Phytopharmaceutical regulated new class: An Industrial initiative of Ayurvedic drugs towards the advancement of India system of medicine

Abstract

Ethnopharmacological relevance: The growing demand for medicinal plants and their products has led to safety and efficacy concerns. The evaluation of herbal medicines, registration and regulation are important challenges to their safety and efficacy. The provisions for synthetic drugs do not apply to ayurvedic-based herbal products. Furthermore, the regulatory mechanism for ensuring the quality of herbal medicines has become a top priority for Indian drug regulators and drug manufacturers. Aim of study: The aim of this study is to identify and characterise the different features of Ayurveda-related government policies and efforts. AYUSH and CDSCO design and establish regulations for the development of phytopharmaceutical drugs as necessary, utilizing botanical-based medications that have a long history but have thus far lacked adequate documentation. Methods: We conducted a review of the literature on Ayurveda's history, principles, and current status. We have presented the data in a systematic manner that includes all of the initiatives brought forth by the Indian government. To conduct a thorough and comprehensive analysis, we went through various reports, policies, and ancient Ayurvedic texts, and consulted AYUSH-related websites, such as those run by the Ministry of AYUSH. Results: The Ministry's objective is to elevate AYUSH systems to the forefront of living and practise, and to make AYUSH methods the preferred method for achieving a healthy nation. The newer class of drugs allows the development of drugs through advanced solvent extraction, fractionation, modern formulation and pharmacokinetics, etc. Conclusion: The promotion and development of Ayurveda is being actively pursued by the government through its policies. The present commentary is designed to highlight core and assembled information on the regulatory requirement in contrast to the new category phytopharmaceuticals under AYUSH. Phytopharmaceuticals may be a balanced approach with guidelines in the United States of America, China, and other countries connecting scientific validation and data generation, including revalidation of AYUSH-regulated product specifications.

Phytopharmaceuticals Regulatory requirements and licensing process

“…As per the new Phytopharmaceuticals standards, expanding drug development through the use of sophisticated procedures such solvent extraction, fractionation, current formulation development, etc. (7) The manufacturers utilize the freedom to use more advanced extraction processes, potentiating techniques, as well as newer formulations and process development techniques are given by newly designed Phytopharmaceutical regulations. Phytopharmaceutical drug NDA regulation: Applicable regulatory requirements include standards for identifying, authenticating, sourcing, and processing the plant used for extraction and fractionation, formulation information for plant-based pharmaceutical drugs, formulation manufacturing process, stability data, pharmacological data, human studies, and confirmatory clinical trials.…”

“…Phytopharmaceutical drug NDA regulation: Applicable regulatory requirements include standards for identifying, authenticating, sourcing, and processing the plant used for extraction and fractionation, formulation information for plant-based pharmaceutical drugs, formulation manufacturing process, stability data, pharmacological data, human studies, and confirmatory clinical trials. (7) 2. Requirements for submitting an application to import or produce a Phytopharmaceutical drug in the country or to perform a clinical trial there (10) e-ISSN: 2321-6794…”

“…The lack of drug standardization is the biggest barrier to the commercialization of traditional Indian herbal products. (7) Concerns over safety and efficacy have arisen because of the rising demand for medicinal plants and their products. Ayurvedic-based herbal products are not covered under the regulations for synthetic drugs.…”