Counterfeit drug rackets
Note
India's domestic drug-quality enforcement operates through the Central Drugs Standard Control Organisation (CDSCO), which holds inspection, sampling, and recall powers under the Drugs and Cosmetics Act. State drug licensing authorities conduct front-line licensing and market surveillance of spurious and substandard medicines. Post-market surveillance identifies manufacturing and labelling failures after products reach consumers. Where manufacture and distribution are entirely domestic with no cross-border network, enforcement remains within this regulatory architecture rather than involving anti-laundering or smuggling mechanisms.
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Questions on this topic
Consider the following pairs regarding offences and definitions under the Drugs and Cosmetics Act, 1940:
- Spurious drug — a drug that is an imitation of, or a substitute for, another drug, or which purports to be a drug but does not contain the drug, or bears the name of another drug
- Adulterated drug — a drug in which any substance has been mixed or packed so as to reduce its quality or strength
- Misbranded drug — a drug which is not labelled in the prescribed manner or whose label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug
Which of the pairs given above is/are correctly matched?
Explanation
Under the Drugs and Cosmetics Act, 1940, the three categories are distinctly defined. A 'spurious drug' (Section 17B) includes a drug that is an imitation of or substitute for another drug, or one that purports to be a drug but does not contain it, or that falsely bears the name of another drug — directly relevant to the practice of repackaging generic formulations and labelling them as branded products. An 'adulterated drug' (Section 17A) refers to a drug in which any substance has been mixed or packed so as to reduce its quality or strength, or where any substance has been substituted wholly or in part. A 'misbranded drug' (Section 17) refers to a drug which is not labelled in the prescribed manner or whose label makes any false claim. All three definitions are correctly matched with their respective descriptions as laid down in the Act. The distinctions among these three categories matter because they attract different penal provisions under the Act and implicate different regulatory obligations of the Drug Controlling Authorities.
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