Applicants vs State Of Uttarakhand & Another
2025 Latest Caselaw 3725 UK

Uttarakhand High Court

Applicants vs State Of Uttarakhand & Another on 27 August, 2025

Author: Pankaj Purohit

Bench: Pankaj Purohit

                                               REPORTABLE
                           Judgment reserved on: 18.08.2025
                          Judgment delivered on: 27.08.2025
HIGH COURT OF UTTARAKHAND AT NAINITAL
      Criminal Misc. Application No.1878 of 2023
                  (Under Section 482 of Cr.P.C)

M/s Brooks laboratories Through Managing Director
Rajesh Mahajan & others
                                          --Applicants
                        Versus
State of Uttarakhand & another
                                       --Respondents
                         With


       Criminal Misc. Application No.264 of 2024
                  (Under Section 528 of BNSS)

M/s Brooks laboratories Through MD Rajesh Mahajan &
others
                                          --Applicants
                        Versus
Union of India
                                        --Respondent

----------------------------------------------------------------------
Presence:-
     Mr. Arvind Vashistha, learned Senior Advocate assisted by
     Mr. Hemant Singh Mahra, learned counsel holding brief of
     Mr. Vaibhav Singh Chauhan, learned counsel for the
     applicants.
     Mr. B.C. Joshi, learned AGA for the State.
     Mr. Lalit Sharma, learned counsel for respondent no.2
----------------------------------------------------------------------
Hon'ble Pankaj Purohit, J.

Since common questions of law and fact are involved in both these C482/C528 applications, therefore, they are heard together and are being decided by a common judgment. However, for the sake of brevity, facts of C482 No.1878 of 2023 alone are being considered and discussed.

2. By means of the present C482 application, applicants has put to challenge the impugned order dated 28.09.2016, passed by learned Chief Judicial Magistrate, Haridwar as well as the order dated 03.06.2023 passed by learned Second Additional Sessions Judge, Haridwar in Criminal Revision No.392 of 2018, M/s Brooks Laboratories through Managing Director Rajesh Mahajan & others vs. State of Uttarakhand and another.

3. Brief facts of the case are that the drug in question, Polytaz 1.125 (Ceftriaxone & Tazobactam for Injection), manufactured by the applicant, was drawn for analysis during an inspection. Pursuant to Office Order No.NZ/UCH-2013-14/2259/13 dated 23.10.2013, received from the Deputy Drugs Controller, CDSCO, North Zone, Ghaziabad, the Drug Inspector (hereinafter referred to as "Respondent No. 2") visited JNSM Government Combined Medical Hospital, Roorkee, Haridwar on 29.10.2013 and collected samples of the aforesaid drug in the presence of the Chief Pharmacist of the hospital. Thereafter, one sealed portion of the sample was forwarded to the Central Drugs Laboratory, Kolkata (CDL) for statutory analysis. Vide report dated 22.05.2015, the CDL declared the sample "Not of Standard Quality," as it failed to conform to the specifications of the Indian Pharmacopoeia, 2010, particularly with respect to particulate matter and clarity of solution. Consequently, a show cause notice dated 28.05.2015 was issued to the applicants under Sections 25(2) and 18A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act, 1940"), directing them to disclose details of suppliers and production records, and to cease distribution of the said batch.

4. In response, the applicants furnished certain documents along with their reply dated 30.06.2015. In the meantime, the Deputy Drugs Controller, Ghaziabad, and the Assistant Drugs Controller, Chandigarh, conducted an inquiry at the premises of the applicants. The joint investigation report dated 21.08.2015 affirmed the earlier finding regarding the nature of the drug. Thereafter, the matter was referred to the Drugs Controller General of India (DCGI) for the necessary sanction. The DCGI, vide order dated 04.12.2015, granted approval to initiate prosecution against the applicants, pursuant to which the learned Chief Judicial Magistrate, Haridwar took cognizance of the matter and passed the impugned summoning order dated 28.09.2016 against the applicants. This order was challenged before the revisional court of the learned 2nd Additional Sessions Judge, Haridwar, but the revision was dismissed. Hence, this application under Section 482 of the Code of Criminal Procedure (CrPC).

5. The learned Senior Advocate appearing for the applicants vehemently argues that the impugned summoning order dated 28.09.2016, passed by the learned Chief Judicial Magistrate, Haridwar and the subsequent order dated 03.06.2023, passed by the learned 2nd Additional Sessions Judge, Haridwar, dismissing the revision, were issued without proper application of mind and are unsustainable in law. He further contends that both the courts below failed to consider the reply submitted by applicant no.1, vide letter dated 30.06.2015, addressed to respondent no.2.

6. The learned Senior Advocate appearing for the applicants further submits that both the courts below failed to consider the delay of one and a half years i.e.,

from 29.10.2013 to 22.05.2015 in the testing of the said drug. He also submits that the learned Chief Judicial Magistrate, Haridwar took cognizance of the matter nearly three years after the sample was drawn (i.e., from 29.10.2013 to 28.09.2016), and more than a year after the expiry of the drug. Therefore, it is contended that both courts have gravely erred in law and have wrongly summoned the applicants. He further argues that the applicants were denied their valuable statutory right under Section 25(3) of the Act, 1940. The record reveals that the notice of the Government Analyst's Report was received on 12.06.2015, and the applicants duly communicated their intention to controvert the said report by submitting a reply dated 30.06.2015 well within the statutory period of 28 days. Therefore, the issuance of summons by the trial court are contrary to law as the applicants have been denied of reasonable opportunity, in violation of their statutory rights.

7. It is also contended by the learned Senior Advocate appearing for the applicants that the analysis of the seized drug does not conclusively establish adulteration or spuriousness; rather, the finding merely indicates the presence of undissolved particles, which could have resulted from improper storage conditions. He further submits that applicant nos. 2, 3, and 4 cannot be held vicariously liable in the absence of any specific allegation in the complaint stating that they were in charge of, or responsible for, the conduct of the business at the relevant time. In this context, he placed reliance upon the judgment of the Hon'ble Supreme Court in State (NCT of Delhi) vs. Rajeev Khurana, (2010) 11 SCC 469, wherein it was held that, in the absence of specific averments regarding responsibility, no vicarious

liability can be fastened upon directors or other officers of a company.

8. The learned counsel for the applicants submits that the applicants' right to seek re-analysis of the drug sample was frustrated due to the inordinate delay of several years in filing the complaint, by which time, the shelf life of the drug had already expired. In support of this contention, he placed reliance on the judgment in Pravin Chandra vs. State of M.P., reported in 2006 Cri. LJ 1736 (MP), wherein the Hon'ble Madhya Pradesh High Court held that failure to enable re-examination of the sample vitiates the proceedings. He further submits that there is no mention in the complaint regarding the conditions under which the sample was stored, and it is apparent that the storage conditions were not in accordance with the required standards, which could have adversely affected the quality of the drug.

9. Per contra, the learned State Counsel submits that, under Section 32 of the Act 1940, the Drug Inspector was well within his powers to file the complaint, and once such a complaint is filed, the Magistrate is empowered to take cognizance. He further submits that, since the Act is intended to protect public health, its provisions must be interpreted broadly. Therefore, the learned courts have rightly taken cognizance and summoned the applicants.

10. Respondent No. 2 has filed his counter affidavit. In the counter affidavit, it has been stated that the applicants' contentions regarding stability studies, compatibility of rubber stoppers, diluents, syringes, and other regulatory requirements under the Act are baseless. It is further stated that the statutory scheme

clearly provides that such requirements are essential for ensuring the safety, efficacy, and quality of drugs. The respondent also submits that the reliance placed by the applicants on case law is wholly misplaced, as none of the judgments cited lay down any absolute proposition barring the complainant from filing the complaint or the court from taking cognizance. The learned counsel submits that the applicants are merely attempting to delay the proceedings by filing such applications.

11. Having heard the learned counsel for both parties, this Court is of the view that the right conferred upon an accused under Section 25(3) of the Act, 1940, is a significant safeguard that cannot be disregarded. The said provision clearly stipulates that the report of the Government Analyst shall be treated as conclusive evidence unless, within 28 days of receiving the report, the person from whom the sample was taken notifies the Inspector or the Court of his intention to contest it. For ready reference, Section 25(3) of the Act, 1940, is reproduced below::-

"25. Reports of Government Analysis.-(1)................ (2)...................................................................... (3)Any document purporting to be a report signed by a Government Analyst under this Chapter 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 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."

12. In the present case, the applicants have demonstrated that they gave such intimation on 30.06.2015, well within the stipulated period of twenty- eight days from the date of receipt of the Analyst's report dated 12.06.2015. By doing so, they clearly expressed their intention to challenge the said report. Once such a

right is exercised within the prescribed time, it becomes the duty of the prosecution to take the necessary follow- up steps. The failure to do so has effectively deprived the applicants of their valuable statutory right.

13. The Hon'ble Supreme Court in the case of Medicamen Biotech Ltd. & another vs. Rubina Bose, Drug Inspector; reported in (2008) 7 SCC 196 has held as under:-

"19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."

14. The present case is fully covered by the aforementioned principle. Since the applicants were deprived of their statutory right to contest the Analyst's report, the continuation of the proceedings would be unjust and contrary to the principles of natural justice. Permitting the prosecution to proceed in such circumstances would amount to an abuse of the process of law. Therefore, to prevent such abuse and in the interest of justice, quashing of the proceedings becomes necessary.

15. Accordingly, both the C482/C528 applications are allowed. The summoning order dated 28.09.2016

passed by the learned Chief Judicial Magistrate, Haridwar, as well as the order dated 03.06.2023 passed by the learned 2nd Additional Sessions Judge, Haridwar in Criminal Revision No. 392 of 2018, M/s Brooks Laboratories through Managing Director Rajesh Mahajan & Others vs. State of Uttarakhand and Another, are hereby quashed. As a necessary consequence, all further proceedings, including the bailable warrants issued vide order dated 26.10.2017, non-bailable warrants issued vide order dated 02.12.2019, and the issuance of non- bailable warrants vide order dated 15.10.2022 passed by the learned Chief Judicial Magistrate, Haridwar in Criminal Complaint Case No. 9373 of 2016, under Sections 18(a)(i) read with Sections 16 and 17A(a), punishable under Sections 27(b)(i) and 27(d) of the Act, 1940, also stand quashed.

16. Let a copy of this judgment and order be transmitted to the court concerned for compliance.

17. Pending application, if any, stands disposed of.

(Pankaj Purohit, J.) 27.08.2025 AK