IN THE HIGH COURT OF ANDHRA PRADESH, AMARAVATI

****

CRIMINAL PETITION No. 13022 of 2014

Between:

J.P.N.Singh,

S/o.P.N.Singh, Aged about 34 years,

Occ:Director, M/s.Galpha Laboratories Limited,

R/o.Flat No.404, Valentine Tower No.1,

Film City Road, Pimplypada,

Goregaon, East Mumbai. ... Petitioner/A.2

And

The State of A.P., through Drug Inspector, Ongole,

Represented by Public Prosecutor, High Court of A.P.,

Amaravati. …. Respondent

DATE OF JUDGMENT PRONOUNCED : 26-09-2023

SUBMITTED FOR APPROVAL :

THE HON’BLE SRI JUSTICE DUPPALA VENKATA RAMANA

1. Whether Reporters of Local Newspapers

may be allowed to see the judgment? Yes/No

2. Whether the copies of judgment may be

marked to Law Reporters / Journals? Yes/No

3. Whether His Lordship wish to

see the fair copy of the Judgment? Yes/No

DUPPALA VENKATA RAMANA, J

2

* THE HON’BLE SRI JUSTICE DUPPALA VENKATA RAMANA

+ CRIMINAL PETITION No. 13022 of 2014

% 26-09-2023

J.P.N.Singh,

S/o.P.N.Singh, Aged about 34 years,

Occ:Director, M/s.Galpha Laboratories Limited,

R/o.Flat No.404, Valentine Tower No.1,

Film City Road, Pimplypada,

Goregaon, East Mumbai. ... Petitioner/A.2

And

The State of A.P., through Drug Inspector, Ongole,

Represented by Public Prosecutor, High Court of A.P.,

Amaravati. …. Respondent

! Counsel for Petitioner : Sri T.S.Anirudh Reddy

^ Counsel for Respondent : Asst.Public Prosecutor

< Gist:

> Head Note:

? Cases referred:

1. 2008 SCC Online Pat 1307

2. MANU/AP/0111/2019

3. 2019 (2) ALT (Crl.) 329 (AP)

4. (1998) 5 SCC 343

This Court made the following:

3

HON’BLE SRI JUSTICE DUPPALA VENKATA RAMANA

CRIMINAL PETITION No.13022 of 2014

ORDER:

This Criminal Petition has been filed by the Petitioner/A.2

under Section 482 of the Code of Criminal Procedure, 1973 (for

short “Cr.P.C”) for quashing the proceedings in C.C.No.405 of

2012 on the file of the Court of II Additional Munsif Magistrate,

Ongole, registered for the offence under Section 18(a)(i) read with

Section 16 punishable under Section 27(d) of the Drugs and

Cosmetics Act, 1940 (hereinafter referred to as “the Act”).

2. Heard Sri T.Pradyumna Kumar Reddy , learned Senior

Counsel instructed by Sri T.S.Anirudh Reddy, learned counsel

for the petitioner and learned Assistant Public Prosecutor for the

respondent.

3. The brief facts of the case are as follows:

(i) A.1-firm, namely, M/s.Galpha Laboratories Limited,

Thana, possessed drug manufacturing licence bearing

No.L/06/256/MB, dated 27.06.2006 , to manufacture the drugs

for sale. The petitioner/A.2 is the responsible Director of the firm

and A.3-O.N.Vaishy is the responsible person for the

manufacturing activities of the firm at Baddi.

4

(ii) On 12.05.2009, the -then Drugs Inspector-

N.Ramamoorthy(L.W.1) inspected Central Drug Stores,

APHMHIDC, Ongole, in the presence of Pharmacist under Form

No.17 as required under Section 23 of the Act and picked up the

drug, namely “Amoxycillin” and Potassium Clavulanate Oral

Suspension I.P., Clanoxy-200 Batch No. CNSF-90071B,

Manufacturing Date 4/ 2009, Expiry Date 3/ 2011,

manufactured by A.1 firm, seized four samples(drugs) separately

under seal, and immediately sent one sealed portion of the said

drug sample - Clanoxy 200, to the Government Analyst, Drugs

Control Laboratory, Hyderabad vide Form No.18, through

Registered Post for analysis. He also sent one copy of Form

No.18 to the Government Analyst, Drugs Control Laboratory,

Hyderabad, separately through Registered Post.

(iii) On 26.05.2010 the Drugs Inspector(L.W.1) received

the Government Analyst Report dated 20.05.2010, declaring the

sample drug is “not of standard quality” as defined under the

Act and Rules framed thereunder for the reason that the sample

does not meet the labelled claim in respect of the Clavulanic

Acid content(found 3.59 mg/28.5 mg).

(iv) On receipt of the Government Analyst’s Report, the

Drug Inspector addressed a letter dated 26.05.2010 to the

5

Executive Engineer, Central Drug Stores, APHMHIDC, Ongole ,

under Section 18A of the Act with a request to disclose the

source of acquisition of the sample drug along with a self-

attested copy of purchase invoice. On 10.06.2010, the Drugs

Inspector received a reply from the Executive Engineer stating

that the sample drug was received vide Bill No.0911NS/11,

dated 25.04.2009. On 30.06.2010 the Drugs Inspector

addressed a letter to M/s. Galpha Laboratories Limited,

Hyderabad(A.1) under Section 18A of the Act requesting to

disclose the source of the acquisition of the drug and to furnish

the self-attested Xerox copy of the purchase invoice. The Drugs

Inspector received a reply dated 14.07.2010 from A.1-firm

stating that “they have manufactured, sold and distributed a

standard quality drug namely Clanoxy-200 Suspension and the

findings of the Government Analyst can be attributed to error in

testing or improper storage”. In view of the above, they requested

the Drug Inspector to take into consideration their submission

and the background submitted above and not to take any action

against them. In another letter dated 26.07.2010 received from

the Authorized Signatory of A.1 Firm, it was stated that “they

have manufactured, sold and distributed standard quality of drug

namely Clanoxy 200 dry syrup and the findings of the

6

Government Analyst can be attributed to error in testing or

improper storage” and requested not to take any action against

them.

(v) On 16.09.2010 the Drugs Inspector addressed

another letter to M/s.Galpha Laboratories Limited, Zirakpur

requesting to disclose the source of supply and to furnish a self-

attested Xerox copy of their purchase invoice. On 18.04.2011

the complainant received a reply from A.1-firm along with the

manufacturing and analytical records , stating that A.3-

O.N.Vaishy, Associate V.P-QA is the responsible person for the

day-to-day activities of A.1-firm. On 25.06.2011, the Assistant

Director, Drugs Control Administration, Hyderabad sent the

constitution particulars of A.1-firm to L.W.2/Assistant Director,

Drugs Control Administration, Ongole and further, “Clanoxy 200

Oral Suspension USP Batch No.CNSF-90071B, Manufacturing

Date 4/09, Expiry Date 3/11, manufactured by the A.1 firm is a

drug within the meaning of Section 3(b) of the Act and the said

drug was declared as “Not of Standard Quality” by the

Government Analyst, Drugs Control Laboratory, Hyderabad.

Thus, the petitioner/A.2, A.1-firm and A.3 contravened Section

18(a)(i) read with Section 16 of the Act by manufacturing and

selling of the “Not of Standard Quality Drug” Clanoxy 200

7

Suspension as described above, and thereby rendered itself

liable for punishment under Section 27(d) of the Act.

(vi) Therefore, the Drugs Inspector filed a complaint

under Section 32 of the Act before the Court of II Additional

Munsif Magistrate, Ongole, and the same was taken on file and

numbered as C.C.No.405 of 2012.

(vii) Aggrieved thereby, the petitioner/A.2 moved the

present criminal petition under Section 482 Cr.P.C for quashing

the proceedings initiated against him in the above C.C.

4. Learned counsel for the petitioner would submit that the

petitioner/A.2 is not responsible for the day-to-day affairs of A.1-

firm and the complaint does not disclose the said fact. He would

further submit that the Drug Inspector picked up the sample of

the drug on 12.05.2009, sent the same to the Government

Analyst, Drugs Control Laboratory, Hyderabad and on

26.05.2010 received the Analyst’s report dated 20.05.2010 and

the complaint was filed on 03.08.2011 and the drug was

manufactured in 04/2009 and expired by 03/2011 and by the

time of filing of the complaint on 03.08.2011 the shelf-life of the

drug was expired and therefore, the complaint is not

maintainable. Further, he would submit that the Drug Inspector

has drawn four samples at Central Drug S tores, APHMHIDC,

8

Ongole and one sample was sent to the Government Analyst,

Hyderabad, the second sample is a retailer sample and the third

sample has to be deposited in the Court. But, the third sample

was not deposited before the Court and the complaint does not

disclose the reasons for the same. He would further submit that

compliance of the provisions of Section 25 of the Act is

mandatory and non-supply of the Government Analyst’s report

to the petitioner before expiry date of the drug resulted in

depriving his valuable right to test the sample drug by the

Central Drug Laboratory, Kolkata. As such, the proceedings are

vitiated and consequently, the complaint filed by the Drugs

Inspector, Ongole, against the petitioner/A.2 is to be quashed.

The Report of the Central Laboratory supersedes the State

Laboratory Report. Therefore, he would pray for quashing of

proceedings against the petitioner/A.2.

5. Learned Assistant Public Prosecutor would submit that the

petitioner/A.2 submitted an affidavit on behalf of A.1-firm, dated

13.05.2008, stating that he is the Director and responsible for

the day-to-day affairs of the Company. Therefore, the

petitioner/A.2 is the person, who is responsible for the

commission of offence of manufacturing the drug which is “Not

of Standard Quality”. Further, he would submit that on receipt

9

of the report from the Government Analyst, Hyderabad, under

Section 25(3) of the Act, the Drug Inspector addressed a letter to

the Executive Engineer, Central Drugs Stores and A.1-Firm. The

Sr.Vice President of A.1-firm sent a reply dated 14.07.2010 and

the Authorized Signatory of A.1-Firm sent a reply 26.07.2010

stating that the findings of the Government Analyst, Hyderabad,

can be attributed to error in testing or improper storage and not

to take any action against them and they never requested to

send the sample drug to the Central Drugs Laboratory for

analysis in exercise of their valuable right conferred under

Section 25(4) of the Act. Therefore, the report of the Government

Analyst becomes final. In this process, loss of their valuable

right does not arise since the petitioner/A.2 has not requested

the Drugs Inspector to send the sample drug to the Central

Drugs Laboratory. He would further submit that the present

complaint is filed within the stipulated time i.e., three years from

the date of the State Analyst Report dated 20.05.2010. Further,

he would submit that the matter requires trial to ascertain the

truth or otherwise. He would further submit that there is no

merit in the contentions raised by the petitioner/A.2 with regard

to the violations under the Act. Therefore, he would pray for the

dismissal of the criminal petition.

10

6. Now the point for determination is:

Whether there are any merits in this criminal

petition to allow?

POINT:

7. At the outset, it will be apposite to extract Section 25 of

the Act. It reads as under:

25. Reports of Government Analysts.—

(1) The Government Analyst to whom a sample of any drug

[or cosmetic has been submitted for test or analysis

under sub-section (4) of section 23, shall deliver to the

Inspector submitting it a signed report in triplicate in the

prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of

the report to the person from whom the sample was

taken [and another copy to the person, if any, whose

name, address and other particulars have been

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

copy for use in any prosecution in respect of the sample.

(3) Any document purporting to be a report signed by a

Government Analyst under this Chapter shall be

evidence of the facts stated therein, and such evidence

shall be conclusive unless the person from whom the

sample was taken [or the person whose name, address

and other particulars have been disclosed under section

18A] has, within twenty -eight days of the receipt of a

copy of the report, notified in writing the Inspector or the

Court before which any proceedings in respect of the

sample are pending that he intends to adduce evidence

in controversion of the report.

(4) Unless the sample has already been tested or analysed

in the Central Drugs Laboratory, where a person has

under sub-section (3) notified his intention of adducing

evidence in contraversion of a Government Analyst’s

report, the Court may, of its own motion or in its

discretion at the request either of the complainant or the

accused cause the sample of the drug [or cosmetic]

produced before the Magistrate under sub-section (4) of

section 23 to be sent for test or analysis to the said

Laboratory, which shall make the test or analysis and

report in writing signed by or under the authority of, the

11

Director of the Central Drugs Laboratory the result

thereof, and such report shall be conclusive evidence of

the facts stated therein.

(5) The cost of a test or analysis made by the Central

Drugs Laboratory under sub-section (4) shall be paid by

the complainant or accused as the Court shall direct.

8. From a bare perusal of Sub-Section (3) of Section 25 of the

Act it is manifest that the report of the Government Analyst

shall be the evidence of the facts stated therein, and such

evidence shall be conclusive unless the person from whom the

sample was taken [or the person whose name, address or other

particulars have been disclosed under Section 18-A] (in this case

manufacturers) has, within 28 days of the receipt of the report

notified in writing the Drugs Inspector or the Court before which

any proceedings in respect of the sample are pending that he

intends to adduce evidence in contravention of the report. Sub-

Section (4) also makes it abundantly clear about the right to get

the sample tested by Central Drugs Laboratory(so as to make its

report override the report of Analyst) through the Court.

9. In the instant case, the petitioner/A.2 has not taken any

steps to send the sample drug to the Central Drugs Laboratory

in exercise of his valuable right conferred under Section 25(4) of

the Act, and instead of availing such right, the Sr.Vice President

of A.1-firm sent a reply letter dated 14.07.2010 stating that they

12

have received the letter in R.C.No.SA/44/D1-OGL/2009, dated

June 2010 along with the copy of the Government Analyst

Report No.1400/DCL/2010, dated 20.05.2010. After going

through the Government Analyst Report, they found that the

sample of Clanoxy-200, Batch No.CNSF90071B has been

declared to be “Not of Standard Quality” for assay of Clavulanic

Acid. Further, he stated that they have manufactured the drug,

sold and distributed standard quality drug namely Clanoxy 200

Suspension and the findings of the Government Analyst can be

attributed to error in testing or improper storage and do not take

any action against them and similarly, the Authorized Signatory

of A.1-firm sent a reply dated 26.07.2010 stating that the

findings of the Government Analyst Report da ted 20.05.2010

can be attributed to error in testing or improper storage and not

to take any action against them.

10. In the light of the above reply, it is clear that the

petitioner/A.2 has not exercised his valuable right under the

provision of Sub-Section (4) of Section 25 of the Act by making a

request to send the sample drug to the Central Drugs

Laboratory to override the report of the State Analyst. Therefore,

it cannot be said that they lost their valuable right. As such, the

13

report of the State Analyst is the conclusive evidence of the

facts.

11. The learned counsel for the petitioner/A.2 has relied on

Sulochna Devi Vs. State of Bihar

1, wherein, the High Court of

Patna held as follows:

“8. The manufacturer M/s.Pravin Pharma have also appeared

and filed counter affidavit wherein they have sought to

support the case of the petitioner of their having received the

consignment containing the drug on 8.2.2000 and selling the

same to the Superintendent on 24.2.2000 and that it had

remained with the retailer for only 16 days. They have also

sought to raise question regarding the storage conditions both

in the hospital as also in the office of the Drug Inspector where

the medicines had been stored and of the possibility of the

medicines having been lost its originality due to improper

storage conditions.

9. From the submissions advanced by the respective parties a

few things are highlighted which requires serious

consideration. Firstly, that the petitioner was never given an

opportunity to explain her stand before initiation of the

proceeding as has been given to the manufacturer, secondly,

the sanction for prosecution had been obtained from the Drug

Controller only with respect to the petitioner who was the

mere retailer. Thirdly, there is no explanation for the delay of

four months in sending the sample for analysis and fourthly

the storage conditions in the hospital as also the office of the

Drug Controller has not been stated and finally no report of

the analysis was supplied to the petitioner. Since there are no

satisfactory answers by the State and the Drug Inspector to

all these questions raised apparently the complaint case as

also the cognizance appears to be an abuse of the process of

the Court and has to be quashed.”

12. The learned counsel for the petitioner/A.2 has relied on

another decision in M.V.Srinivasa Rao Vs. State of A.P. and

Ors.,

2 wherein, this Court held as follows:

1

2008 SCC Online Pat 1307

14

“19. The Apex Court in the judgment in Medicamen Biotech

Ltd. v. Rubina Bose, Drug Inspector MANU/SC/7327/2008 :

2009 (1) ALT (Crl.) 71 (SC) : (2008) 3 SCC (Crl.) 20 held that

there is no explanation as to why the complaint itself had

been filed about a month before expiry of shelf life of the drug

and concededly filing of the complaint had nothing to do with

the appearance of the accused in response to the notices

which were to be issued by the Court after the complaint had

been filed. Likewise, requests for retesting of drug had been

made by the appellants in August/September, 2001 and there

is absolutely no reason as to why the complaint could not

have been filed earlier and the fourth sample sent for retesting

well within time. Facts of the case suggest that the appellants

have been deprived of a valuable right under Sections 25(3)

and 25(4) of the Act, which must necessitate the quashing of

the proceedings against them.

20. The analogy of the aforesaid judgment squarely applies to

the present facts of the case on hand. By the time, the State

Analyst report was furnished to the accused, the shelf-life of

the drug in question already expired long back. Therefore, the

accused lost his valuable right conferred on him by the Statute

under Section 25(3) and 25(4) of the Act to test the correctness

or genuineness of the report of the State Analyst by Sending

the Drug in question for test and analysis by the Central

Drugs Laboratory. Ergo, the proceedings initiated against the

accused in C.C. No.448 of 2011 on the file of the Additional

Judicial Magistrate of First Class, Chirala, Prakasam District,

stood vitiated and they are liable to be quashed.”

13. Having regard to the facts of the case and the material

available on record, this Court is of the opinion that the

decisions referred to supra relied on by the learned counsel for

the petitioner/A.2 are not helpful to the case of the

petitioner/A.2. A given set of facts are different from the facts of

the above cases. In the instant case, the sample drug was

expired by 03/2011. The petitioner/A.2 has not exercised his

valuable right conferred under Section 25(4) of the Act with a

2

MANU/AP/0111/2019

15

request to send the sample drug to the Central Drugs

Laboratory. The State Analyst Report was furnished to the

accused in the month of June 2010. By that time, the shelf-life

of the drug was not expired, and the present complaint was filed

on 03.08.2011. Therefore, the petitioner/A.2 would not have lost

his valuable right conferred on him by the Statute under Section

25(4) of the Act. Therefore, there is no merit in the contentions

raised by the learned counsel for the petitioner/A.2.

14. Now, another contention of the learned counsel for the

petitioner/A.2 is that the petitioner/A.2 is not responsible for

the day-to-day affairs of A.1-firm and the complaint does not

disclose the said fact. A perusal of the affidavit given by

petitioner/A.2, dated 13.05.2008 along with the instructions,

filed by the Drugs Inspector would show that “the petitioner/A.2

JPN Singh is the Director of M/s.Galpha Laboratories Limited and

he is responsible for the day-to-day affairs and conduct of

business of M/s.Galpha Laboratories Limited for the purpose of

Section 34 of the Drugs and Cosmetics Act, 1940 to which

M/s.Galpha Laboratories Limited and its Directors etc., are held

liable for any act of omission punishable under the Drugs and

Cosmetics Act, 1940………”.

16

15. In view of the affidavit given by the petitioner/A.2, it is

clear that he was the Director of A.1-firm and responsible for the

day-to-day affairs of A.1-firm. Therefore, there is no force in the

contentions raised by the learned counsel for the petitioner/A.2

that he is nothing to do with the affairs of the A.1-firm.

16. Learned Assistant Public Prosecutor relied on a decision in

Parenteral Surgicals Ltd., M.P. and others Vs. State of A.P.,

3

wherein, this Court held at Para No.7 as follows:

“7. By reading clause (4) of Section 25, what this court can

understand is that the pre-condition for sending the sample

for second analysis is what is said under clause (3) of

Section 25, which is that the person receiving the copy of the

report has to notify in writing to the Inspector or the court,

that he intends to adduce evidence in contraversion of the

report. In this case, after receiving the report copy, the

petitioners have sent an intimation to the complainant,

which is dated 9-7-2011. A reading of the copy of the said

letter filed before this court shows that the petitioners have

only explained the reason for the contamination, which

resulted in the report coming out with the finding that the

sample is contaminated, stating that it might be only due to

invisible damage to bottles in transit or storage. It does not

anywhere question the analyst report, either with regard to

the genuineness or with regard to the correctness. When

there is no attack made on the report on the said aspects,

the report stands to be conclusive. As specified in Section

25(3) of the Act, no intention to adduce evidence in

contraversion of the report can be gathered from a letter,

which explains only the reason for the report coming out in

the negative. The letter, unless it specifies, either impliedly

or expressly, that the petitioners intend to adduce evidence

in contraversion of the report, cannot be construed as a

notification made in compliance of Section 25(3), that he

intends to adduce evidence in contraversion of the report.

When no such intention can be gathered by the court, the

obligation laid on the court to send the sample on its own or

3

2019 (2) ALT (Crl.) 329 (AP)

17

at the request of the complainant or the accused, for second

sampling, does not come into operation.”

17. The above-said decision is squarely applicable to the

present set of facts. The petitioner/A.2 cannot be compelled to

disclose the grounds on which he seeks to controvert the report.

The burden of proof that the option was exercised within the

prescribed period of 28 days, is on the petitioner/A.2 which

assails a report of consequences of failure to exercise the option

within time, and the report becomes conclusive. The criminal

proceedings initiated under the Act cannot be challenged on the

ground of filing of complaint after the expiry of the shelf-life of

the drug. Prima facie from the complaint, it appears that the

Drug Inspector sent the report of the State Analyst , dated

20.05.20 to the petitioner/A.2 within the time but the

petitioner/A.2 did not file any application for re-analysis of the

drugs within the time by availing Sections 25(3) & (4) of the Act,

to the Director of the Central Drugs Laboratory, Calcutta ,

instead, he sent a reply not to take any action against them.

18. It is relevant to refer to the decision of the Hon’ble Apex

Court in State of Haryana Vs. Brij Lal Mittal and others

4,

wherein, at Para No.7, it was held as follows:

4

(1998) 5 SCC 343

18

“7.…………….. The delay in filing the complaint till the expiry

of the shelf-life of the drugs could not, therefore, have been

made a ground by the High Court to quash the prosecution. It

will not be out of place to mention that the manufacturers'

right under sub-section (3) expired four months before the

expiry of the shelf-life of the drugs. In view of the above

discussion, the reasoning of the High Court for quashing the

prosecution against the three respondents cannot at all be

sustained.

19. In the instant case, there is no apparent basis to conclude

that the Government Analyst Report ought to be excluded from

consideration without being tested at trial . Whether the

petitioner’s right to get the sample in question retested, is

defeated or not, is a moot question that cannot be answered at

this stage as the petitioner’s/A.2’s correspondence, as stated

above, is, in fact, the defence of the petitioner/A.2 which is

refuted and is thus, required to be tested at trial. Thus, there is

no basis for this Court to opine at this initial stage of these

criminal proceedings that the Government Analyst’s Report must

be outrightly rejected or the petitioner’s statutory right to get the

sample in question re-tested stands violated justifying the

quashing of the proceedings arising out of the complaint.

20. Therefore, upon considering the entire material and for the

reasons above stated and after following the principles of law,

this Court does not find any abuse of process of the Court in

continuation of the criminal proceedings against the

19

petitioner/A.2. Therefore, the criminal petition is liable to be

dismissed.

21. Resultantly, the criminal petition seeking quashing of the

proceedings in C.C.No.405 of 2012 on the file of the Court of II

Additional Munsif Magistrate, Ongole, lacks merit and stands

dismissed.

However, the petitioner/A.2 is at liberty to raise all the

contentions before the trial Court at the time of trial. All the

contentions of the parties on merits are left open. It is made

clear that none of the observations contained herein shall have

bearing on the trial of the main case and the trial Court shall

independently arrive at its conclusion based on the material on

record and the evidence rendered before it.

As a sequel, the miscellaneous petitions, pending if any,

shall stand disposed of.

JUSTICE DUPPALA VENKATA RAMANA

26.09.2023

DNS

Mjl/*

L.R.Copy to be marked

20

HON’BLE SRI JUSTICE DUPPALA VENKATA RAMANA

CRIMINAL PETITION No.13022 OF 2014

26.09.2023

DNS

Mjl/*

L.R.Copy to be marked

21