Karnataka High CourtAdministrative and Public LawHealth and Medical Law

Hubballi Drug Distributor May Trade For Now, But Karnataka HC Bars Sales Of Allegedly Spurious Zavicefta Pending Appeal

M/S KOSIK PHARMA AND SURGICAL DISTRIBUTORSv.THE ASSISTANT DRUGS CONTROLLER 2

Hubballi Drug Distributor May Trade For Now, But Karnataka HC Bars Sales Of Allegedly Spurious Zavicefta Pending Appeal. M/S KOSIK PHARMA AND SURGICAL DISTRIBUTORS vs THE ASSISTANT DRUGS CONTROLLER 2. Karnataka High Court. LawLens
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In brief

The question

Whether interim protection should be granted against the licence-cancellation order while the petitioner’s statutory appeal remained pending

The court held

The writ petition was disposed of by staying the cancellation order dated 30 September 2026 until the petitioner’s appeal is considered.

It also directed

During the appeal, the petitioner may carry on business under its licences, but may not deal in “Zavicefta injection.”

The order does not prevent the authorities from taking further steps in accordance with law.

01Facts

The petitioner, a pharmaceutical distributor, held drug licences KA/HB2/20B/222721 and KA/HB2/21B-222722.

pp. 4–5 · ¶ 3–4

Following a show-cause notice alleging that it dealt with a batch of “Zavicefta injection” said to be spurious, the petitioner submitted a reply.

pp. 4–5 · ¶ 3–4

On 30 September 2026, the first respondent cancelled the licences.

pp. 4–5 · ¶ 3–4

The petitioner appealed to the Principal Secretary, Health and Family Welfare Department, under Rule 66(2) of the Drugs and Cosmetics Rules, 1945, and sought interim relief.

pp. 4–5 · ¶ 3–4

While the appeal remained pending, the petitioner filed this writ petition challenging the cancellation order.

pp. 4–5 · ¶ 3–4

02Issues

i.Whether interim protection should be granted against the licence-cancellation order while the petitioner’s statutory appeal remained pending

p. 7 · ¶ 8

ii.Whether the petitioner should be permitted to continue its licensed business during the appeal, subject to restrictions concerning the product alleged to be spurious

pp. 7–8 · ¶ 8–9

03Law Applied

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

pp. 5–6 · ¶ 4

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

pp. 5–6 · ¶ 4

The Court noted that the Rule provides for either suspension or cancellation, wholly or in part.

p. 7 · ¶ 7

04Reasoning

The Court did not examine the merits of the allegation that the product was spurious.

pp. 6–7 · ¶ 6–7

It noted that the petitioner’s statutory appeal was pending and that Rule 66(1) requires an opportunity to show cause before suspension or cancellation; it also observed that the scope of the authority’s power to suspend or cancel wholly or in part could be considered in the appeal.

pp. 6–7 · ¶ 6–7

To preserve the petitioner’s position pending that determination while addressing the allegation concerning the specific product, the Court stayed the cancellation order but prohibited the petitioner from dealing in “Zavicefta injection”.

p. 7 · ¶ 8 · p. 8 · ¶ 9

The parties’ contentions and the merits were expressly left open for the appellate authority.

p. 8 · ¶ 10

05Holding

The writ petition was disposed of by staying the cancellation order dated 30 September 2026 until the petitioner’s appeal is considered.

p. 7 · ¶ 8 · p. 8 · ¶ 9, 11–12

During the appeal, the petitioner may carry on business under its licences, but may not deal in “Zavicefta injection.”

p. 7 · ¶ 8 · p. 8 · ¶ 9, 11–12

The order does not prevent the authorities from taking further steps in accordance with law.

p. 7 · ¶ 8 · p. 8 · ¶ 9, 11–12
Karnataka High Court

Original Court PDF

M/S KOSIK PHARMA AND SURGICAL DISTRIBUTORSvsTHE ASSISTANT DRUGS CONTROLLER 2

Karnataka High Court · October 27, 2026

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