01Facts
The petitioner, an authorised pharmaceutical distributor, received a show-cause notice under Rule 66(1) of the Drugs and Cosmetics Rules, 1945, alleging that it had dealt with two batches of Zavicefta Injection stated to be spurious.
p. 3 · ¶ 2The petitioner replied on 18 September 2026, and on the same day the licensing authority cancelled five wholesale drug licences.
p. 3 · ¶ 3The petitioner appealed under Rule 66(2) on 24 September 2026; while the appeal remained pending, it sought relief under Articles 226 and 227 of the Constitution.
pp. 2–3 · ¶ 302Issues
i.Whether, pending the petitioner’s statutory appeal, it should be permitted to carry on business under its licences despite their cancellation.
pp. 5–6 · ¶ 7–9ii.Whether that interim permission should extend to dealing in Zavicefta Injection, the product connected with the allegation.
p. 6 · ¶ 8–903Law Applied
Rule 66(1) of the Drugs and Cosmetics Rules, 1945 authorises the licensing authority, after giving the licensee an opportunity to show cause and recording reasons in writing, to cancel or suspend a licence wholly or in respect of some of the substances to which it relates.
pp. 4–5 · ¶ 4Under Rule 66(2), a licensee may appeal an order of suspension or cancellation to the State Government within three months, and the State Government is to decide the appeal.
p. 5 · ¶ 404Reasoning
The allegation concerned two batches of one product, yet the authority cancelled all five of the petitioner’s licences.
p. 5 · ¶ 7The Court noted that Rule 66(1) permits cancellation or suspension either wholly or in part, after an opportunity to show cause.
p. 5 · ¶ 6Since the statutory appeal was pending, the Court considered it appropriate to allow the petitioner to continue its licensed business in the meantime, while excluding the product to which the allegation related.
p. 6 · ¶ 8–9It left the parties’ contentions on the merits open for determination in the appeal.
p. 6 · ¶ 1005Holding
The Court disposed of the writ petition by directing that, until adjudication of the appeal, the petitioner be permitted to conduct business under its licences in accordance with law, except for dealing in Zavicefta Injection.
p. 6 · ¶ 9, 12The merits were left open in the appeal, and the order did not prevent the authorities from taking further action in accordance with law.
p. 6 · ¶ 10–11Original Court PDF
M/S SAGAR PHARMA (DIVISION OF SAGAR HEALTH CARE AND DIAGNOSTIC SERVICE PVT LTDvsTHE ASSISTANT DRUGS CONTROLLER-2
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