Drugs & Cosmetics Act | Drug Sample Can Be Sent To Central Drugs Laboratory For Re-Analysis Prior To Filing Criminal Complaint: Punjab & Haryana High Court

Clarifying the procedural mandate under Section 25 of the Drugs and Cosmetics Act, 1940, the Punjab and Haryana High Court has ruled that a drug sample can validly be sent to the Central Drugs Laboratory for re-analysis even prior to the formal institution of a criminal complaint. Justice Manisha Batra, in an order passed on October 14, 2026, held that neither the statute nor judicial precedent restricts the dispatch of controverted drug samples to a post-complaint stage, emphasizing that the primary objective is to safeguard the manufacturer's statutory right of re-analysis before the shelf life expires.

The petitioner, a private limited pharmaceutical company holding manufacturing loan licences, was issued a show-cause notice after a sample of Loperamide Hydrochloride Tablet IP was declared 'not of standard quality' by the Government Analyst. In response, the petitioner notified its intent to controvert the test report under Section 25(3) of the Act. Rather than immediately lodging a formal complaint, the Drugs Control Officer approached the Chief Judicial Magistrate, Karnal, through an application to forward the sample to the Central Drugs Laboratory, Kolkata. The Magistrate allowed the re-testing application, prompting the petitioner to challenge the order under Section 528 of the Bharatiya Nagarik Suraksha Sanhita, 2023.

Whether a drug sample can be referred to the Central Drugs Laboratory for re-analysis under Section 25 of the Drugs and Cosmetics Act, 1940 prior to the formal institution of a criminal prosecution?

Whether the Chief Judicial Magistrate erred in registering a pre-complaint application for re-analysis as a complaint case and issuing summons to the manufacturer under Section 25(3) of the Act?

Section 25 contemplates controversion prior to initiation of prosecution

Examining the statutory scheme, the High Court observed that Section 25(3) expressly enables a party to notify its intention to controvert the report of the Government Analyst either to the Inspector or to the Court where proceedings are pending. This textual bifurcation confirms that the Legislature foresaw controversion arising well before any criminal proceeding is lodged.

The Court added that the opening phrasing of Section 25(4)—"Unless the sample has already been tested or analysed in the Central Drugs Laboratory"—plainly demonstrates that testing by the central facility can transpire before judicial powers under the sub-section are invoked.

Statutory re-analysis powers under pari materia enactments govern the field

Drawing parity with Section 24 of the Insecticides Act, 1968, the bench leaned extensively on the Supreme Court ruling in Indofil Industries Ltd. v. State of Punjab, which established that an Inspector has ample power and a duty to dispatch the sample to the Central Laboratory upon receiving a controversion request.

The Court held that the prosecution has the option either to send the spare sample directly to the central facility or to launch a prosecution and produce the sample in court before its shelf life expires. It observed that when the Drug Inspector seeks judicial leave to forward the sample, such a course does not breach any statutory bar.

Preserving manufacturer's right before product expiry is paramount

Distinguishing rulings where complaints were quashed due to procedural delays, the bench highlighted that in those matters the statutory right was defeated because the shelf life had already lapsed before re-analysis could be sought.

The Court observed that the petitioner had controverted the report and, by doing so, impliedly demanded testing by the Central Drugs Laboratory. With the sample dispatched in September 2026 against an expiry date of December 2026, the manufacturer's right stood secured rather than prejudiced.

Section 25(3) evidentiary provision creates no criminal offence

Addressing the procedural irregularity in the trial court's order, the bench disapproved of the practice of registering a re-testing application as a regular complaint case and summoning the manufacturer as an accused under Section 25(3) of the Act.

The Court clarified that Section 25(3) is an evidentiary rule concerning the conclusiveness of the Government Analyst's report and does not prescribe any penal offence. Consequently, summons issued in that capacity cannot be construed as an order summoning the company as an accused.

Dismissing the quashing petition, the High Court upheld the order sending the drug sample to the Central Drugs Laboratory, Kolkata, while clarifying that the summons issued pursuant to the application shall not constitute an order summoning the petitioner as an accused. The Court directed that any substantive prosecution against the petitioner can only be initiated through a formal complaint under Section 32 of the Act.

Date of Decision: October 14, 2026