Man Mohan Sobti v. Bharti Bachloo C/o Central Drugs Standards Control Organization India
2021-09-21
SANJAY DHAR
body2021
DigiLaw.ai
JUDGMENT : 1. Petitioners have challenged the complaint filed by respondent against them before the Court of Chief Judicial Magistrate, Srinagar, under Section 18(a) (i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940, and the proceedings initiated thereon. 2. It appears that the respondent Drugs Inspector has filed a complaint for offences under Section 18(a) (i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 [for short “the Act” hereinafter] against the petitioners and four more accused before the Court of Chief Judicial Magistrate, Srinagar, and on the basis of the said complaint, the learned Magistrate has, vide order dated 21.08.2014, after observing that, prima facie, commission of offences under Section 18(a) (i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940, are made out against the accused including the petitioners herein, issued process against the accused. 3. In the complaint it has been alleged that on 25.04.2013, when the complainant conducted a routine inspection of drugs in Sub District Hospital, Pampore, she lifted the sample of certain drugs for test/analysis including the one pertaining to “NIMTH {Injection IP} (Batch No.NP-11-63, Mfg. Dt. 09/2011 Exp. Dt. 08/2013” manufactured by M/S Nitin Life Sciences Limited. The sample was sent to Government Analyst, CDL, Kolkatta and vide his certificate bearing test No.32-20/2013-SS/DCA(J)-15/1278 dated 12.06.2013, issued in terms of Section 25(1) of the Act, the sample of the drug in question was declared to be not of standard quality as defined under the Act and it was observed that the sample does not conform to I.P. with respect to assay of Methylergometrine maleate. The complainant thereafter addressed a communication bearing No.JSZ/1-BB/SAMPLE-41/2013/681 DATED 22.06.2013, to BMO, Sub District Hospital, Pampore, seeking details of the dealer from whom the drug in question had been purchased along with the relevant record. A copy of the test report of Government Analyst was also furnished to the BMO, who after collecting information sought vide the aforesaid communication, vide his reply dated 20.09.2013, conveyed to the complainant that the drug in question had been supplied to the Hospital by M/S Manchanda Medicos Shalimar Bagh, New Delhi. Accordingly, the complainant issued another communication dated 25.10.2013 to M/S Manchanda Medicos, New Delhi, seeking disclosure with regard to dealer from whom the drug had been purchased.
Accordingly, the complainant issued another communication dated 25.10.2013 to M/S Manchanda Medicos, New Delhi, seeking disclosure with regard to dealer from whom the drug had been purchased. Vide reply dated 19.11.2013, M/S Manchanda Medicos informed the complainant that the drug in question has been manufactured, sold and supplied by M/S Nitin Life Sciences Limited, of which petitioners happen to be the Directors. A communication bearing No.JSZ/1-1/BB/SAMPLE/41/2013/1030 dated 28.11.2013 was addressed by the complainant to the aforesaid manufacturers seeking stock purchase and sale record of the drug in question. A sealed sample portion and copy of the test report of the Government Analyst was also sent to the company. 4. The complainant goes on to allege that on 20.09.2013, a joint inspection team from the office of the complainant visited the accused company for investigating the matter and vide its reply dated 20.09.2013, the accused company notified its intention to adduce evidence under Section 25(4) of the Act. It is alleged that the accused company failed to justify the reason for the failure of the sample under the standards laid under the Act. It is contended that the sample of the drug had got expired and, as such, the same could not be sent for re-analysis under Section 25(4) of the Act. 5. The complainant is also stated to have taken up the matter with Drug Controller, Haryana and the said Authority suspended the license of the manufacturing company. The accused company is further stated to have addressed two communications dated 28.11.2013 and 25.12.2013, requesting the complainant not to take punitive against the accused. 6. Lastly, it has been alleged by the complainant that the accused No.1 i.e., petitioner No.1 herein is Managing Director whereas accused No.2 and 3 i.e. petitioners No.2 and 3 herein, are the Directors of the accused company whereas accused No.3, 4 and 5 are the persons who are directly involved in the production process of the accused company and it is also alleged that the accused No.1, 2 and 3 are the persons who are responsible for the conduct of affairs of the accused company. The company has been impleaded as accused No.7 to the complaint. 7.
The company has been impleaded as accused No.7 to the complaint. 7. The petitioners have challenged the complaint and the proceedings emanating there from, inter alia, on the following grounds (I) That there are no specific averments in the complaint to allege that the petitioners were in-charge of and were responsible for the conduct of business of the company; (II) That the complainant has failed to establish the extent of liability and the role played by the petitioners in terms of Section 34 of the Act in the alleged offence committed by the company; (III) That the Joint Investigation report absolves the accused from commission of any offence under the Act but this aspect of the matter has not been taken note of by the learned Magistrate while issuing process against the petitioners; (IV) That the statutory requirements of the Act have not been followed by the complainant in the instant case and, as such, the complaint and the proceedings emanating there from are liable to be quashed. 8. I have heard the learned counsel for the parties and perused the material on record including the trial court record. 9. The first and foremost contention raised by the petitioners is that there is no allegation in the complaint that the petitioners were in-charge of and responsible for the conduct of business of the accused company, as such, in view of the provisions of Section 34 of the Act and in the absence of specific averments attributing specific role to the petitioners, no criminal proceedings could have been initiated against them. 10. In order to test the merits of this contention, it would be necessary to have a look at the provisions of Section 34 of the Act. It reads as under : “34.
10. In order to test the merits of this contention, it would be necessary to have a look at the provisions of Section 34 of the Act. It reads as under : “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 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 punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence. (2) Notwithstanding anything contained 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 liable to be proceeded against and punished accordingly. Explanation.—For the purposes of this section— (a) “company” means a body corporate, and includes a firm or other association of individuals; and (b) “director” in relation to a firm means a partner in the firm.” 11. From a perusal of the aforesaid provision, it is clear that when an offence is alleged to have been committed by a company, every person who was in-charge of and was responsible for the conduct of business of the company shall be deemed to be guilty of the offences. So before vicarious liability for the acts of the company is fasted upon the Directors and other office bearers including the employees, it has to be shown that the such Directors/officer bearers/employees were responsible for carrying on business of the company and were in-charge of the business. At the stage of issuing process, an averment in the complaint in this behalf is enough.
At the stage of issuing process, an averment in the complaint in this behalf is enough. The question whether the accused were actually in-charge of or responsible for the conduct of business of the company is a matter to be determined during the trial of the case. I am supported in my aforesaid view by the judgment of the Supreme Court in the case of Dinesh B. Patel & Ors. Vs. State of Gujarat & Anr. (Criminal Appeal No.1464 of 2010 arising out of SLP(Crl) No.8700 of 2008 decided on 6th August, 2010). 12. In the instant case, in para 15 of the complaint it is clearly alleged that the accused No.1 is the Managing Director whereas accused No.2 and3 are Directors of the accused company and it is further alleged that the aforesaid three accused are responsible for the conduct of business and affairs of the company. It is also averred in the said para that the accused No.3, 4, 5 and 6 are the persons who are directly involved in the production process of the accused company and all the accused persons with their common intention and active participation have manufactured the drug in question which has been declared as not of standard quality under the Act. Thus, there are specific allegations against all the accused persons that they were in-charge of and responsible for the conduct of business of the accused company. There are allegations that all the accused persons were privy to the manufacture of the drug in question by the accused company. It is only after trial of the case that it can be determined whether the accused persons were actually in-charge of and responsible for the affairs of the company. At this stage this question cannot be determined. The contention of petitioners in this regard is, therefore, without any merit and deserves to be rejected. 13. The next contention that has been urged by learned counsel for the petitioners is that in the Joint Investigation report, the accused have been absolved of the commission of any offence under the Act. It is pertinent to mention that Joint Investigation report dated 20.09.2013 forms part of the complaint and is attached as Annexure-J to the same. 14.
13. The next contention that has been urged by learned counsel for the petitioners is that in the Joint Investigation report, the accused have been absolved of the commission of any offence under the Act. It is pertinent to mention that Joint Investigation report dated 20.09.2013 forms part of the complaint and is attached as Annexure-J to the same. 14. As already noted while narrating the averments made in the complaint, in para (11) of the complaint it has been specifically stated that a joint inspection team from the office of the complainant visited the accused company for investigating the matter. So, report of the Joint Investigation is a document that was, admittedly, before the trial court. The said report, in these circumstances, assumes significance and, as such, its findings are required to be noticed. The same are reproduced as under : “It is highly likely that proper Storage conditions as per compendial requirements, may not have been met down the distribution chain and at hospital level which may also be corroborated with the Spot Report of Drugs Inspector who took the impugned batch of sample from Sub-district Hospital Pampore (J&K) regarding conditions of storage at the time of drawing the sample. In view of above, the firm has been advised to carry out Simulation studies of injectable Methylergometrine under different quantum of light and also to print “Light Sensitive Product” or “protect from light” on Primary carton in Bold and large font size.” 15. It is pertinent to mention here that as per the aforesaid Joint Investigation report, the investigation was made after the receipt of report of Government Analyst, according to which the sample pertaining to the drug manufactured by the accused company was found to be not of standard quality. The joint inspection was conducted by Mr. Abhishek Chawla, Drugs Inspector, CDSCO(NZ), Mr. Dharmendra Pandey, Drugs Inspector, CDSCO(NZ) and Mr. Pravinder Malik, DCO, Karnal, in the presence of representatives of the accused company which included its Technical Director, QA Manager and Stores Incharge. 16. As per the conclusion drawn by the Joint Investigation team, as has been reproduced hereinabove, it was observed that it is highly likely that proper storage conditions as per compendial requirements may not have been met down the distribution chain and at the hospital level.
16. As per the conclusion drawn by the Joint Investigation team, as has been reproduced hereinabove, it was observed that it is highly likely that proper storage conditions as per compendial requirements may not have been met down the distribution chain and at the hospital level. This means that the finding that the drug in question was found to be not of standard quality, might in all likelihood have been due to the reason that there were no proper storage conditions either at the level of distribution or at the level of hospital. In order to fasten criminal liability on the accused, it was necessary for the complainant to place on record such material as would unerringly point towards the guilt of the accused. In the instant case, the material on record placed by the complainant itself creates a serious doubt about the culpability of the accused company as the joint inspection report points towards the probability of the drug having turned sub-standard on account of improper storage conditions at distribution level and hospital level. 17. Even otherwise, a document, purported to be the report of the Government Analyst, does not become conclusive evidence of the facts stated therein unless the person from whom the sample was taken or whose name, address and other particulars have been disclosed under Section 18-A of the Act forfeits his right to adduce evidence in controversion of the said report. Section 25(3) of the Act is very clear about it. The same reads as under : “25. Reports of Government Analysts.— (1)…………………………………………… (2) …………………………………………..
Section 25(3) of the Act is very clear about it. The same reads as under : “25. Reports of Government Analysts.— (1)…………………………………………… (2) ………………………………………….. (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 5 [or the person whose name, address and other particulars have been disclosed under section 18A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.” From the above, it is clear that the Government Analyst’s report, in the instant case, is not conclusive about the fact that the sample in question was found to be of sub-standard quality, particularly when complainant’s own document in the shape of joint investigation report suggests otherwise. 18. As already noted in the preceding para, a person whose name, address and other particulars have been disclosed under Section 18-A of the Act, has a right to adduce evidence in controversion to the Government Analyst’s report within 28 days of the receipt of copy of the report. In the instant case, as per contents of the complaint and the communications annexed thereto, the complainant came to know about the fact that the accused company was a manufacturer of the drug in question upon receipt of communication dated 19.11.2013 issued by M/S Manchanda Medicos, New Delhi. According to the complainant, it was only thereafter that vide communication dated 28.11.2013, accused company was furnished the report of the Government Analyst. Thus, it is only after receipt of the said communication that the right of accused company to adduce evidence in controversion of the report arose. The complainant has admitted in his complaint that even before formally receiving the report of the Government Analyst, the accused company vide its letter dated 20.09.2013, notified to the complaint its intention to adduce evidence in controversion of the report of the Government Analyst. However, contention of the complainant is that sample of the drug in question had expired and could not be sent for re-analysis under Section 25(4) of the Act. 19.
However, contention of the complainant is that sample of the drug in question had expired and could not be sent for re-analysis under Section 25(4) of the Act. 19. In view of aforesaid sequence of events, it can, by no stretch of imagination, be stated that for the expiry of sample of the drug, the accused company was responsible. It was the duty of the complainant to approach the case with reasonable dispatch and inform the accused company regarding report of the Government Analyst so that the company could avail its right in terms of Section 25 (3) of the Act. In fact, the complainant waited till 30th May, 2014, for lodging the complaint before the Magistrate thereby defeating the right of the petitioners to adduce evidence in controversion of the report of the Government Analyst. This negligence and inaction on the part of the complainant has given a death blow to the case of the prosecution. 20. High Court of Bombay in M/S Zim Laboratories, Bombay and others v. State of Maharashtra, 1999 Cri.L.J. 2903, in somewhat similar circumstances quashed the order of taking cognizance and set aside the complaint. While doing so, the Court relied upon following observations of the Supreme Court in Municipal Corporation of Delhi v. Ghisa Ram, AIR 1967 SC 970 : "It appears to us that when a valuable right is conferred by Section 13(2) of the Act on the vendor to have the sample given to him analysed by the Director of Central Food Laboratory, it is to be expected that the prosecution will proceed in such a manner that right will not be denied to him. The right is a valuable one, because the certificate of the Director supersedes the report of the Public Analyst and is treated as conclusive evidence of its contents. Obviously, the right has been given to the vendor in order that, for his satisfaction and proper defence, he should be able to have the sample kept in his charge analysed by a greater expert whose certificate is to be accepted by Court as a conclusive evidence.
Obviously, the right has been given to the vendor in order that, for his satisfaction and proper defence, he should be able to have the sample kept in his charge analysed by a greater expert whose certificate is to be accepted by Court as a conclusive evidence. In a case where there is denial of this right on account of the deliberate conduct of the prosecution, we think that the vendor, in his trial, is so seriously prejudiced that it would not be proper to uphold his conviction on the basis of the report of the Public Analyst, even though that report continues to be evidence in the case of the facts contained therein." 21. Similarly, in Nikson Pharmaceuticals and Ors. v. State of Rajasthan and Ors., 2008 (3) Crimes 573 (Raj.), the High Court of Rajasthan has observed that expiry date of sample is relevant and in order to safeguard the rights of accused to have sample tested from Central Insecticide Laboratory, it is incumbent upon the prosecution to file complaint expeditiously so that right of accused is not lost. 22. Again, in Shiv Narain Bansal and another v. State of Haryana and another, 1996 Cri. L.J. 338, a Single Judge of Punjab and Haryana High Court, while dealing with a similar situation, made the following observations : “12. In view of my discussion above, I find force in the argument of the learned counsel for the petitioners that the petitioners had informed the Drugs Inspector in time for sending their sample to get it tested from the Central Drugs Laboratory but it was the fault of the Inspector that the sample could not be sent to the Central Drugs Laboratory in time and it was sent only after its expiry date. The petitioners obviously have been deprived of their right given to them under Section 25(3) of the Act. 13. In this view of the matter, the petition is allowed. The complaint as well as other proceedings taken in pursuance thereof including the charge against the petitioners, is quashed.” 23. From the analysis of the legal position, it is clear that once it is shown that the right of accused to adduce evidence in controversion of the Government Analyst’s report is defeated due to acts and omission of the Drugs Inspector, the prosecution against the accused deserves to be quashed. 24.
From the analysis of the legal position, it is clear that once it is shown that the right of accused to adduce evidence in controversion of the Government Analyst’s report is defeated due to acts and omission of the Drugs Inspector, the prosecution against the accused deserves to be quashed. 24. In the instant case, the sequences of event, as narrated in the preceding paras, shows that the respondent Drugs Inspector has failed to adhere to the mandatory statutory requirements, inasmuch as she has not taken steps with reasonable dispatch so that the accused company could avail its right of getting the samples re-tested in accordance with its right under Section 25(3) of the Act. Apart from this, even the complainant’s own document in the shape of joint investigation report throws serious doubts about the culpability of the accused company and its Directors/office bearers/employees. 25. For the foregoing discussion, the petition deserves to be allowed and is, accordingly, allowed. The impugned complaint as well as proceedings emanating there-from against the accused are quashed.