Eight-Year Delay, Lost Sample, Expired Drug: J&K High Court Quashes Drugs Act Prosecution Against Albert David Limited
The High Court quashed a Drugs and Cosmetics Act complaint where the Central Drugs Laboratory never received the sample for retesting, the drug expired in July 2012, and the trial court took cognizance only in February 2020—nearly eight years after the complaint was filed.
The High Court of Jammu & Kashmir and Ladakh, sitting at Jammu, has quashed criminal proceedings under the Drugs and Cosmetics Act, 1940 against Albert David Limited, a pharmaceutical company, after finding that the company had been deprived of its statutory right to have a disputed drug sample retested by the Central Drugs Laboratory, Kolkata. Justice Wasim Sadiq Nargal, sitting singly, pronounced the judgment on 18 August 2026 in CRM(M) No. 618/2024. The court found that the sample—needles bearing Batch No. 4752, with an expiry date of July 2012—never reached the Central Drugs Laboratory despite being sent by the trial court, expired without retesting, and that the Chief Judicial Magistrate, Kathua then took cognizance on the basis of the original Government Analyst's report alone in February 2020. The court held that this course of events amounted to an abuse of the process of law and violated the company's right to a fair trial under Article 21 of the Constitution.
The Complaint and the Statutory Right Invoked
On 27 April 2011, the Drug Inspector, Kathua, conducted a routine inspection of the premises of M/s Hare Rama Hare Krishna, a chemist outlet at Kathua, and drew samples of four drugs. One of the samples—ADIS Needles, Batch No. 4752, manufactured by Albert David Limited—was sent to the Government Analyst, CFDL, Kathua. The Government Analyst's report dated 30 November 2011 declared the sample not of standard quality, having failed the sterility test.
Upon receiving the report, Albert David Limited, through its Quality Assurance Department, tested its own control samples, which passed the sterility test. The company disputed the Government Analyst's findings and, vide communication dated 21 February 2012—within the twenty-eight day period prescribed under Section 25(3) of the Drugs and Cosmetics Act, 1940—formally notified the Drug Inspector and the Assistant Controller, Drugs and Food Control Organisation, of its intention to adduce evidence in controversion of the report. The company specifically sought retesting by the Director, Central Drugs Laboratory, Kolkata.
A Screening Committee of the Drugs and Food Control Organisation thereafter recommended that the sample be sent to the Central Drugs Laboratory for reanalysis. On 14 May 2012, the Drug Inspector filed a complaint before the Chief Judicial Magistrate, Kathua under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 against M/s Hare Rama Hare Krishna and others, including Albert David Limited. The complaint itself contained a prayer for sending the sample to the Central Drugs Laboratory under Section 25 of the Act.
The Sample That Never Arrived
After the complaint was filed in May 2012, no effective order was passed for several months. When the matter came before the then Chief Judicial Magistrate on 14 January 2013, the court observed that one sample had been referred for retesting and that the report was awaited, and directed the concerned court clerk to send a reminder. The sample had an expiry date of July 2012—a date that had already passed by the time the court even directed a reminder.
No report arrived. The trial court continued issuing reminders to the Central Drugs Laboratory for over four years. Eventually, vide communication dated 25 October 2016, the Director-in-Charge, Central Drugs Laboratory, Kolkata, informed the Chief Judicial Magistrate that upon verification of its records, no such sample had been received from the court.
The response to this communication was, in the High Court's assessment, wholly inadequate. The Chief Judicial Magistrate, vide order dated 6 July 2017, merely directed the Drug Inspector to take necessary steps in light of the laboratory's communication. No inquiry was conducted into how the sample had gone missing or at what stage it had failed to reach the laboratory. No responsibility was fixed.
Three more years passed. On 18 February 2020—nearly eight years after the complaint was filed—the Chief Judicial Magistrate took cognizance of the complaint and issued process against all accused persons, including Albert David Limited, on the basis of the original Government Analyst's report alone. The impugned order gave no account of what had happened between 2016 and 2020, why the sample's non-receipt had not been investigated, or how the prosecution could proceed meaningfully when the drug sample had long since expired.
Albert David Limited appeared through an authorised representative on 27 April 2024 and furnished a personal bond of Rs. 50,000, which the Magistrate accepted. By the same order, however, the Magistrate directed issuance of warrants of arrest against accused Nos. 3, 4 and 5—including Albert David Limited as accused No. 5—in the sum of Rs. 10,000 each. A subsequent order dated 29 June 2024 questioned the company's appearance through an authorised representative. Albert David Limited filed CRM(M) No. 618/2024 before the High Court, seeking quashing of the complaint, the cognizance order of 18 February 2020, the arrest warrant order of 27 April 2024, and all subsequent proceedings.
Eight Questions, Eight Answers Against the Prosecution
Justice Nargal framed eight questions for determination and answered each one in favour of the petitioner company. The court's analysis proceeded through the text of Section 25 of the Drugs and Cosmetics Act and the line of Supreme Court authority governing the consequences of depriving an accused of the statutory right of retesting.
The statutory right under Section 25(3) and 25(4). Section 25(3) provides that the Government Analyst's report is evidence of the facts stated in it and becomes conclusive unless the person from whom the sample was taken notifies, within twenty-eight days of receiving the report, his intention to adduce evidence in controversion. Section 25(4) then obliges the court, where such notification has been given, to cause the sample produced before it to be sent to the Central Drugs Laboratory for test or analysis, whose report is made conclusive evidence.
The court held that Albert David Limited had exercised this right squarely and on time. The communication of 21 February 2012 expressly invoked Section 25(3) and sought retesting by the Central Drugs Laboratory. The Screening Committee had endorsed this course. The complaint itself had prayed for retesting. The right was recognised by all parties. The court held that once the statutory right was exercised within the prescribed period, the failure thereafter to secure the Central Drugs Laboratory's report deprived the company of a substantive statutory safeguard.
The court relied on the Supreme Court's judgment in M/s. Medicamen Biotech Ltd. & Anr. v. Rubina Bose, (2008) 7 SCC 196, where the Supreme Court quashed proceedings after finding that despite the accused having given notice to controvert the Government Analyst's report, the fourth sample held by the Magistrate had not been sent for reanalysis and the complaint had been filed close to the expiry of the drug. The same principle was drawn from State of Haryana v. Unique Farmaid (P.) Ltd. & Ors., (1999) 8 SCC 190, where the Supreme Court held that deprivation of the right to have a sample tested by the Central Insecticides Laboratory, through no fault of the accused, prejudiced their defence.
Whether the Government Analyst's report could sustain the prosecution. The court held that once the statutory retesting mechanism had been invoked and the sample sent to the Central Drugs Laboratory, the earlier Government Analyst's report could not serve as the basis for issuing process. The Supreme Court's judgment in Municipal Corporation of Delhi v. Ghisa Ram, AIR 1967 SC 970, was applied: where the valuable right to have a sample tested by the superior laboratory is denied, it is not proper to uphold a prosecution on the basis of the Public Analyst's report alone. The court observed that the mere non-receipt of the Central Drugs Laboratory's report did not restore the Government Analyst's report to the position it had occupied before the right of retesting was exercised. The appropriate course for the trial court was to ascertain what had happened to the sample and to take effective steps—not to fall back on the earlier report as though the statutory process had never been set in motion.
The shelf life issue. The sample's expiry date was July 2012. Cognizance was taken in February 2020. The court held, following the Supreme Court's judgment in Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu, (2018) 15 SCC 93, that a drug sample whose shelf life has expired cannot be meaningfully retested and that the consequences of this irreversible loss cannot be fastened upon an accused who had exercised the statutory right before expiry. The court observed that the statutory right of retesting is inherently time-bound and that its efficacy is directly connected to the shelf life of the sample. Once the sample expired in July 2012 without the retesting being completed, the statutory opportunity was irretrievably lost.
Trial court's procedural failures. The court found that the Chief Judicial Magistrate had failed at multiple stages. After the complaint was filed, no effective order was passed for months while the sample's shelf life was running. After January 2013, the court merely issued reminders without ensuring that the sample had actually reached the laboratory. When the laboratory's communication of October 2016 disclosed that the sample had never arrived, the court directed the Drug Inspector to “take necessary steps” without undertaking any inquiry into how the sample had gone missing or fixing any responsibility. Four further years then passed before cognizance was taken in 2020 on the basis of the original report, with no explanation in the cognizance order of what had happened in the intervening period.
The court held that this approach was contrary to the mandate of the Drugs and Cosmetics Act. Where time is strictly of the essence—because the efficacy of the statutory retesting mechanism depends upon the sample remaining within its shelf life—mere issuance of reminders without securing actual transmission and receipt of the sample defeats the purpose of the statutory right entirely.
Responsibility for the delay. Justice Nargal held that the delay of nearly eight years between the filing of the complaint and the taking of cognizance was not attributable to Albert David Limited. The company had exercised its statutory right on time, had sought retesting while the sample was within its shelf life, and had appeared before the Magistrate. The responsibility lay with the prosecution machinery and the court's clerical machinery, both of which had failed to ensure that the sample reached the Central Drugs Laboratory and that the statutory process was completed within the period when it could still serve its purpose.
The court expressed that the matter “shocks the conscience” of the court and described it as a case disclosing a casual approach to statutory timelines in a matter concerning drug quality. The Magistrate's conduct of allowing eight years to pass, and then proceeding on the basis of the original report without any examination of how the statutory process had failed, was characterised as seriously troubling.
Article 21 and fair trial. The court held that the right to a fair and speedy trial under Article 21 of the Constitution had been materially affected. The delay had not merely prolonged the proceedings; it had destroyed the very evidentiary opportunity which Albert David Limited had sought to avail under Section 25. Keeping a prosecution alive for years and then proceeding on the basis of an earlier report after the statutory opportunity to contest that report had ceased to exist did not satisfy the requirement of a fair procedure.
Lapses Requiring Administrative Examination
While quashing the proceedings against Albert David Limited, Justice Nargal made clear that the order would not mark the end of the matter. The court noted serious lapses at every stage: before the sample expired, after the laboratory's 2016 communication, and in the period between 2016 and 2020. The court directed that the circumstances be examined to fix responsibility and to ensure that similar failures do not recur in prosecutions under the Drugs and Cosmetics Act, where statutory timelines have a direct bearing on public health.
The court also noted that the possibility of mischief in the non-receipt of the sample by the laboratory could not be ruled out and directed the enquiry committee to examine whether any official of Albert David Limited had played any role in ensuring that the sample did not reach the Central Drugs Laboratory—while affording all stakeholders an opportunity of hearing.
The court further observed that the J&K High Court itself had previously, in Cipla Limited v. State of Jammu & Kashmir and Anr., CRMC No. 614/2016, decided on 30 September 2022, applied the Medicamen Biotech principle to quash proceedings where valuable statutory rights under Sections 25(3) and 25(4) had been defeated by acts and omissions of the Drugs Inspector.
Order
Justice Nargal allowed CRM(M) No. 618/2024 and quashed the complaint under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 pending before the Chief Judicial Magistrate, Kathua, along with the cognizance order dated 18 February 2020, the warrant order dated 27 April 2024, and all subsequent proceedings—insofar as they concerned Albert David Limited.
The Registrar General of the High Court was directed to place the judgment and the complete paper-book, including the entire scanned record of the trial court, before the Chief Justice on the administrative side for appropriate action.
The Drug Controller, Drugs and Food Control Organisation, J&K, Jammu, was directed to constitute a Committee within one week of the date of the judgment, headed by the Drug Controller with up to two co-opted members having expertise in the Drugs and Cosmetics Act and the statutory procedure governing testing and analysis of drug samples. The Committee was directed to examine the lapses, fix responsibility whether on the Drug Inspector or any other officer, ascertain why the sample dispatched by the court never reached the Central Drugs Laboratory, and examine whether any official of Albert David Limited had played any role in the non-receipt of the sample. The Committee was directed to complete its inquiry within four weeks of its constitution and submit its report in a sealed cover before the Registrar Judicial of the High Court. The Registry was directed to place that report before the court by way of index for further appropriate action.