Karnataka HC Lets Drug Distributor Resume Business, Bars Two Allegedly Spurious Injections Pending Licence Hearing

The petitioner, a pharmaceutical distributor holding wholesale drug licences Nos. 20B-KA-B22-251265 and 21B-KA-B22-251266, challenged the Licensing Authority’s order dated 19 September 2026 cancelling those licences.

The cancellation followed allegations that the petitioner had dealt in “Zavicefta 2.5 gms Injection” and “Emblaveo Injection,” stated to be spurious drugs.

The impugned order referred to an earlier notice and a show-cause notice, although the writ petition did not aver that the petitioner had received either notice.

The petitioner contended that it had not received an adequate opportunity to be heard and that cancellation of its entire licence was unwarranted.

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 authorises the Licensing Authority, for a licensee’s failure to comply with licence conditions or the Act or Rules, to cancel a licence or suspend it for an appropriate period, wholly or in respect of some of the substances covered by it.

Before doing so, the Authority must give the licensee an opportunity to show cause and issue a written order stating its reasons.

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

The Court observed that Rule 66(1) requires an opportunity to show cause before a licence is suspended or cancelled.

Given the petitioner’s contention that it had not received an adequate hearing, and the fact that the order cancelled the entire licence, the Court considered it appropriate to treat the cancellation order as a show-cause notice, rather than finally determine the merits.

It also directed the Authority to take account of Rule 66(1)’s provision permitting suspension or cancellation in whole or in part.

The petitioner was permitted to reply to the order, treated as a show-cause notice, by 6 November 2026; the Licensing Authority was then to provide a hearing and proceed in accordance with law.

Pending the Authority’s consideration, the petitioner could continue its licensed business, but was prohibited from dealing in “Zavicefta” and “Emblaveo” injections.

All contentions on the merits were kept open.