J&K High Court Quashes Drug Complaint Against Manufacturer After Drugs Inspector’s Delay Destroyed Retesting Right
The High Court of J&K and Ladakh found that the Drugs Inspector’s inordinate delay in filing the complaint extinguished the manufacturer’s statutory right to retest the drug sample under Section 25(3) of the Drugs and Cosmetics Act, 1940, and that cognizance itself was barred by limitation.
The High Court of Jammu & Kashmir and Ladakh, sitting at Jammu, quashed a criminal complaint filed by a Drugs Inspector against Dr. Johns Pvt. Ltd., a pharmaceutical manufacturer, on two independent grounds: the complaint was filed more than three years after the Drugs Inspector received the Government Analyst’s adverse report, placing it beyond the limitation period prescribed by the J&K Code of Criminal Procedure; and, separately, the delay was so prolonged that the drug sample had already expired by the time the complaint reached the Magistrate, permanently destroying the manufacturer’s right to contest the analyst’s findings through retesting. Justice Sanjay Dhar, sitting singly, pronounced the full judgment on 10 July 2026, having reserved it on 7 July 2026.
The Complaint and the Proceedings Below
On 9 January 2014, the Drugs Inspector, Zone-3, Srinagar, conducted a routine inspection of the premises of M/S JAF (accused No. 1) and lifted six drug samples. One of these was “CADCAL capsules (4x5x10 caps)”, batch No. SCDCL-009, manufactured in May 2013 with an expiry date of April 2015, made by Dr. Johns Pvt. Ltd.
The sample was sent to the Government Analyst. On 31 October 2014, the Government Analyst returned a report bearing No. L/DA/2014-15/1095 declaring the drug not of standard quality. The Drugs Inspector received this report on 11 November 2014.
What followed was a prolonged chain of correspondence. Accused No. 1 was asked for purchase records. The matter was taken up with accused No. 2, M/S Sane Enterprises, by communication dated 1 December 2014. Accused No. 2 disclosed it had bought the stock from M/S King Fisher Pharma, accused No. 3. The Drugs Inspector wrote to accused No. 3 on 6 April 2015, but received no reply despite repeated reminders.
The manufacturer — Dr. Johns Pvt. Ltd., accused No. 4 — was first contacted by the Drugs Inspector vide communication dated 2 June 2015. A representative of the company visited the Inspector’s office on 8 December 2016 but provided nothing in writing. Only after obtaining prosecution sanction from the controlling authority by letter dated 30 June 2017 did the Drugs Inspector file the complaint. It was presented before the Chief Judicial Magistrate, Srinagar, on 16 April 2018. The Magistrate issued process against the petitioner and co-accused on 17 April 2018.
Dr. Johns Pvt. Ltd. challenged this complaint and the proceedings in CRM(M) No.461/2022 before the High Court.
Two Grounds of Challenge
The petition raised two distinct contentions. The first was that cognizance was taken after the applicable limitation period had expired. The second was that by the time the complaint was filed, the drug sample had already expired, permanently depriving the petitioner of its statutory right under Section 25(3) of the Drugs and Cosmetics Act, 1940 to adduce evidence in controversion of the Government Analyst’s report.
Limitation Bar Under J&K Cr.P.C.
The offences alleged against the petitioner were under Section 18(a)(i) and Section 18B of the Drugs and Cosmetics Act, 1940, punishable under Section 27(d). Section 27(d) prescribes a minimum of one year and a maximum of two years imprisonment, along with a fine of not less than Rs. 20,000.
Justice Dhar turned to Section 538-B of the J&K Code of Criminal Procedure, which bars cognizance of an offence after the expiry of the applicable limitation period. Sub-section (2) of that provision fixes a limitation of three years for offences punishable with imprisonment exceeding one year but not exceeding three years.
The court identified 11 November 2014 — the date the Drugs Inspector received the Government Analyst’s report — as the starting point for limitation. The complaint was presented on 16 April 2018, more than three years later. The cognizance taken by the Magistrate on 17 April 2018 was therefore time-barred.
Section 538-G of the J&K Cr.P.C. does allow a court to take cognizance after the limitation period if the delay is properly explained or if the interest of justice so requires. However, the court found that the complaint contained no explanation for the delay, and the trial Magistrate recorded no reasons for entertaining the complaint despite the period having lapsed. On this ground alone, the order issuing process was held legally unsustainable.
Loss of Retesting Right Under Section 25(3)
The second ground was independent and equally decisive. Section 25(3) of the Drugs and Cosmetics Act, 1940 provides that the Government Analyst’s report is evidence of the facts stated in it and becomes conclusive evidence unless the person from whom the sample was taken, or the manufacturer whose details are disclosed, notifies the Inspector or the court in writing within 28 days of receiving the report that they intend to adduce evidence in controversion. This right allows the accused to seek retesting of the sample.
Once the drug sample expires, retesting is no longer physically possible. The right under Section 25(3) is thus irreversibly lost.
In this case, the petitioner was informed about the analyst’s adverse report only by the Drugs Inspector’s communication of 2 June 2015. The drug’s expiry date was April 2015. By the time the petitioner received the report, the drug had already expired. When the complaint was filed on 16 April 2018, the situation was no different. The petitioner could not have sought retesting at any point after it was informed, because the sample’s shelf life had already run out.
Justice Dhar held that the Drugs Inspector had failed to act with reasonable dispatch. The delay in informing the petitioner and the further delay in filing the complaint together constituted inaction and negligence that caused the loss of a valuable statutory right.
Precedents Applied
The court drew on a consistent line of authority. In Municipal Corporation of Delhi v. Ghisa Ram, AIR 1967 SC 970, the Supreme Court observed that when a valuable right is conferred on a vendor to have a sample analysed by a superior authority, the prosecution must proceed in a manner that does not deny that right. The Supreme Court held that where such a right is denied by the deliberate conduct of the prosecution, upholding conviction on the basis of the analyst’s report alone would be improper.
In Nikson Pharmaceuticals and Ors. v. State of Rajasthan and Ors., 2008 (3) Crimes 573 (Raj.), the Rajasthan High Court held that the expiry date of a sample is relevant and that the prosecution must file the complaint expeditiously so that the accused’s retesting right is not lost.
In Shiv Narain Bansal and another v. State of Haryana and another, 1996 Cri.L.J. 338, a Single Judge of the Punjab and Haryana High Court quashed the complaint and all proceedings after finding that the accused had been deprived of their right under Section 25(3) because the Inspector sent the sample to the Central Drugs Laboratory only after its expiry date.
In State of Haryana v. Unique Farmaid (P) Ltd., (1999) 8 SCC 190, the Supreme Court, dealing with analogous provisions under the Insecticides Act, affirmed the High Court’s quashing of a criminal complaint on the ground that the accused had been deprived of their right to have the sample tested from the Central Insecticides Laboratory. The Supreme Court observed that continuing such prosecution would be an abuse of the process of the court.
Relying on that line, the Supreme Court in Medicamen Biotech Limited and another v. Rubina Bose Drug Inspector, (2008) 7 SCC 196, quashed proceedings specifically on the ground that the accused had been deprived of their rights under Section 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940.
Justice Dhar synthesised these authorities: once it is established that the accused’s right to adduce evidence in controversion of the Government Analyst’s report has been defeated by the acts or omissions of the Drugs Inspector, the prosecution deserves to be quashed.
Order
Justice Sanjay Dhar allowed CRM(M) No.461/2022. The impugned complaint and all proceedings emanating from it were quashed to the extent they pertained to the petitioner, Dr. Johns Pvt. Ltd. A copy of the order was directed to be sent to the trial Magistrate for information and compliance.