Allahabad High Court

SHARAD GUPTA AND 2 OTHERSversusSTATE OF U.P. AND ANOTHER

Decided: 25 February 2026
Bench: DEEPAK VERMA

Holding

The court held that a prima facie case of offence under Sections 18 and 27 of the Drugs & Cosmetics Act was established, making the summons valid and the application to quash untenable.

Summary

The applicants, Sharad Gupta and others, filed a Section 528 BNSS application seeking to quash the summons issued in a criminal complaint (SST No. 45 of 2016) alleging violations of Sections 18(a)(i) and 27 of the Drugs & Cosmetics Act, 1940. They argued that the investigation was delayed, that they were denied the statutory right to retest the drug sample under Section 25(3), and that the complaint was filed after the drug had expired, rendering it untenable. The State contended that the inspection, laboratory analysis and the show‑cause notice established a prima facie case of sub‑standard and misbranded drug, justifying the summons. The court examined the inspection report, the Government Analyst’s findings, and the applicants’ reply, noting that the applicants neither challenged the report nor sought retesting, and therefore the magistrate was correct in finding a prima facie offence. Relying on the principle that a magistrate need only determine the existence of a prima facie case, the court dismissed the application to quash, upholding the summons.

Issues considered

Whether the delay in filing the complaint and the expiry of the drug bar the prosecution under the Drugs & Cosmetics Act.
Whether the applicants were entitled to a retest of the sample under Section 25(3) and whether the failure to do so defeats the prosecution.
Whether the magistrate erred in issuing summons without a full trial, i.e., whether a prima facie case existed under Sections 18 and 27 of the Drugs & Cosmetics Act.

Legislation cited

Drugs & Cosmetics Act, 1940 — s. 18(a)(i), 25(3), 27

Subjects

Drugs & Cosmetics Act
misbranding
sub‑standard drug
Section 528 BNSS
prima facie offence
retesting
delay in prosecution
summons

Judgment

    HIGH COURT OF JUDICATURE AT ALLAHABAD
         APPLICATION U/S 528 BNSS No. - 8569 of 2026

Sharad Gupta And 2 Others
                                                .....Applicant(s)
                             Versus

State of U.P. and Another
                                                    .....Opposite
                                                          Party(s)

Counsel for Applicant(s)      : Anand Kumar Singh, Aryan
                                Singh
Counsel for Opposite Party(s) : G.A.

Court No. - 73
                 HON'BLE DEEPAK VERMA, J.

1. Heard Sri Anand Kumar Singh, learned counsel for the
applicants and Sri Om Prakash Dwivedi, learned AGA-I for the
State.

2. The present 528 BNSS application has been filed to quash
the entire proceedings of Complaint Case SST No. 45 of 2016
(State of U.P. Versus Sharad Gupta & Others) Under Sections
18 (a) (i), Punishable Under Sections 27 of Drugs & Cosmetics
Act, 1940, Police Station Kavi Nagar, District Ghaziabad, as
well as impugned summoning order dated 02.02.2026 passed
by the learned Special Judge, Drugs & Cosmetics Act/
Additional Session Judge, Court No. 9 District Agra, U.P in
Complaint Case SST No. 45 of 2016.

3. Counsel for the applicant submits that this is second
application U/s 528 BNSS. Earlier, applicants filed application
U/s 528 BNSS No.4060 of 2025 before this Hon'ble Court and
this Court vide order dated 27.05.2025 disposed off the
application and remitted back the matter to court concerned to
pass a fresh order, strictly, in accordance with law. The fact of
the case is that one inspection has been carried out by the O.P.
No. 2 in the medical Store of one M/S Dubey Medical Store,
Devi Road, Mainpuri on 19.11.2013. In the said inspection
                                                 NA528 No. 8569 of 2026
                          2


apart from other samples of certain drug/medicines, one sample
of the subject drug Cetwin Batch No. LLT-91 manufactured by
the company Omni Laboratories Pvt. Ltd was also taken by the
said inspector. The said Sample was sent for the test analysis to
the Government Analyst, U.P. Lucknow. In the said analysis it
was found that the subject sample contained the claimed drug
but the quantum of the drug was found to be more than the
claimed contents of 10 Mg. and was 11.5 mg in place of 10
Mg. After analysis of the sample report dated 20.06.2014
forwarded with the Batch No. LLT-91 "Not of Standard
Quality" and misbranded quality as sample "Does not Meet the
Requirement of Labeling".

4. Applicants' counsel further submits that learned Magistrate
has not considered the guidelines given by the Hon'ble Court
and vide order dated 02.02.2026 and in arbitrary manner,
passed the order issuing summons against the applicants. The
complaint lodged by opposite party no.2 is not sustainable. As
per the complainant's case the sample was drawn from M/s
Dubey Medical Stores on 19.11.2013, it was sent for testing
before the Government Analyst U.P. Lucknow on 19.11.2013
received on 23.11.2013 and the manufacturing date of the said
sample was August 2012 and the expiry date is July, 2015 and
as per the test report dated 20.06.2014 of the Government
Analyst U.P., Lucknow the same was not confirming to the
standard and on 30.07.2014 a notice was issued to the
applicants by the drug authorities along with samples and the
report and the applicants on 06.09.2014 tendered their reply
disputing the report of the Government Analyst while annexing
the copy of the report of an approved by Indian Analytical
Laboratory but the complaint stood lodged on 12.04.2016 even
subsequent to the expiry of the subject drug in the month of
July, 2015. The opportunity of the applicant to get the retesting
done from the Central Drug Lab as per section (4) of section 25
of the Act stood extinguished. The legal right for retesting has
been taken away due to lethargy and delay attributable to the
                                                 NA528 No. 8569 of 2026
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drug administration. The reasons in lodging the complaint after
enormous delay is inconceivable and not liable to be accepted.
In support of his contention, he has placed reliance over the
judgment of Hon'ble The Apex Court passed in the case of
Medicamen Biotech Limited and another Vs. Rubina Bose,
Drug Inspector, (2008) 7 SCC 196.

5. It is further submitted that the test report dated 20.06.2014
shows that the sample is not of standard quality as defined in
the Drugs and Cosmetics Act and Rules for the reasons given
as "The sample is not of the standard quality in respect of
content of Cetirizine Dihydrochloride. It is also misbranded in
respect of labelling." He next submitted that learned Magistrate
without considering the objection of applicant, in arbitrary
manner, issued fresh summons against the applicants. The
summoning order dated 02.02.2026 is illegal and bad in the eye
of law.

6. Per contra, learned A.G.A. opposed the submission raised
by applicants' counsel and submits that prima facie, offense is
made out against the applicants, as such, summon has been
issued against the applicants by the learned Magistrate. Trial
court, while issuance of summon, has gone into the merits of
the case, has found, prima facie offence against the applicant.
On perusal of record and contents of complaint and other
material evidence, discloses, prima facie offence against the
applicant is made out. Summoning by learned Magistrate is just
and proper.

7. Considering the argument raised by applicants' counsel and
learned AGA, it is evident that summoning, by learned
Magistrate, has been issued after hearing both the parties and
has found that prima facie offence is made out U/s 18/27 of
Drugs and Cosmetics Act. It has also been considered that
complainant after getting report from analyst, issued show
cause notice to applicants, the applicants in place of challenge
analyst report that we are not adding overages, the content of
                                                              NA528 No. 8569 of 2026
                                4


the said drug cannot be more than 10mg/tablet. We shall be
more careful in future. The reply shows that applicants were
satisfied with the report and not interested to challenge that
report to test be done by Central Laboratory. Learned
Magistrate, in his judgment has considered that "उक्त के सम्बन्ध में
पत्रावली पर उपलब्ध संलग्नक 2 फार्म 13 राजकीय विश्लेषक उत्तर प्रदेश
लखनउ की रिपोर्ट दिनांकित 20.06. 2014 का अवलोकन किया गया। राजकीय
विश्लेषक उत्तर प्रदेश की रिपोर्ट सं० डी/4329-13 में प्रश्नगत औषधि के सम्बन्ध
में स्पष्ट रूप से यह अंकित किया गया है कि "The sample is not of the
standard quality in respect of content of Cetirizine
Dihydrochloride- It is also Misbranded in respect of Labelling-
" इसी प्रकार पत्रावली पर उपलब्ध संलग्नक 8 ओगनी लैबोरेटरी प्रा० लि० का
जबाव दिनांकित 06.09.2014 का अवलोकन किया गया। पत्र में ओमनी
लैबोरेटरी प्रा० लि० द्वारा स्पष्ट रूप से पैरा 1 में यह अंकित किया गया है कि "As
Shown in the report that the drug is misbranded with respect of
labelling, It is to inform that the name of drug is mentioned in
claim/formulae of drug) however due to oversight the name
could not be written along with the trade name- We have
corrected the above mistake and are enclosing here with new
corrected label for your kind perusal"

इस प्रकार उपरोक्त विवेचन से यह स्पष्ट है कि औषधि निरीक्षक द्वारा दिनांक
19.11.2013 को मैसर्स दूबे मेडीकल स्टोर जिला मैनपुरी के प्रतिष्ठान पर
निरीक्षण कार्यवाही की गयी। जहां से जब्त नमूने को राजकीय विश्लेषक लखनऊ
को विश्लेषण हेतु भेजा गया। राजकीय विश्लेषक उत्तर प्रदेश लखनऊ की रिपोर्ट
दिनांकित 20.06.2014 प्राप्त होने के पश्चात दिनांक 30.07.2014 को कारण
बताओ नोटिस मैसर्स ओमनी लैबोरेटरीस गाजियाबाद को भेजा गया। जिसके
अनुपालन में मैसर्स ओमनी लैबोरेटरीस गाजियाबाद द्वारा दिनांक 06.09.2014
को अपना जबाव दिया गया। यहां यह उल्लेखनीय है कि प्रार्थी /अभियुक्तगण द्वारा
अपनी आपत्ति में स्पष्ट रूप से अंकित किया गया है कि प्रश्नगत औषधि का
अवसान जुलाई 2015 है। प्रश्नगत औषधि के अवसान्न से काफी पूर्व ही प्रार्थी/
अभियुक्तगण को औषधि निरीक्षक का नोटिस प्राप्त हो गया था जिसका जबाव
उनके द्वारा 06.09.2014 को दिया गया। अधिनियम की धारा 25 (3) में दिये
गये प्राविधान के अन्तर्गत प्रार्थी / अभियुक्तगण के पास उपरोक्त रिपोर्ट के प्राप्त
होने के पश्चात उपरोक्त राजकीय विश्लेषक लखनऊ की रिपोर्ट पर आपत्ति किये
जाने के लिये पर्याप्त समय अर्थात प्रश्नगत औषधि के अवसान के दिनांक जुलाई
2015 तक था परन्तु प्रार्थी / अभियुक्तगण द्वारा अधिनियम की धारा 25 (3) के
अन्तर्गत प्रदत्त अधिकार का उपभोग नहीं किया गया। प्रार्थी / अभियुक्तगण की
ओर से कोई प्रलेखीय साक्ष्य पत्रावली पर दाखिल नहीं किया गया है जो यह
दर्शित करता हो कि प्रार्थी / अभियुक्तगण प्रश्नगत राजकीय विश्लेषक लखनऊ
की रिपोर्ट को केन्द्रीय औषधि लैबोरेटरी में चुनौती देना चाहते हैं। पत्रावली के
अवलोकन से यह स्पष्ट है कि प्रश्नगत औषधि का निर्माता अभियुक्तगण की फर्म
                                                                                                      NA528 No. 8569 of 2026
                                                                        5

                                        ओमनी लैबोरेटरी प्रा० लि०. कवि नगर, गाजियाबाद उत्तर प्रदेश है जिसके द्वारा
                                        प्रश्नगत औषधि निर्मित की गयी। उपरोक्त प्रश्नगत औषधि को राजकीय
                                        विश्लेषक उत्तर प्रदेश की रिपोर्ट में अधोमानक घोषित किया गया है। राजकीय
                                        विश्लेषक उत्तर प्रदेश की उपरोक्त रिपोर्ट को निर्माता फर्म द्वारा चुनौती दिया जाना
                                        पत्रावली पर परिलक्षित नहीं होता है। वर्न अभियुक्तगण की फर्म ओमनी लैबोरेटरी
                                        प्रा० लि०, कवि नगर, गाजियाबाद उत्तर प्रदेश द्वारा औषधि निरीक्षक को प्रेषित
                                        पत्र दिनांकित 06.09.2014 के अवलोकन से यह परिलक्षित होता है कि उनके
                                        द्वारा उक्त अधोमानक औषधि के सम्बन्ध में दर्शित की गयी कमी जिसके कारण
                                        उक्त औषधि को राजकीय विश्लेषक उत्तर प्रदेश की स्पिोर्ट में अधोमानक स्तर की
                                        घोषित किया श्गया था, में सुधार कर लिया जाना बताया गया है। जिससे यह
                                        प्रतीत होता है कि अभियुक्तगण द्वारा प्रश्नगत औषधि का निरीक्षण के दिनांक को
                                        अधोमानक होना स्वीकार है। इस प्रकार परिवादी द्वारा परिवादपत्र में किये गये
                                        कथनों के दृष्टिगत व माननीय उच्चतम न्यायालय द्वारा प्रोद्धरित उपरोक्त विधि
                                        व्यवस्थाओं के आलोक में अभियुक्तगण के विरूद्ध प्रथमदृष्टया मामला अन्तर्गत
                                        धारा 18/27 औषधि एं व प्रसाधन सामग्री अधिनियम, 1940 में सृजित होना
                                        परिलक्षित होता है। तदनुसार प्रसंज्ञान लिए जाने के पर्याप्त आधार उपलब्ध है।
                                        तद्नुसार प्रर्सज्ञान लिया जाता है।"

                                        8. The applicant is manufacturing company and his product has
                                        found sub standard and misbranded and prima facie, offence is
                                        made out against the applicants. The court below while issuing
                                        summon, has not to conduct mini trials of the case but he has to
                                        see whether prima facie case is made out or not against the
                                        applicants. On perusal of material evidence, prima facie,
                                        offence is made out against the applicants. Learned Magistrate
                                        has rightly issued summon against the applicants. No
                                        interference is warranted.

                                        9. The present 528 BNSS application of applicants is hereby
                                        dismissed with the aforesaid observation.

                                        February 26, 2026
                                        Nitin Verma

                                                                                                (Deepak Verma,J.)




Digitally signed by :-
NITIN KUMAR VERMA
High Court of Judicature at Allahabad

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