01Facts
The petitioner held wholesale drug licences bearing Nos. KA-B41-120949 and KA-B41-120950.
p. 2Following an allegation that it had dealt in allegedly spurious “Zavicefta injection,” the Assistant Drugs Controller issued a show-cause notice under Rule 66(1) of the Drugs and Cosmetics Rules, 1945, dated 17 September 2026. Although the notice allowed seven days to respond, the authority cancelled the licences on 19 September 2026, two days later.
pp. 2–3The petitioner challenged the cancellation, relying on its reply dated 18 September 2026 and seeking restoration of the licences or, alternatively, a fresh hearing and decision.
pp. 2–302Issues
i.1. Whether the licensing authority could cancel the petitioner’s licences before the expiry of the response period specified in the show-cause notice and without an effective opportunity to be heard.
pp. 3, 5–6ii.2. Whether the authority was required to consider whether cancellation or suspension could be limited to part of the licence.
p. 603Law Applied
Rule 66(1) of the Drugs and Cosmetics Rules, 1945, permits the Licensing Authority to cancel a licence or suspend it wholly or in respect of some of the substances to which it relates, but only after giving the licensee an opportunity to show cause and issuing a written order stating reasons.
pp. 4–5Rule 66(2) provides a right of appeal to the State Government against an order of suspension or cancellation within three months.
pp. 4–504Reasoning
The notice allowed the petitioner seven days to respond, but the authority cancelled the licences after only two days, on 19 September 2026.
pp. 5–6The Court held that this procedure was ex facie unsustainable because Rule 66(1) required an opportunity to show cause before cancellation or suspension.
pp. 5–6It also observed that the authority had to consider whether any action should extend to the whole licence or only part of it.
pp. 5–6The Court did not determine the merits of the allegation that the product was spurious, leaving all merits contentions open.
p. 705Holding
The Court partly allowed the petition and quashed the cancellation order dated 19 September 2026.
pp. 6–7It permitted the petitioner to file a further reply by 29 October 2026 and directed the authority to provide a hearing and proceed in accordance with law.
pp. 6–7Pending the authority’s consideration, the petitioner could continue its licensed business, except in relation to “Zavicefta injection”.
pp. 6–7Original Court PDF
M/S PATEL MEDICALSvsTHE ASSISTANT DRUGS CONTROLLER - 3(P)
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