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Anandkumar Satyanrayan Loya & Anr vs State Of Mah. & Anr
2016 Latest Caselaw 6391 Bom

Citation : 2016 Latest Caselaw 6391 Bom
Judgement Date : 27 October, 2016

Bombay High Court
Anandkumar Satyanrayan Loya & Anr vs State Of Mah. & Anr on 27 October, 2016
Bench: V.K. Jadhav
                                                                          crwp28.03-
                                          -1-




                                                                          
                   IN THE HIGH COURT OF JUDICATURE AT BOMBAY
                              BENCH AT AURANGABAD




                                                  
                        CRIMINAL WRIT PETITION NO. 28 OF 2003


     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,




                                                 
              R/o. Chintamani Colony,
              Urogenital

     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business




                                        
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
                             
              Chikalthana, Aurangabad                      ...Petitioners

                      versus
                            
     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)

     2.       Drug Inspector,
      


              Food and Drugs Administration,
              (M.S.), Aurangabad                           ...Respondents
   



                                        WITH
                        CRIMINAL WRIT PETITION NO. 29 OF 2003





     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,
              R/o. Chintamani Colony,
              Urogenital





     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
              Chikalthana, Aurangabad                      ...Petitioners

                      versus

     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)

     2.       Drug Inspector,


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                                          -2-

              Food and Drugs Administration,




                                                                          
              (M.S.), Aurangabad                           ...Respondents

                                        WITH




                                                  
                        CRIMINAL WRIT PETITION NO. 30 OF 2003


     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,




                                                 
              R/o. Chintamani Colony,
              Urogenital

     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business




                                        
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
                             
              Chikalthana, Aurangabad                      ...Petitioners

                      versus
                            
     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)
      

     2.       Drug Inspector,
              Food and Drugs Administration,
              (M.S.), Aurangabad                           ...Respondents
   



                                        WITH
                        CRIMINAL WRIT PETITION NO. 31 OF 2003





     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,
              R/o. Chintamani Colony,
              Urogenital





     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
              Chikalthana, Aurangabad                      ...Petitioners

                      versus

     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)

     2.       Drug Inspector,


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                                                                           crwp28.03-
                                          -3-

              Food and Drugs Administration,




                                                                          
              (M.S.), Aurangabad                           ...Respondents

                                        WITH




                                                  
                        CRIMINAL WRIT PETITION NO. 32 OF 2003


     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,




                                                 
              R/o. Chintamani Colony,
              Urogenital

     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business




                                        
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
                             
              Chikalthana, Aurangabad                      ...Petitioners

                      versus
                            
     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)
      

     2.       Drug Inspector,
              Food and Drugs Administration,
              (M.S.), Aurangabad                           ...Respondents
   



                                        WITH
                        CRIMINAL WRIT PETITION NO. 33 OF 2003





     1.       Anandkumar s/o Satyanarayan Loya,
              Age 53 years, Occ Business,
              R/o. Chintamani Colony,
              Urogenital





     2.       Shankarlal s/o Ratanlal Jhawar,
              Age 53 years, Occ. Business
              R/o. M/s. Amrit Pharmaceuticals,
              G-5, Industrial Area,
              Chikalthana, Aurangabad                      ...Petitioners

                      versus

     1.       The State of Maharashtra
              (Through the Public Prosecutor
              High Court, Bench at Aurangabad)

     2.       Drug Inspector,


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                                                                              crwp28.03-
                                          -4-

              Food and Drugs Administration,




                                                                             
              (M.S.), Aurangabad                              ...Respondents

                                        .....




                                                     
     Mr. S.G. Ladda h/f Mr. Joydeep Chatterji, advocate for the petitioners
     Mr. P.G. Borade, A.P.P. for respondents
                                          .....

                                                CORAM : V. K. JADHAV, J.

Date of Reserving the Judgment : 06.10.2016

Date of pronouncing the Judgment : 27.10.2016

JUDGMENT:-

1. The petitioners assail the common judgment and order dated

17.10.2002 passed by the learned Additional Sessions Judge,

Aurangabad in Criminal Revision Nos. 203 of 2001, 204 of 2001, 205

of 2001, 206 of 2001, 207 of 2001 and 211 of 2001 (Anandkumar

and another vs. State of Maharashtra and another), thereby

dismissing the said revisions and confirming the common order

passed by learned Chief Judicial Magistrate, Aurangabad, rejecting

thereby the petitioners' application for discharge/dropping of

proceedings.

2. Brief facts, giving rise to the present criminal writ petitions are

as follows:-

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a) The respondent Drug Inspector had filed six separate

complaints in the court of Chief Judicial Magistrate, Aurangabad

against the present petitioners for having committed offence under

Sections 18 (1) (a) of the Drugs and Cosmetics Act 1940 (hereinafter

referred to as the "Act of 1940") punishable under Sections 27 and

34 of the Act of 1940. In all the cases, the petitioners are the same.

The petitioners accused appeared in those cases and filed their

applications at Exh.43, 39, 42, 43, 23 and 39 respectively, praying

therein to drop the proceedings or close the cases.

b) The respondent Drug Inspector on various dates, drew the

samples of sodium chloride injection from General Hospital

Bhandara, Sangli and Grant Medical College, J.J. Mumbai. After

obtaining the samples, the respondent Drug Inspector had sent the

said samples of sodium chloride injection referred to in the

proceedings to the Government Analyst, Maharashtra. According to

the respondent Drug Inspector, he received the report from the

Government analyst in respect of the said samples to the effect that it

was not of standard quality, as defined under the provisions of Act of

1940 and the Rules framed thereunder, because the samples

contained suspended matter visible to the unaided eyes. Thus, the

respondent Drug Inspector had delivered a copy of the said report to

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the Pharmacists of the Hospital as referred above and informed the

Hospital authorities, not to use the said stock and return the same to

the manufacturer. The said samples were drawn from the lot 3907 L-

1. The hospital authorities intimated the Drug Inspector that said

bottles were directly purchased from Amrit Pharmaceuticals,

Aurangabad. It is alleged that thereafter another Drug Inspector

delivered the copies of the report of the Government analyst to the

petitioner Shankarlal. The respondent Drug Inspector had thereafter

filed six separate complaints in the Court on 21.6.1988 against the

petitioners.

3. Learned counsel for the petitioners submits that in terms of

provisions of sub-section (3) of section 25 of the Act of 1940, both

the petitioners had notified to the Drug Inspector in writing within a

period of 28 days under certificate of posting that the report of the

Government analyst was absolutely incorrect and unreliable. The

petitioners intended to adduce evidence in contravention to the said

report at the appropriate time. Furthermore, the petitioners on the

date on which they appeared before the court, in response to the

summons, filed applications in all the complaints in terms of

provisions of sub-section (4) of Section 25 of the Act of 1940 pointing

out to the Court that samples are not produced before the court

alongwith the complaints and that the petitioners want to adduce

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evidence contrary to the report of the Government analyst. The

petitioners in the said applications requested the Court that the

application be kept on record and their right to adduce evidence

contrary to the report of the Government analyst be reserved and

that the petitioners would make necessary application under Section

25(4) of the Act of 1940 at appropriate stage. Learned counsel

submits that the respondent Drug Inspector has failed to produce the

samples in the Court in time and produced it after expiry of the shelf

life of the said Drugs. Thus, the same will amount to denial of

valuable right to the petitioners to get the samples tested from the

Central Laboratory. Learned counsel submits that, as per the chart

which is reproduced herein below, due to delay in launching the

prosecution and further by not producing the samples before the

court though mandatory under the provisions of Sub section (4) of

Section 23 of the Act of 1940, the report of the Government Analyst

cannot be said to be conclusive and since the petitioners have lost

their valuable right, serious prejudice has been caused to their

defence. The continuation of the prosecution against the petitioners

would be abuse of Court process.

CRI. NAME OF SAMPLE DATE OF DATE OF DATE OF DATE OF

W.P. DRUG DRAWN ANALYSIS INTIMATION SUMMON APPLICATION NO. FROM REPORT TO DRUG S TO U/S 25(4) DTO INSPECTOR APPEAR COURT U/S. 25(3)

CRI. SODIUM GENERAL REPORT IS 04/04/1988 16/12/1988 16/12/1988 WP. CHLORID HOSPITAL, DT. through Post NO. E BHANDARA 27/10/1987 28/20 INJECTIO "The 03 N, sample

contains MFG DT. suspended APRIL matter 1987, visible to EXPIRY unaided DT. SEPT. Eye" 1988 (Copy

delivered on 24/03/1988)

CRI. SODIUM WP. CHLORID

GENERAL HOSPITAL, REPORT IS 24/12/1987 16/12/1988 DT. through Post 16/12/1988

NO. E AND SANGLI 13/07/1987

29/20 DEXTROS "The 03 E sample INJECTIO contains N, suspended matter MFG DT. visible to JAN. 1987, unaided

EXPIRY Eye" DT. JUNE (Copy

1988 delivered on 23/12/1987) CRI. SODIUM GRANT REPORT IS 03/02/1988 21/11/1992 21/11/1992 WP. CHLORID MEDICAL DT. through Post NO. E COLLEGE, 15/09/1987

30/20 INJECTIO J.J. MUMBAI "The 03 N, sample contains MFG DT. suspended JUNE matter 1987, visible to EXPIRY unaided DT. NOV. Eye"

1988 (Copy delivered to 19/01/1988) CRI. COMPOU GENERAL REPORT IS 22/12/1987 16/12/1988 16/12/1988 WP. ND HOSPITAL, DT. through Post NO. SODIUM SANGLI 18/03/1987 31/20 LACTATE, "The 03 sample MFG DT. contains JAN. 1987, suspended EXPIRY matter DT. JUNE visible to 1988 unaided Eye" (Copy delivered to

crwp28.03-

21/12/1987)

CRI. SODIUM GENERAL REPORT IS 24/12/1987 16/12/1988 16/12/1988 WP. CHLORID HOSPITAL, DT. through Post

NO. E SANGLI 17/03/1987 32/20 INJECTIO "The 03 N, sample MFG DT. contains FEB. 1987, suspended EXPIRY matter

DT. JULY visible to 1988 unaided Eye" (Copy delivered to account on 23/12/1987)

CRI. SODIUM GENERAL REPORT IS 04/04/1988 16/12/1988 16/12/1988 WP. CHLORID HOSPITAL, ig DT. through Post NO. E BHANDARA 27/10/1987 33/20 INJECTIO "The 03 N, sample MFG DT. contains

MAY 1987, suspended EXPIRY matter DT. SEPT. visible to 1988 unaided Eye" (Copy delivered to

24/03/1988)

Learned counsel for the petitioners submits that as per the

standard mentioned in the Indian Pharmacopoeia, pertaining to

sodium chloride intravenous infusion, the requirements of storage is

in a single dose containers of glass or plastic, in a cool place. The

substances and preparations of the pharmacopoeia are to be stored

under conditions that prevent contamination and, as far as possible,

deterioration. Specific directions have been given with respect to

temperature at which sodium chloride injection should be stored. In

a "cool" place means any temperature between 8° and 25°. It is

further mentioned in respect of sodium chloride injection that on

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keeping, small solid particles may separate from glass container. It

has further directed that label shall state (i) The strength as the

percentage w/v of sodium chloride; and (ii) that a solution containing

visible particles must not be used. So far as the samples drawn by

the respondent Drug Inspector in the present matters are concerned,

it has specifically mentioned on the label that the solution containing

visible particles must not be used. Learned counsel submits that the

development of visible solid particles is a natural phenomena during

storage, if there is variation in temperature, for which the

manufacturer cannot be held responsible. The Government analyst

report does not indicate that there are foreign materials in the Drugs.

Learned counsel submits that the said Drug cannot be said to be of

substandard quality, due to visibility of the suspended matters, as the

said particles are likely to develop, if the drug is not stored in a cool

place. It is a part of record that the said samples were not collected

from the manufacturer and after considerable gap from the date of

manufacture, the said samples were drawn from the stores of

respective hospitals.

Learned counsel for the petitioners submits that the report of

the Government analyst does not state the protocols of the test

applied. In absence of that, the petitioners accused may not get the

full information of the test applied and consequently, it is not possible

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for them to controvert the result by adducing the evidence. The

complaints in all the cases are filed just before expiry of the shelf life

of the product. It deprives the petitioners to exercise their valuable

right, as provided under the provisions of Section 25(3) and 25(4) of

the Act of 1940.

Learned counsel for the petitioners submits that there are no

averments in the complaints that the present petitioners are in charge

and responsible to the conduct of business of the firm. It has simply

alleged in the complaints that on the basis of power of attorney, the

petitioners herein are looking after the day-to-day affairs of the firm. It

is nowhere alleged in the complaints, that the petitioners herein are

looking after the production side and they are responsible for the

business of the company with regard to the same. Learned counsel

submits that there is no compliance of Section 34 of the Act of 1940.

Learned counsel for the petitioners, in order to substantiate

his submissions, placed reliance on the judgments in the following

matters:-

i) Narendrakumar vs. State of Maharashtra, reported in 2002 Bom.C.R. (Cri.) 93

ii) Shyam Madanmohan Ruia and others vs. M.R. Mahakalkar and

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another reported in 1997 BCI 103

iii) Drugs Inspector, Central Drugs Standard Control Organisation

(South) Zone, Madras-6 vs. M/s. Modern Drugs and another reported in 1982 Cri. L.J. 2285

iv) M/s. Prem Pharmaceuticals and others vs. State of M.P.

Reported in 1989 Cri. L.J. 2028

v) Municipal Corporation of Delhi vs. Ghisa Ram reported in AIR 1967 S.C. 970

vi) State of Maharashtra vs. Vasudeo Shivlingappa Takawade and

another reported in 1988(3) Bom. C.R. 207

vii) Plethico Pharmaceuticals and others vs. State of Maharashtra

reported in 2002 Bom. C.R. (Cri.) 402

viii) Umesh Sharma and another vs. S.G. Bhakta and others reported in 2003 Bom. C.R. (Cri.) 1522

ix) Venkaiah Chowdary Nannapaneni and others vs. State of Maharashtra reported in 2003 All MR (Cri) 758

x) Municipal Corporation of Delhi vs. Ram Kishan Rohtagi reported

in 1982 DGLS(SC) 203

xi) Raj Kishan vs. State reported in 1976 Drugs Cases 52

xii) M/s. Medicamen Biotech Limited and another vs. High Court of Delhi, Vineeta Goyal vs. Rubina Bose, Drug Inspector reported in AIR 2008 SC 1939

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4. Learned A.P.P. for the respondent submits that the

respondent Drug Inspector has followed all procedure while drawing

the samples. The petitioners never approached the respondent Drug

Inspector in terms with the provision of sub section (3) of Section 25

of the Act of 1940, notifying in writing thereby that they intend to

adduce evidence in contravention of the report of Government

analyst. Even the petitioners have not annexed the copy of the said

application purportedly filed under Section 25(3) of the Act of 1940

alongwith the writ petitions. Even the petitioners accused have not

filed any application before the learned Magistrate in terms of the

provisions of sub-section (4) of Section 25 of the Act of 1940. The

petitioners have only reserved their right to file application under the

said provisions. In absence of any application before the court under

the provisions of sub-section (4) of Section 25 of the Act of 1940, no

prejudice is caused to the defence of the accused, nor the petitioners

have been deprived to exercise their valuable right in terms of

provisions of sub-section (4) of Section 25 of the Act of 1940. The

Government analyst report is self-explanatory and by unaided eyes,

suspended material in the sample were visible. Further, in terms of

power of attorney issued in favour of the petitioners by other

partners, the petitioners are looking after the business of the firm and

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respondent Drug Inspector has made the averments in the

complaints to that effect. In terms of the standard prescribed by the

Indian Pharmacopoeia, it is clear that the said sample was

substandard. Prima facie case is made out against the petitioners

and, therefore, learned Chief Judicial magistrate has rightly rejected

their application for dropping out the proceeding and further, the

learned Additional Sessions Judge in revision confirmed the said

order passed by the learned Chief Judicial Magistrate.

ig No

interference is required and all writ petitions are liable to be

dismissed.

Learned A.P.P. in order to substantiate his submissions,

places reliance on the judgment of the Supreme court delivered in

Appeal (Cri.) 300 of 2001 decided on 16.3.2001 in the case of

Amery Pharmaceuticals and Anr. vs. State of Rajasthan.

5. It appears from the contents of the complaints that the

respondents Drug Inspector had collected the samples from various

Government Hospitals for the purpose of test/analysis. Admittedly,

accused Nos. 1 and 2 are partners of accused No.3 M/s. Amrit

Pharmaceuticals, having their manufacturing unit at G-5, M.I.D.C.

Chikalthana, Aurangabad. Respondent No.2 Drug Inspector drew

samples of sodium chloride injection I.P. Batch 3907 L-1. The

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manufacturing and expiry dates are given in detail in the above

mentioned chart. Respondent No.2 Drug Inspector has sent the

samples to the Government Analyst and on receiving the report in

respect of each of the sample on various dates, as mentioned in the

chart, found that the said sample is not of standard quality for the

reason that the sample contained suspended matter visible to

unaided eyes. Initially, the test report received from the Government

Analyst was sent to the medical store in charge of the concerned

Hospitals and on communication from the said hospitals about the

manufacturer of the said Drug, the respondent Drug Inspector

delivered a copy of the test report of the Government Analyst

alongwith one intact sealed portion of the said sample of the batch,

as stated above to original accused No.3 Amrit Pharmaceuticals,

Aurangabad, by registered post A.D.

6. It is alleged in the complaint that in terms of Section 25 of the

the Act of 1940, the respondent Drug Inspector has followed the

procedure. It would be appropriate to refer to Section 25 of the Act of

1940, which is reproduced herein below:-

"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

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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 18-A], 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

18-A] 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 controverson of a

Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug [or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or

analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

(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."

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7. In terms of sub-Section (3) of Section 25 of the Act of 1940, if

any of the person, who receives copy of the report of the

Government analyst fails to notify his intention to adduce evidence in

contravention of facts stated in the report within a period of 28 days

of the receipt of the report, then such report of the Government

analyst become conclusive evidence regarding the facts stated

thereunder as against the such person. So far as the accused like

manufacturer in the present case is concerned, he can also avail

remedy indicated in sub-section (4) of section 25 of the Act of 1940,

by requesting the Court to send the other portion of the sample

remained in the court, to be tested by Central laboratory. In terms of

provisions of sub-section (4) of Section 23 of the Act of 1940 the

Inspector shall produce the sample to the Court before which the

proceedings, if any, are instituted in respect of the said drugs.

8. In all the cases, on appearance before the trial court, the

petitioners herein submitted applications, contending therein that

after receipt of copy of the report of Government analyst from the

Drug Inspector, the petitioners have notified the Drug Inspector in

writing within a period of 28 days under certificate of posting that the

report of the Government Analyst was absolutely incorrect and

unreliable. The petitioners intended to adduce evidence in

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contravention of the said report at appropriate stage of the trial. Such

intimation within 28 days given to the respondent Drug Inspector, is

detailed in the above chart. Further, the petitioners also brought to

the notice of the Court that they intended to adduce evidence in

contravention of the said report and since respondent Drug Inspector

has not produced the samples before the Court, though mandatory in

terms of provisions of sub-section (4) of Section 23 of the Act of

1940, they reserved their right to file an application under sub-section

(4) of Section 25 of the Act of 1940 at the appropriate stage of trial.

The petitioners accordingly prayed in the said applications that their

right to adduce evidence in contravention of the report of

Government analyst, be reserved. Learned Magistrate, on such

application in each of the complaints, called upon the other side to

file their say. However, on careful perusal of the record and

proceedings of each and every case, I do not find that the

respondent Drug Inspector has filed his say to the applications filed

immediately on appearance before the Court in each and every

complaint.

9. Further, the petitioners in each and every complaints filed

applications for discharge, mainly on the ground that the respondent

Drug Inspector has committed serious breach of mandatory

provisions of the Act of 1940. It has also brought to the notice of the

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Court that Inspite of the requirements of law, the sample bottles have

not been produced before the Court. The petitioners also be

discharged on the ground that even though they reserved their right

to file application under the provisions of sub-section (4) of Section

25 of the Act of 1940, the respondent Drug Inspector has not

submitted any of the sample bottles before the court. It was also

brought to the notice of the Court that Inspite of the date of expiry

referred to above, the respondent Drug Inspector has deliberately

avoided to submit the sample bottles in the Court. The petitioners

further contended in the said application that their right to lead

contrary evidence was taken away fraudulently.

10. Respondent Drug Inspector has filed his say to the said

application separately in each and every complaint and contended

that no such notification in writing was sent to him by the petitioners

herein and further contended that the respondent Drug Inspector is

ready to produce the sample, if directed by the court. The

respondent Drug Inspector has also contended in the say that the

petitioners have not filed any application before the Court in terms of

provisions of Section 25(4) of the Act of 1940. It further appears from

the record of each and every complaint that afterwards realizing the

mistake of not producing the sample before the court, the respondent

Drug Inspector has produced the sample almost in the year 1992, in

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each and every case.

11. It is a part of record that on appearance before the court, in all

the complaints, the petitioners have immediately submitted

applications requesting thereby to the court to reserve their right to

adduce evidence in contravention of the report of the Government

analyst. Even though the learned Magistrate called upon the

respondent Drug Inspector to file his say, however, no say was filed

to such applications. The petitioners have specifically contended in

the said applications the date on which they had notified the Drug

Inspector in writing, within a period of 28 days by post that the

Government analyst's report was incorrect and unreliable and that

they intended to adduce the evidence in contravention to said report

at the appropriate time. In the information submitted by the

petitioners in the above chart, specific dates are mentioned on which

the petitioners gave intimation to the Drug Inspector in terms of sub-

section (3) of Section 25 of the Act 1940. In the year 1992, in all the

cases, the petitioners when filed applications for discharge on

various counts, as discussed above, the respondent Drug Inspector

has denied about the receipt of such intimation and to my surprise,

also denied the applications filed by the petitioners before the Court

in terms of provisions of sub-section (4) of Section 25 of the Act of

1940. It is a part of the record that till the year 1992, the respondent

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Drug Inspector has not produced before the court the samples,

though it is mandatory on his part to produce the same before the

court in terms of sub-section (4) of Section 23 of the Act of 1940. In

view of above, the petitioners lost their valuable right to adduce

evidence in contravention of Government analyst report.

12. Furthermore, the prosecution came to be launched in each and

every case after much delay and just before expiry of the shelf life of

the sample. In all the cases, the report of the Government analyst

came to be received in the year 1987 itself i.e. during the period from

17.3.1987 to 27.10.1987. However, the prosecution came to be

launched from May 1988 onwards in each and every case. On

careful perusal of each and every complaint, I find that just before

expiry of shelf life of the sample, the complaints came to be filed

before the Magistrate. In that way also, there was no propriety as

such, to send the sample to the Central Laboratory, when its shelf life

was already expired. Furthermore, in order to comply with the

provisions of sub-section (4) of Section 25 of the Act of 1940, the

samples need to be produced before the Court and the court may, in

its discretion, send such samples to the Central laboratory suo moto

or on the application submitted by the accused.

13. In the case of Venkaiah Chowdary Nannapaneni and

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others (supra) relied upon by learned counsel for the petitioners,

this Court has made the following observations:-

"In cases falling under the Act prompt action at every stage is a must though it is not expressly made clear in the Act. The samples

drawn must be sent for analysis forthwith. Portions thereof must be given to the concerned parties without loss of time. Report must be prepared expeditiously. It must be sent to the Inspector with

expedition. Copies of the report must be served on the concerned parties as soon as possible and complaint must be lodged without

wasting time. Reason for this expedition at every stage is the shelf- life of a drug and the need to get it analysed within a particular time

frame. While sub-section (1) of Section 24 of the Insecticides Act 1968, the Insecticide Analyst has to submit his report within a period of 60 days, surprisingly there is no such provision in the Act

providing for an outer limit for submission of the report. It is elementary that no complaint could be filed till such time as the

report of the analyst is received. If the report is delayed consequently the complaint would be delayed. Delayed complaint may result in denying the accused or the complainant the right to

get the samples tested from the Central Drugs Laboratory before the shelf-life of the drug is over. That would frustrate the prosecution. Prompt lodging of the complaint therefore is of prima importance."

14. In the case of M/s. Medicamen Biotech Limited and another

vs. High Court of Delhi, Vineeta Goyal vs. Rubina Bose,, relied

upon by learned counsel for the petitioners, the Supreme Court when

found that the accused disputed the report and requested for test by

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the Central Laboratory and no action was taken thereon and further

the complaint filed just few days before expiry of sample drug,

petitioners lost the valuable right to get the sample re-tested. The

Supreme court in para 10 of the said judgment, made the following

observations:-

"10. We find that this Judgment helps the case of the appellant

rather than that of the respondent because in spite of two

communications from the appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the Magistrate had not

been sent for re-analysis. The observations in Amery Pharmaceuticals's case (supra) are also to the same effect. We find that the aforesaid interpretation supports the case of the appellants

inasmuch they had been deprived of the right to have the fourth

sample tested from the Central Drugs Laboratory. It is also clear that the complaint had been filed on the 2 nd July 2002 which is about a month short of the expiry date of the drug and as such had the

accused-appellant appeared before the Magistrate even on 2 nd July 2002 it would have been well nigh impossible to get the sample tested before its expiry. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has

been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9 th May 2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf-life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the; notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for

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re-testing of the drug had been made by the appellant in

August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the

complaint could not have been filed earlier and the fourth sample sent for re-testing well within time. We are, therefore, of the opinion that the 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."

15.

In the case of Municipal Corporation of Delhi vs. Ghisa

Ram (supra) and State of Maharashtra vs. Vasudeo Shivlingappa

Takawade (supra), relied upon by learned counsel for the

petitioners, though the cases falling under the provisions of

Prevention of Food Adulteration Act, in the similar set of facts and

identical provisions of the Act, the Supreme Court and the Division

Bench of this Court, have taken a similar view and held that the

valuable right available to the accused, to get the sample analyzed

by the Central laboratory, has been lost due to delay in launching the

prosecution.

16. In the instant case, the petitioners original accused have lost

their valuable right available under Section 25(3) and 25(4) of the Act

of 1940. Further, the complaint came to be filed just before expiry of

the shelf life of the drug, virtually making it impossible for the

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petitioners to exercise their right in terms of provision of Section

25(3) and 25(4) of the Act of 1940. The petitioners are entitled for

discharge on this ground alone.

17. In view of Volume No.1 of Indian Pharmacopoeia 1985, as

referred in case of Narendrakumar vs. State of Maharashtra,

(supra) relied upon by learned counsel for the petitioners, so far as

the drug or injection called "Sodium Chloride and Dextrose" is

concerned, it is laid down under the heading "storage" as follows:-

"Storage" Store in single-dose containers in a cool place. On keeping, small solid particles may separate from glass containers."

Further under the head of labellings it is laid down as follows:- .

"Labelling.- (I) The label states the strength as the percentages w/v

of Sodium Chloride and of Dextrose and (ii) that a solution containing visible particles must not be used."

18. It is thus clear that the said drug is required to be stored in a

cool place and as stated in the Indian Pharmacopoeia, the "cool"

place means any temperature between 8° and 25°. This position of

storage conditions and labelling remained as it is, at least till the year

2014 since the Indian Pharmacopoeia of 2014 is placed before this

Court during the course of arguments. It has further made clear that

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if solution containing visible solid particles, the same must not be

used. There is no dispute that the labelling conditions have been

followed by the petitioners, including displaying instructions that

solution containing visible particles must not be used. In the instant

case, much after manufacturing date, the samples of sodium chloride

injection I.P. came to be seized from storage of various hospitals. On

careful perusal of the report, I do not find that any foreign material

was found in the sample. Thus, development of such particles due to

non observance of storage of such drug in a cool place, cannot be

ruled out altogether.

19. In the case of Narendrakumar vs. State of Maharashtra, (supra)

relied upon by learned counsel for the petitioners, this Court in identical

situation in para 7 of the judgment, made following observations:-

"7. Thus the two essential standards or the conditions laid down are that the injection should be stored in a cool place and secondly the injection should not be used if it contains visible solid particles. It

therefore, appears that according to the Pharmacopoeia of India the development of visible solid particles is a natural phenomenon during storage if there is variation in temperature, hence label is required to be put on such drugs with the instructions that the injection should not be used if it contains visible solid particles. If the drug in question contained visible solid particles the hospitals ought not to use those injections on the patients. It is not the case of the prosecution that the drug or injection in question contained any foreign material and the ingredients thereof were not in the

crwp28.03-

prescribed standard proportion. No samples were taken from the

manufacturers directly and as per the complaint which is the subject matter of Criminal Writ Petition No. 975/89 the injections in question

were purchased by the St. George Hospital in September 1986 from the distributors M/s. Delpha Drugs and Pharmaceuticals (India) and the samples in question were taken in the month of November, 1986

from St. George Hospital. The development of particles may be due to non-observance of the standard of storage in a cool place. As stated earlier, it is not the case of the prosecution that these

particles were foreign material and not of Sodium Chloride or of Dextrose. In the above circumstances, it cannot be said that there

was any contravention of the provisions of Drugs and Cosmetics Act by the petitioner-company."

20. The ratio laid down in the above cited case, squarely applies to

the facts and circumstances of the present case. In absence of any

other finding, the possibility of development of particles in the instant

case on account of non following the standard of storage in a cool

place by the respective Government hospitals, cannot be ruled out.

In the circumstances, it cannot be said that the petitioners have

contravened the provisions of the Act of 1940, even accepting the

Government Analyst report as it is.

21. The respondent Drug Inspector has alleged in the complaint

that the present petitioners are partners of accused No.3 i.e. M/s.

Amrit Pharmaceuticals and by virtue of power of attorney, they are

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liable to be prosecuted under Section 34 of the Act of 1940. On

careful perusal of the copy of deed of partnership and general power

of attorney, which is a part of record of the complaints filed by the

respondent Drug Inspector, it appears that the other partners

executed general power of attorney in favour of the present

petitioners, authorizing them to look after the day to day

administration of the firm, such as appointment of agents,

employees, workers and other persons and to remove them as and

when necessary, pay remuneration, wages, bonus, to file suit or

application or commence other proceedings, civil or criminal in

respect of or arising out of the said business to swear affidavits on

behalf of the firm etc. to purchase any property, to borrow loans etc.

However, it is nowhere stated in the general power of attorney that

the petitioners herein are responsible for the conduct of the business

of the firm so far as the production side is concerned.

22. In the case of Umesh Sharma and another vs. S.G. Bhakta

and others, reported in 2003 Bom.C.R. (Cri.) 1522, this Court had

an occasion to deal with similar question and accordingly, this Court

has considered the definition of "Managing Director" as provided

under Section 2(26) of the Companies Act, 1956. This Court has

also referred the definition of "Manager" as provided under Section

2(24) of the Companies Act, 1956. By referring those two definitions,

crwp28.03-

this Court has observed that Manager, by virtue of his office, has the

management of whole or substantially whole of the affairs of the

company, and the Managing Director has to be entrusted with such

powers of the management and powers of management are required

to be delegated upon the Managing Director either, by an agreement

with the company or by resolution passed by the Board of Director in

its general meeting or by virtue of its memorandum or article of

association. It is not the name by which the person is called, but the

position he occupies and the functions and duties which he

discharges that determines whether in fact, he is in charge of and

responsible to the company or not as defined in Section 2(26) of the

Companies Act. Even this Court has distinguished the case in U.P.

Pollution Control Board Vs. Mohan Meakins Limited and Others,

reported in (2000) 3 SCC 745. In the said case, there are specific

allegations in the complaint by which the Manager or Director of the

company can also proceed against when the company, which is

alleged to be guilty of the offence. Thus, By referring the two cases of

the Supreme Court i.e. Municipal Corporation of Delhi Vs. Ram

Kishan Rohatagi (supra) and State of Haryana Vs. Brij Lal Mittal

and Others, reported in AIR 1998 SC 2327, this Court held that in

absence of any averment in the complaint that the accused, who is

named in the complaint as Managing Director, is responsible and in

charge of the entire affairs of company, the process issued against

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such an accused is required to be recalled. A similar view is taken by

this Court in the cases of Narendrakumar Mangilal Dani and

Others Vs. State of Maharashtra and another and Venkaiah

Chowdary Nannapaneni and Others Vs. State of Maharashtra

(supra).

23. Though section 34 of the Act of 1940 creates presumption of

liability, however, it does not say that the person being merely a

partner and in charge of administration of the firm is criminally liable.

It is nowhere averred in the complaints that the petitioners are

responsible for the objectionable drug and same was manufactured

with their consent or in their connivance or production of the said

drug is attributed to any neglect on their part.

24. In view of the above discussion and the ratio laid down in the

various cases by the Supreme Court and also by the High Courts, I

am of the view that the continuation of prosecution in the present

case would be a mere formality. Learned Additional Sessions Judge,

Aurangabad almost accepted all grounds raised by the petitioners, as

discussed above, however, declined to interfere in the order passed

by the Magistrate on the ground that these grounds were not at all

raised in the applications for discharge before the Magistrate and that

the proceedings are pending since more than 14 years. The learned

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Additional Sessions Judge has declined to interfere in the order

passed by the Magistrate on the ground that all these scientific

aspects can be looked into during the course of trial. Thus, the

approach of the Courts below is not proper, correct and legal. The

petitioners are therefore, entitled for discharge. Hence, I proceed to

pass the following order:-

ORDER

I. All criminal writ petitions are hereby allowed.

II. The common order dated 13.8.2001 passed below Exh.43 in R.C.C. No 1144 of 1997, Exh.39 in R.C.C. No

1145 of 1997, Exh.42 in R.C.C. No 1146 of 1997,

Exh.43 in R.C.C. No 1147 of 1997, Exh.23 in R.C.C. No 1148 of 1997, Exh.39 in R.C.C. No 1149 of 1997 (State (Drug Inspector vs. Shankarlal and others) by the learned

Chief Judicial Magistrate, Aurangabad and the common judgment and order passed by the Additional Sessions Judge, Aurangabad dated 17.10.2002, in Criminal

Revision Nos. 203 of 2001, 204 of 2001, 205 of 2001, 206 of 2001, 207 of 2001 and 211 of 2001, confirming thereby the order passed by the Chief Judicial Magistrate, are hereby quashed and set aside.

III. The application Exh.43 in R.C.C. No. 1144 of 1997, application Exh.39 in R.C.C. No. 1145 of 1997,

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application Exh.42 in R.C.C. No. 1146 of 1997,

application Exh.43 in R.C.C. No. 1147 of 1997, application Exh.23 in R.C.C. No. 1148 of 1997 and

application Exh.39 in R.C.C. No. 1149 of 1997, are hereby allowed and the petitioners herein are discharged for the offences committed under Sections 18 (1) (a)

punishable under Sections Sections 27 and 34 of the Drugs and Cosmetics Act 1940.

IV. Rule is made absolute in the above terms

V. Writ petitions are disposed of accordingly.

( V. K. JADHAV, J.) rlj/

 
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