Bangalore District Court
M/S Venus Remedies Ltd vs State At The Instance Of The Drugs ... on 22 October, 2024
Crl.A.No. 1010/2018
KABC010145832018
IN THE COURT OF THE LII ADDL. CITY CIVIL & SESSIONS
JUDGE, BANGALORE (CCH-53)
Dated this the 22nd day of October, 2024
PRESENT
Sri.Gangappa Irappa Patil., B.A., LL.B(Spl).,
LII Addl. City Civil & Sessions Judge,
Bangalore.
Crl.A.No.1010/2018
Appellant/ M/s Venus Remedies Ltd
Accused: No. 51-52, Industrial Area
Phase 1, Panchakula
Haryana 134 113
Represented by its
Authorized Signatory
& Sr. Manager (CRA Dept)
Mr. Vijay Pal.
(By Sri G.Desu Reddy, Advocate)
-V/S-
Respondent/ State at the Instance of
Complainant The Drugs Inspector
Bengaluru Circle IV
Bengaluru.
Represented by
Public Prosecutor
2
Crl.A.No.1010/2018
Court of Principal City Civil
& Sessions Judge, Bengaluru.
JUDGMENT
This appeal is filed by the Appellant praying to set-aside the judgment of conviction dated 28.04.2018 passed by learned Special Court for Economic Offences, Bengaluru in C.C.No.949/2007 and to acquit him in the said case.
2. The appellant of this appeal was the accused before the Trial Court. The respondent of this appeal was the complainant before the Trial court. The rank of the parties to this appeal will be hereinafter referred to with the same rank as assigned to them before the trial court for the sake of convenience.
3. The brief facts which leads to file this appeal in nutshell are as follows:
The complainant/the State at the instance of Drugs Inspector, Bangalore Circle-IV, Bangalore, filed the complaint u/s. 200 of Cr.P.C. alleging that the accused No.1 to 4 have committed the offence punishable u/s. 27 (d) of the Drugs and Cosmetics Act, 1940. (Herein after referred as "the Act") 3 Crl.A.No.1010/2018
4. The complainant's case is that the accused No.1 i.e., M/s. Venus Remedies Ltd is a registered company, Haryana, engaged in manufacturing and sale of drugs. Accused No. 2 is the Managing Director of accused No.1 and he was responsible for the day to day business of company. Accused No.3 is the Manufacturing Chemist and he was responsible for the manufacturing of drugs. Accused No.4 is the Analytical Chemist and he was responsible for the testing of the drugs. On 29.04.2004, C.w.2-Sri.Ajayraj D. Shah, the then Drug Inspector of Circle-IV, Bangalore has drawn the legal sample of 4x3 50x2ml of Diazeparn Injection I.P., B.No.AJ17011, M/D:10/2003, E/D:09/2005, manufactured by accused No.1 under From No.17 along with other drugs for test and analysis from the premises of Government Medical Stores, Magadi Road, Bangalore. The legal sample was sent to the Government Analyst, Drugs Testing Laboratory, and Bangalore and on 30.07.2004, the report was received to the effect that the sent legal sample is "Not of Standard Quality" with respect to description. The Additional Director of Government Medical Store informed that the drugs were purchased from accused No.1. Then on 18.08.2004 C.w.2 sent a portion of sealed sample of the drug to accused No.1 and it contested and intended to adduce evidence to controvert the test report of the Government Analyst, Bangalore. Then on 19.03.2015 C.w.2 filed a petition and by virtue of the order, the portion of sample was sent to the Central drugs Laboratory, Kolkotta. After the test, it was reported that sent the legal sample is "Not of Standard Quality".4 Thereafter, 4 Crl.A.No.1010/2018 the complainant collected necessary documents and then obtained the sanction, and filed the complaint.
5. On filing of the complaint, cognizance was taken and case was registered against accused persons for the offence punishable u/ s. 27 (d) of the Act. In response to the summons, accused No.2 who is also representing accused No.1 appeared through his respective counsel and enlarged on bail. Copies of the complaint and other documents were furnished to him.
6. During the trial, the presence of accused No.3 and 4 could not be secured, hence, the case against them was ordered to be split up and separate case in CC No.286/2011 was registered. The case was proceeded against accused No.1 and 2.. To prove the case, the complainant examined 3 witnesses as P.w.1 to 3 and got marked the documents Ex.p.1 to 36 and Ex.C.1 to 3 and materials objects are not marked.
7. After closure of complainant's side evidence, the statement of accused No.2 who is also representing accused No.1 were recorded as provided u/s.313 of Cr.P.C. Accused No.2 who is also representing accused No.1 denied incriminatory evidence framed against them. Accused No.2 who is also representing accused No.1 not chosen to lead either oral or documentary evidence. After full fledged trial the Trial Court has convicted the accused.
5Crl.A.No.1010/2018
8. Being aggrieved by the said order of conviction the appellant has preferred this appeal on the following Grounds;
a) The judgment passed by the trial court is erroneous and it is not sustainable in the eye of law.
b) The learned Magistrate has erred in not appreciating the evidence on record. The learned Magistrate has erred in not considering the fact that the complaint filed by the complainant is barred by limitation.
c) The learned Magistrate has erred in not considering the fact that the prosecution has not produced Government Notification or any other document to show the respondent Drugs Inspector is having jurisdiction to investigate into the matter and seize the alleged drugs under the provisions of the Act.
d) The Trial Court has erred in not considering the fact that all the material facts which are mandatory, are not at all reflected in Sanction order Ex.P. 24 issued by the Drugs Controller and Controlling Authority. The complainant has not at all produced any protocal test and particulars. The sample tested by the Government Analyst is questionable and doubtful.
e) The prosecuted utterly failed to produce cogent evidence or material to show that the subject drug in question was kept in proper storage condition. The prosecution failed to produce all relevant documents and evidence of Pws is not supported the case of the prosecution.
6Crl.A.No.1010/2018
f) There are many infirmities in the evidence of the prosecution which have been overlooked by the learned Magistrate.
g) The impugned judgment passed by the learned Magistrate is not reasoned one. The findings of the learned Magistrate is unreasonable and perverse.
On these and other grounds as urged in the appeal memorandum, the appellant has prayed to allow the appeal and prayed to acquit him for the offence punishable u/sec. 27(d) of the Act.
9. After filing of the appeal, it is registered as Crl.A.No.1010/2018 and notice was issued to the respondent. After service of the notice, the respondent has appeared before the court through learned PP. Thereafter, the trial court record was called for. After securing the trial court record, the matter was posted for arguments.
10. Heard the arguments. Perused the appeal memorandum, trial court record and other materials on record.
11. The points that arise for consideration before this court are as under:
(1) Whether the judgment passed by the trial court is just and proper and in accordance with law?7
Crl.A.No.1010/2018 (2) Whether the interference of this court is required in the impugned judgment of the trial court?
(3) What order?
12.The findings on the above points are as under:
(1) Point No.1 .. In the Affirmative
(2) Point No.2 .. In the Negative.
(3) Point No.3 .. As per final order
for the following:
REASONS
13. Point No.1 and 2 :- These two points are interrelated to each other and as such, they are taken together for discussion to avoid repetition of facts.
The appellant who is the accused before the Trial Court has preferred this appeal and one of the grounds for appeal is the complainant has not filed the complaint within the period of limitation. On perusal of the records it is forthcoming that the complainant came to know that the drugs in question was `not of standard quality` on 30.7.2004. But the appellant who is the accused has challenged the report and that compelled the Drug Inspector to send the legal sample for the rest at Central Drugs Laboratory (CDL) by virtue of Section 25(4) of the Act. The report from the CDL Kolkatta was received on 12.5.2005. The report of the Government Analyst lost its evidentiary value in view of the challenged and expressing of intention to adduce evidence in contravention of the report of the Government Analyst. In view of the 8 Crl.A.No.1010/2018 challenged , the test report dated 30.7.2004 is not available for the complainant to substantiate that the drug is `Not of standard quality` and he has to wait till the receipt of the report from the CDL. On receipt of the report from the CDL the cause of action arose to file the complaint. Hence, the contention of the appellant that the complaint is barred by limitation is not sustainable.
14. Further the appellant has taken a contention that the Drug Inspector who investigated the matter has not jurisdiction to seize the spurious drugs in question and investigate the matter and file the complaint. In the complaint there is reference about the Notification under which the appointment of the complainant and CW. 2 were notified. Section 21 of the Act and in various rulings reported by our Hon`ble High Court of Karnataka and other High Courts makes it clear that only the person appointed as Drug Inspector through Notification published in the official Gazette empowered to investigate the matter relating to the contravention of the provisions of the Act. Here the appellant not upto the specific contention that the Drug Inspector who investigated the matter are the Drug Inspectors appointed through the Notification. Mere suggestion that the Drug Inspector had no jurisdiction is not sufficient. Even otherwise the copies of the Notification produced by the complainant disclose that the Drug Inspector who investigated the matter were the Drug Inspectors legally appointed and the Drug Inspector who seized the drug had jurisdiction.
9Crl.A.No.1010/2018
15. Further the appellant has taken the contention that there is no proper sanction to prosecute the accused persons. Ex.P. 24 is the sanction order dated 16.10.2007 issued by the Drug Controller. The appellant has taken the contention that the sanction lacks the required ingredients to constitute the valid sanction. It is not stated what are the evidence pursued to confirm the existence of primafacie evidence. Thus, it can be considered as valid sanction. The question here is whether the sanction is mandatory to launch the criminal case for contraventions of the provisions envisaged under Chapter IV of the act. The Act contains the Chapter IV which deals with the manufacture, sell and distribution of drugs and cosmetics. Chapter IV A deals with provision relating to deals with taking cognizance of offence relating to the Ayurvedic, Siddha and Unani drugs. Sec. 32 of the Chapter IV deals with taking of cognizance and it no where says that there must be sanction from the higher authority to initiate the prosecution under that Chapter. Rule 51 (5) of the ACT says that the inspector subject to the instructions of the controlling authoirty shall initiate any complaint in writing which may be made in him . The reading of the Section and rule referred above, it can be very well inferred that what required is only the instruction from the controlling authority and not the sanction. Thus the contention of the learned counsel for the appellant that the complaint is not maintainable in view of the non carrying the investigation by the concerned officer and not having valid sanction is not sustainable in the eye of law.
10Crl.A.No.1010/2018
16.It is admitted fact that accused No.1 manufactured Diazeparn Injection I.P., B.No.AJ17011, M/D:10/2003, E/D:
09/2005 and supplied to the Health Department of Karnataka Government. The complainant's case is that jurisdictional Drug Inspector drawn the legal sample of that drug on 29.04.2004 and sent them for test for Government Analyst and report received to the effect that the drug is declared as "Not of Standard Quality" with respect to description. The accused No.1 challenged the report, hence the legal sample was sent to the CDL, and there also similar report was received.
17. C.w.1-Mr.Shankar Naik examined as P.w.1 deposed in line with complaint averments. The letter of report, the letter submitted to the Drugs Controller of Haryana, the letter submitted to accused No.1 to give particulars are marked as Ex.p.1 to 4. The statement given by the General Manager of a. No.1, Form No.28, Form No.26, product permission letter, invoice, Memorandum of Association and Articles of Association and copy of letter given by the Drugs Controller are marked as Ex.p.5 to 14. The report of the investigation conducted at accused No.1. The reports submitted to the Drugs Controller are marked as Ex.p.15 and 16. The letter given by the General Manager of accused No.1 and the documents furnished by the accused No.1 are marked as Ex.p.17 to 22. The letter where under permission was sought and the sanction are marked as Ex.p.23 and 24.
11Crl.A.No.1010/2018
18. C.w.2-Mr.Ajay Raj D. Shah examined as P.w.2 deposed about the drawing of legal sample of the drug and sending them to the test. The Form No.17, the memorandum, the test report, copy of the notice, reply, copies of the challan and distribution particulars are marked a Ex.p.27 to 33. The copy of the test report and acknowledgement are marked as Ex.p.34 and 35. The copy of the Crl.Misc.P.No.08/2005, notice issued to accused No.1 and the report of Central Drugs Laboratory are marked as Ex.C.1 to 3. C.w.4-Mr.R.Chandrashkar, Retired Chief Pharmacist, Bangalore examined as P.w.3 deposed that C.w.2 drawn the legal samples of the drugs in Form No.17 as per Ex.p.27.16
19. The above referred oral and documentary evidence did show that C.w.2 had taken the legal samples of the drugs and it was sent to the Government Analyst and report was received to the effect that the sample is "Not of Standard Quality" with respect to description. Then in view of the dispute of the corroboration of the report, another legal sample was sent to the CDL and from there report was received to the effect that it is "Not of Standard Quality"
in respect of description.
20. The learned counsel of the accused No.1 and 2 argued that the protocol particulars are not produced and the Director who issued the Form No.2 is not examined, hence the report in Form No.2 cannot be looked into. In support of this line of argument, the learned counsel relied upon the ruling rendered by the Hon'ble 12 Crl.A.No.1010/2018 Mumbai High Court, in the case of State of Maharashtra Vs.R.A. Chandawarkar and others, reported in 1999 Drugs Cases 94. In the said ruling by relying on the ruling of the Hon'ble Supreme Court, in the case of T. A. Krishnaswamhy Vs. State of Madras, reported in AIR 1966 SC 1022, wherein it is held that "in view of subsequent amendment to Rule.46 of the Drugs andCosmetics Rules, 1945 with effect from 21.07.1962, the analyst report is not required to state the protocols only to given the results of the analysis and it was held that the said report was admissible in evidence." Our Hon'ble High Court in the case of State Of Karnataka Vs Vikram Chemical Laboratories reported in 1975 Cr.L.J 332 held that "When the sample tested is a pharmacopial drug, reference to tests and method prescribed is sufficient compliance of Rule 46 and the Govt. Analyst report is conclusive evidence of the facts stated therein." Thus the contention of the accused that for the reason of non examination of author of Form No. 2 and for non production of protocol test particulars, the report cannot be over looked. As far as the Judgment relied by the learned counsel in the case of Vishal Pharmaceuticals and another Vs. State of M.P. reported in 1999 (2) MPLJ 378, is concerned, in the said ruling Rule-46 is not considered. Added to this in the presence of the ruling of Hon'ble Apex Court and our Hon'ble High Court, the ratio laid down in the above cited ruling cannot be relied.
21. The learned counsel argued that there is no evidence to the effect that the drug in question was kept in proper storage 13 Crl.A.No.1010/2018 conditions. It is argued that the legal samples was in the laboratory for quite long period and the legal sample sent to the Central Drugs Laboratory was with the Drug Inspector for the period of more than one year and there is absolutely no evidence to the effect that during that period the drug was kept in proper storage condition. It is argued that the burden of proving that the drug was kept in proper storage condition is upon the complaint. In support of this line of argument, the learned counsel relied upon the ruling rendered by the Hon'ble Patna High Court, in the case of Sulochna Devi vs. State of Bihar, in Crl. Misc. No. 34874/200319CC.No.949-07 and the ruling rendered in the case of State of Goa Vs.M/s.Caryl Pharma and others, reported in legalcrystal.com/1176487.
22. The Senior Pharmacist in his evidence deposed that the drug was kept in cool place and it was protected from light. There is absolutely no evidence to the effect that the drug was not stored in a proper storage condition. It is argued that the legal samples of other drugs drawn on that day passed the test. If the storage conditions were not proper, then they would have also failed in the test. It is argued that the test at the Central Drugs Laboratory was conducted before expiry of shelf period, hence, the contention thatthere is delay, is not acceptable.
23. Once the accused opts to send the sample to the C D L and obtains the report, then conclusiveness attaches to the report of the C D L by virtue of Sec. 25(4) of the Act. The only option available for 14 Crl.A.No.1010/2018 the accused is to show that the drug was not stored in proper storage condition and that resulted in loss of potentiality. The accused has to show that the deficiency in the drug was not on account of defect at the stage of manufacture, but that was become not keeping the drug in proper storage condition. Except denials and suggestions, there is no evidence to the effect that the sample drugs were stored in improper storage condition. It is argued that in the April, there will be high temperature. The drug is supposed to withstand the temperature variations. The drug was tested in 55' C. The cool and dry place means room temperature or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperature between 15C' to 25C' (59"-77p) or up to 30C' depending on the climate conditions. There is no evidence to the effect that the temperature was much higher than 30C' during period. It is argued that the Drug Inspector not verified the storage condition at the time of taking sample, however, the provision of Act and Rules not mandates such requirement. There is no evidence to the effect that the drugs were stored in improper condition and that resulted in deterioration of quality of the drugs.
24. Accused No.1 in the reply dated: 18.04.2007 marked as Ex.p.17 taken up the contention that I.P says for the raw material that, "White or almost white to pale yellow, crystalline powder, odorless or almost odorless. Therefore, for the reason of declaration not of standard quality is unjustified." It is contended that this should not be construed as a matter of discoloration since the raw 15 Crl.A.No.1010/2018 material itself is permitted in I.P as white to pale yellow colour. The accused No.1 except taking up the contention not produced any scientific evidence to substantiate this contention. Description of Diazepam Injection is stated in IP as "A clear, colourless or almost colourless solution." Thus the contention raised by the accused No.1 in this regard is not sustainable.
25. Thus, on appreciation of evidence on record, the learned Magistrate hold that the complainant succeeded in proving that the drug failed in description as it found light yellow coloured liquid instead of clear colourless solution. This amounts to commission of offence punishable u/s.27 (d) of the Act by the accused No.1. The learned Magistrate has properly appreciated the evidence on record and has rightly convicted the accused.
26. The learned counsel for the appellant has filed the written argument and also filed the rulings in support of his argument. This court has gone through the written argument and the citations filed by the learned counsel for the appellant. But the citations and the contentions of the appellant/accused not made out any ground to absolve accused No.1/appellant from the criminal liability.
27. In view of the aforesaid discussion and in view of the reasons assigned by the trial court, this court feels that the judgment passed by the trial court is just and proper which need not requires the interference of this court. As such, this court is of 16 Crl.A.No.1010/2018 the opinion that the impugned judgment of the trial court is deserves to be confirmed and appeal filed by the appellant is deserves to be dismissed. Accordingly , this court answers Point No.1 in the Affirmative and Point No.2 in the Negative.
28. Point No.4:- In view of the findings on point No.1, 2 and 3, this court proceeds to pass the following:
ORDER The Appeal filed by the appellant u/s.374(3) of Cr.P.C., is hereby dismissed.
The judgment of conviction and sentence dated 28.04.2018 passed by learned Special Court for Economic Offences, Bengaluru in C.C.No.949/2007 is hereby confirmed.
Send back the Trial court records along with copy of this judgment.
************* (Dictated to the Sr. Shr/SG I on Computer, script thereof is corrected, signed and then pronounced by me in the open court on this the 22 nd day of October, 2024.) GANGAPPA I Digitally signed by GANGAPPA I PATIL PATIL Date: 2024.11.08 10:27:33 +0530 ( GANGAPPA IRAPPA PATIL ) LII Addl. City Civil & Sessions Judge, Bengaluru.
17 Crl.A.No.1010/2018 Judgment pronounced in the open court (vide separate Judgment ) ORDER The Appeal filed by the appellant u/s.374(3) of Cr.P.C., is hereby dismissed.
The judgment of conviction
and sentence dated 28.04.2018
passed by learned Special Court for
Economic Offences, Bengaluru in
18
Crl.A.No.1010/2018
C.C.No.949/2007 is hereby
confirmed.
Send back the Trial court
records along with copy of this
judgment.
LII Addl. City Civil & Sessions Judge,
Bengaluru