J&K High Court Quashes Drug Quality Case Against Himachal-Based Pharma Firm
It stated that failure by the authorities to supply the drug sample to the manufacturer deprived the company of its legal right to seek reanalysis.
Published : March 11, 2026 at 7:49 PM IST
Srinagar: The High Court of Jammu & Kashmir and Ladakh on Wednesday quashed criminal proceedings against a Himachal Pradesh-based pharmaceutical manufacturer in a drug quality case, holding that the prosecution violated the company's statutory right to challenge the findings of a government analyst.
In his 24-page judgment, Justice Sanjeev Kumar ruled that failure by the authorities to supply a portion of the drug sample to the manufacturer and doubts regarding service of the analyst's report deprived the company of its legal right to seek re-analysis, rendering the prosecution unsustainable.
"Viewed from any angle, the complaint filed by respondent No. 2 (Drug Inspector, Jammu Zone-V) was not maintainable in law and, therefore, proceedings taken in such complaint are completely vitiated," the court said, adding that allowing the case to proceed would amount to "sheer abuse of the process of law".
Himachal Pradesh-based August Remedies approached the High Court in 2013, through its partner Sanjay Taneja, under the inherent criminal jurisdiction of the court under Section 561-A of the Code of Criminal Procedure (CrPC), seeking quashing of proceedings in a complaint titled State through Drug Inspector vs Surjit Singh and others, pending before the Chief Judicial Magistrate of Jammu.
The respondents in the case included: State of Jammu and Kashmir, through the Deputy Controller, Drugs & Food Control Organization, Muthi, Jammu, Drug Inspector Gagan Bhardwaj, Jammu Zone-V, Surjit Singh, son of Shukar Singh, proprietor of M/s Shiv Shakti Medicos, Sure Chak, Phallan Mandal, Jammu, Koushal Jain, competent person of M/s J.K. Pharma, Shalimar Road, Jammu, Pankaj Pharma, Dr. Mukherjee Nagar, Delhi, through its proprietor/partner, and Amro Pharma, Commercial Complex, Dr. Mukherjee Nagar, Delhi, through its proprietor/partner.
According to the case record, the drug inspector lifted samples of the drug "Tab CEFAM-250' (Batch No. 349, manufactured in September 2009 and expiring in August 2011) from the premises of M/s Shiv Shakti Medicos at Sure Chak, Phallan Mandal, Jammu on February 22, 2010.
The sampling was conducted during a routine inspection under the provisions of the Drugs and Cosmetics Act, 1940. The inspector filled Form No. 17 and divided the drug sample into four portions in the presence of the retailer. One portion was handed to the retailer, one was sent to the government analyst at the Central Drugs Laboratory, Jammu, and others were retained as per the statutory procedure. The analyst's report dated July 19, 2010, declared the drug sample "not of standard quality", stating that it had failed the assay test for the active ingredient Cefuroxime.
Following this, the drug inspector directed the retailer to stop the sale of the drug and disclose the source of its purchase. The retailer informed authorities that the medicine had been supplied by M/s JK Pharma, which in turn said it had obtained it from Delhi-based Pankaj Pharma. The manufacturer was identified as August Remedies in Himachal Pradesh. The manufacturer challenged the prosecution primarily on the ground that it had been deprived of its statutory right to contest the analyst's findings.
Under the Drugs and Cosmetics Act, a manufacturer has the right to have the sample retested by the Central Drugs Laboratory if it disputes the government analyst's report. However, the court noted that the authorities failed to send a portion of the drug sample to the manufacturer as required by law.
Justice Kumar observed that the statutory procedure clearly requires a portion of the sample to be supplied to the manufacturer whose details are disclosed during the investigation. "A reading of the provisions… would indicate that in the present case the sample having been taken from the premises of the retailer had to be divided into four portions… the last one to the manufacturer whose name, particulars, etc. is disclosed," the court noted.
The High Court said the failure to send the sample to the manufacturer made it impossible for the company to independently verify the quality of the drug or seek re-analysis. "When the part of the sample was not sent to the manufacturer, it could not have got the same analysis even if it wanted to do so and, therefore, it was not in a position to contest the findings of the government analyst," the judgment stated.
The court also expressed doubt over whether the report of the government analyst had actually been served on the petitioner in time. "A serious doubt is created in the mind of the Court about the actual service of the report of the government analyst on the petitioner," the judge said, adding that if service had not occurred properly, the company's right to challenge the report within 28 days stood violated.
The court said that because of these lapses, the manufacturer was deprived of multiple statutory protections, including the right to obtain independent testing and to request that the court send the sample for reanalysis to the Central Drugs Laboratory. The judgment emphasised that these procedural safeguards are crucial in drug quality prosecutions.
"Failure of the complainant to supply a portion of the lifted sample to the petitioner has also deprived the petitioner of its right to get it tested or analysed from any independent laboratory," Justice Kumar observed.
The court further held that such procedural violations undermined the fairness of the prosecution. Allowing the petition, the High Court quashed the complaint pending before the Chief Judicial Magistrate, Jammu, along with all consequential proceedings. "For all these reasons, I find merit in this petition and the same is, accordingly, allowed. The complaint filed by respondent No.2… along with all proceedings taken thereon is quashed," the court said.
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