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58 Textbook of Pharmacognosy
communities. At the same time, intellectual property rights with regard to
the source material must also be respected too.
To account for all these issues and overcome the drawbacks if any, the
World Health Organisation in cooperation with other specialised agencies
of the United Nations and many international organisations to strengthen
and update the relevant issues, proposed some technical guidelines under
the heading, Good Agricultural Practices (GAP) to be followed all over the
world. These problems can be overcome to ensure the safety and quality
of a variety of food commodities including the medicinal plant material
by the establishment of specific guidelines for good agricultural practice
by the concerned. The quality control for the cultivation and collection of
medicinal plants as the raw material for herbal medicines is more
demanding than that for food plants, and as such some countries like China,
the European Union and Japan have recently developed some guidelines
on good agricultural practices for the medicinal plants which sometimes
may not be applicable universally. Recently, at an informal meeting it was
recommended that the World Health Organisation should give high
priority to the development of globally applicable guidelines to promote
the safety and quality of medicinal plant material through the formulation
of codes for good agricultural and good collection practices for the
medicinal plants and it was also envisaged that the guidelines would help
to ensure the safety and quality at the first stage of the herbal medicine
production.
The medicinal plant material is supplied through collection from wild
populations and cultivation. For the quality assurance and control of herbal
medicines, World Health Organisation developed the Guidelines on Good
Agricultural and Collection Practices (GACP) for the medicinal plants which
are basically intended to provide the general technical guidance on
obtaining the medicinal plant materials of a good quality for the sustainable
production of herbal products classified as medicines. These guidelines
also apply to the cultivation and collection of medicinal plants including
the postharvest operations which vary in accordance with the situation of
a country, and also work on the protection of medicinal plants thus aiming
at the promotion of sustainable use and cultivation of medicinal plants.
OBJECTIVES OF GUIDELINES
The main objectives of these guidelines are:
• To contribute to the quality assurance of medicinal plant materials
used as the source for the herbal medicines aiming at improving the
quality, safety and efficacy of the finished herbal products, and are to
be produced hygienically with care so that the negative impacts can
be limited.
Good Agriculture Practices (GAP) Strategies of Obtaining Improved .... 59
• To guide the formulation of the national and/or regional guidelines
and monographs for medicinal plants and related standard operating
procedures.
• To encourage and support the sustainable cultivation and collection
of the medicinal plants of good quality which support the
conservation of the medicinal plants and the environment.
Such guidelines should be considered in conjunction with the existing
documents, publications related to the quality assurance, the conservation
and protection of the natural resources of the medicinal plants for
sustainable use as well as the guidelines and codes of practices developed
by the Joint FAO/WHO Codex Alimentarius Commission. In following these
guidelines, every care must be taken and the grower should be conscious
of the critical steps, the risks associated with the production of low quality,
the risks associated with the residue and contamination and the risks
associated with the unsustainable wild collection to ensure constant high
quality and standard safety level, the full traceability of the production,
keep up of the records and to establish the basic production quality
assurance system.
Our country has a rich tradition of healthcare systems based on
medicinal plants contained in its ancient classical texts such as Charaka
Samhitha and Sushrutha Samhitha. On the basis of the diverse healthcare
practices, our Government has recognised Ayurveda, Yoga and Naturopathy,
Unani, Siddha and Homoeopathy as the alternative systems of medicine under
its National Health Policy. The department of AYUSH in the Ministry of
Health and Family Welfare has the responsibility for quality assurance
and standardisation of production processes of medicines and guidelines for the production of raw material used in these medicines. These
guidelines lay down the standards for the production of the raw material
that goes into the making of the medicines and standardise the production
processes from the farm to the factory. Our subcontinent has 16 agroclimatic
zones, about 45,000 different plant species and 15,000 medicinal plants.
Indian systems of medicine have identified 1,500 medicinal plants of which
500 species are mostly used in the preparation of drugs catering to 80% of
the raw materials used in the drug preparation. In addition, there is also a
growing demand for the natural products such as the items of medicinal
value, pharmaceuticals, food supplements and cosmetics. The herbal
medicines are the natural answer for some ailments, but some reports of
the patients experiencing negative health consequences are on the rise
which is directly linked to the poor quality of the herbal medicines and to
the wrong identification of the plant species used in their preparation.
Hence, cultivation, collection and classification are of utmost importance
for the quality and safety of the products. In addition, the growing
herbal market might pose a great threat to the biodiversity through
60 Textbook of Pharmacognosy
overharvesting of the raw material and if this is not curbed, such practices
may lead to the extinction of the endangered species as well as the
destruction of the natural habitats and resources. The guidelines released
by World Health Organisation ensure the production of good quality herbal
medicines which are safe and sustainable and pose no threat to either people
or the environment. These cover the cultivation and collection practices of
the medicinal plants and also guide the postharvest operations including
the legal complications related to the quality standard, status of the patient
and other benefits.
A Good Agricultural Practice (GAP) with reference to medicinal
plants is, a programme of cultivation which is designed to ensure
optimum yield in terms of both quality and quantity of any crop that is
intended for health purposes. The good agricultural practices for
medicinal plants mainly include: the identification and proper
authentication of the cultivated medicinal plants (selection), botanical
identity, specimens, seeds and other propagation material, cultivation,
site selection, ecological environment and the social impact, climate,
soil, irrigation and drainage, plant maintenance and protection, harvest,
primary processing, packaging, storage and transport, personnel and
documentation.
IDENTIFICATION OR AUTHENTICATION OF CULTIVATED MEDICINAL
PLANTS (SELECTION)
The selected medicinal plant species or the varieties meant for cultivation
should be the same as that specified in the national pharmacopoeia or
recommended by the national authority. In the absence of the national
documents, the documents of other countries should be considered. In the
case of newly introduced species or variety, it should be properly identified
and documented as the source material used or described in traditional
medicine of the country.
Botanical Identity
The scientific name of the medicinal plant under cultivation (identity)
should be properly verified and recorded with reference to the genus, the
species, the subspecies/variety, the author and the family. The common
names in English and local names (in other languages) should be recorded.
The information related to the name of the cultivar, ecotype, chemotype,
phenotype and the genotype should be provided. For commercial cultivars,
the name of the cultivar and the name of the supplier should be provided.
The details related to the locally named line, origin and the source of seeds,
plants or propagation materials should be recorded for land races collected,
propagated and disseminated.
Good Agriculture Practices (GAP) Strategies of Obtaining Improved .... 61
Specimens
In the case of the first registration in a country, the grower should submit
a voucher botanical WHO - GACP for the specimen to a regional or national
herbarium for identification. If possible, a genetic pattern should be
compared to that of an authentic specimen. The documentation of the
identity should be included in the registration file.
Seeds and other Propagation Material
The seeding materials are to be identified botanically and it should be 100%
traceable. This also applies to the vegetative propagated starting material
and the material used in organic production should necessarily be certified
to be organically productive. It should meet the standards concerning
the purity and germination. The seeds and other propagation materials
should be specified with reference to the name as per the pharmacopoeia
nomenclature and the trade name, botanical name, cultivar, phenotype,
genotype, etc. The suppliers should provide all the information relating to
the identity, quality and performance of the product in addition to their
breeding history. The material should be free from contamination and
diseases in order to promote healthy plant growth. The material should be
resistant to tolerant to biotic or abiotic factors. When resistant or tolerant
species or origins are available, they should be preferred. The quality of
the material including any genetically modified germplasm should comply
with regional and/or national regulations and be appropriately labelled
and documented. Every care should be taken to exclude extraneous species,
botanical varieties and strains of medicinal plants during the production
process. The propagation material if found to be counterfeit, substandard
or adulterated should be avoided. The important precautions with reference
to the selection of the propagation material are as follows: The seeds chosen
for cultivation should be free from pests, diseases, foreign and inert matter.
If fresh, the seeds must have originated from the recent harvests and the
seeds from the wild sources must invariably be from the recently collected
lots and only the mature seeds should be collected. The process of
transplantation should be carried out only with healthy seedlings. In case
of stem cuttings, the source should be well-authenticated for the botanical
identity and the quality of the vegetative propagules. The stem cuttings
chosen for the root induction should be of uniform dimension in terms of
their length and diameter and should give desired rooting. Similarly, the
root cuttings chosen should be of uniform size and maturity and must be
free from disease and infection.
Cultivation
The cultivation requires intensive care and management. The required
conditions and duration vary depending on the quality of the plant material
62 Textbook of Pharmacognosy
required. If, scientifically documented cultivation data is not available, the
traditional methods of cultivation should be followed or a method should
be developed through research. The principles of appropriate rotation of
plants selected according to environmental suitability should be followed
and tillage should be adapted. The techniques of building-up of organic
matter and conservation of soil humidity and no-tillage systems should be
followed. Such techniques of conservation agriculture aim to conserve, to
improve and make efficient use of natural resources through integrated
management of the available soil, water and biological resources combined
with the external outputs. This also contributes to the environmental
conservation as well as to enhanced and sustained agricultural production,
and is resource–efficient and/or resource–effective. Every care should
be taken to avoid the environmental disturbances. The principles of good
crop husbandry must be followed including an appropriate rotation of
crops.
Site Selection
The selected site should qualify in terms of overall soil health for the purpose
of the cultivation of medicinal plant species. The material derived from
the same species can show significant differences in its quality when
cultivated at different sites, due to the influence of the soil, climate and
other environmental factors. Such differences may be related to the physical
appearance or to variations in its constituents. The biosynthesis may get
affected by the extrinsic environmental factors which include ecological
and geographical variables which are to be taken into consideration. The
risk of contamination due to the pollution of the soil, air or water by the
hazardous chemicals should be avoided. The impact of past land use on
the site including the previous crops and application of products of plant
protection should be also evaluated. In general, sites with a high degree of
stress factors like salinity, acidity and toxicity, water-logged conditions,
industrial wastes and effluents should be avoided. Similarly, the sites nearer
to grave yards, crematoria should also be avoided. The selected site must
be in close proximity to a reliable source of irrigation water.
ECOLOGICAL ENVIRONMENT AND SOCIAL IMPACT
The grower should identify the best possible environment where the plant
can express its full potential in terms of both the quality and quantity during
its entire growth period, from germination to maturity. The medicinal plant
cultivation in a site may affect the ecological balance and the genetic
diversity of the flora and fauna in the surrounding habitats. The quality
and growth of the medicinal plants can also be affected by other plants,
living organisms and human activities. The introduction of non-indigenous
medicinal plant species into the cultivation could result in a detrimental
Good Agriculture Practices (GAP) Strategies of Obtaining Improved .... 63
effect on the biological and ecological balance of that particular region,
and such activities should be carefully monitored overtime.
One should examine the social impact of the cultivation on the local
communities to ensure that negative impacts on local livelihood are
avoided. Small-scale cultivation is preferable if the farmers are organised
to market their products jointly. If large-scale cultivation has been
established, every care should be taken that the local communities benefit
directly from fair wages, equal employment opportunity and capital
reinvestment.
Climate
The climatic conditions such as the length of the day, precipitation and
field temperature influence the physical, chemical and biological qualities
of the medicinal plants under cultivation. The duration of the sunlight,
average rainfall, average temperature, differences in the temperature of
the day and the night also influence the physiological and biochemical
activities of plants and these should also be considered.
Soil
The soil where cultivation is to be taken up should contain appropriate
amounts of the nutrients, organic matter and other inorganic elements to
ensure optimum plant growth and quality. These include the soil type,
drainage, soil moisture retention capacity, soil fertility and soil pH which
determine the plant species and/or the target part. The medicinal plants
cannot be grown in soils that are contaminated by sludge, heavy metals,
residues of the plant protection products and other not naturally occurring
chemicals. The fertiliser use is often indispensable in order to achieve larger
yields of plants. Hence, the correct type and quantity of the fertilisers are
to be used by determination through agricultural research. In general
practice, organic and chemical fertilisers are used. The manure applied
should be void of human faeces and if animal manure is to be used, it
should be thoroughly composted to meet the safe sanitary standards of
acceptable microbial limits and destroyed by the germination capacity of
the weeds, and this should be documented. The chemical fertilisers
approved by the country of cultivation should be used. These fertilisers
should be used sparingly in accordance with the needs of the particular
plant species and the soil supporting capacity. The leaching of the fertilisers
should be minimised. The cultivator should follow the practices that mainly
contribute to soil conservation and minimise soil erosion such as creation
of stream-side buffer zones and planting of cover crops and green manure.
Irrigation and Drainage
The quality of irrigation water in terms of total salt concentration, sodium
absorption ratio, bicarbonate and boron concentration should be adequate
64 Textbook of Pharmacognosy
in terms of the target crop. Soil irrigation and soil drainage should be
minimised as far as possible and carried out in accordance with the needs
of the individual plant species during the various stages of its growth. The
water that is used should invariably comply with local, regional and/or
national quality standards and should be free from contaminants such as
faeces, heavy metals, pesticides, herbicides and substances which are
toxicologically hazardous. Every care should be taken to ensure that
the plants under cultivation are neither over-watered nor under-watered.
The risks of vector disease transmission through irrigation practices should
be taken care of. Water harvesting and water conservation methods should
be followed and the impounding of water through heavy rains should be
avoided.
PLANT MAINTENANCE AND PROTECTION
Initial flush of weeds must be controlled effectively and all intercultural
operations like weeding, topping, bud nipping, pruning, shading and
earthing up must be adhered to control the growth and development of
the medicinal plant to improve the quality and quantity of the material
being produced. Minimum amount of agrochemicals should be used to
promote the growth of/or to protect the plants and these should be applied
only when no alternative measures are available. Use of organic manure is
preferred for growing the medicinal plants. Use of compost, vermicompost,
poultry manure, and green leafy manure is desirable. But, the use of sludge,
city waste, night soil and any other manure with known toxicities must be
avoided. Where appropriate, the integrative pest management should be
followed. The application of pesticides and herbicides should be avoided
as far as possible. If necessary, the approved pesticides and herbicides
should be used at their minimum effective level in accordance with the
instructions of the individual product and the regulatory requirements
that apply for the cultivator. The application and storage of these products
has to be in accordance with the recommendations of the manufacturers
and the authorities. The pesticide and herbicide applications should
necessarily be carried out by the certified and qualified staff with the
approved equipment and all such applications should be documented. It
is also obligatory that the buyer be informed of the brand, quantity and
the date of pesticide use in a written form. The application should invariably
precede the harvest by a period either defined by the buyer or indicated
by the producer of the product. The minimum interval between such
treatments and the harvest should be consistent with the instructions
inserted on the label and/or package of the plant protection product.
Growers and the producers should always comply with the maximum
pesticide and herbicide residue limits as was stipulated by the local, regional
and/or national regulatory authorities of the growers and the end users,
Good Agriculture Practices (GAP) Strategies of Obtaining Improved .... 65
countries and/or the regions. International agreements like International
Plant Protection Conventions and Codex Alimentarius should be consulted
on the use of pesticides and their residues. In general, the crop protection
methods should be limited to the use of biocontrol agents and biopesticides.
Harvest
The medicinal plants should be always harvested during the optimal season
to ensure the production of the material and finished herbal product of the
best possible quality and the time of harvest should depend on the plant
part to be used. The concentration of the biologically active compounds
varies with the stage of plant growth and development which also applies
to the non-targeted toxic or poisonous plant constituents. The best time
for the harvest should be determined according to the quality and quantity
of biologically active compounds rather than the total yield of the plant
parts. At the time of the harvest, every care must be taken to ensure that
no foreign material, weeds or toxic plants are mixed up with the harvested
plant material. The plants should be harvested when there is no dew, rain
or high humidity. If done under wet conditions, the material should be
immediately transported to an indoor drying facility to prevent possible
deleterious effects due to microbial fermentation and molds. All the devices
and the machines should be kept clean to reduce the damage and soil
contamination and they should be stored in a dry place free from the insects,
rodents, birds, other pests and should be inaccessible for the livestock and
other domestic animals. You should avoid contact with the soil to minimise
the microbial load by the use of clean muslin interface between the
harvested material and the soil. The adhering soil from the underground
parts must be removed immediately after harvest. The raw plant material
should be transported in a clean and dry condition and placed in clean dry
and well-aerated containers like sacks, baskets, trailers, containers, etc.
before carried onto the transport process facility. Overfilling of the sacks,
stacking up of the sacks, occurrence of heating is to be avoided. In case of
the plastic containers, special attention is to be paid to possible moisture
retention and when not in use, these should be kept dry protected from
the insects, rodents and pests. The mechanical damage should be avoided
and the decomposed plant material should be discarded during harvest to
avoid microbial contamination and loss of the product quality. The delivery
of the harvested material must occur as quickly as possible to the processing
facility.
Primary Processing
This includes the steps such as washing, freezing, distilling, drying, etc.
These steps must confirm the local, regional and/or national standards.
Prior to processing, the material should not be exposed to sunlight or
rainfall. The buildings must be clean and well-aerated. Suitable pest control
66 Textbook of Pharmacognosy
measures are to taken care of. The drying process should be initiated in a
continuum. Drying directly on the ground should be avoided unless it is
required. Sorting is to be carried out after drying. The material must be
inspected to eliminate the substandard and foreign products. Everything
is to be documented.
Packaging
The product should be packed in clean, dry new sacks, bags or cases. They
are to be labelled and the labels should be clear and permanently fixed
and made from nontoxic material. It must be guaranteed that no
contamination takes place by the use of the packaging material. If the
packaging material is reusable, it should be thoroughly cleaned and
perfectly dried prior to its usage and must be guaranteed that no
contamination occurs by reusing the containers.
Storage and Transport
The packaged material is to be stored in a dry, well-aerated building with
limited daily temperature fluctuations and good aeration. The windows
and doors must be wire-netted so as to protect it from pests, birds, rodents
and domestic animals. Storage of packaged dry crop in concrete buildings
with easy to clean floors, with a sufficient distance to the wall, separated
from other crops to avoid cross-contamination is always recommended.
Organic products must be stored separately. In the case of bulk transport,
it is advisable to use aerated containers. Fumigation should be carried out
in case of necessity during transport with registered chemicals and by
qualified personnel which is to be documented.
Personnel
The growers and the producers should necessarily have adequate
knowledge of the medicinal plant concerned which includes identification,
cultivation methods, environmental requirement, methods of harvest and
storage. The field workers and other personnel associated with the
propagation, cultivation, harvest and postharvest processing should
invariably maintain personal hygiene and they should wear protective
clothing like overalls, gloves, helmets, goggles and face masks during the
application of agrochemicals. The growers and producers should
necessarily receive instructions related to all issues for environmental
conservation of the plant species concerned.
Documentation
All the documents related to the entire process should be maintained. These
include the meteorological data, reports of soil and water testing, the source,
quantity and the time of procurement and collection of seeds or the planting
material, the procedures adapted to handling the plant material during
Good Agriculture Practices (GAP) Strategies of Obtaining Improved .... 67
the nursery stage, preparation of the soil, transplantation procedure, crop
management, weeding cycles, inter-culture practices, photographic records,
etc. for a minimum period of 3 to 5 years. All starting materials and different
steps of processing have to be documented. Field records should be
maintained by all the growers. All the batches of the material should be
perfectly labelled. It is also essential to document the type, quantity and
the date of the harvest of the crop in addition to the chemicals and other
substances used during the production. The application of the fumigation
agents must be entered into the documentation. All the processes and the
procedures which bear an impact on the quality of the product, all
agreements between the producer and the buyer, and special circumstances
during the growth period which may influence the chemical composition,
etc. must be documented.
The cultivation, collection and harvesting of medicinal plants and the
postharvest processing must be carried out in accordance with the legal
and environmental requirements and with the ethical codes and norms of
the community and the country. The provisions of the Convention on
Biological Diversity must be respected. The medicinal plants that are
protected by national and international laws may be collected only by
relevant permission. The provisions of the CITES (Convention on
International Trade in Endangered Species of Wild Fauna and Flora) must
be complied with.
SAMPLE RECORD OF DOCUMENTATION FOR CULTIVATED
MEDICINAL PLANTS
a. Identification of the Cultivated Medicinal Plant
Scientific name: .............................................................................................
Pharmacopoeia name: .................................................................................
Local name(s) and Language(s) for: ..........................................................
Common name (in English): .......................................................................
Intended plant part for medicinal use and harvested: ...........................
Crop code number: ......................................................................................
b. Identification of Cultivation Site
Identification of field site: ...........................................................................
Location of the field: ....................................................................................
Village/District/Region/State/Country: ...............................................
c. Identification of Cultivator
Name of the grower/cultivator: ................................................................
Contact address for communication: ........................................................