WP/30368/2026 of M/S MALLESHWAR SPECIALITIES Vs THE ASSISTANT DRUGS CONTROLLER-1 on 25 September 2026

ORAL ORDER

The present writ petition is filed seeking for the following reliefs: "a) Issue a writ of certiorari or any other appropriate writ, order or direction, quashing the impugned order dated 19.09.2026, bearing Ref. No. ¸ÀA:D¸ÀÄOD/¸ÀO¤-1/¨ÉAªÀÈ- 2/24/26-27 passed by respondent No.1, whereby the petitioners drug licences bearing Nos.20B-KA-B21- 120477 and 21B-KA-B21-120478 have been cancelled, produced as Annexure-B;

b) Issue a writ of mandamus directing the respondents to restore/reinstate the petitioners drug licences bearing Nos. 20B-KA-B21-120477 and 21B-KA-B21-120478 and permit the petitioner to carry on its licensed

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wholesale pharmaceutical business in accordance with law;

c) Pass such other order or orders as this Hon'ble Court may deem fit in the facts and circumstances of the case, in the interest of justice and equity."

2. The petitioner seeks to impugn the order dated 19.09.2026 (Annexure-B to the writ petition) passed under Section 66(1) of Drugs and Cosmetics Rules, 19451 by respondent No.1 - The Assistant Drugs Controller-1, and Licensing Authority, Bengaluru, whereunder, the license of the petitioner who is a distributor of pharmaceutical products has been cancelled.

3. The allegation against the petitioner is that he has carried on business in the purchase and sale of "Zavicefta 2.5 gms Injection" which has been stated to be spurious drug.

4. In this context, it is also pertinent to note that Rule 66(2) of Rules reads as under: "66. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this part or suspend it for such period as he thinks fit, 1 Hereinafter referred as to 'Rules'

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either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder: 1[Provided that, where such failure or contravention is the consequence of an Act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority−

(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or

(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or (d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.] 2[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]"

5. A remedy of an appeal is available to the petitioner under Sub-rule (2) of Rule 66 of Rules.

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6. However, it is the contention of learned counsel for the petitioner that the license of the petitioner ought not to have been cancelled without the petitioner having had an opportunity to show cause. It is further contended that merely on the allegation of the petitioner having dealt with one spurious drug the licence of the petitioner itself has been cancelled.

7. It is forthcoming from perusal of Sub-rule (1) of Rule 66 of Rules that the licensing authority is entitled to pass an order cancelling or suspending a license either wholly or in part after giving the licensee an opportunity to show-cause.

8. In the present case, vide the impugned order dated 19.09.2026 the entire licence of the petitioner has been cancelled without the petitioner having had an opportunity to show cause before the license of the petitioner was cancelled. Further, the authority has not applied its mind as to whether the license is to be cancelled in its entirety or in respect of some of the items dealt with by the petitioner.

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9. It is clear from the aforementioned, that the impugned order dated 19.09.2026 is ex-facie un-sustainable in law.

10. In view of the same, the impugned order dated 19.09.2026 shall be treated as a show-cause and the petitioner shall be permitted to reply to the same on or before 01.10.2026 along with does, if any.

11. Consequent to the reply of the petitioner, the concerned authorities shall take further action in accordance with law after offering an adequate opportunity to the petitioner.

12. Till the decision of the concerned authorities, the impugned order dated 19.09.2026 (Annexure-B to the writ petition) shall remain stayed and the petitioner shall be permitted to carry on its business except dealing with the purchase and sale of "Zavicefta 2.5 gms Injection", in accordance with law;

13. This order shall not come in the way of the concerned authorities carrying out further inspection in accordance with law.

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14. The writ petition is disposed of, in the aforementioned terms.

(C.M. POONACHA) JUDGE

PNV List No.: 1 Sl No.: 15