MEDICAMEN BIOTECH LIMITED Vs. RUBINA BOSE

JUDGEMENT

(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 & 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.