There is need for these standards for evaluating safety, quality and efficacy of herbal drugs because they are complex mixtures from biological sources. Constant and adequate quality of these herbal drugs should also be ensured.
The needs or Importance of standardisation of herbal drugs include the following;
- There is always chance of contamination of herbal drugs with other plant materials.
- Adulteration in case of high potent and costly drugs (due to commercialisation )
- Identification of deterioration
- Variation of phytoconstituents due to change in factors like environmental, geographical soil composition etc.
- Possibility of variation in plant constituents due to variation in species and strains.
- Therapeutic active constituents in most cases are unknown.
- The method of harvesting, time of collecting, drying and storing has effect on the crude drug.
- Ecological conditions e.g. insect, microbial infection may affect there chemical composition and secondary metabolites.
- Different plant parts has different concentration of chemical constituents (the therapeutic or toxic components of plant parts vary depending on the part of plant used as well as stage of ripeness).
- Most of the herbal formulations are polyherbal.
- The lack of quality standards has resulted in mild to serious adverse effects ranging from hepatotoxicity to death. Hence, herbal ingredients require tools for determining identity, purity and quality and tools have to be technically sufficient, rapid and cost effective with GMP requirements.