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The State of Kerala & Anr. v. M/s. Panacea Biotec Ltd. & Anr.

Criminal Appeal · 2026 INSC 200Decided 26 Feb 2026
Crl.A. No.-001155-001155 - 2026 (arising out of SLP (Crl.) No. 4524 of 2023)
Justice Ahsanuddin Amanullah · Justice S.V.N. Bhatti · Justice R. Mahadevan

Background

In 2005-06, a discrepancy was noticed in the labelling of a pentavalent/tetravalent vaccine manufactured by Panacea Biotec Ltd. : the outer carton was labelled "Easy Five" (a five-in-one vaccine including Hepatitis-B protection) while the inner vial was labelled "Easy Four" (a four-in-one vaccine without the Hepatitis-B component), raising an allegation that the drug was misbranded and mislabelled contrary to the Drugs & Cosmetics Rules. The State's Drugs Inspector filed a complaint in 2009 against the company under the Drugs & Cosmetics Act, 1940, and the Magistrate took cognizance and issued summons in 2012. Panacea Biotec approached the Kerala High Court to quash the proceedings, and the High Court did so, holding that the Magistrate had not conducted the mandatory inquiry required under Section 202 CrPC before issuing process to accused residing outside its jurisdiction. The State of Kerala appealed this quashing order to the Supreme Court.

Decision Breakdown

The Supreme Court identified two questions: whether cognizance was barred by limitation under Sections 468/469/473 CrPC, and whether the mandatory Section 202 CrPC inquiry (required when an accused resides outside the court's jurisdiction) had to be conducted here. On limitation, the Court found the prosecution was validly within time. On the Section 202 point, relying on its earlier decision in Cheminova India Limited, the Court held that complaints filed by public servants in their official capacity, supported by admissible government analyst reports, stand on a different footing from private complaints, and no separate inquiry under Section 202 was mandatorily required in these circumstances; the accused seller was also, in any event, within the Magistrate's local jurisdiction. The Court therefore set aside the High Court's quashing order, restored the Magistrate's cognizance and summoning order as valid in law, and allowed the appeal, while directing that the deceased original accused be substituted with the persons currently responsible for running the respondent companies before fresh summons issue.

Lesson Learnt

A criminal complaint filed by a public servant (like a Drugs Inspector) in the discharge of official duty, supported by an admissible government analyst report, is not automatically subject to the same mandatory pre-summoning inquiry under Section 202 CrPC that applies to private complaints: regulatory prosecutions by public officials get somewhat more procedural latitude at the cognizance stage.

Official source (sci.gov.in)View Judgment (PDF)

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