Bombay High Court
Ashwani Singla W/O Desh Raj Aggrawal vs Government Of India Thr Its Drug … on 19 August, 2025
2025:BHC-NAG:8277
Judgment
452 apl319.25
1
IN THE HIGH COURT OF JUDICATURE AT BOMBAY,
NAGPUR BENCH, NAGPUR.
CRIMINAL APPLICATION (APL) NO.319 OF 2025
Mr.Ashwani Singla, s/o Desh Raj Aggrawal,
r/o 14, Aman Colony, near 22 No. Phatak,
Patiala (Service), Punjab 147 001. ..... Applicant.
:: V E R S U S ::
Government of India, through its Drugs Inspector,
Pushparaj Kumar Singh, aged 35 years, M.No.8224090507,
office of the Deputy Drugs Controller (India), Central
Drugs Standard Control Organization (CDSCO), West
Zone, 4th Floor, GMSD Compound, Bellasis Road, Mumbai
Central, Mumbai - 400008 (MS). ..... Non-applicant.
Shri Akshay Naik, Senior Counsel assisted by Shri Rohan
Deo, Advocate for the Applicant.
Mrs.Mugdha Chandurkar, Counsel for the Non-applicant.
CORAM : URMILA JOSHI-PHALKE, J.
CLOSED ON : 14/07/2025
PRONOUNCED ON : 19/08/2025
JUDGMENT
1. Heard learned Senior Counsel Shri Akshay Naik
for the applicant and learned counsel Mrs.Mugdha
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Chandurkar for the non-applicant. Rule. Heard finally
by consent.
2. The non-applicant is the original complainant
appointed as Inspector under Section 21 of the Drugs
and Cosmetics Act, 1940 and, therefore is authorized to
initiate prosecution under the said Act.
3. The applicant is arraigned as accused No.2 in
Complaint Case No.2450/2020 filed before learned
Chief Judicial Magistrate at Nagpur. The applicant
approached this court by way of this application under
Section 482 of the CrPC by making following prayers:
“(A) quash and set aside the criminal complaint
and all proceedings being Regular Criminal Case
No.2450/2020 pending before the learned
Additional Chief Judicial Magistrate, Nagpur,
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(B) Quash and set aside the order issuing process
dated 21.10.2020 passed by the learned
Additional Chief Judicial Magistrate, Nagpur
against the applicant in Regular Criminal Case
No.2450/2020,
(C) Quash, cancel and set aside the Non-Bailable
Warrant purportedly issued by the learned
Additional Chief Judicial Magistrate, Nagpur on
14th June 2024, and reissued on 21st August, 2024
(D) Stay the effect, operation and
implementation of the order issuing process
against the applicant dated 21st October 2020 as
well as the non-bailable warrant issued in Regular
Criminal Case No.2450 of 2020 by the learned
Additional Chief Judicial Magistrate, Nagpur
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during the pendency and final disposal of this
application, and
(E) Stay all further proceedings in Regular
Criminal Case No.2450/2020 pending before the
learned Additional Chief Judicial Magistrate,
Nagpur during the pendency and final disposal of
this application.”
4. Brief facts of the case are as under:
The non-applicant filed a complaint registered
as Complaint Case No.2450/2020 filed before learned
Chief Judicial Magistrate at Nagpur drug sample Enteric
Coated Rabeprazole and Domperidone (sustained
released) Capsules (Rabetroy-DSR) B.No.TPC16007 has
been drawn by Dr.Kamal Halder on 23.9.2016 for testing
and analysis under the provisions of Section 23 of the
Drugs and Cosmetics Act, 1940 (the said Act). It is
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claimed that the drug was manufactured by M/s.IBN
Herbals which is a unit of Curetech Formulations Private
Limited, and the sample thereof was drawn from a retail
firm namely Ms/. Sidhivinayak Medical Agencies in
presence of the said firm’s proprietor Shri Harish Vaidya
in Forms 17 and 17A. Out of that, one part of the
sample was sent to the Government Analyst, the Central
Drugs Testing Laboratory, Mumbai in Form No.18 along
with covering letter. The sampled drug was
manufactured in May 2016 and its expiry date was April
2018. It is further contended that the sample was
forwarded to the Central Drug Testing Laboratory on
26.9.2016 which was received by the said centre on
29.9.2016. On 17.7.2017, the Government Analyst, the
Central Drugs Testing Laboratory prepared its analytical
report in Form No.13 and forwarded to the Drug
Inspector in triplicate on the same day. As per the
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analyst report, the sample in question “was not of
standard quality” since it did not confirm with the claim
regarding the testing of Assay of Rabeprazole.
5. After receipt of the analytical report, the non-
applicant issued letter to Ms/. Sidhivinayak Medical
Agencies seeking disclosure of the details of the firm
from which sample drug was procured. By letter dated
26.7.2017 M/s.Sidhivinayak Medical Agencies disclosed
by way of letter that the said drug was purchased from a
supplier namely Triokaa Pharmaceuticals Limited.
Accordingly, communication was issued to the said
Triokaa Pharmaceuticals Limited on 9.11.2017 stating
that it had purchased the sampled drug from
manufacturer M/s. IBN Herbals on 13.8.2016.
6. Since the sample drug was not of a standard
quality, a joint investigation was carried out by the
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Drugs Inspector from Sub Zoje, Baddi, Himachal
Pradesh at the premises of IBN Herbals. On 7.3.2015,
the Drug Inspector issued communication to the Drugs
Controller General of India seeking sanction for lodging
prosecution against the manufacturing firm.
Accordingly, the sanction was granted on 25.9.2018 and
thereafter the complaint was lodged on 8.10.2020.
7. M/s.IBN Herbals rigorously tested drug and
upon its analysis, it was found that the concerned drug
confirms with the claim with respect to the Test Assay
of Rabeprazole. Therefore, the applicant did not agree
with the issuance of findings of the analyst report. But,
since proceeding was not instituted by the complainant
before learned Magistrate during the shelf life of the
medicine, he was deprived of the invaluable right to
challenge the analysis report. Therefore, the present
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application is filed challenging the institution of the
proceedings as well as issuance of process against the
present applicant.
8. It is contended by the applicant that he has
been arraigned as accused on the premise that he is
Director of manufacturing unit of M/s. IBN Herbals.
However, as per the joint investigation report one
Mr.Sumit Singla was alleged to be proprietor of the
manufacturing firm. The applicant was not incharge
and looking after the day to day activities of the said
firm. Moreover, IBN Herbals which is a unit of Curetech
Formulations Private Limited, which is not made party
to the criminal complaint. It is further contended that
the IBN Herbals is not body corporate and therefore not
the company as defined under Section 4 of the said Act
and he is not Director of said IBN Herbals. The
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applicant is only Director of Curetech Formulations
Private Limited which has not been arraigned as
accused. Therefore, the application is filed on the
following grounds:
“(i) in view of sub-sections 3 and 4 of Section
25 of the said Act, the accused has valuable
right of challenging findings of the analysis
report prepared by the government analyst or
getting the same sampled drug analyzed.
During delayed registration of the compliant,
the applicant was deprived of his valuable right
conferred under Section 25 of the said Act,
(ii) The government analyst though received
sample on 29.9.2016, he prepared report on
17.7.2017 nearly ten months after receipt of the
sample which is complete violation of Rule 45
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of the said Act. In view of the said Rule 45, the
government analyst is under obligation to
analyze the sample in any case within 60 days
of receipt of the sample,
(iii) The complaint ought to have been filed
within a period of 3 years from the date of the
analysis report. Therefore barred by the law of
limitation, and
(iv) The vicarious liability cannot be fastened on
applicant as he was not the person incharge and
responsible of the day to day conduct of the
business of the company. Merely because she is
director of the company does not ipso facto
establish that he was in fact responsible of the
day to day business of the company. Except the
statement of the complainant, there is nothing
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on record to show that the applicant was
incharge and was responsible for the day to day
activities of the company and, therefore, the
prosecution against him is unwarranted and
prays for the quashing of the proceeding”.
9. Per contra, learned counsel for the non-
applicant by filing reply denied all the contentions and
submitted that after the chain established and as
disclosed under Section 18A of the said Act, one copy of
test report with one sealed portion of the sample was
sent to the Distributor and Marketer. By letter dated
2.11.2017, a copy of the letter was addressed to the
manufacturer. A joint investigation has been carried out
wherein firm provided memorandum and articles of
Curetech Formulations Private Limited shows name of
the applicant as one of Directors of the same company.
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The notice under Section 25(3) was duly sent to the
manufacturer with test report in Form No.31 to provide
explanation within 28 days, however no response was
received. The manufacturer never informed the Drugs
Inspector that they wanted to challenge the findings of
the test report issued in Form No.13 by the Government
Analyst not intended to send remaining one sealed
portion of the sample.
10. On analysis, the sample was not found
complying with the manufacturers specifications. The
sample was tested and reported after 9 months before
the date of expiry. Thus, sample was tested well before
the date of expiry. After complying all requirements, the
complaint was filed and considering involvement of the
applicant, process was issued against the applicant.
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11. Learned Senior Counsel for the applicant has
taken me through various provisions of the said Act
namely Sections 23 and 25 and Rule 45 of the Rules of
1945. To point out the right of the applicant to lead
evidence against analytical report and further time line
fixed for providing such analytical report to show non-
compliance of the said provisions, he submitted that
such non-compliance vitiates the proceedings. He also
submitted that the sample was not analyzed within 60
days. The applicant was deprived from challenging the
finding of the analyst as complaint was filed after 3
years i.e. beyond limitation after the expiry of shelf life
of the said drugs. Moreover, in view of Section 34 of the
said Act, it deals with aspect of offences by companies.
M/s.HBN Herbals is a unit of Curetech Formulations
Private Limited and it is not made as a necessary party
to the complaint. There is nothing on record to show
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that the applicant was Director of said HBN Herbals.
But, she was Director of Curetech Formulations Private
Limited. Similarly, there is no material on record to
show that the applicant incharge and responsible for day
to day activities of the said company and, therefore, she
is responsible for the day to day activities of the said
company. For all above these grounds, the proceeding
initiated against the applicant deserves to be quashed
and set aside.
12. In support of his contentions, learned Senior
Counsel for the applicant placed reliance on following
decisions:
1. P.R.Naik and anr vs. State of Maharashtra,
reported in 2024 SCC OnLine Bom 3856;
2. Medicamen Biotech Limited and anr vs.
Rubina Bose, Drug Inspector, reported in
(2008)7 SCC 196;
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3. Prabhu Chawla vs. State of Rajasthan and
anr, reported in (2016)16 SCC 30,
4. Criminal Application (APL) No.1623/2022
(Mahadeo s/o Shankar Jadhav and ors vs. The
State of Maharashtra) decided by this on
19.3.2025,
5. Lalankumar Singh and ors vs. State of
Maharashtra, reported in 2022 SCC OnLine SC
1383,
6. Cognizance for Extension of Limitation,
reported in (2022) 3 SCC 117,
7. Himanshu vs. B.Shivamurthy and anr,
reported in (2019)3 SCC 797,
8. Laborate Pharmaceuticals India Limited and
ors vs. State of Tamil Nadu, reported in
(2018)15 SCC 93, and
9. GHCL Employees Stock Option Trust vs. India
Infoline Limited, reported in (2013)4 SCC 505.
13. In the matter in hand, it is evident that there is
no averment or statement in the complaint that the
applicant working as Director of the company was
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responsible or incharge of the conduct of the business of
the company in respect of which the offence in question
alleged to have been committed so as to determine the
vicarious liability for the offence committed by the
company. Moreover, there is no satisfaction recorded by
learned Magistrate about prima facie case against the
applicant and role played by him in the capacity of the
Director. On the contrary, the joint investigation report
shows details of M/s.IBN Herbals and also shows that
one Mr.Sumit Singla is the proprietor of the firm. It
further reveals that during course of the investigation,
the documents are verified relevant to the
manufacturing and quality control of the impugned
batch. Thus, the documents on record shows that
Mr.Sumit Singla is the Proprietor of M/s.IBN Herbals.
Thus, this document shows that the applicant is not
Director of said IBN Herbals, but he is the Director of
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Curetech Formulations Private Limited which is not
made an accused to the present complaint.
14. Learned Senior Counsel vehemently submitted
that in absence of impleading the company as a party of
which the applicant is Director, no responsibility can be
casted on the present applicant. He invited my attention
towards Section 34 of the said Act which deals with
offences by companies. The said Section is reproduced
for reference:
“34. Offences by companies. — (1) Where an
offence under this Act has been committed by a
company, every person who at the time the
offence was committed, was in charge of, and
was responsible to the company for the conduct
of the business of the company, as well as the
company shall be deemed to be guilty of the
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offence and shall be liable to be proceeded
against and punished accordingly:Provided that
nothing contained in this sub-section shall
render any such person liable to any
punishment provided in this Act if he proves
that the offence was committed without his
knowledge or that he exercised all due
diligence to prevent the commission of such
offence.
(2) Notwithstanding anything contained in sub-
section (1), where an offence under this Act has
been committed by a company and it is proved
that the offence has been committed with the
consent or connivance of, or is attributable to
any neglect on the part of, any director,
manager, secretary or other officer of the
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company, such director, manager, secretary or
other officer shall also be deemed to be guilty
of that offence and shall be liable to be
proceeded against and punished accordingly.
Explanation.–For the purposes of this section-
(a) “company” means a body corporate, and
includes a firm or other association of
individuals; and
(b) “director” in relation to a firm means a
partner in the firm.
15. In the present case, except the statement that
the applicant was Director of the M/s.IBN Herbals, there
is no other statement that he was at the relevant time
incharge and responsible to the firm for the conduct of
its business.
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16. While considering pari materia provisions
under Section 141 of the Negotiable Instruments Act,
the Hon’ble Apex Court by referring Three Judge Bench
Judgment, in the case of Aneeta Hada vs. M/s.Godfather
Travels and Tours Pvt.Ltd., reported in (2012)5 SCC 661
observed that applying the doctrine of strict
construction, we are of the considered opinion that
commission of offence by the company is an express
condition precedent to attract the vicarious liability of
others. Thus, the words “as well as the company”
appearing in the Section make it absolutely
unmistakably clear that when the company can be
prosecuted, then only the persons mentioned in the
other categories could be vicariously liable for the
offence subject to the averments in the petition and
proof thereof. One cannot be oblivious of the fact that
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the company is a juristic person and it has its own
respectability.
It is further held that in view of our aforesaid
analysis, we arrive at the irresistible conclusion that for
maintaining the prosecution under Section 141 of the
Act, arraigning of a company as an accused is
imperative. The other categories of offenders can only
be brought in the dragnet on the touchstone of vicarious
liability as the same has been stipulated in the provision
itself.
17. Thus, liability depends on the role one plays in
the affairs of a company and not on designation or
status. If being a director or manager or secretary was
enough to cast criminal liability, the section would have
said so. If being director/manger, secretary are not
liable by their designations. They are liable if they are
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by holding responsibility in day to day affair of the
company and only persons who can be said to be
connected with the commission of a crime who are
incharge of the said company.
18. Perusal of Section 34 of the said Act, shows that
every person connected with the company will not fall
within the ambit of the provision. It is only those
persons who were in charge of and responsible for the
conduct of business of the company at the time of
commission of an offence, who will be liable for criminal
action. It follows from this that if a director of a
company who was not in charge of and was not
responsible for the conduct of the business of the
company at the relevant time, will not be liable under
the provision. The liability arises from being in charge of
and responsible for the conduct of business of the
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company at the relevant time when the offence was
committed and not on the basis of merely holding a
designation or office in a company. Conversely, a person
not holding any office or designation in a company may
be liable if he satisfies the main requirement of being in
charge of and responsible for the conduct of business of
a company at the relevant time.
19. In the light of the above legal provisions, there
is no dispute that M/s.IBN Herbals which is a unit of
Curetech Formulations Private Limited is not made an
accused of which the applicant was Director. The
documents on record no where show that the applicant
was Director of M/s.IBN Herbals which is a unit of
Curetech Formulations Private Limited.
20. Thus, in absence of the satisfaction recorded by
the Magistrate about prima facie against the applicant
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and role played by him in capacity of the Director which
is sine qua non for initiating criminal action against him.
Therefore, I have no hesitation to hold that learned
Magistrate has committed error in issuing the process
against the applicant.
21. Before adverting to merits of the case, it is
necessary to refer relevant provisions of the said Act.
22. Section 16 of the said Act deals with the
standards of quality for drugs and cosmetics. The said
Section is reproduced for reference:
“16. Standards of quality.–
(1) For the purposes of this Chapter, the
expression “standard quality” means–
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(a) in relation to a drug, that the drug
complies with the standard set out in the
Second Schedule, and
(b) in relation to a cosmetic, that the
cosmetic complies with such standard as
may be prescribed.
(2) The Central Government, after consultation
with the Board and after giving by notification
in the Official Gazette not less than three
months’ notice of its intention so to do, may by
a like notification add to or otherwise amend
the Second Schedule for the purposes of this
Chapter, and thereupon the Second Schedule
shall be deemed to be amended accordingly.
23. Section 18 of the said Act prohibits the
manufacture, sale, or distribution of certain drugs and
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cosmetics. Whereas, Section 18(a) deals with disclosure
of the name of the manufacturer. Said Section 18 is
reproduced for reference:
“18. Prohibition of manufacture and sale of
certain drugs and cosmetics.–
From such date as may be fixed by the State
Government by notification in the Official
Gazette in this behalf, no person shall himself or
by any other person on his behalf–
(a) manufacture for sale or for distribution, or
sell, or stock or exhibit or offer for sale, or
distribute–
(i) any drug which is not of a standard quality,
or is misbranded, adulterated or spurious;
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(ii) any cosmetic which is not of a standard
quality, or is misbranded, adulterated or
spurious;
(iii) any patent or proprietary medicine, unless
there is displayed in the prescribed manner on
the label or container thereof the true formula
or list of active ingredients contained in it
together with the quantities, thereof;
(iv) any drug which by means of any statement
design or device accompanying it or by any
other means, purports or claims to prevent, cure
or mitigate any such disease or ailment, or to
have any such other effect as may be prescribed;
(v)any cosmetic containing any ingredient
which may render it unsafe or harmful for use
under the directions indicated or recommended;
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(vi) any drug or cosmetic in contravention of
any of the provisions of this Chapter or any rule
made thereunder.”
24. Section 25 of the said Act deals with Reports of
Government Analysts, which is reproduced as under:
“25. Reports of Government Analysts. —
(1) The Government Analyst to whom a sample
of any drug or cosmetic has been submitted for
test or analysis under sub-section (4) of section
23, shall deliver to the Inspector submitting it a
signed report in triplicate in the prescribed
form.
(2) The Inspector on receipt thereof shall
deliver one copy of the report to the person
from whom the sample was taken and another
copy to the person, if any, whose name, address
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and other particulars have been disclosed under
section 18A, and shall retain the third copy for
use in any prosecution in respect of the sample.
(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.
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(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 or cosmetic produced before the
Magistrate under sub-section (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,
and such report shall be conclusive evidence of
the facts stated therein.
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(5) The cost of a test or analysis made by the
Central Drugs Laboratory under sub-section (4)
shall be paid by the complainant or accused as
the Court shall direct.
25. Rule 45 of the Drugs and Cosmetics Rules is
reproduced as under:
“45. Duties of Government Analysts.−(1) The
Government Analyst shall cause to be
analyzed or tested such samples or drugs 1[and
cosmetics] as may be sent to him by Inspectors
or other persons under the provisions of
Chapter IV of the Act and shall furnish reports
of the results of test or analysis in accordance
with these Rules.
(2) A Government Analyst shall from time to
time forward to the Government reports giving
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the result of analytical work and research with
a view to their publication at the discretion of
Government.”
26. As far as present matter is concerned, Section
18(a)(i) of the said Act is relevant which says that no
person shall himself or by any other person on his behalf
manufacture for sale or for distribution, or sell, or stock
or exhibit or offer for sale, or distribute any drug which
is not of a standard quality, or is misbranded,
adulterated or spurious.
27. Section 18(a) mandates ever person, not being
the manufacturer of a drug or cosmetic or his agent for
the distribution thereof, shall, if so required, disclose to
the Inspector the name, address and other particulars of
the person from whom he acquired the drug or
cosmetic.
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28. Section 20 of the said Act, empowers the State
Government or the Central Government to appoint the
Government Analyst in respect of such drugs areas in
the State and in respect of such drugs or classes of drugs
or such cosmetics or classes of cosmetics as may be
specified in the notification issued for such appointment.
29. Section 22 of the said Act deals with powers of
inspector. Section 24 says that every person for the time
being in charge of any premises whereon any drug or
cosmetic is being manufactured or is kept for sale or
distribution shall, on being required by any Inspector so
to do, be legally bound to disclose to the Inspector the
place where the drug or cosmetic is being manufactured
or is kept, as the case may be. Section 25(1) relates to
report of Government Analyst. Section 25(2) mandates
Inspector on receipt thereof shall deliver one copy of the
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report to the person from whom the sample was taken
and another copy to the person, if any, whose name,
address and other particulars have been disclosed under
section 18A, and shall retain the third copy for use in
any prosecution in respect of the sample. Section 25(3)
provides that 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 contravention of the report. Section 25(4)
lays down that unless the sample has already been
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tested or analysed in the Central Drugs Laboratory,
where a person has under sub-section (3) notified his
intention of adducing evidence incontroversion 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 or cosmetic produced before the Magistrate under
sub-section (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, and such report shall be
conclusive evidence of the facts stated therein.
30. Similarly, Rule 45 is relevant which lays down
that Government Analyst shall cause to be analyzed or
tested such samples of drugs and cosmetics as may be
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sent to him by Inspectors or other persons under the
provisions of Chapter IV of the Act and shall furnish
reports of the results of test or analysis in accordance
with these rules within a period of sixty days of the
receipt of the sample. Provided that where it is not
possible to test or analyse the sample within the
specified period, the Government Analyst shall seek
extension of time from the Government giving specific
reasons for delay in such testing or analysis.
31. In the light of the above said referred
provisions, the facts of the present matter are to be
appreciated and, therefore, the dates are relevant:
1. on 23.9.2016 drug sample Enteric Coated
Rabeprazole and Domperidone (sustained released)
Capsules has been drawn by Dr.Kamal Halder for testing
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and analysis under the provisions of Section 23 of the
said Act;
2. The sampled drug was manufactured in May
2016 and its expiry date was April 2018;
3. the sample was forwarded to the Central
Drug Testing Laboratory on 26.9.2016 which was
received by the said centre on 29.9.2016; and
4. on 17.7.2017, the Government Analyst, the
Central Drugs Testing Laboratory prepared its analytical
report in Form No.13 and forwarded to the Drug
Inspector i.e. approximately after 9 months.
32. To see whether there is compliance or not,
again reference is to be made to some of provisions.
33. Section 23(4) of the said Act states that the
Inspector shall restore one portion of a sample so
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divided or one container, as the case may be, to the
person from whom he takes it, and shall retain the
remainder and dispose of the same as follows:–
(i) one portion or container he shall forthwith
send to the Government Analyst for test or
analysis;
(ii) the second he shall produce to the Court
before which proceedings, if any, are instituted
in respect of the drug or cosmetic; and
(iii) the third, where taken, he shall send to the
person, if any, whose name, address and other
particulars have been disclosed under section
18A.
34. Sub-sections 3 and 4 of Section 25 of the said
Act confers an accused valuable right of challenging
findings of the analysis report prepared by the
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government analyst or getting the same sampled drug
analyzed. It expressly provides for right to challenge
the said report by adducing evidence before the
Magistrate, only when the proceeding in respect of
sample drug has already been instituted.
35. Admittedly, sample drug in April 2018 and
impugned complaint was filed on 21.10.2020. Thus, by
that time the shelf life of the said drug had expired and
therefore it was unfit for re-analyzing. In view of the
delayed registration the complaint, the applicant lost his
valuable right conferred under sub-sections 3 and 4 of
Section 25 of the said Act. This aspect is sufficient to
vitiate the prosecution against the accused.
36. In the case of Medicamen Biotech Limited and
anr supra the Hon’ble Apex Court held that there is
no explanation as to why the complaint itself had been
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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.
It is further held that unless requirement of
sub-section (3) is complied with by the person
concerned he cannot avail of his right under sub-section
(4). From a bare perusal of sub-section(3) it is manifest
that the report of the Government Analyst shall be
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41
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 incontroversion of the report. Sub- section (4)
also makes it abundantly clear that the right to get the
sample tested by the Central Government Laboratory (so
as to make its report override the report of the Analyst)
through the court accrues to a person accused in the
case only if he had earlier notified in accordance with
sub-section (3) his intention of adducing evidence
incontroversion of the report of the Government Analyst.
To put it differently, unless requirement of sub-section
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(3) is complied with by the person concerned he cannot
avail of his right under sub-section (4).
37. One part of the sample drug was forwarded the
Government Analyst on 26.9.2016 which was received
in the lab on 29.9.2016. The government analyst
analyzed the sample drug and prepared report on
17.7.2017 nearly 10 months after receipt of the sample
in violation of Rule 45. Thus, when the compliance
under Rule 45 if taken into consideration, the date of
the receipt of the sample and date of report are
considered, it is evident that beyond the stipulated
period of 60 days.
38. In the present case, the report was submitted
approximately after 9 months.
39. The co-ordinate bench of this court, while
dealing with importance of time frame given under the
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said Act and Rules thereof, observed that fastest course
of action as it relates to drugs which are consumed by
the consumer and public at large. It relates to the life of
the consumer who consumed these drugs across the
counter as they are prescription drugs. Therefore any
action taken by the Drugs Inspector in accordance with
the provisions of the said Act and more specifically the
provisions delineated hereinabove have to be in strict
compliance of the said Act and timelines have to be
scrupulously followed for taking and initiating any
action.
40. In present case, it took about 9 months to
furnish report against timeline of 60 days fixed for such
report.
41. Thus, considering the date of expiry of the drug
in April 2018, it can be said that the analytical report is
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44
prejudicial to the rights of the accused. It is so because
28 days time frame is provided under Section 25(3) of
the said Act from the date of receipt of the reply of the
report to notice to adduce evidence in contravention of
the report.
42. The chronology of the events shows that on
receipt of the analytical report, a letter was issued to
M/s.Sidhivinayak Medical Agencies on 26.7.2017 and,
thereafter, M/s.Sidhivinayak Medical Agencies issued
letter to the complainant disclosing that said drug was
purchased from a supplier namely Triokaa
Pharmaceuticals Limited. Thereafter, a communication
was issued on 9.12.2017 to Triokaa Pharmaceuticals
Limited and said Triokaa Pharmaceuticals Limited
disclosed that the drug was purchased from M/s.IBN
Herbals.
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45
43. It is to be noted that under Section 18 of the
said Act, the memorandum was issued to the
Government Analyst wherein the name of M/s.IBN
Herbals was mentioned. However, no communication
was issued to M/s.IBN Herbals on the date of collection
of sample drug.
44. It is indeed common knowledge and a
regulatory requirement that drug labels include essential
information. This includes the manufacturer’s name,
generic name, active ingredients, storage conditions,
expiry date, and distributor information. Despite this, it
is the contention of the complainant that first time by
way of communication from Triokaa Pharmaceuticals
Limited on 9.11.2017 i.e. approximate after 1 year they
received information as to the name of the manufacturer
and the complainant got knowledge of the name of the
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manufacturer. Thus, the above said thing that about
more than 12 months to find out name of manufacturer
cannot be ignored and discarded while considering the
timeline framed under the said Act and Rules thereof
and also the right of the applicant to lead evidence in
such matters incontroversion of the Government Analyst
Report.
45. The further action on the part of the
complainant shows that he issued communication to the
drugs controller general on 7.3.2015 and the drug
controller granted sanction on 25.9.2018 and copies of
the communication as well as the order of granting
sanction received is of dated 25.9.2018 and the
complaint was filed on 8.10.2020 i.e. approximately
after one and half year.
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46. In the entire complaint, there is no averment
made to the effect that copy of the Government Analysis
Report was supplied to the applicant or to the company.
The supply of such report is significant to notify the
intention to lead evidence incontroversion of the report.
47. Thus, in this case, the applicant is deprived
from exercising his right to adduce the evidence against
analytical report within a period of 28 days as stipulated
under Section 25(3) of the said Act. There is no
compliance of Rue 45.
48. As observed earlier, there is no averment in the
complaint that the applicant was Director and was
incharge and looking after day to day affairs of the said
company.
49. The Hon’ble Apex Court in the case of
Lalankumar Singh and ors supra observed that simply
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because a person is a director of the company it does not
necessarily mean that he fulfills both the above
requirements so as to make him liable. Conversely,
without being a director a person can be in charge of
and responsible to the company for the conduct of its
business. From the complaint in question we, however,
find that except a bald statement that the respondents
were directors of the manufacturers, there is no other
allegation to indicate, even prima facie, that they were
in charge of the company and also responsible to the
company for the conduct of its business. merely because
a person is a director of a company, it is not necessary
that he is aware about the day to day functioning of the
company. There is no universal rule that a director of a
company is in charge of its everyday affairs. It was,
therefore, necessary, to aver as to how the director of the
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company was in charge of day to day affairs of the
company or responsible to the affairs of the company.
50. Thus, the delay in giving report by the
Government Analyst denying right to the applicant to
lead evidence incontroversion of the report is
prejudicial to the applicant in absence of the averments
as to the fact that the applicant is responsible for the day
to day affairs of the company. These facts are ignored by
the trial court while issuing the process and, therefore, it
would be abuse of process of court if the prosecution is
allowed to continue against the applicant.
51. The words used in Section 204 of the CrPC
“sufficient grounds for proceeding” are to be taken into
consideration which are the most important. If a prima
facie case has been made out, the Magistrate ought to
have issued process. At the same time, summoning a
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person is a serious act and, therefore, a person ought
not to be dragged in the court merely because a
complaint has been filed and, therefore, an opinion is to
be formed only after due application of mind that there
is sufficient basis for proceeding against the said accused
and formation of such an opinion is to be stated in the
order itself, as observed by the Hon’ble Apex Court in
Lalankumar Singh and ors supra.
52. In the light of the above discussion and
circumstances, it will be abuse of process of court if the
prosecution is allowed to be continued against the
applicant. It is apparent on the face of the record that
the Magistrate has not applied his own mind to satisfy
himself whether prima facie case has been made out. In
this view of the matter, I proceed to pass following
order:
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ORDER
(1) The Criminal Application is allowed.
(2) Complaint Case No.2450/2020 against the present
applicant pending before learned Chief Judicial
Magistrate at Nagpur is quashed and set aside
(3) The order of issuance of process dated 21.10.2020 is
also quashed and set aside.
Rule is made absolute in the above said terms.
(URMILA JOSHI-PHALKE, J.)
!! BrWankhede !!
Signed by: Mr. B. R. Wankhede
Designation: PS To Honourable Judge …../-
Date: 22/08/2025 11:24:40