Section 17 of Drugs and Cosmetics Act 1940 - Misbranded Drugs
Section 17 of the Drugs and Cosmetics Act, 1940 specifies when a drug is deemed to be misbranded for the purposes of Chapter IV of the Act. The provision focuses on deceptive appearance, failure to comply with prescribed labelling requirements, and false or misleading claims made on or with a drug.
Text and meaning of Section 17
For the purposes of this Chapter, a drug shall be deemed to be misbranded in any of the following circumstances:
A drug is misbranded if it is coloured, coated, powdered or polished in a manner that conceals damage, or if it is made to appear to possess better or greater therapeutic value than it actually has.
A drug is misbranded if it is not labelled in the prescribed manner. The detailed labelling requirements are primarily found in the Drugs Rules, 1945, including the rules governing prohibition of sale without prescribed labelling and the manner in which drug labels are to display required particulars.
A drug is misbranded if its label, container or anything accompanying it bears a statement, design or device that makes a false claim for the drug or is false or misleading in any particular.
What is a "drug" for this provision?
Section 3(b) of the Drugs and Cosmetics Act, 1940 contains the statutory definition of "drug". Broadly, it covers medicines for internal or external use in human beings or animals, specified substances intended for diagnosis, treatment, mitigation or prevention of disease or disorder, specified substances intended to affect the structure or function of the human body, and substances intended for use as components of a drug, subject to the precise wording and notifications under the Act.
Labelling and Section 17(b)
Clause (b) links Section 17 directly with the labelling requirements prescribed under the Drugs Rules, 1945. Rule 95 addresses the prohibition on sale or distribution of drugs unless labelled in accordance with the Rules, while Rule 96 lays down the manner of labelling and the particulars required on drug containers and coverings. The applicable requirement can vary with the nature and category of the drug.
Practical effect of Section 17
The three clauses cover different forms of misbranding. Clause (a) deals with deceptive physical presentation or an appearance suggesting greater therapeutic value. Clause (b) deals with non-compliant labelling. Clause (c) addresses false or misleading claims or representations appearing on the label, container or accompanying material.
Related provisions
Section 17 should be read with the surrounding provisions of Chapter IV. Section 17A deals with adulterated drugs and Section 17B deals with spurious drugs. Section 18 contains prohibitions concerning the manufacture for sale or distribution, sale, stocking, exhibition, offering for sale or distribution of specified drugs and cosmetics, subject to the Act. Penalties for contraventions involving drugs are dealt with under Section 27, with the applicable consequence depending on the nature of the contravention.
Official legal resources
For current regulatory material, amendments and notifications, refer to the official Central Drugs Standard Control Organisation resources: CDSCO Acts and Rules, Drugs Rules, 1945, and CDSCO Gazette Notifications.
This page is an informational presentation of the statutory provision. For a particular product or regulatory issue, the Act, applicable Rules, amendments, notifications and licence conditions should be checked together.