SRINAGAR: The High Court of Jammu and Kashmir and Ladakh has dismissed petitions filed by a drug manufacturer, distributors, stockists and dealers seeking quashing of criminal proceedings arising from a 2014 case involving “Macnim Plus Tablets”, holding that they failed to exercise their statutory right to seek retesting of the drug sample within the prescribed period.
Justice Sanjay Parihar, who heard the connected petitions, said the material on record prima facie showed that the Drug Inspector had followed the statutory safeguards while drawing the sample and tracing the distribution chain. The court held that the petitioners could not seek quashing merely on the ground that a portion of the sample had not been directly supplied to the manufacturer, particularly when no timely request for retesting had been made.
The judgment was pronounced on August 11, 2026, in CRMC No. 364/2016, CRMC No. 15/2017 and CRM(M) No. 223/2022. The petitions were filed by M/s Simran Pharmaceuticals, Jammu, M/s Sunil Medicates, Pathankot, M/s Affine Formulations Pvt Ltd, Himachal Pradesh, and M/s Luv Kush Drug House, Karnal, in connection with proceedings under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940.
The case originated from an inspection conducted on January 4, 2014, when the Drug Inspector, Doda, purchased and sampled “Macnim Plus Tablets”, Batch No. 13329, manufactured in May 2013 and having an expiry date of April 2015, from M/s Lucky Medical Hall, Doda. The Government Analyst subsequently declared the sample “Not of Standard Quality” after it failed the disintegration test.
The sample was divided into four portions and sealed in accordance with the prescribed procedure. One portion was handed over to the retailer, another was sent to the Government Analyst, while a third portion was later handed over to M/s Simran Pharmaceuticals after the retailer disclosed that firm as the source from which the drug had been procured. The fourth portion was required to be produced before the court in accordance with the statutory scheme.
The Government Analyst’s report was received by the complainant on January 29, 2014, declaring the drug to have failed the disintegration test. The retailer disclosed Simran Pharmaceuticals as the supplier, which in turn disclosed M/s Sunil Medicates as the wholesaler. Sunil Medicates subsequently identified M/s Luv Kush Drug House as the source, while M/s Sian Biotech was identified as the authorised distributor of the manufacturer, M/s Affine Formulations.
The manufacturer was thereafter informed about the failure of the drug sample. In a communication dated April 28, 2014, it maintained that the drug conformed to the Indian Pharmacopoeia and offered an explanation concerning the disintegration test, suggesting that the tablet could swell after a longer period during testing. It also appears to have instructed its distributor to recall the product.
The petitioners argued before the High Court that the Drug Inspector was not duly empowered to draw and have the sample analysed and that the Public Analyst was similarly not competent to analyse the drug, which fell under Schedule C of the Act. They further contended that the manufacturer had been deprived of its valuable statutory right to have the sample retested because no portion had been directly supplied to it.
The petitioners also relied upon an earlier judgment of a coordinate bench in August Remedies, Village Ogli, Nahan Road v State of J&K and others, arguing that non-supply of the sample to the manufacturer had denied it an effective opportunity to challenge the Government Analyst’s report. They further argued that the drug had been dealt with by licensed retailers, stockists, wholesalers and distributors and that there was no allegation that the prescribed storage conditions had been violated while the drug remained in their custody.
The respondents opposed the petitions, maintaining that four portions of the sample had been prepared and that the statutory requirements had been complied with. They submitted that the third portion was personally handed over to Simran Pharmaceuticals on February 28, 2014, after the retailer disclosed its particulars. The respondents further argued that none of the petitioners had sought retesting within the 28-day period prescribed under Section 25(3) of the Act.
The respondents also relied upon SRO 137 dated March 28, 2013, to contend that the Drug Inspector, Doda, was duly authorised to draw samples. They argued that objections concerning the manner of analysis involved disputed questions of fact that could be tested during trial through examination and cross-examination of the Public Analyst rather than in proceedings seeking quashing of the prosecution.
The court examined the statutory right to seek retesting in the light of several Supreme Court judgments, including State of Haryana v Brij Lal Mittal, Amery Pharmaceuticals v State of Rajasthan, Medicamen Biotech Ltd v Rubina Bose and GlaxoSmithKline Pharmaceutical Ltd v State of Madhya Pradesh. It noted that under Section 25(3), the person concerned must notify the authorities within 28 days of receiving the Government Analyst’s report of an intention to contest it or seek reanalysis.
The High Court found that the facts of the present case were materially different from those in which accused persons had genuinely been deprived of an opportunity to have a sample retested. It noted that the manufacturer had become aware of the adverse test result while the drug’s shelf life was still valid and had sufficient time to invoke the statutory remedy.
“Neither the manufacturer nor the distributor, nor any of the other petitioners, ever expressed an intention to have the sample retested,” the court observed.
The court further noted that the manufacturer had not expressly indicated an intention to controvert the Government Analyst’s report. Instead, it had sought to explain the failed disintegration test and had proceeded to recall the remaining stock.
The judgment said the manufacturer had directed its distributor to recall approximately 2,000 boxes of Macnim Plus Tablets, which, according to the court, demonstrated that it was aware of the adverse test result.
The court rejected the argument that the manufacturer’s failure to receive a sample portion directly rendered the prosecution invalid. It held that because the sample had been taken from a retailer, the Drug Inspector was required to follow the procedure under Section 18-A by obtaining the particulars of the person from whom the drug had been received and supplying the requisite portion to that person.
“Merely because the manufacturer was not directly supplied with a portion of the sample would not, in the facts of the present case, render the procedure adopted by the Drug Inspector illegal,” the court held.
The court also rejected the petitioners’ challenge to the competence of the Public Analyst at the stage of quashing proceedings, holding that questions concerning whether the analysis was conducted according to the prescribed standards and whether the analyst was competent were matters requiring evidence at trial.
Justice Parihar observed that the petitioners had failed to show that they had invoked the statutory remedy under either Section 25(3) or Section 25(4) for retesting. He held that the earlier August Remedies judgment relied upon by the petitioners arose from different facts, where the manufacturer had not received the Government Analyst’s report until summons were issued and had consequently been deprived of its statutory opportunity.
The court also distinguished the case from Neena Gupta v Union Territory of Ladakh, observing that the material before it did not suggest that the retailers, stockists, dealers or distributors had improperly stored the drug.
Finding no material infirmity warranting interference, the High Court dismissed all three petitions and vacated any interim directions that had been passed. The court said the disputed issues concerning the analytical process, compliance with testing standards and competence of the Public Analyst could appropriately be determined during the trial.
The petitioners were represented by advocates Sachin Gupta and Varut Kumar Gupta, while the respondents were represented by Additional Advocate General Raman Sharma, assisted by advocate Saliqa Sheikh.
