A REVIEW ON QUALITY, SAFETY AND LEGALISATION FOR HERBAL

MEDICINES
Dr. Lalchand1, Dr. Archana2, Dr. Joshi Pravin Kumar3, Dr. Rout Om Prakash4
1
M.D. Scholar, Post Graduate Department of Dravyaguna, Govt. Ayurved College, Raipur,
Chhattisgarh
2
M.D. Scholar, Post Graduate Department of RSBK, Govt. Ayurved College, Raipur, Chhattisgarh
3
Reader, Post Graduate Department of Dravyaguna, Govt. Ayurved College, Raipur, Chhattisgarh
4
Lecturer, Post Graduate Department of Dravyaguna, Govt. Ayurved College, Raipur,
Chhattisgarh
ABSTRACT
With the growing awareness of health care and safety aspects, people are moving towards Herbal
products. In last a few decades, market of herbal and traditional medicines have grown up leap and
bound. Till recently Ayurvedic medicines used to be prepared by the practicing physician himself
for the use of his patients. In ancient time collection, processing was done by Vaidya’s in smaller
quantity, proper season and used locally. Around 9000 licensed herbal manufacturers in India.
Though there is Global interest but there is a concern about Untested medicine Unregulated
medicine Quality Standardization Clinical safety & Efficacy. The use of ineffective, poor quality,
harmful medicines can result in the therapeutic failure, exacerbation of disease, resistance to
medicines and sometimes to death. Adulteration, substitution, ignorance of dealers creates
problems, hence it has become necessary to standardize the quality and safety assurance measures
so as to ensure supply of medicinal plants of good quality. In view of the present trend of
commercialization in the preparation and marketing of Ayurvedic medicines and to ensure the
interests of the profession and public, the Government of India considered it expedient to utilize
the existing law which controls the standards of allopathic drugs, namely the Drugs and Cosmetics
Act, 1940, to also control, in a limited measure, the Ayurvedic, Siddha and Unani drugs by
amending the Act. Govt. needs to establish strong regulatory authorities to ensure the quality,
safety and efficacy of herbal drugs.
Keywords: Ayurveda, Quality, Herbal drugs, Standardization.
Corresponding Author:
Dr. Lalchand
M.D. Scholar, Post Graduate Department of Dravyaguna, Govt. Ayurved College, Raipur,
Chhattisgarh
Contact No.: 9522555475
Email Id: lalchandsahu11@gmail.com
Introduction
The term “herbal drugs” denoted by means of plant or part of plants that have been converted into
phytopharmaceuticals by simply means of processes involving collection or harvesting, drying and
storage1. Medicinal plant have play an important role in world health. They are circulated
worldwide, but they are most rich in tropical countries. It is noted that about 25% of all modern
medicines are indirectly or directly obtained from higher plants. The use of herbal drugs as
medicine is the ancient form of healthcare known to delicacy and it is used in all cultures
throughout history. Ancient humans well known their dependence on nature for a good healthy
life and since that time humankind depended on the variety of plant resources for food, shelter,
clothing and medicine to cure immensurable of diseases. Led by nature, taste and experience,
primeval men and women cured illness by using plant parts, animal parts and minerals that were
not a part of usual diet. Primeval persons learned by trial and error basis to identified beneficial
plants with helpful effects from those that were inactive or toxic, and also which processing
methods or mixtures had to be used to meet steady and ideal results. Even in a ancient cultures
ethnic, ancestral or tribal people collect information related to herbal plant and developed which
is defined herbal phrmacopeais2,3.
World Health Organization (WHO) has individual herbal drugs as whole, labeled medicinal
products that have robust ingredients, aerial or secret parts of the whole plant or other plant
material or mixture of them. World Health Organization (WHO) has a set of specific Guidelines
for the evaluation of the safety, efficacy and Quality of herbal drugs or herbal medicines. WHO
find out that 80% of the world people currently use herbal medicine or drugs for the most important
health cares. Herbal drugs is a main constituent in usual medicine and a general ingredient in
Homeopathic, Ayurvedic, Naturopathic and in other medicine system. Herbs are usually measured
as safe toxicity, side effects of allopathic drugs, has led to more increased in number of herbal
drugs manufacturers. For the past few years, herbal drugs have been mostly used by the people
with no prescription, Leaves, stem, bark, flower, seeds, roots and extract of all these have been
used in herbal drugs over the thousands of their use4,5.
Classification of herbal drugs
Ayurvedic herbalism: It is derived from the Sanskrit word “Ayurveda” means “The science of
life”. Which is originated in India more than 4000 years ago.
Chinese herbalism: Which is a element of traditional related medicine.
African herbalism
Western herbalism: which is originated from Rome, Greece and then multiply to North, Europe
and South America.
Ayurvedic and Chinese herbalism have produced into extremely sophisticated system of diagnosis,
identification and treatment over the centuries. It should have the long term and effective history
of results.
Advantages of herbal drugs
1. Low cost of production.
2. They may have fewer side effects.
3. Effective with chronic condition.
4. Wide spread availability.
Disadvantages of herbal drugs
1. Lack of dosage instruction.
2. Poison risk associated with wild herbs.
3. Can interact with other drugs.
4. Inappropriate for many condition.
5. Some are not safe to use.

Herbal drug technology includes all the steps that are involved in converting botanical materials
into medicines, where standardization and quality control with proper integration of modern
scientific techniques and traditional knowledge will remain important6.
Classification of herbal medicines
(Based on their origin, evolution and the forms of current usage)
Category 1: Indigenous herbal medicines
Historically used in a local community or region and is very well known through long usage by
the local population in terms of its composition, treatment and dosage. Detailed information on
this category of TM, which also includes folk medicines, may or may not be available. However,
if the medicines in this category enter the market or go beyond the local community or region in
the country, they have to meet the requirements of safety and efficacy laid down in the national
regulations for herbal medicines.
Category 2: Herbal medicines in systems
Medicines in this category have been used for a long time and are documented with their special
theories and concepts, and accepted by the countries. Ayurveda, Unani and Siddha.
Category 3: Modified herbal medicines
These are herbal medicines as described above in categories 1 and 2, except that they have been
modified in some way–either shape, or form including dose, dosage form, mode of administration,
herbal medicinal ingredients, methods of preparation and medical indications. They have to meet
the national regulatory requirements of safety and efficacy of herbal medicines.
Category 4: Imported products with a herbal medicine base
This category covers all imported herbal medicines including raw materials and products. Imported
herbal medicines must be registered and marketed in the countries of origin. The safety and
efficacy data have to be submitted to the national authority of the importing country and need to
meet the requirements of safety and efficacy of regulation of herbal medicines in the recipient
country.
Requirements for assessment of safety of herbal medicines
Safety category
A drug is defined as being safe if it causes no known or potential harm to users. There are three
categories of safety that need to be considered, as these would dictate the nature of the safety
requirements that would have to be ensured.
Category 1: safety established by use over long time
Category 2: safe under specific conditions of use (such herbal medicines should preferably be
covered by well-established documentation)
Category 3: herbal medicines of uncertain safety (the safety data required for this class of drugs
will be identical to that of any new substance)
Specific requirements for assessment of safety of four categories of herbal medicines
Category 1: Indigenous herbal medicines - If the medicines in this category are introduced into the
market or moved beyond the local community or region, their safety has to be reviewed by the
established national drug control agency. If the medicines belong to safety category 1, safety data
are not needed. If the medicines belong to safety category 2, they have to meet the usual
requirements for safety of herbal medicines. Medicines belonging to safety category 3, i.e. ‘herbal
medicines of uncertain safety’, will be identical to that of any new substance.
Category 2: Herbal medicines in systems - The medicines in this category have been used for a
long time and have been officially documented. Review of the safety category is necessary. If the
medicines are in safety categories 1 or 2, safety data would not be needed. If the medicines belong
to safety category 3, they have to meet the requirements for safety of ‘herbal medicines of uncertain
safety’.
Category 3: Modified herbal medicines - The medicines have to meet the requirements of safety
of herbal medicines or requirements for the safety of ‘herbal medicines of uncertain safety’,
depending on the modification.
Category 4: Imported/exported products with a herbal medicine base - Exported products shall
require safety data, which have to meet the requirements for safety of herbal medicines or
requirements for safety of ‘herbal medicines of uncertain safety’, depending on the safety
requirement of the importing/recipient countries7.

WHO GUIDELINES ON HERBAL MEDICINES

World Health Organisation has given Guidelines for assessing the quality of botanical materials
mainly emphasize the need to ensure the quality of medicinal plant products by using the modern
techniques and applying suitable standards. In 1997, WHO developed draft guidelines for
methodology on research and evaluation of traditional medicine(TM). A typical monograph for
herbal drugs as per WHO guidelines is mentioned in Table 18.
Table 1: WHO guidelines for Standardization of Herbal drugs
Parameters Description
Botanical Organoleptic evaluations, Foreign matter, Microscopic
observation
Physicochemical TLC, Ash, Extractable matter, Water content and Volatile
matter
Pharmacological Bitterness value, Hemolytic value, Astringency, Swelling
Index, Foaming Index
Toxicological Pesticide residues, Arsenic, Heavy metals
Microbial contamination Total viable aerobic compound, Pathogens, Aflatoxins
Radioactive contaminations

HERBAL DRUG REGULATIONS IN INDIA

Recognizing the global demand, Government of India has realized Good Manufacturing Practices
(GMPs) for the pharmacies manufacturing Ayurvedic, Siddha and Unani medicines to improve the
quality and standard of drugs. The new rules came into force from June 2000 as an amendment to
the Drugs and Cosmetics Act, 1940. Department of Indian Systems of Medicine and Homeopathy
(ISM&H) is trying to frame safety and efficacy regulations for licensing new patent and
proprietary botanical medicines. Indian Pharmacopoeia covers few Ayurvedic medicines.
Monographs have been given for some Ayurvedic drugs like clove, guggul, opium, menthe, senna.
The ayurvedic pharmacopoeia of India gives monographs for 258 different Ayurvedic drugs. The
standards mentioned are quite inadequate to build quality of the botanical materials. Indian Drug
Manufacturers Association (IDMA) has published Indian Herbal Pharmacopoeia (2002) with 52
monographs of widely used medicinal plants found in India. The latest available scientific data has
been incorporated in theses monographs. Ayurvedic, Siddha and Unani Drugs Technical Advisory
Board mentioned in section 33-C. The Ayurvedic, Siddha and Unani Drugs Consultative
Committee- mentioned in section 33-D. Misbranded drugs-mentioned section 33E. Adulterated
drugs-mentioned in section 33EE. Spurious drugs-mentioned in section 33EEA. Regulation of
Manufacture of Ayurvedic, Siddha and Unani (ASU) Drugs-Section-33-EEB states the regulations
on manufacture and sale of ASU drugs.

(A) Requirements of factory premises and hygienic conditions described in schedule 1 (Rule 157)
(B) Manufacture on more than one set of premises
(C) Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs-mentioned
in section-33-EEC
(D) Power of Central Government to Prohibit Manufacture etc. of ASU Drugs in Public Interest-
mentioned in section-33-EED5
Government Analysts - mentioned in section 33F
Inspectors - mentioned in section 33G
Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention of this
Chapter-As prescribed under section 33-I
Penalty for subsequent offences-As mentioned in section 33J
Confiscation-As mentioned under the section 33K
Application of provisions to Government departments.- As mentioned in section 33L
Cognizance of offences - As mentioned in section 33M
Power of Central Government to make rules-As mentioned in section 33N
Power to amend First Schedule-As mentioned in section 33-O9.

Steps of Standardisation of herbal drugs

1. Standardisation of raw drugs – This includes the Herbal, mineral and animal origin drugs.
2. Standardisation of process procedure to prepare formulations – This includes the
purification etc procedures to prepare a particular formulation.
3. Standardisation of Finished products – This includes a quality of finished products.

Parameters for Standardisation of herbal drugs

The development of parameters for quality control of Herbal drugs is a big task involving
biological evaluation for a particular disease area, chemical profiling of the raw material and laying
down specifications for the finished product. Therefore, the word "standardization" should
encompass the entire field of study from birth of a plant to its clinical application. The herbal drug
assessment in Ayurveda is about the whole drug rather than concentrating on the active principles
or phytoconstituents, thus finer methods of standardization should be developed. General testing
parameters for characterization and standardization of herbal medicines are given in Table 210.

Table 2: General Testing Parameters for Characterization and Standardization of Herbal

Medicines
Testing parameters Guidelines
General data Geographical Good Agricultural
Harvesting time Practices (GAP)
Harvesting process
Processing GMP
Identity Macroscopic According to
Microscopic Pharmacopoeias
 Chemical
TLC & DNA fingerprints
Purity Foreign matter According to
Ash/Sulfated ash Pharmacopoeias
Content of extractable matter
Water content
Assay Constituents with known therapeutic activity According to
(biomarker) Pharmacopoeias
Constituents with unknown therapeutic
activity (marker substances)
Titrimetric
Photometric
HPLC/GC/TLC
Contaminants Pesticides Ph. Eur.
Heavy metals Recommended limits for
Aflatoxins herbal drugs(oct. 91)
Microbiological purity Regulation on aflatoxins
Radioactivity (Nov. 90)
Ph. Eur. 1997 Suppl.
1999

Conclusion
Herbal drug standardization is very important for the safety and efficacy of the drug. The routine
methods of herbal drug standardization address quality related issue using botanical and
organoleptic parameters of crude drugs, and chemoprofiling assisted characterization with
spectroscopic techniques but the new era of herbal drug standardization includes
pharmacognostical, chemical, biological, biopharmaceutical and molecular approaches. Herbal
drug standardization should be done through multiple modes as the concentration of the
phytochemicals varies according to climate, soil and environment. Newer aids of research should
be used to identify minute variations. Various regulatory authorities and industry are trying to
address this issue of quality and efficacy. Regulatory authorities of different countries have
contributed in developing guiding principles addressing issues related to these aspects of botanical
medicine. This review discusses various regulatory issues related to quality of herbal drugs. As
Ayurvedic drugs are also included in the Drugs and Cosmetics Act, 1940 the drugs have to be safe
and effective at the same time. This brings about the need for finer standardization of herbal drugs.
These guidelines may be applicable to uplift quality of herbal medicines globally.
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