M/S. SAGAR PHARMA (UNIT-II) vs THE ASSISTANT DRUGS CONTROLLER-1,
- Court
- Karnataka High Court
- 1 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
IN THE HIGH COURT OF KARNATAKA AT BENGALURU
TH
DATED THIS THE 17 DAY OF OCTOBER, 2026
BEFORE
THE HON'BLE MR. JUSTICE C.M. POONACHA
WRIT PETITION NO. 31389 OF 2026 (GM-RES)
BETWEEN:
M/S. SAGAR PHARMA (UNIT-II)
(DIVISION OF SAGAR HEALTH CARE AND
DIAGNOSTIC SERVICE PVT. LTD.,
REGISTERED UNDER THE DRUGS AND
COSMETICS ACT, 1940 AND THE RULES
MADE THEREUNDER REGISTERED
OFFICE AT NO.44/54, 4TH FLOOR,
SAGAR HOSPITAL,
39TH CROSS, TILAKNAGAR,
BENGALURU-560041
REPRESENTED BY ITS GPA HOLDER AND
AUTHORISED SIGNATORY
MR. DR. SHARATH CHANDRA H.
AGED ABOUT 59 YEARS,
S/O. LATE. BYRANNA HANUMAIAH.
PETITIONER
(BY SRI. ABHISHEK. H., ADVOCATE FOR
SRI. PRASANNA KUMAR B T.,ADVOCATE)
AND:
1. THE ASSISTANT DRUGS CONTROLLER-1,
AND LICENSING AUTHORITY,
OFFICE OF THE ASSISTANT DRUGS
- 2 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
CONTROLLER, ADC-1,
AYUSH DRUG TESTING LABORATORY,
NEAR ASHOKA PILLAR, 1ST STAGE,
JAYANAGAR,
BENGALURU 560011.
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. SHIVA REDDY., AGA)
THIS WP IS FILED UNDER ARTICLES 226 AND 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
18.09.2026, BEARING REF. NO. A SU OU A/ SA OU NI KA/ BEM
BRU-3/304/26-27 ISSUED BY R1, WHEREBY THE PETITIONERS
WHOLESALE DRUG LICENCES BEARING NOS. KA/B31/20-
183191, KA/B31/21-183193, KA/B31/20B-184677 AND KA-
B31/21B-184678 HAVE BEEN SUSPENDED UNDER RULE 66 OF
THE DRUGS AND COSMETICS RULES, 1945, PRODUCED AT
ANNEXURE-C AND ETC,.
THIS PETITION, COMING ON FOR PRELIMINARY
HEARING, THIS DAY, ORDER WAS MADE THEREIN AS UNDER:
CORAM: HON'BLE MR. JUSTICE C.M. POONACHA
- 3 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
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
18.09.2026, bearing Ref. No.
D¸ÀÄOD/¸ÀO¤PÀ/¨ÉAªÀÈ-3/304/26-
issued by respondent No.1, whereby the petitioners
27
wholesale drug licences bearing Nos. KA/B31/20-183191,
KA/B31/21-183193, KA/B31/20B-184677 AND KA-
B31/21B-184678 have been suspended under Rule 66 of
the Drugs and Cosmetics Rules, 1945, produced at
Annexure-C.
b) Issue a writ of mandamus directing the respondents to
restore/reinstate the petitioners drug licences bearing
Nos. KA/B31/20-183191, KA/B31/21-183193,
KA/B31/20B-184677 AND KA-B31/21B-184678 and
permit the petitioner to carry on its licensed wholesale
pharmaceutical business in accordance with law produced
at Annexure-C.
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 interests of justice and equity."
2. The petitioner is an authorized distributor of
pharmaceutical products and was issued with a Show Cause
notice dated 17.09.2026 (Annexure-B to the writ petition)
1
under Rule 66(1) of the Drugs and Cosmetics Rules, 1945 .
Vide the said notice, the petitioner was required to show cause
1
Hereinafter referred to as ' Rules'
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
- 4 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
and give its response to the assertions made in the said notice.
It was alleged that the petitioner has dealt with "Zavicefta
Injection", batch Nos. 23K05158 and 23K03976 which was
stated to be spurious.
3. It is the contention of the petitioner that before the
petitioner could respond to the Show Cause notice dated
17.09.2026, the impugned order dated 18.09.2026 (Annexure-
C to the writ petition) was passed, whereunder the license of
the petitioner has been suspended.
4. It is forthcoming that, subsequently the petitioner
has furnished its reply dated 23.09.2026 (Annexure-E to the
writ petition), which reply was given to the Show Cause notice
dated 17.09.2026. Being aggrieved by the impugned order
dated 18.09.2026, the present writ petition is filed.
5. This Court vide order dated 07.10.2026 has granted
interim stay. The said order reads as under:
1. "Learned AGA takes notice for respondents.
2. Learned counsel for the petitioner seeking for
grant of interim relief submits that vide the impugned
order dated 18.09.2026 (Annexure C to the writ
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
- 5 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
petition) the pharmaceutical licence of the petitioner
has also been cancelled which is contrary to the Rules
66 of the Drugs and Cosmetic Rules, 1945.
3. In view of the aforementioned, ad-interim stay as
prayed for is granted till the next date of hearing.
4. The petitioner shall also be permitted to carry on
its pharmaceutical distribution business till the next
date of hearing in accordance with law.
5. This order will not preclude the respondents from
taking such measures as may be permissible under
law.
6. The petitioner shall co-operate with the authorities
in any action that is undertaken in accordance with
law.
7. List on 09.10.2026."
6. At this juncture, it is necessary to notice Rule 66 of
the Rules which reads as under:
"66. Cancellation and suspension of licenses.
(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 license 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 license 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 license shall not be canceled or
suspended if the licensee proves to the satisfaction of the
licensing authority-
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
- 6 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
(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 license or the provisions
of the Act or the rules thereunder were observed.
(2) A licensee whose license has been suspended or
canceled 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."
7. It is forthcoming from a plain reading of sub-rule
(1) of Rule 66 of the Rules that the concerned authorities are
entitled to pass an order canceling or suspending a license,
either wholly or in part, after giving the licensee an opportunity
to Show Cause.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
- 7 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
8. In this context, it is pertinent to notice that the
allegation against the petitioner is that it has dealt with two
batches of "Zavicefta Injection" which is stated to be spurious
and the entire license of the petitioner has been suspended. It
is further pertinent to note that although a Show Cause notice
dated 17.09.2026 was issued, without granting adequate time
to the petitioner to respond to the same, the license of the
petitioner was suspended the very next day i.e., vide the
impugned order dated 18.09.2026.
9. In view of the aforementioned, in addition to the
reply dated 23.09.2026 (Annexure-E to the writ petition), the
petitioner shall be permitted to file an additional reply on or
before 28.10.2026 to the Show Cause notice dated 17.09.2026
(Annexure-B to the writ petition). Consequent to the reply and
further reply of the petitioner, the concerned authority shall
take further steps in accordance with law, keeping in mind the
scope and ambit of sub-rule (1) of Rule 66 of the Rules after
affording an adequate opportunity to the petitioner.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
- 8 -
HC-KAR
NC: 2026:KHC:59257
WP No. 31389 of 2026
CNR: KAHC010690922026
10. The impugned order dated 18.09.2026 (Annexure-C
to the writ petition) is hereby quashed.
11. The petitioner shall be permitted to carry on its
business in terms of the license granted in its favour until
further orders are passed by the concerned authorities, except
dealing with "Zavicefta Injection".
12. The rights and contentions of the parties on the
merits of the matter are kept open.
13. This order shall not preclude the concerned
authorities from taking further steps / measures in accordance
with law.
14. The writ petition is disposed of in the
aforementioned terms.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
(C.M. POONACHA)
JUDGE
PNV List No.: 1 Sl No.: 58