Whether approved for reporting?

Sandeep Sharma, J.

1. 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 14/3 of 2022 titled ‘Union of India through Drugs Inspector vs. M/s VADSP Pharmaceuticals and ors.’ as well as consequent proceedings initiated under Sections 16, 18(a)(i), 18 (a)(vi) read with Section 27(d) of the Drugs and Cosmetics Act, 1940 pending before the Court of Ld. Chief Judicial Magistrate, Nalagarh, Baddi, Himachal Pradesh.

2. Precisely facts of the case are that complainant, Mr V. Kaviyarasan, the then Drugs Inspector drew a sample on Form-17 of drug ‘Chloramphenicol and Dexamethasone Sodium eye drops (Polymicin Eye Drops’, Batch No. POLY-07, DoM- 07/2018, DoE 06/2020, manufactured by M/s VADSP Pharmaceuticals, Plot No. 124, E.P.I.P, Industrial Area Phase-1, Jharmajri, Baddi, H.P., from the premises of M/s Ticoma Pharmacia, E-17, Focal Point, Derabassi, District Mohali, Punjab from the premises of M/s Ticoma Pharmacia, E-17, Focal Point, Derabassi, District Mohali, Punjab.

3. Thereafter, the Drugs Inspector, on 07.09.2018, sent one sample of the drug on Form-18 to the Government Analyst, Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh-160036, after completing the codal formalities. On 27.02.2019, complainant received test and analysis report from the Government Analyst on Form-13 whereby the said sample of the drug was declared as “Not of Standard Quality” for the reason that the sample does not conform to the claim as per Patent and Proprietary in respect to the Assay of Chloromphenicol (obtained 27.0% against the limit of 90%-110%). Dexamethasone Sodium Phosphate (obtained 84.0% against limit of 90%-110%.

4. Again, on 07.03.2019, Drugs Inspector drew a sample of aforesaid sample from the premises of M/s Ticoma Pharmacia in the presence of Mr. Varun Kapoor. The sample was divided into four portions and signatures of Mr Varun were taken on each sample portion. It was then sealed as per the procedure. The drugs inspector also handed over a copy of Form-17 along with one portion of a sealed sample to Mr. Varun. The Drugs Inspector, on 11.03.2019, sent one sample of the drug on Form-18 to the Government Analyst, Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh-160036, after completing the codal formalities. On 02.05.2019, Drugs Inspector received test and analysis report from the Government Analyst on Form-13 whereby the said sample of the drug was declared as “Not of Standard Quality” for the reason that the sample does not conform to the claim as per Patent and Proprietary in respect to the Assay of Chloromphenicol (obtained 27.0% against the limit of 90%-110%). Dexamethasone Sodium Phosphate (obtained 84.0% against limit of 90%-110%.

5. After receipt of the said sample analysis report, on 10.05.2019, Drugs Inspector served a notice to M/s Ticoma Pharmacia alongwith the test report dated 02.05.2019 thereby directing them to stop the sale /distribution and recall the drug. M/s Ticoma Pharmacia replied on 22.03.2019 disclosing therein the name of manufacturing company i.e. M/s VADSP Pharmaceutical- petitioner no. 1. On 30.05.2019, Drugs Inspector served notice upon M/s VADSP Pharmaceuticals on Form-13. M/s VADSP Pharmaceuticals in its reply requested for retesting from Central Drugs Laboratory. Drugs Inspector moved an application before Ld. Judicial Magistrate First class, Nalagarh for re-testing which was accorded and sample was again sent for-retesting to Director, CDL, Kolkta on 02.07.2019. On 19.09.2019, test and analysis report was received declaring the sample as ‘Not of Standard Quality’ with remarks that sample does not conforms to claim with respect to Assay/Content of ‘Dexamethasone Sodium Phosphate’.

6. The necessary investigation was conducted, and accused Nos. 1 to 3, being a manufacturing firm, had manufactured the drug, which was not of standard qua