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Karnataka High Court

M/S Health Care Products And Packages vs State Of Karnataka on 3 July, 2024

Author: N S Sanjay Gowda

Bench: N S Sanjay Gowda

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                                                    NC: 2024:KHC:26017
                                                CRL.P No. 4679 of 2012




                 IN THE HIGH COURT OF KARNATAKA AT BENGALURU

                      DATED THIS THE 3RD DAY OF JULY, 2024

                                     BEFORE
                   THE HON'BLE MR JUSTICE N S SANJAY GOWDA
                      CRIMINAL PETITION NO. 4679 OF 2012


            BETWEEN:

            1.    M/S HEALTH CARE PRODUCTS AND PACKAGES
                  B-45,SECTOR-7, NOIDA,
                  GAUTHAM BUDH NAGAR,
                  UTTAR PRADESH-201 301,
                  REPRESENTED BY ITS PROPRIETOR,
                  SRI ANUPAM GHOSH.

            2.    SRI ANUPAM GHOSH, S/O S K GHOSH
                  PROPEIETOR M/S HEALTH CARE PRODUCTS
                  AND PACKAGES,
                  R/AT -B-3/162, JANK PURI,
                  NEW DELHI-110 192.

            3.    SRI. SURENDRA PAL
                  S/O LALCHAND,
Digitally         ANALYTICAL CHEMIST,
signed by
KIRAN             R/AT AGGRAWALMANDI,
KUMAR R
Location:
                  BAGPAT DISTRICT,
HIGH              UTTAR PRADESH-201 334
COURT OF
KARNATAKA                                               ...PETITIONERS
            (BY SRI. V R SARATHY., ADVOCATE)

            AND:


            1.    STATE OF KARNATAKA
                  REP BY STATE PUBLIC PROSECUTOR,
                  HIGH COURT PREMISES,
                  HIGH COURT BUILDING,
                  BANGALORE-560 001.
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                                              NC: 2024:KHC:26017
                                         CRL.P No. 4679 of 2012




2.   ASSIATANT DRUGS CONTROLLER
     DAVANAGERE CIRCLE,
     DAVANAGERE-577 002.
                                         ...RESPONDENTS
(BY SMT. RASHMI PATEL, HCGP FOR R-1 & R-2)

      THIS CRL.P IS FILED UNDER SECTION 482 CR.P.C BY
THE ADVOCATE FOR THE PETITIONERS PRAYING THAT THIS
HON'BLE COURT MAY BE PLEASED TO QUASH THE ENTIRE
PROCEEDINGS INITIATED AGAINST THE PETITIONERS HEREIN
AND ALSO ACT OF TAKING COGNIZANCE AND ISSUANCE OF
SUMMONS     IN   C.C.NO.2062/2006   ON        THE   FILE    OF   THE
J.M.F.C.(I COURT), DAVANAGERE.


      THIS PETITION, COMING ON FOR HEARING, THIS DAY,
THE COURT MADE THE FOLLOWING:


                          ORDER

1. The facts, as could be ascertained from the complaint filed under Section 200 of the Criminal Procedure Code, 1973 ("the CrPC") by the complainant-respondent, are as follows.

2. On 06.09.2003, during a routine inspection, the Assistant Drugs Controller found a stock of "Enjoy Perfumed Condoms" and he proceeded to take a sample of -3- NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 this stock from Kum. N. Nagaveni, the Proprietrix of Sri. Ganesh Pharma.

3. He thereafter sent one sealed sample of the drug to the Government Analyst on the same day.

4. This sample was received by the Government Analyst on 16.09.2003 and the Government Analyst, after conducting a test/analysis of the sample, furnished his report dated 05.01.2004 and the same was received on 09.01.2004 by the Inspector.

5. The Inspector, in turn, sent a notice to Kum. K. Nagaveni and called upon her to reveal the source from which said drug was procured. Kum. K. Nagaveni replied stating that the drug was purchased by her from M/s. Naresh Pharma under the invoice dated 15.08.2003.

6. The Inspector then proceeded to send one portion of the sealed sample and the test report to M/s. Naresh Pharma on 21.01.2004. Accordingly, M/s. Naresh Pharma replied by way of the letter dated 13.02.2004 stating that -4- NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 they had purchased the drug from M/s. Veeru Brothers under the invoice dated 12.07.2002.

7. On 17.09.2004, the Inspector called upon M/s. Veeru Brothers to confirm the sale of the drug to M/s. Naresh Pharma and pursuant to said notice, a reply dated 17.12.2004 was received from M/s. Veeru Brothers stating that they had received said drug from M/s. Health Care Products and Packages (accused No.2) under an invoice dated 10.01.2003 and had thereafter supplied it to M/s. Naresh Pharma.

8. Following the above, the Inspector was directed by the Drugs Controller to investigate the matter and, accordingly, he approached the Drugs Controller of Uttar Pradesh and requested his assistance in conducting the investigation.

9. The Drugs Controller of Uttar Pradesh provided the services of the Assistant Drugs Controller, Meerut to assist the Inspector, and on 17.06.2005, the Inspector along -5- NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 with the local Drug Inspector visited accused No.1's firm and made an enquiry to seek confirmation and clarification of certain information.

10. This enquiry revealed that accused No.1(a) was the Proprietor of accused No.2 and he was also responsible for the day-to-day activities of two firms i.e., accused Nos.1 and 2. It also revealed that the drug had been repacked under the supervision of accused No.1(a) and accused No.1(b) i.e., the Analytical Chemist of accused No.1, who was stated to have analysed the drug and who had also identified the sealed sample portion shown by the Inspector, before confirming that it had been manufactured by accused No.1 and marketed by accused No.2. He further confirmed that it was sold by accused No.2 to M/s. Veeru Brothers.

11. It is pertinent to state that thereafter, the Inspector visited the unit of M/s. Veeru Brothers and conducted an enquiry wherein the sealed portion of the sample had been identified and receipt of the drug was also confirmed. -6-

NC: 2024:KHC:26017 CRL.P No. 4679 of 2012

12. On further enquiry with M/s. Naresh Pharma, it was also revealed that the drug had been purchased from M/s. Veeru Brothers and the same had thereafter been sold to Sri. Ganesh Pharma. The complainant therefore concluded that the accused were guilty of supplying a product which was not of standard quality and of not mentioning the name and addresses of the manufacturer and also actual manufacturing licensing number on the label of the drug (cited as "misbranded drugs") and they had therefore committed an offence as provided under Section 27(d) of the Drugs and Cosmetics Act, 1940 (for brevity, "the Act").

13. Learned Magistrate, on the complaint being presented, has taken cognizance before ordering issuance of process.

14. The petitioners, being aggrieved by initiation of these criminal proceedings, are before this Court. -7-

NC: 2024:KHC:26017 CRL.P No. 4679 of 2012

15. It is contended by the learned counsel for the petitioners that the Inspector who had presented the complaint was not the notified Inspector as provided under Section 21 of the Act and, therefore, the entire proceedings are without jurisdiction.

16. It is also submitted that under the provisions of Section 23 of the Act, the Inspector was required to divide the drug sample into four portions and he was required to hand over one portion to the person from whom it had been seized, the second portion to the Government Analyst for conducting a test, the third portion to the Court (if there were any pending proceedings), and the fourth portion was required to be sent to the person whose particulars have been revealed under Section 18A of the Act by the source of the drug.

17. It is submitted by the petitioners that the Inspector

-- though after issuance of notices under Section 18A of the Act had concluded that accused Nos.1 and 2 were the manufacturers of the drug and were thus the source of the -8- NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 drug -- had not sent a copy of the test report and, more importantly, a copy of the sample portion for them to have an opportunity to challenge the report and also analyse the portion of sample which had been seized by the Inspector. It is therefore contended that the valuable right that the accused had under the Act was defeated and the proceedings would have to thus be quashed.

18. Learned High Court Government Pleader Smt. Rashmi Patel, however, supported the prosecution by contending that so long as there was a report by the Government Analyst that the drug was not of standard quality, the Inspector had the right to prosecute the manufacturer of the drug and technicalities should not impede the prosecution.

19. As far as the jurisdiction of the Inspector to initiate proceedings is concerned, she submitted that vide the Notification issued under Section 21 of the Act dated 23.07.2003, the Officers who had been appointed therein were to be Inspectors and since the appointment of an -9- NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 Inspector was to the person holding the post of an Assistant Drugs Controller, any person who was the Assistant Drugs Controller had the jurisdiction to present the complaint.

20. The notification dated 23.07.2003 states that the Government of Karnataka was appointing the persons specified therein as Inspectors for the areas in the corresponding entries in the columns. The persons notified to be the Inspectors were described by designation and not by their names. Thus, in law, the officers mentioned in the notification would the Inspectors appointed under the Act and not the persons who were holding said post on the date of the notification. In other words, the person manning the office notified under the notification would automatically become the Inspector as contemplated under Section 21 of the Act.

21. In the instant case, it is not in dispute that the Assistant Drugs Controller would be the Inspector for the area comprising the entire State of Karnataka and since

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 the complainant was admittedly the Assistant Drugs Controller, he would be the notified Inspector under Section 21 of the Act and he would consequently have the jurisdiction to present a complaint.

22. Section 21 of the Act empowers the State Government to issue a notification under the gazette and appoint such persons it thinks fit as Inspectors for the areas that they may assign. The only requirement is that the persons appointed should have the prescribed qualification. It is not the mandate of the law that persons are required to be named personally in order to confer upon them the status of an Inspector under Section 21 of the Act.

23. The notification of the officers of a particular rank and designation in the Drugs Department is not barred under Section 21 of the Act. If an office of the Department is notified to be an Inspector, it goes without saying that the person who holds the office at the relevant time would necessarily be the Inspector as contemplated under

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 Section 21 of the Act. Thus, the contention that the complainant did not have the jurisdiction to present a compliant as he had not been named as a Drug Inspector cannot be accepted.

24. On merits, it is to be noticed here that the Inspector did take 4x48x3 pieces as samples from Kumari K. Nagaveni, the Proprietrix of Sri. Ganesh Pharma and he also issued a Form-17 notice i.e., the intimation to persons from whom the sample was being taken.

25. Section 23(3) of the Act stipulates that the Inspector is required to take a sample of the drug for the purpose of test or analysis and while doing so, he is required to intimate that purpose in writing in the prescribed form to the person from whom he takes it. He is also required to divide the sample into four portions and effectively seal and suitably mark the same in the presence of the person from whom the sample is taken.

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012

26. Section 23(4) of the Act requires that the Inspector should give one portion of the sample to the person from whom he had taken the drug and is required to send another portion forthwith to the Government Analyst for test or analysis.

27. In this case, the complaint does not disclose that a portion of the sample was handed over to Kumari K. Nagaveni, the Proprietrix of Sri. Ganesh Pharma from whom the sample had been taken. This would therefore be a clear contravention of Section 23(4) of the Act.

28. The Inspector received the test report from the Government Analyst on 09.01.2004 and he thereafter sent this test report to Kumari Nagaveni and she, in turn, informed him that the drug had been procured from M/s. Naresh Pharma. The Inspector then proceeded to send the report and the portion of sample to M/s. Naresh Pharma.

29. The Proprietor of M/s. Naresh Pharma informed the Inspector that he had purchased the drug from M/s. Veeru

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 Brothers under an invoice dated 12.07.2002 and the Inspector thereafter called upon M/s. Veeru Brothers to confirm the sale of the drug to M/s. Naresh Pharma. M/s. Veeru Brothers by the letter dated 10.12.2004 informed the Inspector that they had supplied the drug to M/s. Naresh Pharma and that said drug was supplied to them by M/s. Health Care Products and Packages and the Inspector thereafter approached the Drugs Controller, Lucknow, Uttar Pradesh requesting his assistance and during the course of enquiry, certain clarifications are stated to have been obtained by the Inspector from accused No.2.

30. One of the clarifications was that the drug was analysed by the Analytical Chemist of accused No.2 i.e., accused No.1 (b) and the sealed sample portion was shown to them, and he then obtained confirmation that said drug had been manufactured by them.

31. It may be pertinent to state here that as per the averments in the complaint, the Inspector did not furnish

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 the sample portion to the manufacturer to enable them to conduct its own tests.

32. Section 23(4)(iii) of the Act states that a portion of the sample that had been taken by the Inspector was required to be furnished to the person whose name and address and other particulars had been disclosed to the Inspector under Section 18A of the Act. It is no doubt true that Kumari K. Nagaveni, the Proprietrix of Sri. Ganesh Pharma, from whom the drug was taken, informed the Inspector that she had secured the drug from M/s. Naresh Pharma, but sending the portion of the sample to Naresh Pharma would not satisfy the requirement under Section 23(4)(iii) of the Act because M/s. Naresh Pharma was only a reseller having purchased from M/s. Veeru Brothers, who had in turn procured the drug from accused No.2.

33. Thus, M/s. Naresh Pharma and M/s. Veeru Brothers were only intermediaries, and sending a portion of the sample to either of them would really be of no consequence. The Inspector was required to send a

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 portion of the sample to accused Nos.1 and 2 as they were admittedly the persons who were responsible for manufacturing of the drug. Non-furnishing of a portion of the sample to the manufacturer results in a situation where the manufacturer loses the right provided to him under Section 25(4) of the Act to challenge the report of Government Analyst and it would also result in losing the right to adduce evidence in contravention of the report or for making a request to the Magistrate to refer it to the Central District Laboratory. If the statute enables the person who was responsible for the manufacture of the drug to challenge the report of the Government Analyst and if he is not given the portion of the sample of the drug seized to enable him to exercise this right, the entire proceedings would stand vitiated.

34. The power conferred under Section 18A of the Act is to ultimately enable the Inspector to secure the name, address and other particulars from the person from whom the drug was secured. It is to be noticed that the notice is

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 to be given to every person who is not the manufacturer of the drug and, therefore, the entire exercise under Section 18A of the Act is to ensure that the Inspector ultimately discovers as to who the manufacturer of the drug is, and the manufacturer is required to be furnished with the sample.

35. The complaint in this case states as follows regarding the interaction with the accused:

"19. That on 17.06.2005 complainant (C.W-1) along with Sri. Sri. S.K.Panth Drgus Inspector, Goutambudha Nagar, U.P.(C.W.-8) visited accused A-1 firm and enquired accused A1(A) Sri.Anupam Ghosh, S/o S.K.Ghosh, vide his letter dated 17.06.2005 to confirm and clarify certain points required for investigation, in reply accused no.A1(a) vide letter dated:17.06.2005 revealed as follows:
i) That, accused A1(a) was the proprietor of A-2 and he is also proprietor cum approved competent person of A-1, and he is responsible for day to day activities of the firms A-1 & A-2.
ii) That said drug was repacked under supervision of accused A1(a).
iii) That said drug was analysed by accused A1(b)
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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012

iv) That accused A-2 is the marketing division of accused A-1.

v) That they are dealing in repacking of drugs under licences in Form-25B bearing No.02/RPL of 2001.

vi) That, he has identified sealed sample portion shown by the complainant and confirmed that said drug was manufactured by them at A-1.

vii) That they have sold said drug from accused A1 to their marketing division accused A-2 and from A-2 said drug was sold by them to M/s. Veeru Brother, Bangalore, CW-6 under invoice 119 dated:10.01.2002.

viii) That, they have not mentioned name and addresses of their firm on the label of the said drug.

ix) That, they have not mentioned actual manufacturing (repacking) licence number on the label of the said drug.

x) That manufacturing records of said drug was not available.

xi) Further, he submitted photocopy of the invoice of A-1, invoice of A-2, licence in Form 25B, Affidavit of Sri.Surendra Pal, and Fire claim form."

(emphasis supplied)

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012

36. As could be seen from paragraph 19, the sealed sample was only shown by the complainant and confirmation was obtained that the drug was manufactured by the accused. If the sample of the drug seized was not furnished to the manufacturer so as to enable them to undertake their own test or analysis, the manufacturer loses the right to challenge the report of the Government Analyst. This loss of statutory right to receive the portion of the sample of the drug seized and as a consequence, the inability to conduct their own test and analysis on the subject drug has rendered the entire proceedings vitiated.

37. It is to be stated here that if the sample is not available to the manufacturer, he also cannot adduce evidence as provided under Section 25(4) of the Act in contravention of the report. The evidence that the manufacturer can adduce under Section 25 of the Act is the result of their own test or analysis of the sample which is furnished to them and since this right to adduce

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 evidence in contravention to the report of the Government Analyst is defeated by not furnishing the portion of the sample drug seized to the accused, the prosecution would clearly stand vitiated.

38. The argument of the complainant that portion of the sample of the drug seized was sent to M/s. Naresh Pharma and therefore, there was compliance of Section 25(4) cannot be accepted.

39. As stated above, the entire exercise under Section 18A of the Act is to discover who the manufacturer is and merely because the person from whom the drug was taken informed the Inspector that M/s. Naresh Pharma had sold the drug to her, sending the sample to M/s. Naresh Pharma would not be of any consequence since Naresh Pharma would not conduct the test or analysis of the sample as he was only the reseller and not the manufacturer. In that view of the matter, the entire proceedings are vitiated and are liable to be quashed.

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NC: 2024:KHC:26017 CRL.P No. 4679 of 2012 Accordingly, the proceedings against the petitioners are quashed.

This petition is allowed accordingly.

Sd/-

(N S SANJAY GOWDA) JUDGE PKS/List No.: 1 Sl No.: 63