A drug licence cannot be suspended before the licensee receives an opportunity to show cause.

The petitioner, a pharmaceutical distributor, challenged action concerning its drug licences after allegedly procuring Zavicefta Injection from a supply channel not authorised by Pfizer and supplying the product to other entities

The petitioner’s prayer referred to a cancellation order dated 21 September 2026, while the Court’s consideration and directions concerned a show-cause-cum-suspension notice dated 19 September 2026

The petitioner had submitted a reply to that notice and also filed an appeal or representation dated 24 September 2026

The Registry objected that the petition should be presented before the Dharwad Bench because the petitioner carried on business in Belagavi; the petitioner responded that its appeal was before an authority situated in Bengaluru

1. Whether the notice dated 19 September 2026 could both call upon the petitioner to show cause and immediately suspend its licence under Rule 66(1) of the Drugs and Cosmetics Rules, 1945

2. Whether the petitioner should be permitted to continue its business pending the authorities’ further action on the notice

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 empowers the licensing authority to suspend or cancel a licence, wholly or partly, after giving the licensee an opportunity to show cause and recording reasons in writing; the Rule also provides specified protections where the alleged breach results from an agent’s or employee’s act or omission

Under Rule 66(2), a licensee may appeal an order of suspension or cancellation to the State Government within three months

The Court also noted that the authority’s choice between whole or partial suspension or cancellation must be considered when taking further action

The Court read Rule 66(1) as requiring an opportunity to show cause before an order of suspension or cancellation is made.

Because the notice both stated the allegations and suspended the petitioner’s licence, the Court found that it could not operate as a final suspension order at that stage.

It therefore treated the notice only as a show-cause notice, allowed the petitioner to file an additional reply, and left the merits and appropriate scope of any further action to the authorities.

The Court did not expressly decide the Registry’s objection regarding presentation before the Dharwad Bench.

The petitioner could file an additional reply by 8 October 2026, after which the concerned authorities were to pass appropriate orders in accordance with law.

Pending further action, the petitioner was permitted to continue its business in accordance with law, except in relation to Zavicefta and Emblaveo Injection; the authorities remained free to take further lawful steps.