Volume : 13, Issue : 08, August – 2026

Title:

STUDY ON THE REGULATORY REQUIREMENTS FOR FACILITY INSPECTIONS UNDER CDSCO GUIDELINES.

Authors :

Kondoju Arun Kumar Chary*, Dr.R.Narasimha Rao, Dr.T.Vijaya Kumari

Abstract :

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority of India responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, cosmetics, and clinical trials. Facility inspections conducted under CDSCO guidelines are a critical regulatory mechanism to ensure compliance with statutory requirements such as the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, along with subsequent amendments and regulatory frameworks including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). This study examines the regulatory requirements governing facility inspections under CDSCO, focusing on their objectives, scope, inspection procedures, documentation requirements, and compliance expectations. It also highlights the roles and responsibilities of inspectors and regulated entities, common inspection deficiencies, and enforcement actions arising from non-compliance. The study aims to provide a comprehensive understanding of the CDSCO inspection framework and its significance in maintaining public health standards, promoting regulatory compliance, and aligning Indian regulatory practices with global standards.
Keywords:
CDSCO, Facility Inspections, Regulatory Requirements, Good Manufacturing Practices (GMP), Drugs and Cosmetics Act, Quality Compliance

Cite This Article:

Please cite this article in press K Arun K Chary et al., Study on the Regulatory Requirements for facility Inspections under CDSCO guidelines.,, Indo Am. J. P. Sci, 2026; 13(08).

REFERENCES:

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