Child-safety warning for chlorpheniramine–phenylephrine medicines applies prospectively; Glenmark protected from coercive action for older stocks subject to public notices

The Petitioners challenged the Notification dated 18.08.2026 issued by the Union of India under Section 26A of the Drugs and Cosmetics Act, 1940, restricting the manufacture, sale and distribution of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride unless the label, package insert or promotional literature carried the warning that the combination “shall not be used in children below four years of age”.

The Petitioners stated that their formulations had been lawfully approved and that one formulation had received approval from the State Drugs Controller, Himachal Pradesh, on 06.04.2026.

The Petitioners complied with the Notification for formulations manufactured after 18.08.2026, but challenged its alleged retrospective application to pre-existing stocks.

They withdrew the prayers challenging the Advisory and Letter, sought liberty to pursue appropriate remedies, and requested deletion of Respondent Nos. 3 to 5.

Whether the Notification dated 18.08.2026 operated retrospectively so as to impose its warning requirement upon stocks manufactured before its publication in the Official Gazette?

Whether the Petitioners should receive protection from coercive action under Section 28B of the Drugs and Cosmetics Act, 1940, in respect of pre-18.08.2026 stocks, subject to specified safeguards?

What consequential directions should govern the Petitioners’ existing stocks and compliance with the public-health object of the Notification?

The Court applied Section 26A of the Drugs and Cosmetics Act, 1940, under which the Central Government may regulate, restrict or prohibit the manufacture, sale or distribution of drugs in the public interest.

It also considered Section 28B of the Act, concerning penal consequences for contravention of specified regulatory provisions, and directed that no coercive measures under that provision be taken subject to compliance with the Court’s conditions.

The Court relied on its earlier order dated 24.04.2025 in Glenmark Pharmaceuticals Limited & Anr. v. Union of India & Anr., W.P.(C) 5037/2025, which held that a notification imposing an identical warning requirement could not operate retrospectively in the absence of express retrospective language; a notification taking effect upon publication in the Official Gazette ordinarily operates prospectively.

The use of “shall” in the warning requirement and the express commencement clause were treated as indicating prospective operation from the date of publication.

The Court noted that the Notification expressly came into force upon publication in the Official Gazette on 18.08.2026 and prescribed a mandatory warning for stocks manufactured and circulated thereafter.

Since it contained no express provision giving it retrospective effect, and employed mandatory language linked to its commencement date, the Court held that the Notification operated prospectively from 18.08.2026.

The Petitioners had already undertaken to comply with the warning requirement for post-18.08.2026 manufacture, and their surviving grievance concerned only pre-existing stocks.

Balancing the prospective operation of the Notification against the public-health concern regarding administration of the combination to children below four years, the Court adopted safeguards analogous to those imposed in the earlier Glenmark matter.

Protection from coercive action was made conditional upon full compliance with those directions.

The Petitioners were directed to comply with the warning requirement for all stocks manufactured and circulated after 18.08.2026.

For pre-18.08.2026 stocks, they were directed to publish prominent notices in one English and one Hindi national newspaper, issue advisories to doctors, retailers and chemists stating that the combination must not be prescribed for children below four years, and file an affidavit detailing such stocks within four weeks.

Upon compliance, no coercive measures under Section 28B were to be taken against the Petitioners.

The newspaper notice was not to be treated as an advertisement violating the manufacturing licence conditions.

The prayers challenging the Advisory and Letter were dismissed as withdrawn with liberty to pursue remedies in law, Respondent Nos. 3 to 5 were deleted, and the petition was disposed of with the matter listed for compliance on 05.11.2026.