Karnataka HC Lets Pharma Distributor Resume Business Except Zavicefta For Now, Quashing Suspension Issued A Day After Show-Cause Notice

The petitioner, a pharmaceutical distributor holding four wholesale drug licences, received a show-cause notice dated 17 September 2026 alleging that it had dealt with two batches of “Zavicefta Injection” stated to be spurious.

Before the petitioner had an opportunity to respond, the licensing authority suspended its licences by order dated 18 September 2026.

The petitioner subsequently submitted a reply dated 23 September 2026 and challenged the suspension in a writ petition.

The High Court granted interim relief and considered the matter under Rule 66 of the Drugs and Cosmetics Rules, 1945.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 authorises the licensing authority to cancel or suspend a licence, wholly or in part, for non-compliance with licence conditions or the Act and Rules, but only after giving the licensee an opportunity to show cause; the authority must issue a written order stating its reasons.

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

The alleged dealing concerned two batches of a specified product, but the authority suspended the petitioner’s licences the day after issuing the show-cause notice, without providing adequate time for a response.

The Court held that further action under Rule 66(1) had to follow an adequate opportunity to respond. It therefore directed the petitioner to submit an additional reply by 28 October 2026, after which the authority was to proceed in accordance with law.

It permitted the petitioner to carry on business under its licences until the authorities passed further orders, but prohibited it from dealing with “Zavicefta Injection” in the meantime.

The parties’ rights and contentions on the merits were left open, and the authorities were not precluded from taking further lawful steps.