Madras High Court
K.Kalyanasundaram vs State Of Tamilnadu Rep.By on 21 December, 2024
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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
Crl.OP.No.20069 of 2022
and Crl.MP.Nos.13190 & 13191 of 2022
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
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.
https://www.mhc.tn.gov.in/judis
1/16
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For Petitioner : Mr.N.Manokaran
For Respondent : Mrs.G.V.Kasthuri,
Additional Public Prosecutor
JUDGMENT
This Criminal Original Petition has been filed to quash the proceedings in S.C.No.163 of 2021 on the file of the I Additional Sessions Judge, Thiruvallur.
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, https://www.mhc.tn.gov.in/judis 2/16 3 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. https://www.mhc.tn.gov.in/judis 3/16 4 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 https://www.mhc.tn.gov.in/judis 4/16 5 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.
3. The learned counsel appearing for the petitioner would submit that the respondent lodged a complaint against the petitioner alleging that the drugs collected on 19.02.2020 was sent for Government Analyst, DTL, Chennai, and as per the report of lab analyst they are not of standard quality, thereby the respondent police has lodged a complaint. The alleged seizure of the drugs is on 19.02.2020 and the same was sent for lab analyst, on the same day itself. The report was received by the respondent on 24.07.2020 and thereafter on 12.05.2020, show cause notice was issued to one M/s. Modern Medicals, where the drug was seized. M/s. Modern Medicals gave a reply that they purchased the drugs from M/s. Mathu Health Care. Immediately, the respondent issued a show cause notice on 14.05.2020 to the M/s. Mathu Health Care. M/s.Mathu Health Care in turn gave a reply stating that the drugs were purchased from M/s. Neomediispecs Private Ltd.. Thereafter, the https://www.mhc.tn.gov.in/judis 5/16 6 respondent issued show cause notice to the Ms/.Neomediispecs Pvt., Ltd., on 14.07.2020 and thereafter, reply was issued stating that they purchased the subject drugs from the petitioner namely M/s.Emkay Bio Products. Thereafter, the respondent issued a show cause notice to the M/s.Emkay Bio Products and the same was suitably replied. The respondent has not followed the procedures contemplated under Sections 23 (5) (b) and Section 24 (1) (2) of the Drugs and Cosmetics Act. The sanction for prosecution was received on 07.11.2020, but the complaint was lodged only on 26.03.2021. Thereafter, the petitioner filed a petition for sending the drugs analysis before the Central Drugs Laboratory, Kolkatta and the same was allowed and the drugs was sent to the Central Drugs Laboratory on 12.08.2021 and the analysis test was conducted between 16.08.2021 and 25.08.2021. As per the lab report dated 09.09.2021, the sample does not contain the Assay of Phenylephrine Hydrochloride, it should have contain 90% where the sample tested contains 82.68%. There is a small fraction due to the lack storage condition and also the test was conducted at the fag end of the self-line expiry date.
https://www.mhc.tn.gov.in/judis 6/16 7 3.1. The respondent failed to send the drugs for analysis before the Central Drugs Laboratory and the said drug was sent only at the fag end of the self-line expiry date. Therefore, there will be chances for small fraction for the percentage. As per Section 25(1) to (5) of Drugs and Cosmetics Act, the Government Analyst to whom a sample of a drug or cosmetic has been submitted for test or analysis under Section (4) of Section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken 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. As per Section (4) of 25 of Drugs and Cosmetics Act, unless the sample has already been tested or analysed in the Central Drugs Labortory, where a person has under sub-section (3) notified his intention of adducing evidence in contravention 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 or cosmetic produced before the Magistrate under sub-section (4) of Section 23 to be https://www.mhc.tn.gov.in/judis 7/16 8 sent for test or 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. In this case on hand, the drug was seized on 19.02.2020 but the prosecution was only lodged a complaint on 26.03.2021 and thereafter the petitioner filed a petition to send the Drugs for medical analysis before the Central Drugs Laboratory and the same was analysed between 16.08.2021 and 25.08.2021. Therefore, the drugs was analysed on the fag end of the expiry date. Therefore, the petitioner lost his defence to send the drugs for laboratory analysis within time due to the failure on the part of the respondent. Moreover, the complaint for prosecution under Section 32 of the Act has to be filed before the Court of Session whereas it was filed before the Chief Judicial Magistrate on 26.03.2021. Thereafter, cognizance was taken by the Chief Judicial Magistrate, in C.C.No.152 of 2021 and again the case was transferred to the Court of Sessions for trial, and it was taken on file in S.C.No.163 of 2021. Therefore, there cannot be two cognizance, hence there is a procedure of violation, therefore, the pending proceedings as against the petitioner is liable to be quashed. https://www.mhc.tn.gov.in/judis 8/16 9
4. The learned Additional Public Prosecutor appearing for the respondent would submit that the respondent, Senior Drugs Inspector, Tiruvallur Zone, made inspection on 19.02.2020 at M/s. Modern Medicals and seized the drugs, CEPE Batch No CPS 101, Date of Mfg :
Sep 2019, date of Expiry: August 2021, manufactured in India by, Emkay Bio Products, Chrompet, Chennai and the same was sent for medical analysis. As per the report, the sample does not confirm to the label claim with respect to the content of Phenylephrine Hydrochloride and Chlorcheniramine Maleate. Hence, the subject drugs is deemed to be spurious. Based on the test report on 12.05.2020, an inspection was conducted at the premises of M/s. Modern Medicals and the sample was drawn for analysis and they seized the subject drugs through mahazaar. Thereafter, the show cause notice dated 12.05.2020 was issued to M/s. Modern Medicals and they in turn replied that they purchased the said drugs from M/s. Mathur Health care, Chennai. Thereafter, the respondent issued show cause notice to the M/s.Mathur Health Care, Chennai and they stated that they purchased the drugs from M/s.Neomediispecs Private Limited and thereafter the show cause notice https://www.mhc.tn.gov.in/judis 9/16 10 was issued to the M/s. Neomediispecs Private Limited and in reply they stated that they purchased the drugs from Emkay Bio Products at Chrompet, Chennai. Thereafter, show cause notice was issued to the petitioner dated 04.09.2020 and they sent a reply dated 28.09.2020. The samples seized from the M/s. Modern Medicals manufactured by the petitioner M/s.Emkay Bio Products, contravention of Section 18(a)(i) read with Section 17 - B of Drugs and Cosmetics Act. Thereafter, the proposal seeking for sanction was submitted to the Drugs control and the same was allowed. Thereafter the respondent filed the complaint before the Chief Judicial Magistrate, Tiruvallur on 26.03.2021. During the pendency of the complaint, the petitioner filed a petition to send the sample for medical analysis to the Central Drugs Laboratory and the same was allowed and the drug was audited by the authorities concerned. Even as per the Central Drugs laboratory report, the drugs is not of the standard quality. The allegations are grave in nature and there is no any procedural violations and the tests were conducted within the period of expiry date of the drugs. Therefore, the present petition is liable to be dismissed.
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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 https://www.mhc.tn.gov.in/judis 11/16 12 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 https://www.mhc.tn.gov.in/judis 12/16 13 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.
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, https://www.mhc.tn.gov.in/judis 13/16 14 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 https://www.mhc.tn.gov.in/judis 14/16 15 petitioner as and when required for adjudication during the trial proceedings.
21.12.2024 drl / mjs Index : Yes / No Speaking / Non-speaking Neutral Citation : Yes / No To
1. The First Additional Sessions Judge, Tiruvallur
2.The Senior Drugs Inspector, O/o. The Assistant Director of Drugs Control, Tiruvallur Zone, 201, 1st Floor, Vishnu Complex, J.N.Road, Tiruvallur – 1.
3.The Public Prosecutor,High Court, Madras.
P.DHANABAL.J., drl / mjs https://www.mhc.tn.gov.in/judis 15/16 16 Pre-delivery Order made in Crl.OP.No.20069 of 2022 and Crl.MP.Nos.13190 & 13191 of 2022 21.12.2024 https://www.mhc.tn.gov.in/judis 16/16