Karnataka HC Quashes Drug-Licence Suspension, Lets Distributor Trade Except In Zavicefta Injection Pending Hearing

The petitioners, a pharmaceutical distributor and its partner, challenged the Assistant Drugs Controller’s order dated 18 September 2026 suspending their drug licences after issuing a show-cause notice dated 15 September 2026.

The allegation was that the petitioners had dealt in “Zavicefta injection,” alleged to be spurious.

The petitioners contended that the licences were suspended before they had a meaningful opportunity to respond to the notice.

They sought quashing of the order and restoration of their licences.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 empowers the licensing authority to cancel or suspend a licence, wholly or in respect of some of the substances covered by it, for failure to comply with licence conditions or the Act or Rules; before doing so, the authority must give the licensee an opportunity to show cause and state its reasons in writing.

Rule 66(2) provides for an appeal to the State Government against an order of suspension or cancellation within three months.

The Court held that Rule 66(1) required the petitioners to be given an opportunity to respond before their licences were suspended.

The notice was issued on 15 September 2026, but the suspension order followed on 18 September 2026, before the petitioners had the opportunity contemplated by the notice; the Court therefore found the suspension unsustainable.

It also observed that the authority had to consider whether any suspension or cancellation should apply only in part, rather than to the licences as a whole.

It permitted the petitioners to reply to the show-cause notice by 29 October 2026 and directed the authority, after hearing them, to proceed in accordance with law.

Pending that consideration, the petitioners could carry on business under their licences, except in relation to “Zavicefta injection”; all contentions on the merits were left open.