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High Court Quashes Drug Case Against Albert David Over Lost Sample Right
In a significant judgment that underscores the importance of procedural safeguards in drug regulation, the has quashed criminal proceedings against pharmaceutical company after finding that the company was deprived of its valuable to get the disputed drug sample re-tested by the Central Drugs Laboratory before its shelf life expired.
Justice Wasim Sadiq Nargal, allowing a petition under , observed that the case "" of the court, as a sample stated to have been sent for never reached the laboratory for almost eight years, yet was eventually taken on the basis of the earlier adverse report.
Case Background: Failed Sterility Test and Invoked Right to Retest
The controversy began on , when a Drug Inspector in Kathua collected samples of four drugs from a chemist outlet, including "ADISTM Needles" manufactured by with batch No. 4752, having an expiry date of . The sample was sent for testing to the Government Analyst, who reported on that it had failed the sterility test and was not of standard quality.
Within the statutory period of 28 days, wrote to the Drug Inspector on , disputing the findings and notifying its intention under to adduce evidence in controversion of the report. The company specifically requested that the sample be re-tested by the Director of the , Kolkata. The recommended reanalysis, and the complaint filed in itself contained a prayer to send the sample to the CDL.
The trial court's record indicated that the sample had been referred for , but despite repeated reminders, no report was received. Finally, in , the CDL informed the court that no such sample had ever been received from the . Despite this, the magistrate proceeded to take on and issued based on the original Government Analyst's report — by which time the sample had long expired.
Arguments: Deprivation of vs. Public Health Concern
The petitioner, represented by Senior Advocate , argued that the company had diligently exercised its right under Section 25(3) to controvert the Government Analyst's report and sought . The failure of the sample to reach the CDL and the subsequent delay of nearly eight years in taking , despite the sample's expiry, deprived the company of a . Continuing the prosecution in such circumstances, it was contended, would amount to an .
The official respondent, represented by Additional Advocate General , opposed the , submitting that the complaint disclosed a serious offence touching public health and that disputed questions of fact could not be adjudicated in . It was also argued that the petitioner had not appeared before the magistrate promptly.
Court's Analysis: Eight Questions Answered
The High Court framed eight questions for determination and answered each in favour of the petitioner.
On the first question — whether the petitioner was deprived of its
– the court held that the right under Section 25(3) and (4) is
"a
and not a mere
."
The company's timely communication seeking
was unequivocal. Citing the
's decision in
Medicamen Biotech Ltd. v. Rubina Bose
(2008), the court observed that once the
is exercised,
"the accused cannot subsequently be deprived of the corresponding opportunity of having the sample examined by the Central Laboratory on account of a failure in the statutory process."
On the second question — whether the trial court could proceed on the earlier Government Analyst's report – the court ruled that after the petitioner invoked Section 25(4), the earlier report
"could not thereafter be treated as the report upon which the prosecution could finally proceed."
The issuance of process on its basis after the sample became incapable of
had "no legal sanctity."
The court further held that both the trial court and the Drug Inspector had a duty to ensure timely transmission and receipt of the sample at the CDL.
"The statutory procedure could not be reduced to a paper exercise, where reminders were issued for years while the sample's shelf life continued to run out,"
the judge remarked.
Shelf Life: A Decisive Factor
Addressing the significance of the sample's expiry in
, the court noted that the efficacy of the
of re-analysis is
"closely connected with the shelf life of the drug."
Relying on the
's decision in
Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu
(2018), the court held that a sample whose shelf life has expired cannot be treated as capable of meaningful . The loss of opportunity could not be attributed to the petitioner, which had invoked its right well before expiry.
Delay, Fair Trial and Abuse of Process
The court found the nearly eight-year delay between filing of the complaint (2012) and taking
(2020) to be entirely attributable to the prosecution and court machinery.
"The requirement of a
cannot be satisfied by keeping the prosecution alive for years and thereafter proceeding on the basis of an earlier report after the statutory opportunity to test that report has ceased to exist,"
the judgment read.
Invoking the
under
, the court concluded that continuing the prosecution would require the petitioner to face criminal proceedings
"even though the statutory mechanism for testing the disputed sample was never effectively completed, and the possibility of such testing has since been lost due to circumstances not attributable to the petitioner."
This, the court held, constituted an
.
Key Observations
"This is a rare case which of this Court, where a sample stated to have been sent by the Court to the Central Drugs Laboratory was not received by the said Laboratory for almost eight years, while the Court continued to await the report without taking any effective or coercive measures to secure the same or examining the circumstances in which the sample had failed to reach the Laboratory."
"The right so conferred upon the person concerned is, therefore, a and not a mere ."
"Once the to controvert the analyst's report is exercised within the prescribed period, the accused cannot subsequently be deprived of the corresponding opportunity of having the sample examined by the Central Laboratory on account of a failure in the statutory process."
Decision and Directions: and Inquiry
The High Court allowed the petition and quashed the order dated taking and issuing process against , along with all consequential proceedings. However, the court did not stop there. Noticing serious lapses in the handling and transmission of the sample, it directed the Registrar General to place the matter before the Chief Justice on the administrative side for appropriate action.
Additionally, the court ordered the , J&K to constitute a committee within one week to examine the lapses, fix responsibility, and ascertain why the sample never reached the CDL. The committee was also asked to investigate whether any mischief or manipulation occurred, including on the part of the petitioner's officials, after providing an opportunity of hearing to all stakeholders. The report is to be submitted in a sealed cover within four weeks.
Implications
The judgment reinforces the principle that the right to under Section 25 of the Drugs and Cosmetics Act is a valuable safeguard that cannot be rendered illusory by administrative delays. It also sends a strong message to trial courts and drug inspectors about the need for meticulous compliance with statutory timelines, especially when the sample's shelf life is limited. For pharmaceutical companies, this decision provides a clear precedent: if the prosecution fails to facilitate timely after the accused invokes the , the proceedings may be liable to be quashed.
