Suspending an entire drug licence over allegations concerning one specific medicine is unsustainable.

The petitioner, a pharmaceutical distributor holding three drug licences, received a show-cause notice dated 15 September 2026 under Rule 66(1) of the Drugs and Cosmetics Rules, 1945, concerning its alleged dealing in “Emblaveo 1.5 mg Injection,” suspected to be spurious.

Although the notice allowed seven days for a reply, the licensing authority suspended the petitioner’s licences on 18 September 2026, before that period expired.

The petitioner challenged the suspension by writ petition.

1. Whether the licensing authority could suspend the petitioner’s licences before giving it an effective opportunity to show cause under Rule 66(1).

2. Whether suspension of the petitioner’s entire licences was sustainable where the allegation concerned a specific drug.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 empowers the licensing authority to cancel or suspend a licence, wholly or in part, after giving the licensee an opportunity to show cause and recording reasons in writing.

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

No judicial precedent was cited.

The Court observed that Rule 66(1) required an opportunity to show cause before suspension or cancellation.

The authority issued the notice on 15 September 2026 but suspended the licences on 18 September, despite the notice allowing seven days for a reply.

The Court also considered the breadth of the suspension disproportionate to the allegation, which concerned dealings in a particular suspected drug, and held that suspending the petitioner’s entire licences was ex facie unsustainable.

The authorities were directed to pass appropriate orders thereafter, having regard to Rule 66(1).

Pending those orders, the petitioner could continue its licensed business, except for dealing in “Emblaveo Injection.”

The petition was allowed in part, with the parties’ contentions on the merits left open.