Ayurveda is a 5,000-year-old system of natural healing that has its origins in the Vedic culture of India. Although suppressed during years of foreign occupation, Ayurveda has been enjoying a major resurgence in both its native land and throughout the world. More than a mere system of treating illness, Ayurveda is a science of life (Ayur = life, Veda = science or knowledge). It offers a body of wisdom designed to help people stay vital while realizing their full human potential.

Homeopathy is a gentle and effective form of natural, holistic medicine that can be used to treat many conditions, illnesses, and diseases. Homeopathic remedies are made from minute, potentized doses of substances found in nature. These medicines are prepared according to scientific principles that allow them to be easily utilized by your body to support your body’s attempts to heal it.  

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Discussion

Central  council for research in Ayurvedic sciences (CCRAS), an autonomous body under Ministry of AYUSH, Govt. of India is an apex body in India for undertaking, coordinating, formulating, developing and promoting research on scientific lines in Ayurvedic sciences. The Ministry of AYUSH, Govt. of India is the President of the Governing Body of the council, while the Joint Secretary chairs the standing Finance committee. The scientific/ Research programmes are supervised by the Scientific Advisory Board and Scientific Advisory Group.   Central Council for Research in Homoeopathy (CCRH) is an apex research organization under Ministry of AYUSH, Govt. of India which undertakes, coordinates, develops, disseminates and promotes scientific research in Homoeopathy.

In Indian regulations, the major class of herbal products is:     

1. Classical Ayurveda drugs as mentioned in the authoritative books of Ayurveda system, which are manufactured and named in accordance with the formulations described in the authoritative texts.   
2. Patent or Proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine. 

None of these classes of herbal medicines come under purview of DCGI as they do not fall into categories of new drugs. Hence, DCGI approval is not required for clinical trial of herbal products. 

Drugs & Cosmetic Rules 2016 

122E. Definition of new drug - for the purpose of this part, new drug shall mean and include:  

A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21. 

Case Study Results

A 2007 systematic review found that highly diluted homeopathic remedies, taken under the supervision of trained professionals, are generally safe and unlikely to cause severe adverse reactions. However, like any drug or dietary supplement, these products could pose risks if they are improperly manufactured (for example, if they are contaminated with microorganisms or incorrectly diluted). 

In 2008, an NCCIH-funded study examined the content of 193 Ayurvedic products purchased over the Internet and manufactured in either the United States or India. The researchers found that 21 percent of the products contained levels of lead, mercury, and/or arsenic that exceeded the standards for acceptable daily intake. Other approaches used in Ayurvedic medicine, such as massage, special diets, and cleansing techniques may have side effects as well.

A 2012 systematic review of case reports and case series concluded that using certain homeopathic treatments (such as those containing heavy metals like mercury or iron that are not highly diluted) or replacing an effective conventional treatment with an ineffective homeopathic one can cause adverse effects, some of which may be serious. 

Liquid homeopathic remedies may contain alcohol. The FDA allows higher levels of alcohol in these remedies than it allows in conventional drugs. 

Conclusion

With Ayurveda, the problem is, the regulatory structure is weak. While there are many classical formulation drugs that derive from ancient texts that are listed in the Drugs Act, there are many other patented and propriety drugs that may completely pass through without any safety or efficacy tests. 

With homeopathic drugs, the problem is that there is no fixed kind of formulation. For one disease there may be up to 200 dose formulations of same active ingredient. These formulations when sold without the advice of proper homeopathic practitioner can cause serious adverse reactions. 

With rise in the use of Ayurvedic medicines as a replacement of Allopathy, there is an immediate need to implement stringent rules and research for the approval and use of these medicines. 

Thank& Regards

Lucy Morgan

Editorial assistant

Journal of Medical Research & Health Education

Email: medresearch@echemistry.org