Failure to supply drug sample portion to manufacturer violates statutory rights, vitiating subsequent criminal prosecution.

The Drug Inspector (Respondent No. 2) lifted samples of the drug "Tab CEFAM-250" from a retail vendor (Respondent No. 3) on 22.02.2010.

The Government Analyst’s report dated 19.07.2010 declared the sample "not of standard quality" due to failure in the assay of Cefuroxime.

After tracing the supply chain, the Inspector issued a notice to the petitioner-manufacturer on 28.08.2010.

A criminal complaint was subsequently filed before the Chief Judicial Magistrate, Jammu.

The petitioner challenged the proceedings on the grounds that they were never supplied a portion of the sample as required by law, and by the time they appeared in court (10.07.2012), the drug’s shelf life (expired August 2011) had lapsed, depriving them of their right to independent testing.

Whether the failure of the Drug Inspector to provide a portion of the lifted sample to the manufacturer, as required under Section 23(4)(iii) of the Drugs and Cosmetics Act, 1940, vitiates the prosecution.

Whether the delay in serving the analyst's report and the expiration of the drug's shelf life before the accused could challenge the report constitutes a violation of the right to a fair trial.

The Court applied Sections 23 and 25 of the Drugs and Cosmetics Act, 1940.

Section 23(4)(iii) mandates that the Inspector must send one portion of the sample to the person whose particulars are disclosed under Section 18A (the manufacturer).

Section 25(3) provides the accused a 28-day window to notify their intention to adduce evidence to controvert the Government Analyst's report.

Section 25(4) empowers the Court to send the retained sample to the Central Drugs Laboratory (CDL) for conclusive analysis.

The Court also relied on the Supreme Court precedent in *Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu (2018)*, which held that depriving a manufacturer of the sample for re-analysis constitutes a fatal procedural lapse.

The Court observed that Section 23(4)(iii) creates a statutory obligation to send a sample portion to the manufacturer simultaneously with the analyst's report to enable independent testing.

In this case, there was no evidence that a portion of the sample was ever sent to the petitioner.

Furthermore, the Drug Inspector failed to prove actual service of the Analyst’s report; the notice was sent to an incomplete address, omitting the District.

Because the shelf life of the drug expired in August 2011—nearly a year before the petitioner was summoned to Court—the petitioner’s "valuable right" to have the sample tested by the CDL under Section 25(4) was permanently lost.

The Court reasoned that since the delay was not attributable to the accused, the continuation of the trial would be a "lame prosecution" and an abuse of the process of law.

The Court allowed the petition and quashed the complaint titled *State through Drug Inspector v. Surjit Singh and others* pending before the Chief Judicial Magistrate, Jammu, along with all consequential proceedings.