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    <title>Who is responsible for ‘Faulty Formulation in Medicines’?</title>
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    <description>Faulty Formulation denotes medicines whose composition, quality, or stability does not meet approved standards due to causes such as poor raw materials, inadequate process control, failure to follow Good Manufacturing Practices, insufficient validation, counterfeit production, or data manipulation. Manufacturers are responsible for QA/QC, authentic API sourcing, batch records, stability studies, self-inspections, post-market surveillance, and recalls; CDSCO and state authorities enforce approvals, inspections, testing, pharmacovigilance, import control, and public alerts under the Drugs and Cosmetics regulatory framework.</description>
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