Ethical issues regarding research on ayurvedic drugs

Abstract

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.