Bangalore District Court
State By vs M/S Ciron Drugs & on 26 May, 2021
BEFORE THE LXVI ADDL.CITY CIVIL & SESSIONS
JUDGE, BENGALURU CITY.
(CCH-67)
DATED: This the 26 th day of May, 2021
PRESENT
Smt.K.KATHYAYANI, B.Com., L.L.M .,
LXVI Addl.City Civil & Sessions Judge,
Bengaluru.
Criminal Appeal No.436 of 2017
Appellant: State by
Assistant Drugs Controller,
Office of the Assistant Drugs
Controller,
Chikkamagaluru Circle,
Chikkamagaluru.
(By Learned Public Prosecutor.)
/Vs/
Respondent : 1.M/s Ciron Drugs &
Pharmaceuticals Pvt. Ltd.,
N-118, MIDC, Tarapura District,
Thana District - 401 506.
Maharashtra.
Represented by A-2.
2.Keerthi T.Shah,
Director,
M/s Ciron Drugs & Pharmaceuticals
Pvt.Ltd.,
N-118, MIDC, Tarapura District,
Thana - 401 506. Maharashtra.
(By Sri.G.Desu Reddy, Advocate.)
2 Crl.A.No.436/2017
JUDGMENT
The appellant/the complainant has preferred this appeal against the respondents/accused through the prosecution under Section 378(1)(a) of Cr.P.C. being aggrieved by the judgment of acquittal passed in CC.No.100/2013 dated 19.11.2016 by the learned Presiding Officer, Special Court for Economic Offences, Bengaluru.
2. For the sake of convenience, the ranks of the parties are retained as they are before the trial Court.
3. The brief facts of the case are that;
a) The complainant/CW-1 (for convenience, "CW-1") is the Assistant Drug Controller appointed under Section 21 of the Drugs and Cosmetic Act of 1940 (for short, "the Act") vide Government Order No.HFW/31/IMM/1998 dated 19.08.1998.
b) CW-1 was posted as Assistant Drug Controller, Chikkamagaluru since 04.06.2010 having jurisdiction over entire Chikkamagaluru District vide order No.ಆಕಕಕ/53/ಐಎಎಎ/2010 read with office order No ಔನಇ/147/ಸಬಬಎದ/2010-11 dated 01.06.2010. 3 Crl.A.No.436/2017
c) CW-1 is a public servant under Section 21 of IPC and empowered to initiate this prosecution vide powers vested with him under Section 32(1) of the Act.
d) Chapter-IV of the Act came into effect in Karnataka from 01.04.1957 vide Gazette Notification No.LLH/10/MDH/57 dated 22.03.1957 and Section 18 of the Act came into effect from 01.03.1959 vide Gazette Notification No.LLH/39/MDR/57 dated 19.12.1958.
e) A-1 M/s Ciron Drugs and Pharmaceuticals Pvt. Ltd. is a Manufacturing Company situated at N-118, MIDC, Tarapura District, Thane - 401 506, Maharashtra (for short, "A-1").
f) A-2 is one of the directors of A-1 possessing valid drug license in Form 28 which was in force from 01.01.2007 to 31.12.2011 issued by the Joint Commissioner, Food and Drug Administration, Maharashtra State, Thane for manufacture and sale of concentrated Vitamin A Solution I.P. i.e., B.No.006025, M/D: 01/08, E/D: 12/09 and was responsible for manufacture of the said drugs.
4 Crl.A.No.436/2017
g) On 04.10.2008, the then Assistant Drug Controller/CW-2 received information from their head office that the drug Vitamin A-Solution I.P. is not of standard quality and it was supplied to various districts through DHO and was instructed to take proper steps and to investigate the matter.
h) Accordingly, on the same day i.e., 04.10.2008, CW-2 has drawn samples 8 x 100 ml of concentrated Vitamin A solution IP labeled as B.No.006025, M/D: Jan- 1998 D/E: Dec-2008 at the Office of the DHO, Chikkamagaluru under Form 17 and 17-A in the presence of the then DHO/CW-7.
i) On the same day, i.e., 04.10.2008, CW-2 issued prohibitory order in respect of the remaining drugs of the same batch in Form 15.
j) On 06.10.2008, CW-2 sent the sampled drugs for test and analysis to the Government Analyst, Karnataka, Drugs Testing Laboratory, Bengaluru/CW-6 under Form
18. 5 Crl.A.No.436/2017
k) On 18.12.2008, the test report was received in Form 13 wherein it was reported that the above said drug was not of standard quality.
l) So, on the same day i.e., on 18.12.2008, CW-2 had issued legal notice under Section 18A and B of the Act to CW-7 along with the copy of the report in Form 13 to disclose the source of acquisition of drugs sampled.
m) CW-7 given reply on 24.12.2008 that the said drug was supplied by the Director of Health Service, Anand Rao Circle, Bengaluru, but did not furnish any invoice. However, submitted that they have not received such invoice and would furnish soon after they receive.
n) On 30.12.2008, CW-2 served the copy of report in Form 13 to the manufacturer/A-1 through RPAD.
o) As the DHO/CW-7 did not give invoice for more than 2 months, CW-2 sent 3 rd potion of sampled dug along with the report in Form 13 to the Director of Health Service, Anand Rao Circle, Bengaluru through RPAD as required under Sections 23 and 25 of the Act and the same was reported to Assistant Drugs Controller, Bengaluru on 23.12.2008.
6 Crl.A.No.436/2017
p) On 20.07.2009, CW-2 submitted a detailed report to Deputy Drugs Controller, Mysuru and on his transfer handed over the case file to his successor in office/CW-1.
q) CW-1 on the directions of the Additional Drugs Controller, State of Karnataka, handed over the copies of the necessary documents for investigation to the Assistant Drugs Controller, Bengaluru Circle-3/CW-3 to investigate at manufacturer level.
r) CW-3 who was entrusted by the Drugs Controller, State of Karnataka/CW-8 to join Sri.Ajay Mudugal, Drugs Inspector, Circle-3, Bengaluru to collect some documents form the manufacturer of the questioned drug and to handover the same to CW-1.
s) CW-3 on receipt of the necessary copies of Form 13, 17 and stock transfer note from CW-1 along with Sri.Ajay Mudugal, Sri.Jayanth Yadav, Drugs Inspector, Thane visited A-1 on 14.06.2011.
t) The Quality Assurance Manger/CW-5 was present and on their request, CW-5 handed over the attested copies of renewal license, product permission copy, copy of Articles of Association and Analytical report and also 7 Crl.A.No.436/2017 furnished the names and addresses of the directors and he had handed over the same to CW-1.
u) Thereafter, CW-1 received the letter from DHO, Chikkamagaluru that the drug in question was manufactured by A-1 enclosing the invoice.
v) As the investigation was completed, CW-1 wrote the letter to CW-8 on 03.08.2011 for sanction to prosecute against the accused and on 03.11.2011, he received the sanction and accordingly, filed the complaint on 09.12.2011 before the Additional JMFC., Chikkamagaluru.
4. The trial Court record reveals that on receipt of complaint, the I Additional JMFC., Chikkamagaluru took the cognizance and after registering the case, the accused were appeared through their counsel who filed application under Section 205 of Cr.P.C. which was came to be allowed.
a) Thereafter, as the accused remained absent, NBW was ordered against the accused.
b) In the mean time, by virtue of the order dated 28.11.2012 passed by the Hon'ble High Court of Karnataka in Criminal Petition No.5947/2012, the case was 8 Crl.A.No.436/2017 transferred to the Special Court for Economic Offences, Bengaluru, before whom, the accused were appeared through their common counsel and were enlarged on bail.
c) Plea of the accused was recorded wherein A-2 on his behalf and on behalf of A-1 pleaded not guilty and claimed to be tried. Accordingly, the matter was posted for prosecution evidence.
d) In support of its case, the prosecution was successful in getting examined 7 witnesses i.e., CWs-1, 3, 2, 6, 7, 5 and 8 respectively as PWs-1 to 7; getting exhibited 25 documents at Ex.P-1 to 25 and 44 material objects at MOs-1 to 44.
e) Statement of the accused was recorded under Section 313 of Cr.P.C., wherein A-2 on his behalf and also on behalf of A-1 has denied the incriminating evidence against them and submitted that he has no defence evidence to lead.
f) After hearing both sides on merits of the case and on going through the evidence on record, the trial Court has passed the impugned judgment by acquitting the accused.
9 Crl.A.No.436/2017
5. The complainant has come up with this appeal reiterating the oral evidence of the prosecution witnesses and on the grounds that;
a) The trial Court holding that;
1) The drugs were not seized in the presence of panchas.
2) Copy of report in Form 13 was not furnished to the manufacturer.
3) The Gazette Notification appointing CW-6 was not produced has passed the impugned judgment.
b) The trial Court has passed the impugned judgment without appreciating and considering the provisions of Section 27(d) of the Act.
c) The findings that the sample of alleged drug not collected as per law is not proper.
d) The facts of the case are contradictory to the reasons assigned in the judgment that the mahazar was not drawn and the procedures of seizure were not followed while drawing the sample.
e) The trial Court has not considered the mandates followed under Section 23(3)(4) of the Act and the 10 Crl.A.No.436/2017 correspondence with the alleged manufacturer under Section 25 of the Act.
f) The trial Court has failed to consider the evidence of the Scientific Officer regarding the scientific analysis of the alleged drug.
g) The complainant being a public officer is duty bound to register the complaint to safe guard the public interest in the process of maintaining standard quality of the medicines which may cause adverse affect on the health of general public.
h) Though the prosecution has proved the alleged accusations against the accused beyond reasonable doubt with all cogent oral and documentary evidence, the trial Court has neglected to consider the same and passed the impugned judgment acquitting the accused which is not maintainable in law and is liable to be set aside.
i) The appeal is well within time and accordingly, prayed to allow the appeal and to set aside the impugned judgment and convict the accused in the ends of justice. 11 Crl.A.No.436/2017
6. In response to the due service of notice, the respondents/accused appeared through their common counsel.
7. Secured the trial Court record.
8. Heard both the sides on merits of the case.
a) In support of his oral arguments, the learned Public Prosecutor has relied on the judgment of the Hon'ble Apex Court passed in the case of Amery Pharmaceuticals and Another vs State of Rajastan delivered on 16 th March, 2001 and has produced the online printout of the same.
b) On the other hand, the learned counsel for the respondents/accused has relied on the following decisions of which he has produced the xexox copies/online printouts in the connected Criminal Appeal No.1402/2016.
1) Crl.Misc.No.34874/2003 on file of the Hon'ble High Court of Patna.
2) 1999 Drugs Cases 94 on the file of the Hon'ble High Court of Bombay.
3) Criminal Appeal No.341/2011 on the file of Hon'ble High Court of Karnataka.
4) 2002 Crl.LJ 1353
5) Criminal Petition No.15263/2011 on the file of
the Hon'ble High Court of Karnataka.
6) Criminal Petition No.8431/2015 on the file of the Hon'ble High Court of Karnataka.
7) 2017(2) Drugs Cases (DC) 49 on the file of the Hon'ble High Court of Bombay.
12 Crl.A.No.436/2017
8) 2017(2) Drugs Cases (DC) 27 on the file of the Hon'ble High Court of Bombay.
9) 2015(1) Drugs Cases (DC) 2 on the file of the Hon'ble High Court of Andhra Pradesh.
10) 2013(2) Drugs Cases (DC) 2006 on the file of the Hon'ble High Court of Gujarath.
11) 2011(2) Drugs Cases DC 18 on the file of the Hon'ble High Court of Karnataka.
12) 2007 Drugs Cases (DC) 3 on the file of the Hon'ble High Court of Andhra Pradesh.
b) This Court has carefully gone through the above noted decisions and perused the record.
9. On the basis of the grounds made out, the following points are arose for the due determination of this Court;
1) Whether the appellant/the prosecution proves the grounds urged in support of the present ap- peal?
2) Whether the impugned judg-
ment requires interference by this Court?
3) What order?
10. The findings of this Court on the above points are;
1) Point No.1 : In Partly Affirmative.
2) Point No.2 : In Negative.
3) Point No.3 : As per final order for the following reasons.
13 Crl.A.No.436/2017REASONS
11. POINTS Nos.1 AND 2:- As the finding on point No.2 is consequential to the findings on point No.1, these points are taken together for consideration.
12. The trial Court record demonstrates that all the witnesses examined for the prosecution i.e., CWs-1 to 3 and 5 to 8 deposed supporting the case of the prosecution noted above; produced all the documents referred therein i.e., Ex.P-1 to 25; the drugs samples at MOs-1 and 2; and also the remained drugs against which CW-2 has passed the prohibitory order i.e., MOs-3 to 44. The witnesses have identified their signatures over the documents and also the drugs samples at MOs-1 to 44.
13. The impugned judgment demonstrates that holding that;
a) the sample was not drawn in the presence of two independent witnesses under mahazar;
b) Gazette Notification of the officer drawn the samples was not produced; and
c) the report in Form 13 cannot be relied upon, the case was ended in acquittal.
14 Crl.A.No.436/2017
14. Out of the above points for acquittal, in the grounds urged, the complainant has attacked only,
a) The drugs were not seized in the presence of panchas.
b) The report in Form 13 cannot be relied upon.
15. So, the point for acquittal in the impugned judgment observed above i.e., non production of the Gazette Notification of the officer drawn the samples is not attacked by the complainant. On the other hand, the complainant has raised the ground on the non production of the Gazette Notification of the Scientific Officer/CW-6.
16. However, in support of the above points, the counsel for the accused has drawn the attention of this Court to the provisions of Sections 20 and 21 of the Act which are extracted here below;
"20. Government Analyst - (1) The State Government may, by noti- fication in the Official Gazette, ap- point such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the State and in respect of such drugs or (classes of drugs or such cosmetics or classes of cosmet- ics) as may be specified in the notifi-
cation.
15 Crl.A.No.436/2017(2) The Central Government may also, by notification in the Offi- cial Gazette, appoint such persons as it thinks fit, having the pre-
scribed qualifications, to be Govern- ment Analysts in respect of such drugs or {classes of drugs or such cosmetics or classes of cosmetics} as may be specified in the notification. (3) Notwithstanding anything contained in sub-section (1) or sub- section (2), neither the Central Gov- ernment nor a State Government shall appoint as a Government Ana- lyst any official not serving under it without the previous consent of the Government under which he is serv- ing.
(4) No person who has any finan-
cial interest in the import, manufac- ture or sale of drugs or cosmetics shall be appointed to be a Govern- ment Analyst under sub-section (1) or sub-section (2) of this section.
"21. Inspectors.- (1) The Central Government or a State Government may by notification in Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.
(2) The powers which may be ex-
ercised by an Inspector and the du- ties which may be performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics in 16 Crl.A.No.436/2017 relation to which the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.
(3) No person who has any finan-
cial interest in the import, manufac- ture or sale of drugs or cosmetics shall be appointed to be an Inspec- tor under this Section.
(4) Every Inspector shall be deemed to be a public servant within the meaning of Section 21 of the Indian Penal Code (45 of 1860), and shall of officially subordinate to such authority having the pre-
scribed qualification, as the Govern- ment appointing him may specify in this behalf".
17. On these points, he has also drawn the attention of this Court to the following decisions.
a) 1999 Drugs Cases 94 (between State of Maharashtra versus R.A.Chandwarkar and others in Criminal Revision Application No.228 of 1991 decided on 18/19th February, 1999 before his Lordship S.Radhakrishnan, J.) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Bombay that;
" .....17 Crl.A.No.436/2017
B) Drugs & Cosmetics Act, 1948 -
Section 20 - provisions mandatory
- the State must publish in an offi- cial Gazette the appointment of the Government Analyst specifying therein the area wherein the Gov- ernment Analyst can operate and also specifying therein the products with which the Government Analyst can test and analyze - the State can appoint the Government Ana-
lysts only by publication of Gov- ernment Gazette Notification as contemplated under section 20 of the Drugs and Cosmetics Act, 1940, and not otherwise. The general notification dated 15th Octo- ber, 1971 being Ex.P-32 referred to and relied upon by the learned A.P.P. would not suffice for the pur- poses of compliance with section 20 of the said Act. Since the said notifi- cation dated 15th October 1971 pub- lished in the Government Official Gazette is totally ambiguous and uncertain, inasmuch as, it is diffi- cult to ascertain as to who exactly will be the Government Analyst and for which area and for which prod- ucts. The said notification is to- tally vague - The Government ought to have issued a notification and published the same in an Offi- cial Gazette with regard to the ap- pointment of Dr.A.D.Nadkarni, which has not been done at all in the instant case - Dr.A.D.Nadkarni was not appointed as a Govern -
ment Analyst validly and properly as per the provisions of section 18 Crl.A.No.436/2017 20 of the Drugs and Cosmetics Act,1940.
C) Drugs & Cosmetics Act, 1940
- Section 21 - Drugs Inspector - ap- pointment of - the appointment of Drug Inspector can only be through an official Gazette Notifi- cation and not otherwise - such a notification should also indicate the area in which such a Drugs Inspector can operate and exer-
cise his powers, and the same should not be left to conjectures and surmises of the public - The said Drug Inspector Mr.V.D.Patil had no authority whatsoever to seize the said samples of Drug Van-
mycetin Opticops and forward the same for analysis to the Government Analyst and that he had no jurisdic- tion whatsoever to launch the said prosecution and file the criminal complaint against the accused.
....."
b) 2007 Drugs Cases (DC) 3 (M/s Gaba Pharmaceuticals, Hyderabad and Another Vs State of AP in Crl.R.C.No.1121 of 2002 decided on 6 th April 2006 before his Lordship Hon'ble Mr.Justice K.C.Bhanu) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Andhra Pradesh that;
"Drugs and Cosmetics Act, 1940
- Sections 20, 21 - non compliance of - no Gazette Notifications pro-19 Crl.A.No.436/2017
duced to show the appointment of Public Analyst and Drugs Inspector
- judgment set aside.
.....
10. The revisional jurisdiction ..... as follows:
"20. Government Analysts: (1) The State Government may, by noti- fication in the Official Gazette, ap- point such persons as it thinks fit, having the prescribed qualifications, to be Government Analyst for such areas in the State and in respect of such drugs or (classes of drugs or such cosmetics or classes of cosmet- ics) as may be specified in the notifi-
cation.
It was further held as follows:
The provisions of Section 20 of the Act are mandatory and thus, the State must publish in an Offi- cial Gazette the appointment of the Government Analyst specify- ing therein the area wherein the Government Analyst can operate and also specifying, therein the products with which the Govern - ment Analyst can test and ana- lyze."
.....
14. The provisions of Sections 20 and 21 of the Act have not been complied with in spite of the fact that the accused raised objection before the Trial Court as well as Appellate Court. It is expected that the prosecution has to produce the Gazette Notification. Since the 20 Crl.A.No.436/2017 Gazette Notification as published in the Official Gazette has not been placed before the Courts be-
low, illegal and improper findings are given. Further in view of the ju- risdiction of the Public Analyst and Inspector has been taken, there is no need to adjudicate the other grounds as contended by the learned counsel for the petition- ers. In the above circumstances, the judgment impugned is liable to be set aside.
....."
c) 2011(2) Drugs Cases DC 18 (between M/s Sanjeevini Medical General Stores and another Vs State of Karnataka in Criminal Revision Petition No.15/2006 decided on 29th January, 2009 before his Lordship Hon'ble Mr.Justice V.Jagannathan) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Karnataka that;
" Drugs and Cosmetics Act, 1940 ..... - no notification was also pro- duced to show that the person con- cerned, who visited the premises of the petitioners, had the required au- thority by virtue of a notification is- sued appointing him as a public an- alyst and drugs inspector - ..... .....
11. In the case of M/s Gaba Phar- maceuticals Vs. State of A.P. re-21 Crl.A.No.436/2017
ported in 2007 Drugs Cases (DC) 3, the Andhra Pradesh - High Court has taken the view that non compli- ance of Sections 20 and 21 of the Act viz., not producing the Gazette Notification regarding appointment of public analyst and drugs inspec- tor would render the judgment of the trial Court unsustainable in law. To the same effect is another of the Bombay High Court in the case of State of Maharashtra Vs. R.A.Chan- dawarkar, reported in 1999 Drugs Cases 94, and it has been observed in the said decision that the provi- sions of Section 20 are mandatory and the State Government must publish in an official gazette the ap- pointment of the Government Ana- lyst specifying therein the area wherein the Government Analyst can operate and also specifying therein the products with which the Government Analyst can test and analyze. It is further held in the very same decision that appoint- ment of a Drug Inspector can only be through a Government Gazette Notification and not oth- erwise.
....."
18. So, in view of the provisions of Sections 20 and 21 of the Act and the decisions noted above, it is mandatory to appoint not only the Government Analyst but also the Drugs Inspector by notifications in the official 22 Crl.A.No.436/2017 gazette specifying the area having jurisdiction to exercise the powers specified therein.
19. The prosecution has not drawn the attention of this Court to any exceptional provisions or the decisions over ruling the principles rendered in the above decisions. On the other hand, as noted above, there is no attack in the grounds in support of the present appeal in respect of Section 21 of the Act i.e., the appointment of the Drug Inspector.
20. In the present case on hand, it is apparent on the face of record that even in the complaint, only the Notifications in respect of the appointment of CW-1, his posting to Chikkamagaluru and his having jurisdiction over the entire Chikkamagaluru District are referred.
21. Though the true copy of the notification in respect of posting of CW-1 to the Chikkamagaluru District as Assistant Drugs Controller is on record, it is not got exhibited and the notification in respect of the appointment of CW-1 is neither produced nor got exhibited.
22. So far, CW-2 who did the material investigation i.e., drawn the sample, sent the sample to the test, received 23 Crl.A.No.436/2017 the report, issued the notice to CW-7 to disclose the name and address of the manufacture of the sampled drug, sent the copy of the report to the manufacturer/A-1, sent the copy of the report along with the sampled drug to the Director, Health and Service, Anand Rao Circle, Bengaluru, prepared the detailed report and sent the same to the Deputy Drugs Controller, Mysuru, there is neither mention in the complaint about the notification of appointment of CW-2, his jurisdiction, power and etc., nor the copy of the said notification is produced, nor it is got exhibited for the prosecution.
23. With regard to CW-2 who investigated at the manufacturer level and collected the necessary documents as well as handed over the same to CW-1, there is no mention/reference about his appointment, jurisdiction and power etc., in the complaint and though the true copy of the said notification is on record, it is only the front sheet and thus, it is an incomplete document and not got exhibited for the prosecution.
24. With regard to compliance of Section 20 i.e., appointment of CW-6 as Government Analyst, no 24 Crl.A.No.436/2017 notification is either produced or got exhibited for the prosecution. CW-6 in her cross examination has specifically deposed that she has not produced the copy of notification as to her appointment either before the trial Court or enclosed the same to her report in Form No.13.
25. Moreover, the non production of the notification in respect of the appointment of CW-6 as Government Analyst, her jurisdiction and powers, there is no dispute. On the to her hand, it is the ground urged by the prosecution that the said notification is a public document at the public domain and thus, there is no need to produce the same.
26. But, the view taken in the above decisions in particular, the 2nd decision noted above i.e., M/s Gaba Pharmaceuticals, Hyderabad's case supra is that "since the Gazette Notification as published in the Official Gazette has not been placed before the trial Court, there is no need to consider the other grounds urged by the prosecution. As noted above, the prosecution has not drawn the attention of this Court to any exceptional circumstances or the 25 Crl.A.No.436/2017 citations over ruling the principles rendered in the above decisions.
27. Thus, though there is no need to consider the other grounds urged by the prosecution as the acquittal sustains on these grounds alone i.e., non production of the necessary notifications in respect of the appointment of CWs-2, 3 and 6 under Sections 20 and 21 of the Act specifying their jurisdiction and power.
28. However, to see the sustainability of the other grounds, let this Court to consider the other grounds urged by the prosecution. The other ground is that the trial Court has passed the impugned judgment without appreciating and considering the provisions of Section 27(d) of the Act.
29. Admittedly, in the present case, the offence alleged is Section 18(a)(i) punishable under Section 27(d). So, before venturing to discuss on this ground, let this Court to go through the above provisions first which are extracted here below;
"18. Prohibition of manufac- ture and sale of certain drugs and cosmetics - From such date as may be fixed by the State Govern- ment by notification in the Official 26 Crl.A.No.436/2017 Gazette in this behalf, no person shall himself or by any other person on his behalf -
(a) (manufacture for sale or for distribution, or sell, or stock or ex-
hibit or offer for sale) or distribute - {(i) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;
"27. Penalty for manufacture, sale, etc., of drugs in contraven- tion of this Chapter - Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distrib- utes -
.....
(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years (and with fine which shall not be less than twenty thousand rupees) Provided that the Court may for any adequate and special reasons to be recorded in the judgment impose a sentence of imprisonment for a term of less than one year.
30. In the present case on hand, as noted above, it is the allegation of the prosecution that A-1 has 27 Crl.A.No.436/2017 manufactured the subject drug which is of not standard quality and A-2 was in charge of the said manufacture. So, the prosecution allegation attracts the offence alleged.
31. Thus, the present ground with regard to non consideration of the provision of Section 27(d) of the Act holds no water. So far the appreciation of the evidence with regard to the prosecution allegation, it will be considered with the other necessary grounds urged in that regard.
32. The other connected grounds urged by the prosecution are that;
a) The findings that the sample of alleged drug not collected as per law is not proper.
b) The facts of the case are contradictory to the reasons assigned in the judgment that the mahazar was not drawn and the procedures of seizure were not followed while drawing the sample.
c) The trial Court has not considered the mandates followed by the complainant under Section 23(3)(4) of the Act and the correspondence with the alleged manufacturer under Section 25 of the Act.
28 Crl.A.No.436/2017
d) The trial Court has failed to consider the evidence of the Scientific Officer regarding the scientific analysis of the alleged drug.
33. So, before considering these grounds on merits, let this Court first to go through the provisions referred above i.e., Sections 23 and 25 of the Act which are extracted here below;
"23. Procedure of Inspectors.-
(1) Where an Inspector takes any sample of drug or cosmetic under this Chapter, he shall tender the fair price thereof and may require a writ- ten acknowledgement there for. (2) Where the price tendered un-
der sub-section (1) is refused or where the Inspector seized the stock of any drug or cosmetic under clause (c) of Section 22, he shall tender a receipt there for in the prescribed form.
(3) Where an Inspector takes a sample of drug or cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed from to the per- son from whom he takes it and, in the presence of such person unless he willfully absents himself, shall di- vide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and 29 Crl.A.No.436/2017 mark to all or any of the portions so sealed and marked:
Provided that where the sample is taken from premises whereon the drug or cosmetic is being manufac- tured, it shall be necessary to di- vide the sample into three por- tions only:
Provided further that where the drug or cosmetic is made up in con- tainers or small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said container after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remained and dispose of the same as follows:-
(i) one portion or container shall forthwith send to the Govern- ment Analyst for test or analysis;
(ii) the second he shall produce to the Court before which proceed-
ings, if any, are instituted in respect of the drug or cosmetic; and
(iii) the third, where taken, he shall send to the person, if any, whose name, address and other par- ticulars have been disclosed under Section 18A.
30 Crl.A.No.436/2017(5) ......
25. Reports of Government An-
alysts.- (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 In- spector 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 particu- lars have been disclosed under Section 18A and shall retain the third copy for use in any prosecu- tion 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 con-
clusive unless the person from whom the sample was taken of the person whose name, address and other particulars have been dis- closed under Section 18A has, within twenty-eight days of the re- ceipt of a copy of the report, notified in writing to 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 al-
ready been tested and analyzed in the Central Drugs Laboratory, where 31 Crl.A.No.436/2017 a person has under sub-section (3) notified his intention of adducing ev- idence in controversion of a Govern- ment 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 cos- metic produced before the Magis- trate under sub-section (4) of sec- tion 23 to be sent for test or analysis to the said laboratory, which shall make the test for analysis and re- port 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 Labora-
tory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct".
34. So, it is necessary go to through the provision of Section 18A of the Act which reads;
"18A. Disclosure of the name of the manufacturer, etc. - Every per- son, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so re- quired, disclose to the Inspector the name, address and other particulars of the person from whom he ac- quired the drug or cosmetic".32 Crl.A.No.436/2017
35. In the present case on hand, as noted above, it is the case of the prosecution that on the information from the head office, CW-2 drawn the sample in the office of CW-7 and sent the same to CW-6 for test and report.
36. It is in the trial Court record that neither CW-2 nor CW-7 deposed anything with regard to the procedures followed while drawing the sample. However, it is in the evidence of CW-2 that as CW-7 did not give the invoice for more than two months, he sent the 3 rd portion of the sampled drug along with the report in Form 13 to the Director of Health Service, Ananda Rao Circle, Bengaluru.
37. The Form 17 at Ex.P-13 demonstrates that there is an endorsement by CW-7 that he received a copy of Form 17 with sealed portion of the sample. As noted above, 2 sample drugs are marked in this case as MOs-1 and 2. Hence, it can be safely concluded that CW-2 has drawn 4 samples under Form 17.
38. So, the prosecution is successful in establishing the compliance of Section 23(3) with regard to taking of samples in the required forms in the presence of the person from whom/in whose office it was taken. 33 Crl.A.No.436/2017
39. So, for the other requirement of Section 23(3) of the Act i.e., effectively sealing and suitably marking the sample and permitting CW-7 to add their own seal and mark to the portion so sealed and marked by CW-2, there is nothing in the evidence of either CW-2 or CW-7.
40. On the other hand, it is in the cross examination of CW-6 that she does not remember whether she has seen any signatures on the sample portion. There is also no mention in Form 17 with regard to effectively sealing and suitably marking the sample.
41. However, it is in Ex.P-15 i.e., Form 18 that the portion has been marked with the seal "GRG". There is no cross examination on behalf of the accused in that regard. Hence, it can also be safely concluded that the sample was suitably marked. With regard to the effective sealing of the sample drug, there is no evidence on record.
42. So far the compliance of Section 23(4) of the Act, it is the case of the prosecution that CW-7 acknowledged the sample so drawn. As noted above, there is nothing in the evidence of CWs-4 and 7 in that regard. However, as 34 Crl.A.No.436/2017 noted above, there is acknowledgment of CW-7 in Form 17 at Ex.P-13.
43. So far the dispose of remaining 3 samples i.e., Section 23(4)(i), i.e., sending one portion to the Government Analyst, CWs-2 and 6 deposed supporting the prosecution.
44. In respect of disposal of second portion i.e., compliance of Section 23(4)(ii) i.e., the portion to be sent to the Court, there is nothing on record either in the evidence of CW-2 who drawn the sample or in the evidence of CW-3 who did the further investigation of the case or CW-1 who filed the complaint; no document in that regard is exhibited in the case.
45. However, as noted above, 2 sampled drugs are marked in this case as MOs-1 and 2. There is no cross examination with regard to the compliance of Section 23(4)
(ii) of the Act. Hence, it can be safely concluded that the above statutory mandate is complied.
46. With regard to compliance of Section 23(4)(iii) i.e., disposal of third portion of sample to the manufacturer i.e., the accused, it is the case of the prosecution that on 35 Crl.A.No.436/2017 receipt of scientific report, notice under Section 18A was issued to CW-7, who intimated that the drug was supplied by Director, Health Service, Ananda Rao Circle, Bengaluru and on notice to the above Director, it was intimated that the manufacturer of the said drug is A-1 and the manufacture in charge was A-2.
47. In that regard, CWs-1 to 3 and 7 deposed supporting the prosecution and the copies of the said notices at Ex.P-17, reply of CW-7 at Ex.P-18, notice to the above Director at Ex.P-21 and the reply from the office of the above Director to the office of CW-7 at Ex.P-25 are also on record.
48. In respect of sending the third portion of the samples to the accused, as noted above, CW-2 has deposed that since CW-7 did not give the invoice for more than 2 months, he sent the 3rd portion of the sample to the Director of Health Service, Ananda Rao Circle, Bengaluru, which is supported by the copy of the notice at Ex.P-21.
49. As noted above, under Section 23(4)(iii) of the Act, the third portion shall be sent to the person whose name, address and other particulars have been disclosed under 36 Crl.A.No.436/2017 Section 18A of the Act and under Section 18A of the Act, the name, address and other particulars of the person from whom the the drug was acquired shall be furnished.
50. In this case, as noted above, in response to the notice under Section 18A of the Act issued by CW-2, CW-7 by his reply intimated that the questioned drug was supplied to their office from the office of Director, Health Service, Ananda Rao Circle, Bengaluru. So, CW-2 is right in sending the drug sampled with a copy of the report under Form 13 to the above Director.
51. But, it is important to note that as observed above, it is the case of the prosecution and in the evidence of CW-2 that on receipt of reply by CW-7 disclosing the source of acquisition of the questioned drug is the Director, Health Service, Ananda Rao Circle, Bengaluru, vide his reply dated 24.12.2008 at Ex.P-18 and before sending the third portion of the sampled drug with a copy of the report in Form 13 vide his letter at Ex.P-21 dated 12.02.2009, CW-2 had sent a copy of the report in Form 13 to A-1 with his covering letter at Ex.P-19 dated 30.12.2008. 37 Crl.A.No.436/2017
52. At this stage, let this Court to have a look at the decision on which the learned Public Prosecutor has relied on in support of his argument with regard to compliance of Section 23(4)(iii) of the Act by the complainant i.e., the judgment of the Hon'ble Supreme Court of India in Amery Pharmaceuticals and Another vs. State of Rajastan decided on 16th March, 2001 before their Lordships K.T.Thomas, R.P.Sethi JJ. wherein he has relied on the observations of the Hon'ble Apex Court that;
".....
18A. Disclosure of the name of the manufacturer, etc.- Every per- son, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so re- quired, disclose to the Inspector the name, address and other par- ticulars of the person from whom he acquired the drug or cos- metic.".
Thus, the obligation of the In-
spector is to give one portion of the sample to the person whose name, etc., have been disclosed as the per- son from whom the vendor acquired the drug. The requirement of the provision would complied with when the Inspector gives one por- tion of the sample to the person from whom he took the sample, and forward the second portion to the 38 Crl.A.No.436/2017 Government Analyst and the third portion to the Court (before which the prosecution is pending and the fourth portion to the person whose name and address, etc. were disclosed by the vendor. This position is made very clear as can be seen from the first proviso to sub- section (3) of Section 23 of the Act,. .....
....."
53. But, in the present case on hand, as noted above, before sending the letter at Ex.P-21 dated 12.02.2009 to the Director, Health Service, Ananda Rao Circle, Bengaluru, CW-2 was knowing the manufacturer of the questioned drug is A-1.
54. Hence, a question arises in the mind of a reasonably prudent man that then, why CW-2 did not send the third portion of the sampled drug to A-1, instead sent to the above Director that too after 13 days from the date on which, he sent the copy of report in Form 13 to A-1. So, in the circumstances of the case, it cannot be said that the complainant has complied the mandate under Section 23(4)(iii) of the Act.
55. In respect of compliance of Section 25(2) of the Act i.e., delivery of one copy of the report to the 39 Crl.A.No.436/2017 manufacturer i.e., the accused, as noted above, it is supported by the oral evidence of CW-2 and the covering letter at Ex.P-19 and the postal acknowledgement at Ex.P-
20. Thus, the mandate under Section 25(2) of the Act is complied in this case.
56. As it is not the case of the accused that they have notified in writing within 28 days to either CW-2 or CW-3 or CW-1 that they intend to adduce evidence in controversion of the report at Ex.P-16 in Form 13, prima facie, by virtue of Section 25(3) of the Act, the report of CW-6 in Form 13 at ExP-16 became conclusive.
57. However, at this stage, it is pertinent to go through the following decisions relied on by the counsel for the accused in support of his arguments that the valuable rights of the accused under Section 25(3) and (4) of the Act were deprived of, as they were not furnished with the sampled drug.
a) 2015(1) Drugs Cases (DC) 2 (between M/s Johnson & Johnson Ltd & Ors. Versus State of Andhra Pradesh and another in Criminal Petition No.2277 of 2012 decided on 14th October, 2014 before Hon'ble Sri Justice S. 40 Crl.A.No.436/2017 Ravi Kumar) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Andhra Pradesh that;
"Drugs & Cosmetics Act, 1940 - ..... the Officer who lifted the sample has not followed the mandatory pro- visions of Section 25 of the Act - further contended that petition- ers have lost the valuable right of sending second sample for analy- sis because the complaint is filed long after the expiry of the shelf life of the Drug - when right to an- alyze the second sample was lost due to inaction of the prosecuting agency, continuation of proceedings would amount to abuse of process of court. Therefore, on a scrutiny of the material and on a consideration of facts and circum- stances of the case, Court is of the view that continuing the prosecution against petitioners will be a futile exercise and would amount to abuse of process of court and that the powers under Section 482 Cr.P.C. have to be exercised. .....
6. It is contended that when the sample of a drug in question, could not be sent for second analysis be- fore its expiry date for the fault of the Drug Inspector, the accused is deprived of his right under Sec- tion 25(3) of the Act, therefore, the complaint under other pro- ceedings are liable to be quashed 41 Crl.A.No.436/2017 as observed by Hon'ble Supreme Court in Medicamen Biotech Lim- ited and Another Vs.Rubina Bose, Drug Inspector 2008 Drugs Cases (Drugs & Cosmetics) 163 : (2008) 7 Supreme Court Cases 196 and Northern Mineral Ltd., Vs. Union of India (UOI) and Another (Crim- inal Appeal No.766 of 2003).
7. On the other hand, learned Public Prosecutor submitted that all the objections raised on behalf of pe- titioners are matter of evidence which has to be considered during trial and these aspects cannot be decided in a quash petition under Section 482 Cr.P.C.
.....
28. As seen from the ..... In MEDICAMEN BIOTECH LIMITED AND ANOTHER Vs. RUBINA BOSE, DRUG INSPECTOR 2008 DRUGS CASES (DRUGS & COSMETICS) 163 (2008) 7 SUPREME COURT CASES 196, Honourable Supreme Court quashed the proceedings for non-
compliance of Section 25(3) and 25(4) of the Act in that case the Honourable Supreme Court held as under:
"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 conced- edly the filing of the complaint had nothing to do with the ap- pearance of the accused in re- sponse to the notices which were to be issued by the Court after 42 Crl.A.No.436/2017 complaint had been filed. Like- wise, requests for testing of drug had been made by the appellant in for retesting of drug had been made by the appellant in August/Septem- ber, 2001 and there is absolutely no reasons as to why complaint could not have been filed earlier and fourth sample sent for retesting well within time. Facts of the case suggest that the appellants have been deprived of a valuable right un- der Sections 25(3) and 25(4) of the Act which must necessitate quash- ing of proceedings against them."
29. In this case, the sample was lifted on 02.08.2007 and the analyst gave report on 05.12.2008 and the same was forwarded to A-1 firm on 27.02.2009 and A-1 firm through letter dated 03.03.2009 requested the authorities to arrange for re- peat of analysis but the authori- ties have not taken any steps but filed the complaint on 13.04.2011 long after the expiry of shelf life.
30. In STATE OF HARYANA Vs. UNIQUE FARMAID (P.) LTD. AND ORS. 1999(2) 8 SUPREME COURT CAES 190, the Honourable Supreme Court upheld the orders of the High Court which quashed the proceed- ings on the ground that the accused was deprived of the right to get the sample tested by Central Labora- tory.
31. In that case, the issue before Supreme Court was under insecti- cides Act but the provisions of that 43 Crl.A.No.436/2017 Act and the provisions of the Drugs Act in respect of right of accused to have the test of sec-
ond sample are similar. In that case, the facts and findings are as follow:
.....
Held:
32. If the expiry date of the sam-
ple was not relevant, there was no reason why in the form pre-
scribed for submission of the re- port by the Insecticide Analyst, the dates of manufacture of the article and the expiry date are mentioned.
....."
b) 2013(2) Drugs Cases (DC) 2006 (between Galpha Laboratories Ltd & Ors. Versus State of Gujarat & Another in Criminal Misc. Application No.8205 of 2012 decided on 12th December 2013 before his Lordship Hon'ble Mr.Justice R.M.Chhaya) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Gujarat that;
"Drugs & Cosmetics Act 1940 - section 18(a)(i) and 27(c) - complaint under - by way of this petition un- der Article 226 of the Constitution of India read with Section 482 of the Code of Criminal Procedure, 1973 the petitioners have prayed for quashing and setting aside the im-44 Crl.A.No.436/2017
pugned complaint filed against the petitioners - in the instant case, in view of the fact that the complaint was filed after shelf life of the sam- ple of the drug, the petitioners - accused have been deprived of their valuable statutory right of getting the sample re analyzed from the Central Drug Laboratory
- as the complaint came to be lodged after shelf life of the sample, which as per the admitted factual position, was to expire in January, 2008, any further continuance of the criminal proceedings against the petitioners would amount to abuse of process of law and Court
- this is a fit case for exercise of in- herent powers under Section 482 of the Code to Prevent the same and to secure the ends of justice. .....
4. Mr.Y.H.Motiramani, learned advocate for the ..... The learned advocate for the petitioners submit- ted that the prosecution has lodged the complaint after shelf life of the drug was over and therefore, the same has prejudiced the defence. The learned advocate for the peti- tioners, relying upon the judgment of the Hon'ble Supreme Court in the case of State of Haryana Vs. Unique Farmaid (P) Ltd. & Ors., reported in 1999(2) FAC 399: (1999) 8 SCC 190, the judgment of the Hon'ble Bombay High Court in the case of M/s Zim Laboratories, Bombay & Ors. Vs. State of Maharashtra, reported in 1999 Drugs Cases 332: 1999 Cr-45 Crl.A.No.436/2017
l.L.J. 2903, the decision of this Court in the case of Mukesh Laljib- hai Thakkar & Ors. Vs Food Inspec- tor C/o Food and Drug Control & Anr. reported in 2013(1) FAC 434 and unreported judgment of this Court (Coram: H.N.Devani, J.) in the case of Pepsico India Holdings Pvt.Ltd. & Ors. Vs. State of Gujarat & Anr. rendered in Special Criminal Application No.539 of 2011, con- tended that the provisions which are relied upon by this Court are similar and as held by the Hon'ble Apex Court in the case of State of Haryana (supra), the im- pugned complaint would amount to abuse of process of law and Court. It is, therefore, submitted that on this ground alone, the im- pugned complaint deserves to be quashed qua the present petitioners. ....."
58. In this case, it is an admitted fact and evident on record that the sampled drug was not furnished to the accused. Therefore, prima facie, it appears that the accused were deprived of the valuable statutory rights under section 25(3) and 25(4) of the Act.
59. Accordingly, the principles rendered in the above decisions are applicable to the case on hand and therefore, it is clear that the initiation of the present proceedings 46 Crl.A.No.436/2017 against the accused is abuse of process of law as laid down in the above decisions.
60. With regard to the scientific report at Ex.P-16 in Form 13, it is in the cross examination of CW-6 that the required temperature to preserve the drug in question was temperature below 25 degree Celsius and she has denied the suggestion that it was not kept in the required temperature, due to which, test report varied in its result.
61. In this regard, the counsel for accused has drawn the attention of this Court to the decision reported in 2010(1) Drugs Cases (DC) 203 (between Sulochana Devi Versus State of Bihar in Criminal Miscellaneous No.34874 of 2003 decided on 26th August, 2008 before his Lordship Hon'ble Mr.Justice Abhijit Sinha), wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Patna that;
"CrPC, 1973 - application under - for quashing the entire criminal pro- ceedings - Drugs and Cosmetics Act, 1940 - Section 27 - ..... the storage conditions in the hospital as also in the office of the Drug Controller has not been stated. .....
.....47 Crl.A.No.436/2017
7. 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 re- ceived the consignment containing the drug on 08.02.2000 and selling the same to the Superintendent on 24.02.2000 and that it had re- mained with the retailer for only 16 days. They have also sought to raise question regarding the storage con- ditions 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 origi- nality due to improper storage con- ditions.
8. From the submissions ad- vanced by the respective parties ..... Thirdly, there is no explanation for the delay of four months in sending the sample for analysis and fourthly, the storage conditions in the hospi- tal as also the office of the Drug Controller has not been stated and finally, no report of the analysis was supplied to the petitioner. ..... ....."
62. In the present case on hand also, as noted above, there is no supportive evidence to the oral testimony of CW-6 with regard to the storage of drug in the required temperature.
48 Crl.A.No.436/2017
63. At this stage, it is also important to note that it is the case of the prosecution and in the evidence of CW-2 that the sample was drawn on 04.10.2008 and it was sent for test on 06.10.2008. But, it is in the evidence of CW-6 and in her report at Ex.P-16 in Form 13 that the sample was received on 20.10.2008 and the report is dated 15.12.2008.
64. So, the sampled drug was subjected to examination (as there is no mention of the date of examination, either in Ex.P-16 or in the evidence of CW-6, the date of report has to taken as the date of examination and accordingly,) 2 months 10 days from the date on which the sample was drawn.
65. Hence, in view of no supportive evidence to the oral testimony of CW-6 that they have kept the sampled drug in the required temperature, the dictum laid down in the above decision is helpful to the accused.
66. CW-6 has deposed that she has not produced the protocols test before the Court. Of course, she has deposed that the test was conducted as per IP-1985 where 49 Crl.A.No.436/2017 producing protocols is not necessary, but to substantiate her above evidence, she has not produced any authority.
67. On the other hand, the counsel for the accused has drawn the attention of this Court to the Rule 46 of the Drugs and Cosmetics Rules of 1945 which reads;
"46.Procedure on receipt of sample.-
On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet (or on portion of sample or container) with the specimen im- pression received separately and shall note the condition of the seals on the (packet or on portion of sam- ple or container). After the test or analysis has been completed, he shall forthwith supply to the In- spector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied.
68. In this regard, he has also relied on the judgment in Criminal Appeal No.341/2011 between State of Karnataka Vs Bimal Kumar Gupta and another decided on 11th October, 2019 before his Lordship Hon'ble Mr.Justice K.N.Phaneendra wherein he has drawn the attention of this 50 Crl.A.No.436/2017 Court to the observations of the Hon'ble High Court of Karnataka that;
".....
13. The fact remains that another important point raised by the re- spondents Counsel before this Court with reference to the contents of Ex.P40 the State Analyst report, is nowhere considered either by the Trial Court or by the Appellate Court. Therefore, it becomes the re- sponsibility of this Court to examine the contents of the State Analyst's report because of the simple reason that if the State Analyst's report is accepted as it is, it raises a pre- sumption that it is conclusive evi- dence so far as the contents of the said document is concerned. There- fore, the Court should be very care- ful before accepting the State Ana- lyst's report, but ascertain before ac- cepting the same whether it com- plies with the strict mandatory pro- visions of law. In this background, let me consider the Analyst's report which is marked as Ex.P40.
14. Before adverting to the Ana- lysts report marked as Ex.P40, I feel it just and necessary to have a brief look at Rule 46 of the Drugs and Cosmetics Rules, 1945 which con- templates what should be the proce- dure that should be followed by a Government Drug Analyst and how the report has to be given and what should be contents of the said re- port. The said Rule reads as follows:51 Crl.A.No.436/2017
"46. Procedure on receipt of sam- ple.- On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet (or on portion of sample or container) with the specimen im- pression received separately and shall note the condition of the seals on the (packet or on portion of sam- ple or container). After the test of analysis has been completed, he shall forthwith supply to the Inspec- tor a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied. .....
21. It is very curious to note here that the cross examination of the witness it further creates serious doubt with regard to the contents of the quantity as described in the said report. He admits that in Ex.P40 he has not mentioned the full protocols, but it is mandatory as noted above under Rule 46 of the Rules. ..... When he specifically states that he has conducted vari- ous tests those tests ought to have been mentioned in the report Ex.P.40. Therefore, the said report is not in full compliance with Rule 46 of the Rules.
22. In such cases the Court should be very meticulous in looking to the legal aspects and technical aspects involved in a particular case. Technically the procedure fol-52 Crl.A.No.436/2017
lowed by the Drugs Inspector in sending the sample to the Analyst and the Analyst conducting the analysis may be sound enough. But in order to draw a conclusive proof of the said document the other legal requirements have to be complied by the Analyst. As I have already noted there is a proce- dure prescribed under Rule 46 of the Rules which clearly mandates as to, in what manner the analysis has been done and what should be the contents of the report sent by the Analyst to the complainant (Drugs Inspector). Therefore, though the trial Court and the Appellate Court have lost sight of this par- ticular aspect and they have not in detail meticulously gone into the contents of Ex.P40, the trial Court has raised as if a presumption that the contents of Ex.P40 is proved and it is not controverted by means of leading any evidence by accused as contemplated under Sec- tion 25(4) of the Act. But, when the document itself is not in accor- dance with law, the question of controverting the said document does not arise. The document be- comes void abinitio for considera- tion by this Court if it is legally not acceptable by Courts. There- fore, .....
....."
69. In the present case on hand also, as noted above, CW-6 has not furnished the test protocols with her report. 53 Crl.A.No.436/2017 Of course she has claimed the exemption i.e., she has stated that as she has conducted the test as per IP 1985, the production of protocols is not necessary. But, has failed to produce the authority in support of her claiming exemption.
70. At this stage, it is important to have a look at the observations of the Hon'ble High Court of Bombay in R.A.Chandwarkar's case supra on which the counsel for accused has also relied on, that;
" .....
68. In this behalf, Mr.Ganatra, the learned counsel for the respon- dents has relied upon the judgment of this Court in K.T.Rajkotwala Vs The State of Maharashtra, 1976 U.C.R. (Bom) 474. In this case the judgment of the Division Bench of this Court in Criminal Appeal No.1008 to 1011 of 1967 decided on 25th April, 1969 is quoted, which reads as under;
"In each case the certificate which the analyst has given is "I further certify that I have caused to be ana- lyzed the aforesaid sample and de- clare the result of the analysis to be a follows". This is a direct declara- tion of the result of the analysis and without anything more nec- essarily implies that the result was obtained on the date on 54 Crl.A.No.436/2017 which the certificate was signed. If it was the prosecution case the public Analyst has made his analy- sis soon after the receipt of the sam- ples but had kept a record of the analysis with him and merely gave the certificate from that record then this report will loose the eviden- tiary value which is imparted to it by the Act. It will really be these en- tries which will be endowed with the evidentiary value which the Act im- parts to the Public Analyst's report".
69. Thus, it was held that the Public Analyst should make the re- port at the same time when the sample is analyzed, but if made later on, it will cease to have evi- dentiary value. The learned Judges have observed in the above men-
tioned judgment that the primary evidence of analysis has not been produced and there is, therefore, no legal evidence on record to show that the sample was not of the prescribed purity, and accordingly, the report of the Public Analyst would not be relied upon and the conviction of the appellant was set aside.
....."
71. In the present case on hand also, in view of the above observations, the report of CW-6 at Ex.P-16 looses the evdentiary value.
55 Crl.A.No.436/2017
72. The one more ground urged by the prosecution is that the complainant being a public officer is duty bound to register the complaint to safe guard the public interest in the process of maintaining standard quality of the medicines which may cause adverse affect on the health of general public.
73. The fact rather the principle in the above ground is not in dispute, but at the same time, the complainant being the public servant discharging his duty under the Act is duty bound to follow the mandate under the Act in conducting the investigation and initiating the prosecution which are not followed/complied in this case as noted above.
74. The other ground urged by the prosecution is that though it has proved the alleged accusations against the accused beyond reasonable doubt with all cogent oral and documentary evidence, the trial court has neglected to consider the same and passed the impugned judgment acquitting the accused which is not maintainable in law and is liable to be set aside.
56 Crl.A.No.436/2017
75. As noted above, in view of non compliance of the statutory mandates, the prosecution has not only failed to establish its case, at the same time, it has deprived the accused from their valuable right and thereby to have a fair trial.
76. In the course of arguments, the counsel for the accused has drawn the attention of this Court to the sanction letter at Ex.P-5 and the cross examination of CWs-1 and 8 and it is his arguments that no details of the facts and circumstances of the case as well as the penal clause are not mentioned in the permission letter.
77. In this regard, he has drawn the attention of this Court to Sanjeevini Medical General Stores' case supra wherein the Hon'ble High Court of Karnataka has observed that;
" Drugs and Cosmetics Act, 1940 ..... - the very contents of the sanction order reveal total non application of mind. Neither the sections of the Act which are contra- vened nor the offences attracted against the petitioners are men- tioned in the sanction order - con- viction and sentence orders of the petitioners set aside - appeal al-57 Crl.A.No.436/2017
lowed - acquittal on benefit of doubt.
....."
78. But, in the present case on hand, the sanction at Ex.P-5 demonstrates that in the preamble the nature of drug, the details of the batch of drug, the inspection report and the observations therein are referred and based on the same, the opinion with regard to prima facie materials for the offence alleged is also noted and thereafter only, the sanction was ordered for prosecution of the accused for the offence alleged. Hence, this ground raised by the accused in support of their defence on sanction at Ex.P-5 holds no water.
79. The counsel for the accused has also drawn the attention of this Court to the provision of Section 34 of the Act which reads;
"34. Offences by companies -
(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence 58 Crl.A.No.436/2017 and shall be liable to be proceeded against and punished accordingly;
Provided that nothing contained in the sub-section shall render any such person liable to any punish- ment provided in this Act if he proves that the offence was com-
mitted without his knowledge or that he exercised all due dili-
gence to prevent the commission of such offence.
(2) Notwithstanding anything con- tained in sub-section (1) where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be li- able to be proceeded against and punished accordingly".
80. In support of the defence that A-2 was not the Director of A-1 and was not in charge of the manufacture of the subject drug as well as he was not responsible for the day to day affairs of A-1, the counsel for the accused has relied on the following decisions.
a) 2002 CRI.L.J. 1353 (between Sanjay G Ravankar and etc. Petitioner v. State of Karnataka etc. Respondents 59 Crl.A.No.436/2017 in Criminal Revn.Petn.No.265 of 1997 c/w Crl.Petn.Nos.256, 255, 257, 258 of 1999 : 209 of 2000, 2933, 2934, 2935 and 2936 of 1999 and 736, 737, 739 and 738 and 3070 of 2001 etc decided on 15.10.2001 before his Lordship S.R.Bannurmath, J.) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Karnataka that;
" .....
(B) Drugs and Cosmetics Act (23 of 1940), S.34 - Offences by compa-
nies - Quashing of complaint - Com- plaint filed alleging offence under Section 18 against Manager of Com- pany, Technical staff as well as its partners and Directors - No specific averment about role of each of Di- rectors except baldly stating in com- plaint that these are Directors of ac- cused Company - Merely because petitioners are Directors of Com- pany, is not a prima faice indica- tion of their committing offence vicariously - Order taking cog-
nizance and issuing process against petitioner - Directors of Company li- able to be quashed - However, aver- ment in complaint showing that other petitioners namely Manager of Company and technical staff are person in charge of and responsible to Company for conduct of its busi- ness - Order taking cognizance and issuing process against such 60 Crl.A.No.436/2017 other petitioners cannot be quashed.
....."
b) Judgment in Criminal Petition No.15263/2011 between Ritesh Vs The State of Karnataka decided on 19 th November, 2011 before his Lordship Hon'ble Mr.Justice Aravind Kumar, wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Karnataka, Gulbarga Bench that;
".....
Re:Point No.1:
17. It has been contended by the complainant that "ferrous Sulphate tablet NFI" is a drug within the meaning of Section 3(b) of the Act which has been manufactured and sold and it is not of standard quality thus attracting Section 18(a)(1) of the Act. In the complaint at para-
graph 6 to 10 it has been alleged as under:
"That the accused persons are responsible for conducting the busi- ness of A-1 factory."
.....
21. A perusal of the complaint filed against the petitioners in the instant case would disclose that only an assertion has been made in the complaint that petitioners have committed offence by manufacturing 61 Crl.A.No.436/2017 and selling the drugs that are not of standard quality. It is nowhere stated in the complaint as to the role of petitioners in either par- ticipating in the day to day affairs of the A-1 industry and as to their actual role in manufactur-
ing the drugs in question. It would also be of relevance to note at this juncture itself that license is- sued to A1 factory would specifically state as to who are the persons namely persons who are engaged in the manufacture and it is specifi- cally stated therein the approved ex- pert staff of A1 factory and testing officials and laboratories engaged in testing and certifying the drug man- ufactured by A1 industry are speci- fied in the License granted who can be construed as persons manufac- turing the drugs in question.
22. Thus, on examination of facts namely the averments made in the complaint and the case laws ex- tracted herein above, I am of the considered view that the averments made in the complaint regarding the role and responsibilities of the petitioners not being specific precise, they cannot be proceeded against and complaint does not re- veal that petitioners herein were in charge and responsible for the con- duct of the business of A1 firm ex- cept a bald and vague statement made in the complaint stating that petitioners were the directors of the firm and they were in charge of day to day affairs when the license is- 62 Crl.A.No.436/2017
sued goes to show the persons in-
volved in the Manufacturing process as someone else. In that view of the matter, I am of the con- sidered view that learned Magistrate was not justified in taking cog-
nizance of the offence alleged against petitioners herein and issu- ing summons.
....."
c) Judgment in Criminal Petition No.8431/2015 between M/s Zee Laboratories and Another Vs. Union of India decided on 21st August, 2018 before his Lordship Hon'ble Mr.Justice Budihal R.B., wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Karnataka that;
".....
4. Learned counsel for the peti- tioners ..... The learned counsel draws the attention of this Court to para No.18 of the complaint and submitted that the complainant himself has specifically pleaded that accused Nos.4 and 5 are responsible for manufacturing and analyzing testing the subject matter of drug and therefore, taking cognizance against the petitioners herein is against the mandatory provisions of law. Hence, he submitted to allow the petition and set aside the im- pugned order of taking cognizance.63 Crl.A.No.436/2017
In support of his contentions, the learned counsel has relied upon the following decisions:
1. 2015(1) Drugs Cases (DC) 185
- Himachal Pradesh High Court.
2. 2005 Crl.L.J. 2424 (Andhra Pradesh High Court)
3. 2002 Crl.L.J. 1353 (Karnataka High Court)
5. Per contra, learned Central Government counsel submitted that the entire materials are to be looked into and see the cumulative effective emerging out of it. It is not to be considered in isolation, drawing the attention of the Court to the con-
tents of the complaint, the learned Central Government Counsel sub- mitted that the contents in the com- plaint clearly goes to show that even the petitioners accused Nos.1 and 2 were involved in the manufacturing process and they were liable for the offences alleged. Hence, she sub- mitted that the prosecution must have an opportunity to explain all these aspects by leading evidence during the course of trial. There- fore, the petitioners are not entitled for quashing of the proceedings. Hence, she submitted to dismiss the petition.
.....
8. I have also perused the deci-
sions relied upon by the learned counsel for the petitioners herein. Looking to the entire materials, I am of the opinion that so far as peti- 64 Crl.A.No.436/2017
tioner No.2 Rajiv Mukul is con-
cerned, there is no case made out by the complainant because the mandatory requirements under Sec- tion 34 of the Act are not complied with. Therefore, the criminal pro- ceedings initiated against peti- tioner No.2 accused No.2 (Rajiv Mulrul is not maintainable. There- fore, the petition is allowed only in respect of petitioner No.2 accused No.2. The Criminal proceeding against petitioner No.2 accused No.2 is hereby quashed. ....."
d) 2017(2) Drugs Cases (DC) 49 (between Ramprakash Gulati and Ors Versus State of Maharashtra in Criminal Application No.3684 of 2009 decided on 1 st September, 2017 before his Lordship M.Deshpande, J.) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Bombay, Nagpur Bench that;
"A) Quashment of complaint - ap-
plication filed for - on the ground since it lacks in respect of the plead- ings on material aspect - selling of eye ointment that is not of stan-
dard quality - the applicants are the directors of accused no.4, how- ever as per the scheme of the Act merely because a person is a di-
rector that by itself is not suffi- cient to bring him within the clutches of the Act, if the said di- 65 Crl.A.No.436/2017 rector is not responsible for the day to day affairs of the company - spe- cific averments in the complaint are made in respect of accused no.5 who is the manufacturing chemist and accused no.6 who is Analytical Chemist and their roles, however, at the same time the complaint is totally silent in respect of the role of the applicants - held that merely because that a person is director is not self sufficient to establish that the offence is com- mitted with his consent or con-
nivance in the absence of basic pleading in that behalf, thus, in absence of such, merely because the complaint is filed against the di- rectors, they are not required to face gamut of the prosecution at the be- hest of the complainant - complaint set aside qua the applicants - appli- cation allowed.
B) Drugs and Cosmetics Act 1940
- section 34 - offences by Company
- Where an offence under the Act has been committed by a company and it is proved that the offence has been committed with the con-
sent or connivance of, or is at-
tributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such as director, man-
ager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be pro- ceeded against and punished ac-
cordingly.
.....
66 Crl.A.No.436/2017
15) It is not in dispute that the applicants are the directors of ac- cused no.4, however as per the scheme of the Act merely because a person is a director that by it-
self is not sufficient to bring him within the clutches of the Act, if the said director is not responsible for the day to day affairs of the com- pany. In the complaint specific avermetns are made in respect of Shri Ramesh Chandra Malik, ac-
cused no.5 who is the manufac-
turing chemist and accused no.6 Smt.Sarita Bhatnagar, who is An- alytical Chemist and their roles. However, at the same time the com- plaint is totally silent in respect of the role of the present applicants. Section 34 of the Act deals with the offences by companies. The Sec- tion 34 of the Act is reproduced herein as under:
"Offences by companies; (1) Where an offence under this Act has been committed by a company, ev- ery person who at the time of the offence was committed was in- charge of, and was responsible to the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. Provided that nothing contained in this sub section shall render any such person liable to any punish- ment provided in this Act if he 67 Crl.A.No.436/2017 proves that the offence was com- mitted without his knowledge or that he exercised all due dili- gence to prevent the commission of such offence.
(2) Not withstanding anything contained in subsection (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any negligence on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer, shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Explanation: For the purpose of this Section
(a) "company" means a body cor-
porate, and includes a firm or other association of individuals; and
(b) "director" in relation to a firm means a partner in the firm".
16) The reading of sub section 2 of Section 34 of the Act shows that where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attribut- able to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to 68 Crl.A.No.436/2017 be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
17) Thus, sub section 2 of section 34 of the Act clearly mandates that if the director, manager, secretary or any other officer of the company is shown to be an accused in the com-
plaint, then it is obligatory on the part of the complainant to show that the offence is committed with the consent or connivance.
Merely because that a person is di- rector is not self sufficient to estab- lish that the offence committed with his consent or connivance in the ab- sence of basic pleading in that be- half. In absence of such, merely be- cause the complaint is filed against the directors in my view the directors are not required to face gamut of the prosecution at the behest of the complainant.
....."
e) 2017(2) Drugs Cases (DC) 27 (between Rashmi Kamal Shah Vs The state of Maharashtra in Criminal application (APL) No.680 of 2011 decided on 19 th September 2017 before his Lordship V.M.Deshpande, J.) wherein he has drawn the attention of this Court to the observations of the Hon'ble High Court of Bombay, Nagpur Bench that;
69 Crl.A.No.436/2017
"Drugs and Cosmetics Act, 1940
- Section 34 - Offences by Compa- nies - sub Section 2 of Section 34 of the Act clearly mandates that in or- der to launch prosecution against the director, manager, secretary or any other officer of the company then it is obligatorty on the part of the complainant to show that the offence is committed with the consent or connivance. Merely be- cause he or she is a director that by itself is not sufficient to bring such person within the clutches of the Act, if the said director is not re- sponsible for the day to day af- fairs of the company - the appli- cant was not director of the com- pany at all at the time of manufac- turing of the drug in question - criminal complaint against the ap- plicant quashed - application al- lowed."
81. In view of the provision of Section 34 and the principles rendered in the above noted decisions, the complainant is required to establish that A-2 being the director of A-1 was in charge of the manufacture of subject drug and was responsible for the day to day affairs of A-1.
82. In this regard, it is pertinent to note that CW-5 who is admittedly the authorized signatory of A-1 in his chief evidence at para No.2 has specifically and unequivocally deposed that he has confirmed the 70 Crl.A.No.436/2017 manufacturing of the subject drug and also informed that A-2 is the Director and responsible for the day to day affairs of the Company and handed over the self attested copies of the necessary documents when the concerned officials visited their Company/A-1.
83. Though it is suggested and got admitted in his cross examination that he has just produced the copies of the documents and he does not know the contents therein, the evidence of CW-6 that A-2 is the Director of A-1 and responsible for the day to day affairs of A-1 is not questioned in his cross examination.
84. Thus, the evidence of CW-6 that A-2 was the director and was responsible for the day to day affairs of A-1 remained unchallenged. Hence, the above noted decisions are not helpful to the accused to establish their defence that A-2 was neither the director at the relevant point of time, nor responsible for the day to day affair of A-1 or in charge of the manufacture of the subject drug.
85. Therefore, in view of the above discussions, though the prosecution is successful in establishing that the findings of the trial Court that the sample was not 71 Crl.A.No.436/2017 drawn in the presence of two independent witnesses under mahazar is not correct as there is special provision in the Act i.e., Section 23 of the Act in respect of the procedures to be followed by a Drug Inspector while drawing sample which does not say to draw sample in the presence of any independent witness under a mahazar and it is also successful in establishing the service of the test report at Ex.P-16 in Form 13 on the manufacturer/A-1, it has failed to prove the other grounds it has urged and in view of non compliance of statutory mandates under Sections 20 and 21 of the Act; failure to establish the compliance of Section 23(4)(iii) of the Act and thereby depriving the accused from their valuable rights under Section 25(3) and (4) of the Act, it has failed to establish that the findings of the trial Court with regard to the other points are not sustainable and the impugned judgment needs to be set aside.
86. Therefore, in veiw of the prosecution successful in establishing its grounds in support of this appeal partially and thus, point No.1 is answered partly in affirmative, point No.2 is answered in negative. 72 Crl.A.No.436/2017
87. POINT No.3:- From the above discussions and the findings on points Nos.1 and 2 noted above, this Court proceeds to pass the following order.
ORDER The Criminal Appeal filed by the appellant under Section 378(1)(a) of Cr.P.C. is hereby dismissed.
In the result, the judgment of ac- quittal passed by Special Court for Economic Offences, Bengaluru in CC.No.100/2013 dated 19.11.2016 is hereby confirmed.
Send back TCR along with the copy of this judgment forthwith to the trial Court for necessary action. (Dictated to the Judgment Writer directly on computer, corrected by me and then pronounced in the open Court on this the 26th day of May, 2021).
(K. KATHYAYANI ), LXVI Addl.CC & SJ, Bengaluru.
73 Crl.A.No.436/2017Both the parties and their respective counsels are absent.
As per SOP dated 21.05.2021, the entrance of the litigants and the advocates to the Court Premises is prohibited.
Since no phone number and e-mail address are not available in the record, the intimation in respect of delivering the judgment could not be given to the counsel for the respondents. However, intimation is given to the learned PP.
The Order is pronounced in the open Court (vide separate Order).
ORDER The Criminal Appeal filed by the appellant under Section 378(1)(a) of Cr.P.C. is hereby dis- missed.
In the result, the judgment of acquittal passed by Special Court for Economic Offences, Bengaluru in CC.No.100/2013 dated 19.11.2016 is hereby con-
firmed.
Send back TCR along with the copy of this judgment forthwith to the trial Court for necessary action.
LXVI Addl.CC & SJ, Bengaluru.
74 Crl.A.No.436/2017