M/S SAGAR PHARMA (DIVISION OF SAGAR HEALTH CARE AND DIAGNOSTIC SERVICE PVT LTD vs THE ASSISTANT DRUGS CONTROLLER-2
- Court
- Karnataka High Court
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HC-KAR
NC: 2026:KHC:59258
WP No. 31500 of 2026
CNR: KAHC010687992026
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. 31500 OF 2026 (GM-RES)
BETWEEN:
M/S SAGAR PHARMA (DIVISION OF SAGAR HEALTH
CARE AND DIAGNOSTIC SERVICE PVT LTD
REGISTERED UNDER THE DRUGS
AND COSMETICS ACT 1940
AND THE RULES MADE THEREUNDER
REG OFFICE AT 7TH FLOOR
SHIVAGE MALLESHWAR HILLS
KUMARSWAMY LAYOUT
BENGALURU 560 078
REPRESENTED BY ITS GPA HOLDER
AND AUTHORISED SIGNATORY
MR DR SHARATH CHANDRA H.
PETITIONER
(BY SRI. ABHISHEK K., ADVOCATE FOR
SRI. PRASANNA KUMAR B.T., ADVOCATE)
AND:
1. THE ASSISTANT DRUGS CONTROLLER-2
AND LICENSING AUTHROITY
OFFICE OF THE ASSISTANT DRUGS
CONTROLLER ADC 2
AYUSH DRUG TESTING LABORATORY
NEAR ASHOKA PILLAR 1ST STAGE
JAYANAGAR, BENGALURU 560 011.
2. THE COMMISSIONER
DEPARTMENT OF FOOD SAFETY AND DRUGS
ADMINISTRATION
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GOVERNMENT OF KARNATAKA
BENGALURU 560 001.
3. THE PRINCIPAL SECRETARY
HEALTH AND FAMILY WELFARE DEPARTMENT
GOVERNMENT OF KARNATAKA
VIKASA SOUDHA
BENGALURU 560 001.
RESPONDENTS
(BY SRI. SHIVA REDDY. V ., AGA)
THIS WP IS FILED UNDER ARTICLES 226 AND 227 OF
THE CONSTITUTION OF INDIA PRAYING TO QUASHING THE
IMPUGNED ORDER DATED 18.09.2026, BEARING REF. NO.
ISSUED BY RESPONDENT NO.1, WHEREBY THE PETITIONERS
WHOLESALE DRUG LICENCES BEARING NOS. KA/B32/20-
21/205, KA/B32/20B-13, KA/B32/20B 21B-12, KA/B32/20F-14,
KA/B32/20G-11, HAVE BEEN CANCELLED UNDER RULE 66(1)
OF THE DRUGS AND COSMETICS RULES, 1945, PRODUCED AT
ANNX-C AND ETC,.
THIS PETITION, COMING ON FOR ORDERS, THIS DAY,
ORDER WAS MADE THEREIN AS UNDER:
CORAM: HON'BLE MR. JUSTICE C.M. POONACHA
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.
¸ÀA:D¸ÀÄOD/¸ÀO¤PÀ//¨ÉAªÀä-
issued by respondent No.1, whereby the
3/303/26-27
petitioners wholesale drug licences bearing Nos.
KA/B32/20-21/205, KA/B32/20B-13, KA/B32/20B 21B-
12, KA/B32/20F-14, KA/B32/20G-11, have been cancelled
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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WP No. 31500 of 2026
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under rule 66(1) 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/B32/20-21/205, KA/B32/20B-13, KA/B32/20B
21B-12, KA/B32/20F-14, KA/B32/20G-11 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 an authorized distributor of
pharmaceutical products, was issued with a Show Cause notice
dated 17.09.2026 (Annexure-B to the writ petition) under Rule
1
66(1) of the Drugs and Cosmetics Rules, 1945 . It is the
allegation against the petitioner that it has dealt with "Zavicefta
Injection bearing batch Nos. 25K02759 and 25K03108", which
was spurious.
3. The petitioner has filed its reply to the said Show
Cause notice on 18.09.2026. On the same day respondent No.1
passed the impugned order dated 18.09.2026 (Annexure-C to
the writ petition) canceling the license of the petitioner. Being
aggrieved, the petitioner preferred an appeal under Rule 66(2)
1
Hereinafter referred to as ' Rules'
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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of the Rules on 24.09.2026. The appeal of the petitioner not
having been considered till date, the present petition is filed.
4. At this juncture, it is pertinent 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-
(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
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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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."
5. It is the contention of the petitioner that an
adequate opportunity of hearing has not been afforded and that
the entire license of the petitioner has been cancelled which is
erroneous.
6. It is forthcoming from a perusal of sub-rule (1) of
Rule 66 of the Rules that the licensing authority is entitled to
pass an order canceling or suspending a license either wholly or
in part after giving the licensee an opportunity to show cause.
7. In the present case, although the allegation against
the petitioner is with regard to dealing with two batches of one
product which was stated to be spurious, the entire license of
the petitioner has been cancelled.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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8. In any event, since the appeal of the petitioner is
pending before the Appellate Authority, it is expedient that until
consideration of the appeal of the petitioner, the petitioner be
permitted to carry out its business in terms of the license,
except dealing with the particular product (Zavicefta Injection)
in respect of which the allegation is made against the
petitioner.
9. Accordingly, until adjudication of the appeal of the
petitioner, the petitioner shall be permitted to carry on its
business in terms of the license granted to it, in accordance
with law, except dealing with "Zavicefta Injection".
10. All the contentions of the parties on the merits of
the matter are kept open to be adjudicated in the appeal filed
by the petitioner.
11. This order shall not come in the way of the
concerned authorities taking further action in accordance with
law.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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12. 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.: 81