M/S SURYA SPECIALITY PHARMA vs THE ASSISTANT DRUGS CONTROLLER AND LICENSING AUTHORITY
- Court
- Karnataka High Court
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HC-KAR
NC: 2026:KHC:58137
WP No. 32250 of 2026
CNR: KAHC010704722026
IN THE HIGH COURT OF KARNATAKA AT BENGALURU
TH
DATED THIS THE 14 DAY OF OCTOBER, 2026
BEFORE
THE HON'BLE MR. JUSTICE C.M. POONACHA
WRIT PETITION NO. 32250 OF 2026 (GM-RES)
BETWEEN:
M/S SURYA SPECIALITY PHARMA
K.NO.387/349, ADJ NO.257/A, GF,
NARAYANA YATRI RESIDENCY,
BOMMASANDRA INDUSTRIAL AREA
HOSUR ROAD, BENGALURU - 560 099,
(REPRESENTED BY ITS PROPRIETOR,
SRI. TALARI SURESH
AGED ABOUT 33 YEARS
…PETITIONER
(BY SRI. H.V. MANJUNATHA, ADVOCATE)
AND:
1. THE ASSISTANT DRUGS CONTROLLER AND
LICENSING AUTHORITY
BENGALURU VRUTHA-2, PALACE ROAD,
BENGALURU - 560 001
2. THE COMMISSIONER,
DEPARTMENT OF FOOD SAFETY AND DRUGS
ADMINISTRATION,
GOVERNMENT OF KARNATAKA,
BENGALURU - 560 001.
3. THE PRINCIPAL SECRETARY,
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HC-KAR
NC: 2026:KHC:58137
WP No. 32250 of 2026
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HEALTH AND FAMILY WELFARE DEPARTMENT,
GOVERNMENT OF KARNATAKA,
VIKASA SOUDHA, BENGALURU - 560 001.
…RESPONDENTS
(BY SRI. RAHUL CARIAPPA K.S., 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,
PASSED BY RESPONDENT NO.1, WHEREBY THE
CONSEQUENTIAL SUSPENSION OF THE PETITIONER'S DRUG
LICENCES BEARING NOS. KA-B62 230458 KA B62 230459 KA
B62 230460 AND KAB62 230461 A TRUE COPY OF THE
IMPUGNED ORDER IS PRODUCED AND MARKED AS ANX-B ETC.
THIS PETITION, COMING ON FOR PRELIMINARY
HEARING, 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, O¤E/¸ÀO¤E/¨ÉA.
6/ £ÉÆÃn¸ï/156/26-27 passed by respondent No.1,
ವೃ-
whereby the consequential suspension of the
petitioner's drug licences bearing Nos. KA-B62
230458 KA B62 230459 KA B62 230460 AND KAB62
230461. A true copy of the impugned order is
produced and marked as Annexure-B;
(b) Quash and/or set aside the impugned order
dated 18.09.2026 vide Annexure-B insofar as the
same have resulted in suspension of the petitioner's
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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NC: 2026:KHC:58137
WP No. 32250 of 2026
CNR: KAHC010704722026
licences without completion of a lawful rule 66(1)
process;
(c) Declare that no suspension or cancellation under
rule 66(1) of the Drugs and Cosmetics Rules, 1945
can be sustained unless the petitioner is afforded an
effective opportunity to show cause, the relied-upon
material necessary for an effective response is
disclosed, and the petitioner's defence and
documents are duly considered;
(d) Issue a writ of mandamus directing the
respondents to restore/activate the petitioner's drug
licences bearing Nos. KA-B62 230458 KA B62
230459 KA B62 230460 AND KAB62 230461 and
permit the petitioner to carry on its lawful licensed
pharmaceutical distribution business, subject to such
reasonable safeguards as this Hon'ble Court may
deem fit;
(e) In the alternative, if this Hon'ble Court considers
any restriction necessary pending fresh
consideration, direct that such restriction be
confined to ZAVICEFTA 2.5 gm injection, batch
No.25K02759, and permit the petitioner to continue
dealing in all other lawful pharmaceutical products
covered by its licences;
(f)Grant such other relief or order 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 a notice dated
15.09.2026, under Rule 66(1) the Drugs And Cosmetics Rules,
1
1945 .
1
Hereinafter referred to as 'Rules'
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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HC-KAR
NC: 2026:KHC:58137
WP No. 32250 of 2026
CNR: KAHC010704722026
3. It is the contention of the petitioner that although,
seven days time was given vide the said notice dated
15.09.2026, after lapse of three days i.e., on 18.09.2026 an
order has been passed (Annexure-B to the writ petition)
suspending the license of the petitioner which is impugned in
the present writ petition.
4. It is forthcoming that it is alleged that the petitioner
was dealing with "Zavicefta 2.5 gm Injection Batch
No.25K02759", which was suspected to be spurious.
5. In this context, 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-
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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(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."
6. 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.
7. In this context, it is pertinent to notice that
although the petitioner has been notified vide notice dated
15.09.2026 of the allegation, the impugned order dated
18.09.2026 (Annexure-B to the writ petition) has been passed
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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within three days wherein the license of the petitioner has been
suspended.
8. 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 either suspending a license either wholly or in
part after giving the licensee an opportunity to show cause.
Further, a remedy of an appeal is available to the petitioner
under Sub-rule (2) of Rule 66 of the Rules vide the impugned
order dated 18.09.2026.
9. Although, the allegation against the petitioner is
with regard to dealing of a specific drug / medicine which is
suspected to be spurious, the entire license of the petitioner
has been suspended, which is ex-facie unsustainable law.
10. In view of the aforementioned, the petitioner shall
be permitted to file his reply to the notice dated 15.09.2026 on
or before 19.10.2026, consequent to which the concerned
authorities shall pass appropriate orders keeping in mind the
scope and ambit of Sub-rule (1) of Rule 66 of the Rules.
11. The impugned order dated 18.09.2026 (Annexure-B
to the writ petition) is hereby quashed.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
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HC-KAR
NC: 2026:KHC:58137
WP No. 32250 of 2026
CNR: KAHC010704722026
12. Till the appropriate orders are passed by the
concerned authorities on the show cause notice dated
15.09.2026, the petitioner shall be permitted to carry on
business in terms of the license granted to it except dealing
with "Zavicefta Injection".
13. All rights and contentions of the parties on the
merits of the matter are kept open.
14. The writ petition is allowed-in-part in the
aforementioned terms.
Digitally Signed by CHEPPUDIRA
MONNAPPA POONACHA
(C.M. POONACHA)
JUDGE
PNV
List No.: 1 Sl No.: 16