HIGH COURT OF JUDICATURE AT ALLAHABAD APPLICATION U/S 528 BNSS No. - 8569 of 2026 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 Versus Counsel for Applicant(s) : Anand Kumar Singh, Aryan Singh Counsel for Opposite Party(s) : G.A. Sharad Gupta And 2 Others .....Applicant(s) State of U.P. and Another .....Opposite Party(s) 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 2 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 3 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 फामर् 13 राजकीय िवश्लेषक उत्तर प्रदेश लखनउ की िरपोटर् िदनांिकत 20.06. 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 फामर् 13 राजकीय िवश्लेषक उत्तर प्रदेश लखनउ की िरपोटर् िदनांिकत 20.06. 2014 का अवलोकन िकया गया। राजकीय िवश्लेषक उत्तर प्रदेश की िरपोटर् सं० डी/4329-13 में प्रश्नगत औषिध के सम्बन्ध में स्पष्ट रूप से यह अंिकत िकया गया है िक "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 िल० का जबाव िदनांिकत 06.09.2014 का अवलोकन िकया गया। पत्र में ओमनी लैबोरेटरी प्रा० िल० द्वारा स्पष्ट रूप से पैरा 1 में यह अंिकत िकया गया है िक "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 िववेचन से यह स्पष्ट है िक औषिध िनरीक्षक द्वारा िदनांक 19.11.2013 को मैससर् दूबे मेडीकल स्टोर िजला मैनपुरी के प्रितष्ठान पर िनरीक्षण कायर्वाही की गयी। जहां से जब्त नमूने को राजकीय िवश्लेषक लखनऊ को िवश्लेषण हेतु भेजा गया। राजकीय िवश्लेषक उत्तर प्रदेश लखनऊ की िरपोटर् िदनांिकत 20.06.2014 प्राप्त होने के पश्चात िदनांक 30.07.2014 को कारण बताओ नोिटस मैससर् ओमनी लैबोरेटरीस गािजयाबाद को भेजा गया। िजसके अनुपालन में मैससर् ओमनी लैबोरेटरीस गािजयाबाद द्वारा िदनांक 06.09.2014 को अपना जबाव िदया गया। यहां यह उल्लेखनीय है िक प्राथीर् /अिभयुक्तगण द्वारा अपनी आपित्त में स्पष्ट रूप से अंिकत िकया गया है िक प्रश्नगत औषिध का अवसान जुलाई 2015 है। प्रश्नगत औषिध के अवसान्न से काफी पूवर् ही प्राथीर्/ अिभयुक्तगण को औषिध िनरीक्षक का नोिटस प्राप्त हो गया था िजसका जबाव उनके द्वारा 06.09.2014 को िदया गया। अिधिनयम की धारा 25 (3) में िदये गये प्रािवधान के अन्तगर्त प्राथीर् / अिभयुक्तगण के पास उपरोक्त िरपोटर् के प्राप्त होने के पश्चात उपरोक्त राजकीय िवश्लेषक लखनऊ की िरपोटर् पर आपित्त िकये जाने के िलये पयार्प्त समय अथार्त प्रश्नगत औषिध के अवसान के िदनांक जुलाई 2015 तक था परन्तु प्राथीर् / अिभयुक्तगण द्वारा अिधिनयम की धारा 25 (3) के अन्तगर्त प्रदत्त अिधकार का उपभोग नहीं िकया गया। प्राथीर् / अिभयुक्तगण की ओर से कोई प्रलेखीय साक्ष्य पत्रावली पर दािखल नहीं िकया गया है जो यह दिशत करता हो िक प्राथीर् / अिभयुक्तगण प्रश्नगत राजकीय िवश्लेषक लखनऊ की िरपोटर् को के न्द्रीय औषिध लैबोरेटरी में चुनौती देना चाहते हैं। पत्रावली के अवलोकन से यह स्पष्ट है िक प्रश्नगत औषिध का िनमार्ता अिभयुक्तगण की फमर् NA528 No. 8569 of 2026 4 ओमनी लैबोरेटरी प्रा० िल०. किव नगर, गािजयाबाद उत्तर प्रदेश है िजसके द्वारा प्रश्नगत औषिध िनिमत की गयी। उपरोक्त प्रश्नगत औषिध को राजकीय िवश्लेषक उत्तर प्रदेश की िरपोटर् में अधोमानक घोिषत िकया गया है। राजकीय िवश्लेषक उत्तर प्रदेश की उपरोक्त िरपोटर् को िनमार्ता फमर् द्वारा चुनौती िदया जाना पत्रावली पर पिरलिक्षत नहीं होता है। वनर् अिभयुक्तगण की फमर् ओमनी लैबोरेटरी प्रा० िल०, किव नगर, गािजयाबाद उत्तर प्रदेश द्वारा औषिध िनरीक्षक को प्रेिषत पत्र िदनांिकत 06.09.2014 के अवलोकन से यह पिरलिक्षत होता है िक उनके द्वारा उक्त अधोमानक औषिध के सम्बन्ध में दिशत की गयी कमी िजसके कारण उक्त औषिध को राजकीय िवश्लेषक उत्तर प्रदेश की िस्पोटर् में अधोमानक स्तर की घोिषत िकया श्गया था, में सुधार कर िलया जाना बताया गया है। िजससे यह प्रतीत होता है िक अिभयुक्तगण द्वारा प्रश्नगत औषिध का िनरीक्षण के िदनांक को अधोमानक होना स्वीकार है। इस प्रकार पिरवादी द्वारा पिरवादपत्र में िकये गये कथनों के दृिष्टगत व माननीय उच्चतम न्यायालय द्वारा प्रोद्धिरत उपरोक्त िविध व्यवस्थाओं के आलोक में अिभयुक्तगण के िवरूद्ध प्रथमदृष्टया मामला अन्तगर्त धारा 18/27 औषिध एंव प्रसाधन सामग्री अिधिनयम, 1940 में सृिजत होना पिरलिक्षत होता है। तदनुसार प्रसंज्ञान िलए जाने के पयार्प्त आधार उपलब्ध है। तद्नुसार प्रसर्ज्ञान िलया 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 NA528 No. 8569 of 2026 5 (Deepak Verma,J.) Digitally signed by :- NITIN KUMAR VERMA High Court of Judicature at Allahabad Digitally signed by :- NITIN KUMAR VERMA High Court of Judicature at Allahabad