
Srinagar, Aug 20: The High Court of Jammu and Kashmir and Ladakh has quashed criminal proceedings against pharmaceutical company Albert David Limited in a case involving an allegedly substandard drug sample, holding that the company was denied its statutory right to have the sample re-tested.
Justice Wasim Sadiq Nargal passed the judgment on August 18, 2026, while hearing a petition filed by the company through its Jammu Regional Sales Manager.
The case dates back to April 2011, when the Drugs Inspector, Kathua, collected samples of four medicines during an inspection of a chemist outlet. One of the samples, ADIS Needles, Batch No. 4752, manufactured by Albert David, was declared “not of standard quality” after failing a sterility test in the Government Analyst’s report issued on November 30, 2011.
Albert David challenged the report within the prescribed statutory period and sought re-testing of the sample by the Director, Central Drugs Laboratory (CDL), Kolkata, invoking Sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940.
A complaint was subsequently filed before the Chief Judicial Magistrate, Kathua, in May 2012. However, the sample crucial to the re-testing process apparently never reached the Kolkata laboratory.
The High Court noted that the Director-in-Charge of the CDL informed the trial court in October 2016 that its records showed no such sample had been received for examination.
Despite this, the proceedings continued. More significantly, the sample had already expired in July 2012, while the trial court took cognizance of the complaint only in February 2020—almost eight years after the complaint was filed.
The High Court held that once the company had exercised its statutory right to challenge the Government Analyst’s report, the right to re-testing could not be defeated because of failure to transmit the sample to the designated laboratory. With the sample having expired, the statutory safeguard had effectively become impossible to exercise.
Justice Nargal expressed serious concern over the prolonged delay and the absence of an effective inquiry into the whereabouts of the sample. Describing the matter as one that “shocks the judicial conscience”, the court observed that lapses in drug-testing procedures could have serious ramifications for public health.
The court accordingly quashed the February 18, 2020 cognizance order and all consequential criminal proceedings against Albert David Limited.
However, the court stopped short of treating the matter as merely a procedural lapse and ordered an administrative inquiry into the handling and transmission of the drug sample.
The Registrar General has been directed to place the judgment, paper-book and relevant trial-court records before the Chief Justice for appropriate action. Meanwhile, the Drug Controller, Drugs and Food Control Organization, J&K, has been directed to constitute a committee headed by the Drug Controller, with the option of including two experts familiar with the Drugs and Cosmetics Act and statutory drug-testing procedures.
The committee will examine the circumstances surrounding the missing sample, identify any negligence and fix responsibility wherever warranted. It will also examine whether any official or other stakeholder deliberately interfered with the process or attempted to prevent the sample from reaching the Central Drugs Laboratory.
The inquiry has been ordered to be completed within four weeks of the committee's constitution, with the report to be submitted before the Registrar Judicial of the High Court.
The judgment, therefore, not only provides relief to the pharmaceutical company but also raises important questions about accountability, chain-of-custody safeguards and procedural integrity in drug-quality testing.
Srinagar, Aug 20: The High Court of Jammu and Kashmir and Ladakh has quashed criminal proceedings against pharmaceutical company Albert David Limited in a case involving an allegedly substandard drug sample, holding that the company was denied its statutory right to have the sample re-tested.
Justice Wasim Sadiq Nargal passed the judgment on August 18, 2026, while hearing a petition filed by the company through its Jammu Regional Sales Manager.
The case dates back to April 2011, when the Drugs Inspector, Kathua, collected samples of four medicines during an inspection of a chemist outlet. One of the samples, ADIS Needles, Batch No. 4752, manufactured by Albert David, was declared “not of standard quality” after failing a sterility test in the Government Analyst’s report issued on November 30, 2011.
Albert David challenged the report within the prescribed statutory period and sought re-testing of the sample by the Director, Central Drugs Laboratory (CDL), Kolkata, invoking Sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940.
A complaint was subsequently filed before the Chief Judicial Magistrate, Kathua, in May 2012. However, the sample crucial to the re-testing process apparently never reached the Kolkata laboratory.
The High Court noted that the Director-in-Charge of the CDL informed the trial court in October 2016 that its records showed no such sample had been received for examination.
Despite this, the proceedings continued. More significantly, the sample had already expired in July 2012, while the trial court took cognizance of the complaint only in February 2020—almost eight years after the complaint was filed.
The High Court held that once the company had exercised its statutory right to challenge the Government Analyst’s report, the right to re-testing could not be defeated because of failure to transmit the sample to the designated laboratory. With the sample having expired, the statutory safeguard had effectively become impossible to exercise.
Justice Nargal expressed serious concern over the prolonged delay and the absence of an effective inquiry into the whereabouts of the sample. Describing the matter as one that “shocks the judicial conscience”, the court observed that lapses in drug-testing procedures could have serious ramifications for public health.
The court accordingly quashed the February 18, 2020 cognizance order and all consequential criminal proceedings against Albert David Limited.
However, the court stopped short of treating the matter as merely a procedural lapse and ordered an administrative inquiry into the handling and transmission of the drug sample.
The Registrar General has been directed to place the judgment, paper-book and relevant trial-court records before the Chief Justice for appropriate action. Meanwhile, the Drug Controller, Drugs and Food Control Organization, J&K, has been directed to constitute a committee headed by the Drug Controller, with the option of including two experts familiar with the Drugs and Cosmetics Act and statutory drug-testing procedures.
The committee will examine the circumstances surrounding the missing sample, identify any negligence and fix responsibility wherever warranted. It will also examine whether any official or other stakeholder deliberately interfered with the process or attempted to prevent the sample from reaching the Central Drugs Laboratory.
The inquiry has been ordered to be completed within four weeks of the committee's constitution, with the report to be submitted before the Registrar Judicial of the High Court.
The judgment, therefore, not only provides relief to the pharmaceutical company but also raises important questions about accountability, chain-of-custody safeguards and procedural integrity in drug-quality testing.
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