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HERBAL MEDICINES: OVERVIEW ON REGULATIONS IN INDIA AND SOUTH AFRICA

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Herbal medicines, also known as Phytomedicines or Botanical medicines, involves the use of plant parts (leaves, roots, stem, flowers, and seeds) for medicinal/therapeutic purpose. It is the oldest and still the most generally used system of medicine in the world at present.
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690
Kumar. World Journal of Pharmaceutical Research
HERBAL MEDICINES: OVERVIEW ON REGULATIONS IN INDIA
AND SOUTH AFRICA
Vijay Kumar*
Department of Regulatory Affairs, School of Pharmaceutical Science, Lovely Professional
University, Phagwara-144 001.
ABSTRACT
Herbal medicines, also known as Phytomedicines or Botanical
medicines, involves the use of plant parts (leaves, roots, stem, flowers,
and seeds) for medicinal/therapeutic purpose. It is the oldest and still
the most generally used system of medicine in the world at present.
The earliest recorded evidence of use of these medicine in Indian,
Chinese, Egyptian, Greek, Roman and Syrian texts dates back to about
5000 years. 80% of the world population relies on herbal medicines as
their primary healthcare system. As per World Health Organization
(WHO) herbal medicines are of three types: Raw plant materials,
Processed plant materials and Medicinal herbal products. In India,
herbal medicines are regulated by the Ministry of Ayurveda, Yoga and
Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). Regulatory
provisions for Ayurveda, Unani, Siddha medicine are laid down in Drugs and Cosmetics Act
1940 and Rules 1945. On the other hand In South Africa these medicines known as
complementary medicines. These regulated according to the Medicines and Related
Substances Act, 1965 (Act 101 of 1965) for manufacturing, distributing, marketing of the
CAM. There was no regulatory body present for controlling these medicines. Medicines
Control Council with various committees control these medicines in South Africa. There is in
South African Common Technical Document (Za CTD) or South African Electronic
Common Technical Document (Za eCTD) present for registration of these medicines.
KEYWORD: Herbal medicines, AYUSH,CAM,ZaCTD,GMP.
World Journal of Pharmaceutical Research
SJIF Impact Factor 7.523
Volume 6, Issue 8, 690-698. Review Article ISSN 2277 7105
Article Received on
13 June 2017,
Revised on 03 July 2017,
Accepted on 24 July 2017
DOI: 10.20959/wjpr20178-9091
*Corresponding Author
Vijay Kumar
Department of Regulatory
affairs, School of
Pharmaceutical Science,
Lovely Professional
University, Phagwara-144
001.
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691
Kumar. World Journal of Pharmaceutical Research
INTRODUCTION
Herbal medicine is the oldest and still the most generally used system of medicine in the
world at present.[1] It is medicine made completely from plants parts (leaves, roots, stem,
flowers, and seeds). Herbal medicine, also entitled as botanical medicine or phytomedicines.
The World Health Organization (WHO) evaluates that 80 percent of the world population,
currently using herbal medicine for some aspect of primary health care.[2]
As per WHO there are three kinds of herbal medicines: crude plant materials, processed plant
materials and medicinal herbal products.[3] The earliest recorded evidence of herbal medicine
use in Indian, Chinese, Egyptian, Greek, Roman and Syrian texts dates back to about 5000
years. The classical Indian texts on herbal medicines include Rigveda, Atherveda, Charak
Samhita and Sushruta Samhita. Herbal medicines are used by practitioners of traditional
system of medicines across the world due to their well-established and widely acknowledged
use. The well accepted and accumulated experience of many practitioners and patients over
an extended period of time make herbal medicines more popular. Furthermore, the use of
herbal medicine is generally and currently regarded as safe.
Classification of Herbal Medicines
Herbal medicines can be classified into four categories as per WHO, based on their origin,
evolution and the forms of current usage. While these are not always mutually exclusive,
these categories have sufficient distinguishing features for a constructive examination of the
ways in which safety, efficacy and quality can be determined and improved.
Category 1: Indigenous herbal medicines
This category of herbal medicines is 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 traditional medicines (TM),
which also includes folk medicines, may or may not be available. It can be used freely by the
local community or in the local region. 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.
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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. For example, Ayurveda, Unani
and Siddha would fall into this category of TM.
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 wayeither 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.[4]
Indian Regulations
In India, herbal medicines are regulated under the Drug and Cosmetic Act (D and C) 1940
and Rules 1945, where regulatory provisions for Ayurveda, Unani, Siddha medicine are
clearly laid down. Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and
Homoeopathy (AYUSH) is the regulatory authority and mandate that any manufacture or
marketing of herbal drugs have to be done after obtaining manufacturing license, as
applicable. The main focus of this department is on development of Education and Research
in Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy systems. Laws and
regulations on herbal medicines are partly the same as those for conventional
pharmaceuticals. The D&C Act extends the control over licensing, formulation composition,
manufacture, labelling, packing, quality, and export. Schedule "T" of the act lays down the
good manufacturing practice (GMP) requirements to be followed for the manufacture of
herbal medicines.[5] The official pharmacopoeias and formularies are available for the quality
standards of the medicines. First schedule of the D&C Act has listed authorized texts, which
have to be followed for licensing any herbal product under the two categories:
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Ayurvedic, Siddha or Unani drugs
Patent or proprietary medicines [5]
Ministry of AYUSH
The Ministry of AYUSH was formed on 9th November 2014 to ensure the optimal
development and propagation of AYUSH systems of health care. Earlier it was known as the
Department of Indian System of Medicine and Homeopathy (ISM&H) which was created in
March 1995 and renamed as Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha
and Homoeopathy (AYUSH) in November 2003, with focused attention for development of
Education and Research in Ayurveda, Yoga and Naturopathy, Unani, Siddha and
Homoeopathy. In India, manufacturing, marketing, promotion of ASU drugs is controlled by
Ayush.[6]
Drug and cosmetic Act 1940
Herbal drugs are regulated under the Drug and Cosmetic Act (D and C) 1940 and Rules 1945
in India, where regulatory provisions for Ayurveda, Unani, Siddha medicine are clearly laid
down in Chapter IV-A. There are 18 different section are present from section 33C to 33 O
Table 1. These all sections provide all information related to ASU drugs regulations for
manufacture, sale, registration, GMP certificate, licensing, and penalties
Table 1: List of ASU drug regulation different section[5]
Sections
33C.
33D.
33E.
33EE.
33EEA.
33EEB.
33EEC.
33EED.
33F.
33G.
33H.
33-I.
33J.
33K.
33L.
33M.
33N.
33O.
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Schedule T -Good Manufacturing Practices for Ayurvedic, Siddha and Unani medicines
In India for getting approval to manufacture or sale of ASU drugs, manufacturer have to take
GMP certificate. According to D and C act rule 157, for getting a certificate of „Good
Manufacturing Practices „of ASU drugs, the applicant has to file application on a plain paper
with full information on existing infrastructure of the manufacturing unit including
instruments available, equipment‟s and technical staff name with qualification. After full
verification by licensing authority as per Schedule „T‟ requirements licensing authority will
issue the certificate within a period of 3 months in Form 26-E-I.[5]
New Guidelines for Herbal Medicines
Ayush providing time to time new revised regulations for ASU drugs. Before there is no such
guidelines for conducting clinical trials, but in March 2013 Ayush publish new GCP
guidelines for clinical trials on ASU drugs.[7]
Good Clinical Practice is a set of guidelines which incorporates the design, conduct,
termination, audit, analysis, reporting and documentation of the studies involving human
subjects. The fundamental tenet of GCP is that in research on man, the interest of science and
society should never take precedence over considerations related to the well-being of the
study subject. Its intention to ensure that the studies are scientifically and ethically sound and
that the clinical properties of the ASU medicine under investigation are properly documented.
The guidelines seek to establish two cardinal principles: protection of the rights of human
subjects and authenticity of ASU medicine clinical trial data generated.
These guidelines are formulated based on CDSCO Document on GCP Guidelines (2001) for
Clinical Trials on Pharmaceutical Products.[7] They should be followed for carrying out all
ASU medicine research in India at all stages of drug development, whether prior or
subsequent to product registration in India. These GCP guidelines have to be followed during
a clinical trial, if this not follow than clinical trial will be suspended by regulatory authorities.
GCP guidelines also provide the compensation related guidelines for participants if any
unwanted result or death of participants occur during clinical trial.
From 2017 onwards, its also mandatory that there must be expiry and manufacturing date
present on product label.[6]
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Regulation in South Africa
In South Africa herbal medicines known as “Complementary Medicine” (CAM). These
medicines regulated according to the Medicines and Related Substances Act, 1965 (Act 101
of 1965). There is 40 sections present in this ACT, related to registration procedure, labelling,
prohibition, penalty, establishment and power of Medicines Control Council.[8] According to
this act “complementary medicine” means any substance or mixture of substances that- (a)
originates from plants, minerals or animals; (b) is used or intended to be used for, or
manufactured or sold for use in assisting the innate healing power of a human being or animal
to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical
or mental state; and (c) is used in accordance with the practice of the professions regulated
under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).
Earlier there was no such regulations for manufacturing, distributing, marketing of the CAM.
There was no regulatory body present for controlling these medicines. Now South Africa has
developed a medicines regulatory authority with internationally recognised standing that is
known as Medicines Control Council (MCC) Fig.1.[9]
Fig. 1: Flow chart of Medicines Control Council with other regulating committees[10]
MCC applies standards laid down by the Medicines and Related Substances Act, (Act 101 of
1965) which governs the manufacture, distribution, sale, and marketing of medicines. The
prescribing and dispensing of medicines is controlled through the determination of schedules
for various medicines and substances.[9]
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The MCC operates through external experts who are members of Council Committee
structures. Most experts evaluate data sets submitted by the pharmaceutical industry for
purposes of registration. Many of these evaluators are from various academic institutions,
mainly medical and pharmacy schools.[10]
New Advancements in CAM Regulation
Registration guidelines
Earlier there is no need to register the CAM drugs. There was no regulations related to
labelling, no stability data required. But according to new regulations implemented by MCC,
there is need to register the CAM drugs and stability, toxicity data also required.
Registration of CAM drugs
MCC published the new format for registration of CAM drugs. Now the manufacturer has to
submit the registration application in South African Common Technical Document (Za CTD)
or South African Electronic Common Technical Document (Za eCTD). The Za CTD and Za
eCTD both are organised into five modules. 1. region-specific information 2.Summary
documents 3. Quality-related information 4. Nonclinical study reports 5. Clinical study
reports Fig.2. Review process in case of CTD it will take more time for approval and lengthy
process time consuming process.[11]
Fig. 2: Common Technical Document Modules
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But in case of eCTD, it is easier for MCC Committees to review data, approve new drugs,
and monitor drugs after they go on the market.[12] Using Za eCTD also simplifies the process
for submitters, because it is the same format used by drug regulatory agencies in other
countries.
New Labelling guidelines Developed
Previously there is no need to mention category of the drug and expiry date on labels of CAM
drugs. But according to latest guidelines manufacturer has comply with these guidelines.
In terms of the provisions of Regulation 8 of the Medicines and Related Substances Act, 1965
all medicines falling in Category D must comply with the labelling requirements. This
implies that label of each CAM drugs.
A. Shall be written in English and at least one other official language.
B. State on the product label.
The category of medicine[8]
The pharmacological classification of the medicine.
The discipline of medicine.
The words “This medicine has not been evaluated by the Medicines Control Council.
This medicine is not intended to diagnose, treat, cure or prevent any disease.[8]
CONCLUSION
From this review we conclude that there is regulations present for herbal medicines in India
and South Africa. But in case of South Africa they developed strict guidelines in less time in
comparison to India. India develop guideline for conduct clinical trial on herbal medicines,
but registration process is not regulated properly. But in South Africa there is Za CTD and Za
eCTD both advanced regulation present for registration of complementary medicines.
REFERENCES
1. Khattri, K. N. and Tyagi, A. K, Tectonophysics, 1993; 96: 281 297.
2. Herbal medicines, http://www.nhaa.org.au/public/information-resources/what-is-herbal-
medicine.
3. Guidelines for the appropriate use of herbal medicines. Who regional publications,
western pacific series no. 23, World Health Organization, Regional Office for the
Western Pacific, Manila, 1998.
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4. Traditional medicines, http://www.who.int/medicines/areas/traditional/definitions/en/.
5. The Drugs and Cosmetics act, 1940, http://comtax.up.nic.in/Miscellaneous%20Act/the-
drugs-and-cosmetics-act-1940.pdf.
6. Ministry of AYUSH, http://ayush.gov.in/about-us/about-the-ministry.
7. Good Clinical Practice Guidelines for clinical trials of ASU Medicine,
http://ayush.gov.in/acts-rules-and-notifications/good-clinical-practice-guidelines-clinical-
trials-asu-medicine.
8. Medicines and related substances control act 101 of 1965,
http://www.mccza.com/documents/b335d1c0Act_101_of_1965_published_2003.
9. Medicines Control Council: General Information,
http://www.kznhealth.gov.za/research/mccinfo.pdf.
10. MCC and Committees, http://www.mccza.com/About/Committees.
11. Registration of Medicines, http://www.kznhealth.gov.za/research/mccinfo.
12. Registration of Medicines, ZA eCTD Module 1 Technical Specification,
http://www.mccza.com/documents/3b05ddd621_ZA_eCTD_Module_1_Technical_v1.

Supplementary resource (1)

Data
August 2017
... The AYUSH is the regulatory body that recommends that any manufacturer or distributor of herbal pharmaceuticals seek manufacturing licensing before litigation and has been established in 2004. The well-accepted and accumulated experience regarding herbal medicines is becoming more popular among many indigenous practitioners and patients over an extended period (Kumar, 2017). In India, the Ministry of AYUSH was established on 9 th November 2014 to certify the optimal propagation and development of the traditional system. ...
... There are 18 different sections present from 3C to 33 O are given in Table 1. These all sections emphasize all the information associated with ASU pharmaceutical drug regulations for the manufacturing, trading, licensing, registration, GMP certificate, and penalties (Kumar, 2017). The Drug and Cosmetic Act (D and C) 1940 and Rules 1945 regulates herbal-based medicines in India which include regulations of Ayurveda, Unani, and Siddha medicine. ...
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Herbal medicines have been used for the treatment of various health-related problems since immemorial times. However, Indian Pharmaceuticals Act 1948 states that still there is no special group for herbal drugs. Thus, the expansion of the Indian medicinal systems such as Ayurveda, Siddha, and Unani require scientific validation and documentation of indigenous knowledge to work on patenting and research based on literature. At present, various governmental organizations are actively playing a significant role in the promotion and development of medicinal plants such as the Ministry of Ayush, CDSCO (Central Drugs Standard Control Organization), and D&C Act 1940 & 1945 (amendment) are used to regulate the processing, branding and marketing of herbal medicines. A total of 8000 herbal medicines have been recognized by the Ministry of Ayush to treat various ailments in India. This chapter illustrated various approaches of regulatory bodies for plant-based herbal drugs discovery and validation.
... Division of AYUSH is the regulatory authority that gives any manufacturing rights or promotes herbal medications after acquiring license, as relevant. In that capacity, no safety and viability studies are required for marketing endorsement, according to the Drugs and Cosmetics Act of 1940 (Kumar, 2017). ...
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Guidelines for the appropriate use of herbal medicines. Who regional publications, western pacific series no. 23, World Health Organization, Regional Office for the Western Pacific
Guidelines for the appropriate use of herbal medicines. Who regional publications, western pacific series no. 23, World Health Organization, Regional Office for the Western Pacific, Manila, 1998. www.wjpr.net Vol 6, Issue 8, 2017.