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Glenmark Pharmaceuticals Limited & Anr. vs. Union of India & Ors.

Writ Petition (Civil) · 2026:DHC:8137-DBDecided 18 Sept 2026New Delhi Bench
W.P.(C) 13762/2026CNR: DLHC010445822026
Chief Justice Devendra Kumar Upadhyaya · Justice Tejas Karia

Background

Glenmark challenged a Central Government notification dated 18.08.2026, issued under Section 26A of the Drugs and Cosmetics Act, 1940, requiring a warning label ("not to be used in children below four years of age") on fixed-dose combination drugs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, issued without prior notice or hearing to the manufacturer. Glenmark said it complied immediately for all stock made after the notification, but two state drug authorities (Himachal Pradesh and Bangalore) tried to also apply the warning requirement, effectively a recall, to stock manufactured before the notification.

Decision Breakdown

Relying on its own 2025 ruling on a near-identical earlier notification concerning the same drug combination, the Court held that since the notification used the word "shall" without any express provision for retrospective effect, and took effect only upon Gazette publication, it operates prospectively from 18.08.2026 and cannot be applied to stock manufactured earlier. The Court disposed of the petition on terms: Glenmark must label all stock made after 18.08.2026, publish clear public notices in one English and one Hindi national newspaper and issue advisories to doctors, chemists and retailers within two weeks, and file an affidavit detailing pre-notification stock within four weeks, subject to which no coercive recall action under Section 28B would be taken against it.

Lesson Learnt

A government regulation or notification, unless it expressly says otherwise, generally applies only prospectively from its date of publication: manufacturers cannot ordinarily be forced to recall or relabel goods already made before the rule came into force, though courts may still impose reasonable public-safety conditions like consumer notices.

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