As per case facts, the petitioners supplied Benzyl Benzoate Application bottles to the Uttar Pradesh Medical Supplies Corporation Limited (UPMSCL). Subsequently, UPMSCL declared 26 batches as "not of standard quality" ...
IN THE HIGH COURT AT CALCUTTA
(Constitutional Writ Jurisdiction)
APPELLATE SIDE
Present:
The Hon’ble Justice Krishna Rao
W.P.A. No. 3159 of 2026
Kemecos India Private Limited & Ors.
Vs.
Uttar Pradesh Medical Supplies
Corporation Limited & Ors.
Mr. Kamalesh Bhattacharya
Mr. Ashim Ghosh
Mr. Sujit Bhattacharya
Mr. Ushananda Jana
Mr. Ashok Mazumdar
Mr. Swadin Pan
....For the petitioners.
Mr. Avinash Chandra
Mr. Abhijit Prasad
….For the respondents.
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Hearing Concluded On : 06.08.2026
Judgment Delivered On : 27.08.2026
Judgment Uploaded On : 27.08.2026
Krishna Rao, J.:
1. The petitioners have filed the present writ petition for issuance of
mandamus upon the respondent authorities particularly the
respondent no.2 not to take any action on the basis of the show cause
notice dated 31
st
December, 2025, the order being UPMSC/05/2025-
26/1512 dated 29
th
January, 2026, and for release of payment to the
tune of Rs. 1,53,91,742.16/-.
2. The respondent no.1, namely, Uttar Pradesh Medical Supplies
Corporation Limited (hereinafter referred to as “UPMSCL”) decided to
procure Benzyl Benzoate application 25% W/W, 100 ml. bottle and
supply the same to various healthcare establishments across all the
districts of Uttar Pradesh.
3. For procurement of the Benzyl Benzoate Application 25% W/W 100 ml
bottle, the respondent no.2 published an e-tender notice inviting
eligible and qualified bidders. The petitioners have participated in the
bid process and were selected for supply of Benzyl Benzoate
Application 25% W/W, 100 ml bottle in tranches within a period of
one year.
4. The petitioners have supplied the Benzyl Benzoate Application 25%
W/W, 100 ml bottle having quantity of 1401000 bottles for a value of
3
Rs. 1,65,38,525/-. As per agreement, the petitioners have also
uploaded test reports certified by National Accreditation Board for
Testing and Calibration Laboratories (NABL) prior to the delivery of
Benzyl Benzoate Application 25% W/W 100 ml bottle since the year
2022 till March, 2025.
5. Mr. Kamalesh Bhattacharya, Learned Advocate, representing the
petitioners submits that the respondents did not raise any objection
regarding the test reports. The test reports did not depict any result of
Biological Tests since 2022 to March, 2025.
6. Mr. Bhattacharya submits that there was no abbreviated term of I.P.
incorporated after the name of drugs i.e. Benzyl Benzoate Application
I.P.25% W/W 100 ml bottle in terms of Rule 104 of the Drugs Rules,
1945. He submits that I.P. stands for Indian Pharmacopoeia. He
submits that Benzyl Benzoate Application 25% W/W 100 ml is a drug
in terms of Section 3(b) of the Drugs and Cosmetics Act, 1940, thus
the question of I.P. standard does not arise.
7. Mr. Bhattacharya submits that after supply of materials in terms of
contract, the petitioners have submitted invoices and made several
requests for disburse of the amount but no amount is paid to the
petitioners instead the respondent no.2 has issued First Show Cause
notice dated 16
th
July, 2025 to the petitioners by informing the
petitioner no.1 that 26 batches of the Benzyl Benzoate Application I.P.
25% W/W 100 ml bottle were found to be not of standard quality. It
4
was further alleged that based on the feedback given by purported
technical experts, the biological tests were found to be of allegedly
higher specificity and sensitively and has been giving inconsistent
results. He submits that the purported test reports were not carried
out in presence of the petitioners.
8. Mr. Bhattacharya submits that the petitioner no.2 has submitted
detailed written reply on 21
st
July, 2025 and clarified that the high
standard of the Benzyl Benzoate Application 25% W/W 100 ml bottle
supplied and further informed the respondents that not a single
complaint was received by the petitioner no.1 from July, 2022 till
June, 2025 when the petitioners supplied the said materials to the
respondents.
9. Mr. Bhattacharya submits that on 26
th August, 2025, the respondents
have issued an order upon the petitioner company declaring that (i)
quantity corresponding to twenty six batches are not of standard shall
be deemed as non-supply and flat 20% penalty shall be levied on the
value of the corresponding quantity, (ii) 0.2% demurrage shall be
levied on the value of corresponding quantity and in addition cost for
destruction shall be liable to pay (iii) the petitioners have been
blacklisted for the Drug Benzyl Benzoate Application 25% W/W 100
ml bottle for three years with effect from 26
th
August, 2025.
10. Mr. Bhattacharya submits that the petitioners have obtained an
information under Right to Information Act, 2005, regarding whether
5
Microbiological test for Benzyl Benzoate Application 25 % W/W 100 ml
bottle is required before the Director of State Drugs Control and
Research Laboratory, Government of West Bengal and in reply, it is
informed that the test parameters of Benzyl Benzoate 25% W/W as per
Indian Pharmacopoeia- 2022, Monograph and General Chapter of
I.P.2022, namely, “Mircobial Contamination of non-sterile products”
does not include any Microbiological tests.
11. Mr. Bhattacharya submits that the activities of empanelled testing
laboratories and UPMSCL are not in consonance with Drugs and
Cosmetics Rules and official compendiums. He submits that the
respondents have issued 2
nd show cause notice dated 31
st December,
2025, to show cause why the petitioners shall not be debarred from
supplying the subject drug for a period of two years. He submits that
the petitioners have submitted reply to the show causes notices but
without considering the reply submitted by the petitioners, the
respondents no. 2 has issued an order of blacking of the petitioners for
a period of three years for the Drug Benzyl Benzoate application 25%
W/W 100% ml bottle and other punitive steps by allowing only 15
days to recall the drugs of 26 batches declared as not of standard
quality by the empanelled testing approved laboratories of the
respondents.
12. Mr. Bhattacharya submits that again on 2
nd
February, 2026, the
respondent no. 2 has issued a third show cause notice alleging that
the petitioners have not supplied the standard quality of two batches
6
being Batch Nos. 819 and 808 of Benzyl Benzoate Application 25%
W/W 100 ml bottle and on receipt of the said show cause notice, the
petitioners have submitted reply to the show cause notice. He submits
that second show cause notice was issued without passing a final
order on the first show cause notice, and as such the second show
cause notice is premature and improper and thus, the order dated 29
th
January, 2026, has become infructuous. He further submits that
issuing the second show cause notice on the same cause of action
without passing any order on the first show cause notice, is irregular
and actionable and issuing a third show cause notice dated 2
nd
February, 2026, is also irregular and actionable.
13. Mr. Bhattacharya submits that the respondents’ empanelled
Laboratories are not accredited for Microbiological testing for the drug
Benzyl Benzoate Application 25% W/W 100 ml bottle in terms of
Form- 36 read with Rule 150-B of the Drugs and Cosmetics Rules,
1945. He submits that the said laborites are only entitled to do
microbiological tests of Schedule C and C(1) Drugs only. He submits
that Benzyl Benzoate Application 25% W/W 100 ml bottle is not
coming under Schedule C and C/1.
14. It is the contention of the petitioners that the Drug Inspectors are the
authority for sampling of drugs in terms of Section 23 of the Drugs
and Cosmetics Act read with Rule 51 of Drugs and Cosmetics Rules,
1945, by sending one part of sample to the Government analyst
appointed under Section 20 of the said Act and the Government
7
analyst shall deliver test reports in Form-13 to the Inspector of Drugs
within 60 days as per Rule 45 of Drugs and Cosmetics Rules, 1945
but in the present case, the Inspector of Drugs has not taken any
samples and the Government analysts did not test or done any
analysis.
15. Per contra, Mr. Avinash Chandra, Learned Advocate, appearing for the
respondents submits that Clause 11(ii) of the tender condition which
is an admitted document by the petitioners provides that the samples
of all batches of all drugs shall be subjected to confirmatory quality
testing as per UPMSCL Quality Policy. Clause 4 of the Quality Policy
empowers the UPMSCL to empanel the laboratories for conduct of
confirmatory quality testing and Clause 5 provides that in case, no
empanelled laboratory of testing of drugs or in case of unavailability of
more than two empanelled labs for confirmatory testing or in case of
recommendation by Quality Council, the testing may be done by the
Government labs.
16. Mr. Chandra submits that Clause 6 of the Quality Policy provides for
the method of sample preparation and randomization. For the purpose
of executing the liabilities of the Corporation, EAushidhi (Drugs and
Vaccine Distribution Management System) has been introduced in the
corporation which is centralized automated web-based application
dealing in the management of stocks, of various drugs a surgical item,
the demands made and its satisfaction. He submits that for the said
purpose, the Government of Uttar Pradesh has independently entered
8
into a Memorandum of Understanding with Center for Development of
Advanced Computing (C-DAC), a Scientific Society under the
Department of Electronics and Information Technology, Ministry of
Communications and Information Technology, Government of India
and operation of the said application is beyond the control of the
answering respondent.
17. Mr. Chandra submits that in the instant case, the Drug samples were
sent for testing to three Laboratories which are licensed by the
Licensing Authorities under the provisions of the Drugs and Cosmetics
Act, 1945 and Rules and are accredited by National Accreditation
Board of Testing and Calibration Laboratories at relevant point of time.
18. Mr. Chandra submits that the system adopted by UPMSCL for
masking the identity of the manufacturer and batch number before
dispatch of samples to empanelled analytical laboratories is an
established quality assurance mechanism intended to ensure
impartial, objective and unbiased testing. He submits that at the time
of dispatch of samples, the original particulars relating to the
manufacturer, manufacturing license number, logo and batch number
are intentionally concealed and replaced with a unique confidential
identification (Secret Code) through DVDMS portal. The laboratory
receives only the coded samples. He submits that the Secret Code is
not an anonymous or arbitrary. It is a unique traceable code generated
and maintained by DVDMS portal.
9
19. Mr. Chandra submits that the Indian Pharmacopoeia monograph for
the subject drug was in force on the date of manufacture, supply and
quality testing. The microbial limit test was not introduced by
UPMSCL as an additional or contractual condition. It is an integral
requirement of the Indian Pharmacopoeia for the concerned drug.
Failure of the supplied batch to comply with the prescribed microbial
limit rendered the batch Not of Standard Quality (NSQ). He submits
that irrespective of whether the suffix “IP” is expressly mentioned in
the tender schedule, every drug having an applicable IP monograph is
required to confirm to the standards prescribed therein.
20. The UPMSCL has issued show cause notice to the petitioners on 16
th
July, 2025, directing the petitioners to explain the followings:
i. why as per condition no. 11(v) of tender the
supplied quantity of drug batches- BB-791, BB-
793, BB-794, BB-795, BB-796, BB-798, BB-799,
BB-802, BB-803, BB-804, BB-810, BB-811, BB-
812, BB-816, BB-817, BB-818, BB-826, BB-833,
BB-837, BB-838, BB-843, BB-845, BB-853, BB-
863, BB-864, BB-865 should not be treated as
non-supply and payment of corresponding value
should not be deducted.
ii. why as per condition no. 11(v) of tender, 20% of
the above value should not be taken from
Company as penalty for supplying "Not of
standard quality drug".
iii. why to take back the said drug batches by
Company's own arrangement within 30 days of
receipt of this notice otherwise after 30 days,
0.2% demurrage shall be levied on the value of
corresponding quantity and the stock of said
drug shall be destroyed by the UPMSCL and the
cost incurred for such destruction would be
charged from Company. Available stock of
10
above drug batch as per DVDMS portal is
attached with this notice.
iv. why as per condition no. 13 (1) of tender,
Company Kemecos India Private Limited should
not be blacklisted for drug "Benzyl Benzoate
Application: 25% w/w (-) 100 ml Bottle" due to
supply of 26 drug batches (Batch no. BB-791,
BB-793, BB-794, BB-795, BB-796, BB-798, BB-
799, BB-802, BB-803, BB-804, BB-810, BB-
811, BB-812, BB-816, BB-817, BB-818, BB-
826, BB-833, BB-837, BB-838, BB-843, BB-
845, BB-853, BB-863, BB-864 & BB-865) to
different District warehouses of UPMSCL.”
21. Condition Nos. 11(v), 11(vi), 11(vii) and 13 of the tender conditions,
reads as follows:
“11. QUALITY ASSURANCE
v. Quantity corresponding to NSQ batch
shall be deemed as non-supply and flat
20% penalty shall be levied on the value of
corresponding quantity.
vi. In case a batch is declared NSQ, the
supplier has to take back the
corresponding quantity supplied by its own
arrangement within 30 days of intimation.
Beyond 30 days, 0.2% demurrage charge
per day shall be levied on the value of
corresponding quantity remaining un-lifted.
vii. In case the supplier does not take the
stock of NSQ drugs back within 90 days of
intimation, then UPMSCL shall be at liberty
to destroy the quantity lying at its
warehouses. Supplier shall be liable to pay
the expenses incurred for such destruction
in addition to the demurrage charges
applicable.
vii. The decision of the Tender Inviting
Authority or any officer authorized by him
as to the quality of the supplied items shall
be final and binding.
11
13. DEBARRING & BLACKLISTING
i. If two batches of any drug supplied by a
Company/firm is found not of standard
quality, then the Supplier Company/firm
shall be blacklisted for that particular drug
for a period of three years.
ii. If the Supplier fails to execute at least 70%
of the order quantity for any particular
drug for more than two purchase orders,
then the Supplier shall be debarred for
supply of that particular drug for a period
of two years.
iii. lf a Supplier is blacklisted for more than
two drugs for quality issues, then the
Supplier shall be debarred as whole for a
period of three years.
iv. The bidder/Supplier who have submitted
forged documents in tender or in
correspondence to any subsequent
communication from UPMSCL shall be
declared ineligible to participate in the
tenders for a period of 5 years.
v. The Supplier shall be blacklisted for a
period of 3 years if any of the drugs
supplied is declared spurious or
adulterated by the regulatory authority.
vi. The Supplier shall be blacklisted for 3
years if proved to have manipulated expiry
date of the drugs.
vii. Goods against orders placed prior to
blacklisting/debarring any Supplier shall
be received as per normal protocol.”
22. The petitioners have obtained information under Right to Information
Act on the issue whether Microbiological test for Benzyl Benzoate
Application 25% W/W 100 ml bottle is required before the Director of
State Drugs Control and Research Laboratory, Government of West
12
Bengal. In reply to the said issue, it was informed to the petitioners
that the test parameters of Benzyl Benzoate Application 25% W/W 100
ml bottle as per Indian Pharmacopeia-2022, Monograph and General
Chapter of I.P. 2022, namely, “Microbial Contamination of non-sterile
products” does not include any Microbiological tests.
The UPMSCL by an email dated 27
th
March, 2026, asked for
Clarification on Microbial Limit Test (MLT) Requirement for Benzyl
Benzoate Application I.P. 25% W/W and in reply to the said
clarification, the Indian Pharmacopoeia Commission clarified that:
“The Indian Pharmacopoeia (IP) serves as the
official book of standards for drugs in accordance
with the Drugs and Cosmetics Act, 1940.
As Benzyl Benzoate is intended for cutaneous
use, you are requested to refer to General Chapter
2.2.9 “Microbial Contamination in Non-sterile
Products” (refer pages 56 of IP 2026). Under Table
6 – Acceptance criteria for microbial quality of non-
sterile dosages forms, the applicable limits for
cutaneous use are as follows:
Total Aerobic Count (TAC): 10
2
CFU per g or
ml
Total Fungal Count (TFC): 10
1 CFU per g or
ml
Specified Microorganisms: Staphylococcus
aureus and Pseudomonas aeruginosa –
Absent in 1 g or 1 ml
Accordingly, the above limits shall be
applicable to Benzyl Benzoate preparations
intended for cutaneous use.”
13
Chapter 2.2.9. Microbial Contamination in Non-Sterile Products
reads as follows:
“Acceptance Criteria for Microbiological
Quality of Non-Sterile Pharmaceutical
Substances and Non-Sterile Doses Forms.”
This provides, acceptance criteria for microbiological quality of
non-sterile substances of pharmaceutical use and non-sterile dosage
forms, unless otherwise specified in the monograph.
If microorganisms are present in a pharmaceutical preparation,
they can reduce or in activate the therapeutic activity of the products
or can adversely affect the health of the patients. Hence,
pharmaceutical preparations should have low bio-burden and they
should not have specified microorganisms, which are harmful.
Microbial examination of non-sterile product is performed
according to the methods given above. Acceptance criteria for
microbiological, quality of non-sterile substances for pharmaceutical
use and non-sterile pharmaceutical products based upon the Total
Aerobic Viable Count (TAC) and the Total Fungal Count (TFC) are
given in Tables 5 and 6 respectively. Thus, “Microbial Contamination
of Non-Sterile Products” does not include any Microbiological test, is
contrary to the Indian Pharmacopeia-2022.
23. The petitioners have raised the issue that the activities of the
empanelled testing laboratories and UPMSCL are not in consonance
with the Drugs and Cosmetics Rules and official compendiums. The
14
Drugs and Cosmetics Rules, 1945, was amended and various
provisions were amended/substituted/added by G.S.R. 223 (E) dated
18
th March, 2019. Thereafter, Rules 150B, 150C, 150E of the Drugs
Rules, 1945, were substituted with the new provisions and now, the
laboratories may be approved, licensed and conduct testing for
procurement agencies also. A new Form-39A is inserted. As per Rule
150-E(f) of the Drugs Rules, 1945, the report can be given in Form-
39A and thus, it is not necessary that the samples should be collected
only by the Government Analyst and reports should be signed only by
Government Analyst.
24. The petitioners have raised the issue that the Drug Inspectors play
crucial role in sampling of drugs in terms of Section 23 of the Drugs
and Cosmetics Act, 1940, read with Rule 51 of the Drugs and
Cosmetics Rules, 1945 by sending one part of sample to Government
Analyst appointed under Section 20 of the Act and the Government
Analyst shall deliver test reports in Form-13 to the Inspector of Drugs
within 60 days as per Rule 45 of the Drugs Rules. As per the
contention of the petitioners that the test reports of the approved
laboratories as empanelled by the respondents are not in accordance
with law and have no legal sanctity.
25. The Drugs Rules, 1945, was amended on 15
th
December, 2020 and in
Rule 150 test for procurement agencies were also permitted through
independent laboratories and a new Form-39 was introduced of test
reports on the request of procurement agencies. In the present case,
15
tests were conducted as per the provisions of the Drugs and Cosmetics
Rules therein. As per modified Quality Policy of UPMSCL which was
approved on 13
rd Board held on 3
rd March, 2022, the samples
preparation and randomization was approved. Sub-Clauses (c), (d) and
(e) of Clause 6 of modified Quality Policy of UPMSCL, reads as follows:
“6. Sample Preparation & randomization
(c)(i) Consignee selection of drug batches from
all samples received to Quality Control
Division of UPMSCL Lucknow Drug
warehouse will be done by the headquarter
Pharmacist (Quality Control) through DVDMS
portal. Quality control division shall wait for
7 days of receipt of first sample of any batch
or up to samples of same batch is received
from 3 warehouses (Whichever is earliest) for
consignee selection and sending sample for
testing at empanelled lab.
(ii) If single batch of a drug is supplied to
single district drug warehouse then
consignee selection of that single batch will
be done immediately without waiting for 7
days after "permission of MD, UPMSCL.
(D) All marks of manufacturer's identity
including batch number shall be
erased/masked for the sample to be sent to
empanelled lab & sample shall be sent with
system encrypted code, product name &
strength.
(E) software system/ DVDMS shall
recommend the laboratory to which sample is
to be sent based on a randomized logic in
consideration with various lab empanelled for
respective drug and total sample load
balance (cumulative number of samples sent
to the labs & total samples pending for
testing at the labs at that point of time).”
16
26. At the time of dispatch of samples, the original particulars relating to
the manufactures, manufacturing license number, logo and batch
number are intentionally concealed and replaced with a unique
confidential identification within (Secret Code) through DVDMS portal
and the laboratory receives only the coded samples. The respondents
have disclosed the details of the batch number against each secret
code of 26 NSQ declared drugs batches downloaded from DVDMS
portal which shows that the respondent authorities have sent the
drugs by masking the batch number and by giving a secret code.
27. Considering the above, this Court finds that the drugs supplied by the
petitioners to UPMSCL were sent to the laboratories and after receipt
of the report from the concerned laboratories, the respondents find
that the same were not of standard quality and thus the respondents
have issued show cause notice to the petitioners and after considering
the reply of the petitioners, the UPMSCL has passed the order dated
26
th August, 2025. This Court did not find any illegality in the
impugned order.
28. The respondents have raised preliminary objection with regard to
maintainability of the writ petition on the ground that Clause 21 of the
conditions of contract which provides for resolution of disputes and
also raised the point of Territorial Jurisdiction. Clause 21 of the
conditions of contract reads as follows:
“21. RESOLUTION OF DISPUTES
17
1. If dispute or difference of any kind shall
arise between the Tender Inviting Authority/
Purchaser and the successful bidder in
connection with or relating to the contract, the
parties shall make every effort to resolve the
same amicably by mutual consultations.)
2. If, after thirty (30) days from the
commencement of such informal negotiations,
the Purchaser and the Supplier have been
unable to resolve amicably a Contract dispute,
either the Tender Inviting Authority/Purchaser
or the successful bidder/Supplier may give
notice to the other party of its intention to
commence arbitration, as provided by the
applicable arbitration procedure and shall be
as per the Arbitration and Conciliation Act,
1996,
3. In the case of a dispute or difference arising
between the Tender Inviting Authority/
Purchaser and a bidder/Supplier relating to
any matter arising out of or connected with the
contract, such dispute or difference shall be
referred to a sole arbitrator as mutually
decided by the parties. The fees, if any, for the
arbitration including arbitrator fees, if required
to be paid before the award is made and
published, shall be borne equally by both
parties. The Arbitrator's award shall be final
and Conclusive.
4. Seat of Arbitration: The seat of
arbitration shall be at Lucknow, Uttar
Pradesh, India. Courts of Lucknow shall have
exclusive jurisdiction.
5. The language of Arbitration shall be English
language and shall be governed, construed in
accordance with applicable Indian laws.”
29. There is no denial that the registered office of the petitioners is
situated at Kolkata. Letter of Intent (LOI) was issued in favour of the
petitioners on 6
th November, 2024, which was received by the
petitioners at the registered office at Kolkata. After issuance of LOI, the
18
petitioners have executed an agreement at Kolkata and were also duly
notarized before the Notary Public at Kolkata. The petitioners had
opened Bank Guarantee for Performance Security at Punjab National
Bank at Bosepukur Rajdanga Branch, Kolkata and all
correspondences were made by the respondents with the petitioners at
the registered address at Kolkata.
30. Considering the above, this Court finds that the preliminary objection
and territorial jurisdiction raised by the respondents are not
sustainable.
31. In view of the above, WPA No. 3159 of 2026 is dismissed.
Parties shall be entitled to act on the basis of a server copy of the
Judgment placed on the official website of the Court.
Urgent Xerox certified photocopies of this judgment, if applied for,
be given to the parties upon compliance of the requisite formalities.
(Krishna Rao, J.)
In a significant ruling by the Hon'ble Justice Krishna Rao, the Calcutta High Court recently addressed crucial aspects of pharmaceutical litigation in India, upholding the decision to blacklist a supplier over "Not of Standard Quality" drugs. This judgment, W.P.A. No. 3159 of 2026, involving Kemecos India Private Limited & Ors. versus Uttar Pradesh Medical Supplies Corporation Limited & Ors., underscores the stringent application of drug quality control regulations. This case, alongside many others, is meticulously documented on CaseOn, providing invaluable insights for legal professionals and researchers.
The case originated from a writ petition filed by Kemecos India Private Limited (the petitioners) seeking a mandamus to nullify a show-cause notice and blacklisting order issued by the Uttar Pradesh Medical Supplies Corporation Limited (UPMSCL) and other respondents. The petitioners also sought the release of a payment amounting to Rs. 1,53,91,742.16/-.
The dispute began when UPMSCL decided to procure Benzyl Benzoate Application 25% W/W, 100 ml bottles for healthcare establishments across Uttar Pradesh. The petitioners successfully bid for the contract, supplying over 1.4 million bottles worth Rs. 1,65,38,525/-. They had also submitted NABL-certified test reports for their products from 2022 to March 2025.
The petitioners, represented by Mr. Kamalesh Bhattacharya, contended several points:
Mr. Avinash Chandra, representing the respondents, countered the petitioners' arguments:
The primary legal question before the Calcutta High Court was whether the actions taken by the Uttar Pradesh Medical Supplies Corporation Limited (UPMSCL)—namely, declaring the petitioners' drug batches as "Not of Standard Quality" (NSQ), imposing penalties, and subsequently blacklisting the firm—were legally sound and in accordance with the Drugs and Cosmetics Act, 1940, the Drugs Rules, 1945, Indian Pharmacopoeia standards, and the agreed-upon tender conditions. A secondary but critical issue was the maintainability of the writ petition, specifically concerning the territorial jurisdiction of the Calcutta High Court given an arbitration clause pointing to Lucknow.
The core legal framework for this case involved:
The Calcutta High Court meticulously examined the arguments presented by both sides. The petitioners largely focused on perceived procedural irregularities and a narrow interpretation of the Indian Pharmacopoeia's requirements for microbiological testing, supported by an RTI response from a West Bengal lab.
However, the respondents effectively demonstrated that their actions were grounded in comprehensive contractual obligations and updated regulatory provisions. The court found compelling the respondents' assertion that the Indian Pharmacopoeia, specifically Chapter 2.2.9, indeed mandated microbiological testing for Benzyl Benzoate preparations intended for cutaneous use. The clarification from the Indian Pharmacopoeia Commission directly contradicted the petitioners' RTI from the West Bengal authority, swaying the court's view on the applicability of microbial limit tests.
Furthermore, the court accepted the respondents' position regarding the validity of testing by empanelled independent laboratories. The amendments to the Drugs Rules, 1945 (G.S.R. 223(E) and 15th December 2020), explicitly permit procurement agencies like UPMSCL to utilize such laboratories and accept their reports in the prescribed Forms. This addressed the petitioners' argument that only samples collected by Drug Inspectors and tested by Government Analysts were valid.
The court also considered the UPMSCL's quality assurance mechanism, including the DVDMS portal and the "Secret Code" system for masking manufacturer identity during testing, as a legitimate method to ensure impartiality. The fact that SCNs were issued, and the petitioners' replies were considered before the impugned order of 26th August 2025 was passed, satisfied the principles of natural justice.
For legal professionals seeking swift comprehension of such detailed rulings, CaseOn.in's 2-minute audio briefs prove invaluable. These concise summaries distill complex judgments, making them accessible for quick analysis and reference, particularly for cases involving intricate regulatory frameworks like drug quality control regulations.
Regarding the preliminary objection on territorial jurisdiction, the court sided with the petitioners. Despite the arbitration clause specifying Lucknow as the seat and giving Lucknow courts exclusive jurisdiction, the court acknowledged that the petitioners' registered office was in Kolkata, the Letter of Intent (LOI) was received there, the agreement was executed and notarized in Kolkata, and the Bank Guarantee was opened in Kolkata. All correspondence also occurred in Kolkata. Based on these facts, the court concluded that the territorial jurisdiction objection raised by the respondents was not sustainable.
Based on its analysis, the Calcutta High Court found no illegality in the impugned order dated 26th August 2025, issued by UPMSCL. The court upheld the respondents' actions of declaring the drug batches as "Not of Standard Quality" and the subsequent punitive measures including blacklisting. Consequently, the writ petition, W.P.A. No. 3159 of 2026, was dismissed.
The Calcutta High Court dismissed the writ petition filed by Kemecos India Private Limited, affirming the Uttar Pradesh Medical Supplies Corporation Limited’s decision to declare several batches of Benzyl Benzoate Application 25% W/W 100 ml bottle as "Not of Standard Quality." The court found that the respondents' actions, including the microbiological testing process, the imposition of penalties, and the blacklisting of the supplier, were in accordance with the amended Drugs Rules, 1945, and the specific requirements of the Indian Pharmacopoeia for cutaneous preparations. The court also rejected the respondents' objection to the Calcutta High Court's territorial jurisdiction, noting the significant operational links of the contract to Kolkata.
This judgment serves as a critical reference for legal professionals and students specializing in:
1. Pharmaceutical Law and Compliance: It clarifies the interpretation and application of the Indian Pharmacopoeia, particularly for microbiological testing of non-sterile products intended for cutaneous use. It highlights that even without an explicit "I.P." suffix, if a monograph exists, its standards are mandatory.
2. Public Procurement and Contract Law: The case emphasizes the binding nature of tender conditions, especially those related to quality assurance, penalties, and blacklisting. It illustrates how courts evaluate the procedural fairness of such actions (e.g., issuance of SCNs and consideration of replies).
3. Administrative Law and Writ Jurisdiction: The ruling explores the limits of judicial review in contractual matters involving government bodies and statutory compliance. It also offers a detailed examination of factors determining territorial jurisdiction in writ petitions when a contract contains a specific jurisdiction clause.
4. Regulatory Updates: It reinforces the impact of recent amendments to the Drugs Rules, 1945, permitting procurement agencies to use independent, approved laboratories, thereby shifting from the traditional reliance solely on Drug Inspectors and Government Analysts for sampling and testing in certain contexts.
5. Dispute Resolution: The judgment provides a practical example of how a court may interpret and apply jurisdictional clauses in contracts in the context of a writ petition, balancing contractual agreements with the factual nexus of the cause of action.
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