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The Drugs Inspector & Anr. Vs Vimal Kumar Khemkha & Anr.

  Supreme Court Of India CRIMINAL APPEAL NO. OF 2026 [@ SPECIAL LEAVE
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Case Background

As per case facts, a Drugs Inspector filed a complaint against Panacea Biotec Ltd. for drug misbranding. The CJM summoned the company, but the High Court later quashed the proceedings, ...

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Document Text Version

2026 INSC 200 REPORTABLE

IN THE SUPREME COURT OF INDIA

CRIMINAL APPELLATE JURISDICTION

CRIMINAL APPEAL NO. OF 202 6

[@ SPECIAL LEAVE PETITION (CRIMINAL) NO.4524 OF 2023 ]

THE STATE OF KERALA & ANR. …APPELLANTS

A1: THE STATE OF KERALA REPRESENTED BY HOME

SECRETARY

A2: THE DRUGS INSPECTOR (INTELLIGENCE BRANCH) OFFICE OF

ASSISTANT DRUGS CONTROLLER, THRISSUR, KERALA

VERSUS

M/s. PANACEA BIOTEC LTD. & ANR. …RESPONDENTS

1

R1: M/S PANACEA BIOTEC LTD.

R2: PANACEA BIOTEC LTD.

WITH

CRIMINAL APPEAL NO. OF 2026

[@ SPECIAL LEAVE PETITION (CRIMINAL) NO. O F 2026 ]

[@ DIARY NO.18999 OF 2023]

M/s. PANACEA BIOTEC LTD. & ANR. …APPELLANTS

A1: M/s. PANACEA BIOTEC LTD.

A2: PANACEA BIOTEC LTD.

VERSUS

STATE OF KERALA & ANR. …RESPONDENTS

R1: STATE OF KERALA THROUGH HOME SECRETARY

R2: THE DRUGS INSPECTOR (INTELLIGENCE BRANCH)

OFFICE OF ASSISTANT DRUGS CONTROLLER, THRISSUR

WITH

CRIMINAL APPEAL NO. OF 2026

[@ SPECIAL LEAVE PETITION (CRIMINAL) NO.8867 OF 2023 ]

1

(Original) R2 deleted vide Order dated 16.10.2023.

1

THE DRUGS INSPECTOR & ANR. …APPELLANTS

A1: THE DRUGS INSPECTOR, OFFICE OF ASSISTANT DRUGS

CONTROLLER, KOZHIKODE

A2: STATE OF KERALA

VERSUS

VIMAL KUMAR KHEMKHA & ANR. …RESPONDENTS

R1: VIMAL KUMAR KHEMKHA

R2: NARENDRA KUMAR KAPOOR

J U D G M E N T

AHSANUDDIN AMANULLAH, J.

The matters are dealt with as follows:

CRIMINAL APPEAL NO._____ OF 2026

[@ SLP (CRL.) NO.4524/2023]

1.1Leave granted.

2.The present appeal assails the Final Judgment and Order dated

14.07.2022 passed in Crl. M.C. No.2802 of 2012 (hereinafter referred to

as the ‘Impugned Order’) passed by a learned Single Judge of the High

Court of Kerala at Ernakulam (hereinafter referred to as the ‘High Court’).

2

FACTUAL MATRIX:

3.On 21.10.2005, one Mr. Joy Mandi was informed, about an alleged

discrepancy in the labelling of the subject drug, alleged to be

manufactured and sold by the Respondents, by the Medical Officer,

Primary Health Centre, Thrissur, Kerala.

4.On 05.01.2006, Mr. Joy Mandi filed a Complaint with Appellant

No.2-Drug Inspector regarding the discrepancy in the labelling of the

drug alleged to be manufactured and sold by the Respondents.

Admittedly, no bill of purchase of the drug was placed on record in the

Complaint Case.

5.On 16.01.2006, Appellant No.2 received the Complaint dated

05.01.2006 filed by Mr. Joy Mandi, whereafter Appellant No.2

commenced an enquiry into the subject-matter of the said Complaint.

6.On 20.01.2009, Appellant No.2 filed a Complaint Case before the

learned Chief Judicial Magistrate, Court, Thrissur, Kerala (hereinafter

referred to as the ‘CJM’), against, inter alia, the Respondents for the

alleged commission of offences under Sections 18(a)(i) read with 17(b)

and 17(c) of the Drugs & Cosmetics Act, 1940 (hereinafter referred to as

3

the ‘Act’) read with Rule 96 [of the Drugs and Cosmetics Rules, 1945

(hereinafter referred to as the ‘Rules’)] punishable under Section 27(d) of

the Act.

7.The core allegation as per the Complaint Case was that there was

an alleged discrepancy in the label on the carton concerned vis-à-vis the

label on the top of the vial of the drug manufactured and sold by the

Respondents. To be specific, the carton was labelled as ‘Easy five,

Pentavalent vaccine B. No.:PO124 SBPC, Mfg. date: 14/August/2004,

Exp.: 13/August/2006, manufactured by: Panacea Biotech Ltd., A 241

Okhla, Industrial Area-1, New Delhi - 110020, India. Retail price not to

exceed Rs.550/- LT extra, Manufacturing Licence No:1259’ (sic)

2

. But,

allegedly, on the seal cap of the vial, it was labelled as ‘pentavalent

vaccine Easy Five, B.No: P0124 SBPC, Mfg. Date: 14/Aug,2004, Exp.

date: 13-Aug 2006’ (sic)

3

. Whereas, on the vial it was labelled as

‘Tetravalent Vaccine Easy Four. B.No: TO124SBC, Mfg. date:

29/August/2004, Exp. date: 28/August/2006. Manufactured by Panacea

Biotec Ltd., A-241, Okhla, Industrial Area-1, New Delhi-110020, India.

Retail price not to exceed Rs.500/- LT extra’ (sic)

4

.

2

As per the True Typed Copy of the Complaint annexed with the Paperbook.

3

Ibid.

4

Ibid.

4

8.The Complaint alleged ‘… As per the label claim of outer carton,

the drug is Easy Five pentavalant vaccine which is a combination of 5

different vaccines including HbSAg 10 mcg. (vaccine for Hepatitis). But

as per label claim of inner vial Easy Four tetravalent vaccine which is a

combination of four different vaccines, an does not contain HbSAg 10

mcg. (vaccine for Hepatitis) as claimed on the outer carton label …’

(sic)

5

. It was averred that as the contents differed on the outer and inner

labels, the drug was not labelled in the prescribed manner as specified in

Rule 96 of the Rules; that the outer carton label makes a false claim for

the drug and is misleading, and; that the drug is misbranded.

9.Pursuant to the Complaint, vide Order dated 29.01.2009 in the

Complaint Case, the CJM summoned, inter alia, the Respondents.

10.On 04.08.2009, the Respondents filed a Petition being Crl. M.C.

No.2551/2009 before the High Court under Section 482 of the Code of

Criminal Procedure, 1973 (hereinafter referred to as the ‘Code’), seeking

to set aside the Summoning Order dated 29.01.2009. Subsequently, vide

Order dated 17.06.2011, the High Court directed the CJM to consider

whether the delay in filing the Complaint Case could be condoned in

terms of Section 473 of the Code.

5

Ibid.

5

11.Vide Order dated 10.07.2012, the CJM condoned the delay on the

part of Appellant No.2 in filing the Complaint Case under Section 473 of

the Code and summoned, inter alia, the Respondents to face the trial.

12.Aggrieved by the Summoning Order dated 10.07.2012, on

21.08.2012, the Respondents filed Crl. M.C. No.2802/2012 before the

High Court under Section 482 of the Code to quash the afore-mentioned

Order on the grounds that the CJM did not conduct the mandatory

statutory enquiry under Section 202 of the Code to ascertain the

sufficiency of grounds to proceed against the Respondents.

13.The High Court vide the Impugned Order dated 14.07.2022

quashed the Complaint Case qua the Respondents on the ground that

they resided beyond the territorial jurisdiction of the CJM and yet the

CJM failed to conduct the mandatory statutory enquiry under Section 202

of the Code. However, be it noted, the High Court did not interfere with

the Order dated 10.07.2012 on the ground of limitation/under Section

473 of the Code.

THE APPELLANTS’ SUBMISSIONS :

6

14.The learned counsel, Mr. H. V. Hameed, for the State argued that

the procedure under Section 202 of the Code cannot be treated as a

mandatory requirement for a complaint filed by a public servant, as they

would stand on a different pedestal. Parallelly, the learned counsel urged

that the Complainant cannot be faulted for an omission, if any, on the

part of the CJM and the Respondents-accused persons cannot take

undue advantage therefrom.

15.Learned counsel proceeded to invite the Court’s attention to the

gravity of the alleged offences and the material/evidence collected by the

Drugs Control Inspector. It was submitted that keeping in view the facts

and circumstances of the case, since the offences affect the public at

large and violate the rights of various citizens, especially innocent

consumers, who would be totally ignorant of the misbranding, the

Complaint Case was erroneously quashed by the High Court.

16.Learned counsel placed reliance on Cheminova India Limited v

State of Punjab, 2021 SCC OnLine SC 573

6

, wherein it was held:

’18. The legislature in its wisdom has itself placed the public

servant on a different pedestal, as would be evident from a

perusal of proviso to Section 200 of the Code of Criminal

Procedure. Object of holding an inquiry/investigation before

taking cognizance, in cases where the accused resides

outside the territorial jurisdiction of such Magistrate, is to

6

Alternatively, (2021) 8 SCC 818.

7

ensure that innocents are not harassed unnecessarily. By

virtue of proviso to Section 200 of the Code of Criminal

Procedure, the Magistrate, while taking cognizance, need not

record statement of such public servant, who has filed the

complaint in discharge of his official duty. Further, by virtue of

Section 293 of Code of Criminal Procedure, report of the

Government Scientific Expert is, per se, admissible in

evidence. The Code of Criminal Procedure itself provides for

exemption from examination of such witnesses, when the

complaint is filed by a public servant.’

17.Learned counsel for the Appellants submitted that the present case

is squarely covered by the afore-noted dictum.

18.Touching upon the concept of vicarious liability apropos

ascertainment of the culpability of the then Managing Director of the

Respondents-companies (original Respondent No.2), the learned

counsel further submitted that the primary allegation is with respect to

misbranding and a bare reading of Section 34 of the Act makes it clear

that whenever an offence under the Act has been committed by a

company, every person who, at the time the offence was committed, was

in charge of or 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.

8

19.Learned counsel pointed out that even though the High Court in the

Impugned Order noted that the Order dated 10.07.2012, passed by the

CJM condoning the delay, cannot be said to be perverse, proceeded to

quash the Complaint. It was prayed that the appeal be allowed.

THE RESPONDENTS’ SUBMISSIONS :

20.Per contra, learned senior counsel Mr. Siddharth Luthra, argued

the point of non-compliance of the mandatory provisions of Section

202(1) of the Code and stressed that vide the 2005 Amendment [as

made vide Act 25 of 2005 with effect from 23.06.2006] to the Code, the

words ‘and shall, in a case where the accused is residing at a place

beyond the area in which he exercises his jurisdiction’ were inserted

before the words ‘postpone the issue of process against the accused,

and either inquire into the case himself or direct an investigation to be

made by a police officer or by such other person as he thinks fit, for the

purpose of deciding whether or not there is sufficient ground for

proceeding’. Learned senior counsel submitted that the said Amendment

did not carve out any exception in Section 202 of the Code for a case

where the Complainant is a public servant.

9

21.Learned senior counsel vehemently submitted that the CJM ought

not to have summoned the Respondents without conducting an enquiry

as prescribed under Section 202 of the Code. Ergo, it was advanced that

the Impugned Order suffers from no infirmity and the Appellants’

challenge thereto is liable to be rejected.

22.In other words, the straight submission canvassed was that

compliance of Section 202 of the Code is a sine qua non and merely

because the Complainant happens to be a public servant, cannot be

used to circumvent the clear statutory mandate.

23.To substantiate the argument, learned senior counsel submitted

that the Legislature has expressly provided Exceptions to the provisions

of Section 202 of the Code in the Proviso to the said Section 202 itself. In

the event, it was urged, the intent of the Legislature was to carve out an

exception for public servants, the Legislature would have done so in the

said Proviso.

24.Learned senior counsel opposed the applicability of Cheminova

India Limited (supra), relied upon by the Appellants, stating that the

allegations in the underlying Complaint Case were not corroborated by

the Report of a Government Analyst. Pertinently, Appellant No.2 was,

10

inter alia, relying on the allegations made by Mr. Joy Mandi in his

‘complaint’ dated 05.01.2006 and the alleged label of the carton of the

subject drug to corroborate the allegation of misbranding.

25.Learned senior counsel also contended that Appellant No.2 had

failed to adduce the label of the vial of the drug in question or any

independent third-party evidence or even a Government Analyst’s Report

to prima facie prove the allegation of misbranding, which was contrary to

the judgment cited, wherein the specific facts and circumstances of that

case, were considered by the Court. It was submitted that in Cheminova

India Limited (supra), firstly, the allegations in the Complaint filed by a

public servant were corroborated by Report(s) of Government Analyst(s)

(which are per se admissible in law), therefore there was no need to

examine the Complainant-public servant and/ or the Government

Analyst(s) on oath, and; secondly, no prejudice was caused to the

Appellants therein at the concerned stage. It was urged that the appeal

merited outright dismissal.

ANALYSIS, REASONING AND CONCLUSION :

26.Having considered the rival contentions at the Bar, we find that a

case for interference has been made out by the Appellants. For the

11

purposes of adjudication in the case at hand, the Court is confronted with

twin questions that arise:

(a) re limitation in taking cognizance as stipulated under Sections

468 and 469 read with Section 473 of the Code, and;

(b) re territorial jurisdiction in terms of Section 202 of the Code.

27.On the initial question, let us take note of the relevant extract from

the Complaint dated 20.01.2009 by the State of Kerala, represented by

the Drugs Inspector (Intelligence Branch), Office of the Assistant Drugs

Controller, Thrissur, Kerala (hereinafter referred to as the ‘Drugs

Inspector’). The same is culled out and reproduced hereunder:

‘The facts of the case are as follows:-

A petition dated, 5/1/2006 was received in the office of

the Asst. Drugs Controller, Thrissur from Mr. Joy Mandi

Kanakamala, Thrissur Dt regarding improper labeling of a

drug namely Easy five vaccine, B.No: PO 124/SBPC Mfg.

date: 14/August 2004, Exp. Date: 13 August 2006,

manufactured by: Panacea Biotec Ltd., A 241 Okhla

Industrial Area-1, New Delhi-110020, India. T.V. Rajathan,

the then Drugs Inspector conducted enquiries at the

residence of petitioner on 18/1/2006. Petitioner vide letter

dated 18/1/2006 informed that 44 the subject drug was

purchased from Meenakshi Medical Stores, Thrissur.

One vial along with the packing of subject drug

maintained in the custody of the petitioner was also

handed over to the Drugs Inspector voluntarily and free of

cost. After making necessary enquiries the then Drugs

Inspector T.V. Rajathan informed the petitioner that

Meenakshi Medical Stores, Thrissur has not purchased

or sold the subject drug. In response the petitioner vide

12

letter dated 21/1/2006 clarified that the subject drug was

purchased from Meenakshi Medical Agencies, Thrissur.

On verifying the vial produced by the petitioner it was

found that the subject drug was packed in carton labelled

as Easy Five. Pentavalent vaccine, B. No: P0124 SBPC,

Mfg. Date: 14/August/2004, Exp.: 13/August/2006,

manufactured by: Panacea Biotech Ltd., A 241 Okhla,

Industrial Area-1, New Delhi – 110020, India. Retail price

not to exceed Rs.550/- LT extra,

Manufacturing Licence No:1259.

Each dose 0.5 ml. contains:

Diphtheria Toxoid 20 LF,

Tetanux Toxoid 7.5 LF,

Inactivated W-8, pertussis 12.0U

(12000 X 10 Organisms)

HS.Sag 10 mcg.

H influenzae type b

Oligosaccharides 10 mcg.

Conjugated to CRM 197 Protien

Aluminium content (A1 *3+) 0.25 mg

As Aluminium Phosphate gel

Thiomersal I.P. 0.025 mg,

Water for injection I. P. Q.S.

On the seal cap of the vial it was labelled as

pentavalent vaccine Easy Five, B.No: P0124 SBPC, Mfg.

Date: 14/Aug,2004, Exp. Date: 13-Aug 2006. But on the

vial it was labelled as Tetravalent Vaccine Easy Four.

B.No: TO 124SBC, Mfg. date: 29/August/2004, Exp. date:

28/August/2006. Manufactured by Panacea Biotec Ltd.,

A-241, Okhla, Industrial Area-1, New Delhi-110020, India.

Retail Price not to exceed Rs.500/- LT extra.

Manufacturing Licence No: 1259.

Each dose 0.5 ml.contains:

13

Diphtheria Toxoid 20 LF,

Tetanux Toxoid 7.5 LF,

Inactivated W-B, pertussis 12.0U

(12000 X 10 Organisms)

H influenzae type b

Oligosaccharides 10mcg.

Conjugated to CRM 197 Protien

Aluminium content (A1 *3+) 0.25mg

As Aluminium Phosphate gel

Thiomersal. I. P. 0.025 mg,

Water for injection I.P. Q.S.

As per the label claim of the outer carton, the drug is

Easy Five pentavalent vaccine, which is a combination of

5 different vaccines, including HbSAg 10 mcg. (vaccine

for Hepatitis). But as per label claim of inner vial Easy

Four tetravalent vaccine which is a combination of four

different vaccines, an does not contain HbSAg 10 mcg.

(vaccine for Hepatitis) as claimed on the outer carton

label. The drug is not labelled in the prescribed manner

as specified in Rule 96, and the carton accompanying the

drug makes a false claim for the drug and is misleading.

The drug is misbranded as per Section 17 (b) and 17

(c) of the Act read with Rule 96 of the Drugs and

Cosmetics Rules 1945.

On 21/1/2006 Drugs Inspector T.V. Rajathansupreme

court of india inspected the premises of A7 M/s.

Meenakshi Medical Agencies Thrissur in presence of

witnesses. The Subject drug was not available in the

premises. Original invoices towards purchase of subject

drugs by A7 from A5, Carbon copies of invoices towards

sale of subject drugs by A7 and credit notes towards

return of subject drug to A5 by A7 were seized under a

14

mahazar and form 16 dated, 21/1/2006. The seized

documents were produced before this Honourable court

on 23/1/2006 and were taken into safe custody. AB wide

his statement dated, 21/1/2006 has stated that some of

the vials of the subject drug were wrongly labelled and

that the balance stock of subject drug was returned to

supplier due to improper labeling (misbranded). Sales

representative of A7 firm C.Rajendran vide his statement

dated, 21/1/06 has stated that 2 vials of subject drug

were sold to the petitioner (CW2) from A7 firm and

balance stock of subject drug was returned to supplier A5

due to improper labelling. He has also stated that 4 vials

of subject drug were traced from balance stock with

labelling defects. (Misbranded) AB vide his statement

dated, 6/4/2006 has submitted his explanation for the

discrepancies in the sales records of subject drug. In the

letter he has confirmed that some of the vials of subject

drug were found wrongly labelled and returned to supplier

A5 and credit note obtained from them. As per the

request of Drugs Inspector (Intelligence Branch),

Thrissur, the Drugs Inspector (lnetelligence Branch)

Ernakulam inspected the premises of A5 firm. On

18/4/2006, Certified copies of original invoices pertaining

to purchase of subject drugs by A7 from A5, Certified

copies of invoices pertaining to sale of subject drug from

A5 to A7, and certified copies of credit notes issued by A5

to A3 were taken along with other connected documents.

From the above documents it is proved that A5 has

purchased, stocked for sale and sold the subject drug.48

The Drugs Inspector (Intelligence Branch), Ernakulam

also inspected the premises of A3 firm on 18/4/06.

Certified copies of purchase invoices pertaining to the

purchase of the subject drug by A3 from A 1, Certified

copies of invoices pertaining to the sale of drugs by A3 to

A5, and certified copies of credit notes pertaining to

return of subject drug from A3 to A1 were taken. From

above documents it is proved that A3 has purchased

stocked for sale and sold the subject drug. The Drugs

Inspector (Intelligence Branch), Office of the Asst. Drugs

Controller, Ernakulam forwarded the certified copies of

relevant details taken from A3 and A5.’

15

(sic)

28.From the aforesaid, it transpires that the initial ‘complaint’ dated

05.01.2006 was made by one Mr. Joy Mandi and was received by the

Drugs Inspector on 16.01.2006, alleging that although he had purchased

two ampoules of ‘Easy Five Pentavalent Vaccine’ for immunization of his

child at the Primary Health Centre, as was represented on the outer

packaging, but the vial inside had the label ‘Tetravalent vaccine Easy

Four’.

29.On 21.01.2006, the Drugs Inspector inspected the premises of M/s

Meenakshi Medical Agencies, Thrissur, Kerala from where the said drug

had been purchased by Mr. Joy Mandi and found that the subject drug

was not available and thus, original invoices towards purchase of the

subject drugs by A-7 from A-5, carbon copies of invoices towards sale of

subject drugs by A7 and credit note towards return of subject drug to A-5

by A-7 were seized. A-8 in his Statement on 21.01.2006 stated that some

vials of the subject drugs were wrongly labelled and that the balance

stock of the subject drug was returned to the supplier due to improper

labelling (Misbranded). The Sales Representatives of A-7 (firm), Mr.

Rajendran, on the same day, made a Statement that two vials of the

subject drug were sold to Mr. Joy Mandi/CW-2 from A7 firm, and the

16

balance stock of the subject drug was returned to the Supplier-A5 due to

improper labelling. He further stated that four vials of the subject drug

were traced from the balance stock with labelling defects (misbranded).

A-8 vide Statement recorded on 06.04.2006, submitted his explanation

for the discrepancies in the sales record of the subject drug. A-8 affirmed

that some of the vials of the subject drugs were found wrongly labelled

and returned to the Supplier-A5, and a credit note was obtained from

them. Thereafter, as per request, the Drugs Inspector inspected the

premises of A-5 (firm).

30.On 18.04.2006, certified copies of original invoices pertaining to the

purchase of the subject drug from A-5 by A-7, certified copies of invoices

pertaining to the sale of the subject drug from A-5 to A7 and certified

copies of the credit note issued by A-5 to A-3 were taken along with other

connected documents. On the same day i.e., 18.04.2006, the Drugs

Inspector also inspected the premises of A-3 (firm) from where certified

copies of purchase invoices pertaining to the subject drug by A-3 (firm)

from A-1, certified copies of invoices pertaining to the sale of drugs by A-

3 (firm) to A-5 and certified copies of credit notes pertaining to return of

subject drugs from A-3 (firm) to A-1 were taken. The aforesaid certified

copies of relevant details/documents obtained from A-3 (firm) to A-5 were

then forwarded by the Drugs Inspector.

17

31.We may end the narration here. The question/objection put forth by

the Respondents-accused has to be noticed in terms of Sections 468

and 469 read with Section 473 of the Code, quoted hereunder:

‘468. Bar to taking cognizance after lapse of the period of

limitation.—

(1) Except as otherwise provided elsewhere in this Cr.P.C, no

Court shall take cognizance of an offence of the category

specified in sub-section (2), after the expiry of the period of

limitation.

(2) The period of limitation shall be—

(a) six months, if the offence is punishable with fine only;

(b) one year, if the offence is punishable with

imprisonment for a term not exceeding one year;

(c) three years, if the offence is punishable with

imprisonment for a term exceeding one year but not

exceeding three years.

(3) For the purposes of this section, the period of limitation, in

relation to offences which may be tried together, shall be

determined with reference to the offence which is punishable

with the more severe punishment or, as the case may be, the

most severe punishment.

469. Commencement of the period of limitation.—

(1) The period of limitation, in relation to an offender, shall

commence,—

(a) on the date of the offence; or

(b) where the commission of the offence was not known

to the person aggrieved by the offence or to any police

officer, the first day on which such offence comes to the

knowledge of such person or to any police officer,

whichever is earlier; or

(c) where it is not known by whom the offence was

committed, the first day on which the identity of the

offender is known to the person aggrieved by the offence

or to the police officer making investigation into the

offence, whichever is earlier.

18

(2) In computing the said period, the day from which such

period is to be computed shall be excluded.

xxx

473. Extension of period of limitation in certain cases.—

Notwithstanding anything contained in the foregoing

provisions of this Chapter, any Court may take cognizance of

an offence after the expiry of the period of limitation, if it is

satisfied on the facts and in the circumstances of the case

that the delay has been properly explained or that it is

necessary so to do in the interests of justice.’

32.Section 468 of the Code explains the period of limitation that bars

taking cognisance. For now, this Court is restricting its discussions in the

light of the relevance of the said provision to the facts of the present

case. Thus, stricto sensu, on a plain reading, there is a bar to taking

cognisance of the offence [i.e., Section 27(d) of the Act, which provides

for ‘imprisonment for a term which shall not be less than one year but

which may extend to two years and with fine which shall not be less than

twenty thousand rupees’] after 3 years, in view of Section 468(2)(c) of

the Code. Section 469 of the Code relates to the commencement of the

period of limitation and that it shall commence on the date of the offence

or where the commission of the offence was not known to the person

aggrieved by the offence or to any police officer, the first day on which

such offence comes to the knowledge of such person or to any police

19

officer, whichever is earlier; or where it is not known by whom the offence

was committed, the first day on which the identity of the offender is

known to the person aggrieved by the offence or to the police officer

making investigation into the offence, whichever is earlier. Section 473 of

the Code, however, begins with a non-obstante provision and permits

‘any Court’ to take cognizance of any offence even after the expiry of the

limitation period prescribed, upon satisfaction with regard to the facts and

circumstances of the case that the delay has been ‘properly explained’ or

‘it is necessary so to do in the interests of justice.’

33.Taking a cue from the aforesaid, the bar to taking cognizance in the

present case would be covered by Section 469(1)(c) of the Code

inasmuch as the period of limitation would commence from the ‘first day

on which the identity of the offender is known to the person aggrieved by

the offence or to the police officer making investigation into the offence,

whichever is earlier.’ Thus, Section 469(1)(c) of the Code clearly

contemplates that the identity of the offender may emerge during

‘investigation into the offence’. In the present case, though the initial

‘complaint’ was made by Mr. Joy Mandi on 05.01.2006, but for

authentication and verification of the persons allegedly involved, an

exercise was undertaken. We are of the considered opinion that the

State adopted the correct approach, by virtue of Section 32 of the Act.

20

34.In the present case, the Complaint was made by a Gazetted Officer

of the State of Kerala, who was authorised in this behalf viz. the Drugs

Inspector (Intelligence Branch), Office of the Assistant Drugs Controller,

Thrissur, Kerala.

35.It is deemed necessary to quote Section 32 of the Act, as it stood

at the relevant time i.e., on 20.01.2009, when the Complaint was made

to the Court (prior to the amendment thereto which came into effect on

10.08.2009 by Act 26 of 2008), which reads as under:

‘32. Cognizance of offences—

(1) No prosecution under this Chapter shall be instituted

except by an Inspector or by the person aggrieved or by a

recognised consumer association whether such person is a

member of that association or not.

(2) No Court inferior to that of a Metropolitan Magistrate or of

a Judicial Magistrate of the first class shall try an offence

punishable under this Chapter.’

35.1 Only for completeness, we also note Section 32 of the Act as it

now stands i.e., after amendment by Act 26 of 2008, effective from

10.08.2009:

‘32. Cognizance of offences—

(1) No prosecution under this Chapter shall be instituted

except by—

(a) an Inspector or

(b) the person aggrieved; or

21

(c) a recognised consumer association, whether such

person is a member of that association or not.

(2) Save as otherwise provided in this Act, no court inferior to

that of a Metropolitan Magistrate or of a Chief Judicial

Magistrate shall try an offence punishable under this Chapter.

(3) Nothing contained in this Chapter shall be deemed to

prevent any person from being prosecuted under any other

law for any act or omission which constitutes an offence

against this Chapter.’

36. From the aforesaid, it is clear that the Drugs Inspector, who made

the complaint in the present case, satisfied the legal requirements of

being a complainant. In other words, the Drugs Inspector was an

‘Inspector’ within the fold of Section 32 of the Act. On a conjoint reading

of the provisions discussed hereinabove, the chain that emerges is that

the Competent Authority having received a ‘complaint’ from a private

party, namely Mr. Joy Mandi on 05.01.2006, put in motion a

verification/investigation process, which was completed within three

months, only whereafter the exact identity of the accused was

established. In our considered view, hence, the time for making a

complaint to the Court would start ticking only therefrom. In this context,

we find that for the first time only on 18.04.2006, the identity of all the

accused persons was before the Competent Authority. Undoubtedly, the

Competent Authority was required to file a proper complaint before the

Court, which was, however, ultimately done only on 20.01.2009. Though

there is an inordinate delay, between the period from 18.04.2006 to

22

20.01.2009, in making the complaint, whereafter cognisance was taken

and summons issued on 29.01.2009, the said exercise was completed

within the 3-year period, as per Section 468(2)(c) read with Section

469(1)(c) of the Code. Therefore, in our view, the limitation bar does not

come in the way. The limitation period would run out, in the present case,

only on 17.04.2009, i.e., on completion of three years from the date the

identity of the accused became known to the Competent Authority. On

this question, we unhesitatingly hold in favour of the Appellants. As such,

the Order passed by the High Court in Crl. M. C. No.2551/2009 dated

17.06.2011 was incorrect to the extent that it computed limitation as

having started from ‘21.10.2005’, as the provision attracted was not

Section 469(1)(b), but Section 469(1)(c) of the Code. Be that as it may,

the legality, or otherwise, of the said Order dated 17.06.2011 has

become academic today, in view of subsequent developments.

37.Coming to the second question, on the aspect of jurisdiction, on

which learned senior counsel for the Respondents laid great emphasis,

the same is to be examined from the perspective of Section 202 of the

Code:

‘202. Postponement of issue of process.—

(1) Any Magistrate, on receipt of a complaint of an offence of

which he is authorised to take cognizance or which has been

made over to him under section 192, may, if he thinks fit, and

23

shall, in a case where the accused is residing at a place

beyond the area in which he exercises his jurisdiction,

postpone the issue of process against the accused, and either

inquire into the case himself or direct an investigation to be

made by a police officer or by such other person as he thinks

fit, for the purpose of deciding whether or not there is

sufficient ground for proceeding:

Provided that no such direction for investigation shall be

made,—

(a) where it appears to the Magistrate that the offence

complained of is triable exclusively by the Court of

Session; or

(b) where the complaint has not been made by a Court,

unless the complainant and the witnesses present (if

any) have been examined on oath under section 200.

(2) In an inquiry under sub-section (1), the Magistrate may, if

he thinks fit, take evidence of witnesses on oath:

Provided that if it appears to the Magistrate that the offence

complained of is triable exclusively by the Court of Session,

he shall call upon the complainant to produce all his

witnesses and examine them on oath.

(3) If an investigation under sub-section (1) is made by a

person not being a police officer, he shall have for that

investigation all the powers conferred by this Cr.P.C on an

officer in charge of a police station except the power to arrest

without warrant.’

38.A plain but relevant reading of Section 202(1) of the Code indicates

that a Magistrate, on receipt of a complaint of an offence of which he is

authorized to take cognizance, may, if he thinks fit, and shall, in a case

where the accused is residing at a place beyond the area in which he

exercises his jurisdiction, postpone the issue of process against the

accused and either inquire into the case himself or direct an investigation

to be made by a police officer or by such other person as he thinks fit, for

24

the purpose of deciding whether or not there is sufficient ground for

proceeding.

39.At this juncture, we turn to Section 200 of the Code, which provides

as under:

‘200. Examination of complainant.—

A Magistrate taking cognizance of an offence on complaint

shall examine upon oath the complainant and the witnesses

present, if any, and the substance of such examination shall

be reduced to writing and shall be signed by the complainant

and the witnesses, and also by the Magistrate:

Provided that, when the complaint is made in writing, the

Magistrate need not examine the complainant and the

witnesses—

(a) if a public servant acting or purporting to act in the

discharge of his official duties or a Court has made the

complaint; or

(b) if the Magistrate makes over the case for inquiry or

trial to another Magistrate under section 192:

Provided further that if the Magistrate makes over the case to

another Magistrate under section 192 after examining the

complainant and the witnesses, the latter Magistrate need not

re-examine them.’

40.The present case emanates from a complaint by an officer, made in

writing. In terms of Section 200 of the Code, the Magistrate is not

required to examine the complainant and the witnesses, if a public

servant is acting or purporting to act in discharge of his official duty or a

Court has made the complaint. Here, an official complaint was made on

authorisation by the State Government. In this factual setting, Section

25

202 of the Code would necessarily have to be construed harmoniously

with Section 200 of the Code when considering postponement of the

issue of process. Euclidean geometry tells us that the shortest distance

between two points is a straight line. We, therefore, straightaway come to

Cheminova India Limited (supra), relied upon by learned counsel for

the Appellants, and valiantly attempted to be distinguished, factually, by

learned senior counsel for the Respondents. At the cost of repetition, we

re-extract Paragraph 18 thereof:

‘18. The legislature in its wisdom has itself placed the public

servant on a different pedestal, as would be evident from a

perusal of proviso to Section 200 of the Code of Criminal

Procedure. Object of holding an inquiry/investigation before

taking cognizance, in cases where the accused resides

outside the territorial jurisdiction of such Magistrate, is to

ensure that innocents are not harassed unnecessarily. By

virtue of proviso to Section 200 of the Code of Criminal

Procedure, the Magistrate, while taking cognizance, need not

record statement of such public servant, who has filed the

complaint in discharge of his official duty. Further, by virtue of

Section 293 of Code of Criminal Procedure, report of the

Government Scientific Expert is, per se, admissible in

evidence. The Code of Criminal Procedure itself provides for

exemption from examination of such witnesses, when the

complaint is filed by a public servant.’

(emphasis supplied)

40.1 In Cheminova India Limited (supra), a coordinate Bench of this

Court recognised that the Legislature had accorded, to public servants

discharging their duties in their official capacity(ies), a different footing

26

qua when they were complainant(s), vis-a-vis complaints made in private

capacity. As previously noted, Mr. Luthra, learned senior counsel,

stressed upon the factual differences between the position in

Cheminova India Limited (supra) as compared to the instant matter.

Having bestowed thoughtful consideration thereon, we are not inclined to

accept his contentions, in view of the clear enunciation in Cheminova

India Limited (supra). The second question also stands answered in the

Appellants’ favour.

40.2 We may add that we have borne in mind the earlier pronouncement

of another Coordinate Bench in Birla Corporation Limited v Adventz

Investments and Holdings Limited, (2019) 16 SCC 610

7

, referred to by

the High Court, as also the case-law discussed therein. In Birla

Corporation Limited (supra), the complainant was a private person. As

such, no aid therefrom can flow to the Respondents’ advantage.

41.Furthermore, admittedly the accused who actually sold the

medicine to Mr. Joy Mandi was residing within the limits of the local

jurisdiction of the Magistrate concerned. The allegation/prosecution story

also commences with the purchase of the medicines by Mr. Mandi from

such accused seller. We have noted this only to complete the loop.

7

The coram in Birla Corporation Limited (supra) included the learned Judge who authored

Cheminova India Limited (supra).

27

42.We would, however, necessarily add a few words of caution.

Inasmuch as we have held in favour of the Appellants on both points

above, we would emphasise that the same have been examined bearing

in mind the facts and circumstances herein, to the extent called for.

43.As a sequel to the aforesaid, the Impugned Order is set aside, and

the Order taking cognisance and issuing summons dated 10.07.2012 is

held to be good in law. However, due to the efflux of time and the fact

that in this appeal [arising out SLP (Crl.) No.4524/2023], out of the three

respondents, two are juristic entities and the third (i.e., Original

Respondent No.2) having passed away, being the Managing Director,

shall be substituted by the person(s) in charge of running the affairs of

the Respondents-companies, at the relevant point of time. The Court

concerned, upon appropriate application filed by the

Appellants/Prosecution, shall array the said person(s) as accused and

issue fresh summons.

44.In the above terms, this appeal stands allowed.

CRIMINAL APPEAL NO. OF 2026

[ARISING FROM SLP (CRL.) NO._______OF 2026 @ DIARY

NO.18999/2023]

28

45.Delay condoned.

46.Leave granted.

47. This appeal is at the instance of the accused assailing the Final

Judgment and Order dated 14.07.2022 in Crl. M.C. No.2802/2012

passed by the High Court, on the ground that the High Court ought to

have quashed the Summoning Order on the aspect of limitation as well.

48.In view of and for the reasons already stated in the Criminal Appeal

arising from SLP (Crl.) No.4524/2023, the instant appeal stands

dismissed.

CRIMINAL APPEAL NO. OF 2026 [@ SLP (CRL.) NO.8867/2023]

49.Leave granted.

50.This appeal assails the Final Judgment and Order dated

01.07.2021 in Crl. M.C. No.2188/2020 (hereinafter referred to as the

‘Impugned Judgment’) passed by the High Court of Kerala.

29

THE FACTUAL SETUP :

51.The Complainant is an Inspector appointed under Section 21 of the

Act. On, 13.11.2014, the said Drugs Inspector visited the premises of

Community Health Centre, Balussery, Kozhikode, Kerala and drew

samples of 10ml Sterile Hypodermic Single-use Syringe Safe-plus

manufactured by a company in the name of Veekay Surgicals Pvt. Ltd.

One of the portions of the sealed sample and Form 18 were sent to the

Government Analyst, Drugs Testing Laboratory, Thiruvananthapuram,

Kerala as per Section 23(4)(i) of the Act.

52. On 27.01.2016, Government Analyst, Drugs Testing Laboratory,

Thiruvananthapuram in Form 13 declared the above drug as being ‘not

of standard quality’ as it had failed the test of ‘Freedom from Extraneous

matter and Sterility’. Pursuant to subsequent inquiry, on 03.06.2016, the

Managing Director, Kerala Medical Service Corporation Limited,

Thiruvananthapuram, vide Letter of even date, forwarded the

constitutional details of the afore-mentioned accused company to the

Appellants.

30

53. Consequently, Appellant No.1 initiated prosecution against M/s.

Veekay Surgicals Pvt. Ltd., accused No.1 and respondents herein as

Accused Nos.2 and 3, who are Directors in accused No.1, alleging

offence under Section 18(a)(i) of the Act, punishable under Section 27(d)

of the Act, by filing a formal complaint before the Court of the learned

Judicial First Class Magistrate-II, Perambra, Kozhikode on 29.06.2016.

54. Aggrieved, the Respondents herein moved the High Court for

quashing the proceedings and vide the Impugned Judgment, a learned

Single Judge of the High Court quashed the proceedings in C.C.

No.433/2016, on the ground of non-compliance with the provisions of

Section 202(1) of the Code and insufficient compliance with Section 34 of

the Act.

55. Considering the nature of arguments advanced by the learned

counsel on behalf of the parties who assisted this Court, as they relate to

Section 202(1) of the Code, they are not repeated as they have already

been noted/discussed in the Criminal Appeal arising out of/from SLP

(Crl.) No.4524/2023.

56. Our view on the finding recorded by the High Court on Section 34

of the Act is dealt with later.

31

ANALYSIS, REASONING AND CONCLUSION :

57. Admittedly, the Drugs Inspector visited the premises of the

Community Health Centre, Balussery, Kozhikode, Kerala on 13.11.2014

and drew samples of 10ml Sterile Hypodermic Single-use Syringe Safe-

plus which were subsequently sent to the Government Analyst, Drugs

Testing Laboratory. On 27.01.2016, the subject drug was found ‘not of

standard quality’ as it had failed the test of ‘Freedom from Extraneous

matter and Sterility’. Formal complaint was made against the accused for

offences under Section 18(a)(i), being punishable under Section 27(d), of

the Act. Upon being assailed, the High Court quashed the subject

complaint, inter alia, on the grounds of non-compliance with the

mandatory provisions of Section 202(1) of the Code. Be it noted, the

High Court also opined that ‘a mere bald statement in the petition that

they are the persons who are manufacturing the hypodermic syringes

found to be below standard, is not sufficient compliance of Section 34 of

the Act.’

58. As the primary challenge in the instant appeal was with regard to

Section 202(1) of the Code, the said point has already been answered in

32

the above-mentioned Criminal Appeal arising out of SLP(Crl.) No.4524 of

2023 in favour of the concerned Appellants, to which we add no more.

59. On the aspect of Section 34 of the Act, we are of the opinion that

the High Court’s view per se was premature. The Respondents-Directors

were in the accused-Company’s management. Whether or not, they were

‘in charge of’ and ‘responsible to the company for the conduct of the

business of the company’ are questions of fact. To our mind, bearing in

mind a holistic conspectus of the case, these questions are best left to

be determined by the Trial Court, at the appropriate stage. Accordingly,

the instant appeal also stands allowed by setting aside the Impugned

Judgment.

OBSERVATION QUA ALL THE AFORESAID APPEALS :

60. The discussions hereinabove are purely for the purposes of

deciding the questions raised in this set of appeals. Nothing therein shall

be construed as a final adjudication/findings on the merits of the

underlying Complaint Case(s) and will not prejudice any party. Parties

are at liberty to other issues of fact and law at trial at the appropriate

stage. Since the date/s for entering appearance have already elapsed in

all the matters, the Court(s) concerned shall issue fresh summons to all

33

accused. Thereafter, the matter shall be proceeded with, strictly in

accordance with law. We propose no order as to costs.

...………………..................…..J.

[AHSANUDDIN AMANULLAH]

...………………..................…..J.

[S.V.N. BHATTI]

NEW DELHI

FEBRUARY 26, 2026

34

Description

Supreme Court Clarifies Mandates for Drugs and Cosmetics Act Offences and Section 202 CrPC Inquiry

In a significant ruling, the Supreme Court of India has provided crucial clarifications regarding the procedural mandates for prosecuting Drugs and Cosmetics Act offences and the applicability of a Section 202 CrPC inquiry, particularly when the complainant is a public servant. This judgment, State of Kerala & Anr. v. M/s. Panacea Biotec Ltd. & Anr., along with other related appeals, solidifies existing legal positions and streamlines the judicial process for such cases. These pivotal rulings are now readily available on CaseOn, offering legal professionals and students comprehensive insights into their implications.

The Court addressed appeals concerning the quashing of criminal complaints by the High Court of Kerala, primarily on grounds of limitation and the requirement for a mandatory inquiry under Section 202 of the Code of Criminal Procedure, 1973 (CrPC).

Factual Background of the Panacea Biotec Case

The primary case involved allegations of misbranding against M/s. Panacea Biotec Ltd. A complaint was initially lodged in 2005 by an individual regarding a discrepancy between a drug's outer carton label (Easy Five pentavalent vaccine) and its inner vial label (Tetravalent Easy Four). Following an inquiry, the Drugs Inspector, a public servant, filed a formal complaint with the Chief Judicial Magistrate (CJM) in 2009 for offences under Sections 18(a)(i) read with 17(b) and 17(c) of the Drugs & Cosmetics Act, 1940, punishable under Section 27(d).

The CJM summoned the respondents, but this order was challenged before the High Court, which eventually quashed the complaint. The High Court's reasoning was two-fold: first, the accused resided beyond the CJM's territorial jurisdiction, necessitating a mandatory inquiry under Section 202 CrPC, which was not conducted; and second, while it acknowledged the CJM's condonation of delay, it implicitly raised questions on limitation.

IRAC Analysis of the Supreme Court's Ruling

Issue 1: Limitation Period for Cognizance

Rule: Sections 468, 469, and 473 of the CrPC govern the limitation period for taking cognizance of offences. Section 468(2)(c) stipulates a three-year limitation for offences punishable with imprisonment exceeding one year but not exceeding three years. Section 469(1)(c) clarifies that the period commences from the date the identity of the offender is known to the aggrieved person or the investigating police officer. Section 473 allows for condonation of delay if properly explained or in the interests of justice.

Analysis: The offence under Section 27(d) of the Drugs & Cosmetics Act, with a punishment of 1 to 2 years imprisonment, falls under the three-year limitation period. The Supreme Court found that while the initial complaint was in 2006, the identity of all accused was fully established only on April 18, 2006, after a verification process. The formal complaint was filed on January 20, 2009, which falls within the three-year period from the date the offenders' identities were known. The Court thus concluded that the limitation bar did not apply, correcting the High Court's earlier computation that started the period from an incorrect date.

Issue 2: Mandatory Inquiry under Section 202 CrPC for Accused Residing Beyond Jurisdiction

Rule: Section 202(1) of the CrPC mandates a Magistrate to postpone the issue of process and conduct an inquiry or direct an investigation when the accused resides beyond their territorial jurisdiction, to ascertain sufficient grounds for proceeding. However, Section 200 CrPC provides an exemption, stating that a Magistrate need not examine a complainant on oath if the complaint is made by a public servant acting in discharge of official duties. The Court referenced Cheminova India Limited v. State of Punjab, 2021 SCC OnLine SC 573, which placed public servants on a different pedestal in this context.

Analysis: The Supreme Court emphasized a harmonious construction of Sections 200 and 202 CrPC. It reiterated that the object of a Section 202 inquiry is to prevent unnecessary harassment of innocent individuals. When a complaint is filed by a public servant, such as a Drugs Inspector, in their official capacity, who has already conducted an inquiry as part of their duties, the rationale for a further mandatory inquiry under Section 202 is attenuated. The Court highlighted that public servants, by virtue of their official duties and the reliability of their reports (e.g., Government Scientific Expert reports being *per se* admissible under Section 293 CrPC), stand on a different footing than private complainants. The Court distinguished this case from Birla Corporation Limited v Adventz Investments and Holdings Limited, (2019) 16 SCC 610, noting that the latter involved a private complainant. The Supreme Court effectively ruled that the High Court erred in strictly enforcing the Section 202 inquiry mandate given the public servant complainant.

While analyzing these complex legal points, legal professionals often benefit from tools that distill information quickly. CaseOn.in offers 2-minute audio briefs that provide concise summaries and key takeaways from such intricate rulings, enabling lawyers and students to grasp the essence of judgments like this one on Drugs and Cosmetics Act offences and Section 202 CrPC inquiry without sifting through extensive texts.

Issue 3: Vicarious Liability under Section 34 of the Drugs & Cosmetics Act

Rule: Section 34 of the Drugs & Cosmetics Act stipulates that when an offence is committed by a company, every person who, at the time of the offence, was in charge of and responsible to the company for the conduct of its business, shall also be deemed guilty and liable for punishment.

Analysis: In a related appeal (SLP (Crl.) No.8867 of 2023), the High Court had quashed proceedings against directors, stating that a 'mere bald statement' of their involvement was insufficient for vicarious liability under Section 34. The Supreme Court found this view premature. It clarified that whether individuals were 'in charge of' and 'responsible to' the company's business are questions of fact that must be determined by the Trial Court based on evidence presented during the trial. The High Court's intervention at this initial stage was therefore unwarranted.

Conclusion and Implications

The Supreme Court allowed the appeals, setting aside the High Court's orders that had quashed the criminal complaints. It upheld the CJM's orders taking cognizance and issuing summons. For cases where an accused director had passed away, the Court directed the substitution of such individuals with the person(s) in charge of the company's affairs at the relevant time, upon appropriate application. The matters are to proceed in accordance with law, with fresh summons issued as needed.

Why This Judgment is Important for Lawyers and Students

This Supreme Court judgment is a vital read for legal practitioners and students for several reasons:

  • Clarification on Limitation: It offers definitive guidance on how the limitation period under CrPC Sections 468 and 469 should be computed, especially when the identity of the offender is established post-initial complaint through investigation.
  • Role of Public Servants in Criminal Complaints: The ruling reinforces the 'different pedestal' accorded to public servants as complainants, reducing the procedural burden of a mandatory Section 202 CrPC inquiry when they act in an official capacity. This is critical for prosecutions involving regulatory bodies.
  • Vicarious Liability: It clarifies the stage at which vicarious liability under Section 34 of the Drugs & Cosmetics Act should be determined, preventing premature quashing of proceedings against company directors. This emphasizes that these are factual determinations for the trial court.
  • Procedural Efficiency: The judgment contributes to judicial efficiency by streamlining the process for regulatory offences, ensuring that meritorious complaints by public authorities are not dismissed on technical procedural grounds prematurely.
  • Harmonious Construction: It demonstrates the principle of harmonious construction of statutory provisions (Sections 200 and 202 CrPC) to achieve legislative intent while preventing misuse.

Disclaimer

All information provided in this article is for informational purposes only and does not constitute legal advice. Readers are advised to consult with a qualified legal professional for advice on specific legal issues.

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