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Adulteration of drugs refers to the process in which pharmaceutical products are debased or substituted with inferior, substandard, or harmful substances, either intentionally or unintentionally. In the context of Drugs Regulatory Affairs, adulteration is considered a serious violation of quality control standards and legal provisions, as it compromises the safety, efficacy, and therapeutic value of drugs. According to the Drugs and Cosmetics Act, 1940 in India, a drug is deemed to be adulterated if it contains any filthy, putrid, decomposed substance, or if it has been manufactured under insanitary conditions, or if it contains an unsafe ingredient that may render it injurious to health. The regulatory framework strictly prohibits the manufacture, sale, and distribution of adulterated drugs, with stringent penalties for offenders to safeguard public health. Deliberate adulteration __________ __________ ___ _____ ___.
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