product.

A simplified registration scheme for traditional herbal medicines, according to the EU government, is equally accessible to large corporations and medium and small enterprises. Thus, this procedure does not reduce access for Chinese or Indian Ayurvedic medicines or products of companies with limited funds.

It should be noted that EMA does not take part in the process of registration of traditional herbal preparations, this function has been completely entrusted to the regulatory authorities of the EU Member States. However, in 2004, the EMA created the Committee for Herbal Medicinal Products (HMPC), which was entrusted with the mission of creating a list of herbal preparations and substances. Thus, according to the directive, if a herbal preparation is registered in one of the EU member states and is included in this list, then other EU member states must register it automatically. At the same time, the initial registration of a medicinal product can be carried out even if it is not included in this list.

Separately, it should be noted that all these innovations apply exclusively to plant-based products marketed as medicines. Regulatory authorities will decide separately whether a given plant-based product is a drug. To do this, it must have such properties that allow for the treatment or prevention of human diseases, in particular, to have certain pharmacological, immunomodulatory or metabolic effects. The same plant-based products that do not meet these characteristics will be classified as food additives, the marketing of which is regulated by Directive 2002/46/EC and Regulation (EC) No 1924/2006.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) can serve as an example of the work of the regulatory bodies of the EU member states, which has published more than 10 warnings about the unsafe use of certain traditional medicines in the past 2 years. plant-based, including the use of extracts of the plant kirkazon (Aristolochia), which was found to be toxic after two cases of kidney failure when using it.

In Europe, about 200 medicinal plants based on 27 plant species have been registered, while the number of medicinal plants used in the UK is 300 species.

It should be noted that evidence of the unsafe use of traditional herbal preparations appears not only in the EU. So, researchers from the Boston University School of Medicine found that every fifth sample of traditional Indian herbal medicines purchased through online stores contains lead, mercury, and arsenic.

And I want, and it pricks

The Alliance for Natural Health estimates that licensing costs range from £80,000-120,000 ($130,000-194,000) per medicinal plant. These costs are only justified for high-volume herbal preparations containing only one medicinal plant, such as echinacea-based preparations (cold and flu remedy). Thus, the increase in costs will stimulate the exit from the market of small manufacturers that produce herbal preparations based on several plants.

The lack of economic interest of manufacturers to register traditional herbal medicines will lead to the disappearance of a large number of herbal medicines from the pharmaceutical market. Consumers in search of their usual medicines may start using the services of online stores, which may carry additional risks, since the quality of products marketed in this way is rather doubtful, and they themselves may be falsified.

Another reason for the disinterest of manufacturers in the registration of these drugs is the impossibility of patenting them. As a result, an entrepreneur, having spent a large amount on registration, does not have any guarantees of the exclusivity of his product, which means that these costs will be compensated.

Dissenters

The directive has sparked debate not only among manufacturers and distributors of traditional herbal medicines, but also among the general public. This is because, as a result of the introduction of the registration process for traditional herbal medicines, the access of EU citizens to this group of medicines may be significantly limited.

The initiative group has compiled a petition, the main arguments of which are the infringement of the rights of the population in their free access to medicines and the inability of small manufacturers, which mainly represent the market of traditional herbal preparations, to pay the registration costs, thus giving competitive advantages to large pharmaceutical corporations. And those who still manage to finance the registration process will be forced to include these costs in the cost of production, which will lead to a significant increase in its cost.

Manufacturers of traditional herbal medicines are concerned about the new registration requirements, as this entails a significant increase in costs, which may be too much for small enterprises, which are usually manufacturers of traditional herbal medicines. Thus, according to the Alliance for Natural Health organization, which represents the interests of manufacturers of this group of drugs, at the end of 2010, not a single drug belonging to traditional Chinese or Indian medicine was registered.

In addition, about 200 medicinal plants based on 27 plant species have been registered in Europe, while the number of medicinal plants used in the UK is 300 species. According to information published by the MHRA, at the end of 2010, the regulator processed 166 registration applications, of which 78 were approved, and as of March 18, 2011, their number reached 100.

Opinion

Edzard Ernst, Professor of Complementary Medicine at the University of Exeter, noted that along with the need to regulate the registration process for traditional herbal medicines, attention should be paid to verifying the appropriate qualifications of professionals working in the field of alternative therapies. In addition, according to E. Ernst, it is necessary to oblige them to inform patients about the development of side effects when using traditional herbal preparations.

Evgenia Lukyanchuk,
based on www.europa.eu, www.independent.co.uk, www.mhra.gov.uk, www.gopetition.com, www.pr-inside.com, www.chinapost.com.tw, www.jama. www.etnof.fciencias.unam.mx
(©) Ppart | Dreamstime.com \ Dreamstock.ru

*Homeopathic medicines are made from products of natural origin (from plant substances, animal products, mineral origin, etc.) using long-term complex high-tech processing methods.

Despite the progress of modern pharmacology, "grandmother's" recipes and traditional medicine tips are still popular among the population. Undoubtedly, there are a huge number of herbs with beneficial therapeutic properties. But not all people are aware of what self-treatment with their use can turn into. Even those plants that doctors actively use in their practice should only be prescribed by a specialist. What herbs can be used in combination with drugs and is herbal medicine able to replace them completely?

The medicinal properties of many plants were known to mankind as early as the third millennium BC. The pioneers in the field of herbal treatment were the peoples of Ancient Egypt, Assyria, China and India. Since ancient times, our ancestors used the gifts of nature as medicines, not only healing from diseases, but also strengthening the body as a whole.

From century to century, people have improved their knowledge of the healing properties of plants and their significance for human health. And today, traditional medicine does not exclude the possibility of using medicinal herbs, but looks at them from a scientific point of view. Inflorescences, stems, leaves and rhizomes - each part of the plant is valuable in its own way. The following dosage forms can be made from them:

Infusions that allow you to preserve the healing properties of herbs and ensure the rapid absorption of active substances. For their preparation, crushed herbal raw materials are poured with water (cold or hot - depending on the recipe), after which it is infused for a certain time.
Decoctions that provide slower absorption of active substances than infusions, but have a long therapeutic effect. For their preparation, crushed vegetable raw materials are poured with water and brought to a boil. After that, the resulting broth is filtered and diluted with water to the required volume.
Tinctures made with the addition of alcohol and characterized by a strong effect. Such preparations are prepared by insisting crushed plant materials on alcohol for a certain period of time. Their use has many restrictions and contraindications, and you cannot use any herbal tinctures on your own.
Ointments intended for external use as compresses. During the manufacturing process, the crushed raw materials are mixed with an astringent, such as vaseline or lard.

Also, medicinal herbs can be used as part of syrups, in the form of powder or natural extracts. The use of any remedy made on the basis of medicinal herbs must be previously agreed with the doctor.

Today, in traditional medicine, medicinal herbs are used mainly in combination with medicines and other means of basic therapy. It is not necessary to completely replace drugs with them. Among the most common medicinal plants actively used in modern medicine, it is worth noting chamomile, ginseng, sage, echinacea, calendula, St. John's wort and coltsfoot.

Chamomile is one of the most common medicinal plants. Chamomile extract is an active ingredient in many pharmaceutical preparations. The plant has a calming effect, helping to cope with insomnia or stress. The phenols contained in its composition destroy pathogenic microflora and stimulate the immune system. Chamomile is also effective for digestive disorders and some diseases of the gastrointestinal tract. The antibacterial, anti-inflammatory and antiseptic properties of the plant make it effective for dermatological problems (dermatitis, diaper rash, eczema).

Despite the versatility and effectiveness of chamomile, it is quite dangerous to use it as a medicinal and prophylactic agent without a doctor's prescription. The main side effect is an allergic reaction. In addition, if too much of the herbal tea is consumed, nausea and, in some cases, vomiting may occur. Contraindications include:

pregnancy and lactation period;
chronic diseases of the liver, kidneys;
allergic reaction to the plant component.

Although chamomile decoction is effective for colic, fever or stool disorders in children, it must be used with extreme caution, no more than 0.5 cups per day. Chamomile decoctions and preparations made on its basis thin the blood. Therefore, taking anticoagulants with them is not recommended.

Sage: benefits and dangers

The use of sage in modern pharmacology is quite common. Sage decoctions are widely used in the treatment of diseases of the upper respiratory tract and inflammatory lesions of the oral mucosa. Substances contained in the plant component help to regulate sweating and increase male and female libido. Sage extract is used in the manufacture of medicines for the treatment of diseases of the liver, bronchi or kidneys, hypertension and diabetes. On the basis of sage, preparations are made to improve the functioning of the brain and memory.

It is not recommended to use sage for therapeutic and restorative purposes without the appointment of a specialist. Only a qualified doctor will be able to correctly determine the dosage of the medicinal plant and the method of its preparation. With an overdose of decoction, the heartbeat may become more frequent, tremors may appear, swelling of the nasopharynx, an allergy in the form of a rash on the skin, and even convulsions can be observed.

The main benefits attributed to calendula are bactericidal, anti-inflammatory and antiseptic properties. Use it for:

the need to gargle or rinse the nose with acute respiratory infections;
treatment of burns and purulent lesions, skin;
dermatitis and skin diseases caused by a fungal infection.

Calendula is also used for baths or douches, inhalations. Regardless of the purpose of use, a doctor should prescribe preparations based on calendula. In addition, they can only be used as additional means to the main therapy.

People who are prone to allergies should be especially careful with calendula. Carotene in the composition of the flower makes it a strong allergen. Also, calendula stimulates the active secretion of gastric juice, which excludes the possibility of its use in gastritis or ulcers. The use of a herbal component for therapeutic or prophylactic purposes should be previously discussed with a doctor.

Echinacea: description of properties

Echinacea is a unique plant that is actively used in the production of drugs to enhance the body's natural defenses (immunity) and prevent viral diseases. For self-preparation, tinctures are best suited. Their use is relevant for:

bacterial and viral diseases of the upper respiratory tract;
the need to restore the body after poisoning;
treatment of inflammation of the oral cavity;
skin lesions (wounds, ulcers, bedsores, burns).

Echinacea-based preparations are contraindicated in patients with autoimmune diseases. Strengthening immunity with their help in HIV or tuberculosis is categorically excluded. The chemical composition of the plant component is not compatible with the drugs used to treat such serious diseases. Especially dangerous is the use of echinacea with antifungal drugs.

St. John's wort is distinguished by hemostatic, antibacterial, soothing, astringent, bile and diuretic properties. It can be used for the treatment of non-healing wounds and inflammatory lesions of the skin, as well as for the treatment of diseases of the upper respiratory tract. St. John's wort has a beneficial effect on the central nervous system (CNS), which is effective in the treatment and prevention of depressive conditions.

When using products based on St. To avoid side effects, you can not use St. John's wort for fever, gastritis or ulcers.

Ginseng: a medicinal root from the East

Speaking of medicinal herbs, it is impossible not to mention the popular ginseng root today. The plant, which came to us from the East, has a stimulating effect. Its use is relevant for increasing endurance during mental stress, achieving a state of physical vigor and for enhancing performance. Substances in the composition of ginseng increase the tone of blood vessels.

The use of a herbal component or preparations based on it may be recommended for people with low blood pressure and problems associated with visual acuity. Another benefit of ginseng is its effectiveness in normalizing cholesterol and blood sugar levels. With extreme caution, ginseng root should be consumed:

pregnant and lactating;
children under the age of 12;
people with heart disease and hypertension;
patients suffering from hyperexcitability and epilepsy.

The combination of ginseng root with various drugs should be discussed with the doctor beforehand. It is impossible to use a plant component on your own to treat diseases and strengthen the body.

Fresh coltsfoot flowers have an enveloping effect and can be used to treat diseases of the throat and oral cavity. The expectorant and anti-inflammatory properties of the plant are especially valued. No less effective is the use of coltsfoot for digestive disorders. Products made on its basis can be used for both external and internal use. For internal use, teas and decoctions are most often prepared on the basis of coltsfoot.

Contraindications to the use of the herbal component are pregnancy and lactation. Also, its use is not recommended for patients with liver disease or people who abuse alcohol. The admissibility of the use of coltsfoot for therapeutic purposes, the duration of the course of its administration and dosage should be determined only by a doctor.

Can herbs replace medicines?

The importance of medicinal herbs in modern pharmacology is undeniable. It is a mistake to believe that herbal treatment is the prerogative of exclusively traditional medicine. Various plants can be used as adjunctive therapy in the main treatment. But they should be appointed only by relevant specialists.

In most countries of the world, the level of development of modern medicine is quite high, but many people in developing countries still resort to the services of traditional medicine specialists1, use medicinal plants and preparations based on these plants for first aid. Over the past decades, interest in herbal treatment has also increased in developed countries, which has led to an increase in the demand for medicinal plants.

The variety of types of traditional medicines has developed in different ethnic, cultural, climatic, geographical and even philosophical conditions.

The registration rules and legal framework associated with these drugs must guarantee their safety and efficacy, but the development of these documents presents certain difficulties.

Traditional herbal medicines and human health

Natural preparations, which served as the basis of medicine in antiquity, are widely used today. They make up a significant share of international trade.

Medicinal plants play an important role in pharmacological research and drug development, not only when plant components are used directly as a therapeutic agent, but also when they are used as raw materials for the production of drugs or as samples for the synthesis of pharmacologically active compounds. Therefore, it is necessary to regulate the use and export, as well as international cooperation and coordination of the conservation of medicinal plant species.

The UN Convention on Species Diversity states that the conservation and sustainable use of biological species is of great importance to meet the needs of the world's population for food, treatment, etc. A prerequisite for achieving this goal is open access to genetic resources and technologies and their even distribution.

The development of the legislative framework related to medicinal plants does not follow a single model. Different countries have adopted different definitions of medicinal plants and products derived from them. In addition, different countries have different approaches to licensing, dispensing, manufacturing and marketing of medicines to ensure their safety, quality and efficacy.

Despite the fact that the use of drugs based on medicinal plants has a long history, the therapeutic effect of a relatively small number of plant species has been studied so far. And data on safety and efficacy are available for an even smaller number of plants and preparations based on them.

Regulation and registration of medicinal plant products

In some countries, herbal medicines have the same status as other medicines, in others they are equated with food and their use for therapeutic purposes is prohibited. In developing countries, herbal preparations are traditionally used, they are widely used in traditional medicine. However, in these countries, there is almost no regulatory framework for traditional herbal medicines to be classified as medicines.

In the legislation of different countries, the following criteria are used to classify natural medicines: description in a pharmacopoeial monograph, prescription status of the drug, claim that the drug has a therapeutic effect, registered ingredients or many years of experience in use. In some States, a distinction is made between "officially recognized" and "officially approved" products, the latter being allowed to be marketed without scientific review.

The legislative approach to herbal medicines falls into the following categories:

regulatory requirements are the same for all products;
all regulatory requirements include exemptions for natural/traditional products;
exceptions for natural products only apply to registration or marketing authorization.

In cases where herbal medicines are not registered and controlled by regulatory authorities, a specific licensing system is needed through which health authorities can verify the composition of the medicine, require confirmation of its quality before marketing, ensure correct and safe use, and also require licensees to report suspected side effects.

WHO policy and activities. WHO Traditional Medicine Program

The World Health Assembly (WHA) passed a series of resolutions to draw attention to the fact that large populations in developing countries still use traditional medicine and that traditional medicine is a workforce potentially important to primary health care . The Alma-Ata Declaration of 1978 recommended that proven traditional remedies be included in national programs and regulatory documents for the use of drugs.

The policy of the World Health Organization with respect to traditional medicine was set out in the report of the WHO Director-General "On Traditional Medicine and Modern Health" at the 44th World Health Assembly in 1991.

This report states that "WHO Member States have reviewed national programmes, legislation and decisions on the nature and extent of the use of traditional medicine in their health systems." According to the relevant WHA regulations, the main objectives of the Traditional Medicine Program are: to promote the integration of traditional medicine into national health systems; promote the rational use of traditional medicine by developing technical guidelines and international standards for herbal medicine and acupuncture; and to inform about the various forms of traditional medicine.

WHA regulation 42.43 (1989) calls on WHO Member States to: conduct a comprehensive assessment of traditional medicine; conduct a systematic registration and examination (preclinical and clinical) of medicinal plants used by traditional medicine professionals and the public, introduce measures to control products based on medicinal plants and to implement and maintain relevant standards; as well as to find out which medicinal plants and preparations based on them have a satisfactory ratio of efficacy and safety and which of them should be included in national registries or pharmacopoeias.

Herbal medicines have been part of the program of the International Conference on Drug Control Authorities since 1986. In 1986 and 1989, at the 4th and 5th conferences, seminars were held on the control of the circulation of natural drugs in international trade. It was decided that WHO would develop standards defining the basic requirements for registration and circulation of natural products.

A draft Rule for the Evaluation of Medicinal Plant Products was prepared at the WHO meeting in Munich in June 1991 and adopted at the 6th Conference on Drug Control Authorities in October 1991 in Ottawa. These rules define the main criteria for assessing the quality, safety and efficacy of drugs based on medicinal plants. The rules are intended to encourage government regulators, scientific organizations and manufacturers to evaluate documentation related to these products. The general rule for such an assessment is that it is necessary to take into account the traditional experience of their use, as well as take into account medical, historical and ethnic aspects.

These rules contain the main criteria for assessing quality, safety and efficacy, as well as important requirements for labeling and information inserts in the package. Pharmaceutical evaluation requirements relate in particular to issues such as identification, analysis and stability. The safety assessment should be carried out, at a minimum, on available reports relating to safety and toxicological studies. The performance evaluation should include an analysis of traditional applications based on available materials.

In 1994, the WHO Regional Office for the Eastern Mediterranean Region published Guidelines for the Formulation of Public Policy on Medicinal Plant Products. Most of the world's population uses traditional methods of treatment, especially with the use of medicinal plants, which are most effective in the treatment of diseases of the gastrointestinal tract, upper respiratory tract, urinary tract and skin diseases. In view of the foregoing, there is no doubt that there is a need to develop a public policy on traditional medicines and to encourage cooperation among WHO Member States. The goal of such public policy would be to develop regulatory and legal reform to ensure good practice and the provision of first aid on a larger scale, while at the same time guaranteeing the authenticity, safety and efficacy of these drugs. A proposal was made to create in each state a National Expert Commission, which would develop specific measures for the formation of state policy in this region, and then would develop, direct and monitor the various stages of its implementation. The responsibilities of the National Expert Commission include compiling state lists of essential herbal medicines, preparing instructions on registration requirements, advising on the state licensing system and how to account for side effects, and developing adequate methods of cooperation with the Ministry of Health. The main selection criteria for essential herbal preparations should be safety, efficacy, the need for this preparation and the availability of raw materials. Based on the approved list of medicinal plants for each state, clear principles for ensuring the stock of these plants should be developed, which should include the collection, cultivation, processing, import of these plants and the protection of the flora of this state. The rules also contain a separate chapter on criteria for research on traditional herbal medicines and criteria for their rational use.

Since scientific research is needed for most medicinal plant products, WHO assists Member States in the selection of safe and effective drugs that can be used in the health system of these countries.

In 1992, the WHO Regional Office for the Western Pacific organized a meeting of experts in order to develop criteria and general principles for research work on the examination of herbal preparations. The rules developed at this meeting serve as the basis for WHO Member States to develop their own guidelines for research, as well as for the exchange of research data and other information, which will create a reliable database for registration of medicinal plants. The adoption of this policy should help overcome legal barriers to the use of herbal products.

Requirements for natural products in individual countries

Canada

Under Canadian law, herbal preparations are treated as medicines and are therefore subject to labeling and other requirements under the Food and Drugs Act. This means that, unlike in the US, there are a large number of herbal products legally on the Canadian market. To register or assign an identification number to a drug, it is necessary to study its composition and obtain approval for the label.

On August 13, 1987, after lengthy discussions, Health Canada issued a Bulletin listing plants that pose a hazard or require warning labels. These products were allowed to be sold as food, drugs and even cosmetics, depending on their properties, action and method of application. At the same time, plants can be considered medicinal products, subject to the submission and approval of the application and data on the quantitative content of active ingredients. In today's practice, herbal medicines used to treat benign diseases can be assigned a drug identification number (DIN) based on a pharmacological rationale and bibliographic information that supports traditional use that is consistent with current research findings. In addition, with the emergence of the need for a special mechanism for the registration of medicinal plants and preparations based on them, the project "Standard monographs on preparations" (SMP) was proposed. Combinations of several plants described in such monographs will be approved if their use is justified on the basis of sound therapeutic principles.

On January 5, 1990, another Bulletin was issued to clarify the policy of the Ministry of Health regarding herbal preparations.

It contains regulatory requirements and recommendations on the mechanism for assigning these products to the TIN. The document clearly states that the most important criteria for classifying a plant-based product as a food or as a drug is the pharmacological activity of the ingredients, the intended use of the product, and available information on its use. In this Bulletin, herbal medicines are divided into two groups:

Plants, information about which is available in pharmacopoeias and pharmacological reference books. Due to the long practice of use, the properties of these plants are known, as well as indications and contraindications for their use. Products containing such herbal ingredients should be considered as other medicinal products; such products are widely marketed in the form of prescription and over-the-counter products.
Plants that are not well documented in the scientific literature, so they are not well known in Canada. However, there is literature on their traditional use based on empirical observations, and such information is valuable in determining the acceptability of a particular herbal medicine. It is expected that drugs from this group will be used to treat diseases that do not pose a health risk. These products, used traditionally or used in traditional medicine, must be given a special designation. Consideration of applications for INP using the SMP should ensure that the manufacturer ensures that its products meet the conditions of the SMP.

In October 1990, by order of the Minister of Health, the instructions "Traditional Herbal Preparations" were published to assist manufacturers in preparing applications for CPI and labeling products falling under the category "Traditional Herbal Preparations" (TPOMA). ). Applications must include a draft label that clearly states the indications for the use of the traditional herbal preparation. Recommendations must be attached to the application. If an SMP exists for that medicinal plant and if the application complies with the terms of this monograph, it is considered an acceptable alternative to other recommendations. Terms such as "tonic", "supplement", "cleansing agent", etc. are unacceptable. Some combinations of herbs, such as a diuretic with a laxative, as well as combinations of herbs with an opposite effect, are considered dubious.

Expertise is primarily based on traditional data on efficacy and dosage. If there are doubts about safety, instead of traditional information, experts use modern research methods.

USA

Importance of herbal medicines for the US market

Herbal medicines are less common in the United States than in most developed countries. This is explained by the fact that the sale of these drugs is carried out mainly by dietary stores, whose clientele is a small percentage of the population. It is difficult to expand the scope of sales of these products by selling them in pharmacies, since it is impossible to declare the therapeutic effect of these drugs and customers would seek advice from pharmacists, who, in most cases, are poorly versed in medicinal herbs.

Legal status

At the end of 1930s. The Food, Drug, and Cosmetic Products Act was passed, and since then, the FDA considers any product that has medicinal, analgesic, or preventive properties to be a drug. Therefore, herbal preparations must go through the same approval process as any chemical preparation. Most natural products in the US are classified as food or dietary supplements, despite the fact that many of them are used by consumers as folk remedies. Most of the regulations are about safety. If a product is "recognised as safe", this ensures that the product is properly labeled and not counterfeit. Natural products theoretically acquire the status of "safe" when this status is confirmed by a competent specialist and not refuted by other specialists.

Some particularly well-known medicinal plants are given OTC status by the FDA. However, most medicinal plants were excluded from this list. This was mainly because US medicinal plant manufacturers did not provide evidence to support their use. In November 1992, the FDA appointed a new advisory committee that included outside experts on over-the-counter drugs.

New legislation

Since 1976, dietary market regulations have stated that foodstuffs, including dietary supplements and medicinal plants, are not medicines. Therefore, the FDA did not work on writing monographs on dietary supplements, vitamins, minerals, and medicinal plants.

In 1990, Congress passed the Food Labeling Act, which required all foods to be labeled with nutritional information and required the FDA to determine criteria for approval of food value labels for human health. The Law takes into account that the consumption of vitamins, minerals, medicinal plants and other similar products differs from the consumption of ordinary food products, and therefore, according to the Law, softer standards for determining their health value should be applied to these products. Congress has given the FDA one year to solicit public opinion on a mechanism for introducing standards and procedures for evaluating claims of value for supplements that are not covered by the Food Labeling Act. The design submitted by the American Plant-Based Foods Association did not receive FDA approval.

Diet Supplements, Not Dietary Supplements

In October 1994, the Dietary Supplements Act recognizes that these supplements are beneficial in the prevention of chronic disease and therefore help limit health care costs in the long run. Herbs and other medicinal plants, vitamins and minerals now fall under the definition of "dietary supplements" that come in the form of capsules, tablets, liquids, etc., and which are not food in the usual sense, but are labeled as a dietary supplement. Dietary supplements do not include substances that have previously been marketed as drugs or are in clinical trials. The law provides that a dietary supplement is considered a food that does not require FDA approval to market, not a food supplement that does. Labeling of dietary supplements is permitted if they claim to be useful in classical malnutrition, if there is a description of the role of the nutritional or dietary component, or if the mechanism of action of the product is described. In addition, the label must clearly state that this information has not been reviewed by the FDA and that this product is not intended to diagnose, treat, treat, or prevent any disease.

It is also necessary to have a list of constituents, plants or their parts, with a clear indication of their quantity. If a supplement is claimed to meet the official compendium standard and it does not meet that standard, the product label is considered mislabeling. A mislabelled product is also considered a product that is not described in the compendium, but does not have the characteristics it claims.

The new law provides for the creation of the Dietary Supplement Administration at the National Institutes of Health. This department should study the role of dietary supplements in the health of the population and stimulate scientific research on these products.

The signing of the Dietary Supplement Act in October 1994 should accelerate the recognition of the importance of plant-based products to the US market, as the act allows these products to be marketed as dietary supplements provided there is evidence of their safety and there is evidence that as stated in the application. The likelihood that plant-based products will be marketed as medicinal products and recognized for their therapeutic effect is very low, since the FDA does not currently accept bibliographic data on their effectiveness, preferring randomized clinical trials.

Translation by Olga Sotnikova

Medicines on a natural basis

Agri - used for the treatment and prevention of acute respiratory viral infections, is for children and adults. Homeopathic, and therefore, without chemistry.
Aqua Maris - based on a sterile solution with sea salt, is used for a cold even in children under 1 month old. It is good to use as a prophylactic for ARVI - it washes away viruses from the mucous membrane.
AquaLor - also based on a solution of sea water. Of the indisputable advantages - a large variability of the drug, for solving different problems.
Arnigel is a homeopathic gel for bruises and bruises, based on the Arnica mountain plant. Arnica is the #1 herb for bruises. What is useful - you can children after 1 year. I’ll add on my own that the bruises disappear on the second or third day, it’s been checked more than once.
Bronchicum - based on thyme extract, quickly stops coughing, relieves spasm in the bronchi. Children - from 6 months, but should be given carefully - there is alcohol in the composition.

Bronchipret is an herbal expectorant, allowed for children from 3 months.
Valerian - well, everything is clear here, folk and inexpensive sedative ..
Venitan - a gel based on plant extract, fights tired legs quickly and effectively.
Venza - complex homeopathic drops, recommended for varicose veins, venous circulation disorders.
Galstena is also a homeopathic medicine used as maintenance therapy for chronic liver and gallbladder diseases.
Gedelix is an expectorant based on ivy extract. The manufacturer reports that the drug is especially indispensable for smokers. Be that as it may, it can be used for children up to a year.
Gelarium Hypericum - a sedative based on St. John's wort, can be used by children from 12 years old.
Gerbion - plantain syrup with a natural composition, most effective for dry cough.
Girel is a multi-component homeopathic remedy for cold symptoms. In severe cases of the disease, they are combined with Engystol and Traumeel
Gentos - homeopathic tablets, are most effective in the complex treatment of the prostate and bladder.
Homeostres - pills to reduce nervousness, normalize sleep. The components are natural, the impact is not only on the emotional, but also on the physical level - it relieves not only irritability, but also dizziness, stomach cramps and muscle pain associated with stress. It is important that they do not cause drowsiness and addiction
Dantinorm Baby - special drops for oral administration, relieving various symptoms of teething in children - with pain and inflammation of the gums, also affects the temperature, increased tearfulness, and normalizes the stool. Pretty much the only "natural" medicinal solution to teething problems.
Deprim is a sedative drug based on St. John's wort extract, the maximum effect is achieved during a course of admission
Doctor Mom is a cough syrup and ointment with natural ingredients, more often used to treat children, but adults can also. Especially the ointment, it has a good warming effect. Due to the presence of essential oils, it is not recommended for people with allergic reactions.
Immunal - based on echinacea juice, an immunostimulating drug for restoring the body. It is good to take courses during the epidemiological season. Not recommended for people with autoimmune diseases.
Influcid - homeopathic tablets for the treatment of acute respiratory viral infections, can be given to children from 3 years old. It is good to use when an adult stays with the child - they should be given every hour, but not more than 12 per day.
Irikar - ointment, effectively treats dermatitis, helps with eczema and after insect bites. It is possible for children from 1 year old with diathesis.
Traumeel - a homeopathic ointment for bruises and sprains can also be used by pregnant women after consulting a doctor. Sufficiently broad action.
Kanefron is an effective herbal remedy for cystitis, often used to treat pyelonephritis in pregnant women.
Klimadinon is a drug for reducing vegetative-vascular disorders during menopause. As a rule, the effect occurs after 2 weeks from the start of administration.
Climaxan is a homeopathic remedy that copes well with the unpleasant manifestations of menopause, according to women's reviews - even without side effects. No addiction.
Negrustin is a phytopreparation based on St. John's wort extract, for adherents of "non-synthetic" antidepressants. It is better to take it for a long time, without interruptions.
Nervochel is a homeopathic sedative drug, a separate indication for use is neurosis-like reactions in the menopause.
Notta - also a homeopathic remedy, relieves anxiety. From myself I can say that he is also struggling with insomnia very successfully. The main thing is to take the course - from 1 to 4 months.
Oscillococcinum is the most popular cold remedy in Europe. It is believed that if you take it at the very beginning of the disease, then this will allow you not to get sick at all. In the worst case, you will simply get sick in a milder form.
Persen is a phytopreparation with a sedative effect, another natural sedative. What is useful, does not cause drowsiness.
Plantex is a phytopreparation for improving digestion, with fennel extract. Especially important for babies, relieves gas and colic. It will not help if the cause of gas and colic in your child is lactase deficiency or dysbacteriosis.
Prospan - vegetable cough syrup, pleases the absence of sugar and alcohol in the composition. It is allowed for children from 1 year old, as well as for pregnant women as directed by a doctor.
Remens is a homeopathic remedy prescribed both for women of mature age to alleviate the symptoms of menopause, and for young girls to regulate the menstrual cycle. You need to take it for a long time and do not forget about consulting a doctor.
Senade is a laxative based on senna, taken with caution in liver diseases.
Sinupret - a herbal medicine in the form of dragees and drops, used for acute respiratory diseases, can be used by children from 6 years of age. Effective in combination with antibacterial drugs.
Sinuforte - able to cure sinusitis. When applied, it may not cause the most pleasant sensations, but this is part of the healing process.
Stodal is a complex cough syrup. Some of its components act on a dry cough, the other - on a wet one. Pediatricians especially recommend for the treatment of a prolonged cough, because the use of cough medicines is limited in time of use.
Tantumverde, spray is an antiseptic agent which includes both herbal and chemical components. It is effective in diseases of the oral cavity and ENT organs. Children under 3 years of age are not recommended.
Tonsilgon - plant-based drops using alcohol, has an antiseptic and anti-inflammatory effect. Caution with use in allergy sufferers and in children under one year old.
Tonsipret - homeopathic, on extracts of three plants, is used in adults for sore throats.
Sleep formula (for children) - natural, with herbal extracts and vitamins. A fairly popular sedative in syrup for children with trouble sleeping.
Cycaderma is a healing ointment with herbal ingredients. According to the manufacturer, it is produced only from fresh plants. Acts very quickly, especially in the case of minor household burns and insect bites, abrasions; removes inflammation.
Cinnabsin is a homeopathic remedy used for sinusitis. It is allowed for children from 3 years old, it works best as part of complex therapy.
Edas is an effective alternative to vasoconstrictor drugs for a cold, in addition, it eliminates the effect of addiction to other drops.

Currently, herbal medicines make up a good third of the entire register of medicines used in modern medicine. As a rule, they are dispensed in pharmacies without a doctor's prescription. However, this does not mean that everyone can self-medicate uncontrollably. The illiterate use of medicinal plants can be not only ineffective, but also dangerous to health.

When using herbal medicines, you need to remember the following points:

Approximately 4-5% of people have intolerance, hypersensitivity to certain herbal preparations. Taking such drugs, even in small doses, can cause an allergic reaction in the form of hives, eczema, swelling, itching, and asthma attacks.
In addition to allergic reactions, there is such a thing as individual sensitivity. Schisandra chinensis, for example, usually has a stimulating effect on the nervous system, but Schisandra chinensis can cause lethargy and depression in some people. And valerian, which usually has a calming effect, can cause excitement in some people.
Herbal medicines may not be compatible with the chemicals you are taking. Valerian is not recommended to be taken with antihistamines. When using birth control pills, you should not use St. John's wort at the same time: according to some reports, it reduces their effectiveness. Ginseng, which is often used as a tonic, is incompatible with coffee and preparations containing caffeine: their combination can cause increased excitability and irritability instead of cheerfulness. Soothing herbs are not recommended to be taken together with antiallergic drugs - diphenhydramine, tavegil and suprastin. With this combination, lethargy and drowsiness may increase. And when using tetracycline and sulfonamides together with St. John's wort, the photosensitivity of the skin increases sharply, which can lead to burns even after a few minutes of exposure to the sun.
With prolonged use of the same herbal remedy, it can become addictive and its effectiveness will noticeably decrease. Therefore, it is recommended to update the herbal treatment regimen every 3-4 weeks. And if there is no effect, switch to more serious drugs.
It is known that plants contain many active substances, and they do not always combine successfully.
Although medicinal herbs, although they have been used for thousands of years, have been studied much worse by modern science than synthetic pills. No one has conducted large-scale studies confirming their effectiveness and safety.
Since the concentration of medicinal substances is not the same even in different branches of the same plant, when using plants, overdoses or, conversely, “shortfalls” in the dose of the drug are inevitable. Although some herbal preparations are still standardized in terms of the content of active substances in one tablet (this applies to antidepressants based on St. John's wort).
Contrary to the common misconception that there are no “harmful chemistry” in herbal preparations, today a lot of “chemistry” has got into the cycle of substances in nature. All harmful compounds can accumulate in medicinal plants.
Most herbal medicinal components do not copy biologically active compounds in the human body. Like synthetic medicines, herbal preparations only resemble the regulatory substances of the human body. Therefore, herbs can have both a therapeutic effect and side effects.
Even non-poisonous medicinal plants have many contraindications for use: