Prayer
Criminal Original Petition filed under Section 482 of Cr.P.C., 1973, pleased to call for the records relating to the Criminal Case in S.C.No.163 of 2021 on the file of the learned First Additional Sessions Judge, Tiruvallur and quash the same by allowing this Criminal Original Petition.
2. The short facts necessary to dispose the case are as follows:-
The petitioner is the proprietor of M/s.Emkay Bio Products, manufacturing drugs. The respondent has lodged a complaint under Section 32 of the Drugs and Cosmetics Act, 1940 for the alleged contravention of Sections 18(a)(i) r/w Section 17-B (d) punishable under Section 27(c) of the Drugs and Cosmetics Act, 1940. After complaint, the trial has taken cognizance in S.C.No.163 of 2021. As per the allegations made in the complaint, the Senior Drugs Inspector, Tiruvallur had collected a sample drug CEPE (Phenylephrin Hydrochloride, Chlorpheniramine Maleate and Paracetamol Suspension) manufactured by the petitioner namely Emkay Products for analysis from M/s.Modern Medicals, Poonamallee, Chennai, under Form 17 dated 19.02.2020. The sample was sent to the Government Analyst (Drugs), Drugs Testing Laboratory, Chennai under Form 18 dated 19.02.2020, wherein the subject drug was declared as “not of standard quality” by the Government Analysis, DTL, Chennai, through its report in Form No.13 dated 27.04.2020.
2.1. The Government analyst in his report had arrived at a conclusion that the sample does not confirm to the label claim with respect to the content of Phenylephrine Hydrochloride and Chlorcheniramine Maleate. Based on the test report on 12.05.2020, an inspection was conducted and available stocks were seized through Form-No.16. The said subject stock was not of standard quality only on 12.05.2020. The respondent has issued a Show Cause Notice to the petitioner on 04.09.2020. The petitioner has sent a report on 28.09.2020. As per the report of Government Analyst Drugs Testing Laboratory, the sample drug does not consist Assay of Phenylephrine Hydrochloride. Hence complaint was lodged before the Chief Judicial Magistrate, Tiruvallur and thereafter, it was committed to Sessions Court. Now the petitioner challenged the said cognizance taken by the Sessions Court through this petition.
2.3. According to the petitioner, the sample was collected on 19.02.2020 and the sanction for prosecution was issued on 07.11.2020 and the complaint was lodged on 26.03.2021 before the learned Chief Judicial Magistrate, Tiruvallur. Thereafter, the petitioner filed a petition to send the report given by the Government Analyst to the Central Drug Testing Laboratory, Kolkatta to re-assess the samples collected from the petitioner. The petition was allowed on 09.08.2021 and the Central Drugs Laboratory, Kolkatta received the sample dated 19.02.2020 on 12.08.2021 and conducted the analysis test between 16.08.2021 and 25.08.2021. Finally, the Central Drugs Laboratory, by its report dated 09.09.2021 opined that the samples does not contain the Assay of Phenylephrine Hydrochloride. It should have contain 90% whereas, the sample tested contains only 82.68 %. The other component namely Chlorpheniramine Maleate was well within the prescribed quality. The subject matter drugs tested by the Central Drugs Laboratory, Kolkatta at the fag end of the expiry date. Thus failure on the part of the respondent to send the sample drug to the Central Lab in time has caused serious prejudice to the petitioner.
Analysis
5. Heard both sides counsel and perused the materials available on record.
6. In this case, there is no dispute that the drugs sample drawn by the authorities have been manufactured by the petitioner’s company. There is no dispute that the said drug was initially subjected to chemical analysis by the Government Analyst, DTL, Chennai. As per the lab report the drug was declared as “not of standard quality” and thereafter the copy was served to the petitioner and thereafter complaint was filed on 26.03.2021 before the Chief Judicial Magistrate, Tiruvallur. Thereafter, the petitioner filed a petition to send the drugs for chemical analysis before the Central Drugs Laboratory, Kolkatta and it was also send on 12.08.2021 and conducted the analysis between 16.08.2001 and 25.08.2001. The Central Drugs Laboratory report received on 09.09.2021. As per the report, the Assay of Phenylephrine Hydrocholride should have contains 90% whereas the sample tested contains 82.68%, therefore, there is a fraction of around 7.32%.
7. According to the petitioner, since there is a delay in sending the drugs to the Central Drugs Laboratory, the small percentage which would caused delay in sending the sample and also for lack of storage condition. As per the Government Analyst report, the date of manufacturing of CEPE (Phenylephrine Hydrochloride, Chlorpheniramine Maleate and Paracetamol Suspension) is on September 2019 and the date of expiry is August 2021. But the Central Drugs Laboray test was conducted before the expiry date i.e, between 16.08.2021 and 25.08.2021. Therefore, the contention of the petitioner that due to fag end of the self-line expiry test was conducted, thereby there is a small fraction of 7.32% cannot be accepted because as per the manufacturing expiry date is only August 2021. Whether any chances for the above said fraction due to lack of storage and the fag end of the self-line expiry date also to be decided by the Court after elaborate evidence and not through this petition.
8. Initially, a complaint filed before the Chief Judicial Magistrate, Tiruvallur and taken cognizance in CC.No.152 of 2021 and thereafter the same was committed to the Sessions Court and taken cognizance in S.C.No.163 of 2021. The petitioner has to prove the grave prejudice caused to the petitioner and the same also cannot be decided at this stage. Even as per Section 323 of Cr.P.C., if, any enquiry into an offence of a trial before the Magistrate it appears to him at any stage of the proceedings before signing judgment that the case is one which ought to be tried by the court of sessions, he shall commit it to that Court under the provisions herein before contain and thereupon the proviso of chapter 18 shall applied to the commitment so made. Therefore, the contention of the petitioner that two times cognizance taken on the two different complaints is not acceptable. Whether any prejudice caused to the petitioner or not has to be decided through trial, but not through this petition at this stage.
Judgments relied on by the petitioner
9. Moreover the petitioner has produced the following judgment for consideration.
(a) Medipol Pharmaceutical India Private Limited vs. Post Graduate Institute of Medical Education and Research and another reported in (2021) 11 Supreme Court Cases 339.
(b) Laborate Pharmaceuticals India Limited and Others Vs. State of Tamil Nadu, reported in (2018) 15 SCC 93
(c) M/s.Embiotic Laboratories (P) Ltd, vs Drugs Inspector, Erode reported in 2013-2-L.W. (Crl.) 475. (d) Biogenetics Drugs Pvt. Ltd and Ors. Vs. Union of India, High Court of Madras in Crl.OP.No.2148 of 2018.
10. On a careful perusal of the above judgments, it is seen that the said case laws are not applicable to the present facts of the case. In this case, the tests were conducted within the period of the life expiry of the drugs.
11. In view of the above said discussions, this Court is of the opinion that this petition has no merits and deserves to be dismissed. In the result, this Criminal Original Petition is dismissed. Consequently, connected Miscellaneous Petitions are closed.
12. At the time of pronouncing orders and before signing, the learned counsel appearing for the petitioner requested this Court to dispense with the personal appearance of the petitioner before the trial Court. Considering the facts and circumstances of the case, the request of the learned counsel appearing for the petitioner is accepted and the personal appearance of the petitioner before the trial Court is dispensed and it is for the learned trial Judge to decide the appearance of the petitioner as and when required for adjudication during the trial proceedings.
Party
K.Kalyanasundaram …. Petitioner vs. State of Tamilnadu rep.by The Senior Drugs Inspector, O/o. The Assistant Director of Drugs Control, Tiruvallur Zone, 201, 1st Floor, Vishnu Complex, J.N.Road, Tiruvallur – 1. … Respondent – Crl.OP.No.20069 of 2022 and Crl.MP.Nos.13190 & 13191 of 2022 – IN THE HIGH COURT OF JUDICATURE AT MADRAS RESERVED ON : 29.10.2024 PRONOUNCED ON : 21.12.2024 CORAM: THE HON’BLE MR.JUSTICE P.DHANABAL
