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| REVIEW ARTICLE |
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| Year : 2019 | Volume
: 14
| Issue : 6 | Page : 92-94 |
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Ethical issues regarding research on ayurvedic drugs
Swapnil Borage1, Priyanka Shelotkar2
1 Department of Shalakyatantra, MGACH and RC, Salod, Wardha, Maharashtra, India
2 Department of Kaumarbhritya, MGACH and RC, Salod, Wardha, Maharashtra, India
| Date of Submission | 03-Mar-2019 |
| Date of Decision | 16-Mar-2019 |
| Date of Acceptance | 03-Apr-2019 |
| Date of Web Publication | 30-Sep-2020 |
Correspondence Address:
Dr. Swapnil Borage
Department of Shalakyatantra, MGACH and RC, Salod, Wardha, Maharashtra
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jdmimsu.jdmimsu_206_19
Human beings are using herbal and herbomineral drugs since ancient era. Majority of the herbomineral medicines and formulations are used in different disciplines of medicine such as Ayurveda, Siddha, and Unani. According to the WHO, about 25% of modern medicines are descended from plant sources first used traditionally. Furthermore, 70% of modern medicines in India are derived from natural products. Developing countries fail to create a major contribution in the international market of herbal medicine, due to lack of global standards for evaluating efficacy, toxicity study, and quality control of the herbal preparations. This creates a need to standardize the evaluation protocols, including quality control and quality assurance of the herbal and herbomineral drugs. Formation of standard operational protocols for evaluation of herbal and herbomineral drugs will have a great impact on manufacturing of highly potent and universally acceptable herbal medicines. This will not only help in generating revenue for the developing countries, but also in creating reliability in the herbomineral preparations, across the world. This article intends to focus various ethical issues faced by researchers in Ayurveda and suggest a unique approach for the preparation of standard operating procedures for the standardization of all herbomineral formulations. Factors contributing to problems related to research on herbal medicines can be summarized as use of improper dosages of herbal medicines, lack of standardization and quality control of the herbal drugs, improper methods of randomization, insufficient number of patients for the gaining statistical significance, problems in making placebos because of the taste and smell, and wide variations in the crude drugs collected from different area, season, etc. Formation and adoption of universal guidelines for the research on ayurvedic drugs is a need of time. All the drugs administered during the research must go through pharmacovigilance, and the database must be updated regarding the same. All the analytical tests applied to the formulations should be gold standard. All herbal preparations should be manufactured and marketed under the Drugs and Cosmetics Act. The herbal formulations as well as treatments containing oral and local procedures, which are not standardized, should follow the universally accepted WHO guidelines for research. The clinical trials on ayurvedic drugs must be strictly registered under Clinical Trials Registry – India, even for the researchers at the level of graduation and postgraduation education. The data obtained through these studies must be documented and published in the pharmacopeia.
Keywords: Ayurvedic, Clinical Trials Registry – India, herbal, placebo, research
How to cite this article:
Borage S, Shelotkar P. Ethical issues regarding research on ayurvedic drugs. J Datta Meghe Inst Med Sci Univ 2019;14, Suppl S2:92-4 |
| Introduction | |  |
Natural products from plants, animals, and minerals had been the basis of treatments of ailments since ancient times. More than 500 plants with medicinal use are mentioned in ancient literature and around 800 plants are being used in various disciplines of medicine.[1] India is a vast repository of medicinal plants that are used in traditional medical treatments.[1] During the past decades, public interest in herbal medicine has increased not only in developing countries but also in industrialized countries. This has renewed the international trade in herbal medicine enormously and has attracted most of the pharmaceutical companies. Developing countries fail to create a major contribution in the international market of herbal medicine, due to lack of global standards for evaluating efficacy, toxicity study, and quality control of the herbal preparations. This creates a need to standardize the evaluation protocols, including quality control and quality assurance of the herbal drugs.
Formation of standard operational protocols for evaluation of herbal drugs will have a great impact on manufacturing of highly potent and universally acceptable herbal medicines. This will not only help in generating revenue for the developing countries, but also in creating reliability in the herbomineral preparations, across the world. This article intends to focus various ethical issues faced by researchers in Ayurveda and suggest a unique approach for the preparation of standard operating procedures for the standardization of all herbomineral formulations. It also highlights the need for systematic clinical trials of medicinal herbal medicines to enhance global acceptance.
| Materials and Methods | | |
The study comprises ethical issues faced by researchers in Ayurveda. References are established on data pertaining to available peer-reviewed journals, Ayurveda texts, modern texts regarding herbal medicines, and their clinical trials.
| Description of Concept | | |
The variables, which contribute to the difference in the evaluation of allopathic medicines and herbal medicines, and the suggested methods to overcome them are listed as:
Dose
Dose calculation of herbal medicines is a major challenge, unlike drugs in modern medicine, where the doses of drugs are calculated by body weight.
Ayurveda texts mention the doses on the basis of the form of the drug used such as swarasa (juice), kalka (paste), and kwatha (decoction).[2] The dose is not calculated on the factor whether a crude drug is used or the extract. If the extract is used, extractive value can be used to form the dose.
Evidence of safety
Most of the herbal medicines are marketed as dietary supplements because they are regulated under the Dietary Supplement Health and Education Act.[3] By this, the pharma companies do not require any evidence of safety or efficacy. Hence, they bypass the quality control in the Drugs and Cosmetics Act, 1940.
Placebo
The researchers experience problems during making placebo drugs with similar appearance, smell, and taste. The same problem arises with the trial and control groups.
Drugs with multiple ingredients
Herbomineral preparations, containing multiple drugs, create problem during the exact mechanism of action of the drug.
Storage
Storage of the herbal medicines is also an important issue to consider. The place storage of these drugs, the temperature required, the humidity, and other factors contributing to the preservation of the active principle are not standardized for every medicine. Methods mentioned in the Ayurveda classics are not applicable to all herbal medicines and also to the proprietary herbal preparations.
Good manufacturing practices
Good manufacturing practices are not strictly adopted while formulating an ayurvedic medicine, and it is need of an hour to inspect the medicines for any adulteration.
Consideration of multiple factors
Ayurveda considers many factors before advising a medicine to a patient, such as dosha (humor in body), rutu (season), vaya (age), kala (time of drug administration), and prakriti (constitution) of the patients.[4] Hence, the same medicine can show different outcomes in different patients, if these factors are not considered.
Multiple therapies at once
In many diseases, Ayurveda has advised local therapeutic procedures in conjunction with enteral route of administration, which may or may not be standardized. Standardizing these procedures is also a major challenge to Ayurveda researchers.
Variations on the crude drug
The crude drug used to prepare herbal medicine shows variations as per climate, method of harvest, method of collections, and area. Hence, standardization of end product prepared is a challenge.
Variation at different stages of disease
In many diseases, ayurvedic literature has advised different lines of treatment, at different stages of the same disease, in the same patient as in jwara (fever).[5],[6]
Diet and behavioral changes
Ayurveda is a science of treating the patient and not the disease. Ayurveda always mentions the adjuvant dietary changes and behavioral changes during treatment. Different dietary changes, behavioral changes, and compliance of the patients have a contribution in the final outcome of the study.
Pharmacovigilance
Herbal medicines given in small doses for less duration may not show any detectable adverse effect. However, this does not imply that the same medicine will not show any adverse drug reaction on prolonged use in high doses. Rare toxicity studies and pharmacovigilance studies are available for herbal medicines with multiple ingredients.
| Conclusion | | |
Formation and adoption of universal guidelines for the research on ayurvedic drugs is a need of time. All the drugs administered during the research must go through pharmacovigilance, and the database must be updated regarding the same. All the analytical tests applied to the formulations, such as heavy metal contents and tests for specific pathogens, should be as per global standards. All herbal preparations should be manufactured and marketed under the Drugs and Cosmetics Act.
The herbal formulations as well as treatments containing oral and local procedures, which are not standardized, should follow the universally accepted WHO guidelines for research. The clinical trials on ayurvedic drugs must be strictly registered under Clinical Trials Registry – India, even for the researchers at the level of graduation and postgraduation education. The data obtained through these studies must be documented and published in the pharmacopeia.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Varma S, Singh P. Current and future status of herbal medicines. Vet World 2008;1:347-50.  |
| 2. | Shukla V, Tripathi R, editors. Agnivesha, Charaka, Chakrpani, Dhrudabala, Charaka Samhita. Shatashritiya Adhyaya Sutra Sthana, Shadvirechana. Vol. 1, Ch. 4, Ver. 7. Delhi: Chaubhamba Sansjkrit Prakashan; 2011. p. 67. |
| 3. | Wollschlaeger B. The Dietary Supplement and Health Education Act and supplements: dietary and nutritional supplements need no more regulations. Int J Toxicol 2003;22:387-90. |
| 4. | Sharma A, Kumar R, Mishra A, Gupta R. Problems associated with clinical trials of Ayurvedic medicines. Braz J Pharmacogn 2010;20:276-81. |
| 5. | Shukla V, Tripathi R, editors. Agnivesha, Charaka, Chakrpani, Dhrudabala, Charaka Samhita, Chikitsa Sthana, Jwara Chikitsa Adhyaya. Vol. 2, Ch. 3, Ver. 142. Delhi: Chaubhamba Sansjkrit Prakashan; 2009. p. 91. |
| 6. | Shukla V, Tripathi R, editors. Agnivesha, Charaka, Chakrpani, Dhrudabala, Charaka Samhita, Chikitsa Sthana, Jwara Chikitsa Adhyaya, Vol. 2, Ch. 3, Ver 164. Delhi: Chaubhamba Sansjkrit Prakashan; 2009. p. 94. |
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