Writ petition, Quality assurance, Drugs and Cosmetics Act, Blacklisting, Show cause notice, Territorial jurisdiction, Indian Pharmacopoeia, Microbial limit test, UPMSCL
 27 Aug, 2026
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Kemecos India Private Limited & Ors. Vs. Uttar Pradesh Medical Supplies Corporation Limited & Ors.

  Calcutta High Court W.P.A. No. 3159 of 2026
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Case Background

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" ...

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Document Text Version

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.

2

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.)

Reference cases

Description

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.

Case Background: The Dispute Over Drug Quality

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.

Petitioners' Stance: Allegations of Procedural Flaws and Misinterpretation

The petitioners, represented by Mr. Kamalesh Bhattacharya, contended several points:

  • The respondents initially raised no objections regarding their submitted test reports, which did not include biological tests.
  • They argued that their product, Benzyl Benzoate Application 25% W/W 100 ml bottle, falls under Section 3(b) of the Drugs and Cosmetics Act, 1940, and thus, the 'I.P.' (Indian Pharmacopoeia) standard requiring microbiological tests was not applicable, especially since the term "I.P." was not incorporated in the drug's name as per Rule 104 of the Drugs Rules, 1945.
  • After supplying the materials, and repeated requests for payment, UPMSCL issued a First Show Cause Notice (SCN) on 16th July 2025, declaring 26 batches as "not of standard quality" (NSQ) due to alleged inconsistent biological tests. The petitioners argued these tests were not conducted in their presence.
  • Despite their detailed reply on 21st July 2025, clarifying the high quality and absence of complaints, UPMSCL issued an order on 26th August 2025. This order deemed the 26 batches as non-supply, imposed a 20% penalty, 0.2% demurrage, charged for destruction, and blacklisted the petitioners for three years for that specific drug.
  • Further, they obtained information via RTI from the Director of State Drugs Control and Research Laboratory, Government of West Bengal, indicating that the Indian Pharmacopoeia-2022 (Monograph and General Chapter of I.P.2022, "Microbial Contamination of non-sterile products") does not include microbiological tests for Benzyl Benzoate 25% W/W 100 ml bottle.
  • They also challenged the validity of the subsequent 2nd (31st December 2025) and 3rd (2nd February 2026) SCNs, arguing they were premature and irregular as no final order was passed on the first SCN.
  • A crucial argument was that UPMSCL's empanelled laboratories were not accredited for microbiological testing of this specific drug and were only authorized for Schedule C and C(1) Drugs, which Benzyl Benzoate is not. They emphasized that sampling should be done by Drug Inspectors and tested by Government Analysts, as per the Drugs and Cosmetics Act, 1940, and Rules, 1945.

Respondents' Defense: Upholding Quality Standards and Amended Regulations

Mr. Avinash Chandra, representing the respondents, countered the petitioners' arguments:

  • He highlighted Clause 11(ii) of the tender conditions, which the petitioners had accepted, mandating confirmatory quality testing for all drug batches as per UPMSCL’s Quality Policy.
  • The UPMSCL Quality Policy (Clauses 4, 5, and 6) empowers the corporation to empanel laboratories for testing and outlines methods for sample preparation and randomization.
  • The respondents clarified that the Indian Pharmacopoeia monograph for the subject drug was in force, and a Microbial Limit Test (MLT) is an integral requirement, not an additional contractual condition. Failure to comply with MLT standards renders a batch "Not of Standard Quality" (NSQ). They cited an email from the Indian Pharmacopoeia Commission (dated 27th March 2026) clarifying that for Benzyl Benzoate intended for cutaneous use, General Chapter 2.2.9 "Microbial Contamination in Non-sterile Products" applies, which does include specific microbiological limits (Total Aerobic Count, Total Fungal Count, Specified Microorganisms like Staphylococcus aureus and Pseudomonas aeruginosa). This directly contradicted the petitioners' RTI information from West Bengal.
  • Regarding testing authority, Mr. Chandra referred to amendments in the Drugs Rules, 1945 (G.S.R. 223(E) dated 18th March 2019, and 15th December 2020), which permit procurement agencies to use approved, licensed, and independent laboratories for testing. New Forms 39 and 39A were introduced, making it unnecessary for samples to be collected solely by Government Analysts or for reports to be signed only by them.
  • He also explained the DVDMS portal system, a centralized web-based application that masks the identity of manufacturers and batch numbers with a unique confidential "Secret Code" before samples are dispatched to empanelled laboratories, ensuring impartial and unbiased testing.
  • The respondents reiterated that the SCNs were issued based on laboratory reports indicating NSQ, and the petitioners' replies were duly considered before the final order of 26th August 2025 was passed, outlining penalties as per tender conditions (Clause 11(v)-(vii)) and blacklisting as per Clause 13(1) for two or more NSQ batches.

The Legal Issues: IRAC Breakdown

Issue: Validity of NSQ Declaration and Associated Penalties

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.

Rules: Navigating India's Drug Regulations and Tender Conditions

The core legal framework for this case involved:

  • Drugs and Cosmetics Act, 1940: Particularly Section 3(b) (definition of drug), Section 20 (Government Analysts), and Section 23 (powers of Inspectors).
  • Drugs Rules, 1945: Including Rule 45 (submission of analyst reports), Rule 51 (procedure for sampling), Rule 104 (labeling), and crucially, the amended Rules 150, 150B, 150C, 150E (which permit procurement agencies to use independent, approved laboratories for testing and reports in Forms 39/39A).
  • Indian Pharmacopoeia-2022: Specifically, General Chapter 2.2.9 on "Microbial Contamination in Non-sterile Products," which details acceptance criteria for microbiological quality for cutaneous dosage forms like Benzyl Benzoate.
  • UPMSCL Tender Conditions: These contractual clauses governed the procurement, quality assurance (e.g., Clause 11(ii) for confirmatory testing, 11(v)-(vii) for NSQ penalties, 11(viii) for finality of quality decisions), debarring and blacklisting (Clause 13(1) for two NSQ batches), and dispute resolution (Clause 21, including arbitration and territorial jurisdiction).
  • UPMSCL Quality Policy: Outlining procedures for empanelling labs (Clause 4, 5) and sample preparation/randomization (Clause 6), including the use of a "Secret Code" system.
  • Principles of Natural Justice: Implied in the requirement for issuing show-cause notices and considering replies before passing punitive orders.

Analysis: Court's Examination of Arguments and Evidence

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.

Conclusion: The Court's Final Decision

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.

Summary of the Ruling

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.

Why This Judgment Matters for Legal Professionals and Students

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.

Disclaimer

All information provided in this article is for informational purposes only and does not constitute legal advice. While efforts have been made to ensure accuracy, readers should consult with a qualified legal professional for advice pertaining to their specific circumstances. CaseOn.in and its affiliates are not liable for any actions taken or not taken based on the information provided herein.

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