Crops2Industry “Non-food Crops-to-Industry schemes in EU27”. WP 3 Task 3.4 Pharmaceutical and other specialty products Task leader: Alice Grigore. Content. Objectives Progress of work Results Status of deliverables & milestones Problems encountered Plans for the next 6 Months.
“Non-food Crops-to-Industry schemes in EU27”
Restricting factors in technology ● Restricting factors in economics ● Quality control
Medicinal plants value chain – Establishing of the pathway to develop herbal products with high added-value
The strategy for sustainable use of MAP has two main components:
→ to protect biodiversity
→ to achieve a more stable production base and greater control over quality
→provide new income opportunities to farmers
→to meet demand
The product should meet market requirements
Recent Comtrade statistics (2008-2009) show that:
As regards plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered
As regards essential oils (other than those of citrus fruit):
• increased costs of pharmaceutical-based health care
• search for new drugs and treatments of serious diseases
• consumers seeking an alternative to pharmaceutical drugs
•large pharmaceutical and OTC companies placing botanical medicines more strongly on the mass
• increased emphasis on safety, efficacy and quality to conform to international standards
• increased requests for organically certified raw material
• need for new and eco-friendly herbal-based products – insecticides, dyes, etc.
Pharmacopoeial tests and acceptance criteria
The European Pharmacopoeia contains important requirements pertaining to certain analytical procedures and acceptance criteria that are relevant to:
The experience and data accumulated during the development of a herbal medicinal product should form the basis for the setting of specifications.
Specifications = a list of analytical or biological procedures which provide assurance that the appropriate quality of the product will be maintained. The setting of specifications is part of an overall control strategy which includes control of raw materials and excipients, in-process testing, process evaluation/validation, stability testing and testing for consistency of batches, intended to ensure safety and efficacy.
A key issue in manufacturing herbal products and medicines is standardization. Standardization is the process of producing herbal extracts or phytochemicals in which product potency is guaranteed through consistency in specific active compound content level. This process requires high knowledge in phytochemical analysis and process technology to ensure the quality assurance required.
Product value increases in the following order: fresh material < dried powder < non-standardized extract < freeze/spray dried extract < standardized extract < phytomedicine.
The herbal medicinal market in Europe is currently affected by substantial changes of the regulatory environment.
General intention is to harmonize the regulation of medicinal products, food and other consumer goods at centralized European level.
Difficulties come from:
-the heterogeneity of the starting material itself (chemical composition, natural variability, diverse sources),
-the heterogeneity of plant preparations (plant part used, type of preparation, manufacturing process), and the lack of accurate quality/safety data for often non-standardized low price products.
There are great differences between Member States in the definition and categorization of herbal medicines. A single medicinal plant may be defined as a food, a functional food, a dietary supplement or a herbal medicine in different countries, depending on the regulations applying to foods and medicines in each country.
→This makes it difficult to define the concept of herbal medicines for the purposes of national drug regulation and also confuses patients and consumers.
Besides EMEA, other key players are involved in the regulation of herbal market:
-European Directorate for the Quality of Medicines (EDQM) with the Commission of the European Pharmacopoeia (Ph Eur) and the European Scientific Cooperative on Phytotherapy (ESCOP, founded 1989). The EDQM includes 36 European Member States and 20 observers such as the American FDA and the WHO. Its role is to harmonise the quality standards for use by healthcare professionals.
Screening on the European specialty products based on MAP Focus on the selected 5 medicinal plants
Pharmaceutical and other specialty crops are the starting point for a wide range of products:
● essential oils ● human and veterinary drugs ● herbal health products ● inks ● colorants and dyes ● perfumes ● beauty products ● novel plant protection products ● a range of intermediate products from which the above are manufactured
An internet survey regarding species selected – Calendula officinalis, Lavandula angustifolia, Mentha piperita, Echinacea angustifolia and Plantago lanceolata – and their various uses in different European countries showed that
these herbs are used for various purposes and are presented in various forms
most of the raw material used by these manufacturers comes from own plantations
Data received from few important Romanian manufacturers show that:
Small and medium companies prefer to develop their own network starting from raw material to final product.
The products are designed mainly for medicinal and cosmetic use
High income in the last year were obtained mainly from tea, tablets, capsules, volatile oil, solution for spa use and syrup sales
The products are impossible to substitute with one synthetic drug (herbal products are usually mixture of active principles). Herbal products are adjuvant in classical medicine or have a preventive action. In pharmacological testing, the activity is compared to synthetic drugs.
Processing methods (primary and specific) conduct to herbal products
of higher yield, lower operating costs, and faster production times.
Products diversity- new products come from new technologies and new equipment .
→Need for appropriate equipment for extraction, processing, conditioning and packing herbal products
- the product price (and not the product quality) is the most important factor that affects buying decision for many market segments. Local production have to compete with the import of cheap products and raw materials (especially from China and India)
-Roots of Parthenium integrifolium L., have been found to be
adulterants/substitutes for Echinacea root;
-Lavender oil is often adulterated by acetylated lavandin, aspic, synthetic linalool, linalyl acetate,
-Mentha oil is the most adulterated oil, usually with Mentha arvensis -difficult to detect even at 85% or with synthetic compounds)
There are several ways in which plant science can address future demand in this area.
-optimising the profile and possibly increasing the content of active components of the raw material itself.
-better preservation of these phytochemicals during crop maturation, post-harvest treatment and storage.
-the factors that play a major role in bioactivity during processing should be at least maintained and possibly enhanced.
- improvement of plant performance and quality in different environments by revealing genetic and epigenetic mechanisms controlling plant plasticity in response to environmental stimuli
ex. Cold or drought tolerant M. x piperitasuitable for Finnish climate conditions; Lavandula for dry areas
- hybrids are generally less susceptible to environmental fluctuations than their parents.
-Herbicide-resistant crops his means less spraying, less traffic on the field, and lower operating costs.
-As regards innovative products, the areas that could be developed are -pesticide and insecticide based natural compounds.
-environmentally friendly methods for crop protection
-Phytotherapy in veterinary medicine is a domain which needs further study.
- the consumers must understand that the quality is more important than price.
- development of stable molecular markers which assure without doubt the quality of herbal medicines.
- conducting clinical trials in Europe in order to comply with regulatory requirements for product registration, especially in Germany and France which regulate botanical products mainly as drugs. In the past 20 years, completely new markets were created for botanicals based upon scientific support.
Results mentioned above
were delivered on time
Information on the specialty crops and crop products sector is difficult to analyze, because of its extreme diversity and variability and is limited by the reluctance of certain parts of the industry to document for commercial reasons.
Update report with relevant data
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