Innovation and Regulation of Ayurvedic System

Mushtaq Ahmad Wani15PIM2244

M.S. (Pharm.) 3rd SemesterDepartment Of Pharmacoinformatics

NIPER, S.A.S. Nagar

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IntroductionThe 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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The 5 Éléments of The The 5 Éléments of The BodyBodyAccording 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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These 5 elements combine in the human body to form three lifeforces or energies, called doshas. They control how your body works.

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The DoshasThe Doshas

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To Balance KaphaTo Balance Kapha

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To Balance PittaTo Balance Pitta

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To Balance VataTo Balance Vata

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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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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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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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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

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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.

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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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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.

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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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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).

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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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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

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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

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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

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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

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