Drugs & Cosmetics Act | Prosecution For 'Not Of Standard Quality' Drugs Must Be Filed Before Expiry Of Shelf Life To Protect Accused's Right To Re-Analysis: Himachal Pradesh High Court

"By the time the summons was received, the drug had already expired and under such circumstances now proceeding with the complaint would be a futile exercise and therefore, continuance of proceeding would clearly be an abuse of process of law." Himachal Pradesh High Court, in a significant ruling, held that launching a prosecution under the Drugs and Cosmetics Act, 1940, after the shelf life of the drug has expired is a patent abuse of the process of law.

A Single Judge bench of Justice Sandeep Sharma observed that such a delay deprives the accused of their valuable statutory right to seek re-analysis of the sample through the Central Drugs Laboratory under Section 25(4) of the Act. The Court emphasized that if the drug expires before the accused can challenge the initial report, the prosecution is bound to fail.

The petitioners, M/s Crystal Pharmaceuticals and its proprietor, approached the High Court seeking to quash two complaint cases registered for manufacturing drugs found to be 'Not of Standard Quality' (NSQ) following samples drawn in 2017. While the shelf life of the drugs in question expired in 2018, the State launched the criminal prosecution only in 2023, nearly five years after the medicines had crossed their expiry dates. The petitioners argued that the inordinate delay and the failure to comply with the mandatory testing timelines rendered the trial a nullity.

The primary question before the Court was whether the proprietor of a firm can be vicariously liable without specific averments of being in-charge of daily business. The Court was also called upon to determine if the violation of the 60-day testing window under Rule 45 and the loss of the right to re-test due to expired shelf life warrants the quashing of criminal proceedings under Section 482 CrPC.

Court Explains Limitations On Vicarious Liability Of Proprietors

The Court delved deeply into the concept of vicarious liability as encapsulated under Section 34 of the Drugs and Cosmetics Act. It noted that for an offence committed by a company or firm, every person who at the time of the offence was "in charge of and was responsible to the company" for the conduct of its business shall be deemed guilty. However, the bench clarified that simply being a proprietor or a director does not automatically attract criminal liability.

The Court observed that the record showed the firm had appointed competent technical staff and authorized representatives for the manufacturing process, as evident from Form 28 and affidavits. Since these technical persons were responsible for the day-to-day manufacturing and analysis, liability could not be fastened on the proprietor in a casual or mechanical manner without specific evidence of his involvement.

"Simply because a person is a director [or proprietor] of the company, it does not necessarily mean that he fulfils both the above requirements so as to make him liable."

Mandatory Nature of Rule 45 And The 60-Day Testing Window

Addressing the procedural delays by the Government Analyst, the Court referred to Rule 45 of the Drugs and Cosmetics Rules, 1945. The Rule mandates that the test or analysis of a sample must be conducted within a period of sixty days from the date of receipt. The Court noted that in the present case, the reports were issued several months after the samples were drawn, which was a clear violation of the statutory mandate.

The bench held that the insertion of this timeline by way of amendment is mandatory and not directory. It noted that if a sample cannot be analyzed within this period, the Government Analyst is required to seek an extension giving specific reasons. In the absence of such compliance, the Court found that the prosecution's foundation was significantly weakened.

"The testing of the sample was beyond statutory period prescribed under Rule 45 which is required to be decided within 60 days. For non compliance of this the proceeding was quashed."

Expiry Of Shelf Life Deprives Accused Of Right To Challenge Report

The Court placed heavy reliance on Section 25(4) of the Act, which provides the accused with a right to have the sample re-tested by the Central Drugs Laboratory if they disagree with the Government Analyst's report. The bench observed that this is a "valuable right" which becomes illusory if the prosecution is launched after the drug has expired, as no laboratory can re-test an expired medicine.

In the present case, the drugs expired in August and December 2018, but the complaints were filed in 2023. The Court held that by the time the petitioners received the summons, their right to controvert the report had already been lost. Continuing such a trial would be a "futile exercise" and would subject the petitioners to the ordeal of a protracted trial that is bound to fail.

"The valuable right to controvert the test report of the Chemical Analyst is lost... continuance of proceeding would clearly be an abuse of process of law."

Scope Of Section 482 CrPC In Quashing Malicious Prosecutions

While exercising its inherent powers, the High Court referred to the landmark judgment in State of Haryana v. Bhajan Lal, reiterating that criminal proceedings can be quashed where there is an express legal bar or where the allegations do not prima facie constitute an offence. The Court noted that saving the High Court's inherent powers is designed to achieve a salutary public purpose, ensuring that court proceedings do not degenerate into weapons of harassment.

The Court concluded that since the complaints were barred by the principles of natural justice and statutory violations, the trial could not pass the test of judicial scrutiny. It noted that the Drug Inspector's failure to file the complaint within the three-year limitation period further supported the quashing of the cases.

The High Court allowed both petitions and quashed the complaint cases pending before the Additional Chief Judicial Magistrates at Mandi and Nurpur. The Court discharged the petitioners and set aside the summoning orders, holding that the continuation of the trial would be a sheer abuse of the process of law.

Date of Decision: July 10, 2026