Karnataka HC Refuses To Quash Impcal Tablet Case, Saying Two-Day Testing Delay Was Not Undue And Maker’s Retest Request Came Nearly Eight Months Later

The Assistant Drugs Controller filed a private complaint alleging that M/s Life Vision Healthcare manufactured and marketed “Impc al Tablets,” which were reported as not of standard quality for the Vitamin D3 assay.

The drug sample was drawn on 18 February 2020 and sent for analysis on 20 February 2020; the test report was received on 24 August 2020, and the petitioners were informed of it on 28 August 2020.

The petitioners sought re-analysis on 15 April 2021, after the drug’s shelf life had expired in February 2021.

The Magistrate took cognizance of the alleged offence under Section 18(a)(i), punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940, and issued summons.

The petitioners sought to quash the proceedings under Section 482 CrPC.

Section 18(a)(i) of the Drugs and Cosmetics Act prohibits the manufacture or sale of drugs in contravention of the Act, and Section 27(d) provides the relevant penalty; Section 23(4)(i) requires a seized sample to be sent to the Government Analyst “forthwith”; and Sections 25(3) and 25(4) provide the statutory process for challenging an analyst’s report and seeking further analysis.

The Court held that “forthwith” does not necessarily require dispatch immediately upon seizure, without completion of other prescribed procedural steps.

It considered Medicamen Biotech Ltd. v. Rubina Bose, State of Punjab v. National Organic Chemical Industries Ltd., Inox Air Products Ltd. v. State of Andhra Pradesh, and Lalankumar Singh v. State of Maharashtra, but held the petitioners’ reliance on those authorities distinguishable on the facts.

The Court also considered the allegations against the Managing Partner in the complaint in assessing whether the proceedings should be quashed.

The sample was forwarded for analysis two days after it was seized. The Court found that this interval did not amount to undue or unexplained delay, given that the authorities had to follow the prescribed procedure; it therefore rejected the alleged breach of Section 23(4)(i).

The petitioners had received the test report in August 2020 but sought re-analysis only in April 2021, after the drug’s shelf life had expired. The Court found no basis on the record to attribute the resulting inability to re-analyse the sample to procedural lapse or negligence by the authorities.

It also considered the complaint’s allegations that petitioner No. 2, as Managing Partner, was actively involved in the company’s affairs, and found no ground to terminate the prosecution at that stage.

Given the allegations and material on record, the Court held that the matter should proceed to trial.

It found no basis at that stage to interfere with the cognizance or summons, while leaving the petitioners at liberty to raise their contentions before the Magistrate during trial.