Section 17B of Drugs and Cosmetics Act 1940 - Spurious Drugs

Section 17B of the Drugs and Cosmetics Act, 1940 defines when a drug is deemed to be a "spurious drug" for the purposes of Chapter IV of the Act. The provision focuses on false identity, deceptive imitation, fictitious manufacturers, substitution, and false claims about the true manufacturer.

In brief: A drug may be treated as spurious where its identity or source is falsely represented, where it imitates or substitutes another drug in a deceptive manner, where a fictitious manufacturer is shown, or where the drug or substance has been wholly or partly substituted.

Section 17B - Spurious drugs

Statutory provision

For the purposes of this Chapter, a drug shall be deemed to be spurious:

if it is manufactured under a name which belongs to another drug; or
if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
if it has been substituted wholly or in part by another drug or substance; or
if it purports to be the product of a manufacturer of whom it is not truly a product.

Meaning and scope of Section 17B

Section 17B is a deeming provision. If a drug falls within any of the situations specified in clauses (a) to (e), it is treated as spurious for Chapter IV of the Act. The provision is therefore concerned not merely with the physical contents of a drug but also with its identity, presentation, source, manufacturer, and substitution.

Clause (a): Use of the name of another drug

A drug is deemed spurious if it is manufactured under a name that belongs to another drug. This clause addresses false identification through the name under which the product is manufactured.

Clause (b): Imitation, substitution or deceptive resemblance

A drug is spurious if it imitates, substitutes for, or resembles another drug in a manner likely to deceive. The clause also covers use of another drug's name on the drug, label, or container, unless the true character of the product and its lack of identity with the other drug are plainly and conspicuously disclosed.

Clause (c): Fictitious or non-existent manufacturer

The provision applies where the label or container names an individual or company as the manufacturer but that individual or company is fictitious or does not exist.

Clause (d): Whole or partial substitution

A drug is deemed spurious where it has been substituted, wholly or partly, by another drug or substance.

Clause (e): False representation of manufacturer

A drug is also spurious if it purports to be the product of a manufacturer when it is not truly a product of that manufacturer.

Related provisions of the Drugs and Cosmetics Act

Section 3: Contains definitions used in the Act, including the statutory definition of "drug".
Section 16: Deals with standards of quality for drugs.
Section 17: Defines misbranded drugs.
Section 17A: Defines adulterated drugs.
Section 18: Contains prohibitions relating to manufacture for sale or distribution, sale, stocking, exhibition, offer for sale, and distribution of specified drugs and cosmetics.
Section 27: Prescribes penalties for manufacture, sale and other specified dealings with drugs in contravention of Chapter IV. The applicable clause and punishment depend on the nature and consequences of the contravention.
Sections 36AB and 36AC: Contain special procedural provisions concerning specified offences relating to adulterated or spurious drugs, including Special Courts and cognizable/non-bailable treatment in the cases covered by those provisions.

Difference between spurious, adulterated and misbranded drugs

The Act treats these as distinct statutory categories. Section 17 primarily concerns misbranding, Section 17A addresses adulteration, and Section 17B deals with spurious drugs. A particular set of facts should therefore be examined against the wording of the relevant provision rather than treating the three expressions as interchangeable.

Regulatory context

The Drugs and Cosmetics Act, 1940 regulates matters including the import, manufacture, distribution and sale of drugs and cosmetics. The Central Drugs Standard Control Organisation is India's national regulatory authority for drugs and performs central regulatory functions under the Act and the rules made under it. The Drugs Rules, 1945 continue to contain the principal rules governing drugs, subject to amendments and other specialised rules applicable to particular categories.

Legal note: This page is a general statutory guide. Classification of a product and the applicable offence, procedure, penalty, licensing requirement, or defence depend on the facts, the relevant provision, applicable rules and notifications, and the law in force on the relevant date.