Specific averments regarding a director's role in the company's affairs are necessary to establish liability under the Drugs and Cosmetics Act, and the impact of the offense on public health is a relevant consideration.

JUDGMENT :

Rule. Rule made returnable forthwith.

2. The applicant, a Joint Director of pharmaceutical company, has questioned the legality, correctness and propriety of the order dated 19-1-2022 passed by the Sessions Court, Wardha in Sessions Case No. 59/2018 whereby the application filed by the applicant seeking discharge for the offences punishable under Section 18(a)(i) read with Sections 16, 14 and 27(d) of the Drugs and Cosmetics Act, 1940 (for short ‘the Act of 1940’) has been dismissed. The challenge is mainly on the ground of absence of requisite averments in the complaint to the effect that the applicant was, at the relevant time, in-charge of the company and also responsible to the company for the conduct of its business.

3. The facts necessary to decide the application are as under.

The respondent – complainant has filed complaint before the Chief Judicial Magistrate against ten accused, of which accused nos. 6 to 8 and 10 came to be discharged vide order dated 30-8-2014 passed by the Sessions Court in Criminal Revision No. 47/2013. According to the complainant, he collected sample of Cepy-O Dry syrup from M/s. Quality Drugs on 13-10-2011 which was Cefpodoxime Oral Suspension IP for pediatric use. The said drug was alleged to have been manufactured by the accused no. 1 – company, namely, M/s. Lincoln Pharmaceuticals Limited, Ahmedabad. The sample was forwarded for analysis to the Government Analyser, who reported it to be of substandard quality. During the enquiry, it was revealed that M/s. Quality Drugs had purchased the said syrup from M.S. Sales Corporation, Nagpur who intimated that it was purchased from the accused no. 1 - company, the holder of valid manufacturing licence. The said medicine/syrup, however, was manufactured under the licence of M/s. Sakar Healthcare Pvt. Ltd., Changodar under the approved technical person deployed by the said company. It further transpired that though the manufacturing licence was held by the accused no. 1-company but it was the a loan licence with the accused no. 5 – company and accused no. 5 used to manufacture the said drugs and same was marketed by accused no. 1 - company.

4. The contentions before the trial Court were that accused nos. 1 to 3 have not actually manufactured the drugs and, therefore, they are not responsible. The only role attributed is that accused no. 1 – company facilitated its licence. Accused nos. 2 and 3 are directors. There is no averment or evidence against them that they were looking after the day to day affairs of accused no. 1 – company.

5. The aforesaid contentions were countered by the prosecution, contending that accused no. 1 is the licence holder, who provided raw material to the accused no. 5 – company. The quality of final goods depend upon raw material as well. Accused nos. 2 and 3 have played the active role in commission of the crime. The trial Court noted that there is ample material against the accused nos. 1 to 3. They have played active role in commission of the crime and accordingly rejected the application.

6. Learned Senior Counsel appearing for the applicant has invited my attention to the averments made in the complaint. The applicant herein was accused no. 3 before the trial Court. The cause title indicates that he was Joint Managing Director of accused no. 1 –company. Accused no. 2 is described as Executive Director of the company. In the body of the complaint, however, the complainant has described accused nos. 2 and 3 as Directors of accused no. 1 - company. The drug under question was found to be of substandard quality, as reported by the Government Analyser. The accused nos. 1 and 3 have vide letter dated 6-2-2012 have requested to reanalyze the drug from Central Drugs Laboratory, Kolkata in terms of Section 24 of the Act of 1940. The sample was accordingly sent to Central Laboratory whose report has confirmed the drug to be of not standard quality.

7. The complainant has averred that during investigation, it was revealed that ac