Drug sample missing for 8 years, expires: HC says case ‘Shocks Judicial Conscience’, orders probe

20/08/2026

JAMMU, Aug 19: The High Court of Jammu & Kashmir and Ladakh has quashed criminal proceedings against pharmaceutical company Albert David Limited in a case under the Drugs and Cosmetics Act, holding that the company was deprived of its statutory right to have a disputed drug sample re-tested by the Central Drugs Laboratory (CDL), Kolkata after the sample failed to reach the laboratory and subsequently expired.
Justice Wasim Sadiq Nargal, in a detailed and reportable judgment pronounced on August 18 in CRM(M) No. 618/2024, described the matter as a "rare case which shocks the judicial conscience" and ordered a detailed inquiry into how the sample disappeared from the statutory testing process and why the proceedings continued for nearly eight years without an effective determination of its whereabouts.
The Court quashed the February 18, 2020 order passed by the Chief Judicial Magistrate, Kathua, whereby cognizance had been taken against Albert David Limited and process issued against the company, along with all consequential proceedings arising from that order.
The case originated from a routine inspection conducted by the Drug Inspector, Kathua, on April 27, 2011, at M/s Hare Rama Hare Krishna, a chemist/drug outlet in Kathua. Samples of four drugs were lifted, including ADIS needles, Batch No. 4752, manufactured by Albert David Limited. The sample had a manufacturing date of 2007/08 and an expiry date of July 2012.
The Government Analyst, after testing the sample, issued a report dated November 30, 2011, declaring it "not of standard quality" after it failed the sterility test.
Albert David disputed the findings and, through a communication dated February 21, 2012, notified the Drug Inspector within the prescribed 28-day period of its intention to controvert the Government Analyst's report. The company specifically sought re-testing of the sample by the Director, Central Drugs Laboratory, Kolkata under Section 25(3) and (4) of the Drugs and Cosmetics Act.
The company also stated that it had tested its control samples through its Quality Assurance Department and that those samples had passed the sterility test. As a precautionary measure, it informed the authorities about withdrawal of stocks from the market.
The Drugs and Food Control Organisation's Screening Committee subsequently recommended that the sample be sent to the Central Drugs Laboratory, Kolkata, for re-analysis. The complaint itself, filed before the CJM Kathua on May 14, 2012 under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, contained a prayer for sending the sample to the CDL for re-testing.
However, the statutory process did not reach its intended conclusion.
The High Court noted that the trial court kept awaiting the re-testing report for more than four years. Eventually, the Director-in-Charge of the Central Drugs Laboratory, Kolkata, through a communication dated October 25, 2016, informed the court that its records had been checked and no such sample had been received from the Court of the Chief Judicial Magistrate, Kathua.
The Court held that the non-receipt of the sample by the CDL could not simply result in the trial court reverting to the original Government Analyst's report.
Once Albert David had exercised its statutory right to challenge that report and the sample had allegedly been sent for re-testing, the earlier report could not again be treated as the final basis for prosecution merely because the CDL report was unavailable, Justice Nargal held.
The Court emphasised that the statutory right of re-analysis was a valuable right intended to provide the accused an opportunity to challenge the Government Analyst's findings through examination by the superior laboratory.
In the present case, the sample expired in July 2012. Thus, by the time the Magistrate took cognizance and issued process on February 18, 2020, the sample had long ceased to be capable of meaningful re-testing.
The High Court said the statutory right could not be preserved merely on paper while the sample itself became incapable of being tested because of the passage of time. It relied upon Supreme Court judgments recognising the importance of an accused's right to have a drug sample re-tested where such a right has been timely invoked.
The Court also found serious lapses in the manner in which the matter was handled after the CDL communicated in 2016 that the sample had never reached it.
The Magistrate, through an order dated July 6, 2017, merely directed the Drug Inspector to take necessary steps. However, the record did not disclose any effective inquiry into the whereabouts of the sample, the stage at which it went missing or the person responsible for the failure.
The Court observed that neither the Court nor the Drug Inspector could treat the statutory procedure as a mere paper exercise by issuing reminders for years while the sample's shelf life continued to run out.
It noted that the Court, its clerical machinery and the Drug Inspector were required to act with greater diligence because the statutory scheme attached importance to timely testing and the sample had a limited shelf life.
The Bench further observed that the position became "more inexplicable" because even after the CDL's communication in 2016 and the Magistrate's direction in July 2017, no effective proceedings were undertaken until 2020.
The Magistrate ultimately proceeded on the basis of the earlier Government Analyst's report even though the sample had expired almost eight years earlier. The High Court said the record did not disclose what steps had been taken to ascertain the fate of the sample or how the prosecution could meaningfully continue after the expiry of its shelf life.
Justice Nargal held that the circumstances warranted a "threadbare inquiry" into the non-receipt of the sample at the CDL, the prolonged inaction thereafter and the responsibility for allowing the proceedings to continue despite the expiry of the sample.
The Court also underlined the public-health dimension of the matter, observing that serious lapses in ensuring timely compliance with the statutory mechanism governing drug testing could have direct and serious ramifications for public health.
As part of the directions, the Court ordered the Registrar General to place the judgment, complete paper-book and the entire scanned trial court record before the Chief Justice on the administrative side for appropriate action.
The Drug Controller, Drugs and Food Control Organisation, J&K, Jammu, has been directed to constitute a committee within one week, headed by the Drug Controller. The latter may co-opt two members having expertise in the Drugs and Cosmetics Act and the statutory procedure governing testing and analysis of drug samples.
The committee has been tasked with examining the lapses in the case and fixing responsibility, including determining whether there was negligence on the part of the Drug Inspector or any other officer concerned and ascertaining why the sample, once stated to have been dispatched by the competent court, did not reach the Central Drugs Laboratory, Kolkata.
Significantly, the inquiry has also been directed to examine whether there was any "mischief" or role played by any official of Albert David Limited in manipulating the record with the intention of preventing the sample from reaching the CDL. The Court directed that all stakeholders be given an opportunity of being heard.
The committee has been directed to complete the exercise within four weeks of its constitution and submit its report in a sealed cover before the Registrar Judicial. The Registry will thereafter place the report before the High Court for further appropriate action.
The High Court consequently allowed the petition and quashed the proceedings against Albert David Limited, while making it clear that the institutional lapses surrounding the missing sample would continue to be examined through the ordered inquiry.
Senior Advocate Sunil Sethi appeared for Albert David Limited along with advocates Shivam Mahajan, Sachin Shukla and Shubham Sharma, while AAG Raman Sharma represented the UT of J&K.
The judgment is available as a full, reportable judgment pronounced by the High Court on August 18, 2026.

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