The High Court of Jammu & Kashmir and Ladakh has quashed criminal proceedings against the Managing Director of a pharmaceutical company accused of manufacturing a drug that allegedly failed quality standards.
The Court held that the prosecution could not continue because the accused was deprived of the opportunity to seek re-testing of the drug sample before its shelf life expired. The delay in the prosecution process effectively denied the statutory right available under the Drugs and Cosmetics Act.
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The ruling was delivered by Justice Sanjeev Kumar while allowing a petition filed by Sudhir Kumar, Managing Director of Jacksons Laboratories Pvt. Ltd.
Background of the Case
The case dates back to December 7, 2013, when a Drug Inspector inspected the premises of a pharmaceutical distributor in Pulwama and collected samples of several medicines, including Molcin Plus, which had been manufactured by Jacksons Laboratories Pvt. Ltd.
One portion of the drug sample was sent to the Government Analyst at the Drug Laboratory in Srinagar. On December 27, 2013, the analyst reported that the medicine was “not of standard quality.”
Following the report, the Drug Inspector traced the supply chain of the drug through various distributors and eventually linked the medicine to the manufacturing company. A statutory notice along with the analyst’s report and a portion of the sample was sent to the manufacturer.
In response, the company disputed the findings of the Government Analyst and informed the authorities that it intended to challenge the report and present evidence to contradict it.
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Despite this communication, a criminal complaint was later filed before the Chief Judicial Magistrate (CJM), Pulwama, against several accused including the company’s Managing Director. The Magistrate took cognizance of the case on November 16, 2015.
The petition before the High Court raised important questions about the procedure under the Drugs and Cosmetics Act, 1940, particularly regarding the right of an accused to challenge the report of a Government Analyst.
The petitioner argued that once the manufacturer notified authorities of its intention to dispute the analyst’s report, the authorities should have ensured the possibility of re-testing the sample through the Central Drugs Laboratory.
However, by the time the petitioner appeared before the trial court in June 2016, the shelf life of the drug had already expired in March 2016, making re-testing impossible.
The High Court examined the provisions of Sections 23 and 25 of the Drugs and Cosmetics Act, which regulate the procedure for sampling and testing drugs.
Justice Sanjeev Kumar clarified that the law does not make it mandatory for the Drug Inspector to automatically send a drug sample to the Central Drugs Laboratory merely because the accused expresses an intention to contest the Government Analyst’s report.
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“The Court observed that the retesting or re-analysis of a drug sample can be undertaken only upon a request by either the complainant or the accused, and the Court retains discretion in deciding such a request,” the judgment explained.
However, the Court also noted that the circumstances of the case showed the petitioner had clearly indicated his intention to challenge the analyst’s report and expected the sample to be tested by the Central Drugs Laboratory.
Justice Kumar pointed out that the authorities did not act promptly. Because of this delay, the shelf life of the drug expired before the accused had the opportunity to seek retesting through the court.
“The Court noted that the petitioner, who intended to have the sample tested by the Central Drugs Laboratory, was deprived of that opportunity due to the delay in the prosecution.”
Considering these circumstances, the High Court held that continuing the criminal prosecution would amount to an abuse of the process of law.
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Allowing the petition, the Court quashed the criminal proceedings pending before the Chief Judicial Magistrate, Pulwama, along with the order taking cognizance issued on November 16, 2015.
Justice Sanjeev Kumar concluded that the denial of the opportunity to seek re-testing of the drug sample before the expiry of its shelf life was sufficient ground to set aside the prosecution.
Case Title: Sudhir Kumar v. Peerzada Tasaduq Hussain (Drug Inspector)
Case No.: CRMC No. 453/2018
Decision Date: 09 March 2026
