A minor label variation consistent with the licensed composition does not constitute misbranding.

The Drug Inspector drew samples of “Theruptor Hand Rub” on 26 May 2020 and sent them for analysis. The samples were reported to be of standard quality, but the prosecution alleged misbranding and manufacture without a valid licence, under Section 18(c) of the Drugs and Cosmetics Act, 1940, read with Rule 74 and Condition 3 of Form 25.

The petitioners stated that the manufacturer had obtained a licence on 23 April 2020 and that the product’s composition matched the licence. The alleged labelling defect was the statement “each 100g”.

They sought to quash C.C. No. 42 of 2026 pending before the Chief Judicial Magistrate, Kancheepuram.

1. Whether the prosecution for manufacture without a valid licence could proceed when a manufacturing licence had been issued before the relevant sampling.

2. Whether describing the product’s contents as “each 100g” rendered the drug misbranded under Section 17(c) of the Act.

Section 18(c) of the Drugs and Cosmetics Act, 1940, read with Rule 74 and Condition 3 of Form 25, governs manufacture of drugs without the required licence.

Under Section 17(c), a drug is misbranded if its label or accompanying material contains a statement that is false or misleading in any particular.

The Court also referred to guidelines framed under Section 33(P), which identify labelling errors among minor defects and support resolving minor variations by administrative measures rather than criminal prosecution.

The Court found that the existence of a manufacturing licence was undisputed; accordingly, the allegation of manufacture without a valid licence could not be sustained.

As to misbranding, the analyst found the drug to be of standard quality, and the prosecution did not dispute that its composition, weight, or volume differed from the licence. The only alleged defect was the “each 100g” wording, which the Court found did not make the label false or misleading; the word had also been removed after the show-cause notice.

In light of the minor nature of the labelling variation and the cited guidelines, the Court held that it did not warrant prosecution for misbranding.

It allowed the Criminal Original Petition and quashed the proceedings in C.C. No. 42 of 2026 before the Chief Judicial Magistrate, Kancheepuram; the connected miscellaneous petitions were closed.