The High Court, while making these observations, directed an inquiry into lapses after the sample, stated to have been sent to the Central Drugs Laboratory, failed to reach it for almost eight years.

The Court was hearing a petition under Section 482 of the CrPC, seeking quashing of a complaint under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, the cognisance order passed by the Chief Judicial Magistrate, Kathua, and consequential proceedings arising from it.

A Bench of Justice Wasim Sadiq Nargal, while stating that “a sample whose shelf life has expired cannot, in the peculiar facts of the present case, be treated as capable of meaningful re-testing”, further observed,

“This is a rare case which shocks the judicial conscience 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 Bench added,

“Once the validity of the sample had expired in July, 2012, the question as to how and under what circumstances the proceedings before the learned 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.”

The matter arose after the petitioner company, a pharmaceutical manufacturer, was proceeded against after a Drug Inspector lifted samples of four drugs from a chemist outlet. The sample concerning the petitioner was ADIS Needles, which was reported by the Government Analyst to have failed the sterility test and was declared not of standard quality.

After receiving the Government Analyst's report, the company disputed the findings within the statutory period and informed the authorities that its control samples had passed the sterility test. It also notified its intention under Section 25(3) of the Drugs and Cosmetics Act, 1940 to adduce evidence in controversion of the report and sought re-testing of the sample by the Director, Central Drugs Laboratory, Kolkata.

The Screening Committee recommended reanalysis, and the complaint itself contained a prayer to send the sample to the Central Drugs Laboratory. The trial court record showed that the sample was stated to have been sent for retesting, but the Central Drugs Laboratory later informed the court that no such sample had been received from the Chief Judicial Magistrate, Kathua. Despite that position, cognisance was ultimately taken years later based on the earlier Government Analyst's report.

The petitioner argued that it had been deprived of a valuable statutory right under Sections 25(3) and 25(4), and that the sample's expiry made meaningful retesting impossible. The official respondent opposed quashing, contending that the complaint disclosed offences concerning manufacture, sale and distribution of a drug allegedly not conforming to prescribed standards and involving public health.

Section 25 Retesting Is A Substantive Safeguard

The High Court, upon hearing the matter, explained that Section 25 gives evidentiary force to the Government Analyst's report, but its conclusiveness is displaced when the concerned person notifies an intention to controvert it within twenty-eight days.

The Court observed: “The right so conferred upon the person concerned is, therefore, a substantive statutory safeguard and not a mere procedural formality.”

The Court found that the petitioner had consciously invoked this mechanism through its communication seeking re-testing by the Central Drugs Laboratory.

It held,

“The aforesaid communication leaves little scope for doubt that the petitioner had not merely disputed the findings of the Government Analyst, but had consciously and expressly invoked the statutory mechanism under Section 25(3) and sought re-testing of the sample by the Director, Central Drugs Laboratory.”

The Bench, accordingly, remarked: “… once the statutory right 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”.

Government Analyst's Report Could Not Substitute CDL Reanalysis

The Court held that once the Section 25(4) route had been invoked, the earlier Government Analyst's report could not be treated as the final basis to proceed against the petitioner without obtaining the Central Drugs Laboratory's report or addressing the failure of that mechanism.

The Court observed,

“Once this statutory course had been adopted, the earlier report of the Government Analyst could not thereafter be treated as the report upon which the prosecution could finally proceed, particularly when, the very purpose of sending the sample to the Central Drugs Laboratory was to obtain the report contemplated under Section 25(4) of the Act.”

The Bench underscored that “the issuance of process on the basis of the earlier Government Analyst's report, after the statutory mechanism had been invoked and the sample had become incapable of re-testing, therefore had no legal sanctity in the peculiar facts of the present case”.

Trial Court And Drug Inspector Had To Ensure Effective Compliance

The Court held that the duty of the Trial Court and the Drug Inspector did not end with recording that the sample had been sent. The statutory process had to be completed while the sample could still be meaningfully analysed.

The Court observed,

“Once the sample had been sent, it was the bounden duty of the Court to ensure that the sample reached the laboratory timely and the report was received within the period during which the validity and shelf life of the sample subsisted.”

It further observed,

“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.”

Shelf Life Made The Lost Opportunity Irreversible

The Court further held that the statutory right of reanalysis is tied to the sample remaining capable of testing. Since the sample expired in July 2012, the failure to obtain a Central Drugs Laboratory report could not be treated as a curable procedural lapse.

The Court observed,

“The statutory scheme of the Drugs and Cosmetics Act assumes particular significance in this regard, as the procedure contemplated thereunder is inherently time-bound and the efficacy of the statutory right of re-analysis is closely connected with the shelf life of the drug.”

The Court added that permitting prosecution to proceed on the earlier report would prejudice the petitioner despite the petitioner having exercised the statutory right before expiry of the sample.

Public Health Did Not Dilute Fair Procedure

The Court accepted that the Drugs and Cosmetics Act serves a public-health purpose, but held that this made timely compliance with the statutory mechanism more important, not less.

The Court observed,

“The statutory safeguards contained in the Drugs and Cosmetics Act must accordingly be understood as serving not merely a regulatory purpose, but also as an important legislative mechanism for protecting the health and life of persons who may be required to consume such drugs.”

On delay, the Court held,

“The present case demonstrates how delay can affect both sides of the statutory scheme. On one hand, prolonged delay defeats the timely determination of whether the drug was actually of substandard quality; on the other, it deprives the accused of the opportunity to obtain an independent statutory determination from the Central Drugs Laboratory.”

Delay Attracted Article 21 And Abuse Of Process Principles

The Court found that the delay was not merely delay in trial, but delay which destroyed the very evidentiary opportunity invoked by the petitioner under Section 25.

The Court observed,

“The requirement of a fair and speedy procedure 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.”

Invoking inherent jurisdiction, the Court held,

“Thus, continuation of the prosecution would therefore 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.”

Examination Of Lapses

The Court found serious lapses in the court and prosecution machinery after the sample allegedly sent to the Central Drugs Laboratory did not reach it. The Court observed: “The learned trial Court, the clerical staff and the Drug Inspector were required to ensure compliance with the statutory procedure, which this Court is afraid to observe was not done.”

The Court, accordingly, directed placing the matter before the Chief Justice on the administrative side for appropriate action.

The Court also directed the Drug Controller to constitute a committee to examine the lapses, fix the responsibility for the same, and also to ascertain the reasons why the sample once dispatched by the competent Court has not reached the Central Drugs Laboratory, Kolkata.

“The committee shall also inquire whether there was any mischief or role played by any official of the petitioner-Company in manipulating the record with the intention that the sample should not reach before the Central Drugs Laboratory, Kolkata by providing an opportunity of being heard to all the stakeholders”, the Bench added.

The High Court allowed the petition and quashed, qua the petitioner, the cognisance order passed by the Chief Judicial Magistrate, Kathua, along with consequential proceedings arising from it.

Case Title: Albert David Limited v. Union Territory of J&K and others

Citation: 2026 LiveLaw (JKL) 326

Appearances

For the Petitioner: Senior Advocate Sunil Sethi with Advocates Shivam Mahajan, Sachin Shukla and Shubham Sharma

For the Respondents: AAG Raman Sharma

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