Section 9B of the Drugs and Cosmetics Act, 1940 - Spurious Drugs

Section 9B defines when a drug is deemed to be a spurious drug for the purposes of Chapter III of the Drugs and Cosmetics Act, 1940, which regulates the import of drugs and cosmetics.

Scope of Section 9B: The provision applies within Chapter III and identifies forms of false identity, imitation, substitution and false manufacturer representation that make an imported drug spurious.

Meaning of spurious drug under Section 9B

For the purposes of Chapter III, a drug is deemed to be spurious if it falls within any of the following statutory categories:

Clause (a): Wrong drug name. The drug is imported under a name that belongs to another drug.
Clause (b): Imitation, substitution or deceptive resemblance. The drug is an imitation of, or substitute for, another drug, resembles another drug in a manner likely to deceive, or bears the name of another drug on the product, label or container, unless it is plainly and conspicuously marked to disclose its true character and lack of identity with that other drug.
Clause (c): Fictitious manufacturer. The label or container bears the name of an individual or company purporting to be the manufacturer when that individual or company is fictitious or does not exist.
Clause (d): Substitution of substance. The drug has been substituted wholly or partly by another drug or substance.
Clause (e): False manufacturer identity. The drug purports to be the product of a manufacturer when it is not truly that manufacturer's product.

How Section 9B differs from related provisions

Section 9B should be read with the neighbouring provisions in Chapter III. Section 9 deals with misbranded drugs, while Section 9A deals with adulterated drugs. Section 9B separately addresses drugs whose identity, composition or claimed manufacturer is false in the ways specified by the section.

Effect on import

Section 10 prohibits the import of specified categories of drugs and cosmetics. A drug deemed spurious under Section 9B therefore has consequences under the import-control provisions of Chapter III. Section 13 separately prescribes offences relating to prohibited imports, including import of a drug deemed spurious under Section 9B.

Legislative note

Sections 9A and 9B were substituted by Section 6 of the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983.

Related provisions

Section 8 - Standards of quality Section 9 - Misbranded drugs Section 9A - Adulterated drugs Section 9C - Misbranded cosmetics Section 9D - Spurious cosmetics Section 10 - Prohibition of import Section 13 - Offences Drugs and Cosmetics Act, 1940

This page is an informational presentation of Section 9B and related provisions. For authoritative statutory text and regulatory updates, consult the official sources linked on this page.