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
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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.
1
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.
2
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.,
3
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
4
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
5
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
6
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
7
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
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