Drug Inspector’s Prosecution Voids If Specific Area Of Jurisdiction Is Not Notified In Official Gazette: Kerala High Court

"Criminal prosecutions launched against the petitioners herein cannot survive, since the complainants who launched those prosecutions lacked the authority which the law prescribed," Kerala High Court, in a significant ruling dated May 20, 2026, held that a prosecution launched by a Drug Inspector is legally unsustainable if their name and specific area of jurisdiction have not been notified in the official gazette as required under the Drugs and Cosmetics Act, 1940.

A bench of Justice G. Girish observed that the requirement for gazette notification under Section 21 is mandatory and not a mere technicality, emphasizing that "the legislation prescribes any mode of publication it has to be scrupulously followed."

The court dealt with a batch of 15 petitions filed by various pharmaceutical companies and individuals, including M/s. Agron Remedies Pvt. Ltd. and Zee Laboratories, seeking to quash criminal proceedings initiated against them for allegedly manufacturing substandard drugs. The common grievance was that the Drug Inspectors who filed the complaints lacked the territorial jurisdiction notified via the official gazette at the time the samples were collected and prosecutions launched.

The primary question before the court was whether the lack of a gazette notification specifying the area of jurisdiction for a Drug Inspector under Section 21 of the Drugs and Cosmetics Act, 1940, vitiates the prosecution. The court was also called upon to determine whether the "de facto doctrine" could save acts performed by such Inspectors and whether the lack of similar notification for Government Analysts under Section 20 would have the same effect.

Mandatory Nature of Gazette Notification Under Section 21

The court closely examined Section 21 of the Drugs and Cosmetics Act, which stipulates that the Government may, by notification in the Official Gazette, appoint persons as Inspectors for such areas as may be assigned to them. The bench noted that while the initial appointments of the Inspectors were notified, their subsequent transfers and postings to the specific areas from where the cases were booked were not published in the official gazette.

The Court held that where a statute demands a specific mode of publication, that mode must be followed to provide notice to those governed by the law. Justice Girish observed that law must be known and made in a manner that it can be known to the public.

"Where the parent statute prescribes the mode of publication or promulgation that mode must be followed."

Recent Notifications Lack Retrospective Effect

The State attempted to defend the prosecutions by producing a recent gazette notification from March 2026, which assigned the "whole State of Kerala" as the jurisdiction for 57 Drug Inspectors. However, the court rejected this argument, stating that such a notification could not retrospectively validate the omissions of previous years.

The bench emphasized that the omission to notify the area of jurisdiction at the time the complaints were lodged was a fatal flaw that could not be cured by subsequent general notifications.

"The gazette notification effected on 05.03.2026... cannot be said to be having retrospective effect to cover up the omission in effecting the gazette notifications showing the appointment and area of jurisdiction of the Drug Inspectors concerned who had lodged these complaints on yester years."

Inapplicability of the De Facto Doctrine to Complainants

The prosecution relied on the "de facto doctrine" established in Gokaraju Rangaraju v. State of AP, arguing that the acts of the Inspectors should be protected to avoid public mischief. The court, however, drew a sharp distinction between third-party acts and the acts of a direct party to a litigation.

The bench held that the de facto doctrine is intended to protect the interests of the public or third persons and prevent chaos, but it cannot be extended to authorities who are themselves parties to the issue. Since the Drug Inspectors were the complainants, they could not claim the status of disinterested third parties to save an unauthorized prosecution.

"The Drug Inspectors concerned who lodged the complaints in the present cases cannot be termed as third parties not interested in the results of the litigations, to claim the benefit of ‘defacto doctrine’."

Distinction Between Inspectors and Government Analysts

While the court quashed the prosecutions based on the Inspector's lack of authority, it reached a different conclusion regarding the Government Analysts. The court noted that although the appointments of Government Analysts for specific areas were also not notified under Section 20, their reports could still be used.

The Court reasoned that the Government Analysts stand as third parties in the litigation between the state and the accused. Therefore, the de facto doctrine could be applied to protect the validity of their laboratory analysis in the interest of public health and safety.

"The mere technicality in not effecting the gazette notification of the appointment of the Government Analysts, cannot be taken as a reason vitiating the entire prosecution proceedings, in view of the larger public interest and health safety of the citizens."

The Court concluded that since the complainants (Drug Inspectors) lacked the legal competence and authority prescribed by the statute, the prosecutions could not survive. The bench allowed all the petitions, quashing the proceedings in fourteen cases and discharging the accused in one revision petition.

The ruling reinforces the principle that statutory requirements for the exercise of official power must be strictly adhered to, especially in criminal prosecutions. By distinguishing between the Inspector as a "party" and the Analyst as a "third party," the court balanced the need for procedural compliance with the practicalities of expert evidence.

Date of Decision: 20 May 2026