Observing the case as “rare one” shocking judicial conscience, the High Court of J&K and Ladakh has ordered a probe into a drug sample that failed to reach the Central Drugs Laboratory, Kolkata, for nearly eight years, even as it directed the J&K’s Drug Controller to set up a panel to fix responsibility whether any official had a role in preventing the sample from reaching the facility.
A bench of Justice Wasim Sadiq Nargal ordered the probe while quashing criminal proceedings against pharmaceutical company Albert David Limited in a drug-quality case. The company, the court said, was deprived of its valuable statutory right to have a disputed drug sample re-tested by the Central Drugs Laboratory, Kolkata.
The Court also quashed the order dated February 18, 2020 passed by the Chief Judicial Magistrate, Kathua, whereby cognisance had been taken against the company, along with all consequential proceedings arising therefrom.
The case stemmed from a drug sample drawn during an inspection at a chemist outlet in Kathua in April 2011. The sample of ADIS Needles, manufactured by Albert David Limited, was declared “not of standard quality” after failing a sterility test conducted by the Government Analyst. The company, however, within the prescribed 28-day period, disputed the report and sought re-testing of the sample by the Director, Central Drugs Laboratory, Kolkata, under Section 25 of the Drugs and Cosmetics Act, 1940.
The High Court pointed out that the complaint was filed before the Chief Judicial Magistrate, Kathua on May 14, 2012 and the sample was stated to have been sent for re-analysis. However, in October 2016, the Central Drugs Laboratory informed the trial court that it had not received the sample. Despite this, no effective inquiry was undertaken to ascertain the whereabouts of the sample, while the proceedings remained pending.
The Court observed that the sample had expired in July 2012 and, by the time cognisance was taken in February 2020, meaningful re-testing was no longer possible. The trial court, it said, could not simply revert to the earlier Government Analyst’s report after the statutory mechanism for re-testing had been invoked.
While the court noted that the prolonged delay had materially affected the fairness of the proceedings and attracted the guarantee of a fair and speedy trial under Article 21 of the Constitution, it observed that the eight-year delay had destroyed the evidentiary opportunity to determine independently whether the drug was actually substandard.
The court observed the case as “rare one” which shocked the judicial conscience of the Court as a sample stated to have been sent by the court to the Central Drugs Laboratory was not received by the Laboratory for almost eight years, while the trial Court continued to await the report without taking any effective measures to secure the same or examining the circumstances in which the sample had failed to reach the Laboratory.
The Court noted that after waiting for an inordinate period, the trial Court proceeded to rely upon the earlier report of the Government Analyst and issued process on the basis thereof, notwithstanding that the report had lost its significance in the peculiar facts and circumstances of the case.
The court underscored that once the validity of the sample had expired in July, 2012, the question as to how and under what circumstances the proceedings before the trial Court continued for almost eight years thereafter, and what legal sanctity could attach to such proceedings in the absence of the very sample being available for re-analysis, requires a thorough examination.
“The matter, therefore, warrants a threadbare inquiry into the circumstances leading to the non-receipt of the sample by the Central Drugs Laboratory, the prolonged inaction thereafter, and the responsibility for permitting the proceedings to continue despite the expiry of the sample.”
Observing that the lapses were required to be examined administratively, the Court ordered the Registrar General to place the judgment, complete paper-book and scanned trial court record before the Chief Justice for appropriate action.
Moreover, it directed the Drug Controller, Drugs and Food Control Organisation, J&K, Jammu to constitute, within one week, a committee headed by him and comprising experts in the Drugs and Cosmetics Act and the statutory procedure for testing drug samples.
About The Author
