M/S FORTUNE MEDICAL SOLUTIONS vs THE ASSISTANT DRUGS CONTROLLER 1
- Court
- Karnataka High Court
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HC-KAR
NC: 2026:KHC:58640
WP No. 31213 of 2026
CNR: KAHC010684742026
IN THE HIGH COURT OF KARNATAKA AT BENGALURU
TH
DATED THIS THE 15 DAY OF OCTOBER, 2026
BEFORE
THE HON'BLE MR. JUSTICE C.M. POONACHA
WRIT PETITION NO. 31213 OF 2026 (GM-RES)
BETWEEN:
1. M/S FORTUNE MEDICAL SOLUTIONS
REGISTERED UNDER THE DRUGS AND
COSMETICS ACT, 1940 AND THE
RULES MADE THEREUNDER
HAVING OFFICE AT NO.37.
GROUND FLOOR, FIRST FLOOR,
ND
SURVEY NO. 17/21, 32 MAIN,
CHINNAPPA NAIDU LAYOUT.
RSK 3RD STAGE, BENGALURU - 560085
REPRESENTED BY ITS MANAGING PARTNER
MR NAGARJUN MG,
S/O SRI. M GOVINDARAJU,
AGED ABOUT 37 YEARS,
2. MRS. NIKHILA G L,
W/O MR.NAGARJUN M G.,
AGED ABOUT 36 YEARS,
R/AT NO. 405, 4TH FLOOR,
SRI SAI SINDHUJA RESIDENCY.
1ST CROSS, 7TH MAIN,
NANDAKUMAR LAYOUT, AREHALLI,
UTTARAHALLI, BENGALURU - 560061.
…PETITIONERS
(BY MS.S.M. ASHA, ADVOCATE FOR
SRI. PRASANNA KUMAR B T.,ADVOCATE)
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WP No. 31213 of 2026
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AND:
1. THE ASSISTANT DRUGS CONTROLLER 1
AND LICENSING AUTHORITY,
OFFICE OF THE ASSISTANT
DRUGS CONTROLLER, ADC-1,
BENGALURU CIRCLE-4, PALACE ROAD,
BENGALURU 560001.
2. THE COMMISSIONER,
DEPARTMENT OF FOOD SAFETY AND
DRUGS ADMINISTRATION,
GOVERNMENT OF KARNATAKA,
BENGALURU 560001.
3. THE PRINCIPAL SECRETARY,
HEALTH AND FAMILY WELFARE DEPARTMENT,
GOVERNMENT OF KARNATAKA,
VIKASA SOUDHA, BENGALURU 560001.
…RESPONDENTS
(BY SRI. RAHUL CARIAPPA K S, AGA)
THIS WP IS FILED UNDER ARTICLES 226 & 227 OF THE
CONSTITUTION OF INDIA PRAYING TO ISSUE A WRIT OF
CERTIORARI OR ANY OTHER APPROPRIATE WRIT, ORDER OR
DIRECTION QUASHING THE IMPUGNED ORDER DATED
19.09.2026 BEARING NO. A SU OU A/SACHOU-1/BEM BAI TTA-
4/200/2026-27, PASSED BY RESPONDENT NO.3, PRODUCED AT
ANNEXURE-B, WHEREBY THE PETITIONERS WHOLESALE DRUG
LICENCES BEARING NOS. KA/B41/20D-270650 AND
KA/B41/21.B270652 HAVE BEEN CANCELLED.
THIS PETITION, COMING ON FOR PRELIMINARY HEARING
IN 'B' GROUP, THIS DAY, ORDER WAS MADE THEREIN AS
UNDER:
CORAM: HON'BLE MR. JUSTICE C.M. POONACHA
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WP No. 31213 of 2026
CNR: KAHC010684742026
ORAL ORDER
1. The present petition is filed seeking for the following
reliefs:
"a. Issue a writ of CERTIORARI or any other
appropriate writ, order of direction quashing the
impugned order dated 19.09.2026 bearing No.
passed by
D¸ÀÄOD/¸ÀO¤-1/¨ÉA.ªÀÈvÀÛ-4/200/2026-27,
Respondent No.3, produced at ANNEXURE-B,
whereby the Petitioner's wholesale drug licences
bearing Nos. KA/B41/20B-270650 and KA/B41/21B-
270652 have been cancelled;
b. Declare that the impugned order is contrary to
Rule 66(1) of the Drugs and Cosmetics Rules, 1945,
violative of principles of natural justice and Articles
14 and 19(1)(g) of the Constitution of India;
c. Direct the Respondents to restore/revive the
Petitioner's wholesale drug licences bearing Nos.
KA/B41/20B-270650 and ΚΑ/Β41/218-270652
forthwith, produced at ANNEXURE-B.
d. In the alternative, remand the matter to
Respondent No.3 for fresh consideration strictly in
accordance with Rule 66(1) of the Drugs and
Cosmetics Rules, 1945 after issuing a proper and
specific show-cause notice proposing cancellation,
furnishing all material relied upon and granting the
Petitioner a reasonable and effective opportunity of
hearing ; "
2. The petitioner is an authorized dealer of Pharmaceutical
Products. It is the case of the petitioner that an inspection was
conducted by the respondent - authorities on 02.09.2026.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 31213 of 2026
CNR: KAHC010684742026
Subsequently, an order dated 19.09.2016 has been passed,
whereunder the licence of the petitioner has been cancelled
1
under Rule 66(1) of the Drugs and Cosmetics Rules, 1945 . It is
the allegation against the petitioner that it has dealt with
'Zavicefta' and 'Emblaveo' injections which are alleged to be
spurious.
3. In this context, it is relevant to note Rule 66 of the Rules,
1945, which 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, 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:
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
1
Hereinafter referred to 'Rules'
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 31213 of 2026
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(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) 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."
4. A plain reading of sub-rule (1) of Rule 66 of the Rules,
clearly indicates that the petitioner is entitled to be given a
show cause notice before an order of either suspension or
cancellation is passed.
5. It is forthcoming from the impugned order dated
19.09.2026 that pursuant to the inspection conducted on
02.09.2026, a notice dated 17.09.2026 has been issued and
the petitioner has furnished his reply dated 18.09.2026 (date of
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 31213 of 2026
CNR: KAHC010684742026
reply is mentioned as 18.09.2002 in the order dated
19.09.2026). The notice dated 17.09.2026 stated to have been
issued to the petitioner has not been placed on record.
However, it is clear and forthcoming from the aforementioned
factual matrix that although the petitioner is stated to have
furnished a reply to the notice dated 17.09.2026, the impugned
order dated 19.09.2026 is passed within two days of the notice
dated 17.09.2026.
6. It is further relevant to note that by virtue of sub-rule (1)
of Rule 66 of the Rules, the licence of the petitioner could be
suspended or cancelled either in whole or part. The said aspect
of the matter is also required to be taken into account by the
concerned authorities.
7. In view of the aforementioned peculiar factual matrix, the
impugned cancellation order dated 19.09.2026 shall also be
treated as a show cause notice and the petitioner shall be
permitted to file its reply to the impugned order dated
19.09.2026 (this is since the same has been treated as a show
cause notice), which reply shall be filed on or before
29.06.2026. This reply shall be, in addition to any reply that
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 31213 of 2026
CNR: KAHC010684742026
has already been filed by the petitioner. Consequent to reply of
the petitioner, the concerned authority shall afford an
opportunity of hearing to the petitioner and take further steps
in accordance with law.
8. Until consideration of the matter by respondent No.1, the
petitioner shall be permitted to carry of its business in terms of
the licence except dealing with 'Zavicefta' and 'Emblaveo'
injections.
9. All contentions of the parties in the merits of the matter
are kept open.
10. Writ petition is partly allowed in the aforesaid terms.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
(C.M. POONACHA)
JUDGE
BS
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