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Manufacture of Ayurvedic Medicines – Regulatory Aspects
Published in D. Suresh Kumar, Ayurveda in the New Millennium, 2020
V. Remya, Alex Thomas, D. Induchoodan
Considering the growing interest in Ayurveda, the Department of A.Y.U.S.H., Government of India, published Good clinical practice guidelines for clinical trials in Ayurveda, Siddha and Unani medicine (GCP-ASU). The guidelines are intended to develop methodologies for evaluation of research and to provide appropriate methods to streamline the regulation and registration of products from Indian traditional medicine including Ayurveda. Department of A.Y.U.S.H. considers this document as a reference source for scientists of traditional medicine, registered medical practitioners, manufacturers and health authorities (Anonymous 2013).
Clinical Trials in Ayurveda
Published in Saroya Amritpal Singh, Regulatory and Pharmacological Basis of Ayurvedic Formulations, 2017
The department of Ayush has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting the ASU clinical trials.
Globalisation of Traditional Medicine under the Modern Medicine Portfolio
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
Pulok K. Mukherjee, Subhadip Banerjee, Amit Kar
For globalising the system and its products, the Ministry of AYUSH has focused its attention on standardisation and quality control of Ayurvedic drugs. Good manufacturing practices (GMPs) have been notified under ‘Schedule T’ of the Drugs & Cosmetics Rules, 1945, and testing for heavy metals such as mercury, arsenic, lead and cadmium in all purely herbal Ayurvedic drugs is mandatory for export purposes (Anonymous 2013). All these measures have been introduced to give greater impetus to consumer awareness, consumer and doctor benefit, acceptance in the globalised markets and to ensure safety, which is of utmost concern while using Ayurveda medicines. Clinical safety and efficacy documentation proof for Ayurvedic medicine has been a persistent and increasing demand globally (Singh 2010). The history of ‘good clinical practice’ (GCP) statutes traces back to one of the oldest enduring traditions in the history of medicine – Ayurveda. Therefore clinical trials in Ayurveda need to be guided by the principle of GCP. The safety and therapeutic efficacy of the AYUSH drugs can be readdressed to assure their quality. Thus clinical research in these lines helps us to generate quality data acceptable to regulatory authorities. Research has focused more on ethical guidelines while treating a patient with medical/surgical interventions. The requirement for proof of effectiveness in licensing on the patent or proprietary AYUSH medicine for the enactment of Drugs & Cosmetics Rule 158 B since August 2010 has necessitated the development of present guidelines of GCP. These guidelines have been prepared by a comprehensive consultative process and are fine-tuned to the best interest of Ayurveda (Katoch 2017).
The Impact of Embarrassment to Product Purchase and Brand Influence on the Perceived Benefits and Availability of Ayurveda Products in the COVID-19 Era: an Investigation by SEM Approach
Published in Hospital Topics, 2022
This study concludes that embarrassment related to post-purchase of Ayurveda products is an important and significant variable, diluting the perceived benefits of Ayurveda product usage. Similarly, brand influence also substantiates the perceived benefit of the safe and effective nature of Ayurveda products. Lastly, the perceived benefits such as "safe and effective nature" and "preventive benefits against Covid-19" improve the perception about the availability of the Ayurveda products in the market. This study also provides valuable insight to the Ayurveda products manufacturers that those customers who go against the majority opinion and purchase Ayurveda products are more susceptible to have attitudinal conflict and change of perception from positive to negative about the benefits associated with the usage of Ayurveda products; hence the manufacturers should not make false claims. At the same time, this study also concludes that there is a general perception in the population about the preventive benefits of Ayurveda products against Covid-19; thus, this perception will not only motivate the people to increase the consumption of Ayurveda products but also will bring positive lifestyle changes and the people will consciously take these steps to increase their immunity. However, these positive perceptions about the efficacy of Ayurveda products can be maintained in the long run only when the results are evident. However, that can be possible if clinical trials of Ayurveda Products are done in compliance with the Central Council for Research in Ayurveda Sciences (Ministry of Ayush, India) before launching the products in the market. Lastly, Ayurveda product manufacturers should take active measures to maintain and improve the attitude associated with the benefits of consuming Ayurveda products, which will motivate the consumers to demand and purchase Ayurveda products from the market.