- 1 - NC: 2025:KHC:8906 WP No. 33271 of 2024 IN THE HIGH COURT OF KARNATAKA AT BENGALURU DATED THIS THE 27TH DAY OF FEBRUARY, 2025 BEFORE THE HON'BLE MR JUSTICE S.R.KRISHNA KUMAR WRIT PETITION NO. 33271 OF 2024 (GM-RES) BETWEEN: M/S ULTRA LABORATORIES (P) LTD PLOT NO 102 B AND 102 B(1) PHARMACEUTICALS SEZ, KIADB INDUSTRIAL ESTATE, HASSAN. AUTHORIZED PERSON REP BY COMPANY C.B VIJAYAKUMAR COMPANY INCORPORATION YEAR 2006. …PETITIONER (BY SRI. ANANTHA NARAYANA B N, ADVOCATE) AND: STATE AT THE INSTANCE OF ASST.DRUGS CONTROLLER-2 (ADC) OFFICE OF THE REGIONAL DEPUTY DRUGS CONTROLLER NO.851, 1ST FLOOR, KAVERI TOWERS 7TH CROSS MAIN ROAD, DAVANAGERE CIRCLE ADC2, VIDYANAGAR, DAVANAGERE – 577 004. REPRESENTED BY DRUGS CONTROLLER OFFICER. …RESPONDENT (BY SRI.THEJESH.P, HCGP) THIS W.P IS FILED UNDER ARTICLES 226 AND 227 OF THE CONSTITUTION OF INDIA READ WITH SECTION 482 OF THE CPC, PRAYING TO ORDERS TO SET ASIDE THE ORDER IN CRL.MIS. NO. 947/2024 PASSED ON 11/09/2024 VIDE ANN-B FILED BY THE PETITIONER BEFORE THE 2ND ADDL. CIVIL JUDGE AND JMFC AT DAVANAGERE REGISTERED AS MISC. APPLICATION NO. 947/2024 AND WITH A DIRECTION TO RE-TEST THE LEGAL SAMPLE OF SODIUM CHLORIDE INJECTION (0.9 PERCENT) W/V BATCH NO. 11113154 DATE OF MANUFACTURE NO. 2023, EXPIRY DATE OCT-2026, MANUFACTURED BY PETITIONER, TO SEND THE SAID LEGAL SAMPLE TO THE DIRECTOR OF Digitally signed by LEELAVATHI S R Location: High Court of Karnataka - 2 - NC: 2025:KHC:8906 WP No. 33271 of 2024 CENTRAL DRUGS TESTING LABORATORY KOLKATA FOR RE-TEST AS PER SECTION 25(3) AND 25(4) OF THE DRUGS AND COSMETICS ACT, 1940 AND RULES THERE UNDER 1945, IN SO FAR AS PETITIONER HEREIN IS CONCERNED. THIS PETITION, COMING ON FOR PRELIMINARY HEARING IN ‘B’ GROUP, THIS DAY, ORDER WAS MADE THEREIN AS UNDER: CORAM: HON'BLE MR JUSTICE S.R.KRISHNA KUMAR ORAL ORDER This petition by the petitioner in Crl.Misc.No.947/2024 is directed against the impugned order at Annexure-B dated 11.09.2024 passed by the II Addl.Civil Judge and JMFC, Davanagere, whereby the said application / petition filed by the petitioner under Section 25(4) of the Drugs and Cosmetics Act, 1940 (for short ‘the said Act of 1940’) for a direction to send the sample drugs collected by the respondent to the Central Drugs Laboratory, Kolkata for re-test / re-examination was rejected by the trial court. 2. A perusal of the material on record will indicate that pursuant to the subject drugs manufactured by the petitioner being collected by the respondent on 22.02.2024, the same was sent to the State Government Analysit Drugs Testing Laboratory, Bangalore, who submitted a report dated 15.04.2024 to the effect - 3 - NC: 2025:KHC:8906 WP No. 33271 of 2024 that the drugs had not conformed or met with the standards prescribed in the said Act of 1940. The said report of the respondent was communicated to the petitioner vide communication dated 05.06.2024 informing / intimating the petitioner that the subject drugs were not of standard quality. Subsequently, the petitioner submitted replies dated 20.06.2024 and 06.07.2024 requesting the respondent to conduct re-test / re- examination of the said samples in terms of Section 25(4) of the said Act of 1940 by sending the samples to the Central Drugs Laboratory, Kolkata. Since the respondent did not take any steps in this regard, the petitioner filed the instant Crl.Mis.No.947/2024 which was rejected by the trial court vide the impugned order dated 11.09.2024, which is assailed in the present petition. 3. Heard learned counsel for the petitioner and learned HCGP for the respondent and perused the material on record. 4. Before adverting to the rival submissions, it is necessary to extract Section 25(4) of the Drugs and Cosmetics Act, 1940, which reads as under:- 25. Reports of Government Analysts.— (1) The Government Analyst to whom a sample of any drug 1 [or cosmetic] has been submitted for test or analysis under - 4 - NC: 2025:KHC:8906 WP No. 33271 of 2024 sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. (2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken 4 [and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the sample. (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 5 [or the person whose name, address and other particulars have been disclosed under section 18A] has, within twenty -eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contraversion of the report. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst’s report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused cause the sample of the drug 1 [or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or - 5 - NC: 2025:KHC:8906 WP No. 33271 of 2024 analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein. (5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct. 5. A plain reading of Section 25(4) of the said Act of 1940, will clearly indicate that pursuant to the subject sample being tested by the Drugs Laboratory at Bangalore, it was open for the petitioner to adduce evidence in controversion of the said report by seeking re-testing / re-examination by the Central Drugs Laboratory, Kolkata. In the instant case, it is an undisputed fact borne out from the material on record that in the first instance the subject samples were sent to the State Drugs Laboratory, Bangalore, which is undisputedly not a Central Drugs Laboratory and consequently, the petitioner was fully justified in filing the instant application/petition seeking re-test / re-examination by the Central Drugs Laboratory, Kolkata in terms of Section 25(4) of the said Act of 1940. 6. Under these circumstances, I am of the considered opinion that the trial court completely misdirected itself in rejecting - 6 - NC: 2025:KHC:8906 WP No. 33271 of 2024 the application / petition filed by the petitioner in Crl.Misc.No.947/2024 without considering or appreciating the material on record and has clearly misconstrued, misinterpreted and misread the provisions contained in Section 25(4) of the said Act of 1940, warranting interference by this Court in the present petition. 7. In the result, I pass the following:- ORDER (i) Petition is hereby allowed. (ii) The impugned order dated 11.09.2024 passed in Crl.Misc.No.947/2024 by the trial court is hereby set aside. (iii) Crl.Misc.No.947/2024 is hereby allowed. (iv) The respondent and trial court are directed to send the sample drugs to the Central Drugs Laboratory, Kolkata and secure / obtain a report and submit the same to the trial court as expeditiously as possible. Sd/- (S.R.KRISHNA KUMAR) JUDGE Srl.