Swiss standards in the field of pharmacology are becoming an obstacle in the way of manufacturers of alternative medicines. Lucky for us?
Does Switzerland need non-traditional medicines from Asia?
Manufacturers and importers of Asian alternative medicines would like to be freed from the strict standards and restrictions that apply to the Swiss drug market, pointing out that they do not allow them to gain a foothold in such a promising market of the Confederation. On the other hand, these standards and norms are not designed to force someone out of the market, but to guarantee patients the quality of medical care. Is it possible to find some golden mean here?
This content was published on October 21, 2016 – 11:00 October 21, 2016 – 11:00 Anand Chandrasekhar
India expert at SWI swissinfo.ch covering a wide range of topics from bilateral relations to Bollywood. He also knows some of the secrets of the Swiss watchmakers and what is happening in the French-speaking part of the country.
- Deutsch (de) Asiatische Heilkunde verlangt weniger strenge Vorschriften
- Español (es) Medicinas asiaticas buscan alivio a regulaciones estrictas
- Português (pt) Medicamentos asiaticos procuram alívio em regulamentação
- 中文 (zh)
- عربي (ar)
- Français (fr) Les médicaments traditionnels asiatiques butent sur une réglementation stricte
- English (en) Asian medicines seek relief from strict regulations (Original)
- 日本語 (ja) 伝統医薬の輸入に厳しい規則
- Italiano (it) La medicina asiatica cerca un antidoto contro i regolamenti stretti
Wetzikon is a 20-minute train ride from Zurich. This is the most ordinary average Swiss town with a railway station, a church, several shops and restaurants. Only about 25 thousand people live here, but at the same time this settlement is well known to Tibetans around the world. The fact is that it is in Wetzikon that the head office of the company "Padma External link ”, which produces medicines for the needs of patients of Tibetan medicine. This is the only place of its kind outside of India.
The basis of Tibetan medicine is, as you know, the doctrine of the three "nyepa" ("culprits") of diseases, which are "wind", "bile" and "mucus". Life in Tibetan medicine is defined as "pulsation", and health and disease are considered dependent on these three "pulsating" entities. The basis of therapy here was the use of natural remedies of plant and animal origin, and at the moment there are up to one thousand items of medicines developed for patients by Tibetan doctors.
In their opinion, "there is no such substance in nature that would not be suitable as a medicine." However, the peculiarity of the Padma company is that, no matter how unconventional the prescription of the medicine is, the production process here is no different from the industrial technologies used in other pharmaceutical companies in Switzerland, meeting the most stringent criteria.
So, for example, one of the bestsellers of the company, the drug "Padma 28", designed to treat circulatory disorders, passed about three hundred different tests and tests before it was allowed to market. The challenge of the company's pharmacists is to ensure that their product is compliance with the GMP standard in Switzerland ("Good Manufacturing Practice" / "Good Manufacturing Practice"), the system of norms and rules in the production of medicines, food, food additives and other active ingredients.
Show more
Switzerland, machine intelligence and digital revolution
Is Switzerland ready to digital future?
Show more
Traditional medicine and pharmaceutical High-tech
This content was published on October 21, 2016 on October 21, 2016 by the head office of Padma, producing medicines for the needs of Tibetan medicine patients, is located in the city of Vetzikon.
"From the point of view of regulatory requirements there is no difference with which we are dealing with ordinary or non-traditional drugs. All of them must correspond to the same, in force in Switzerland, the quality and safety standards of medicines, "said Swissinfo.ch Selyl, the head of the Padma regulatory regulatory department.
Unique products
Swiss legislation governing the procedure for admission to the drug market is very well developed, but it does not sometimes be at the highest degree of nature of the origin of many medicinal plants used in various non-traditional medical practices. For example, in the manufacture of some Tibetan drugs, up to five types of various herbs and active ingredients are used.
"We are in a constant active dialogue with the authorities, since they do not really trust us, considering that our products are too, let's say, specifically," says Cecile. In 2012, five species of alternative therapy, including phytotherapy and traditional Chinese medicine, were included in the basic medical insurance package as an experiment in Switzerland. Since then, the need to understand the nuances of various means and methods of traditional medicine every day is becoming increasingly acute and relevant. It is obvious that the issue of safety has the highest priority for the authorities and regulators in this context.
Show more
Does the Nobel Prize threatens Chinese medicine?
This content was published on December 11, 2015 on December 11, 2015 How compatible methods of traditional Chinese and modern medicine are compatible and what are the chances of TKM in the context of globalization?
Swiss agency for regulating therapeutic products "SwissMedic External Link ", Controlling the turnover of medicines in Switzerland, very seriously refers to measures to ensure this security itself."Each drug can potentially be used to benefit and have negative side effects.
Possible risks to predict is very difficult, and for this reason, we always approach the need to combine freedom in the area of admission to the market with the necessary measure of skepticism to the drugs of an unconventional nature, because all this is the life and health of people, " In particular, in an interview with SwissMedic agency "SWISSMEDIC".
Long procedure
One of the unconditional advantages of drugs based on medicinal herbs and plants is less strict standards in the field of confirmation of their effectiveness. For ordinary drugs, there are much more stringent rules. As for the funds of folk or alternative medicine, they do not have to pass costly clinical trials, provided that they are already applied to the treatment of diseases for at least 30 years, and at least 15 years of which Switzerland and Western Europe should be concerned. In addition, these timelines must have documentary evidence, and it is not so easy to do.
"It is very difficult to demonstrate that the agent of traditional medicine was used in Europe for 15 years, especially when you first actually brought this product to the market," says S. Veno. To do this, you need to find such confirming documents as recipes, orders or accounts decorated in the past. As a result, the development and conclusion to the market of new medicinal formulas can turn into a long procedure that does not guarantee a quick solution to the problem. Of course, large manufacturers have the opportunity to surrender to regular clinical trials, but such small companies like "Padma" simply cannot afford this kind of investment.
More Knowledge – More Sorrow for Importers
The importation of medicinal preparations on a vegetable basis from abroad is also not so easy. Importers are required, in particular, to regularly confirm that the foreign manufacturer complies with the GMP regulations operating in Switzerland. The SWISSMEDIC agency may at any time be requested such documents as a certificate of compliance with GMP standards and reports on the results of an audit and / or inspection of the relevant foreign production enterprise.
For medicines from Asia, it is also necessary to provide reports of experts on the absence of their pollution with pesticides, heavy metals and microbes. And this is understandable, because only the observance of these norms can guarantee Swiss consumers access to medical preparations of exceptionally high quality. So, in any case, pay this price to manufacturers and exporters accounts, and they understand it.
According to the Swiss professional organization of specialists in the field of traditional Chinese medicine ("Schweizerische Berufsorganisation für Traditionelle Chinesische Medizin", "SBO-TCM External link ”) in the world today, in general, the trend of tightening the requirements for alternative medicine is becoming more and more stronger. Such drugs have to undergo more and more different kinds of tests so that the consumer has ironclad guarantees of both the identity of the origin of drugs and the quality and purity of the ingredients.
“The number of scientific and analytical monographs devoted to oriental medicines is constantly growing, and therefore the number of criteria that both raw materials and active substances must meet when entering the European and Swiss markets,” points out a Swissmedic representative. For manufacturing companies, however, all these new requirements mean only one thing, namely, an increase in additional costs.
"There is no moral business in an immoral war"!
This content was published on Apr 06, 2022 Apr 06, 2022 Western companies must cease all business dealings with Russia. Why? Five reasons why!
Show more
Treat causes, not symptoms
This content was published on Mar 19, 2013 Mar 19, 2013 Ayurveda is an ancient system of Indian Vedic medicine dating back several thousand years. The name comes from the Sanskrit words "āyus".
“In this regard, products that promise a small rate of return are not very interesting for traditional Chinese medicine firms in Switzerland, which means that the full range of existing alternative medicine medicines is not available to us in this country,” says Najad Brunschweiler (Najad Brunschweiler, official representative of SBO-TCM.
Given the stringent import requirements for plant-based products and raw materials, it is sometimes easier to make or grow the appropriate ingredients in Europe itself. Hans Rhyner, who practices Indian Ayurvedic methods, grows and combines, for example, his own herbal preparations in neighboring Austria.
“This makes it much easier for me to ship my products to Switzerland or any other EU country, as they recognize Austrian quality standards. It is much more difficult for those who import medicines from India, since many of the quality certificates issued there, for example, for organic products, are not recognized in Switzerland,” he says.
The support of the Indian government is indispensable
Despite all the inconvenience associated with the need to comply with strict rules and regulations, not everyone opposes such stringent admission requirements. Oliver Werner, whose company "Maharishi Ayur-Veda Products External link » imports Ayurvedic medicines directly from India, warns against excessive carelessness. “In EU countries, such drugs are treated as food supplements, and not as medicines. And despite the stringent quality control requirements, cases of contamination of these products with heavy metals have already been noted, and such excesses negatively affect the reputation of Ayurveda as a whole, ”he says.
Schweizerische Berufsorganisation für Traditionelle Chinesische Medizin", "SBO-TCM External link
”) in the world today, in general, the trend of tightening the requirements for alternative medicine is becoming more and more stronger. Such drugs have to undergo more and more different kinds of tests so that the consumer has ironclad guarantees of both the identity of the origin of drugs and the quality and purity of the ingredients.
“The number of scientific and analytical monographs devoted to oriental medicines is constantly growing, and therefore the number of criteria that both raw materials and active substances must meet when entering the European and Swiss markets,” points out a Swissmedic representative. For manufacturing companies, however, all these new requirements mean only one thing, namely, an increase in additional costs."There is no moral business in an immoral war"! This content was published on Apr 06, 2022 Apr 06, 2022 Western companies must cease all business dealings with Russia. Why? Five reasons why!
Show more
Treat causes, not symptoms
This content was published on Mar 19, 2013 Mar 19, 2013 Ayurveda is an ancient system of Indian Vedic medicine dating back several thousand years. The name comes from the Sanskrit words "āyus".
“In this regard, products that promise a small rate of return are not very interesting for traditional Chinese medicine firms in Switzerland, which means that the full range of existing alternative medicine medicines is not available to us in this country,” says Najad Brunschweiler (Najad Brunschweiler, official representative of SBO-TCM.
Given the stringent import requirements for plant-based products and raw materials, it is sometimes easier to make or grow the appropriate ingredients in Europe itself. Hans Rhyner, who practices Indian Ayurvedic methods, grows and combines, for example, his own herbal preparations in neighboring Austria.
“This makes it much easier for me to ship my products to Switzerland or any other EU country, as they recognize Austrian quality standards. It is much more difficult for those who import medicines from India, since many of the quality certificates issued there, for example, for organic products, are not recognized in Switzerland,” he says.
The support of the Indian government is indispensable
Despite all the inconvenience associated with the need to comply with strict rules and regulations, not everyone opposes such stringent admission requirements. Oliver Werner, whose company "
Maharishi Ayur-Veda Products External link
» imports Ayurvedic medicines directly from India, warns against excessive carelessness. “In EU countries, such drugs are treated as food supplements, and not as medicines. And despite the stringent quality control requirements, cases of contamination of these products with heavy metals have already been noted, and such excesses negatively affect the reputation of Ayurveda as a whole, ”he says.
According to him, if the ingredients used for the production of such drugs are included in the list of substances allowed by the SWISSMEDIC agency, then there are no problems with imports. However, the problem is that this list is actually revised and adapted, which means that drugs manufactured by the latest formulas cannot be imported, even if SWISSMEDIC and addresses regularly to specialists in other countries for consultations. In order for as soon as possible to fill out the information lacques that arise and be able to keep up with discoveries in the field of alternative medicine.
The "SWISSMEDIC" agency supports close ties with its partners abroad, including colleagues in Australia, Singapore, Canada and EU countries. This gives us the opportunity to regularly take into account all new trends in the field of alternative medicine, "indicates the representative of" SwissMedic ". In practice, all this is often very annoying not only manufacturers and importers, but also practicing doctors.
Franz Rutz (Franz Rutz), President of the Swiss Professional Association of Specialists in the field of Ayurveda and non-traditional therapy (
- Verband Schweizer Ayurveda-Mediziner & -Theraapeuten External Link
- ), I would prefer to be able to count on a stable supply system for high-quality products for Swiss specialists in this area. "In the future, much will depend on the availability of clear legislation, whether we can harmonize with suppliers from India available standards, as well as strengthen confidence in imported products in general. Perhaps we can not do without the support of the Indian government, "he summarizes.
- Alternative medicine? Only with the account!
- In 2005, the project to include traditional and alternative methods of medicine was rejected in Switzerland into the Catalog of Mandatory Services of Companies of OMS, with reference to the insufficiently wide base of scientific evidence of their effectiveness. Nevertheless, it was necessary to return to the discussion of these methods in 2009 after two thirds of the Swiss insisted on a referendum to still include them in the list of mandatory services provided on the policy of compulsory honey insurance.
- As a result, five alternative methods of treatment (homeopathy, holistic medicine, phytotherapy, neural therapy and traditional Chinese medicine) were included in the basic health insurance package as an experiment for the period from 2012 to 2017, provided that they will practice specially certified doctors.
Ayurveda and traditional European medicine, as well as homeopathy and traditional Chinese medicine, were also approved in Switzerland as the types of medical services included in the list of examinations that must be passed to obtain a professional medical diploma. Some insurance companies reimburse the cost of such treatment, even if it is carried out by persons who are not doctors, those who choose an additional insurance plan along with a mandatory basic package of health insurance services.
End of Insertion.
Exception for Canton Appenzell-external
Until 2001, 26 Swiss Cantons had the right to issue tolerances for the use of drugs on its territory without any control from the federal center. In 2001, this rule was canceled and obtaining permission at the level of the Confederation of the SWISSMEDIC agency has become mandatory.