REPORTABLE

2026 INSC 200 IN THE SUPREME COURT OF INDIA CRIMINAL APPELLATE JURISDICTION CRIMINAL APPEAL NO. OF 202 6 [@ SPECIAL LEAVE PETITION (CRIMINAL) NO.4524 OF 2023]

THE STATE OF KERALA & ANR. …APPELLANTS A1: THE STATE OF KERALA REPRESENTED BY HOME SECRETARY A2: THE DRUGS INSPECTOR (INTELLIGENCE BRANCH) OFFICE OF ASSISTANT DRUGS CONTROLLER, THRISSUR, KERALA VERSUS M/s. PANACEA BIOTEC LTD. & ANR. …RESPONDENTS R1: M/S PANACEA BIOTEC LTD.

R2: PANACEA BIOTEC LTD.

WITH CRIMINAL APPEAL NO. OF 2026 [ @ SPECIAL LEAVE PETITION (CRIMINAL) NO. O F 2026 ]

[@ DIARY NO.18999 OF 2023]

M/s. PANACEA BIOTEC LTD. & ANR. …APPELLANTS A1: M/s. PANACEA BIOTEC LTD.

A2: PANACEA BIOTEC LTD.

VERSUS STATE OF KERALA & ANR. …RESPONDENTS R1: STATE OF KERALA THROUGH HOME SECRETARY R2: THE DRUGS INSPECTOR (INTELLIGENCE BRANCH)

OFFICE OF ASSISTANT DRUGS CONTROLLER, THRISSUR WITH Signature Not Verified

Digitally signed by

SAPNA BISHT Date: 2026.02.26 CRIMINAL APPEAL NO. OF 2026 Reason:

[@ SPECIAL LEAVE PETITION (CRIMINAL) NO.8867 OF 2023]

1 (Original) R2 deleted vide Order dated 16.10.2023.

THE DRUGS INSPECTOR & ANR. …APPELLANTS A1: THE DRUGS INSPECTOR, OFFICE OF ASSISTANT DRUGS CONTROLLER, KOZHIKODE A2: STATE OF KERALA VERSUS VIMAL KUMAR KHEMKHA & ANR. …RESPONDENTS R1: VIMAL KUMAR KHEMKHA R2: NARENDRA KUMAR KAPOOR

J U D G M E N T

AHSANUDDIN AMANULLAH, J.

The matters are dealt with as follows:

CRIMINAL APPEAL NO._____ OF 2026 [@ SLP (CRL.) NO.4524/2023]

1.1 Leave granted.

2. The present appeal assails the Final Judgment and Order dated 14.07.2022 passed in Crl. M.C. No.2802 of 2012 (hereinafter referred to as the ‘Impugned Order’) passed by a learned Single Judge of the High Court of Kerala at Ernakulam (hereinafter referred to as the ‘High Court’).

FACTUAL MATRIX:

3. On 21.10.2005, one Mr. Joy Mandi was informed, about an alleged discrepancy in the labelling of the subject drug, alleged to be manufactured and sold by the Respondents, by the Medical Officer, Primary Health Centre, Thrissur, Kerala.

4. On 05.01.2006, Mr. Joy Mandi filed a Complaint with Appellant No.2-Drug Inspector regarding the discrepancy in the labelling of the drug alleged to be manufactured and sold by the Respondents. Admittedly, no bill of purchase of the drug was placed on record in the Complaint Case.

5. On 16.01.2006, Appellant No.2 received the Complaint dated 05.01.2006 filed by Mr. Joy Mandi, whereafter Appellant No.2 commenced an enquiry into the subject-matter of the said Complaint.

6. On 20.01.2009, Appellant No.2 filed a Complaint Case before the learned Chief Judicial Magistrate, Court, Thrissur, Kerala (hereinafter referred to as the ‘CJM’), against, inter alia, the Respondents for the alleged commission of offences under Sections 18(a)(i) read with 17(b) and 17(c) of the Drugs & Cosmetics Act, 1940 (hereinafter referred to as the ‘Act’) read with Rule 96 [of the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the ‘Rules’)] punishable under Section 27(d) of the Act.

7. The core allegation as per the Complaint Case was that there was an alleged discrepancy in the label on the carton concerned vis-à-vis the label on the top of the vial of the drug manufactured and sold by the Respondents. To be specific, the carton was labelled as ‘Easy five, Pentavalent vaccine B. No.:PO124 SBPC, Mfg. date: 14/August/2004, Exp.: 13/August/2006, manufactured by: Panacea Biotech Ltd., A 241 Okhla, Industrial Area-1, New Delhi - 110020, India. Retail price not to exceed Rs.550/- LT extra, Manufacturing Licence No:1259’ (sic)². But, allegedly, on the seal cap of the vial, it was labelled as ‘pentavalent vaccine Easy Five, B.No: P0124 SBPC, Mfg. Date: 14/Aug,2004, Exp. date: 13-Aug 2006’ (sic), Ibid.. Whereas, on the vial it was labelled as ‘Tetravalent Vaccine Easy Four. B.No: TO124SBC, Mfg. date: 29/August/2004, Exp. date: 28/August/2006. Manufactured by Panacea Biotec Ltd., A-241, Okhla, Industrial Area-1, New Delhi-110020, India.

Retail price not to exceed Rs.500/- LT extra’ (sic), Ibid.

2 As per the Tru