A Managing Director cannot be vicariously held criminally liable for product quality offences without specific averments in the complaint demonstrating their direct responsibility for the company's day-to-day business and manufacturing affairs at the material time.

C O M M O N O R D E R

These Criminal Original Petitions, have been filed by the petitioners/A1 & A2, to call for the records in CC/STC No.784/2020 pending before the learned Judicial Magistrate, Mettupalayam and quash the same.

2. (i) The case of the prosecution is that the first accused/petitioner in Crl.OP.No.19832 of 2022 is a company having its business in Uttarkhand; that the second accused/petitioner in Crl.OP.No.19643 of 2022, is the Managing Director of the first accused company [hereinafter referred as 'Company']; that the Company is the manufacturer of a drug by name, 'OMNIGEL'; that on 28.03.2019, a sample of the said drug was drawn for analysis under Form-17 from one M/s.Sri Anushya Agencies at Coimbatore; that the same was sent for analysis on 29.03.2019 under Form-18; and that on 20.05.2019, the Drugs Inspector, Mettupalayam Range, received a report under Form-13 from the Government Analyst (Drugs), stating that the sample is 'Not of Standard Quality', for the reason that the sample does not conform to the Label claim with respect to the content of Diclofenac Diethylamine, Methyl Salicylate and Menthol;

(ii) that notices were sent to M/s.Sri Anushya Agencies and the suppliers of the drug to the said M/s.Sri Anushya Agencies and finally to M/s.Mahaveer Medicare, Rajasthan, who stated that they obtained the drug from M/s.Cipla Limited, Dehradun, under Invoice No.1155729983 (IDST No.334/18/729983 Dt.05.05.18);

(iii) that on 23.07.2019, the respondent sent a letter to the Company, asking them to disclose the name and address of the person/persons from whom they acquired the subject drug; that the Company disclosed that the drug was received from their Loan License Vendor M/s.Pritam International Pvt. Ltd., Haridwar, Uttarakhand; that on the basis of the reply, it was concluded that the Company had manufactured ''Not of Standard Quality'' drug in violation of Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 [hereinafter referred to as 'the Act'];

(iv) that a show cause memo dated 12.09.2019 along with Form-13 was sent to the Company, calling for an explanation for the contravention of Section 18(a)(i) of the Act; that the third portion of the sample which was collected was sent to the Company as mandated under Section 23(4)(iii) of the Act; that finally a show cause notice was sent on 16.12.2019 to the Company to offer their explanation and to produce documents; that in reply to the notices dated 12.09.2019 and 16.12.2019, the Company had stated that they received the subject drug from their Loan License Vendor M/s.Pritam International Private Limited and did not furnish any other particulars called for by the respondent; that the second accused is the Managing Director of the Company; and thus, both the petitioners committed the aforesaid offences.

3. Mr.P.Chidambaram, learned senior counsel for the petitioners submitted (i) that the impugned complaint is liable to be quashed, as the report of the Government Analyst that the drug was 'Not of Standard Quality', cannot be accepted, since, the testing was not done in terms of the guidelines of the department issued under Section 33(P) of the Act in the year 2008; that the drug in question neither formed part of the Indian Pharmacopoeia nor the British Pharmacopoeia; that Guideline No.9 of the said guidelines would show that the patent and proprietary formulations must be tested by the Government Analyst as provided under Rule 46 of the Drugs and Cosmetics Rules, 1945 [now called the Drugs Rules, 1945 and hereinafter referred to as 'the Rules']; that in case of non-pharmacopoeial or modified formulations, the samples should be tested as per the procedure provided by the manufacturer, which has been duly approved by the Licensin