THE HONOURABLE SMT. JUSTICE K. SUJANA CRIMINAL PETITION No.16145 of 2024

ORDER:

This Criminal Petition is filed seeking to quash the proceedings against the petitioners in C.C.No.3071 of 2019 on the file of the learned II Additional Junior Civil Judge-cum-VI Additional Judicial Magistrate of First class, Medchal – Malkajgiri District at L.B. Nagar, registered for the offences punishable under Section 18(b) and 18(c) read with 105 of the Drugs and Cosmetics Act, 1940.

2. The brief facts of the case are that the complainant, is a Drugs Inspector appointed by the Government of Andhra Pradesh under Section 21 of the Drugs and Cosmetics Act, 1940, with statewide jurisdiction and empowered to launch prosecutions under Section 32 of the Act. On 28.10.2015, based on credible information, he along with LW2, LW4, and LW5 inspected the premises of M/s Sun Pharmaceutical Industries Ltd at Uppal, where LW3, the competent person of the firm, was present. During the inspection, they found 19,200 vials of FENAK 30ml (Diclofenac Sodium Injection I.P.)

in multiple-dose vials, which is prohibited under Section 18(b) and 18(c) read with Rule 105 as per Gazette Notification G.S.R. 558(E) dated 17.07.2015 of the Ministry of Health & Family Welfare, Government of India. The stock was seized under proper Panchanama and Form-16, and the seizure was reported to the III MM, L.B. Nagar, Hyderabad.

3. Subsequent investigation revealed that the drugs were manufactured and supplied by M/s Nitin Lifesciences Ltd, Himachal Pradesh (Accused No.1), represented by its Director, Mr. Sanjeev Chuttani (Accused No.2). Despite several notices, the manufacturing firm delayed in providing the required batch manufacturing and analytical records, which were eventually submitted on 21.02.2018. It was confirmed that the accused had manufactured and sold the said drug in violation of the Drugs and Cosmetics Act, 1940, punishable under Section 27(d) of the Act. Aggrieved thereby, the petitioners filed the present criminal petition to quash the proceedings against them.

4. Heard Sri M.S. Srinivasa Iyengar, learned counsel representing Sri Hirendernath, learned counsel appearing on behalf of the petitioners as well as Sri M. Vivekananda Reddy, learned Assistant Public Prosecutor appearing on behalf of the respondent – State.

5. Learned counsel for the petitioners submits that the complaint does not disclose the commission of any offence under the Drugs and Cosmetics Act, 1940, and no offence is made out against the petitioners warranting prosecution and that petitioner No.1 is a company and petitioner No.2 is merely a Non-Executive Director, who is not involved in the day-to-day affairs or conduct of the company. He further submitted that the drug in question, FENAK 30ml (Diclofenac Sodium Injection I.P.) was admittedly manufactured in the month of August 2015, whereas the Gazette Notification G.S.R 558(E), relied upon by the complainant, though issued on 17.07.2015, was only published and made available to the public on 07.09.2015. In terms of Rule 105(2) of the Sixth Amendment Rules, the said notification comes into force only from the date of its publication in the Official Gazette, and thus the alleged manufacture preceded the notification’s enforceability.

6. In support of his submissions, learned counsel for the petitioner placed reliance upon the judgment of the Hon’ble Supreme Court in Union of India v. Param Industries Ltd., (2016) 16 SCC 692 which held that a notification becomes enforceable only upon its publication and availability for public sale. He contended that the entire complaint contains no specific allegation against petitioner No.2 except a bald statement referring to his designation as Director, without any details as to his role or responsibility in the conduct of the company’s business and that vicarious liability cannot be fastened upon directors without specific averments regarding their role. He further contended that in the absence of any specific mater