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Drug Sample Expired Before Re-Testing, J&K High Court Quashes Proceedings Against Maxmed Life Sciences

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J&K High Court quashes proceedings against Maxmed Life Sciences, holding that timely challenge to the drug analyst report preserved its statutory right to re-analysis.

Drug Sample Expired Before Re-Testing, J&K High Court Quashes Proceedings Against Maxmed Life Sciences
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The Jammu & Kashmir and Ladakh High Court at Jammu has quashed criminal proceedings against Maxmed Life Sciences Pvt. Ltd. and its director Sanjeev Wasan in a case arising under the Drugs and Cosmetics Act, 1940. The case concerned a drug sample that was declared “Not of Standard Quality” by the Government Analyst after failing the test for particulate matter.

The company had disputed the report within the prescribed 28-day period and expressed its intention to have the sample re-analysed. Justice Wasim Sadiq Nargal, in a judgment pronounced on September 22, 2026, held that referring to an NABL-accredited laboratory did not by itself amount to giving up the statutory right to challenge the report.

The proceedings arose from a complaint filed under Sections 18(a)(i) and 27(d) of the Drugs and Cosmetics Act, 1940. On January 16, 2014, a sample of the drug “Amzone”, manufactured by Maxmed Life Sciences, was collected from Chest and Disease Hospital, Bakshi Nagar, Jammu. The Government Analyst subsequently reported the sample as “Not of Standard Quality” because it failed the test for particulate matter.

The company was informed of the report on March 1, 2014. Within the statutory 28-day period, it disputed the findings and communicated its intention to adduce evidence against the Government Analyst’s report, seeking re-analysis. The company also stated that control samples tested at its own laboratory and a Government-approved laboratory had conformed to the prescribed standards.

The dispute before the High Court centred on the fact that the company had referred to testing by an NABL-accredited laboratory, rather than expressly naming the Central Drugs Laboratory. The State argued that this meant the statutory procedure had not been properly invoked. The High Court examined whether that wording could result in the company losing its statutory right under Section 25 of the Act.

The High Court examined Sections 25(3) and 25(4) of the Drugs and Cosmetics Act. Section 25(3) allows a person to challenge a Government Analyst’s report by notifying the concerned authority within 28 days that they intend to produce evidence against it. Section 25(4) provides for examination of the sample by the Central Drugs Laboratory, whose report carries conclusive evidentiary value.

The Court held that the essential requirement was the timely communication of an intention to dispute the Government Analyst’s report. Referring to the petitioners’ communication, the Court observed:

“The mere fact that the petitioners, in their communication, referred to ‘any NABL accredited laboratory’ cannot, by itself, be construed as an abandonment or waiver of the statutory right available to them under Section 25(3) of the Act. The fact that the petitioners may have used an expression different from the statutory terminology while requesting re-analysis may render the request imperfect in form, but the substantive requirement under Section 25(3) is whether they had communicated, within the prescribed period, their intention to controvert the Government Analyst's report.”

The Court further considered the fact that the drug’s shelf life expired in November 2015, while the petitioners received summons only in November 2016. By then, meaningful re-analysis of the sample was no longer possible.

The High Court concluded that the petitioners had exercised their statutory right within the prescribed period and that their reference to an NABL-accredited laboratory did not amount to abandonment of that right. Since the sample was not sent to the Central Drugs Laboratory before its expiry, the statutory safeguard had effectively been lost.

Justice Wasim Sadiq Nargal therefore allowed the petition, dismissed the impugned complaint insofar as the present petitioners were concerned pending before the Chief Judicial Magistrate, Jammu, and quashed all consequential proceedings arising from it.

Case Title: Maxmed Life Sciences Pvt. Ltd. and Ors. v. State of Jammu and Kashmir

Case Number: CRMC 17/2017, CrlM(1746/2020), IA(1/2017)

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