IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA Cr.MMO No.929 of 2023 Date of Decision: 07.05.2026 __________________________________________________________________________

M/s Salus Pharmaceuticals and Others ……...Petitioners Versus Union of India …....Respondent Coram Hon’ble Mr. Justice Sandeep Sharma, Judge.

Whether approved for reporting? Yes.

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For the Petitioners: Mr. Sanjay Jain, Mr. Akshay Jain, Mr. Anuj Nag and Mr. Hakam Bhardwaj, Advocate.

For the Respondent: Mr. Shashi Shirshoo, Central Government Counsel.

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Sandeep Sharma, J.

By way of instant petition filed under Section 482 of Code of Criminal Procedure, prayer has been made on behalf of the petitioners herein for quashing of Complaint Case under Drugs and Cosmetics Act/3/2022 (CNR No.HPSO02-000359-2022) for contravening Sections 16, 18(a)(i) & 18(a)(vi), 22(1)(cca), 18(c) & 18-B read with Sections 22(3), 28-A, 27(d) of the Drugs and Cosmetics Act, 1940, along with all other consequential proceedings, including the order of cognizance dated 07.03.2022 passed by the learned Additional Sessions Judge, Nalagarh, District Solan.

2. Quintessential facts as emerge from the pleadings adduced on record by the respective parties are that on 28.08.2019, Drugs Inspector, CDSCO, Sub-Zone Baddi, inspected the premises of Medical Store, Military Hospital, Jalandhar Cantt., and drew samples of tablet Medrofex-180 (Tablets Fexofenadine Hydrochloride 180 mg) (Batch No.SPT190012A, manufacturing date January 2019, expiry date December 2020, manufactured by M/s Salus Pharmaceuticals, petitioner No.1-Firm) for the purpose of test and analysis on Form 17 of the Drugs Rules, 1945. One sample portion was forwarded to Government Analyst, Regional Drugs Testing Laboratory, Chandigarh (for short, ‘RDTL, Chandigarh’) on 29.08.2019 along with a copy of Form 18 by the afore Drugs Inspector, which sample was received in the afore laboratory on 02.09.2019. Afore sample portion was analysed by the Government Analyst, who declared drug in question to be not of standard quality (Annexure P-1).

3. After receipt of aforesaid adverse report from RDTL, Chandigarh, letter dated 08.12.2019 was written to Officer-in-Charge, Military Hospital, Jalandhar (the hospital from whom the sample was taken on 28.08.2019) conveying the adverse report. Along with afore letter, test report in Form 13 was also annexed (Annexure P-2). Afore hospital in return disclosed to the complainant that drug in question was acquired from Kumar and Bros, Jalandhar. Pursuant to notice dated 20.01.2020, afore Kumar and Bros, Jalandhar, disclosed the name of M/s Medroute India Pvt. Ltd., Jalandhar, as the source of acquisition of the said drug in question. Vide letter dated 10.02.2020, complainant conveyed adverse report to afore M/s Medroute India Pvt. Ltd., Jalandhar, which subsequently vide reply dated 20.02.2020, disclosed the name of M/s Arvincare Panchkula, whereafter letter dated 05.03.2020 came to be sent to afore M/s Arvincare, which further disclosed the name of petitioner No.1- Firm, as source of acquisition of drugs vide reply dated 11.03.2020 (Annexure P-3). Complainant further conveyed the adverse report to petitioner No.1 vide letter dated 18.03.2020 (Annexure P-4) along with one sealed sample portion. Joint inspection of the premises of the petitioner No.1-Firm was carried out on 28.08.2020, whereafter permission to prosecute petitioner No.1 as well as its Directors came to be sought by complainant from Drugs Controller General of India vide letter dated 09.12.2020 (Annexure P-6). Afore authority gave permission to prosecute the petitioner as well as other accused vide letter dated 03.05.2021.

4. In the afore background, complaint sought to be quashed in the instant proceedings came to be filed in the Court of learned Additional Sessions Judge, Nalagarh, District Solan on 03.03.2022 (Ann