Regulatory Aspects of Traditional Indian Medicines (TIM) in India and in International Purview.

ABSTRACT

Background: Regulatory affairs play a crucial role in the pharmaceutical industry and are incorporated in all stages of drug development. Objective: Approval criteria practices were developed as a resolution of the government's desire to create policies to protect public health by controlling the safety and efficacy of merchandise in areas including pharmaceuticals, complementary color medicines, veterinary medicines, medical devices, and even food products and cosmetics. Method: Herbal health products are in practices in all parts of the world under either their legal system's or expert council's or agencies' guides. They include botanicals, health supplements, health foods, complimentary medicines, traditional medicines or following pathies like Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The requisite parameters for registration or recognition of products by various major global regulatory agencies were reviewed, and compiled under purview. Results: In India, licensing these products is under the act provisions and the rules known as the Drugs and Cosmetics Act, whereas globally regulatory provisions follow the guidelines of developed countries like the U.S. Food and Drug Administration, European Medicines Agency, the Therapeutic Goods Act, or the World Health Organization's regulations for herbal products. Conclusions: The present communication highlights the provisions of regulatory and/or licensing requirements related to corporates, product composition, specifications, quality parameters, manufacturing methodology, stability, safety, preclinical studies, clinical studies, etc. for herbal products and the respective guidelines at one site. Highlights Ultimately, all regulatory agencies across the world highlight majorly the safety and thereafter the efficacy for any products under the category.