Suspending an entire drug licence is unsustainable when allegations concern a specific product.

The petitioner, a pharmaceutical distributor holding four drug licences, received a notice dated 15 September 2026 under Rule 66(1) of the Drugs and Cosmetics Rules, 1945, concerning its alleged dealings in Zavicefta 2.5 gm Injection, Batch No. 25K02759, suspected to be spurious.

Although the notice allowed seven days to respond, the licensing authority suspended the petitioner’s licences on 18 September 2026, three days later.

The petitioner challenged the suspension, contending that it had been made before the opportunity to respond had elapsed and that suspension of all its licences was disproportionate to an allegation concerning one product.

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

2. Whether suspension of all the petitioner’s licences was sustainable where the allegation concerned dealings in one specific suspected drug.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 authorises the licensing authority, by a reasoned written order, to cancel or suspend a licence wholly or in respect of some of the substances to which it relates, but only after giving the licensee an opportunity to show cause.

Rule 66(2) provides a licensee whose licence is suspended or cancelled a right to appeal to the State Government within three months of the order.

The Court found that the petitioner had been given seven days to answer the notice, yet the licences were suspended after only three days.

This did not afford the petitioner the opportunity to show cause required by Rule 66(1).

Further, because the allegation concerned one specific suspected drug, suspending the petitioner’s entire set of licences was unsustainable; Rule 66(1) permits suspension in respect of only some substances.

The Court therefore quashed the suspension while directing the petitioner to respond to the notice and the authorities to reconsider the matter.

It permitted the petitioner to file its reply to the notice by 19 October 2026 and directed the authorities to pass appropriate orders in accordance with Rule 66(1).

Pending those orders, the petitioner could continue its licensed business except in relation to Zavicefta Injection.

The parties’ rights and contentions on the merits were left open.