Delhi High Court
M/S Zee Laboratries vs Union Of India & Anr on 27 June, 2025
Author: Neena Bansal Krishna
Bench: Neena Bansal Krishna
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Reserved on: 24th March, 2025
Pronounced on: 27th June, 2025
+ W.P.(CRL) 3588/2016 & CRL.M.A. 19498/2016 (Stay)
M/S ZEE LABORATRIES
Through Sh. Chander Shekhar,
Authorized Representative of Petitioner
47, Gondpur Industrial Area,
Paonta Sahib, District Sirmour,
Himachal Pradesh. ....Petitioner
Through: Mr. Vishesh Wadhwa, Ms. Swadha
Gupta and Mr. Vishwash Mishra,
Advocates.
versus
1. UNION OF INDIA
Through Secretary,
Ministry of Health and Family Welfare
Nirman Bhawan, Maulana Azad Road,
New Delhi - 110011 .....Respondent No.1
2. CENTRAL DRUGS STANDARD CONTROL
ORGANISATION
Through Drugs Controller General of India
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India FDA Bhavan, ITO,
Kotla Road, New Delhi - 110002 .....Respondent No.2
Through: Ms. Arunima Dwivedi learned CGSC
with Ms. Swati Jhunjhunwala, Ms.
Pinky Pawar, Advocates for UOI.
+ W.P.(CRL) 3592/2016 & CRL.M.A. 19520/2016 (Stay)
M/S ZEE LABORATORIES
Signature Not Verified
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Through Sh. Chander Shekhar,
Authorized Representative of Petitioner
47, Gondpur Industrial Area,
Paonta Sahib, District Sirmour,
Himachal Pradesh. .....Petitioner
Through: Mr. Vishesh Wadhwa, Ms. Swadha
Gupta and Mr. Vishwash Mishra,
Advocates.
versus
1. UNION OF INDIA
Through Secretary,
Ministry of Health and Family Welfare
Nirman Bhawan, Maulana Azad Road,
New Delhi - 110011 .....Respondent No.1
2. CENTRAL DRUGS STANDARD CONTROL
ORGANISATION
Through Drugs Controller General of India
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India FDA Bhavan, ITO,
Kotla Road, New Delhi - 110002 ....Respondent No.2
Through: Ms. Arunima Dwivedi learned CGSC
with Ms. Swati Jhunjhunwala, Ms.
Pinky Pawar, Advocates for UOI.
CORAM:
HON'BLE MS. JUSTICE NEENA BANSAL KRISHNA
J U D G M E N T
NEENA BANSAL KRISHNA, J.
1. Petitions under Article 226 of the Constitution of India under Section
482 of the Code of Criminal Procedure, 1973 (hereinafter referred to as
“Cr.P.C.”) has been filed to challenge the Summoning Order dated
07.12.2015 in Criminal Complaint No.15/4 of 2015 and 16/4 of 2015 filed
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by the Drug Inspector, Sh. Dharmvir Singh under Section 18(a)(i) read with
Section 16 and punishable under Section 27(d) of the Drugs and Cosmetics
Act, 1940 (hereinafter referred to as “D&C Act”).
2. Briefly stated, the Petitioner, M/s. Zee Laboratories is a Partnership
Firm involved in the manufacturing of Pharmaceutical products, having its
manufacturing unit at Paonta Sahib, District Sirmour, Himachal Pradesh.
The Petitioner manufactures drug, “KETZY EYE DROPS” (Ketorolac
Tromethamine 0.5% Ophthalmic Solution)” licensed with State of Himachal
Pradesh.
3. The Complainant/Respondent No.2 asserted in its aforesaid two
Complaints, both dated 10.08.2015, that Sh. Rajeev Mukul and Sh. Tarun
Kumar are the Partners of the Petitioner Firm and responsible persons for its
affairs at the time of manufacture of drugs in question. They were also in
charge and responsible for the conduct of the business of the Firm.
4. The Complainant/Respondent No.2 asserted that on 26.09.2013,
Drugs Inspector Dharmvir Singh, inspected Guru Gobind Singh Govt.
Hospital, Raghubir Nagar New Delhi (GGSGH) and took three samples of
the drug “KETZY EYE DROPS”, on Form-17 for testing and analysis under
Section 23 of the D&C Act and Drugs and Cosmetics Rules, 1945
(hereinafter referred to as “D&C Rules”). The details of the samples
collected are as follows;
BATCH NO. DATE OF DATE OF
MANUFACTURING EXPIRY
EEZ651 03/2012 02/2014
EEZ652 05/2012 04/2014
EEZ653 07/2012 06/2014
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5. Drugs Inspector, Dharmvir Singh offered fair price of the drugs to Dr.
Alka Gabrayal, Medical Officer In-charge, GGSGH, but she refused to
accept the fair price. The Complainant/Respondent no.2, Drugs Inspector
then filled up Form 17A as per Rule 56-A and 145-AA as the drugs kept for
distribution in Government Hospital, were not for sale and handed over the
copy of Forms to Dr. Alka Gabrayal.
6. The seized samples were sent to Government Analyst, Central Drugs
Laboratory, Kolkata in Form 18 Memorandum dated 27.09.2013. The
CDSCO, Head Quarters, New Delhi received the letter dated 25.10.2013
from the Government Analyst, Central Drug Laboratory, Kolkata for
arranging complete specifications of the Products, complete method of
analysis and Ketoroiac Tromethamine working/reference standard for testing
of “KETZY EYE DROPS”. This Letter dated 25.10.2013 was forwarded to
the Petitioner Firm with a forwarding letter dated 14.11.2013 with directions
to provide the details as sought therein.
7. The Petitioner Firm vide letter dated 19.12.2013 addressed to
CDSCO, Hqrs. New Delhi, gave the requisite intimation about the complete
specification of the product, complete method of analysis and Ketoroiac
Tromethamine working/reference standard for testing of KETZY EYE
DROPS”.
8. The Report, in respect of Sample of Batch No. EEZ652 from Central
Drugs Laboratory, Kolkata was received on 27.12.2012(sic) wherein the
Sample was reported to be as “Not of Standard Quality” with a reason
“Extractable Volume”. Vide Corrigendum Letter dated 31.12.2013, the date
of Test Report was corrected to 27.12.2013 instead of 27.12.2012.
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9. The Reports in respect of Sample of Batch No. EEZ651 & EEZ653
from Central Drugs Laboratory, Kolkata was received on 03.02.2014
wherein it was reported as “Not of Standard Quality” with a reason that
“the samples do not conform to claim with respect to the sterility test.”
10. The copy of the Test Reports was forwarded by the
Complainant/Respondent No.2, to Dr. Alka Gabrayal, Medical Officer In-
charge, GGSGH, under Section 25(2) of the D&C Act along with the Show
Cause Notice under Section 18A and 18B of the D&C Act, vide Letter dated
06.01.2014 and Letter dated 07.02.2014 with a request to disclose the name,
address and the particulars of the person from whom they had acquired the
Drug along with the documents.
11. In response to the Show Cause Notice, Dr. Alka Gabrayal disclosed
the particulars in Form 18A and 18B of the D&C Act, vide Letter dated
08.01.2014. It was informed that the Eye Drop Drug had been manufactured
by the Petitioner Firm in Himachal Pradesh and had been received by her on
16.06.2012, vide Invoice No.04118 and on 31.03.2012 & 04.08.2012 vide
Invoice No. 19744 & 06758, respectively.
12. The Complainant/Respondent No.2 then issued a Show Cause Notice
under Section 18B of Drugs & Cosmetics Act and a Notice dated
09.01.2014 and dated 10.02.2014, respectively, along with the original copy
of the Test Report dated 27.12.2013 and 03.02.2014 along with one sealed
sample portion as required under Sections 25(2) & 23(4)(iii) of the D&C
Act respectively, to the Petitioner Firm. The Complainant/Respondent No.2
also directed the Petitioner Firm to stop the sale of drug in question and
withdraw the stock of the sample drug from the market, where they had been
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sold and also directed to submit the certified copies of documents pertaining
to manufacturing, testing and also to furnish distribution details relating to
aforesaid drug and constitution details of the Firm and recall status of the
subject drug.
13. The Petitioner Firm sent a letter dated Nil with reference to letter
dated 09.01.2014, which was received by the Complainant/Respondent No.2
on 25.02.2014, stating that the control sample in their possession was
complying the test for Extractable Volume and All Tests were within the
limit. The Petitioner Firm also submitted its Manufacturing licence, copy of
Certificate of Analysis of finished product, Batch manufacturing record and
Master Formula record.
14. Petitioner Firm upon receiving the said Show Cause Notice dated
10.02.2014, sent a Letter dated 25.02.2014, to the Respondent No.2, stating
that the control sample in their possession was complying the test for sterlity
and all Tests were within the limit and therefore, they wish to adduce
evidence in controversion of the Test Report.
15. However, it did not submit certified copies of the Firm constitution
details, copy of Memorandum, Article of Association, names and residential
addresses of the Partners responsible for day-to-day conduct of business and
the names and addresses of Production Chemist/competent person,
analytical chemist/competent technical person responsible for production
activities and analytical activities respectively of not of quality standard
drugs batches.
16. The Deputy Drug Controller (India) directed the action to be taken
against the Petitioner‟s Firm under the provisions of D&C Act vide its Letter
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dated 13.01.2014 & 10.02.2014. The Assistant Drugs Controller-cum-Drugs
Licensing Authority, Distt. Simour at Nahan, Himachal Pradesh also
suspended the permission of manufacturing of the said product for 90 days
since 19.05.2014 to 16.08.2014, vide its letter dated 12.05.2014.
17. The permission to launch the prosecution against the
Petitioner/accused persons was accorded by the Drugs Controller General (I)
vide Office Order dated 13.06.2014 from the Controlling Authority. The
two aforesaid Complaints thereafter, were filed under Section 18(a)(i)
read with Section 16 and punishable under Section 27(d) of the Drug
and Cosmetics Act.
18. Summons was issued by Ld. MM, Tis Hazari and the Complaint was
withdrawn due to some technical reasons. Thereafter, the summons was
issued by the Ld. MM. Rohini and Respondent No.2 had appeared on
21.07.2014 and 11.08.2014.
19. The Ld. MM on the Application of the Petitioner for re-testing,
observed that since the drugs namely KETZY EYE DROPS [Ketorolac
Tromethamine Ophthalmic Solution) Batch No EEZ651 Date of
Manufacturing 03/2012, has expired on February2014 and Batch No.
EEZ653 having date of manufacturing as 07/2012, has expired on
June,2014, no purpose would be served by sending the samples for retesting
to CDL, Kolkata and the said Application was accordingly disposed of.
20. The Ld. MM on 07.12.2015 took cognizance on both of the
Complaints and issued summons against the Petitioner. Aggrieved, the
present Petitions have been filed to challenge the Summoning Order.
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21. The grounds of challenge are that Section 25(3) of the D&C Act
gives a valuable right to the accused to rebut the conclusive nature of the
Report of Government Analyst, by notifying its intention to adduce
evidence in contravention of the Report before the Drug Inspector or before
the Court where the proceeding in respect of said sample is pending. No
proceedings were pending before any Court when the Petitioner were served
with the Government Analyst report. However, the Drug Inspector was
obligated to institute Complaint forthwith and produce Sample and request
the Court to send the sample for analysis and test to the Director, Central
Drugs Laboratory.
22. The Petitioner have been deprived of their right to have the samples
examined by the Director of the Central Drugs Laboratory. Therefore, the
prosecution initiated vide the Complaint, is vitiated on account of denial of
valuable right of seeking testing as guaranteed to the Petitioner under
Section 25(4) of the Act.
23. Reliance is placed on the case of State of Haryana Vs. Bhajan Lal,
1992 Supp (1) SCC 335 wherein the Apex Court observed that the criminal
proceedings may be quashed at threshold, if the Complaint taken on its face
value does not disclose any offence or is in violation of mandatory
provisions of law.
24. It is emphasized that the conduct of the Drug Inspector has resulted in
complete denial of right under Section 25(4) to the Petitioner. The drug had
expired much prior to the filing of the Complaint consequent to which his
right to get the second sample sent for examination by Central Laboratory
has been frustrated.
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25. It is further submitted that Form 17 does not provides for the storage
condition of the samples collected by the Respondent No.2, Drug Inspector.
The Petitioner had complied with all the provisions of D&C Act in the
manufacturing of the said drug.
26. The Drugs Controller while considering the matter, suspended the
permission of the Petitioner to manufacture the drug as per the guidelines of
D&C Act, thereby punishing the Petitioner. This was duly informed to the
Complainant, Drug Inspector, but he ignored the facts and launched the
prosecution with mala fide intent. The Petitioner have already been punished
by the State Drug Controller, Himachal Pradesh. The Respondent
No.2/Complainant, Drug Inspector could not have on its own decided for
suspension of permission of manufacturing of the product for 90 days. He
cannot be penalized twice for the same offence.
27. It is contended that the Petitioner have complied with the standards
defined under D&C Act by appointing an approved manufacturing Chemist,
responsible for manufacturing; an approved analytical Chemist, responsible
for testing of the drugs; qualified QA personnel apart from the responsible
person for day-to-day working and conduct of business activities. The Drug
was properly tested and the Test Report of the raw material and finished
goods, were also enclosed.
28. As per the guidelines of CDSCO, the test for Extractable Volume falls
under the Category-C, which is a minor fault and is liable for departmental
action only. In addition, the manufacturer and the manufacturing activities
were not within the jurisdiction of the Drug Inspector. Therefore, the
Petitioner could not have been prosecuted by the Complainant and it was
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only Court which could invoke Section 32A during trial, if the Dealer
proved all the conditions under Section 19(3) (a) to (c) of the D&C Act.
29. The Petitioner has asserted that the Summoning Order dated
07.12.2015 has been passed without considering these aspects and therefore,
the impugned Summoning Order dated 07.12.2015 is liable to be
dismissed.
30. Reliance has been placed on Municipal Corporation of Delhi Vs.
Ghisa Ram AIR 1967 SC 970, State of Haryana Vs. Unique Farmaid (P)
Ltd. And Others (1999) 8 SCC 190 and Medicament Biotech Limited and
Another Vs. Rubina Bose, Drug Inspector (2008) 7 SCC 196.
31. Further objection is taken that the Complaint has been filed by Union
of India through Drug Inspector. The Drug Inspector is not the
Complainant. He also cannot represent Union of India because it can be
represented only by the Secretary of the concerned Department of the
Central Government. For this reason also, the Complaint dated 10.08.2015 is
not maintainable and is liable to the rejected.
32. Further, if Union of India is the Complainant, then there is no
exemption for Union of India under Section 200 Cr.P.C. from examination.
Under Section 200 Cr.P.C, a Magistrate taking cognizance of an offence on
Complaints mandatorily required to examine the Complainant and the
witnesses present, if any, on oath, and the substance of such examination has
to be reduced in writing and signed by the complainant and the witnesses as
well as by the Magistrate. The only exemption given as per the proviso to
Section 200 Cr.P.C., is if a Public Servant acting or purporting to act in
discharge of his official duties or a Court, has made the Complaint. The
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Complaint not being filed by a public servant, the examination of the
complainant and the witnesses under Section 200 Cr.P.C., was mandatory.
33. It is further asserted that there was no justification for exempting the
Complainant, Drug Inspector from examination under Section 200 Cr.P.C.
Such dispensation has been done without there being any such prayer in the
Complaint dated 10.08.2015. The Ld. Trial Court has failed to conduct an
inquiry under Section 202(1) Cr.P.C despite the fact that the
Petitioner/Accused are residing at a place beyond the area in which the
Court exercises its jurisdiction. The inquiry under Section 202(1) Cr.P.C. is
mandatory if the Court wants to initiate prosecution against an accused who
is residing beyond the jurisdiction of the Court. No such inquiry has been
conducted by the Ld. MM before taking cognizance and summoning the
Petitioner.
34. The summons have been issued without recording the statement of the
Complainant, Drug Inspector and without giving any reasons or any kind of
satisfaction, which is against the law.
35. It is also contended that Sh. Rajeev Mukul, Accused No.2, has also
been summoned as one of the partners of the Petitioner Firm, despite there
being on record, documents to show that he was not involved in day-to-day
affairs of the Firm and appointment of a responsible person under the D&C
Act. The Respondent no.2/Complainant, Drug Inspector was well aware
about the constitution of the Firm and had also collected the documents in
regard to the responsible person for day-to-day working and conduct of
business, in compliance of Section 34 of D&C Act and the Complainant has
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intentionally arrayed all the partners of the Firm as accused, in the
Complaints.
36. There are no specific averments against the partners of the Firm and
in the absence thereof, the Complainant has to establish extent of liability
against the partners in terms of Section 34 of the D&C Act. The Complaint
dated 10.08.2015 does not disclose the necessary facts to make him liable as
there must be clear, unambiguous and specific allegations against the
persons who are impleaded as accused for which reliance has been placed on
State of Haryana V/s Brij Lal Mittal, AIR 1998 SC 2327 and Vijay
Chowdhary Vs State, 561-A, CrP.C. No. 44/2003 decided on 23.04.2009.
37. The Complaints were filed with inordinate delay as the Complaint
was filed on 10.08.2015 for both batches of samples and no explanation is
forthcoming as to why the Complaint has been filed after more than one and
a half years of obtaining Report from the Government Analyst.
38. In the end, it is contended that on the face of it, no offence is made out
against the Petitioner and the Summoning Order dated 07.12.2015 in
Criminal Complaint No.15/4 of 2015 and CC No. 16/4 of 2015, be set aside
and be quashed.
39. Respondents No.1&2 in their Counter Affidavit have submitted that
Central Drugs Standard Control Organization, Hqrs. (CDSCO) received a
request from the Directorate of Health Services, Central Procurement
Agency, Swasthya Sewa Nideshalaya Bhawan, F-17, Karkardooma, New
Delhi on 18.09.2013 regarding the supply of sub-standard quality drug
KETZY EYE DROPS Batch No. EEZ652 & KETZY EYE DROPS 5ml Batch
No. EEZ651 and EEZ653, manufactured by the Petitioner.
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40. In response to CDSCO, it deputed the Respondent No.2, Drug
Inspector to draw samples of the Eye Drop from Guru Gobind Singh
Government Hospital, Raghubir Nagar, New Delhi, vide letter dated
24.09.2013. Inspection was accordingly carried out and the sample of the
drugs of the Eye Drop were taken on 26.09.2013 from Guru Gobind Singh
Government Hospital, Raghubir Nagar, New Delhi and Form 17 and 17A
were duly filled and handed over to the Medical In-Charge of the Hospital.
The sample was sent to Central Drugs Laboratory, Kolkata and the Letter
was received for detailed information which was collected and forwarded to
the Central Drugs Laboratory, Kolkata.
41. The Test Report of the sample of batch No. EEZ652 was received vide
Letter dated 27.12.2013 with the observation that the sample was not of
standard quality.
42. The Test Report of the other two samples of Batch No. EEZ651 and
EEZ653 were received on 03.02.2014. On 10.02.2014, Show Cause Notice
along with one sealed sample portion of each batch, were issued upon the
Petitioner.
43. The procedure was duly followed and Show Cause Notice under
Section 18B of D&C Act dated 09.01.2014 was duly sent to the Petitioner.
44. It is further submitted that the Petitioner did not challenge the Test
result under Section 25(3) of D&C Act and merely responded vide its Letter
received in the Department on 25.02.2014 that the sample lying with them
met with the specification.
45. Section 25(3) categorically states that the challenge has to be made
within 28 days from the date of receipt of the Report. However, the
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Petitioner have cleverly not mentioned the date of communication to the
Respondent No.2, Drug Inspector nor has it mentioned in their Letter when
they had received the letter containing the Test Report from the
Complainant, Drug Inspector. It is evident that the Petitioner have
deliberately concealed the dates.
46. It is submitted that the Petitioner have failed to challenge the report of
the Government Analyst, Central Drug Laboratory within the stipulated
period of 28 days from the date of receipt of the copy of the said Report and
also did not submit any document. It is further submitted that the Petitioner
is misleading that the Form 17 does not mention the storage condition;
rather it is only about the intimation from whom the sample was taken.
47. It is submitted on behalf of the Respondent No.2, Drugs Inspector that
the Petitioner had not submitted any Reply to the Show Cause Notice dated
10.02.2014 and no such letter dated 25.02.2014 was received by the
Respondent No.2, Drug Inspector.
48. It is further submitted that the Petitioner has also annexed a letter
dated 13.05.2014 in which it has been mentioned that they have received the
Show Cause Notice on 26.02.2014. Therefore, it is apparent that the alleged
Letter dated 25.02.2014 is a forged document prepared by the Petitioner
afterwards.
49. The Petitioner Firm had not submitted the certified copy of the Firm
constitution details and other particulars including the competent persons,
analytical chemist/competent technical person responsible for production
activities and analytical activities respectively.
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50. It is further explained that the Petitioner‟s Manufacturing Unit is in
the jurisdiction of Drugs Controlling Licensing Authority Himachal Pradesh.
Hence, the Drugs Controller General (I) Hqrs. had sent a letter dated
13.01.2014 & 10.02.2014 to State Licensing Authority, Himachal Pradesh to
take necessary action under the Drugs and Cosmetics Act.
51. Furthermore, the Assistant Drug Controller-cum-Drug Licensing
Authority vide Letter dated 12.05.2014 only suspended the permission of
manufacture of product for 90 days under Rule 85(2) of D&C Rules, but the
action taken was not sufficient and proper. As per D&C Act, necessary
permission for launching the prosecution was accorded on 13.06.2014.
52. It is submitted that the Criminal Complaint has been filed by the
Respondent No.2, Drug Inspector before the Competent Court on
10.08.2015 and summons dated 07.12.2015 have been rightly issued on
against the Petitioner.
53. It is therefore submitted that there is no merit in the present Petition
which is liable to be dismissed.
54. Written submissions have been filed on behalf of the Petitioner as
well as the Respondents, essentially reiterating their rival assertions
contained in their respective pleadings.
55. Submissions heard and record perused.
56. The two Complaints under Section 18(a)(i) read with Section 16 and
punishable under Section 27(d) D&C Act has been filed against the
Petitioner that the Drug KETZY EYE DROPS [Ketorolac Tromethamine
Ophthalmic Solution) Batch Nos. EEZ652, EEZ651 & EEZ653
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manufactured by them, were found to be not of standard quality according
to the D&C Act and D&C Rules made thereunder.
Right of Re-testing of samples under Section 25 D&C Act:
57. The first contention on which the Petitioner have sought the
quashing of summoning order dated 07.12.2015, is that the Complaint dated
10.08.2015, both of the same date, was not filed within one month of the
receipt of the Testing Report whereby the valuable right under Section 25(3)
and (4) to seek re-examination from the Central Testing Laboratory, got
defeated. The relevant part of Section 25 reads as under: –
“25. Reports of Government Analysts
…….
(3) Any document purporting to be a report signed by a
Government Analyst under this Chapter shall be evidence to
the facts stated therein, and such evidence shall be conclusive
unless the person from whom the sample was taken 5 [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 3 [or cosmetic] produced before the Magistrate under
subsection (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,
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and such report shall be conclusive evidence of the facts stated
therein.”
58. Section 25(3) provides that the Report of the Government Analyst
shall be conclusive unless the person from whom the sample is taken has,
within twenty-eight days of the receipt of a copy of the report, notified in
writing to the Inspector or the Court before which proceedings in respect of
the sample are pending, that he intends to adduce evidence in controversion
of the Report.
59. S. 25(4) provides that „unless the sample has already been tested by
the Central Drugs Laboratory’ and under S.25(3) the person has already
notified his intention to adduce the evidence in controversion of the Report
of the Government Analyst, the sample lying with the Court be sent for
retesting to the Central Drug Laboratory, which shall be conclusive evidence
of the fact.
60. The Apex Court in State of Haryana v. Brij Lal Mittal, (1998) 5 SCC
343 has observed that;
“5. From a bare perusal of sub-section (3) it is manifest that the
report of the Government Analyst 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 or other particulars have been disclosed under
Section 18-A (in this case the manufacturers) has within 28
days of the receipt 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. Sub-section (4) also makes it
abundantly clear that the right to get the sample tested by the
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a person accused in the case only if he had earlier notified in
accordance with sub-section (3) his intention of adducing
evidence in controversion of the report of the Government
Analyst. To put it differently, unless requirement of sub-
section (3) is complied with by the person concerned he
cannot avail of his right under sub-section (4).”
61. Therefore, from the reading of S.25(3) & (4), the Conditions for
retesting are:
(i) The intention of the manufacturer to adduce evidence in
contraversion of the report of the Government Analyst
with 28 days of receipt of the report; and
(ii) The said sample has not been tested by the Central
Drugs Laboratory.
Contraversion of the Report of the Government Analyst with 28 days of
Receipt of Report under S.25(3):
62. In the first Complaint case, the sample of Batch No. EEZ652 was
collected on 26.09.2013 and was sent to Central Drugs Laboratory, Kolkata
for testing on the very next day on 27.09.2013. The Report from the Central
Drugs Laboratory was received on 27.12.2013 (though in this Report the
date of Report was mentioned as 27.12.2012 which got corrected on
31.12.2013). Within five days of 31.12.2013, the Report was sent on
06.01.2014, to the Hospital from where the sample was collected and on
09.01.2014, to the Petitioner who were the manufacturers of the drug.
63. The Petitioner gave their Reply to Show Cause Notice dated Nil
which was received by Respondent No.2, Drug Inspector on 25.02.2014
stating therein that the sample lying in the possession are complying the test
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of Extractable Volume & all tests are within the limits and therefore,
requested the Respondent No. 2, Drug Inspector to take a lenient view.
64. It is significant that this option to controvert the Report of Central
Drugs Laboratory, had to be conveyed to the Inspector or the Court within
28 days of receiving the Show Cause Notice. Reply has been sent on
25.02.2014 which is about 15 days more than the prescribed timeframe of 28
days. The Petitioner having failed to submit their option under Section
25(3) within the mandated period of 28 days, cannot now agitate that it
had a right to controvert the Report of Central Drugs Laboratory.
65. Section 25(4) becomes operative only after the compliance of Section
25(3); since there is no compliance and option had not been given within the
statutory period under Section 25(3), the right of re-testing under Section
25(4) would not accrue on the Petitioner.
66. Whereas, in the case of second Complaint pertaining to samples of
Batch No. EEZ651 & EEZ653 , it is important to state that the Report dated
03.02.2014 were received on 10.02.2014 and immediately Show Cause
Notice was issued to the Petitioner. It is the case of the Petitioner that after
receiving the said Show Cause Notice, a letter dated 25.02.2014 was issued
to the Respondent No.2, Drugs Inspector in controversion of the Test
Report. However, the Respondent No.2, Drugs Inspector has denied the
receipt of any such Letter dated 25.02.2014 which is a disputed fact required
to be proved by the Petitioner at the time of trial. This contention of the
Petitioner that he had exercised the right of controversion, cannot be agitated
at this stage, in the present Petition.
Section 25(4): Testing by Central Drugs Laboratory:
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67. Another aspect which is of immense significance is that Section 25(4)
provides that unless the sample has already been tested or analysed in the
Central Drugs Laboratory, the person has a discretion to request the re-
testing of the sample. However, in the present case, pertinently the sample
had been sent to Central Drugs Laboratory, Kolkata which was a Central
Testing Laboratory. Once the testing has been done by the said Central
Drugs Laboratory, there was no question of exercising the right and the
Petitioner had no option for re-testing under Section 25(4) of Drugs and
Cosmetics Act.
68. Therefore, the claim of the Petitioner that their valuable right to get
the sample re-tested has been defeated, is absolutely in the teeth of specific
provisions under Section 25(3) and (4) of the Act and not tenable at this
stage of summoning.
Filing of Complaint after the expiry of the drug:
69. Another contention of the Petitioner connected to Section 25(3) and
(4) of the D&C Act was raised that the aforesaid Complaints had been filed
on 10.08.2015 i.e. after more than one year and seven months of receipt of
the testing report from Central Drugs Laboratory. This belated filing of the
Complaint, has defeated their valuable right under Section 25(4) of the Act.
70. However, as has already been discussed above, the delayed filing of
the Complaint in August, 2015 even though the Testing Report had been
received in December, 2013 and February 2014 respectively, is of little
consequence in the light of the above discussion that no such right of re-
testing had accrued upon the Petitioner under S.25 (4), in the given
circumstances.
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71. The Complaint dated 10.08.2015 has been filed within the period of
limitation which is three years from the date of lifting the sample. Therefore,
as this ground under Section 25 of the D&C Act and delay in filing of the
Complaint, does not ensure to the benefit of the Petitioner, the summoning
Order is not liable to be quashed on this ground.
Liability of the Partners of the Manufacturing Firm:
72. The second contention that has been raised is Rajeev Mukul who is
one of the accused person in the Complaint, was not involved in day-to-day
affairs of the Firm and as was evident from the documents furnished by the
Petitioner and was entitled to be discharged.
73. In the case of Maksud Saiyed vs. State of Gujarat and Others (2008) 5
SCC 668 it was observed that while levelling the charges against the
Company, it is obligatory on the part of the Complainant to make requisite
allegation in the Complaint as to the role of the directors for making him
vicariously liable.
74. In the present case, though this contention may have some merit,
but considering that the present Petition has been filed only by the firm
M/s. Zee Laboratories through an authorized representative and not by the
Partners, this aspect cannot be considered, but is left open to be
considered during the trial.
Jurisdiction in the case of Complaint when Manufacturing Unit is situated
outside:
75. The third objection taken is that the Petitioner, manufacturer was
based in Sirmour, Himachal Pradesh and the Complaint could not have been
filed in Delhi.
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76. In Ashok Sureshchand Bal v. State of Maharashtra, 2001 SCC
OnLine Bom 822, the Bombay High Court has held;
” …. even though the Firm falling in the jurisdiction of
the Court from where the samples had been taken had not been
party yet one of the purchasers who did not fall within the
jurisdiction of the Court, had been a party along with the
manufacturer. In my opinion, taking into account the purpose
sought to be achieved by the said Act, the principle has to be
expanded and wherever an adulterated drug is manufactured,
the manufacturer can be prosecuted at the place where the
drug is sold irrespective of whether the seller has been made
party or not since the consequences ensue at the place where
the goods are sold and purchased. The goods are
manufactured for the purpose of distribution throughout the
country and the manufacturers cannot be permitted to escape
their liability on technical grounds. At any rate, the
consequences of manufacturer of adulterated drug ensue
wherever the drug is sold and as such manufacturer can be
sued at any place of sale of adulterated drug. Of course, the
sale within the jurisdiction of the Court taking cognizance
against the manufacturer will have to be established.
77. In this light of the aforesaid judgement, even though the Manufacturer
was located in Himachal Pradesh, but drug was being distributed in Govt
Hospital in Delhi from where the sample was collected.
Therefore, the contention that Delhi Courts did not have the territorial
jurisdiction, is without merit.
Examination of Public Servant under Cr.P.C. after filing of the
Complaint:
78. The fourth ground that has been agitated on behalf of the Petitioner
is that though the Complaint dated 10.08.2015 had been filed by the
Respondent No.2, Drug Inspector but due procedure under Section 200
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Cr.P.C. was not followed by the Ld. MM before summoning the Petitioner
and on this ground the summoning Order is liable to be quashed.
79. The first Proviso to Section 200 Cr.P.C. reads as under:
Provided that, when the complaint is made in writing, the
Magistrate need not examine the complainant and the
witnesses.
(a) If a public servant acting or purporting to act in the
discharge of his official duties or a court has made the
complaint; or
80. The first Proviso to Section 200 Cr.P.C., thus, provides that the
Magistrate need not examine the complainant if a public servant acting or
purporting to act in the discharge of his official duties or a Court has made
the Complaint in writing.
81. The Complaint dated 10.08.2015 has been lodged by Respondent
No.2, Drug Inspector, Shri Dharmvir Singh who has been duly authorised
vide Notification bearing No. DVS/DI/HQ/2013/14 dated 13.06.2014 to
initiate the prosecution against the Petitioner. Therefore, under the Proviso
to Section 200 Cr.P.C., the Ld. MM rightly exempted the Complainant,
Drug Inspector and his witnesses from examination, before taking
cognizance of the offence on the Complaint.
82. This aspect was considered in detail by the Apex Court in the case of
Cheminova India Limited v. State of Punjab, 2021 SCC OnLine SC 573
wherein similar objection was taken. It was observed that the legislature in
its wisdom, has placed on the public servant on a different pedestal, as is
evident from the proviso to Section 200 Cr.P.C. and the object of holding an
inquiry/ investigation before taking cognizance, in cases where accused
resides outside the territorial jurisdiction of such Magistrate, is to ensure
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that innocent persons are not harassed unnecessarily. By virtue of proviso
to Section 200 Cr.P.C., the Magistrate, while taking cognizance, need not
record statement of such public servant, who has filed the complaint in
discharge of his official duty. Further, by virtue of Section 293 of Cr. P.C.,
report of the Government Scientific Expert is, per se, admissible in evidence.
The Code of Criminal Procedure itself provides for exemption from
examination of such witnesses, when the complaint is filed by a public
servant. Since the Complaint filed by Public Servant under the provisions of
the Insecticides Act, 1968, enclosing several documents including reports of
the Government Laboratories, it was observed that this submission did not
have any merit and the proceedings were not liable to be quashed on this
ground itself. In the absence of showing any prejudice caused to the
appellant at this stage, it was held to be no ground for quashing of the
proceedings in exercise of power under Section 482 Cr.P.C.
83. In the present case as well, the facts involved are para materia. It also
cannot be overlooked that the Sample was taken form Govt. Hospital in
Delhi and part cause of action has arisen in Delhi. Therefore, it cannot be
considered to be a ground for quashing of the impugned summoning
Order.
Conclusion:
84. In view of the aforesaid discussion, no grounds are made out for
quashing of the Summoning Order dated 07.12.2015 in Criminal Complaint
No.15/4 of 2015 and 16/4 of 2015. However, observations made herein do
not tantamount to an expression on merits which may be considered in the
light of evidence led by both the parties.
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85. The present Petition is hereby, dismissed and the pending
Application(s) are disposed of accordingly.
(NEENA BANSAL KRISHNA)
JUDGE
JUNE 27, 2025/pp
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