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International Journal Of Drug Regulatory Affairs
Year : 2023, Volume : 11, Issue : 3
First page : ( 43) Last page : ( 52)
Print ISSN : 2321-7162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v11i3.615

Phytopharmaceuticals Regulatory requirements and licensing process

Prajapati Pooja1, Pathan Asmatbanu1, Prajapati Denish2

1Graduate School of Pharmacy-GTU, Sector 26, Gandhinagar, Gujarat-382027, India

2Assistant Professor, Uka Tarsadiya University, Maliba Campus, Gujarat-394 350, India

Online Published on 29 March, 2024.

Abstract

Since the ancient period, people have used herbal treatments for a wide variety of medical issues. In developing countries, most people utilize herbal remedies to cure a variety of diseases. India, the nation that produces the most medicinal plants, is referred to as the botanical garden of the world. Indian drug regulators are focused on quality in order to uphold the standards for herbal remedies, but manufacturers are struggling to satisfy the higher standards. There are difficulties with standardization, finished formulations, and industry-wide evidence-based practices for AYUSH medicines in India. Phytopharmaceuticals, a modern subclass of medications, contain an enriched fraction with at least four distinct chemical markers with one biomarker. The Central Drugs Standards Control Organization (CDSCO) oversees Phytopharmaceuticals. The Ministry of Health and Family Welfare has released a Gazette Notification GSR 918(E)-Schedule Y, Appendix I(B) regarding Phytopharmaceuticals. This new rule is anticipated to encourage new medication discoveries and evolution using botanicals in a scientific manner and would aid in the modern medical profession's acceptance of Phytopharmaceuticals as a significant alternative to allopathic modern medicine. Phytopharmaceuticals are a wellbalanced approach that believes in everything but places emphasis on the revalidation of the plant material's specification, in contrast to conventional pharmaceuticals that suspect everything and AYUSH medicines that trust everything. The purpose of this article is to give specific detail and compiled knowledge about Phytopharmaceutical medicines, regulatory requirements, and regulatory processes.

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Keywords

Herbal Medicines, Phytopharmaceutical, Standardization, Regulation, Central Drugs Standards Control Organization (CDSCO), Ayurvedic, Siddha, Unani (ASU), Ministry of Health and Family Welfare (MHFW), Food and Drug Administration (FDA), AYUSH.

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