Drugs & Cosmetics Act, 1940–Sec. 17B–Spurious drug–Deviation in the dissolution rate–A delayed dissolution does not render the drug spurious or unless, it merely implies a slower release of active content, which still remains effective–The therapeutic efficacy of the drug is not entirely negated by such delay–Dissolution rates can be influenced by several factors including the quality of excipients manufacturing process, temperature control, and climatic conditions during production and storage–The presence of correct active ingredient in the specified quantity is the primary factor in determining a drugs quality–If the core contents of the drug remains intact and effective, classifying it as substandard, spurious or useless would be legally and scientifically untenable.
