The World Health Organization (WHO) have given some guidelines for standardizing the Ayurvedic and herbal formulations, following these guidelines can be a very effective means for evaluating and standardizing our traditional medicine Bank.

These guidelines describe

1. Quality control of crude drugs material, plant preparations and finished products.
2. Stability assessment and shelf life.
3. Safety assessment; documentation of safety based on experience or toxicological studies.
4. Assessment of efficacy by ethnomedical informations and biological activity evaluations.

The bioactive extract should be standardized on the basis of active principles or major compounds along with the chromatographic fingerprints (TLC, HPTLC, HPLC and GC). The standardization of crude drug materials include the following steps:

1.     Authentication (Stage of collection, parts of the plant collected, regional status, botanical identity like phytomorphology, microscopical and histological analysis, taxonomical identity, etc.)

2.           Foreign matter (herbs collected should be free from soil, insect parts or animal excreta, etc.)

3.      Organoleptic evaluation (sensory characters ? taste, appearance, odor, feel of the drug, etc.)

4.             Tissues of diagnostic importance present in the drug powder.

5.             Ash values and extractive values.

6.             Volatile matter

7.             Moisture content determination

8.        Chromatographic and spectroscopic evaluation. TLC, HPTLC, HPLC methods will provide qualitative and semi quantitative information about the main active constituents present in the crude drug as chemical markers in the TLC fingerprint evaluation of herbals (FEH). The quality of the drug can also be assessed on the basis of the chromatographic fingerprint.

9.             Determination of heavy metals ? e.g. cadmium, lead, arsenic, etc.

10.  Pesticide residue ? WHO and FAO (Food and Agricultural Organization) set limits of pesticides, which are usually present in the herbs. These pesticides are mixed with the herbs during the time of cultivation. Mainly pesticides like DDT, BHC, toxaphene, aldrin cause serious side-effects in human beings if the crude drugs are mixed with these agents.

11.   Microbial contamination ? usually medicinal plants containing bacteria and molds are coming from soil and atmosphere. Analysis of the limits of E. coli and molds clearly throws light towards the harvesting and production practices. The substance known as afflatoxins will produce serious side effects if consumed along with the crude drugs.

Limits for Microbial Contamination 

Afflatoxins should be completely removed or should not be present.

12.         Radioactive contamination ? Microbial growth in herbals are usually avoided by irradiation. This process may sterilize the plant material but the radioactivity hazard should be taken into account. The radioactivity of the plant samples should be checked accordingly to the guidelines of International Atomic Energy (IAE) in Vienna and that of WHO.

In order to obtain quality oriented herbal products care should be taken right from the proper identification of plants; season and area of collection, extraction, isolation and verification process.

Chemical and instrumental analyses are routinely used for analyzing synthetic drugs to confirm its authenticity. In the case of herbal drugs, however the scene is different especially for polyherbal formulation, as there is no chemical or analytical methods available. Therefore, biological-screening methods can be adopted for routine checkup of herbal drugs and formulations.

In the case of herbal drugs, the quality of raw materials and products can be furnished by regular pharmacognostic identifications and phytochemical analysis. The herbal formulations in general can be standardized schematically as to formulate the medicament using raw materials collected from different localities and a comparative chemical efficacy of different batches of formulation are to be observed.