Agartala: The Tripura High Court has quashed criminal proceedings against a Himachal Pradesh-based pharmaceutical company and its directors in a case involving the manufacture and sale of a drug declared “not of standard quality”, holding that the mandatory provisions of the Drugs and Cosmetics Act and Rules were not followed before the prosecution was initiated.
Justice Biswajit Palit allowed a criminal petition filed by M/s Innova Captab and its directors, setting aside a January 10, 2023, order of the Judicial Magistrate First Class, Agartala, which had taken cognisance of a complaint filed by the Central Drugs Standard Control Organisation (CDSCO).
The case stemmed from a sample of Rabeprazole Sodium and Itopride (Sustained Release) Capsules collected during a joint inspection at a medicine shop in Agartala on January 29, 2021. The Regional Drugs Testing Laboratory in Guwahati later reported that the sample was “not of standard quality” after it failed the prescribed assay test.
The High Court held that the prosecution had failed to comply with Section 23(4)(i) of the Drugs and Cosmetics Act, which requires a drug sample to be forwarded to the Government Analyst without delay. Although the sample was collected on January 29, it reached the laboratory only on February 1, and no explanation was provided for the intervening delay.
The court also found a violation of Rule 45 of the Drugs and Cosmetics Rules, 1945, which requires the Government Analyst to submit the test report within 60 days of receiving the sample unless an extension is formally granted.
In this case, the laboratory received the sample on February 1, 2021, but issued its report only on October 12, 2021, without obtaining the required extension.
Rejecting the Centre’s argument that the delay resulted from disruptions caused by the COVID-19 pandemic and the death of the Government Analyst, the court observed that the statutory procedure for seeking additional time had not been followed.
It further clarified that the Supreme Court’s orders extending limitation during the pandemic applied to judicial proceedings and not to the statutory timelines governing laboratory reports.
The court further held that the authorities had not complied with Section 25 of the Act, as the accused were denied the statutory opportunity to challenge the Government Analyst’s findings before the prosecution was launched, thereby depriving them of an important legal safeguard.
Relying on precedents set by the Supreme Court and various High Courts, Justice Palit concluded that the mandatory procedural requirements had been breached, making the prosecution legally unsustainable.
The complaint pending before the trial court was accordingly quashed, and the company and its directors were discharged from the criminal case.