The central legal point established in the judgment is the interpretation and application of section 34 of the Drugs and Cosmetics Act, which holds every person in charge of and responsible to the company for the conduct of its business, as well as the company itself, guilty of the offence committed by the company.

1. The petition is filed by accused Nos.5 to 8 of R.C.C. No.233/2009 which is pending in the Court of the Chief Judicial Magistrate, Beed. The order of issue process made in this matter was challenged by the petitioners by filing Criminal Revision No.115 of 2013 in the Sessions Court and this revision is dismissed. Both the sides are heard.

2. In view of the nature of challenge to the order of issue process, not only the facts in brief of the case but the conduct of the petitioners and developments in the matter also need to be stated in brief. A Drugs Inspector, public servant, has filed the aforesaid complaint and order of issue process has been made for offences punishable under sections 18(a)(1) read with sections 16 and 34 punishable under section 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to “the Act”) against the manufacturer, accused Nos.4 to 10 and also authorised dealer appointed by the manufacturer, accused Nos.1 to 3. M/s Cachet Pharmaceuticals is a private limited company (accused No.4) and has manufacturing unit at Thana Baddi, Tehsil Nalagath, District Solan (Himachal Pradesh). This company is having its Head Office at Worli Mumbai. Accused Nos.5 to 8, petitioners, are Directors of this company. Accused No.9 is Assistant Manager Production and approved manufacturing chemist. Accused No.10 is Assistant Manager Quality Assurance and approved quality control chemist. Dealer, accused No.3, is public limited company and is selling pharmaceutical products of accused No.4 through the branches of accused No.3 which are spread all over.

3. On 30-8-2006, the Drugs Inspector appointed under the Act collected samples of Hemfer syrup bottles having description on labels as manufacturing licence No.MB/05/268 B.No.HMS/6015 CMfg date May-2006 manufactured in India by Cachet Pharmaceuticals Pvt. Ltd. VPO Thana (Baddi) District Solan marketed by Alkem Laboratories Ltd. Mumbai from the premises of M/s Priya Agencies Beed Maharashtra under the provisions of the Act. Sample was sent to Maharashtra State Drug Control Laboratory, Maharashtra State, Mumbai for testing and analysis on 31-8-2006. On 26-2-2007 the complainant, Drugs Inspector, received the report dated 16-2-2007 in respect of the sample and the report is to the effect that the drug was not of standard quality for the reason that content of cyanocobalamin in the samples was less than 39% quantity mentioned on the label of the drug. By visiting the premises of the Priya Agencies, the Drugs Inspector supplied copy of the report of the analysis on 26-10-2007. On the same day during inquiry made by the Drugs Inspector with Priya Agencies information was supplied about main dealer and the name of accused No.3, M/s Alkem Laboratories was supplied by the retailer.

4. On 13-3-2007 copy of report of analysis was sent to accused No.3 by the Drugs Inspector as provided under sections 25(2) and 23(4)(iii) of the Act. On 29-3-2007 the head office of accused No.4 company requested the Drugs Inspector to send second sample for analysis as provided under the Act. Then application was moved by accused No.4 in the Court of the Chief Judicial Magistrate on 12-4-2007 for sending the second sample to Central Laboratory. The learned Chief Judicial Magistrate made order to send second sample on 24-4-2007 and sample was sent to the Central Drugs Laboratory Kolkatta. The Central Drugs Laboratory sent report dated 10-7-2007 and this report is consistent with the report given by the Maharashtra State Drug Control Laboratory. Thus as against the quantity of 39% MCG/15 MM of the aforesaid substance mentioned on the label, the substance of 2.925 MCG/15 MM was found in the drug.

5. Copies of the report of the Central Laboratory were supplied to the main dealer, the manufacturer and retailer. On 16-10-2008 the Drugs Inspector visited the depot of accused No.3 dealer. The dealer informed that it had purchased 13000×200 ml of bottle of the drug from a particular batch, the batch