M/S. SAFECON LIFESCIENCES vs STATE BY DEPARTMENT OF ANIMAL HUSBANDRY
- Court
- Karnataka High Court
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WP No. 20246 of 2022
R
CNR: KAHC010464002022
IN THE HIGH COURT OF KARNATAKA AT BENGALURU
TH
DATED THIS THE 11 DAY OF AUGUST, 2026
BEFORE
THE HON'BLE MR. JUSTICE M.G.S. KAMAL
WRIT PETITION NO. 20246 OF 2022 (GM-RES)
BETWEEN:
M/S. SAFECON LIFESCIENCES
M.P.P.L. VILLAGE-LALPURM
KICHHA-RUDRAPUR ROAD,
RUDRAPUR, U.S. NAGAR,
UTTARKHAND-263 148.
A SOLE PROPRIETORSHIP CONCERN
REPRESENTED BY ITS
AUTHORIZED SIGNATORY
MR. SANGAR CHANDRA,
SON OF MR. HARIHAR,
AGED ABOUT 63 YEARS,
OFFICE AT
M.P.P.L. VILLAGE-LALPUR,
KICHHA,RUDRAPUR ROAD,
RUDRAPUR, U.S. NAGAR,
UTTARAKHAND - 263 148.
…PETITIONER
(BY SRI. H.N.MANJUNATH PRASAD,ADVOCATE)
AND:
STATE BY DEPARTMENT OF ANIMAL HUSBANDRY
AND VETERINARY SERVICES,
GOVERNMENT OF KARNATAKA,
OFFICE AT
THE COMMISSIONER AND DIRECTOR,
PASHUPAALANA BHAVANA,
ST
1 FLOOR, OPP. TO CBI,
Digitally
signed by
SUMA B N
Location:
HIGH
COURT OF
KARNATAKA
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BELLARY ROAD, HEBBAL,
BANGALORE - 560 024.
…RESPONDENT
(BY SRI. SRINIVASA KUMAR.M, HCGP)
THIS W.P. IS FILED UNDER ARTICLE 226 AND 227 OF
THE CONSTITUTION OF INDIA PRAYING TO QUASH AND
SETTING ASIDE THE IMPUGNED OFFICE ORDER NO.
CAH/DD(VMS)/CR-21/DC/SLS/B.L/E-732647/2021-22/255
DTD. 13.09.2022 (ANNX-B) PASSED BY THE RESPONDENT.
THIS PETITION, COMING ON FOR PRELIMINARY
HEARING IN 'B' GROUP, THIS DAY, ORDER WAS MADE
THEREIN AS UNDER:
CORAM: HON'BLE MR. JUSTICE M.G.S. KAMAL
ORAL ORDER
1. Petitioner is before this Court being aggrieved by the
Office Order dated 13.09.2022 issued by the respondent-
Authority produced at Annexure-B, in terms of which the
petitioner has been debarred from participating in all
tenders to be invited by the respondent-Authority for a
period of three years from the date of the order and the
security deposit in a sum of Rs.54,06,852/- which was
furnished in furtherance to the terms of tender, has been
forfeited.
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2. Facts of the case in brief are:
2.1 That, petitioner a Proprietorship concern, carrying on the
business of drug manufacturing, in terms of the Drug
Manufacturing Licence issued in Form 25A. That petitioner
had participate in a tender process called for by the
respondent-authority vide notification dated 27.06.2019,
for the purpose of supply of drugs, chemicals and
miscellaneous items, which was accepted by the
respondent-authority. By a communication dated
04.12.2019, 5% of the contract value being
Rs.52,21,125/- was deposited by the petitioner in the
form of irrevocable bank guarantee in favour of the
Commissioner, Animal Husbandry and Veterinary
Services, payable at Bengaluru with a validity period of 6
months beyond the contract period. Petitioner claimed to
have supplied drugs to the respondent-authority, in
furtherance to the contract.
2.2. That on 14.02.2020, the Assistant Drug Controller-2,
Dharwad Circle, Hubli, had drawn samples of Safemech -
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CT Veterinary (Closantal and Ivermectin solution) Batch
No.SR20-012, M/D:01/2020, E/D:12.2021 manufactured
by the petitioner for the purpose of test.
2.3. Petitioner received a letter dated 07.05.2020 issued by
the Assistant Drug Controller, Hubli, along with the test
report dated 21.04.2020 in Form No.13 from the
Government Analyst, Central Drugs Testing Laboratory,
Chennai, thereby calling upon the petitioner to forthwith
stop the sale/distribution of the said drug and to recall
the entire stock as the same did not meet the standard
quality and were declared as 'not of standard quality'.
Thereafter, a letter dated 12.05.2021 was issued by the
Office of Deputy Director, Animal Husbandry and
Veterinary Service, Ramnagara, informing the petitioner
that the drugs supplied by the petitioner were of not
standard quality and sought for replacement of the same.
2.4. Petitioner responded to the above letters on 23.06.2020
placing his objection stating that the Assistant Drug
Controller had not procured the Working Standards,
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Method of Analysis and Other Testing Protocols from the
petitioner who is the manufacturer of the drugs but
however had subjected that drugs for testing from the
Working Standard of the competitor companies of the
petitioner namely, Esteem Laboratory Pvt. Ltd.,
Hyderabad and Hindustan Therapeutics Pvt. Ltd.,
Hyderabad. Thus, it contended that the report in Form
No.13 did not comply with the specification as it did not
specify the manufacturer's STP number creating doubt on
the methods, applied for conducting test.
2.5. Petitioner had also filed a writ petition in WP
No.147959/2020 seeking quash of the report in Form
No.13. The said petition came to be disposed of on
01.07.2021 with a direction to the respondent-Authority
to adjudicate upon the objections raised by the petitioner.
2.6. That on 24.08.2021, Assistant Drug Controller-2, Dharwad
Circle, Hubli, filed an application under sub-section (4) of
Section 25 of Drugs and Cosmetics Act, 1940 ("the Act"
for short) before the Principal Civil Judge and JMFC-
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Dharwad, in Criminal Miscellaneous No.187/2021, seeking
retesting of the samples through the Central Drugs
Laboratory - Kolkata, only with respect to “content of
Ivermectin”. Pursuant to which, the Principal Civil Judge
and JMFC, Dharwad, on the very next day of filing of the
said application, had passed an order for sending the
samples to Central Drugs Laboratory, Kolkata, for
retesting with respect to "content of ivermectin". No
notice of any nature whatsoever was issued to the
petitioner, providing him an opportunity of being heard.
That the Principal Civil Judge and JMFC did not have
jurisdiction to entertain such an application or pass
orders, inasmuch as sub-section (2) of Section 32 of the
Act, provides any offence to be tried by a Court not
inferior to that of the Sessions Court.
2.7. That the Central Drugs Laboratory, Kolkata, had tested
drugs between 25.11.2021 and 07.12.2021, which is after
expiry of 3 months of the order of the Court. The test was
conducted for a period over 13 days, indicating default
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process and malicious intentions on the part of the
authorities.
2.8. That on 07.09.2021, the Director of Central Drugs
Laboratory, Kolkata, had issued a letter to the Drugs
Control Department, Palace Road, Bangalore, informing
that "while technical screening it was found that the
Central Drugs Laboratory did not have the following items
which was required for conducting of analysis, namely
manufacturer's specification and method of analysis" and
requesting them to provide the same. However, Drugs
Control Department, Palace Road, Bangalore, did not seek
any information from the petitioner with regard to the
same.
2.9. That on 30.03.2022, respondent-authority had issued a
show-cause notice seeking clarification on why the
petitioner shall not be blacklisted. Petitioner issued a
letter dated 27.09.2022 to the Commissioner of Animal
Husbandry and Veterinary Service, Hebbal at Bengaluru,
requesting revocation of disbarment by blacklisting. Being
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aggrieved by non-consideration of the same and the
Office Order dated 13.09.2022, petitioner is before this
Court.
3. Learned counsel for the petitioner taking this Court
through the records submitted;
3.1. That, the Principal Civil Judge and JMFC - Dharwad, did
not have jurisdiction to conduct any proceedings relating
to the issue arising out of Drugs and Cosmetics Act, 1940.
3.2. That, any offence purported to have been committed by
the petitioner was to be tried only by the Court, not
inferior to Sessions Court.
3.3. That, the Central Drugs Laboratory, Kolkata, had delayed
in conducting the test of the samples, i.e. after expiry of
3 months from the date of seizure which is impermissible.
3.4. That, the test conducted by the Central Drugs Laboratory,
Kolkata, was partial and was only in respect of
'Ivermectin' only.
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3.5. That there was non-compliance with the statutory
requirements of the Act, in collecting the samples,
sending the same for test and requiring opportunity to be
given to the petitioner.
3.6. That no instructions have been followed by the testing
agency with regard to preservation and storing of the
drugs which were subject for the test. The tests seem to
have been conducted under the non-conducive
atmosphere contrary to the specification provided for.
3.7. The respondent-Authority had opted selective means to
target the petitioner.
3.8. He also relied upon the judgment of High Court of
Allahabad in the case of DHARAM DEO GUPTA VS.
1
STATE to highlight the statutory requirement to be
complied by the respondent - Authority while drawing the
items for subjecting for test and for providing opportunity
to the petitioner. Hence, seeks for allowing of the
petition.
1
AIR 1958 All 865
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4. Learned AGA appearing for the respondent-authority
submitted that there is substantial compliance with
provisions of Sections 23 and 25 of the Act. However, he
submits when the sample drugs were sent for further test
to the Central Drugs Laboratory, Kolkata, notice does not
seem to have been issued to the petitioner. He fairly
brings to the notice of this Court that the requirement of
compliance of the law, namely, Sections 23, 24 and 25 of
Act, and consequences of non-compliance as held by the
High Court of Jammu and Kashmir in the case of
AUGUST REMEDIES VS. STATE OF JAMMU AND
KASHMIR in CRMC No.402/2013.
5. Heard. Perused the records.
6. The impugned order debarring the petitioner from
participating in the tender process for a period of three
years and forfeiture of the bank guarantee of a sum of
Rs.54,06,852/- has been passed on the purported breach
of terms and conditions contained in clause iii and x of
Condition No.27 of the General Condition of the Contract.
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7. The said clause iii and x of condition No.27 of the
General Condition of the Contract read as under:-
"27. BLACKLISTING OF DEFAULTING
CONTRACTORS:
Contractor may be blacklisted for three
years for the following reasons;
iii. Submission of false documents to get
declared as responsive.
x. Recurrent supply of 'NOT OF STANDARD
QUALITY" items."
8. Reading of the aforesaid conditions indicate that for the
purpose of blacklisting the petitioner, the respondent-
authority should come to conclusion that the document
submitted were false and that there is proof of, recurrent
supply of drugs which are "Not of Standard Quality"
items. In other words, before arriving at such conclusion
of petitioner being guilty of repeatedly supplying the
drugs which are "Not of Standard Quality", the
respondent-Authority should have scrupulously and
strictly followed the provisions provided under the Act, for
the purpose of drawing the samples, sending the same
for tests, providing an opportunity to the petitioner to
raise/file objections, if any, and the role of concerned
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Judicial Magistrate. Appropriate for this purpose to refer
Sections 23 and 25 of the Act, which are extracted
hereunder:
23. Procedure of Inspectors.—
(1) Where an Inspector takes any sample of a drug or
cosmetic under this Chapter, he shall tender the fair price
thereof and may require a written acknowledgement
therefore.
(2) Where the price tendered under sub-section (1) is
refused or where the Inspector seizes the stock of any
drug or cosmetic under clause (c) of section 22, he shall
tender a receipt therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug or
cosmetic for the purpose of test or analysis, he shall
intimate such purpose in writing in the prescribed form to
the person from whom he takes it and, in the presence of
such person unless he wilfully absents himself, shall
divide the sample into four portions and effectively seal
and suitably mark the same and permit such person to
add his own seal and mark to all or any of the portions so
sealed and marked:
Provided that where the sample is taken from
premises whereon the drug or cosmetic is being
manufactured, it shall be necessary to divide the sample
into three portions only:
Provided further that where the drug or cosmetic is
made up in containers of small volume, instead of dividing
a sample as aforesaid, the Inspector may, and if the drug
or cosmetic be such that it is likely to deteriorate or be
otherwise damaged by exposure shall, take three or four,
as the case may be, of the said containers after suitably
marking the same and, where necessary, sealing them.
(4)The Inspector shall restore one portion of a sample
so divided or one container, as the case may be, to the
person from whom he takes it, and shall retain the
remainder and dispose of the same as follows:—
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(i)one portion or container he shall forthwith send
to the Government Analyst for test or analysis;
(ii)the second he shall produce to the Court before
which proceedings, if any, are instituted in respect of the
drug or cosmetic; and
(iii)the third, where taken, he shall send to the
person, if any, whose name, address and other particulars
have been disclosed under section 18A.
(5) Where an Inspector takes any action under clause
(c) of section 22,—
(a) he shall use all despatch in ascertaining
whether or not the drug or cosmetic contravenes any of
the provisions of section 18 and, if it is ascertained that
the drug or cosmetic does not so contravene forthwith
revoke the order passed under the said clause or, as the
case may be, take such action as may be necessary for
the return of the stock seized;
(b) if he seizes the stock of the drug or cosmetic,
he shall as soon as may be, inform a Judicial Magistrate
and take his orders as to the custody thereof;
(c)without prejudice to the institution of any
prosecution, if the alleged contravention be such that the
defect may be remedied by the possessor of the drug or
cosmetic, he shall, on being satisfied that the defect has
been so remedied, forthwith revoke his order under the
said clause.
( 6 ) Where an Inspector seizes any record, register,
document or any other material object under clause (cc)
of sub-section (1) of section 22, he shall, as soon as may
be, inform a Judicial Magistrate and take his orders as to
the custody thereof.
25. Reports of Government Analysts. —
( 1 ) The Government Analyst to whom a sample of any
drug or cosmetic has been submitted for test or analysis
under sub-section (4) of section 23, shall deliver to the
Inspector submitting it a signed report in triplicate in the
prescribed form.
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( 2 ) The Inspector on receipt thereof shall deliver one
copy of the report to the person from whom the sample
was taken and another copy to the person, if any, whose
name, address and other particulars have been disclosed
under section 18A, and shall retain the third copy for use
in any prosecution in respect of the sample.
( 3 ) Any document purporting to be a report signed by
a Government Analyst under this Chapter shall be
evidence of the facts stated therein, and such evidence
shall be conclusive unless the person from whom the
sample was taken or the person whose name, address
and other particulars have been disclosed under section
18A has, within twenty-eight days of the receipt of a copy
of the report, notified in writing the Inspector or the Court
before which any proceedings in respect of the sample are
pending that he intends to adduce evidence in
controversion of the report.
( 4) Unless the sample has already been tested or
analysed in the Central Drugs Laboratory, where a person
has under sub-section (3) notified his intention of
adducing evidence in controversion of a Government
Analyst's report, the Court may, of its own motion or in
its discretion at the request either of the complainant or
the accused: cause the sample of the drug or cosmetic
produced before the Magistrate under sub-section (4) of
section 23 to be sent for test or analysis to the said
Laboratory, which shall make the test or analysis and
report in writing signed by or under the authority of, the
Director of the Central Drugs Laboratory the result
thereof, and such report shall be conclusive evidence of
the facts stated therein.
(5 ) The cost of a test or analysis made by the Central
Drugs Laboratory under sub-section (4) shall be paid by
the complainant or accused as the Court shall direct."
9. There is no dispute of the fact that Assistant Drug
Controller-2, Dharwad Circle, Hubli, had drawn the
samples of Safemech - CT Veterinary (Closantal and
Ivermectin solution Batch No.SR20-012, M/D:01/2020,
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E/D: 12/2021 for conducting test thereon. Petitioner was
indeed supplied with test report in Form No.13 from the
Government Analyst, Central Drugs Testing Laboratory,
Chennai, dated 20.04.2020 along with a letter dated
07.05.2020 issued by Assistant Drug Controller, Hubli,
requesting the petitioner to stop sale and distribution of
the said drug and to recall all the stock as the same was
declared as "not of standard quality".
10. On receipt of the aforesaid report, petitioner had
submitted his statement of objections as per
communication dated 23.06.2020 vide Annexure-G
contents of which read as under;
To:
THE ASSISTANT DRUGS CONTROLLER
RS NO: 392 B, PLOT NO:25A
TAJANAGAR MAIN ROAD, OPP
FIRE BRIDGE QTRS, EKATANAGAR
UNKALPOST, HUBLI-580031.
SUBJECT: REPLY TO THE COPY OF LETTER BEARING
NUMBER-DCD/ D CIRCLE/ADC-2/ TEST/ 28/2020-21,
DATED:07.05.2020 ABOUT TESTING OF SAFEMEC-CT
VETERINARY (CLOSANTAL & IVERMECTIN SOLUTION),
B.NO.: SR20-012,M/D:01/2020, E/D:12/2021.
"Respected Sir,
We have received Letter Bearing Number-
DCD/D CIRCLE/ADC-2/TEST/28/2020-21, DATED:
07.05.2020 late due to Covid-19 Conditions as Agra
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and Rudrapur was in containment zone and due to
lockdown in our Area.
Further now we have tested the samples
provided by you and we are attaching our Test Report
as per the Sample Batch No.: SR20-012. We have also
tested our retained samples and found to be as per
drugs guidelines."
Further we want to state that your esteemed
lab has not procure Working Standards, Method of
Analysis and other Testing Protocols from Manufacturer
(Safecon Lifesciences) but tested the Drug from the
MOA/ Working Standards from our Competitors
Companies i.e. (M/s Esteem Laboratories Pvt. Ltd,
Hyderabad, M/s Hindustan Therapeutics Pvt. Ltd.
Hyderabad) that companies which have also quoted in
the Tender.
We have strong objection to this practice and
we request you to test the product as per Method of
Analysis/Protocol of Manufacturer (Safecon
Lifesciences).
We are sending our Working Standard, Method
of Analysis and other protocol in next week for proper
testing of Drug.
Hoping for your kind and favourable consideration."
11. The aforesaid communication of petitioner could be read
and construed as objections in compliance to sub-section
(3) of Section 25 of the Act, as noted above, which is,
petitioner expressing his intention of adducing the
evidence in controversion to the report.
12. What was required thereafter to be followed was that the
concerned Magistrate before whom the proceedings were
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initiated by the respondent-Authority seeking process of
conclusiveness of the report ought to have issued notice
to the petitioner, providing him an opportunity to adduce
evidence in controversion of the report.
13. Perusal of the order dated 25.08.2021 passed by the
Principal Civil Judge & Principal JMFC Court, Dharwad,
produced at Annexure-J, indicate that upon the
application filed by the respondent-authority under sub-
section (4) of Section 25 of the Act, the Magistrate had
directed for sending of one item of Safemec-CT
Veterinary (Closantel and Ivermectin solution) to the
Central Drugs Laboratory, Kolkata. The order does not
indicate any notice having been issued to the petitioner
prior to that. The order sheet further indicate that the
report was received on 01.01.2022 declaring that the
drug as "not of standard quality". The report as received
has been accepted by the Magistrate and has closed the
petition. Based on the order of the Magistrate, the
impugned order dated 13.09.2022 at Annexure-B has
been issued conclusively holding that the petitioner was
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guilty of breach of condition-iii of the tender contained in
condition No.27 of the General Conditions of Contract
providing for blacklisting as noted above resulting in
debarring him from participating in the tender for three
consecutive years and forfeiture of Rs.54,06,852/-
(security deposit).
14. Subsequent to the order passed by the Principle Civil
Judge & Principal JMFC, Dharwad sending the matter for
analysis, the Central Drugs Laboratory, Kolkata had
issued a communication dated 07.09.2021 calling for
certain information. The said communication produced at
Annexure-M read as under;
GOVERNMENT OF INDIA
OFFICE OF THE DIRECTOR
CENTRAL DRUGS LABORATORY
3, KYD STREET, KOLKATA - 700 016
No.2-1/2021-SS/393 Telephone: (033)2229-9380
e-mail: [email protected]
Dated: 07/09/2021
To,
The Drugs Controller,
Drugs Control Department,
PB No. 5377, Palace Road,
Bangalore-560001,
Karnataka
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Sub: Testing of Safemec CT Veterinary (Closantel &
Ivermectin Solution), 250 ml, Batch No.
SR20-012, D/M: 01/2020, D/E: 12/2021,
Manufactured by M/s. Safecon Lifesciences,
Works at M.P.P.I Village - Lalpur, Kichha,
Rudrapur Road, Rudrapur, U.S. Nagar,
Uttarakhand- 263 148, India.
Sir,
The aforesaid sample has been received from The
Principal Civil Judge & Principal J.M.F.C.. Dharwad,
Karnataka in Form I vide Memo No. O. No. 2334/2021
dated 25/08/2021 for analysis.
While technical screening it is found that Central Drugs
Laboratory, Kolkata does not have the following item
which is required for conducting the analysis:
•
Manufacturer's Specification and Method of Analysis
Hence it is requested to obtain the same and forward
to Central Drugs Laboratory, Kolkata at the earliest. If
the Manufacturer's Specification & Method of analysis
is not received by this office within 21 days from the
issue of the letter, this laboratory will carryout the
testing/analysis of the sample by using available
standardized & validated method.
Since it is a court case matter therefore an early action
may kindly be taken in order to supply the above
mentioned requirement.
your's faithfully
sd/-
director in-Charge
Central Drugs Laboratory
Kolkata- 700 016.
15. It appears the information has called for in the aforesaid
communication namely, "Manufacturer's specification and
method of analysis" has not been furnished. There seem
to be no compliance of the aforesaid requisition made by
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the Central Drug Laboratory, Kolkata. Therefore, the
report in the absence of such compliance also cannot be
held as conclusive. It is in the absence of such
information, a certificate of test in Form No.2 dated
23.12.2021 has been issued by the Central Drugs
Laboratory, which reads as under;
FORM - 2
Certificate of test or Analysis by the Central
Drugs Laboratory
Certified that the sample distinguishing number
187/2021 purporting to be a sample of
SAFEMEC-CT Veterinary (Closantel & Ivermectin
Solution) 250 ml, Batch No SR20-012, D/M
01/2020, D/E 12/2021, manufactured by M/s
Safecon Life sciences, Works at MPPL Village,
Lalpur Kichha, Rudrapur Road Rudrapur JS Nagar
Uttarakhand-263148, India received on
30/08/2021 with Memorandum Serial No.
O.No.2334/2021 date 25/08/2021 from The
Prl.Civil Judge & Prl.JMFC Court Dharwad,
Karnataka Pin-580008 has been tested/ analysed
and that the result of such test/analysis is as
stated.
2. The condition of the seals on the packet on
receipt was as follows;
The sample received with seal intact.
3. In the opinion of the undersigned the sample/
is not of standard quality as defined in the drugs
and cosmetics Act, 1940 and rules thereunder for
the reason given below:
(Only "Content of Ivermectin been examined as
per direction of Hon'ble Court)
Date 23-12-2021
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Director Incharge
Central Drugs Laboratory.
(Details of results of test or analysis with
protocols of tests applied)
Date of Testing 25/11/2021 to 07/12/2021
Method Manufacturer's specification
Description : Brown coloured liquid in sealed
white plastic container
Identification : Gives positive test for
Ivermectin
Assay : Found/ml Claim/ml Limit
Ivermectin : 0.0480 3 mg 90% to 110% of
claim (01.60% of claim)
Reason for declaring the sample as not of standard
quality
Remarks : The sample does not conform to
Manufacturer's specification with respect to
Assay/Content of "Ivermectin"
No. 2-1/2021-SS/CC-160/693
Date 23/12/2021/
Director Incharge
Central Drugs Laboratory.
16. The aforesaid report does not provide any factual details
except stating that the sample does not confirm to
Manufacturer's specification. It is beyond comprehension
as to how such a conclusion was arrived at even when
admittedly "Manufacturers' Specification and Method of
Analysis" has not been furnished.
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17. High Court of Allahabad in its judgment, in the case of
DHARAM DEO GUPTA (supra) dealing with identical
situation, with regard to non-compliance of the statutory
requirement of Section 23 and Section 24 at paragraph
Nos. 22, 23 and 24 has held as under:
"22. The Drugs Act contains prescribed forms and
form 2 framed under Rule 6 of the Drugs Rules,
1945, clearly mentions the requirements which a
certificate of test or analysis by the Central Drugs
Laboratory should contain. It is mentioned in this
form which is Form 2 in Schedule A that details of
results of test or analysis with protocols of tests
applied should be given. Ex. P-10 contains no such
details. As a matter of fact it contains no factual
data at all. The reason is not far to seek.
This report was not given for the purpose for which
the prosecution is utilizing it. If the Central Drugs
Laboratory had known that they were to give a
report for the purposes of prosecuting the accused
person under the Drugs Act, they would have given
this data. A report which does, not contain any
factual data cannot be treated as conclusive
evidence of the opinion given in the report. The
relevant entries in Ex. P-10 are as follows :
'Oxidisable matter:-- Above B.P. (British
Pharmacopeia) limit.
Pyrogen test:-- The sample does not pass the
test.
Conclusion :-- The sample is not of acceptable
quality.''
23. It would be seen from the extract cited above
that no factual data is given in this report and only
the opinion of the Government Analyst is
mentioned. It has been repeatedly held by this
Court that such a report is not sufficient to prove
that the sample examined by it was of a sub-
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standard quality. No doubt these decisions are
under Section 10 (2) of the U P. Pure Food Act but
that section is almost analogous to Section 25(4)
of the Drugs Act and the rule of law laid down in
those decisions fully applies to this case. Those
decisions are Din Dayal v. State, 1956 All LJ 276;
((S) AIR 1956 All 520) (B), State v. Nathi Lal.
1956 All LJ 340 (C) & State v. Sahati Ram, 1957
All LJ 647: (AIR 1958 All 34) (D). I will quote only
one extract from these decisions, which is from
State v. Sahati Ram (D), at page 648 (of All LJ):
(at pp. 34-35 of AIR) :
"It has been repeatedly pointed out by this
Court, and in this connection we may refer to two
recent decisions of this Court, the one in Din Dayal
v. State (B), in which one of us was a party, and
the other in State v. Nathi Lal (C), that the
certificate of the Chemical Analyst should contain
the factual data which the analysis should reveal
and not merely the opinion of the Public Analyst as
to what that data indicates about the nature of the
article of food, and that if the certificate merely
gives the final opinion of the Public Analyst and if
such an opinion be held to be conclusive evidence
about the nature of the article of food, the merit of
the case against the accused is really decided by
the public Analyst and not by the Court and the
Court just gives its authority to the conclusion of
the Public Analyst and that this cannot be the
position in law. The report of the Public Analyst in
the present case does not, in our opinion, specify
what Section 10 of the Act required him to specify
and what could have been evidence for the
consideration of the Court."
24. I am in entire agreement with the view
expressed above and in my opinion the legislature
did not contemplate that cases should not be
decided by Courts of law, but by Government
Analysts, who do not even give the reasons for
their opinion. If this was really the intention of the
legislature, it would make Section 25(4) of the
Drugs Act ultra vires of the Constitution, for it
would amount to denying the basic right to an
accused person to defend himself and it would be
against the established procedure of Jaw.
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That a person has a basic right to defend himself
against an accusation has been held again and
again by the Supreme Court. However strong and
believable the evidence might be the accused must
be given an opportunity of rebutting that evidence.
If such an opportunity is not given it violates the
fundamental conceptions of natural justice and it
infringes Art 21 of the Constitution of India.
25. It may also be kept in mind that the
reasonable possibility of an error being committed
by the Government Analyst when he is analysing
or testing a sample cannot be eliminated. The
Court has a right to satisfy itself that the chance of
a mistake has been eliminated. It can do so if
sufficient factual data is given in the report. This
factual data by itself will show that the opinion
given is fully borne out.
But where the opinion is not supported by any
factual data, the Court cannot test the opinion of
the Government Analyst and can only accept it in a
blind manner. The liberty of the people cannot he
taken away from them on such evidence which
cannot be tested. It is, therefore, necessary that
the procedure laid down in the Drugs Act should be
strictly followed and where this procedure has not
been followed the report of the Government
Analyst cannot be treated as conclusive evidence."
18. High Court of Jammu and Kashmir in the case of
AUGUST REMEDIES VILLAGE (supra) decided on
09.03.2026, referring to provisions of Sections 23, 24 and
25 of the Act, at paragraph Nos. 20, 21, 22, 23 and 24
has held as under:-
"20. In view of the aforesaid position emerging from
the scheme underlying Section 23 and 25 of the Act,
it is not debatable that as and when a sample of drug
is lifted by the Inspector from the premises where it is
sold or manufactured, it shall, apart from complying
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with other formalities, divide the sample into four or
three portions, as the case may. Four portions in case
the sample is lifted from a person other than the
manufacturer and three where sample has been lifted
from the manufacturer. It is, thus, clear that if the
sample is lifted from the premises of a person other
than the manufacturer, it has to be divided into four
portions or containers, as the case may. One portion
has to be delivered to the person from it is lifted; one
to be sent to the government analyst for test and
analysis and the one is required to be sent to the
manufacturer. The fourth one is to be retained to be
produced in the Court where the proceedings in
respect of the drug are filed by the
Inspector/complainant.
21. Section 25(2) unequivocally prescribes that the
government analyst's report received by the Inspector
in respect of the sample of Drug alone is to be
furnished to the person from whom it has been lifted
or to the manufacturer as the case may be. There is,
thus, no statutory obligation on the Inspector to send
the portion of sample along with the report of the
government analyst to be served upon the
manufacturer in terms of section 25(2) of the Act. As
is clearly provided in sections 23(4)(iii), the third
portion of the lifted sample is required to be sent to
the manufacturer simultaneously with sending of one
portion to the government analyst for test and
analysis and this is for a purpose and the purpose is
to enable the manufacturer to put that portion of the
sample to test and analysis by an independent Drug
Laboratory, so that if the sample fails and an adverse
report from the government analyst comes, he may
make an informed decision as to whether he should
adduce evidence in controversion of the report or take
an appropriate defence in the complaint that may be
filed by the Inspector on the basis of such report of
the government analyst. I am, therefore, not in
agreement with the learned counsel for the petitioner
that along with the report of the government analyst,
a sample portion is also required to be provided to the
manufacturer. The supply of portion of the lifted
sample before the report of analyst is received is
compliance of Section 23(4)(iii) and a precursor for
the manufacturer to get the lifted sample tested and
analyzed by the drug laboratory of his choice.
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22. As is evident from a reading of Subsection (3) of
Section 25 of the Act, the report of the government
analyst in respect of the sample of drug tested and
analyzed by it submitted to the Inspector concerned is
conclusive evidence of the facts stated therein, if
same is not controverted by the person from whom
the sample had been lifted or the manufacturer, as
the case may be. The procedure for controverting the
report is that such person must within 28 days of
receipt of copy of the report notify to the Inspector or
the Court concerned that he intends to adduce
evidence in controversion of the report. He may not
seek reference of the sample produced before the
Court concerned by Inspector under Section 23 of the
Act and choose to contest the report of the
government analyst by adducing evidence in
controversion thereof. Sending of the sample to the
Central Drug Laboratory in a case where it has been
tested or analyzed by the government analyst cannot
be claimed either by the complainant or the accused
(Manufacturer), as a matter of right. It is left to the
discretion of the Court to either suo moto send such
sample to the Central Drug Laboratory for test or
examination or it may in its discretion send the same
for test and analysis to the Central Drug Laboratory
on the request of either of the complainant or the
accused. However, once the Court on its own motion
or at the request of the complainant or the accused,
as the case may be, sends the drug sample to the
Central Drug Laboratory for test and analysis and the
report comes, such report, in terms of Subsection (4)
of Section 25 shall be the conclusive evidence of the
facts stated therein and the complainant or the
accused shall be left with no discretion or option but
to accept it without any protest or objection.
23. Viewed, thus, we can say that even in a case
where the person from whom the sample of drug is
lifted or manufacturer of such drug, as the case may
be, has not exercised its intention to adduce evidence
in controversion of the report within the prescribed
period, he shall not be debarred from contesting the
complaint and leading its defence but he shall be
precluded from adducing evidence in controversion of
the report.
24. Similarly, notwithstanding that the Court may
have refused to refer the portion of sample produced
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before it by the Inspector under Section 23(4 ) to the
Central Drug Laboratory for test and analysis, report
of the analyst shall be liable to be controverted by the
accused by adducing its evidence and such evidence
could be the report from another Drug Laboratory or
some scientific evidence. The provisions of Sections
23 and 25 are, therefore, required to be understood
in the manner aforesaid."
19. In the instant case, as noted above, there is no
compliance to the requirement of sub-section (4) of
Section 25 of the Act. The petitioner herein who had
submitted his objections to the report vide his
communication dated 23.06.2020 vide Annexure-G, has
not been given opportunity of leading evidence
contraverting the report. The express and implicit
provisions contained in this regard in the statute has been
negated.
20. Another aspect of the matter which is highlighted by the
counsel for the petitioner is that no material was placed
with regard to mode of seizure, mode of preservation and
authority to retain the seized sample drugs till they were
sent to the Central Drugs Laboratory for testing, pursuant
to the order passed by the Jurisdictional Magistrate.
Relevant also in this regard to refer sub-section (2) of
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Section 22 as well as sub-section (6) of Section 23 of the
Act, which read as under:-
22. Powers of Inspectors
(2) The provisions of the Code of Criminal
Procedure, 1973 (2 of 1974) shall, so far as may
be, apply to any search or seizure under this
Chapter as they apply to any search or seizure
made under the authority of a warrant issued under
section 94 of the said Code.
(2A)Every record, register or other document seized
under clause (cc) or produced under clause (cca)
shall be returned to the person, from whom they
were seized or who produce the same, within a
period of twenty days of the date of such seizure or
production, as the case may be, after copies thereof
or extracts therefrom certified by that person, in
such manner as may be prescribed, have been
taken.
23. Procedure of Inspectors
(6) Where an Inspector seizes any record,
register, document or any other material object
under clause (cc) of sub-section (1) of section 22,
he shall, as soon as may be, inform a Judicial
Magistrate and take his orders as to the custody
thereof.
21. These provisions are pari materia to Sections 94, 101 and
102 of the Code of Criminal Procedure. In other words,
when the drugs are seized for the purposes provided
under the provisions of the Act, as noted above, it was
incumbent on the part of the Inspector to have brought to
the notice of the Jurisdictional Magistrate, obtain
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necessary orders either for storing or to retain the same
with him. This is only, as established, to provide
credibility to the sample seized and to avoid any suspicion
or doubt with regard to the process of preservation and
authenticity of the report obtained thereof, which is also
completely lacking in the instant case.
22. Under these circumstances, this Court is of the considered
view that based on the report of the Central Drugs
Laboratory, Kolkata, which itself was incomplete in the
nature of the information sought for by them was not
furnished could not have been the basis for the
respondent - Authority to come to conclusion that the
petitioner had supplied the drugs which are not of
standard quality. Benefit of doubt with regard to the
conclusiveness of the report has to be given to the
petitioner, inasmuch as, the consequences are not only
civil in nature, but are penal in nature. Strict adherence
to the aforesaid rule is contemplated for the very
consequences contemplated therein.
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23. It is settled position of law that blacklisting is a sanction
or is an action in the nature of penalty. It carries with it
severe civil consequences. It is also termed and described
as "civil death" of a person who is foisted with order of
blacklisting. It is an order stigmatic in nature and debars
such a person from participating in Government tenders.
Therefore, it has repeatedly been insisted and
emphasised necessity of giving an opportunity to such a
person by serving a show cause notice enabling him to
meet the allegations. GOKHA SECURITY SERVICES V.
2
GOVERNMENT (NCT OF DELHI) AND OTHERS and
KULJA INDUSTRIES LIMITED V. CHIEF GENERAL
MANAGER, WESTERN TELECOM PROJECT BHARAT
3
SANCHAR NIGAM LIMITED AND OTHERS.
24. For the aforesaid reasons and analysis, the following;
ORDER
(i) Petition is allowed .
(ii) Impugned order/communication at Annexure-B
dated 13.09.2022 is quashed.
2
(2014) 9 SCC 105
3
(2014) 14 SCC 731
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(iii) The respondent–Authority is directed to remove the
name of the petitioner from the list of debarment.
The respondent- authority shall also release the
forfeiture of the bank guarantee as security deposit
made by the petitioner.
Sd/-
(M.G.S. KAMAL)
JUDGE
Vmb
List No.: 1 Sl No.: 23