M/S SWS PHARMA vs THE ASSISTANT DRUGS CONTROLLER-2
- Court
- Karnataka High Court
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HC-KAR
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WP No. 30542 of 2026
CNR: KAHC010668462026
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. 30542 OF 2026 (GM-RES)
BETWEEN:
1. M/S SWS PHARMA
REGISTERED UNDER THE DRUGS AND
COSMETICS ACT, 1940 AND
THE RULES MADE THEREUNDER REG.
OFFICE AT 138, BESIDE JAMIA MASJID,
OPP POLICE STATION,
NANDAGUDI,
BENGALURU RURAL - 562122
REPRESENTED BY ITS PROPRIETOR
MR.SYED TABREZ PASHA,
AGED ABOUT 38 YEARS
S/O. SYED WAZEER.
…PETITIONER
(BY MS. S.M. ASHA, ADVOCATE FOR
SRI. PRASANNA KUMAR B T.,ADVOCATE)
AND:
1. THE ASSISTANT DRUGS CONTROLLER-2
AND LICENSING AUTHORITY,
OFFICE OF THE ASSISTANT
DRUGS CONTROLLER, ADC-2,
BENGALURU CIRCLE-5, 1ST FLOOR,
ANNEXURE BUILDING-I,
BENGALURU VRUTHA-5,
PALACE ROAD,
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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 QUASHING THE
IMPUGNED ORDER DATED 19.09.2026, BEARING REF. NO,
PASSED BY RESPONDENT NO.1, WHEREBY THE PETITIONERS
DRUG LICENCES BEARING NOS. KA/B52/20B/288687 AND
KA/B52/21B/288689 AND KA/B52/20G / 288688 HAVE BEEN
CANCELLED, PRODUCED AS ANNEXURE-B.
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. 30542 of 2026
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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 or direction, quashing the
impugned order dated 19.09.2026, bearing Ref.
ªÀ
No. : / / -5/ / 226/26-27,
ಸಂ ಆಸುಔಆ ಸಔ#ಕ %ೆಂ È ರದು)
passed by Respondent No.1, whereby the
Petitioner's Drug Licences bearing Nos.
KA/B52/208/288687 & ΚΑ/ Β52/218 / 288689 &
KA/B52/20G / 288688 have been cancelled,
produced as ANNEXURE-B;
b) Issue restore/reinstate the writ of Mandamus
directing the Respondents to Petitioner's Drug
Licences bearing Nos. KA/B52/208/288687 & ΚΑ/
Β52/21B / 288689 & KA/B52/20G / 288688 and
permit the Petitioner to carry on its licensed
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 is an authorized distributor of
pharmaceutical products and has been issued with the
impugned show cause notice dated 17.09.2026 (Annexure - C
to the writ petition), consequent to which the impugned order
dated 19.09.2026 (Annexure- B to the writ petition) has been
passed whereunder the license of the petitioner has been
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 30542 of 2026
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cancelled. The notice dated 17.09.2026 has been issued under
1
Rule 66(1) of the Drugs and Cosmetics Rules, 1945 . The
allegation against the petitioner is that it has dealt with
'Zavicefta injection' which is alleged to be spurious.
3. In this context, it is relevant to note Rule 66 of the Rules,
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
(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
1
Hereinafter referred to as 'Rules'
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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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 the contended of the petitioner that although seven
days time was granted under notice dated 17.09.2026 for the
petitioner to respond to the same within two days i.e., on
19.09.2026, the license of the petitioner has been cancelled.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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The action of the respondent for canceling the license of the
petitioner ex-facie unsustainable in law.
6. It is further relevant to note that by virtue of sub-rule (1)
of Rule 66 of the Rules, the license 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. Accordingly, the impugned order dated 19.09.2026
issued by respondent No.1- Assistant Drugs Controller - 2 and
licensing authority is hereby quashed.
8. The petitioner shall be permitted to file reply to the show
cause notice dated 17.09.2026 (Annexure - C to the writ
petition) on or before 29.10.2026. Consequent to the reply of
the petitioner, the concerned authority shall afford an
opportunity of hearing to the petitioner and take further steps
in accordance with law.
9. 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 injection'.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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10. All contentions of the parties in the merits of the matter
are kept open.
11. Writ petition is partly allowed in the aforesaid terms.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
(C.M. POONACHA)
JUDGE
BS - List No.: 1 Sl No.: 55