HIGH COURT OF JAMMU & KASHMIR AND LADAKH

AT JAMMU

CRMC No. 364/2016 c/w

CRMC No. 15/2017

CRM(M) No. 223/2022

Reserved on: 31.07.2026

Pronounced on: 11.08.2026

Uploaded on: 11.08.2026

CRMC No. 364/2016

1. M/S Simran Pharmaceuticals,

Ward No. 3, Indira Colony,

Near Dreamland School, Janipur,

Jammu,

Through its Competent Person, namely,

Rajinder Singh age 42 years,

S/o Sh. Parmod Singh

2. M/S Sunil Medicates,

Ramsharnam Colony,

Dalhousie Road, Pathankot, Punjab,

Through its competent person namely

Sunil Thakur, Age 40 years,

S/o Sh. Kartar Singh

…..Petitioner(s)

Through: Mr. Sachin Gupta, Advocate

Mr. Varut Kumar Gupta, Advocate

Vs.

1. State of Jammu and Kashmir

Through Drugs Inspector, Doda, H.Q. C/o

Office of the Deputy Controller, Drugs and

Food Control Organisation, Jammu

Division.

Through:

.…. Respondent(s)

Mr. Raman Sharma, AAG with

Ms. Saliqa Sheikh, Advocate

Sr. No. 162

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CRMC No. 15/2017

1. Affine Formulations Pvt. Ltd.

1947/3, Village Bhatia, Tehsil Nalagarh

District Solan, Himachal Pradesh.

Through its Director Namely,

Pradhyuman Nyati, Age 34 years

S/o Sh. Mohan Lal Nyati.

Through:

Vs.

1. Stage of Jammu and Kashmir

Through Drugs Inspector, Doda. H.Q.

C/o Office of Deputy Controller,

Drugs and Food Control Organization,

Muthi, Jammu, J&K

2. Government Analyst Doda,

C/o Office of Controller,

Drugs and Food Control Organization,

Patoli Mangotria, Jammu, J&K

Through:

CRM(M) No. 223/2022

1. Veena Rani, Age-75 Years,

W/o Late Wazir Chand,

House No. 1047, Sector 6

Karnal Rural Part 1, Haryana, India,

Proprietor Luv Kush Drug House,

Shop No. 10, Phoosgarh Road,

Karnal

Through:

Vs.

…..Petitioner(s)

Mr. Sachin Gupta, Advocate

Mr. Varut Kumar Gupta, Advocate

.…. Respondent(s)

Mr. Raman Sharma, AAG with

Ms. Saliqa Sheikh, Advocate

…..Petitioner(s)

Mr. Sachin Gupta, Advocate

Mr. Varut Kumar Gupta, Advocate

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1. Union Territory of Jammu and Kashmir,

Through Drugs Inspector Doda, H.Q.

C/o Office of Deputy Controller,

Drugs and Food Control Organization,

Jammu Division.

2. Government Analyst Doda,

Combined Food and Drugs Laboratory,

Controller Drugs J&K,

Drugs and Food Control Organization,

Patoli Mangotria, Jammu.

.…. Respondent(s)

Through:

Mr. Raman Sharma, AAG with

Ms. Saliqa Sheikh, Advocate

CORAM: HON’BLE MR. JUSTICE SANJAY PARIHAR, JUDGE

JUDGEMENT

1. Petitioners herein are aggrieved of the proceedings pending against them for

the alleged commission of offences punishable under Section 18 (a) (i) read

with Section 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred

to as “the Act”), arising out of an incident dated 04.01.2014, when the

complainant-Drug Inspector lifted samples of various drugs from the premises

of M/s Lucky Medical Hall, Doda (A-1) including “Macnim Plus Tablets”,

bearing Batch No. 13329, manufactured in 05/2013 and having expiry date of

04/2015. The said sample was subsequently reported to be not of standard

quality on the ground that it had failed the disintegration test.

2. That CRMC No. 364/2016 has been preferred by the petitioners, namely, M/s

Simran Pharmaceuticals, Janipur, Jammu, and M/s Sunil Medicates Dalhousie

Road, Pathankot, Punjab, who are alleged to be the stockiest/distributors of the

aforesaid drug. CRMC No. 15/2017 has been preferred by M/s Affine

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Formulations Pvt. Ltd., the manufacturer of the drug, whereas the third

petition-CRM(M) No. 223/2022, has been preferred by M/s Luv Kush Drug

House, Karnal also a dealer, through its proprietor.

3. A common and substantial question of law arising for consideration in all the

aforesaid petitions is whether the complainant-Drug Inspector was duly

empowered under the provisions of the Act to draw and have the subject

sample analysed for the purpose of launching prosecution under Section 27(d)

of the Act. It is the specific case of the petitioners that the Drug Inspector was

not competent/empowered to deal with the said sample in the manner in which

it was done. It is further contended that the Public Analyst, who furnished the

report declaring the drug to be not of standard quality, was likewise not

competent/empowered under the statutory scheme to undertake the analysis of

the drug in question, which falls within Schedule C of the Act.

4. It is further the specific case of the petitioners that they have been deprived of

their valuable statutory right and opportunity to have the subject sample

retested/reanalysed in accordance with law. No portion of the sample was ever

forwarded or made available to the manufacturer for the purpose of seeking a

retest/reanalysis. Consequently, by the time the petitioners came to know of the

alleged contravention and the prosecution was initiated, the petitioners were

effectively denied the opportunity contemplated under Section 25(3) of the

Drugs and Cosmetics Act, 1940. Such deprivation has caused serious prejudice

to the petitioners and vitiates the continuation of the prosecution against them.

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5. Per contra, it is the case of the respondents that, at the time of drawing the

sample from the spot, four portions of the sample were prepared. One portion

was handed over to the retailer from whose premises the sample was drawn,

while another portion was transmitted to the Public Analyst for analysis. The

third portion was personally handed over to accused No. 2, namely, M/s Simran

Pharmaceuticals Pvt. Ltd., Janipur, Jammu, on 28.02.2014, with a request to

furnish the particulars/name of the manufacturer from whom the drug in

question had been procured. It is, thus, contended that the statutory requirement

contemplated under Section 18-A of the Act stood duly complied with.

6. That the respondents further contend that none of the petitioners, at the relevant

stage, availed of or sought to invoke the statutory remedy for

retesting/reanalysis of the subject sample. It is submitted that the manufacturer,

vide communication dated 28.04.2014, acknowledged having received the

report of the Public Analyst from the complainant-Drug Inspector; however,

the said communication does not contain even a reference to any intention on

the part of the manufacturer to challenge or controvert the report by seeking

retesting/reanalysis of the sample. According to the respondents, the

petitioners, having failed to exercise the remedy available to them within the

prescribed period, cannot now contend that they were deprived of an

opportunity to have the sample retested. Placing reliance upon Section 25(3) of

the Act, the counsel appearing for the respondents submits that the report of the

Public Analyst attains finality and becomes conclusive unless the person from

whom the sample was taken, or the person to whom the information under

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Section 18-A is furnished, communicates, within a period of twenty-eight days

from the date of receipt of the copy of the report, his intention to adduce

evidence contrary of the report or to have the sample reanalysed/retested. It is,

therefore, contended that, in the absence of any such request or expression of

intention on the part of the petitioners within the prescribed period, the report

of the Public Analyst became conclusive in terms of the statutory scheme. With

reference to Section 25(4) of the Act, the counsel for the respondents further

submits that the onus was upon the petitioners to take appropriate steps for re-

examination/reanalysis of the sample and that, having consciously failed to

avail the remedy available under the Act, they cannot subsequently seek to

assail the prosecution on the ground that such opportunity was not afforded to

them.

7. That learned counsel for the respondents has further relied upon SRO 137 dated

28.03.2013 to contend that the Drug Inspector, Doda, was duly authorised and

competent to draw samples from the premises in question. It is further

submitted that the report furnished by the Public Analyst was prepared in

accordance with the applicable Standard Operating Procedure (SOP) prescribed

by the Drugs and Cosmetics Department and, therefore, the same cannot be

discarded at this stage merely on the basis of the allegations raised by the

petitioners.

8. That, as regards the objections raised by the petitioners concerning the manner

and procedure adopted in conducting the analysis, learned counsel for the

respondents submits that such issues involve disputed questions of fact which

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cannot appropriately be adjudicated in proceedings seeking quashing of the

complaint/prosecution. According to the respondents, any challenge to the

correctness of the analytical process or the findings recorded by the Public

Analyst would be a matter for evidence and could appropriately be tested by

subjecting the Public Analyst to cross-examination during trial, rather than

being determined in the present proceedings.

9. In rebuttal to the submissions advanced on behalf of the respondents, the

counsel for the petitioners, placing reliance upon the judgment rendered by a

Coordinate Bench of this Court in August Remedies, Village Ogli, Nahan Road

v. State of J&K and others, in CRMC No. 402/2013, has contended that non-

supply/non-forwarding of the requisite portion of the sample to the

manufacturer has resulted in denial of a valuable statutory right available to the

petitioners under the Act. It is argued that the manufacturer was thereby

deprived of an effective opportunity to have the sample reanalyzed/retested and

to controvert the report of the Public Analyst. According to learned counsel,

such denial has caused manifest prejudice to the petitioners and, therefore, the

continuation of the criminal proceedings against them is legally unsustainable

and liable to be quashed. Besides, the petitioners have further placed reliance

upon the judgment rendered by a Coordinate Bench of this Court in Neena

Gupta v. UT of Ladakh, and submitted that other petitioners had dealt with the

drug in question in the ordinary course of their respective businesses as retailer,

stockiest, wholesaler and distributor, through duly licensed premises. It is

contended that there is neither any allegation nor any material on record to

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suggest that the prescribed storage conditions in respect of the drug were

violated or compromised at any stage while the drug remained in the custody of

the petitioners. It is further submitted that no contrary evidence has been

brought on record by the prosecution to establish any deviation from the

prescribed conditions of storage. In such circumstances, according to learned

counsel, fastening criminal liability upon the retailer, stockiest, wholesaler and

distributor, in the absence of any specific allegation or material indicating their

culpable conduct, is without legal foundation and the prosecution against them

deserves to be quashed.

10. Heard learned counsel for the parties at length and perused the record. From a

perusal of the complaint, it emerges that on 04.01.2014, the complainant-Drug

Inspector purchased the drug in question from the premises of accused No. 1,

namely, M/s Lucky Medical Hall, Doda, and drew the requisite sample. The

sample was divided into four portions, each of which was duly packed and

sealed in accordance with the prescribed procedure. One portion was handed

over to accused No. 1, whereas another portion was forwarded to the

Government Analyst under Form No. 18 dated 04.01.2014 for analysis. The

report of the Government Analyst was received by the complainant on

29.01.2014, whereby the subject drug was declared to be “Not of Standard

Quality” on the ground that the sample had failed the disintegration test.

11. Upon receipt of the aforesaid report, the complainant conveyed the result to

accused No. 1 and called upon him to furnish the particulars of the

dealer/manufacturer from whom the drug in question had been procured.

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Pursuant thereto, accused No. 1 disclosed the particulars of accused No. 2,

namely, M/s Simran Pharmaceuticals, Ward No. 3, Janipur, Jammu, from

whom the stock had allegedly been purchased. According to the complainant, a

copy of the test report was supplied to accused No. 2 and the third portion of

the sample was also personally handed over to accused No. 2 on 28.02.2014.

12. During the course of further proceedings, accused No. 2 informed the

complainant that the drug in question had been supplied to it by M/s Sunil

Medicates, stated to be the wholesaler, who was, in turn, called upon to furnish

the particulars of the manufacturer/supplier from whom the drug had been

procured. M/s Sunil Medicates disclosed that the drug had been supplied by

M/s Luv Kush Drug House, Karnal, arrayed as accused No. 4. On the basis of

the information so furnished, the particulars of accused No. 5, namely, M/s

Sian Biotech, the authorised distributor, came to be disclosed. The said concern

was also apprised of the analytical report and the proceedings initiated in

respect of the drug in question.

13. Thereafter, the manufacturer, arrayed as accused No. 6, was informed by the

complainant regarding the failure of the subject drug in the prescribed test. The

record further discloses that, vide communication dated 28.04.2014, the

manufacturer responded to the Drug Inspector and furnished the particulars of

the distribution channel, stating that the drug had been supplied through

accused No. 5, M/s Sian Biotech, Chandigarh, which was its authorised

distributor. The manufacturer asserted that the drug conformed to the

prescribed standards under the Indian Pharmacopoeia (IP). At the same time,

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the manufacturer sought consideration of the disintegration test result and

offered an explanation with regard to the possible behavior of the tablet in the

presence of the excipients, suggesting that the tablet might swell after a longer

period during the disintegration process. The manufacturer, accordingly,

appears to have instructed its distributor to recall the product in question.

14. It is further borne out from the record that, according to the complainant, none

of the accused approached the Drug Inspector for reanalysis or retesting of the

subject sample. The complainant thereafter took up the matter with the Drugs

Controller, who, in turn, directed the complainant to initiate prosecution against

the manufacturer and the other persons allegedly connected with the

distribution and sale of the drug in question. It is in the aforesaid backdrop that

the complaint came to be instituted and the proceedings against the petitioners

were set in motion.

15. Before proceeding further, it would be apposite to notice the judgment rendered

by a coordinate bench of this Court in CRMC No. 402/2013, wherein, relying

upon the judgment of the Hon’ble Supreme Court reported as (2018) 15 SCC, it

was held that where the manufacturer was not supplied with the requisite

portion of the sample of the seized drug and, in addition thereto, there was an

unexplained delay on the part of the Court in taking cognizance of the

complaint, such circumstances, which were not attributable to the

manufacturer, could not operate to his prejudice. The Court observed that the

manufacturer and the stockiest possessed a valuable statutory right to seek

reanalysis of the sample and that denial of such right, on account of

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circumstances beyond their control, would materially prejudice their defence.

In the aforesaid circumstances, the proceedings were held liable to be quashed.

16. In the said case, this court had noticed that the report of the Government

Analyst had been submitted, whereas the same was communicated to the

manufacturer after a lapse of approximately five months. By that time, the shelf

life of the drug had already expired, thereby rendering the statutory remedy of

reanalysis/retesting practically unavailable. The manufacturer had also

specifically pleaded that the report of the Government Analyst had never been

served upon it and that it had acquired knowledge of the same only upon

receipt of the summons issued by the Court. Taking into consideration the

aforesaid circumstances, particularly the expiry of the shelf life of the drug and

the consequent frustration of the manufacturer's statutory right to seek

reanalysis, the coordinate bench proceeded to quash the criminal proceedings.

17. However, the legal position governing the right contemplated under Section 25

of the Act also came to be considered by the Hon’ble Supreme Court in State of

Haryana v. Brij Lal Mittal and others, (1998) 5 SCC 343. In that case, the

sample was reported to be not of standard quality and the drug was also alleged

to be misbranded/adulterated. The complainant-Drug Inspector had supplied

the report of the Government Analyst to the retailer, who disclosed the

particulars of the distributor, namely, M/s Ajay Medical Agencies, and the

manufacturer, M/s Mitson Pharmaceutical Pvt. Ltd. The High Court quashed

the proceedings, inter alia, on the ground that the complaint had been instituted

after expiry of the shelf life of the drug, thereby depriving the manufacturer of

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the opportunity contemplated under Section 25(4) of the Act to have the sample

reanalysed by the Central Drugs Laboratory.

18. The Hon’ble Supreme Court, while examining the statutory scheme, noticed

that Section 25(3) of the Act requires the person from whom the sample was

taken, or the person to whom the report was furnished under Section 18A, to

notify the Inspector or the Court, in writing, within twenty-eight days of receipt

of the copy of the Government Analyst’s report, of his intention to adduce

evidence in controversial of the report. The Court found that the manufacturer

in that case had admittedly received the report of the Government Analyst on

19.02.1991, but had failed to communicate, within the prescribed period of

twenty-eight days, its intention to controvert the report or to have the sample

reanalyzed. Instead, the manufacturer had chosen to subject the drug to its own

internal testing. In those circumstances, the report of the Government Analyst

had attained the status of conclusive evidence in terms of Section 25(3) of the

Act.

19. The Hon’ble Supreme Court, therefore, held that merely because the shelf life

of the drug had expired or there had been some delay in instituting the

complaint, the prosecution could not, by itself, be quashed when the accused

had failed to exercise the statutory right available to them within the period

prescribed under Section 25(3) of the Act. The judgment thus makes it clear

that the question whether the accused was effectively deprived of the statutory

right of reanalysis has to be examined in the context of the facts of each case,

including the date of receipt of the Government Analyst’s report, the

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opportunity available to the accused to exercise the right under Section 25(3),

and the circumstances resulting in the sample becoming unavailable for

reanalysis.

20. In Amery Pharmaceuticals v. State of Rajasthan, 2001 (4) SCC 382, the retailer

had disclosed the particulars of the distributor, through whom the identity of

the manufacturer became known to the complainant. The manufacturer claimed

before the learned Magistrate that it was entitled to be discharged on the ground

that it had not been supplied with the sample and, consequently, had been

deprived of its right to contest the complainant’s case. The Hon’ble Supreme

Court held that even where the manufacturer is not initially supplied with a

copy of the report or a portion of the sample, it is not left remediless and retains

the liberty to challenge the correctness of the report by taking recourse to

Section 25(4) of the Drugs and Cosmetics Act. The Apex Court further

observed that acquitting a manufacturer of adulterated drugs merely on a

technical ground would be contrary to the legislative intent. In that case, the

appellant had alleged non-compliance with Section 23(4) on the ground that the

Drug Inspector had failed to send a portion of the sample to the manufacturer.

21. In the said case, although the Sessions Judge deleted the charge relating to the

manufacture of spurious drugs, the remaining charges, including those relating

to misbranding and adulteration, were upheld. The High Court dismissed the

petition preferred by the manufacturer, which led the manufacturer to approach

the Hon’ble Supreme Court. It was in that factual background that the Apex

Court laid down the aforesaid principle.

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22. In Medicamen Biotech Ltd. v. Rubina Bose, 2008 (7) SCC 196, the laboratory

reported that the drug sample seized did not conform to the prescribed

standards. Upon receiving the information, the manufacturer conducted in-

house tests and also obtained an analysis report from another approved

laboratory, both of which confirmed that the drug conformed to the prescribed

standards. The appellant-manufacturer communicated to the Drug Inspector its

intention to contest the findings of the Government Analyst. However, the

Drug Inspector failed to facilitate retesting of the sample and proceeded to file

the complaint.

23. The Hon’ble Supreme Court held, in the facts and circumstances of that case,

that the manufacturer had correctly and timely exercised its statutory right

under Section 25 of the Drugs and Cosmetics Act by indicating its intention to

dispute the Government Analyst’s report. The Drug Inspector, therefore, was

under a mandatory legal obligation to forward the sample for retesting to the

Central Drugs Laboratory. Since the manufacturer had demonstrated its

intention to contest the Government Analyst’s report, the failure of the Drug

Inspector to facilitate such retesting deprived the manufacturer of its valuable

statutory right to a fair defence. The continuation of the criminal proceedings in

those circumstances was consequently held to constitute an abuse of the

process of law.

24. In GlaxoSmithKline Pharmaceutical Ltd. v. State of Madhya Pradesh, Criminal

Appeal No. 1489 of 2011, decided on 28.07.2011, the Government Analyst

reported that the sample was not of standard quality on account of “analytical

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difficulties”. A show-cause notice was thereafter issued to the manufacturer,

which replied that the sample ought to have been tested and analysed with

reference to the Indian Pharmacopoeia (I.P.), 1996, instead of the I.P., 1985.

Criminal proceedings were subsequently initiated and cognizance was taken.

The manufacturer thereafter moved an application before the Chief Judicial

Magistrate under Section 25(3) of the Drugs and Cosmetics Act, seeking that

the sample be sent to the Central Drugs Laboratory for analysis. The

application was rejected, and the High Court also dismissed the challenge

thereto. When the matter reached the Hon’ble Supreme Court, it was held that

Section 25(3) confers upon the manufacturer a statutory right to challenge or

controvert the report of the Government Analyst. However, the Court found

that the manufacturer had failed to notify the concerned authorities within 28

days of its intention to adduce evidence in contravention of the report. Mere

technical objections regarding the methodology adopted for testing, or a request

that the proceedings be closed, were held not to satisfy the mandatory statutory

requirement. Relying upon State of Haryana v. Brijlal Mittal and Others, the

Hon’ble Supreme Court reaffirmed that the right to have the sample tested by

the Central Drugs Laboratory accrues only when the accused complies with the

requirement of Section 25(3) within the prescribed period of 28 days. Since the

manufacturer had itself failed to exercise the statutory right within the

prescribed period, there was no justification for interfering with the orders of

the courts below rejecting its application for retesting. The Court further held

that, once the accused fails to exercise the statutory right under Section 25(3)

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within the prescribed period, any delay on the part of the State in filing the

criminal complaint or instituting the prosecution becomes irrelevant and

immaterial.

25. Having regard to the aforesaid legal precedents, this Court now proceeds to

examine the case of the petitioners. A reading of the complaint reveals that,

since the samples were not lifted from the distributor but from the premises of

accused No. 1, namely, the retailer, the Drug Inspector was required to draw

four portions of the sample, which he admittedly did. Out of the four samples,

one was handed over to accused No. 1; the second, as admitted by the parties,

was forwarded to the Government Analyst, who submitted his report; and the

third sample, as specifically stated in the complaint, was handed over to M/s

Simran Pharmaceuticals, the petitioner in CRMC No. 364/2016.

26. The fourth sample, in terms of the statutory scheme, was required to be

produced before the Court in which the complaint was filed. The sole grievance

projected by the petitioners is that the manufacturer was not supplied with a

portion of the sample. The drug in question was admittedly manufactured by

M/s Affine Formulations and supplied to accused No. 5, M/s Sian Biotech, its

distributor, from whom the drug travelled through the subsequent stages of the

distribution chain, namely, the stockist, wholesaler and, ultimately, the retailer.

27. Section 23(4) of the Act categorically provides that, after the samples are taken,

one portion thereof shall be delivered to the person, if any, whose name,

address and other particulars have been disclosed under Section 18-A. In the

present case, the sample was lifted from accused No. 1, M/s Lucky Medical

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Hall, Doda, which was the retailer to whom the drug had been supplied by

accused No. 2, M/s Simran Pharmaceuticals, the petitioner herein.

Significantly, paragraph 8 of the complaint specifically records that the third

portion of the sample was personally handed over by the complainant to

accused No. 2, thereby complying with the requirement of Section 18(a).

28. Merely because the manufacturer was not directly supplied with a portion of

the sample would not, in the facts of the present case, render the procedure

adopted by the Drug Inspector illegal or contrary to the statutory scheme. This

is also borne out from the communication addressed by the manufacturer to the

complainant on 28.04.2014. There is not even a whisper in the said

communication that the manufacturer intended to have the sample retested or

proposed to exercise its statutory right under Section 25(3) of the Act. Rather,

the manufacturer sought to contend that the disintegration test may not be

applicable to it, suggesting that there could have been some lapse on the part of

the retailer or any other licensee in whose possession the drug had remained.

The manufacturer further requested the Drug Inspector to treat the

disintegration test of Macnim Plus Tablets as having complied with the

prescribed standards, contending that there had been instances where tablets

had exhibited swelling only after a longer period following the testing process.

Thus, the substance of the manufacturer's response was essentially to attribute

the failure in the disintegration test to the manner in which the drug may have

been stored or handled by the distributor, stockist, wholesaler, retailer or any

other person in the distribution chain.

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29. The manufacturer, therefore, nowhere expressed any intention to have the

sample retested or to adduce evidence in contrary of the Government Analyst's

report. Learned counsel for the petitioners has laid considerable emphasis on

the contention that, out of the four portions of the sample, one portion was

mandatorily required to be supplied to the manufacturer. Such an argument

could have some force where the sample itself had been drawn from the

premises or possession of the manufacturer. In such a case, the statutory

procedure would require one portion of the sample to be delivered to the person

from whose possession the sample was taken.

30. However, where the sample is drawn from a retailer or any other person in the

distribution chain, the Drug Inspector is required to comply with the mandate

of Section 18A by obtaining and recording the particulars of the person from

whom the drug was received and by supplying the requisite portion of the

sample to such person whose particulars have been disclosed in accordance

with the statutory requirement. Once the complainant had admittedly delivered

the third portion of the sample to accused No. 2, M/s Simran Pharmaceuticals, a

fact which has not been disputed in the present petitions, the other petitioners

cannot derive any benefit under Section 25(3) merely by contending that the

manufacturer was not directly supplied with a portion of the sample. The

statutory right under Section 25(3) becomes available to the manufacturer upon

it expressing an intention, within the prescribed period of 28 days, to adduce

evidence in contravention of the report of the Government Analyst. In the

present case, no such intention was expressed by the manufacturer within the

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statutory period. Consequently, the petitioners cannot seek to invalidate the

proceedings merely on the ground that a portion of the sample was not directly

supplied to the manufacturer.

31. I now proceed to examine the contention that the complainant did not possess

the requisite authority to inspect the premises and draw the sample. The said

contention is wholly contrary to the statutory position and the mandate of SRO

137. It has also been argued that the Public Analyst was not competent or

authorised to analyse the drug in question as the same falls within Schedule C.

This contention, however, requires consideration in the light of the relevant

statutory provisions and the evidence to be led by the complainant.

32. The report submitted by the Public Analyst on 29.01.2014 records that the

sample had failed the disintegration test as per I.P. 2010. Whether the Public

Analyst possessed the requisite authority to conduct such analysis and whether

the test was carried out in accordance with the applicable standards are matters

which would require factual determination. Such questions can appropriately be

examined after the Public Analyst is produced and examined by the

complainant during trial. Section 25(3) provides that the report of the

Government Analyst shall be conclusive evidence of the facts stated therein

unless the person concerned, within the prescribed period of 28 days, notifies

the concerned authority of his intention to adduce evidence in contravention of

the report. Thus, where no such intention is expressed within the statutory

period by the manufacturer, distributor or any other person concerned, the

report acquires the character of conclusive evidence, subject to the statutory

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remedy available under Section 25(4). Such remedy can be invoked by

approaching the Court for an order directing that the sample be sent to the

Central Drugs Laboratory for analysis, and the report of the Central Drugs

Laboratory would thereafter prevail in accordance with law.

33. In the present case, the petitioners have failed to demonstrate that, at any stage,

they expressed an intention to avail themselves of the statutory remedy

contemplated under Section 25(3) or Section 25(4), as the case may be, for

having the sample retested. Reliance placed upon the judgment of a learned

Single Judge of this Court in August Remedies v. State of J&K and Others,

passed by a Coordinate Bench, is wholly misplaced. The said judgment was

rendered in the peculiar facts and circumstances of that case. There, the

manufacturer had not received the report of the Government Analyst and,

specifically, claimed that it had received the report for the first time along with

the summons issued by the Court. It was in that factual background that the

Court concluded that the manufacturer had been deprived of its valuable right

to adduce evidence contrary of report. The Court also found that the

complainant had failed to supply a portion of the sample to the manufacturer so

as to enable it to seek retesting.

34. The factual position in the present case is entirely different. Neither the

manufacturer nor the distributor, nor any of the other petitioners, ever

expressed an intention to have the sample retested. Even accused No. 2, who, in

terms of Section 18-A, had admittedly been supplied with the third portion of

the sample by the complainant, chose not to seek retesting. Thus, none of the

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petitioners raised any timely objection to the report of the Public Analyst by

invoking the statutory mechanism provided under the Act.

35. So far as the manufacturer is concerned, its reply, already referred to

hereinabove, was essentially an attempt to explain away or dispute the findings

recorded by the Public Analyst without demonstrating any tangible or

unequivocal intention to controvert the report by adducing evidence to the

contrary. On the contrary, the manufacturer proceeded to recall the existing

stock of Macnim Plus Tablets. Such conduct, at least prima facie, indicates that

even the manufacturer was conscious of the adverse report and had proceeded

on the basis that the sample had failed to satisfy the prescribed standards. As

held by the Hon’ble Supreme Court in Criminal Appeal No. 1489 of 2011

(supra), failure to notify the intention to controvert the report of the

Government Analyst, coupled with merely raising technical objections

regarding the methodology adopted for testing, does not fulfil the mandatory

statutory requirement of expressing an intention to adduce evidence in

contravention of the report.

36. Having regard to the peculiar facts of the present case, the complainant was not

under a legal obligation to directly supply one of the portions of the sample to

the manufacturer. The statutory requirement under Section 18-A, stood duly

complied with when the requisite portion of the sample was supplied to the

person whose particulars had been disclosed in the distribution chain. In the

present case, the complainant had supplied the sample not only to the retailer

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but also to the distributor/wholesaler in accordance with the statutory

procedure.

37. There is yet another aspect of the matter which assumes significance.

According to the averments made in the complaint, on 07.04.2014, M/s Sian

Biotech, the distributor, informed the complainant of the particulars of the

manufacturer. This prompted the complainant to issue a communication dated

05.05.2014 to the manufacturer, requiring it to furnish the details concerning

the drug in question as well as the constitution of the firm. However, the

manufacturer, in its communication dated 28.04.2014 addressed to the Drug

Inspector, referred to a letter dated 19.05.2014 allegedly received from the

complainant. The chronology of these communications, as emerging from the

material placed on record, indicates that the manufacturer had already acquired

knowledge regarding the failure of the sample before the complainant formally

approached it for the particulars of the manufacturer. Significantly, even before

such communication from the complainant, the manufacturer had directed its

distributor, M/s Sian Biotech, to recall the remaining stock of approximately

2,000 boxes of Macnim Plus Tablets. This conduct demonstrates that the

manufacturer was aware of the adverse test result and had taken steps in

relation to the remaining stock.

38. By the time the manufacturer acquired knowledge of the adverse test result, the

shelf life of the drug had not yet expired, the expiry date being April 2015. The

manufacturer, therefore, had sufficient opportunity to exercise its statutory right

to seek retesting of the sample. It could have either expressed its intention to

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adduce evidence contrary of the Government Analyst's report within the

prescribed period or sought appropriate orders for retesting of the sample in

accordance with law. No such course was adopted. The manufacturer neither

expressed a timely intention to contest the report by adducing contrary

evidence nor sought from the Court or the Drug Inspector the requisite portion

of the sample for retesting. In view of the aforesaid discussion, the petitioners

have failed to point out any material infirmity or lacuna in the case of the

complainant warranting interference at this stage. Whether the report of the

Public Analyst conforms to the prescribed testing standards, whether the test

was properly conducted, and whether the Public Analyst was competent to

undertake such analysis are matters of evidence which can appropriately be

determined during trial.

39. At the stage of considering a petition for quashing of criminal proceedings, the

relevant material is primarily the complaint and the documents/material

annexed thereto. The material presently available, prima facie, demonstrates

that the complainant followed the statutory safeguards while drawing the

samples and invoked Section 18-A to ascertain the particulars and whereabouts

of the wholesaler, stockist, distributor and manufacturer. The disputed factual

aspects cannot, therefore, be adjudicated upon in proceedings seeking quashing

of the complaint. Reliance placed upon the judgment of a coordinate bench in

Neena Gupta v. Union Territory of Ladakh, is also of little assistance to the

petitioners. In that case, the petitioners before the Court were dealers in the

drug in question and were not the manufacturers. The manufacturer had

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specifically taken the defence that the drug had failed to meet the prescribed

standards on account of the petitioners' failure to store the drug in an

appropriate manner. During the course of investigation, the authorities under

the Drugs and Cosmetics Act had found that the manufacturer was attributing

the failure of the drug to the dealer/retailer. However, from the complaint and

the material placed before the Court, there was no evidence to establish that the

drug in question had in fact been stored improperly by the petitioners, who

were the dealers. In that factual background, the Court held that, once the

material on record satisfied the requirements of Section 19(3), the petitioners

could not have been prosecuted.

40. The factual position in the present case is materially different. Neither the

complaint nor the material annexed thereto contains any averment or material

suggesting that accused Nos. 1 to 5, who dealt with the drug in question in their

respective capacities as retailer, stockiest, dealer or distributor, had stored the

drug in an improper manner. The petitioners, therefore, cannot derive any

substantial benefit from the judgment rendered by a coordinate bench in Neena

Gupta supra. For the foregoing reasons, this court finds no merit in these

petitions. The same are, accordingly, dismissed, interim direction, if any, shall

vacated.

(Sanjay Parihar)

Judge

Jammu

11.08.2026

Rahul Sharma Whether the order is speaking? Yes

Whether the order is reportable? Yes