Regulatory Architecture: AYUSH, Quality Control, and GMP Compliance

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Regulation and quality assurance in the India Ayurvedic Products Market are governed by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) under the overarching framework of the Drugs & Cosmetics Act of 1940 and Rules, 1945. This regulatory structure ensures that products adhere to standards of safety, efficacy, and quality.

Key regulatory mechanisms include:

  • Good Manufacturing Practices (GMP): Manufacturers must comply with specific guidelines, defined under Schedule T, covering everything from raw material sourcing and hygiene to standardized quality control processes.

  • Licensing: State Licensing Authorities (SLA) grant licenses for manufacturing and sale, ensuring adherence to the prescribed requirements.

  • Voluntary Certification: The Quality Council of India (QCI) administers the AYUSH Premium Mark and AYUSH Standard Mark schemes. The Premium Mark certifies compliance with international standards, including WHO-GMP requirements, facilitating export and enhancing consumer trust by providing a recognized quality benchmark within the India Ayurvedic Products Market, as laid out in the official regulatory guidelines, such as the India Ayurvedic Products Market Global Outlook.

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