Karnataka HC Lets Drug Wholesaler Continue Trading, Except In Zavicefta And Emblaveo, Pending Licence Hearing

The petitioners challenged an order cancelling their wholesale drug licences after an inspection on 2 September 2026.

The alleged ground was that they had dealt in ‘Zavicefta’ and ‘Emblaveo’ injections said to be spurious.

The impugned order records that a notice was issued on 17 September 2026 and a reply submitted on 18 September 2026; the notice was not produced before the Court.

The cancellation order is dated 19 September 2026, although the judgment’s narrative contains a date discrepancy, referring once to 19 September 2016.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 empowers the Licensing Authority to suspend or cancel a licence, wholly or in respect of some substances, for specified non-compliance, but only after giving the licensee an opportunity to show cause and issuing a written order stating reasons.

The Rule also requires the authority to consider whether suspension or cancellation should be partial or complete.

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

The Court noted that the notice of 17 September 2026 had not been placed on record and that the cancellation followed within two days of that notice, despite the petitioners’ reply.

In these circumstances, the Court did not treat the opportunity as sufficient to conclude the matter finally; instead, it directed that the cancellation order itself be treated as a show-cause notice and allowed the petitioners to submit a further reply.

The Court also directed that the authority take account of Rule 66(1)’s provision for suspension or cancellation in whole or in part.

The petitioners were permitted to file a further reply to the impugned order, after which the concerned authority was to provide a hearing and proceed in accordance with law.

Pending that consideration, the petitioners could continue their business under the licences, except in relation to ‘Zavicefta’ and ‘Emblaveo’ injections; the parties’ contentions on the merits were left open.

The judgment states that the reply was to be filed by 29 June 2026, a date that precedes the judgment and the impugned order; the text therefore appears to contain a date error, and no corrected deadline can be determined from the supplied judgment.