COMPERHENSIVE OVERVIEW ON GUIDELINES FOR SOLID DOSAGE FORM SUBMISSION AS PER CDSCO IN INDIA


Mr. Avinash D. Hatkar, Mr. Akshay Bhagwan Nagre, Dr. Sunil Jaybhaye, Mr. Gitesh G. Vyas, Mr. Gautam Vijay Magre
Department Dr. Babsaheb Ambedkar Technological University, Raigad, Lonere, Maharashtra
Abstract
Central Drugs Standard Control Organisation (CDSCO) and Regulation of Solid Dosage Forms in India. The Central Drugs Standard Control Organisation (CDSCO) serves as the apex regulatory authority in India for the approval, regulation, and quality control of pharmaceutical products, including solid dosage forms such as tablets, capsules, and powders. Solid dosage forms, being the most common pharmaceutical formulations, are subject to rigorous regulatory oversight. CDSCO establishes standards for manufacturing practices, product testing, and marketing approvals to ensure compliance with Good Manufacturing Practices (GMP) and pharmacopeial standards. Its responsibilities include licensing of manufacturing units, approval of new drugs, T. This framework not only safeguards public health but also promotes the growth of India's pharmaceutical industry in the global market., The regulatory efforts of CDSCO have been instrumental in fostering public trust by ensuring the availability of high-quality and affordable solid dosage forms in India.
Keywords: Drugs and Cosmetics Rules, 1945, Pharmaceutical Regulatory Authority, Good Manufacturing Practices (GMP), Central Licensing Authority, State Licensing Authority, New Drug Approval (NDA), Quality Control (QC), Pharmacovigilance Solid Dosage Forms
Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2024-11-24

Vol : 9
Issue : 11
Month : November
Year : 2024
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