Spurious Drugs under Indian Law

A spurious drug is one falsely presented as another drug, falsely attributed to a manufacturer, or substituted with another substance. Section 17B of the Drugs and Cosmetics Act, 1940 specifies five alternative conditions, and satisfying any one of them makes a drug spurious.

Statutory grounds

Under Section 17B, a drug is deemed spurious in any of the following circumstances:

• It is manufactured under a name that belongs to another drug.
• It is an imitation or substitute for another drug, or resembles that drug in a manner likely to deceive, unless it is plainly and conspicuously marked to reveal its true character and lack of identity with the other drug.
• Its label or container names a purported manufacturer who is fictitious or does not exist.
• It has been wholly or partly substituted by another drug or substance.
• It purports to be the product of a manufacturer of whom it is not truly a product.

Distinction from other defective drugs

Spuriousness concerns deception about a drug's identity, composition or manufacturer. It is distinct from a misbranded drug under Section 17, an adulterated drug under Section 17A, and a drug that merely fails prescribed standards of quality.

Legal significance

Under Section 18, the manufacture for sale or distribution, sale, stocking, exhibition, offering for sale, or distribution of a spurious drug is prohibited. The classification therefore enables regulatory seizure, prosecution and other enforcement under the Act.