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SUPREME COURT OF INDIA
AHSANUDDIN AMANULLAH, S.V.N. BHATTI, JJ.
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. – Respondents1
R1: M/S Panacea Biotec Ltd.
R2: Panacea Biotec Ltd.
Criminal Appeal No. 1155 of 2026 [@ Special Leave Petition (Criminal) No.4524 of 2023]
With
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
Criminal Appeal No. 1156 of 2026 [@ Special Leave Petition (Criminal) No. 3893 of 2026] [@ Diary No. 18999 of 2023]
With
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
Criminal Appeal No. 1157 of 2026 [@ Special Leave Petition (Criminal) No. 8867 of 2023]
Decided On : 26-02-2026
1(Original) R2 deleted vide Order dated 16.10.2023.
Drugs and Cosmetics Act, 1940 – Sections 18(a)(i) read with 17(b) and 17(c) – Criminal Procedure Code, 1973 – Sections 202, 468 and 469 read with Sections 473 and 482 – Seizure of misbranded drug – High Court quashed Complaint Case qua Respondents on the ground that they resided beyond territorial jurisdiction of CJM – Drugs Inspector, who made complaint in present case, satisfied legal requirements of being a complainant – Limitation period would run out, in present case, only on completion of three years from the date identity of accused became known to Competent Authority – Official complaint was made on authorisation by State Government – In this factual setting, Section 202 of Code would necessarily have to be construed harmoniously with Section 200 of Code when considering postponement of issue of process – Impugned Order set aside and Order taking cognisance and issuing summons held to be good in law. (Paras 36, 40 and 43)
Facts of the case:
In case at hand, Court is confronted with twin questions that arise: (a) re limitation in taking cognizance as stipulated under Sections 468 and 469 read with Section 473 of the Code, and; (b) re territorial jurisdiction in terms of Section 202 of the Code
Findings of Court:
Parties are at liberty to other issues of fact and law at trial at the appropriate stage. Since date/s for entering appearance have already elapsed in all the matters, Court(s) concerned shall issue fresh summons to all accused. Thereafter, matter shall be proceeded with, strictly in accordance with law.
Result : Appeal allowed.
The Supreme Court of India, in three consolidated criminal appeals (Nos. 1155, 1156, and 1157 of 2026), addressed challenges to proceedings under Sections 17(b), 17(c), 18(a)(i), and 27(d) of the Drugs and Cosmetics Act, 1940, read with Rule 96 of the Drugs and Cosmetics Rules, 1945, concerning alleged misbranding of drugs. (!) (!) (!) (!)
In the lead matter (Appeal No. 1155), a private complaint on 05.01.2006 alerted authorities to labeling discrepancies on a pentavalent vaccine's carton (claiming "Easy Five") versus its vial (labeled "Easy Four," lacking Hepatitis B component), manufactured by respondent Panacea Biotec Ltd. (!) (!) (!) (!) (!) (!) (!) The Drugs Inspector (a public servant authorized under Section 32 of the Act) investigated from 16.01.2006, seizing documents and tracing the supply chain, with accused identities confirmed by 18.04.2006. (!) (!) (!) (!) (!) (!) (!) A formal complaint was filed on 20.01.2009 before the Chief Judicial Magistrate, Thrissur, who took cognizance and issued summons after condoning delay under Section 473 CrPC. (!) (!) (!) The Kerala High Court quashed proceedings against non-local respondents for the Magistrate's failure to conduct a Section 202 CrPC inquiry. (!)
The Court held that, under Section 469(1)(c) CrPC, the three-year limitation period (per Section 468(2)(c) CrPC for offences punishable up to three years' imprisonment) commences from the date the competent authority first knows the accused's identity during investigation, not the initial complaint or offence date—here, expiring on 17.04.2009, rendering the 20.01.2009 complaint timely. (!) (!) (!) (!) Cognizance on 29.01.2009 and summons post-condonation were valid. (!) (!)
On territorial jurisdiction, Section 202 CrPC (requiring inquiry if accused reside outside the Magistrate's area) must be harmoniously construed with the proviso to Section 200 CrPC, exempting examination of public servant complainants acting in official duty; thus, no mandatory postponement or inquiry was required, placing public servant complaints on a distinct pedestal to prevent undue harassment while ensuring sufficiency of grounds. (!) (!) (!) (!) (!)
In Appeal No. 1156 (by respondents), the limitation challenge failed for the same reasons. (!) (!) In Appeal No. 1157 (by Drugs Inspector re substandard syringes), the High Court quashed for Section 202 non-compliance and insufficient Section 34 Act averments against directors; the Court reversed, holding Section 202 inapplicable as above and Section 34 culpability (in-charge/responsible persons) a trial-stage factual issue. (!) (!) (!) (!)
Impugned High Court orders were set aside; cognizance/summons orders upheld; fresh summons directed; proceedings to continue per law, without prejudice to trial merits. (!) (!) (!)
JUDGMENT :
AHSANUDDIN AMANULLAH, J.
The matters are dealt with as follows:
Criminal Appeal No. 1155 of 2026 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[As per the True Typed Copy of the Complaint annexed with the Paperbook.]. 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) 3[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) 4[Ibid.].
8. The Complaint alleged ‘… As per the label claim of outer carton, the drug is Easy Five pentavalant vaccine which is a combination of 5 different vaccines including HbSAg 10 mcg. (vaccine for Hepatitis). But as per label claim of inner vial Easy Four tetravalent vaccine which is a combination of four different vaccines, an does not contain HbSAg 10 mcg. (vaccine for Hepatitis) as claimed on the outer carton label …’ (sic) 5[Ibid.]. It was averred that as the contents differed on the outer and inner labels, the drug was not labelled in the prescribed manner as specified in Rule 96 of the Rules; that the outer carton label makes a false claim for the drug and is misleading, and; that the drug is misbranded.
9. Pursuant to the Complaint, vide Order dated 29.01.2009 in the Complaint Case, the CJM summoned, inter alia, the Respondents.
10. On 04.08.2009, the Respondents filed a Petition being Crl. M.C. No.2551/2009 before the High Court under Section 482 of the Code of Criminal Procedure, 1973 (hereinafter referred to as the ‘Code’), seeking to set aside the Summoning Order dated 29.01.2009. Subsequently, vide Order dated 17.06.2011, the High Court directed the CJM to consider whether the delay in filing the Co
Seizure of misbranded drug – Limitation period would run out only on completion of three years from the date identity of accused became known to Competent Authority.
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