w w w . L a w y e r S e r v i c e s . i n


Medicamen Biotech Limited v/s Rubina Bose

    C.R.R. Appeal No. 2850 of 2005
    Decided On, 19 May 2006
    At, High Court of Judicature at Calcutta
    By, THE HONOURABLE MR. JUSTICE S.P. TALUKDAR
    For the Appearing Parties: Milon Mukharji, Sandipan Ganguly, Tushar Kauti Mukherjee, Advocates.


Judgment Text
S.P. TALUKDAR, J.


(1) PETITIONERS by filing an application under section 482 of the Criminal Procedure Code prayed for quashing of the proceeding of the Case No. C-1501 of 2002 under section 27 of the Drugs and Cosmetics act, 1940, pending before the learned Chief Judicial Magistrate, Alipore, kolkata. This is further directed against order dated 02. 07. 2002 passed by the learned Chief Judicial Magistrate, Alipore, Kolkata, whereby learned court took cognizance of the alleged offences and directed issuance of process against the petitioners.


(2) GRIEVANCES of the petitioners, as ventilated in the application, may briefly be stated as follows : petitioner No. 1 is a company incorporated under the Companies Act, 1956, with it registered office at S. P. 1192a and B, Phase-IV, Bhiwadi industrial Area, District-Alwar (Rajasthan) and corporate office in Delhi. It is engaged in the business of manufacturing and marketing of various pharmaceutical formulations. Petitioner No. 1 is its Managing Director. On 24. 09. 1999, the petitioner No. 1 manufactured Enalapril Maleate tablets 5mg under a valid drug-manufacturing license within its factory premises. In order to ensure its quality, the petitioner No. 1 on 25. 09. 1999 carried out an in house test of the aforesaid drug and got the same analysed from an approved laboratory namely, Oasis Test House Limited, jaipur (Rajasthan). When both the test reports revealed that the drug conform to the standards of Indian Pharmacopoeia, the petitioner No. 1 on 29. 09. 1999 released the same for sale under batch No. NT 6000 with manufacturing date September, 1999 and expiry date August, 2002 and supplied the same to Government Medical Stores Depot, Kolkata and solace India Private Limited. On 23. 08. 2001, petitioner No. 1 received a show-cause notice dated 14. 08. 2001/17. 08. 2001 from the Government Medical Stores Depot, kolkata, whereby he was informed that the drug in question had been declared sub-standard on testing by the Government Analyst, Central drug Laboratory, Kolkata. Petitioner No. 1 was directed to show-cause as to why the said drug was not de-registered. Immediately on receipt of such show-cause notice on 24. 08. 2001, the petitioner No. 1 got further sample of the drug test from another approved laboratory namely, industrial Test House, Delhi. The report dated 25. 08. 2001, indicated that the sample conforms to the standards of the Indian Pharmacopoeia. On 30. 08. 2001, the petitioner No. 1 sent a detailed reply to the show-cause notice thereby disputing the report of the Government Analyst dated 05. 07. 2001 and requested for retesting of the sample portion. In response to this, petitioner No. 1 was informed that on 14. 06. 2000 sample of the drug in question was collected from the Government Medical stores Depot and was sent to the Government Analyst, Central Drug laboratory, Kolkata, under section 23 of the Drugs and Cosmetics Act, 1940. After analysis it was declared that the same was 'not of Standard quality', vide report dated 05. 07. 2001. Comment of the petitioner No. 1 was called for within ten days. Sub-Section (2) of section 25 of the Act mandates that the Drugs Inspector was bound to deliver one copy of the test report in original to the petitioner no. 1. The Drugs Inspector, however, did not send the same along with her aforesaid letter as a result of which the petitioner No. 1 could not send its comments on the test report. On 10. 09. 2001, petitioner received another letter dated 07. 09. 2001. Petitioner No. 1 was called upon to furnish the details of manufacturing, testing and sale/distribution of the subject batch along with its comments on the test report within a period of fifteen days. On 13. 09. 2001, prtitioner No. 1 sent a detailed reply to the letter dated 07. 09. 2001 thereby disputing the test report dated 05. 07. 2001. Authority was requested to direct reanalysis of the sample. On 04. 10. 2001. the petitioner No. 1 received a letter dated 26. 09. 2001 from the Drugs inspector and he was informed that the test report issued by the government Analyst was always conclusive evidence as per section 25 of the Act. Authority declined to consider the report of any other individual or agency. Thereafter, on 09. 05. 2005, the petitioner No. 1 received summons from learned Court of Chief Judicial Magistrate, Alipore, whereby he was directed to appear in Court on 05. 10. 2005 in order to answer to the accusation of charges under section 27 of the Act. Thereafter, on 02. 07. 2002, after lapse of one year, the Drugs Inspector launched prosecution against the petitioners knowing fully well that in august 2002, the sample portion of the drug in question would expire. No prayer was made bofere the learned Court for sending the sample portion to the Director, Central Drugs Laboratory, for analysis under section 25 (4) of the Act. Being aggrieved by, and dissatisfied with, the continuation of the impugned proceeding being Case No. C-1501 of 2002 pending before the learned Court of Chief Judicial Magistrate, Alipore, 24-Pgs. (S), as also order dated 02. 07. 2002 passed therein, the petitioners filed the present application.


(3) LEARNED Counsel for the petitioner while narrating the backdrop of the present case submitted that the authority concerned was painfully indifferent to the procedure which was required to be adopted. Section 18 (a) (l)clearly mentions that the State Government by notification in the Official gazette may fix any date from which any person either himself or by any other person on his behalf be prohibited from manufacturing for sale (or for distribution), or sell, or stock or exhibit (or offer) for sale, or distribute -any drug which is not of a standard quality, or is rnisbranded, adulterated or spurious.


(4) MR. Mukherjee appearing as learned Counsel for the petitioners submitted that the authority concerned without paying any regard to the mandatory provisions proceeded with the matter.


(5) THE facts and circumstances of the present case reveal that being directed by the Additional Director, Central Government Health Scheme, the Drugs Inspector collected smaple from Belvedere C. G. H. S. Dispensary which were packed and sealed in presence of C. M. O. in-charge, C. G. H. S. Dispensary. On the same day i. e. , 14. 06. 2000 one portion of each of the samples along with one Intimation Form 17a was supplied to the C. M. O. in-charge. On that very day the Drugs Inspector sent one sample to the government Analyst, Central Drugs Laboratory for test. A report was received from the Government Analyst on 05. 07. 2001 to the effect that the sample was not of standard quality On 10. 07. 2001, the Drugs Inspector sent the report to the C. M. O. concerned and requested him to supply the name, address of the supplier of the medicines and further requested to ensure so that the is no further consumption of there said batch medicines.


(6) ON 18. 07. 2001, the Drugs Inspector drew attention of the superior authority for taking action for the letter dated 10. 07. 2001 and to direct all the C. G. H. S. dispensaries to stop further consumption of the said medicines. Thereafter, on 30. 07. 2001, the Drugs Inspector requested the Assistant director General to inform the name and address of the supplier of medicines. On 14. 08. 2001 the Assistant Director General, Kolkata, issued show-cause notice regarding such medicines and directed to make payment of Rs. 2,920/- as test charge. On 22. 08. 2001, a copy of the report of the Government analyst was sent to the petitioner along with a portion of the sample for comments. The petitioner, on 28. 08. 2001, intimated about their disagreement with the report of the Government Analyst and requested to return the unconsumed medicines. On 26. 09. 2001 the Drugs Inspector informed the petitioner that the report of the Government Analyst is conclusive proof. Deputy Drug Controller sought for permission for launching prosecution on 31. 01. 2002 from the Drugs Controller General of India. On 10. 05. 2002 direction for taking immediate action against the present pritioner was given. Thereafter, various steps were taken for initiating proceeding against the present petitioner. On 02. 07. 2002 the case was filed against the petitioners.


(7) MR. Mukherjee appearing as learned Counsel for the petitioners at the very outset referred to section 23 of the Drugs and Cosmetics Act, 1940 while mentioning about the procedural formalities. Referring to sub-section (4) of section 23 of the said Act it was submitted on behalf of the petitioners that the Inspector was required to restore one portion of a smaple so divided or one container as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same in the manner as prescribed. One portion of container was required to be sent for test or analysis, the second one was required to be produced before the Court in case proceedings were instituted. The third, where taken, was required to be sent to the person if any, whose name, address and other particulars had been disclosed under section 18a.


(8) SECTION 18a of the Drugs and Cosmetics Act, 1940 relates to declare of the name of the manufacturer etc. It lays down that every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector, address and other particulars of the person from whom he acquired the drug or cosmetic.


(9) MR. Mukherjee contended that in the present case the complainant/ the authorities did not bother to comply with the procedural formalities. It was submitted that the manner in which proceeding was instituted against as many as six persons clearly reflected non-application of mind. Mr. Mukherjee referring to the status and background of the said accused persons submitted that they could not be said to be directly engaged in the running of the business. It was also submitted that it was the duty on the part of the authority to give a smaple to the petitioners so as to enable them to get the same tested independently.


(10) IN response to the submission made by the learned Counsel Mr. Mukherjee it was submitted by learned Counsel for the opposite party that there is need for taking into consideration the date of expiry of the medicines so seized. According to learned Counsel for the O. P. , the mandatory provisions were all duly complied with. It was submitted that the accused persons managed to evade the process of law for years.


(11) ATTENTION of the Court was drawn to section 25 (4) of the Act while referring to the report of the Government Analyst.


(12) THE stamp as affixed to the copy of the application, which was filed before the learned Court of C. J. M. , gives the date of filing as 01. 04. 2005. The case, however, was of the year 2002 as could be found from the number of the application. This naturally gave a long rope to the petitioner in support of the argument that there had been no attempt on the part of the present petitioners to evade the process of law. No other point was urged by either party in this context.


(13) IN response to the claim that there had been no application of mind at the time of filing of the application, thereby implicating all the six persons, it was submitted that it had been clearly mentioned in the petition of complaint that all such petitioners were directly responsible for the production, manufacture and distribution of the product for consumption of the ailing people.


(14) IT appears that on 14. 06. 2000 being instructed by the Deputy Drugs controller (1), the complainant went to the C. G. H. S. Dispendary at Belvedere and after inspection collected sample for testing. Complainant claimed that the sample so collected were split up into four equal parts containing 100 tablets in each box and then packed and sealed in presence of the store incharge and C. M. O. in-charge. It was then claimed that out of the four samples so collected one portion of the samples was sent for test and analysis. The test report indicating that the sample was not of standard quality was received on 06. 07. 2001. Thereafter, information was collected that the accued persons were the manufacturer of the said product. By letter dated 22. 08. 2001 the complainant asked the accused persons to offer their comments in respoect of the report of the Government Analyst. It was categorically claimed that complainant also sent a sample of the product being Enalapril Maleate received from the Central Drug Laboratory. The petitioner/accused persons received such letters but did not offer any comment. A reminder was sent by speed-post. In reply to the same the accused persons admitted themselves to be manufacturer of the said product and disputed that it was not of standard quality. Request was made by letter dated 13. 09. 2001 for further testing of the said product. Thereafter, permission was sought for launching prosecution and immediately after obtaining the said permission, the present case was filed.


(15) THE case relates to alleged offences under section 27 of the Drugs and Cosmetics Act, 1940, which deals with penalty for manufacturer, sale etc. , of drugs in contravention of the rules.


(16) REFERRING to various correspondences copies of which have been annexed to the application it was submitted by Mr. Mukherjee that apart from non-compliance of the mandatory statutory formalities, there could be no reason for holding that the product did not conform to the standard prescribed. It was also submitted that the present petitioners/accused persons got the material properly tested and the reports indicated otherwise. Mr. Mukherjee further submitted that request was made as far back as on 30. 09. 2001 for retesting and reanalysis of the sample. Question first arises as to how far the present petitioner could be permitted to rely upon such materials in the form of annexures containing copies of various correspondences and test reports.


(17) LEARNED Counsel for the O. P. submitted that it is the settled position of law that the Court cannot look into such affidavits and annexures as sought to have been relied upon by the petitioners while dealing with an application under section 482 of Criminal Procedure Code. It was submitted that such documents and annexures are required to be translated into the form of proper evidence before the same could be acted upon. By and large the Court is to keep itself confined to the allegations made in the petition of complaint and it is to be seen as to how far such allegations could disclose any offence of cognizable nature.


(18) MR. Mukherjee referring to the decision in the case of Drugs Inspector, central Drugs Standard Control Organisation (South) Zone, Madras-6 vs. Modern Drugs and Anr. , reported in 1982 Cr. LJ 2285. submitted that in absence of non-compliance of the provision under section 25 of the Act, the proceeding cannot be allowed to continue. In the said case it was held that the accused having not been supplied copy of the analyst report, the conviction and sentence could not be sustained. Thus, it related to appreciation of materials at the post-conviction stage. In the present case, a close analysis of the allegations as made in the petition of complaint indicates alleged commission of the offence and the allegations made in such petition do not suffer from any such inherent absurdity so as to rais

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e controversy in regard to its maintainability. There is no such inconsistency or antagonistic contradiction which strikes at the root of the case and makes further proceeding an undesirable exercise in futility. In view of the claim, as made in the application, that the sample collected were divided into four portions and one of the same was duly given to the accused persons and the further claim that copy of the report of Government Analyst was duly supplied, there does not seem to be much; merit in the grievances. The petition of complaint which was filed before the learned Court and the copy of which was annexed to the present application and the relevant materials do not lend any support to the claim that continuation of the proceeding will be an abuse of the process of Court. The case at this stage does not seem to be suffering from any such inherent illegality which can justify interference in the way of quashing of the proceeding under section 482 of Criminal procedure Code. (19) CONSIDERING all such facts and relevant circumstances I am inclined to hold that there is no such merit in the present application. (20) ACCORDINGLY, the case being C. R. R. No. 2850 of 2005 be dismissed. Interim order, if any, stands vacated. (21) LEARNED Court of Chief Judicial Magistrate, Alipore, is directed to proceed with the case as expeditiously as possible. Send a copy of this judgment to the learned Trial Court for information and necessary action. (22) CRIMINAL Department is directed to supply urgent xerox certified copy of this order, if applied for, to the learned Counsel for the parties, after due compliance with the legal formalities. Application dismissed.
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