Karnataka High Court
Administrative and Public LawHealth and Medical Law

Rule 66 requires a show-cause opportunity before suspending a drug licence.

VIVA PHARMA vs THE ASSISTANT DRUGS CONTROLLER-3(P),

Karnataka High CourtJUDGMENT: September 25, 20262 MIN READSOURCE JUDGMENT
Rule 66 requires a show-cause opportunity before suspending a drug licence.. VIVA PHARMA vs THE ASSISTANT DRUGS CONTROLLER-3(P),. Karnataka High Court. LawLens
THE ORIGINAL LAWLENS SUMMARY
01

Facts

Viva Pharma, a pharmaceutical distributor based in Belagavi, challenged a show-cause notice-cum-suspension order dated 18 September 2026, issued under Rule 66 of the Drugs and Cosmetics Rules, 1945, which suspended its drug licences.

Source reference: pp. 3–4

The allegation was that Viva Pharma procured Zavicefta Injection through the authorised supply channel but sold it to entities to which it was not entitled to sell.

Source reference: p. 5

The Registry objected that the petition should be presented before the Dharwad Bench because the petitioner carried on business in Belagavi.

Source reference: p. 3

The petitioner submitted that it had appealed under Rule 66(2) to the State Government appellate authority in Bengaluru, but the appeal had not been entertained.

Source reference: p. 3

The petitioner had also filed a reply to the impugned notice.

Source reference: p. 6
02

Issues

Whether a licensing authority may suspend a drug licence through a show-cause notice-cum-suspension order without first giving the licensee an opportunity to show cause, as required by Rule 66(1).

Source reference: pp. 6–7

Whether the Registry’s objection that the petition should be presented before the Dharwad Bench prevented the Court from considering the petition.

Source reference: p. 3
03

Law Applied

Rule 66(1) of the Drugs and Cosmetics Rules, 1945 permits the licensing authority to suspend or cancel a licence for specified non-compliance, but requires that the licensee first be given an opportunity to show cause and that the authority state its reasons in writing.

Source reference: pp. 4–5, 7

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

Source reference: p. 5

The Court cited no precedent.

Source reference: no citation
04

Reasoning

The Court held that Rule 66(1) requires an opportunity to respond before an order suspending or cancelling a licence is passed.

Source reference: p. 7

The impugned instrument both notified the petitioner of the allegations and immediately suspended its licences; the Court found that this combined action was contrary to the Rule.

Source reference: p. 7

It did not decide the merits of the allegations against the petitioner.

Source reference: p. 6

The Court noted the Registry’s territorial objection and the petitioner’s submission concerning the Bengaluru appellate authority, but did not expressly determine the objection.

Source reference: p. 3
05

Holding

The Court directed that the impugned order be read only as a show-cause notice.

It permitted the petitioner to file an additional reply by 1 October 2026, after which the authorities were to pass appropriate orders in accordance with law.

Source reference: p. 7

Pending further action, the petitioner was permitted to carry on its business in accordance with law; the authorities remained free to take further lawful steps, and the petitioner was directed to cooperate.

Source reference: pp. 7–8

The writ petition was disposed of on those terms.

Source reference: p. 8
Karnataka High Court

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VIVA PHARMAvsTHE ASSISTANT DRUGS CONTROLLER-3(P),

Karnataka High Court · September 25, 2026

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