Himachal Pradesh High Court
M/S Marc Laboratories Limited & Others vs Union Of India on 18 November, 2019
Author: Vivek Singh Thakur
Bench: Vivek Singh Thakur
1
IN THE HIGH COURT OF HIMACHAL PRADESH
SHIMLA
Cr.MMO No. 43 of 2019
.
Reserved on: 30.09.2019
Date of Decision: November 18, 2019
M/s Marc Laboratories Limited & others ...Petitioners.
Versus
Union of India ..Respondent.
Coram:
The Hon'ble Mr. Justice Vivek Singh Thakur, Judge.
Whether approved for reporting?1 Yes.
For the Petitioners: Mr. Anuj Nag, Advocate.
For the Respondent: Mr. Balram Sharma, Senior Panel Counsel,
for Union of India.
Vivek Singh Thakur, J.
This petition, under Section 482 of Code of Criminal Procedure (in short 'Cr.P.C.), has been filed for quashing of complaint filed by the Drug Inspector under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'Drugs Act') and Rules framed thereunder, which is pending adjudication before learned Judicial Magistrate. Learned counsel for the petitioners has canvassed for quashing of the complaint on four grounds.
2. Firstly, referring meaning of 'Inspector' prescribed under Section 3(e)(ii) of the Drugs Act, learned counsel for the petitioner has contended that Inspector Sushant Sharma, who has 1 Whether reporters of the local papers may be allowed to see the judgment? Yes. ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 2 taken the sample and Inspector Munish Kakar, who has filed complaints, were not 'Inspectors' appointed in terms of Section 21 of the Drugs Act. According to him, notifications dated 29.10.2009 & 07.11.2013 of their appointment, placed on record as Annexures .
R-7 and R-8 with the reply, are not in consonance with provisions of Section 21 of the Drugs Act, as vide these notifications, though aforesaid Inspectors have been appointed by the Central Government for the purpose of the Drugs Act, but for whole of India without specifying the area assigned to them. Thus, these Inspectors were not competent to take sample and initiate criminal prosecution against petitioners under Section 32 of the Drugs Act.
3. To substantiate the aforesaid contentions, learned counsel for the petitioners has placed reliance upon judgments passed by the Bombay High Court in State of Maharashtra vs. R.A. Chandawarkar and others, 1999 Cri. L. J. 4449; Telangana and Andhra Pradesh High Court in Johnson and Johnson Ltd., Himachal Pradesh and another vs. State of Andhra Pradesh and another, 2015(1) Drugs Cases (DC) 2; and Gauhati High Court in State of Nagaland and others vs. Bendangrenla, reported in AIR 2018 Gauhati 59.
4. Referring pronouncement of the Apex Court in the case of J. Jayalalitha vs. State of Karanataka & others, reported in (2014) 2 SCC 401; wherein it observed that where a power is given to do a certain thing in a certain way, the thing must be done in that way or not at all, and other methods of performance are necessarily forbidden; it is argued that in present case, Central Government, was bound to notify the area assigned to them and ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 3 notification of the Inspectors for whole of India is not in consonance with the provisions of Section 21 of the Drugs Act and therefore, notifications dated 29.10.2009 and 07.11.2013 (Annexures R-7 and R-8) do not appoint the Inspectors validly.
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5. Mr. Balram Sharma, learned Senior Panel Counsel for Union of India has controverted this ground by referring aforesaid notifications (Annexure R-7 and R-8) by pointing out that vide these notifications, these Inspectors were appointed by the Central Government by exercising powers conferred by Section 21 of the Drugs Act by specifying area for them as 'whole of India' as these Inspectors can be posted anywhere in India.
6. Second contention put forth on behalf of the petitioners is that report of Government Analyst is dated 25.09.2014, which was sent to petitioners vide communication dated 20.10.2014 and petitioners had responded to the same vide communication dated 04.11.2014, wherein intention to adduce evidence, in controversion to the report of the Government Analyst, was expressed within the period stipulated under the Drugs Act and thus petitioners were entitled for retesting under Section 25(4) of the Drugs Act, which has not been done in the present case.
7. According to the petitioners, in-spite of receipt of letter of controversion on 10.11.2014, Inspector did not bother to send the sample for reanalysis to Central Drugs Laboratory as envisaged under Section 25(4) of the Drugs Act and filed the complaint before three months from the expiry of the shelf life of the drug in question in December 2015, without complying mandatory provisions of Section 25(4) of the Drugs Act and only petitioners No.5 and 6 were ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 4 served on 05.12.2015 a few days before expiry of shelf life of drug in question. It is further pointed out that on delivery of chemical analysis report from Inspector, which was received by him from the Government Analyst, after test/ analysis, petitioners had responded .
to the same, in writing, in consonance with the provisions of Section 25(3) of the Drugs Act within 28 days of the receipt of copy of the report to the Inspector, stating that on verifying control sample of the petitioners, it had been observed that clarity of solution and particulate matter of C-Zone Plus 1.5 gram passed and that petitioners had further sent the sample of it to an independent approved testing laboratory and NABL certified laboratory for testing, wherein sample had been passed, however, thereafter Inspector did not take steps to ensure sending another sample to Central Drug Laboratory as provided under Section 25(4) of the Drugs Act and for non-compliance of the said provisions of Section 25(4) of the Drugs Act by the Inspector or the Court, a valuable right of the petitioners to reanalyze the sample has been infringed.
8. In support of second contention on behalf of the petitioners, reliance has been placed upon pronouncements of the Apex Court in State of Haryana vs.Unique Farmaid (P.) Ltd and others, 1999(8) SCC 190; Medicamen Biotech Limited and another vs. Rubina Bose, Drug Inspector, (2008) 7 SCC 196; and Northern Mineral Limited vs. Union of India and another, (2010) 7 SCC 726.
9. On the contrary, Mr. Balram Sharma, learned Senior Panel Counsel for Union of India, has contended that petitioners have failed to convey their intention to adduce evidence in ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 5 controversion of the report as required under Section 25(3) of the Act and further that by exercising inherent jurisdiction under Section 482 Cr.P.C., this Court, at this stage, has to see only that prima facie case is made out or not and the contentions, like .
present one, are to be evaluated by trial Court on completion of trial as in present case, in view of the report of the Government Analyst, prima facie case is made out against petitioners, this plea of petitioners is not sustainable.
10. Thirdly, it is contended on behalf of the petitioners that they have been arrayed as accused in the complaint without defining or specifying their individual role in the work of the Company and without any material holding them responsible for the conduct of its business and thus complaint is also liable to be dismissed on this count.
11. Mr. Balram Sharma, learned Senior Panel Counsel for Union of India, referring judgment of the Apex Court in Dinesh B. Patel and others vs. State of Gujarat and another, (2010) 11 SCC 125, has contended that in the complaint, it has been clearly mentioned that all accused are the persons, who are responsible for the conduct and affairs of the accused Firm/Company and as such, are liable to be punished under Section 18(a)(i) read with Section 27(d) of the Drugs Act and accused No.2 and 3 are Directors, whereas accused No.4, 5 and 6 are directly responsible for manufacturing and analysis of drug in question and offence has been committed under the direct supervision of accused No.2 and 3 and therefore, he has contended that all the petitioners are liable to be prosecuted in consonance with Section 34 of the Drugs Act. ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 6
12. Fourth contention put forth on behalf of the petitioners is that the complaint has been filed without complying provisions of Section 33-P of the Drugs Act as matter has not been placed before the Screening Committee comprising of three senior most .
Controllers, to ascertain the criminal intent as provided in Guidelines issued under Section 33-P of Drugs Act, despite the fact that defects of particulate matter and description are minor defects. In response to the contention, learned Senior Panel Counsel for Union of India has submitted that once sample of drug was found 'not of Standard Quality', criminal proceeding can be initiated against the defaulter.
13. For the purpose of first contention raised on behalf of the petitioners, relevant portion of Section 3(e)(ii) of the Drugs Act defining 'Inspector' is as under:-
(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under Section 21."
14. Section 21(1) of the Drugs Act provides methods of appointment of an Inspector by the Central Government or a State Government, which read as under:-
"(1) The Central Government or a State Government may by notification in the 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."
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15. As per Section 21 of the Drugs Act, appointment of a person as an Inspector is to be notified in the official Gazette for such areas as may be assigned to him by the Central Government or State Government, as the case may be. This Section provides .
appointment of persons to be Inspectors for such areas as may be assigned to them. It does not prohibit the Government from appointing more than one person for an area rather empowers to do so and further it does not restrict the area assigned to an Inspector to a particular segment of the Country or State, rather it empowers the Government for appointment of Inspectors for such areas as may be assigned to them. It does not restrict the Government to appoint an Inspector to a particular area, rather it provides appointment of Inspectors for 'areas' as may be assigned to them and when the appointment is to be made by the Central Government, it has power to appoint a person, having prescribed qualification, to be an Inspector for entire India, which includes all such areas where he may be posted by the Central Government during his appointment as Inspector. Therefore, when Central Government or State Government appoints a person or persons as Inspector(s) for whole of India or the entire State, as the case may be, there is substantial compliance of provisions of Section 21 of the Drugs Act with respect to notification of appointment of Inspector for the area which may be assigned to such Inspector. In case contention of the petitioners is accepted, then Government has to notify each and every posting of the Inspector every time in the official Gazette as provided under Section 21 of the Drugs Act, whereas on initial appointment for the entire Country or entire ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 8 State, concerned Government has not to notify the same in compliance of Section 21(1) of the Drugs Act on every posting/transfer of such Inspector from one place to another place having local limits of the said area to exercise powers of Inspector .
under the Drugs Act.
16. So far as case law referred to on behalf of the petitioners is concerned, the same does not render any assistance to the plea of the petitioners as in those cases, there was non- compliance of Section 21(1) of the Drugs Act. Ratio of law laid therein, rather, supports version of the respondent as discussed hereinafter.
17. In R.A. Chandawarkar's case, there was no official Gazette notification appointing Mr.V.D. Patil as a Drug Inspector for Greater Bombay area and therefore, it was held that Mr.V.D. Patil cannot claim to be a Drug Inspector for Greater Bombay area. It is noticeable that at the time of taking sample and filing of the complaint, there was no official Gazette notification notifying Mr.V.D. Patil as a Drug Inspector for Greater Bombay area, which is not the case in present petition.
18. In Johnson and Johnson's case, a notification vide G.O. dated 21.08.2010 issued by the Health, Medical & Family Welfare Department of Andhra Pradesh, was relied upon by the prosecution whereby eight persons mentioned therein were appointed as Drug Inspectors on contract basis for entire State of Andhra Pradesh, but the said order was not having name of the Drug Inspector, who had lifted sample and the said order was containing name of one Mrs. Aparna, who had filed complaint, but it was observed that she was ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 9 not the Officer, who had lifted the sample and, therefore, it was held that there was no prima facie material to show that Inspector, who had lifted sample, was empowered under Sections 21 and 22 of the Drugs Act to lift the sample as the prosecution had not produced .
the G.O. concerning the Inspector, who had lifted sample, but had filed G.O. relating to Aparna, who had filed the complaint. Whereas, in present case, notifications with respect to Inspector, who had taken sample as well as who has filed complaint, have been placed on record.
19. In Johnson and Johnson's case, referred supra, also High Court of Telangana and Andhra Pradesh, had found that notification with respect to Inspector, who had lifted sample, was not issued as required under law, however, with regard to notification with respect to Inspector, who had filed the complaint was notified appointing her as a Drug Inspector for the entire State of Andhra Pradesh, there is no observation by the Court that the said Inspector, who had filed the complaint, was not competent to exercise her power as an Inspector for want of notification of specific area, rather essence of the discussion in the said judgment is that notification with respect to Inspector, who filed the complaint, notifying her as Drug Inspector for the entire State of Andhra Pradesh, was not considered to be defective, but for want of such notification with respect to Inspector, who had taken sample, it was held that there was no prima facie material to show that said Inspector was empowered under the Drugs Act to lift the sample.
20. In Bendangrenla's case, Gauhati High Court, relying upon R.A. Chandawarkar's case, and referring provisions of the Act, ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 10 has quashed the complaint on the ground that prosecution had not produced any appointment order of Drug Inspector issued under Section 21 of the Drugs Act or of the Controlling Authority under Rule 50 of the Rules of 1945 as there was no notification published .
in official Gazette under Section 21 of the Drugs Act specifying or indicating area in which the Drug Inspector therein was going to be appointed as a Drug Inspector so as to enable appointed Drug Inspector to exercise his powers under Section 22 of the Drugs Act upon such area as specified in the official Gazette, as the prosecution had failed to produce any such appointment order of the concerned Drug Inspectors issued under Section 21 of the Drugs Act or of the Controlling officer under Rule 50 of the Rules of 1945.
21. In present case, there are notifications issued under Section 21 of the Drugs Act with respect to Inspectors, who have taken the sample and filed the complaint, indicating area in which they were going to be posted as Drug Inspectors after their appointment, so as to enable them to exercise their powers under Section 22 of the Drugs Act in the entire country, wherever they would be appointed/posted.
22. Therefore, aforesaid case law, including judgment in J. Jaiyallaitha's case, is not applicable in present case. As discussed above, in present case, there is substantial compliance of Section 21 of the Drugs Act, which is evident from Annexures R-7 and R-8, placed on record with the reply.
23. Second issue raised on behalf of the petitioners is that despite compliance of provisions of Section 25(3) of the Drugs Act, for non-compliance of Section 25(4) of the Drugs Act, petitioners ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 11 have been deprived of their valuable rights to get sample tested or analyzed in the Central Drugs Laboratory.
24. In present case, adopting the procedure provided under Section 23(4)(i) of the Drugs Act, the Inspector had sent the sample .
to the Government Analyst i.e. Central Drugs Laboratory, Calcutta, and after receiving report dated 25.09.2014 of test/analysis from the office of Director, Central Drugs Laboratory, the Inspector had delivered one copy thereof to the petitioners, who in turn, vide communication dated 04.11.2014 (Annexure P-3), within 28 days of the receipt of the copy of Report, had notified that they had further sent sample of the drug to an independent approved and NABL certified Laboratory for testing, where their sample has been passed and, therefore, request was made to look into the matter sympathetically. Though, petitioners have not categorically stated that they intended to adduce evidence in controversion of the report but purport of the communication dated 04.11.2014 is exactly the same.
25. The judgments referred by the petitioners, pronounced by the Apex Court in Unique Farmaid (P) Ltd.'s case and Northern Mineral Limited's case, are related to the sample taken under the Insecticides Act, 1968 (hereinafter referred to as the 'Insecticides Act'). It would be relevant to notice that provisions of Section 24 of the Insecticides Act are pari materia to the provisions of Section 25 of the Drugs Act, except the fact that in the Insecticides Act there is reference of Insecticide Analyst and Central Insecticide Laboratory, whereas in the Drugs Act there is reference of Government Analyst and Central Drugs Laboratory, as the authorities who are competent ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 12 to test or analysis sample taken under the provisions of respective Acts. Therefore, ratio of law laid down by the Apex Court in respect to provisions of Section 24 of Insecticides Act, is also applicable in case of Section 25 of the Drugs Act.
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26. In aforesaid judgments, the issue before the Apex Court was that as to whether after conveying its/his intention, within 28 days of the receipt of the report, to adduce evidence in controversion of the report of the Insecticide Analyst/Government Analyst, demand of analysis of the sample by the Central Laboratory is necessary or not and what would be the effect of not sending the sample for test or analysis to the Central Laboratory despite the fact that accused had notified its intention to adduce evidence in controversion of the report and in that context, it was held by the Apex Court that mere intention to adduce evidence in controversion of the report, implies demand to send the sample to the Central Insecticide Laboratory for test and analysis and after notification of such intention before the Inspector or before the Court, where proceedings with respect to the samples is pending, accused acquires right to rebut the conclusive nature of evidence of the Analyst and further that Court has been given power to send sample for analysis and test by the Central Insecticide Laboratory of its own motion or at the request of complainant or accused and where no proceeding is pending before any Court, intention is necessarily required to be conveyed to the Inspector and in such a situation, Inspector is obliged to institute a complaint forthwith and produce sample and request the Court to send sample for analysis and test to the Central Laboratory and failure to do so would ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 13 amount to defeating right of accused leading to abuse of process of the Court, resulting continuation of criminal proceedings will be a futile exercise. In both these cases, sample was sent to the Insecticide Analyst and not to the Central Insecticides Laboratory .
and after receiving the notification/communication with respect to show intention to adduce evidence in controversion to the report, the Inspector had failed to take subsequent steps for ensuring the compliance of Section 23(4) of the Insecticides Act ( pari materia to Section 25(4) of the Drugs Act) and for that reason criminal proceedings against the accused were considered to be futile and as abuse of the process of Court.
27. In Medicamen Biotech Limited's case, Apex Court was dealing with a case related to the Drugs Act. In this case, sample was sent by the Inspector to Central Drugs Standard Control Organization, Kolkata for test/analysis and after receiving the report from the said Laboratory, it was sent to the accused, who within 28 days of receipt thereof had intended to adduce evidence in controversion of the report. Issue raised before the Court and considered by the Apex Court was that despite objection raised by the accused to the correctness of the report of the Government Analyst, by not applying the procedure prescribed under Section 25(4) of the Drugs Act, accused had been deprived of the right to have the sample tested from Central Drugs Laboratory. After considering its earlier pronouncements in State of Haryana vs. Brij Lal Mittal and others, (1998) 5 SCC 343; Unique Farmaid's case supra; and Amery Pharmaceuticals and another vs. State of Rajasthan, (2001) 4 SCC 382, the Apex Court has held that ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 14 non-compliance of Section 25(4) of the Drugs Act, must necessitate quashing of proceedings against the accused.
28. In present case, sample under Section 23(4)(i) of the Drugs Act, was sent, at the first instance, to the Central Drugs .
Laboratory itself. What would be the effect of sending the sample for analysis to Central Drugs Laboratory at the first instance, has not been considered in the judgments referred supra on behalf of the petitioners.
29. Therefore, in present case, questions which are also required to be determined, is that as to whether instead of sending the sample for test or analysis to a Government Analyst other than Central Drugs Laboratory, the Inspector has acted contrary to the procedure prescribed under Section 23 of the Drugs Act and further as to whether, when sample has already been tested or analyzed in the Central Drugs Laboratory, then for not sending another sample for testing or analysis to the Central Drugs Laboratory by the Court on its own motion or at the request of either of the party, there is a non-compliance of Section 25(4) of the Drugs Act, depriving the petitioners from their valuable right provided under the Drugs Act.
30. Section 25(3) of the Drugs Act provides that testing/ analysis report signed by Government Analyst shall be conclusive evidence unless accused, within twentyeight days of receipt of copy of the said report, intends to adduce evidence in controversion of the report. Section 25(4) of the Drugs Act, provides sending of another sample for testing or analysis to the Central Drugs Laboratory by the Court on its own motion or in its discretion at the request of either the complainant or the accused, unless the sample ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 15 has already been tested or analyzed in Central Drugs Laboratory and where accused under Section 25(3) has notified his intention to adduce evidence in controversion of a report of Government Analyst.
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31. Notifying the intention to adduce evidence under Section 25(3) has two effects: First the report of Government Analyst looses its character of conclusive evidence and second a right to test or analyze another sample in the Central Drugs Laboratory accrues in favour of the accused subject to fulfilling other conditions provided under Section 25(4) of the Drugs Act.
32. Opening lines of Section 25(4) of the Drugs Act say 'unless the sample has already been tested or analysed in the Central Drugs Laboratory', which means that in case sample has already been tested or analyzed in the Central Drugs Laboratory, accused will not be having right to get another sample tested or analyzed in the Central Drugs Laboratory. Right to test or analyse the sample in the Central Drugs Laboratory, under Section 25(4) of the Drugs Act, is subject to two conditions: First that the sample must have not already been tested or analyzed in the Central Drugs Laboratory and second accused must have notified his intention to dispute report under Section 25(3) of the Drugs Act. In any case where either of these preconditions is not existing, accused shall not have any right under this Section for testing or analyzing the sample in the Central Drugs Laboratory.
33. The issue whether the Inspector can send the sample for test or analysis under Section 23(4)(i) of the Drugs Act to Central Drugs Laboratory at the first instance or not, is not res integra. The ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 16 Apex Court in Ram Shankar Misra vs. State of U.P., (1980) 1 SCC 255 , has held that there is no prohibition under the Drugs Act or Rules framed thereunder, barring the Inspector for sending sample direct to the Central Drugs Laboratory for test or analysis. It has .
been held by the Apex Court that mode prescribed under Section 25(4) of the Drugs Act is one method of sending it to the Director of the Central Drugs Laboratory and the other method is by the Drugs Inspector sending it direct as contemplated under the first part of Section 25(1) of the Drugs Act. It has been observed by the Apex Court that starting of sub-section (4) with words "unless sample has been tested or analysed in the Central Drugs Laboratory" clearly indicates that apart from the mode prescribed in this sub-section, the sample can be sent for analysis to Central Drugs Laboratory. Section 23(4)(i) of the Drugs Act provides sending of the sample to the Government Analyst for test and analysis, the Apex Court in this judgment, referring definition of 'Government Analyst' under Section 3(c)(2) of the Drugs Act, has held that Government Analyst would include all Analysts appointed by the State Government as well as Central Government including the Director of Central Drugs Laboratory who is also a Government Analyst. Therefore, by sending sample directly to Central Drugs Laboratory, in present case, the Inspector has not committed any illegality, but has acted in accordance with law.
34. For discussions supra, as the sample has already been tested/analyzed in the Central Drugs Laboratory and report thereof has been issued by the office of the Director Central Drugs Laboratory, right to test or analyse the sample from Central Drugs ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 17 Laboratory under Section 25(4) of the Drugs Act, is not available to the petitioners. Therefore, case law cited on this issue is of no help to the petitioners.
35. However, report of the test or analysis has lost its .
nature of conclusive evidence as petitioners have notified their intention to adduce evidence in controversion of the report under Section 25(3) of the Drugs Act and thus petitioners are not only at liberty but have right to adduce any such evidence as admissible under law to rebut the report, but issue raised by the petitioners regarding depriving them from a valuable right available to them under Section 25(4) of the Drugs Act, is not sustainable in the given facts and circumstances of present case, hence contentions raised on their behalf in second plea, are also not sustainable.
36. Third contention raised on behalf of the petitioners is also contrary to the facts on record. Perusal of complaint (Annexure P-3), filed by the Inspector, reveals that Inspector has stated in unambiguous terms that it has been found that accused No.2 and 3 are Directors of accused No.1 Firm, who have manufactured and distributed the drug in question, which has been declared to be not of standard quality by the Central Drugs Laboratory and all the accused persons are the persons, who are responsible for the conduct and affairs of the accused Firm and as such liable to be punished under Section 18(a)(i) read with Section 27(d) of the Drugs Act and Rules framed thereunder and further that accused No.4, 5 and 6 are directly responsible for manufacturing and analysis of drug in question and the offence has been committed under the direct supervision of accused No.2 and 3. ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 18
37. Section 34(1) of the Drugs Act provides that where offence under this Act has been committed by a Company, then every person, who, at the time of offence was committed, was Incharge 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. Proviso to this sub- section provides that in case a person proves that offence was committed without his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence, then he shall not be liable to any punishment. Section 34(2) of the Drugs Act also provides that notwithstanding anything contained in sub-section (1), if 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 liable to be proceeded against and punished accordingly. Explanation (a) to Section 34 of the Drugs Act provides that for the purpose of this Section 'Company' means a body corporate, and includes a firm or other association of individuals; and under explanation (b) "director" in relation to a firm means a partner in the firm.
38. The Apex Court in Dinesh B. Patel's case, wherein in the complaint a statement was made that by manufacturing of the medicine concerned for sale, the Company and its Directors had committed breach of the Act, after holding that there was an ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP 19 allegation that the Directors were privy to the manufacturing of medicine by the Company had rejected the plea that the ingredients to invoke Section 34 of the Drugs Act were not on record.
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39. As referred supra, in present case also, in clear terms, responsibility of all accused has been pointed out in the complaint. Therefore, it cannot be said that petitioners have been arrayed as accused without defining or specifying their individual role. There is substantial compliance of Section 34 of the Drugs Act. So far as benefit of proviso to Section 34(1) of the Drugs Act is concerned, that shall be matter of consideration by the trial Court at the time of evaluating evidence adduced before it during the trial. Therefore, this contention raised on behalf of the petitioners is also not sustainable.
40. So far as fourth contention is concerned, though reference of Guidelines issued under Section 33-P of the Drugs Act has been made in the petition and arguments, but no such Guidelines have ever been placed on record or produced, much less any other material terming compliance of such Guidelines, if any, mandatory before filing criminal complaint under Drugs Act. Nothing has been referred to reflect that substandard quality with respect to 'Particulate matter and clarity of Solution' is a minor defect and if so, matter must be referred to Screening Committee of three senior most Controller before launching prosecution. Therefore, this ground also does not warrant interference in the impugned order.
41. No other point or issue urged/raised.
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42. In view of above discussion, I find no merit in the contentions raised on behalf of the petitioners for quashing the complaint and accordingly petition is dismissed, being devoid of merit. Pending application(s), if any, also stand disposed of.
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43. The parties are directed to appear before the Trial Court on 09.12.2019. The Court of Judicial Magistrate 1 st Class (II) be informed accordingly.
(Vivek Singh Thakur), Judge.
November 18, 2019 (Purohit) ::: Downloaded on - 19/11/2019 20:24:08 :::HCHP