Complementary Medicines are one of the category of medications that need special regulations and care.

1. REGULATIONOFCOMPLEMENTARY
MEDICINES
AMEENA KADAR K A
SECOND SEM M PHARM
DEPT. OF PHARMACY PRACTICE
SANJO COLLEGE OF PHARMACEUTICAL STUDIES

2. COMPLEMENTARY&ALTERNATIVE MEDICINES
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 Complementary and alternative medicine (CAM) is the term for medical
products and practices that are not part of standard medical care.
 Complementary medicine is used along with standard medical treatment but
is not considered by itself to be standard treatment.
 One example is using accupuncture to help lessen some side effects of cancer
treatment. Less research has been done for most types of complementary
medicine.
 Alternative medicine is used instead of standard medical treatment. One
example is using a special diet to treat cancer instead of cancer drugs that
are prescribed by an oncologist. Less research has been done for most types
of alternative medicine.

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 The US National Center for Complementary and Integrative Health
(NCCIH) uses this distinction:
 When a non-mainstream practice is used together with
conventional medicine, it's considered "complementary".
 When a non-mainstream practice is used instead of conventional
medicine, it's considered "alternative".

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TYPES OF COMPLEMENTARY AND ALTERNATIVE
MEDICINE
 People may use the term "natural," "holistic," "home remedy," or "Eastern
Medicine" to refer to CAM.
 However, experts often use five categories to describe it.
1. Mind-body Therapies
2. Biologically Based Practices
3. Manipulative and body-based practices
4. Energy healing
5. Whole Medical systems.

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 Mind–body therapies
These combine mental focus, breathing, and body movements to help relax the body
and mind. Some examples are:
 Meditation
 Biofeedback
 Hypnosis
 Yoga
 Tai chi
 Imagery
 Creative outlets.

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 Biologically based practices
This type of CAM uses things found in nature.
 Vitamins
 Dietary Supplements
 Botanicals
 Special foods or diets.
 Manipulative and body-based practices
These are based on working with one or more parts of the body.
 Massage Therapy
 Chiropractic Therapy
 Reflexology.

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 Energy healing
 Energy healing is based on the belief that a vital energy flows through the
body.
 The goal is to balance the energy flow in the patient.
 There's not enough evidence to support the existence of energy fields.
 However, there are no harmful effects in using these approaches. Some
examples are
 Reiki: placing hands lightly on or just above the person with the goal of
guiding energy to help a person's own healing response.
 Therapeutic touch: moving hands over energy fields of the body or
gently touching a person's body.

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 Whole medical systems
These are healing systems and beliefs that have evolved over time in different
cultures and parts of the world.
 Ayurveda Medicines
 Traditional Chinese Medicine
 Acupuncture
 Naturopathic medicine
 Homeopathy
 Siddha
 Unani
 Aroma Therapy.

10. REGULATION OFCAM
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 The use of alternative or complementary medicines is increasing and they are
prescribed or recommended by both orthodox and alternative practitioners.
 Importantly, they are also self-prescribed following self-diagnosis by
consumers.
 In 1997, the Parliamentary Secretary to the Minister for Health and Family
Services established a new Ministerial advisory committee, the
Complementary Medicines Evaluation Committee (CMEC).
 This advises the Therapeutic Goods Administration (TGA) and the
Government on the regulation of complementary medicines.
 The TGA is including a new Schedule in the Therapeutic Goods Regulations
to define the huge variety of complementary medicines.

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 The Schedule includes vitamins and minerals, plant and animal derived
material, food components such as sugars and mucopolysaccharides, bee
products and charcoal.
 National policies and regulations on TM/CAM could ensure the safety,
quality, and efficacy of these therapies and products and function as important
steps toward integrative healthcare systems.
 Only 25 of WHO's 191 countries have a national policy on CAM and only 64
countries regulate herbal medicines.
 WHO has published a series of technical guidelines and reviewed regulations
on herbal medicines in the document “Regulatory Situation of Herbal
Medicines: a Worldwide Review”.

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 The purpose of the document is to share national experience in formulating
policies on traditional medicinal products, introduce measures for their
registration and regulation, and facilitate information exchange on these
subjects among Member States.

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WHO GUIDELINES FOR HERBAL MEDICINES
 “A few herbal medicines have withstood scientific testing, but others are used
simply for traditional reasons to protect, restore, or improve health.”
 Most herbal medicines still need to be studied scientifically, although the
experience obtained from their traditional use over the years should not be
ignored.
 As there is not enough evidence produced by common scientific approaches to
answer questions of safety and efficacy about most of the herbal medicines now
in use, the rational use and further development of herbal medicines will be
supported by further appropriate scientific studies of these products, and thus
the development of criteria for such studies.
 In this regard, WHO has issued guidelines for the assessment of herbal
medicines.

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 These guidelines defined the basic criteria for the evaluation of quality, safety,
and efficacy of herbal medicines with the goal of assisting national regulatory
authorities, scientific organizations, and manufacturers in assessing
documentation, submissions, and dossiers in respect of such products.
 The below mentioned WHO guidelines stressed the need for assessment of
efficacy including the determination of pharmacological and clinical effects of
the active ingredients, cultivation and collection of the medicinal plants, and
labeling which includes a quantitative list of active ingredient, dosage, and
contraindications.

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WHO TRADITIONAL MEDICINE STRATEGY
(2014-2023)
 In late October of 2013, the World Health Organization (WHO) launched the
WHO Traditional Medicine Strategy 2014-2023 as a follow up to the WHO
Traditional Medicine Strategy 2002-2005, published in 2001.
 This updated document builds on work the WHO has undertaken over the past
decade to identify further and strategize on the future of traditional medicines
(TM) around the world.
 After the first strategy proved to have a strong influence on how countries
undertook regulation and oversight of TM, the 2008 WHO Congress on
Traditional Medicine in Beijing — attended by government representatives
from more than 70 countries — identified the need for WHO to take a leading
role in updating and expanding the original strategy.

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 Participants who represented every WHO region identified several priorities,
collectively known as the “Beijing Declaration,” and endorsed the development of a
new global strategy that would build on the successes of the previous strategy and
reflect the international situation in 2013.
 The key priorities were as follows:
1. The knowledge of traditional medicines, treatments and practices should be
respected, preserved, promoted and communicated widely and appropriately
based on the circumstances in each country.
2. Governments have a responsibility for the health of their people and should
formulate national policies, regulations and standards, as part of comprehensive
national health systems to ensure appropriate, safe and effective use of traditional
medicine.
3. Recognizing the progress of many governments to date in integrating traditional
medicine into their national health system, we call on those who have not yet done
so to take action.

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4. Traditional medicine should be further developed based on research and
innovation in line with the “Global Strategy and Plan of Action on Public
Health, Innovation and Intellectual Property” adopted at the 61st World Health
Assembly in 2008.
5. Governments, international organizations and other stakeholders should
collaborate in implementing the global strategy and plan of action.
6. Governments should establish systems for the qualification, accreditation or
licensing of traditional medicine practitioners. Traditional medicine
practitioners should upgrade their knowledge and skills based on national
requirements.
7. The communication between conventional and traditional medicine providers
should be strengthened and appropriate training programs be established for
health professionals, medical students and relevant researchers.

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 As with all WHO strategies, the primary audience of the WHO Global Strategy
for Traditional Medicine 2014-2023 is WHO member states.
 The aim of the strategy is to help member states “harness the potential
contribution of TM to health, wellness and people-centered health care” and
“promote the safe and effective use of TM by regulating, researching and
integrating TM products, practitioners and practice into health systems, where
appropriate.

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 The WHO Traditional Medicine Strategy 2014-2023 is divided into five
sections, including:
Section 1: An introduction that includes common terminologies, the role of T&CM
around the world, information on how WHO supports T&CM, background on
development of the strategy, and a description of why this new strategy is
important.
Section 2: An outline of the global progress that has taken place in T&CM policy
and regulations, practices, education, and research since publication of the WHO
Traditional Medicine Strategy 2002-2005.
Section 3: An analysis of the current global picture for T&CM including demand,
uses, progress in regulation, importance of universal health coverage, and the
integration of T&CM (including opportunities and challenges).

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Section 4: A clear description of strategic objectives, strategic directions, and
strategic actions. This is the most important section of the document and outlines
the future steps recommended by the numerous advisors and experts throughout the
course of developing the document. The fourth section is described in more detail
below.
Section 5: An overview of the crucial aspects of the strategy and suggestions on
how it can be implemented and measured.

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NATIONAL POLICY ON T&CM
 In India the national policy on T&CM is the National Policy on Indian
Systems of Medicine and Homeopathy, issued in 2002.
 National legislation on T&CM includes the Indian Medicines Central Council
Act 1970, the Homeopathy Central Council Act 1973 and the Drugs and
Cosmetics Act of 1940 (amended in 2009).
 The Government of India created a separate department known as the
Department of Indian Systems of Medicine and Homeopathy in 1995, later
renamed as the Department of Ayurveda, Yoga, Unani, Siddha and
Homeopathy (AYUSH), to serve as the national office for T&CM, which is
administered under the MoH.
 AYUSH was formed in 2014.

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STEPS TAKEN TO ASSURE QUALITY CONTROL OF AYUSH
DRUGS
 As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made
thereunder, enforcement of the legal provisions pertaining to Quality Control
and issuance of drug license of Ayurveda, Siddha, Unani and Homoeopathic
drugs, is vested with the State drug Controllers/ State Licensing Authorities
appointed by the concerned State/ Union Territory Government.
 Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory
guidelines for issue of license to manufacture Ayurveda, Siddha, Unani
medicines and Rule 85 (A to I) in the Drugs and Cosmetics Rules, 1945
provides the regulatory guidelines for issue of license to manufacture
Homoeopathic medicines.

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 It is mandatory for the manufacturers to adhere to the prescribed requirements
for licensing of manufacturing units & medicines including proof of safety &
effectiveness, compliance with the Good Manufacturing Practices (GMP) as per
Schedule T & Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality
standards of drugs given in the respective pharmacopoeia.
 Ministry of AYUSH has taken various steps for assured quality control of
AYUSH drugs in the country:
i. Schemes to support Ayurvedic medicines production: Under National
AYUSH Mission (NAM) from 2014-2021, apart from other services
Grant-in-aid were also provided for Strengthening of State Government
AYUSH Pharmacies.

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A. Strengthening and up-gradation of AYUSH Pharmacies and Drug Testing
Laboratories to achieve higher standards.
B. Pharmacovigilance of AYUSH drugs including surveillance of misleading
advertisements.
C. Strengthening of Central and State regulatory frameworks including
Technical Human Resource & Capacity Building programs for AYUSH drugs.
D. Support for development of standards and accreditation/ certification of
AYUSH products & materials in collaboration with Bureau of Indian Standards
(BIS), Quality Control of India (QCI) and other relevant scientific institutions
and industrial R&D canters.

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 Ministry of AYUSH encourages following certifications of AYUSH products
as per details below:-
 Certification of Pharmaceutical Products (CoPP) as per WHO Guidelines
for herbal products.
 Quality Certifications Scheme implemented by the Quality Council of
India (QCI) for grant of AYUSH Premium mark to Ayurvedic, Siddha and
Unani products on the basis of third party evaluation of quality in
accordance with the status of compliance to international standards.
 27 State Drug Testing Laboratories have been supported for strengthening
their infrastructural and functional capacity.
 81 laboratories are approved or licensed under the provisions of Drugs and
Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani
drugs and raw materials.

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 Pharmacovigilance Centers for Ayurveda, Siddha, Unani and Homoeopathy
(ASU&H) Drugs set up in different parts of the country under the Central
Scheme of Ministry of AYUSH are mandated to monitor and report the
misleading advertisements to the respective State Regulatory Authorities.
REGULATION OF UNANI
 The Unani Pharmacopoeia of India (UPI) and the National Formulary of Unani
Medicine are the regulatory compendia for quality standards and manufacturing
of Unani medicines, respectively.
 The Pharmacopoeia consists of Part I (single drugs) and Part II (formulations).
 UPI Part I is published in six volumes comprising 298 monographs on Unani
drugs.

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 Part II is published in three volumes encompassing formulations, standard
operating procedures, and quality standards for 150 classical formulations of
Unani medicines.
 The National Formulary of Unani Medicine is published in six parts
comprising 1229 formulations of Unani medicines. Each monograph of the
Pharmacopoeia provides specific analytical parameters and limits (standards)
to ensure the quality of drugs or medicines.
 The UPI, the National Formulary of Unani Medicine, regulatory quality
standards (parameters), and analytical techniques adopted for Pharmacopeial
standards of Unani drugs and medicines.

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STANDARDS OF SIDDHA DRUGS
 As per the D&C act, mentioning of manufacturing process in a list of 30 books
allows production of siddha drugs.
 Amongst these 30 books, 29 are old texts and siddha formulary of India (part I)
is the only book published by the Govt. of India recently.
STANDARDS OF HOMEOPATHY
 Homoeopathic Pharmacopoeia of India (HPI) is the official book of standards
of Homeopathic medicine in terms of Schedule-II of the Drugs and Cosmetics
Act, l940 and Rules, l945.
 The Indian manufacturers are legally bound to manufacture Homoeopathic
medicines as per standards and methodology given in the Homoeopathic
Pharmacopoeia of India.

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 The HPI is prepared by the Homeopathic Pharmacopeia Committee (HPC)
constituted by the Government of India with the following objectives:
 To prepare Pharmacopoeia of Homoeopathic drugs whose therapeutic
usefulness have been proved on the lines of the American, German and
British Homoeopathic Pharmacopoeias.
 To lay down principles and standards for the preparation of Homoeopathic
drugs.
 To lay down test of identity, quality, purity and such other matters as are
incidental and necessary for the preparation of a Homoeopathic
Pharmacopoeia.

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SCHEDULE T : GOOD MANUFACTURING PRATICES
FOR AYURVEDIC, SIDDHA, UNANI MEDICINES.

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1. https://www.nps.org.au/australian-prescriber/articles/the-regulation-of-
complementary-medicines-by-the-therapeutic-goods-administration
2. https://www.cancer.gov/about-cancer/treatment/cam
3. https://pib.gov.in/PressReleasePage.aspx?PRID=1883102
4. https://www.herbalgram.org/resources/herbalgram/issues/102/table-of-
contents/hg102-orgnews-whotradmed/
5. https://www.nhs.uk/conditions/complementary-and-alternative-medicine/
REFERENCES
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