Chhattisgarh
Forest Department
NWFP
Certification
Dr. Bisen
also explained the physical methods and chemical methods for quality testing of
the produce. WHO has emphasized the need to ensure quality control of medicinal
plant products by using modern techniques and by applying suitable standards.
The
physical methods are by means of testing:
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General sampling
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Preliminary examination
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Foreign matter
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Microbial contamination
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Moisture content
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Loss on drying.
Chemical
methods are listed below:
Dr.
Bisen thus presented the technical aspects of certification of medicinal plants.
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Presentation
by Dr. P. M. Murali, Director,
Research and Development, Dalmia
Centre for Research and Development (DCRD, Coimbatore)
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Dr. Murali, in his presentation, highlighted that certification is necessary for
consistent treatment as potency of curative chemical ingredient varies in
different specimens of the same species. Most of the herbal products are
formulations and hence, potency shall be well known. Good Agricultural Practice
(GAP) is not always possible and hence Good Manufacturing Practices (GMP) is the
need of the hour. He also emphasized on the generation of toxicology data.
Dr.
Murali made a presentation entitled "Main Thrust area in the Past 10
years." According to him, the objectives and goals of certification are:
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To aid industry by providing a set of specification for herbal drug
preparation.
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Conformance to specification-" when tested according to the listed
analytical procedures, will meet the listed acceptance criteria."
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To bring about product quality and consistency so that in process checks
can be done.
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Dr.
Murali shared his experiences with quality control. According to him, some
experiences of DCRD were in:
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Development of quality control system for plants used in ISM&H
formulations from identification of plants to the final product (Thrust on
finger printing).
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Development of a protocol for obtaining an ISO 9001 for Herbal drug
manufacture.
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Development of standard operating procedures (WHO requirement) for the
manufacture of syrup and capsules for large scale production for herbal
specialities.
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Quality control of the formulations.
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Shelf-life studies of the syrup and capsules.
Dr.
Murali further suggested some work plans for the certification programme. These
suggest to:
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Identify the commercially important plants (genus and species level).
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Location, season etc. fully recorded.
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Finger print (TLC and HPTLC or others)
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Develop the bio-markers
(HPLC, GC, GCMS, Spectrophotometry).
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Have
a record of the complete data of the plant for potential buyers.
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Check for pesticide residues.
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Check for
aflatoxins.
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Check for microbial contamination.
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Check for heavy metal presence.
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Germplasm preservation.
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Finger printing chart/map made available.
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Development of procedures for bioactive molecular work.
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Train the forestry and allied services people on collection, storage, packing, transportation etc.
He summed up his session by stating that DCRD was pleased to be involved with the efforts and would be pleased to be associated in the certification programme as they already have an ISO 9001 lab with established procedures. They have developed SOP based on WHO norms for industries and have already finger printed for more than 42 plants. DCRD has also developed procedures for detection and tracing of bio-active molecules and they have been in constant interaction with international bodies like the FDA and WHO for update of quality and regulatory information.