2026:THC:943 TRHC010019602025

HIGH COURT OF TRIPURA

AGARTALA

Crl.Petn. No.63 of 2025

1. M/s. Innova Captab,

Represented by its Authorized Signatory Plot No.81-B,

EPIP Phase-1, Jharmajri, Baddi Distt., Solan,

Himachal Pradesh

2. Gian Parkash Aggarwal

S/o. Om Prakash Aggarwal,

Partner of M/s Innova Captab,

Plot No.81-B, EPIP Phase-1,

Jharmajri, Baddi Distt.,

Solan, Himachal Pradesh

3. Mr. Manoj Kumar Lohariwala ,

S/o Nand Kishor Lohariwala,

Partner of M/s. Innova Carp Tab,

Plot no.81-B, EPIP Phase-1,

Jharmajri, Baddi Distt.,

Solan, Himachal Pradesh

4. Vinay Lohariwala,

S/o Nand Kishor Lohariwala,

Partner of M/s. Innova Carp Tab,

Plot no.81-B, EPIP Phase-1,

Jharmajri, Baddi Distt.,

Solan, Himachal Pradesh

5. Jitender Singh Narula,

S/o Jswant Singh Vrindaban

Gardens, Peer Machalla, Zirakpur,

Mohali, Punjab

----Petitioner/Accused(s)

Versus

Union of India,

Through Drugs Inspector,

Office of the Assistant Central Drugs Standard

Control Organization, Sub-Zonal Office,

RDTL Campus, Six Mile, Panjabari Road,

Guwahati-781022

---- Respondents (s)

For Petitioner(s) : Mr. Debalay Bhattacharya, Sr.Adv.

Mr. Agniva Chakrabarti, Adv.

Mr. Nitin Bashin, Adv.

For Respondent(s) : Mr. Bidyut Majumder, D.S.G.I.

Date of Hearing : 08.07.2026

Date of delivery of

Judgment and Order : 20.07.2026

Whether fit for

Reporting : YES

Page 2 of 19

HON’BLE MR. JUSTICE BISWAJIT PALIT

Judgment & Order

Heard Learned Senior Counsel Mr. D.

Bhattacharya assisted by Mr. Nitin Bashin and Learned

Counsel Mr. A. Chakrabarti appearin g on behalf of the

accused persons and also heard Learned D.S.G.I. Mr. B.

Majumder appearing on behalf of the respondent -Union of

India.

02. The petitioner has filed this petition under

Section 528 of BNSS corresponding to Section 482 of

Cr.P.C. for quashing of the complaint bearing Case No.CR

302 of 2022 dated 22.11.2022 which is now pending before

the Court of Learned J. M. 1

st

Class, Court No.1, Agartala,

West Tripura under Section 18(a)(i) punishable under

Section 27(d) of Drugs and Cosmetics Act, 1940

03. Taking part in the hearing Learned Senior

Counsel first of all drawn the attention of the Court that on

the basis of a complaint laid by one Pranab Jyoti Das, Drugs

Inspector, Central Drugs Standard Control Organization

(C.D.S.C.O.), Sub-Zone, Guwahati, this case was registered

against the petitioner-accused persons. Referring the entire

complaint filed by Dr. Pranab Jyoti Das Learned Senior

Counsel appearing for the petitioners first of all drawn the

attention of the Court that this petition is not maintainable

as because the statutory provisions as contained in the

Drugs and Cosmetics Act, 1940 was not followed in filing

the complaint against the petitioner-accused persons by the

Page 3 of 19

complainant. First of all he drawn the contents of the

complaint petition filed by the complainant and submitted

that the complainant visited the alleged shop of M/s. Innova

Captab on 29.01.2021. But he filed the complaint on

01.02.2021. Thus there was a delay of four days. In this

regard he drawn the attention of the Court referring the

Provision of Section-23(4)(i) of the Drugs and Cosmetics

Act, 1940 wherein it is specifically mentioned that it was the

duty of the Inspector to restore one portion of a sample so

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 per law and in sub -clause (i) it is

specifically mentioned that one portion or container he shall

forthwith send to the Government Analyst for test or

analysis.

Referring the same he submitted that the sample

was sent to the Government Analyst on 01.02.2021 which

appears from the certificate of the Government Analyst

[Annexure-3]. Thus according to Learned Senior Counsel

there was clear violation of the said provision of law by the

complainant in sending the sample to the Government

Analyst. He intended to say that the sample was not sent

forthwith. He further drawn attention of the Court that in

this case the Government Analyst had received the sample

for testing on 01.02.2021 which appears from Annexure-3,

but the report was submitted on 12.10.2021 which also

transpires from the said report and in this regard nothing

Page 4 of 19

has been explained by the complainant in the complaint

petition which is violative of Rule-45 of the Drugs and

Cosmetics Rules, 1945 wherein it says that the Government

Analyst shall cause to be analysed or tested such sample of

drugs in accordance with the rule within a period of sixty

days of the receipt of the sample. But here in this case the

report was submitted almost after the aforesaid statutory

period as prescribed by law and no extension of time was

sought for by the analyst in this regard and there is also no

such evidence of record like that. It was further submitted

that the complainant also failed to co mply with the

mandatory provision of sub-Section 3 of Section 25 of the

said Act as because in pursuance of the said provision it was

the duty of the complainant to supply a copy of the report

to the respondent-petitioner to allow him to adduce

evidence in controversion of the report. But no such scope

was given to the respondent-petitioner by the complainant

for which the complaint filed by the complainant against the

petitioner was not maintainable.

04. Learned Senior Counsel thereafter drawn the

attention of the Court referring Annexure-6, a copy of letter

dated 21.04.2017 by State Drug Controller to M/s Innova

Captab mentioned that Jitender Singh Narula was endorsed

as a person responsible to the company for the conduct of

business of company under Sec tion-34 of Drugs and

Cosmetics Act, 1940 and further referring form-26 the

certificate issued by the Drugs Controller it is specifically

Page 5 of 19

mentioned that for the purpose of manufacturing one

Shilendra Kumar and Apoorva Mistry and for testing one

Praveen Kumar Jain were entrusted to look after the job of

the company. But unfortunately those persons were not

implicated as accused in this case which is in violation of

Section-34 of the Drugs and Cosmetics Act, 1940. He also

drawn the attention of the Court that the present complaint

was filed on 10.01.2023 by this time the date of the sample

was expired. So legally there was no scope to file the

complaint. In addition to that Learned Senior Counsel has

further drawn the attention of the Court referring Annexure-

R/5 wherein explanation given by the respondent -

department was wholly unsustainable as per law. He further

drawn the attention of the Court referring Annexure-R/5

wherein the respondent has also annexed three accelerated

stability study report wherein the batch number, the

manufacturing date and the expiry date show n are totally

different which does not match with the batch number of

the present complaint. Thus it appears that the explanation

given was not in accordance with law and urged for

dismissal of the complaint petition. In support of the

contention Learned Senior Counsel referred few citations.

05. Learned D.S.G.I. Mr. B. Majumder appearing for

the Union of India submitted that the present petition was

filed by only five accused persons and accordingly they have

given their signature but the respondent P.K. Jain and

Shaktipada Debnath did not come forward to challenge the

Page 6 of 19

petition. Thus it appears they have /had no grievance

against the present complaint filed by the complainant. In

addition to that referring Annexure-R/2 Learned D.S.G.I.

submitted that clear explanation has been given that due to

COVID-19 the report could not be submitted on time and

Hon’ble the Apex Court also extended the period for filing

prosecution during COVID pandemic which h e urged for

taken into consideration at the time of disposal of the

matter.

06. Finally Learned D.S.G.I. drawn the attention of

the Court referring para-24 of the counter-affidavit which

provides as under:

“24. The offences and the offenders in the case of

this nature is manufacturing and distribution of

sub-standard drugs by a Company which is

managed by its Board of Directors. The decision to

manufacture the drugs is the collective decision of

the Board of Directors. Therefore, the Directors

cannot claim that they are not directly involved in

the product of the drugs, when the decision to

produce the drugs itself is the outcome of their

decision. Therefore, the case of Directors signing

the cheque on behalf the Company and the case of

Directors participating in the decision to produce

sub-standard drugs are not one and the same to

hold that these petitioners are not involved in day -

to-day affairs of the Company.”

He also submitted that on 22.11.2021 the

authorized signatory on behalf of Innova Captab stated that

they were not going to challenge the Government Analyst

report. So according to Learned D.S.G.I. at this stage there

is no scope for the present petitioner-accused to challenge

the validity of the report before this Court and urged for

dismissal of this complaint petition filed before the Learned

Trial Court by invoking the jurisdiction of the Court under

Section 528 of BNSS.

Page 7 of 19

07. The brief facts of the complaint filed by the

complainant Dr. Pranab Jyoti Das, Drugs Inspector, Central

Drugs Standard Control Organization (C.D.S.C.O.), Sub -

Zone, Guwahati to C.J. M. with the allegation was that a

drug sample namely ‘Rabeprazole Sodium and Itopride

(Sustained release) Capsules’ bearing Batch no.14200001,

Mfg. date 02/2020, Exp. Date 01/2022, manufactu red by

M/s Innova Captab, situated at 81 -B, EPIP Phase-I,

Kharmajri, Baddi, District: Solan, Himachal Pradesh was

found to be ‘not of standard quality’ as defined under

Section 16 of the Drugs and Cosmetics Act, 1940. The said

sample was drawn on 29.01.202 1 by the complainant Drugs

Inspector during a joint surprise check conducted along with

the State Drugs Inspector, Agartala, Tripura. The sample

was taken from the premises of M/s S.B. Pharma, H.G.B.

Road, Agartala which was engaged in the sale of the said

drug. The sample was drawn in accordance with Section

23(3) and (4) of the Act and Rule 57 of the Drugs and

Cosmetics Rules, 1945.

08. It was the further case of the complainant that

the sample was divided into four portions and sealed in four

containers vide Sample No.ACT/PJD/GHY/68/2021 in the

presence of proprietor of M/s S.B. Pharma. One portion was

sent to the Regional Drugs Testing Laboratory (RDTL),

Guwahati for testing along with duly filled Form -18 on

01.02.2021, while another Form-18 containing the specimen

seal was separately sent to the Government Analyst. The

Page 8 of 19

Government Analyst, RDTL, Guwahati vide report dated

12.10.2021 declared the said batch of drug ‘Not of standard

Quality’ on the ground that the sample did not conform to

the assay test. After that the complainant vide letter dated

13.10.2021 forwarded a copy of the Government Analyst’s

report to M/s S.B. Pharma under Section 25(2) of the Act

directing it to disclose the name and address of the

manufacturer from whom the said drug was purc hased.

09. In response to the said communication M/s S. B.

Pharma, Agartala vide its letter dated 22.10.2021 informed

the complainant that the said batch was manufactured and

supplied by M/s Innova Captab, having its manufacturing

unit at 81-B, EPIP Phase-I, Jharmajri, Baddi, Himachal

Pradesh. Later on, vide letter dated 27.10.2021 the

complainant forwarded a copy of the Government Analyst’s

report and a sealed portion of the sample to M/s Innova

Captab, Baddi. After that M/s Innova Captab through its

authorized signatory vide its letter dated 22.11.2021

informed the complainant that upon internal analysis of the

control sample of the said batch stored under proper

storage conditions at their manufacturing premises

conformed to the standard specifications. It was further

stated that the product was manufactured strictly in

accordance with the approved formula and procedures

under controlled environmental conditions as per Good

Manufacturing Practices(GMP). After that a joint

investigation was conducted by De puty Drugs Controller

Page 9 of 19

along with the Licensing Authority. The joint investigation

report was forwarded to the complainant’s office vide letter

dated 17.12.2021. Thereafter, after the investigation, the

complainant’s office sought prosecution sanction from the

Drugs Controller General (India) vide letter dated

28.12.2021 and accordingly sanction was accorded by the

competent authority vide letter F.No.04/Prosecution/2022

dated 13.10.2022. After that the complaint was filed. This is

the gist of the complaint.

10. The present petitioners have challenged the

entire prosecution i.e. the complaint filed by the

complainant before this Court invoking jurisdiction of

Section 528 of BNSS. Now let us at first mention herein

below the procedure to be followed by the In spector as

mentioned in Section-23 of the Drugs and Cosmetics Act,

1940. Sub-Section 4(i),(ii) and(iii) of Section-23 are

reproduced as under:

“(4) The Inspector shall restore one portion of a sample

so 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 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.”

From the aforesaid sub-section 4 it appears that

after collection of sample the Inspector concerned shall sent

one portion or container forthwith to the Government

Analyst for test or analysis.

Page 10 of 19

11. Here from the report of Government Analyst

[Annexure-3] it appears that the sample was received by

the office of the Government Analyst on 01.02.2021 and the

sample was procured on 29.01.2021, in this regard no

explanation has been offered by the complainant in the

complaint petition. Now for the sake of convenience, let us

reproduced Rule-45 of the Drugs and Cosmetics Rules, 1945

which provides as under:

“45. Duties of Government Analysts. -(1) The Government

Analyst shall cause to be analysed or tested such samples

of drugs [and cosmetics] as may be sent to him by

Inspector or other persons under th e 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.]

(2) A Government Analyst shall from time to time forward

to the Government reports givi ng the result of analytical

work and research with a view to their publication at the

discretion of Government. ”

From the aforesaid provision it appears that the

Government Analyst shall furnish report of the result of test

or analysis within a period of sixty days of the receipt of the

sample. Here in the case at hand, the sample was received

on 01.02.2021 but the report was submitted on 12.10.2021

i.e. after the statutory period as prescribed in Rule-45. In

this regard no satisfactory explanation is given although

Learned D.S.G.I. at the time of hearing referring Annexure-

R/5 i.e. the memorandum dated 08.12.2025 drawn the

attention of this Court wherein it was mentioned during

COVID-19 the then Government Analyst Dr. P. J. Gogoi

passed away in October 202 0 and no such person was

Page 11 of 19

there. Referring the same he tried to draw the attention of

the Court that due to non-availability of the analyst the

report was not submitted on time. In this regard said Rule

further provides that if it is not possible to test or analyse

the sample within the specified period in that case the

analyst shall seek extension of time from the Government

giving specific reason for delay. Here in this case at the time

of hearing Learned D.S.G.I. could not place any material

that the said mandatory provision was complied with from

the office of the Government Analyst seeking extension of

time. So the explanation offered in Annexure-5 appears to

be non-compliance of Rule-45 of the Drugs and Cosmetics

Rule, 1945.

12. Learned D.S.G.I. although tried to draw the

attention of the Court referring the order passed by the

Hon’ble Supreme Court on 10.01.2022 in Miscellaneous

Application No.21 of 2022 and Miscellaneous Application

No.665 of 2021 in Suo Motu Writ Petition (C)No.3 of 2020

wherein that period of extension with effect from

15.03.2020 to 28.02.2022 was extended for the purpose of

limitation in respect of filing cases not in respect of

submitting any report. So, on the basis of the said order of

Hon’ble Supreme Court this Court is of the considered

opinion that the explanation offered by the respondent

Union of India referring Annexure-R/5 cannot be accepted

and legally sustainable in the eye of law.

Page 12 of 19

13. Now regarding non-compliance of provision of

sub-section (2),(3) and (4) of Section 25. Let us reproduce

hereinbelow the provision of Section-25 of the said Act

which provides as under:

(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 and other particulars have

been disclosed under section 18A], and shall retain the

third copy for use in ay 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.

(4) Unless the sample h as already been tested or

analysed in the Central Drugs Laboratory, where a person

has under sub -section (30 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 ana lysis 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.”

From the aforesaid provision it appears that after

receipt of the sample the Inspector shall communicate a

copy of the report of the analyst to the person from whom

the sample was taken to allow him to adduce evidence in

controversion of the report within a period of twenty eight

days. But here in this case nothing has been complied with

by the complainant before filing of prosecution before the

Court. It has already been decided the report was not

submitted within the statutory period as provided in Rule-45

of the Drugs and Cosmetics Rules, 1945.

Page 13 of 19

14. Now regarding filing of prosecution let us

reproduced herein below the relevant provision of Section-

34 of the said Act which provides as under:

“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 shall

be deemed to be guilty of the offence and shall be liable

to the 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 anythi ng 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

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.”

From the aforesaid provision it appe ars that the

prosecution shall be launched against the person who was

in-charge of and was responsible to the company for the

conduct of the business of the company shall be deemed to

the guilty of the offence. Referring the said provision

Learned Senior Counsel for the petitioner tried to draw the

attention of this Court that the prosecution was not

launched against the person who were responsible for the

business manufacturing, testing of the company rather

prosecution was launched against some other pers ons. In

this regard in sub-section 2 of Section-34 it has been

specifically provided that 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

Page 14 of 19

of, or it attributes to any neglect on the part of, any

director, manager, secretary or other officer of the

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.

Since no evidence has yet been recorded in this case, so on

this sole point I do not find any scope to extend any benefit

to the present petitioner accused persons. Furthermore, on

perusal of the Annexure-R/5 and it’s connected accelerated

stability report it appears that the batch number mentioned

on those documents does not match with the batch number

as mentioned in the report of the Government Analyst. The

respondent-Union of India at the time of hearing also failed

to explain anything in this regard.

15. At the time of hearing Learned Senior Counsel

relied upon one citation of Hon’ble Gauhati High Court in

Pratyay Majee and Others vs. Union of India and Ors.

reported in 2025 SCC OnLin e Gau 2441 wherein in para-

19 Hon’ble Gauhati High Court observed as under:

“19. It is, therefore, obvious that it is the clear legislative

intent that the process of taking a sample of the drug,

getting it tested by a notified Analyst and sending a copy

of the report to the persons responsible, are to be

undertaken with a sense of urgency so that the cloud of

suspicion hanging on the drug is resolved promptly. ”

Referring the same Learned Senior Counsel appearing

for the petitioners has drawn the attention of the Court that

the present case is squarely covered by the said judgment.

16. Mr. D. Bhattacharya, Learned Senior Counsel

further referred another citation of the Bombay High Court

Page 15 of 19

in Writ Petition No.2777 of 2024 dated 24.03.2026 in

M/s. C.B. Healthc are and Ors. vs. Union of India

wherein in para No.47, 51, 52 Hon’ble the Bombay High

Court observed as under:

“47. Section 34(1) of the Drugs Act, 1940 provides that

where an offence has been committed by a company,

every person who at the time of 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 offence

and shall be liable to be proceeded against and punished

accordingly.

51. In regard to the invocation of the vicarious liability of

Petitioner Nos.2 to 6 under Section 34, in the complaint,

the allegation qua Petitioner Nos.2 to 6 is that, they were

directors of M/s. C.B. Healthcare (P1) and at the time of

the manufacturing of drug in question were responsible

to day to day activities of the business of the firm and

release for distribution of the said drug batch number. In

paragraph 19 of the complaint, it is further urged that

Accused Nos.2 to 6 (P2 to P6) did manufacture the

subject drug for sale and distribution and sold, “not of

standard quality” drug and they were in charge of and

responsible to the conduct of the business at the

premises of Accused No.1 at the relevant time when the

subject drug was manufactured.

52. The aforesaid averments do not strictly satisfy the

requirement of spelling out the role of the Petitioner

Nos.2 to 6; as to how and in what manner the Petitioners

Nos.2 to 6 were responsible for the conduct of the

business of the firm. Yet, whether the afore said

allegations in the complaint are sufficient to invoke the

principle of constructive criminality under Section 341(1)

of the Drugs Act, 1940, in the light of the view this Court

has taken on the substantive challenge to the

prosecution, need not be ans wered definitively. De hors

the challenge to the initiation of the prosecution qua

Petitioner Nos.2 to 6 by invoking the provisions under

Section 34(1) of the Drugs Act, 1940, this Court has come

to the conclusion that the prosecution of Petitioner No.1 -

firm itself would amount to an abuse of process of the

Court.”

17. Reliance was placed upon another judgment of

Himachal Pradesh High Court in Cr.MMO No.929 of 2023

dated 07.05.2026 in M/s Salus Pharmaceuticals and

Others vs. Union of India wherein in para No.33 Hon’ble

Himachal Pradesh High Court observed as under:

“33. Besides above, the Court finds that adverse report in

Form 13 was issued on 05.12.2019, despite receipt of

sample on 02.09.2019, which is beyond period of sixty

days, as per mandate under R ule 45 of 1945 Rules. On

afore count only, complaint sought to be quashed shall

Page 16 of 19

not pass the test of judicial scrutiny and as such, no

fruitful purpose would be otherwise served in permitting

complaint sought to be quashed to sustain. Reliance in

this regard is place upon M/s G.G. Nutrition and Others

vs. State of Maharashtra and Another, decided by the

High Court of Judicature at Bombay, in Criminal Writ

Petition No.1659 of 2022, which read as under:

"6. The next judgment is in the case of M. Sea

Pharmaceuticals Pvt. Ltd. & anr. Vs. The State of

Maharashtra and anr. reported in 2018 ALL MR

(Cri.) 3946. In that case also, the accused had

replied the notice issued by the authority. The

sanction obtained by the complainant was not

legal. It was contended that the report of the

Analyst was received by the complainant on

20.07.2015 and reply was given on 31.08.2015 and

complaint was filed on 04.03.2016. When there

was knowledge that the sample was to expire in

May 2016 whereas, process was issued on

31.03.2016 an d the summons was made

returnable on 29.06.2016 that is after date of

expiry of the sample. Though the accused were not

served on the first date and they were served after

the returnable date and they were required to

appear before the Court on 03.07.2017, it is held

that, by that time, the vital right of the accused to

get sample re-analyzed and to challenge the report

of the Government Analyst was lost. In this view, it

was held that, continuance of complaint would be

an abuse of process of law and the pr oceeding was

quashed.

7. Learned advocate for the petitioner further

relied upon the judgment delivered by this Court in

the case of M/s. Quixotic Healthcare & Ors. Vs.

State of Maharashtra & Anr. reported in 2020 ALL

MR (Cri) 1880 wherein, there is violat ion of Rule

45 and in that view of the matter the proceeding of

the complainant was quashed. In that case, the

sample was taken just before when the same was

to expire on 31.08.2010. The report was received

on 02.02.2010 by the complainant. The accused

wanted to get the sample re -checked, however,

the complainant lodged the report only on

30.08.2010. There was no averment in respect of

this time period. It was also held in the said

judgment that, the main point was agitated was

that the sample was drawn on 17.11.2009 and the

same was sent for analysis on 18.11.2009. The

report was received on 02.02.2010. However, the

testing of the sample was beyond statutory period

prescribed under Rule 45 which is required to be

decided within 60 days. For non compliance o f this

the proceeding was quashed.

8. After considering the submissions and the

judgments cited above, this Court finds that, the

valuable right to controvert the test report of the

Chemical Analyst is lost. There is also violation of

Rule 45 that the samp le was not tested within 60

days from the date it was drawn. By the time, the

summons was received, the drug had already

expired and under such circumstances now

proceeding with the complaint would be a futile

exercise and therefore, continuance of proceed ing

would clearly be an abuse of process of law.

Therefore, this Court finds that, the petition

deserves to be allowed."

Page 17 of 19

18. He also relied upon another citation of the High

Court of Punjab and Haryana in S.S. Fertililizer and

Another vs. State of Punjab reported in 2017 SCC

OnLine P&H 6106 wherein in para-4 the said High Court

observed as under:

4. Learned counsel for the petitioners submitted that

sample was taken from the original sealed containers,

therefore, petitioners were not liable in terms of

protection granted under Section 30(3) of the

Insecticides Act. No prosecution could be launched

against the petitioners as the petitioners were selling the

insecticides in sealed containers in the original form as

obtained from the registered manufacturers . In the

complaint, there was no averment that the samples were

not in the sealed containers. Section 33 of the

Insecticides Act is to the following effect:— “Section 33 -

Offences by companies — (1) Whenever an offence under

this Act has been committed by a company, every per son

who, at the time the offence was com mitted, was in

charge of, and was responsible to the company for the

conduct of the business of the company as well as the

com pany, shall be deemed to be guilty of the of fence

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 if he proves that he offence was committed

without his knowledge or that he exercised all due

diligence to prevent such offence.

(2) Notwithstanding anything contained in sub section

(1) SCC Online Web Edition, © 2026 EBC Publishing Pvt.

Ltd. Page 4 Wednesday, July 15, 2026 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 offi cer of the company, such Director, Manager,

Secretary or other office 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 any 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.”

Finally Learned Senior Counsel relied upon

another citation of the Hon’ble Apex Court of India in

Lalankumar Singh and Others vs. State of

Maharashtra reported in 2022 SCC OnLin e SC 1383

wherein in para-24 and 28 Hon’ble the Supreme Court

observed as under:

Page 18 of 19

“24. It is further to be noted that, in accordance with the

provisions of Rule 76 of the said Rules read with Form 28,

the Accused Nos. 9 and 10 have specifically been

approved by the licensing authority in Form 28. Accused

No.9 was approved as a person under whose active

direction and personal supervision the manufacture

would be conducted as required under sub rule (1) of Rule

76 of the said Rules. Similarly, Accused No.10, w ho was

approved as a head of the testing unit, was to be in -

charge for carrying out the test of the strength, quality

and purity of the substances as may be required under

the provisions of Part X of the said Rules. We are

therefore of the considered view that the complaint is

totally lacking the requirement of Section 34 of the said

Act.

28. The order of issuance of process is not an empty

formality. The Magistrate is required to apply his mind as

to whether sufficient ground for proceeding exists in the

case or not. The formation of such an opinion is required

to be stated in the order itself. The order is liable to be

set aside if no reasons are given therein while coming to

the conclusion that there is a prima facie case against the

accused. No doubt, that the order need not contain

detailed reasons. A reference in this respect could be

made to the judgment of this Court in the case of Sunil

Bharti Mittal vs. Central Bureau of Investigation9 , which

reads thus:

On the other hand, Section 204 of the Code deals

with the issue of process, if in the opinion of the

Magistrate taking cognizance of an offence, there

is sufficient ground for proceeding. Thi s section

relates to commencement of a criminal proceeding.

If the Magistrate 9 (2015) 4 SCC 609 taking

cognizance of a case (it may be the Magistrate

receiving the complaint or to whom it has been

transferred under Section 192), upon a

consideration of the materials before him (i.e. the

complaint, examination of the complainant and his

witnesses, if present, or report of inquiry, if any),

thinks that there is a prima facie case for

proceeding in respect of an offence, he shall issue

process against the accused.

A wide discretion has been given as to grant or

refusal of process and it must be judicially

exercised. A person ought not to be dragged into

court merely because a complaint has been filed. If

a prima facie case has been made out, the

Magistrate ought to issue process and it cannot be

refused merely because he thinks that it is unlikely

to result in a conviction.

However, the words “sufficient ground for

proceeding” appearing in Section 204 are of

immense importance.

It is these words which amply sug gest that 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. The order

is liable to be set aside if no reason is given therein

while coming to the conclusion that there is prima

facie case against the accused, though the order

need not contain detailed reasons. A fortiori, the

order would be bad in law if the reason given turns

out to be ex facie incorrect.”

Page 19 of 19

19. I have gone through all the aforesaid citations

and after going through the petition along with the

connected documents as well as the counter -affidavits filed

by the respondents Union of India. It appears to this Court

that in the instant case the complainant has failed to comply

with the mandatory provision of Section 23(4)(i), sub -

section (3) and (4) of Section 25 and Rule 45 of the Drugs

and Cosmetics Act and also Rule 45 of the Drugs and

Cosmetics Rule, 1945 for launching prosecution against the

petitioner accused persons and as such the order dated

10.01.2023 passed by Learned J.M. 1

st

Class, Court No.1,

West Tripura, Agartala in Case No.302 of 2022 appears to

be bad in law and the same cannot be sustained in the eye

of law and accordingly the same needs to be interfered with

and dismissed.

20. In the result, the petition filed by the petitioner-

accused persons is allowed and the order dated 10.01.2023

passed by Learned J.M. 1

st

Class, Court No.1, West Tripura,

Agartala in Case No.302 of 2022 s tands quashed and

further proceeding of this case accordingly stands quashed.

The petitioner accused-persons are discharged from the

liability of this case.

Send down the LCR to the Learned Trial Court

along with a copy of this judgment.

JUDGE

Moumita