The document discusses Ayurvedic medicine, including its foundations, doshas, treatments to balance doshas, safety, regulation, and innovations. It notes that Ayurveda focuses on balance and wellness rather than disease, uses diet, herbs, and breathing. It describes the five elements and three doshas that make up the human body. Recent innovations include patents on Ayurvedic formulations, collaboration on clinical trials, and use of herbs in cancer treatment. However, some herbs may be toxic if misused and require more research on safety. Regulation focuses on product quality rather than efficacy.

1. Innovation and Regulation of
Ayurvedic System
Mushtaq Ahmad Wani
15PIM2244
M.S. (Pharm.) 3rd
Semester
Department Of Pharmacoinformatics
NIPER, S.A.S. Nagar
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2. Introduction
The traditional Hindu system of medicine which is based on
the belief that health and wellness depend on a delicate balance
between the mind, body, and spirit uses diet, herbal treatment,
and yogic breathing.
The primary focus of Ayurvedic medicine is to promote good
health, rather than fight disease. But treatments may be
recommended for specific health problems
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3. The 5 Éléments of TheThe 5 Éléments of The
BodyBodyAccording to Ayurveda every person is made of a
combination of five basic elements found in the universe:
1.Space 3.Air 3.Fire 4.Water 5.Earth
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4. These 5 elements combine in the human body to form three life
forces or energies, called doshas. They control how your body
works.
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5. The DoshasThe Doshas
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6. To Balance KaphaTo Balance Kapha
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7. To Balance PittaTo Balance Pitta
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8. To Balance VataTo Balance Vata
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9. Contd….
The fundamental concept of Ayurveda is to maintain health
Ayurveda does not look at the disease. It looks at the host and
an individual's vulnerability
There aren’t enough well-controlled clinical trials and
systematic research reviews about ayurvedic medicines
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10. Is Ayurvedic medicine safe?
 Most of ayurvedic drugs are safe.
 Some of these products which may contain herbs, minerals, or metals may be
harmful if used improperly or without the direction of a trained practitioner.
 Some herbal drugs like Plumbago rosea and Acorus calamus commonly used
in Ayurvedic formulations may be toxic.
 Some herbs can cause side effects or interact with conventional medicines.
E.g:Aloe Vera
 Many materials used in them haven’t been studied for safety in controlled
clinical trials
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11. Regulation of Ayurvedic systems
 Traditional medicines are characterized in many different
ways throughout the various jurisdictions around the world.
 They are commonly sold either as a prescription or over the
counter (OTC) medicine or may be variously described as
self-medication,home remedies, dietary supplements, health
foods, functional foods or phytoprotectants, or by some other
title.
 These types of products are variously marketed under the
banner of traditional medicines, herbal medicines, herbal
supplements, herbal pharmaceuticals,
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12.  Currently in India, traditional medicines under the Ayurvedic
system and Unani system are not required to submit any proof
pertaining to their safety or efficacy.
 In fact when India’s first drug regulatory law the Drugs Act
was enacted in 1940, the law completely excluded from its
purview, traditional medicine systems like Ayurveda and
Unani.
 It was only the Drugs & Cosmetics (Amendment) Act, 1964
that brought traditional medicine systems like Ayurveda and
Unani under the purview of the Drugs Act, 1940
Contd….
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13.  The focus of these amendments was on ensuring quality of the
final product being sold in the market
 The Ayurvedic drug which are manufactured in a factory
should complied with certain safety norms and that the
product had the ingredients as advertised on the packaging.
 According to the Drugs & Cosmetics Act, 1940 there is no
need for the Ayurvedic manufacturer to conduct rigorous
clinical trials and establish that the drug actually has the effect
that it claims to have on the human body.
Contd….
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14. Licensing
 No states in the United States license Ayurvedic practitioners, although a
few states have approved Ayurvedic schools.
 Many Ayurvedic practitioners are licensed in other health care fields, such
as midwifery or massage.
 States use the following approaches to credential practitioners:
1) Mandatory licensure: requires practitioners to have a license for
providing a service.
2) Title licensure: requires practitioners to have credentials before using a
professional title.
3) Registration: requires practitioners to provide information about their
training and experience to a state consumer protection agency.
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15.  States’ requirements for granting a license vary considerably.
 They may require those seeking a license to do one or more of
the following:
 Graduate from a certified program.
 Meet certification requirements of a national organization.
 Complete a specified amount of training.
 Pass a written exam (sometimes a practical exam is
also required).
 Participate in continuing education.
Contd….
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16. Innovations
 Ayurveda treatment is gaining popularity due to its long term benefits.
 It enrobes the mind, body and spirit, healing them and also pampering the
individual for a holistic experience.
 This alternate method of healing originated in India and has risen to fame,
reaching out to different parts of the world.
 It has been accepted with open arms and has become an important part of a
healthy lifestyle.
 The use of natural herbal products which can fight many forms of chronic
illness without harming the body is the prime focus of ayurveda treatments.
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17.  Research and innovation in ayurvedic pharmaceuticals can be analysed in
the context of an increasing competition with the biomedical
pharmaceutical sector in India.
 Patents in ayurvedic research are given only in very exceptional cases, if
the novelty and new avenues for the uses can be proven.
 So far, around 34 patents have been granted mainly under the research of
the Central Council for Research in Ayurveda and Siddha
 India has a growing pharmaceutical sector, which accounts to about six to
seven billion US $ in 2008, representing two per cent of India’s global
market, and ranking fourth in terms of volume and thirteenth in value
(Greene 2007).
Contd….
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18. Some of innovations in ayurvedic
systems
 In the last decade, a large number of biopharmaceutical companies have
begun to take an interest in herbal divisions in their drug research. For
example, Ozone Pharmaceuticals, Sami Labs, Hindustan Lever Ltd. Etc.
 The scientists at the Council of Scientific and Industrial Research (CSIR)
and Department of Biotechnology have received a United States Patent for
inventing a new process to cure diabetes mellitus from Indian green mussel
(Perna viridis) extract. BGR-34
 Indian and Chinese doctors will collaborate to prove through clinical trials
the efficacy of some traditional herbal drugs that have for generations been
known to cure but for which there is no scientific evidence.
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19.  The traditional health booster and ayurvedic formulation
‘Triphala' has found its use in cancer treatment, according to
Radiation biologists of Bhabha Atomic Research Centre
(BARC) in Mumbai.
 The Himachal Pradesh government has formulated a
comprehensive policy for turning itself into a major herbal
destination in the country by 2025.
 The Association of Ayurveda Practioners (India) has
suggested the Centre to hold patents on ayurvedic
formulations. This would be the first step towards getting the
nearly Rs 8,000 crore industry to standardise
Contd….
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20.  Sami Labs has received approval from the Drugs Controller General of
India to manufacture and market a new drug for glaucoma. E.g.Oco-force
 Himani has planed to introduce several products in the Ayurvedic segment,
primarily in competition with Dabur and various other domestic brands
Contd….
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21.  The Indian Council of Medical Research (ICMR) and the National
Innovation Foundation (NIF) have signed a memorandum of understanding
(MoU ) for development of drugs from medicinal plants or multi-herb
formulations.
 A herbal medicine immunepathy-I for cure of Rheumatoid arthritis,
invented by a Chennai based company 21st Century Medical Science has
received Indian patent from the Indian Patent Office.
 The Indian Institute of Chemical Technology (IICT) has isolated an anti-
gastric ulcer molecule (OA-5) from a known Indian medicinal plant which
showed potent antigastric ulcer activity against different types of ulcers
Contd….
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22.  Himani Ayurvedic Health Care, the new division, has already
launched five products which were test marketed in regions of
Uttar Pradesh, Madhya Pradesh, Chhattisgarh and Uttaranchal.
 The products include a memory tonic, a cough syrup, a vapour
rub, a laxative and digestive pills, all based on ayurvedic
formulations
Contd….
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