Introduction:

In the case of Dabur India Ltd v. State of Maharashtra & Ors. (WRIT PETITION NO. 2131 OF 2025), The Bombay High Court adjudicated upon a dispute concerning the labeling of certain Dabur toothpaste products. The issue arose after the Commissioner of the Food and Drug Administration (FDA), Government of Maharashtra, directed Dabur India Ltd to remove terms such as ‘anti-inflammatory,’ ‘anti-bacterial,’ and ‘analgesic’ from its toothpaste labels to comply with the Drugs and Cosmetics Act, 1940. While the FDA observed that the claims were not hazardous to health, they were legally incorrect and in violation of statutory provisions.

Dabur India Ltd responded to the order by submitting an affidavit before the Bombay High Court, agreeing to discontinue the use of these terms on its ‘Dabur Meswak Toothpaste’ and ‘Dabur Herb’ Anti-Bacterial Toothpaste Tulsi.’ The division bench, comprising Justice G. S. Kulkarni and Justice Advait M. Sethna, recorded this commitment and ruled that from June 2025 onward, the company shall not manufacture or sell these products with the contested labels. The Court also allowed the existing stock, valued at approximately Rs. 1 crore, to be utilized by 31 May 2025, beyond which it would not be permitted for sale.

Petitioner’s (Dabur India Ltd) Arguments:

Dabur India Ltd contended that the labels were not misleading in a health hazard context and that their removal would cause financial strain. However, to comply with regulatory directives, the company voluntarily agreed to eliminate the contested terms from its packaging. The company further argued that the restricted stock should be allowed to be sold or disposed of within a stipulated period instead of an outright ban.

Respondent’s (State of Maharashtra & FDA) Arguments:

The FDA emphasized that the use of medical terminologies such as ‘anti-inflammatory,’ ‘anti-bacterial,’ and ‘analgesic’ on toothpaste products could mislead consumers by implying therapeutic efficacy. The authority argued that under the Drugs and Cosmetics Act, 1940, such claims could only be made for medicinal products subject to regulatory approvals. They sought strict compliance to ensure consumers were not misled by exaggerated claims.

Court’s Judgment:

The Bombay High Court accepted Dabur’s commitment and ruled that from June 2025, the company shall not manufacture or sell its toothpaste with the contested claims either on product packaging or individual tubes. The Court permitted the utilization of the existing stock under the following conditions:

The stock forming the subject matter of the impugned order, valued at approximately Rs. 1 crore, must be used or sold before 31 May 2025.

Any remaining stock beyond 31 May 2025 shall not be sold in the market.

Dabur was also required to ensure that its new packaging aligns with regulatory compliance.

With these directions, the Court disposed of the petition, ensuring a balance between regulatory compliance and allowing the company a reasonable transition period for rectification.