Madras High Court
M/S.Alkem Laboratories Ltd vs The State Rep. By on 14 March, 2023
Author: B.Pugalendhi
Bench: B.Pugalendhi
CRL OP(MD). No.19644 of 2016
BEFORE THE MADURAI BENCH OF MADRAS HIGH COURT
( Criminal Jurisdiction )
Date : 14.03.2023
PRESENT
The Hon`ble Mr.Justice B.PUGALENDHI
CRL OP(MD). No.19644 of 2016
and
CRL MP(MD). No.9907 of 2016
1.M/s.Alkem Laboratories Ltd.,
Village – Thana, Baddi, Distt, Solan,
Himachal Prdesh – 173 205.
Rep. by its Director and Power of Attorney
Dhananjay Kumar Singh
2.Dhananjay Kumar Singh
3.Anil Kumar ... Petitioners
Vs
1.The State Rep. by
The Drug Inspector,
Sivagangai Range,
Virudhunagar Zone.
2.The Director of Drugs Control,
Teynampet,
Chennai – 600 086. ... Respondents
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CRL OP(MD). No.19644 of 2016
For Petitioners : Mr.V.Karthic,
Senior Counsel
for Mr.C.Muthusaravanan
For Respondents : Mr.S.Ravi,
Additional Public Prosecutor
PRAYER :-
Petition filed under Section 482 of the Criminal Procedure Code to call
for the records relating to the proceedings in STC.No.297 of 2016 on the
file of the learned Judicial Magistrate No.1, Sivagangai and quash the
same.
ORDER :The Court made the following order :-
The petitioners are accused in STC.No.297 of 2016, on the file of the learned Judicial Magistrate No.1, Sivagangai, which was instituted at the instance of the first respondent / Drugs Inspector, for contraventions under Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act'). Challenging the proceedings pending against them, the petitioners have filed this petition.
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2.The case of the prosecution, in brief, is as follows:
2.1.The first respondent, on 05.05.2015 caused a surprise inspection in the premises of M/s.Elango Medicals, situated at 143/1, Ground Floor, Shop No.3, Gandhi Veethi, Sivagangai and drew samples of a drug named 'Clavam Dry Syrup'. The sample was divided into four portions and one was sent to the Government Analyst for analysis.
2.2.The Government Analyst, after analysis, has submitted a report dated 14.09.2015, holding that the sample did not conform to the IP specification and hence, the sample is 'not of standard quality'.
2.3.The first respondent issued show cause notice dated 23.09.2015 to M/s.Elango Medicals, Sivagangai, to disclose the name of the person, from whom they acquired the product. M/s.Elango Medicals informed that they purchased the product from one M/s.Nagappa Agencies, Madurai. The first respondent thereafter issued a show cause notice dated 23.09.2015 to M/s.Nagappa Agencies, to disclose the name of the person, from whom they acquired the product. M/s.Nagappa Agencies responded that they 3/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 purchased the product from M/s.Alkem Laboratories Ltd., Chennai, who, on receipt of a show cause notice dated 14.10.2015 from the first respondent, responded that they received the product from M/s.Alkem Laboratories Ltd., Mohali. On receipt of a notice dated 03.11.2015 from the first respondent, they replied that they received the product from M/s.Alkem Laboratories Ltd., Himachal Pradesh / the first petitioner herein.
2.4.The first respondent, thereafter, issued notice dated 26.11.2015, to the petitioners Company seeking their explanation for violation of Section 18(i) of the Act and thereafter, lodged the complaint.
3.Sum and substance, the learned Senior Counsel appearing for the petitioners has contended as follows:
3.1.The Drug Inspector took the samples for analysis on 05.05.2015 itself, but the complaint was filed only on 19.05.2016. The expiry date of the samples was April, 2016. The 'best before' date of the sample has already been expired and the sample would have also deteriorated and 4/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 decayed and lost its original ingredients and characteristics. Therefore, the right of the petitioners to have their sample analysed by the Central Food Laboratory, as per Section 25(4) of the Act has been deprived of.
3.2.The samples were drawn on 05.05.2015 and the Government Analyst submitted the report on 14.09.2015. It is not known whether the seized samples were stored in a conducive environment, before the analysis.
3.3.It is not that the petitioners have not responded to the notices issued by the Drug Inspector. In fact, on receipt of show cause notices dated 14.10.2015, 03.11.2015 and 26.11.2015, from the first respondent, the Company controverted the same by referring the reports of the quality assurance and quality control team.
Therefore, he prayed for appropriate orders quashing the complaint.
4.Per contra, learned Additional Public Prosecutor appearing for the respondents submitted that the respondents' Laboratory controlled by the Government Analyst had all the required arrangement for the storage of the drugs and therefore, the subject drug was also stored in required storage 5/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 condition. He further submitted that the petitioners, in no point of time, have notified their intention to controvert the Government Analyst's report.
5.He further submitted that though a show cause notice dated 26.11.2015 was sent to the petitioners' Company, followed by reminders, no reply was forthcoming and therefore, they submitted a proposal for prosecution. Meanwhile, a reply letter dated 16.01.2016 was received belatedly from the petitioners, after requesting sanction for prosecution. However, as the reply was not satisfactory, they proceeded with the matter and after getting sanction, the complaint was filed. He also disputed the date of complaint, as projected by the petitioners' Counsel and submitted that they have lodged the complaint well within the date of expiry. There is no infirmity in the complaint and the same does not warrant any interference.
6.This Court paid it's anxious consideration to the rival submissions made on either side and also perused the available materials. 6/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016
7.Admittedly, the samples were drawn on 05.05.2015 and the Government Analyst gave his report on 14.09.2015. The seized samples expired by April, 2016. Since the learned Additional Public Prosecutor disputed the date of complaint as contended by the petitioners' Counsel, this Court called for a report from the learned Judicial Magistrate No.1, Sivagangai. The learned Magistrate, by report dated 02.07.2021, has submitted that the complaint was filed and taken on file on 04.04.2016 and was posted on 19.05.2016 for service of summons on the accused.
8.From the above, it is clear that though the complaint was lodged and taken on file on 04.04.2016, it was first listed on 19.05.2016 for service of summons on the accused. By then, the sample itself got expired. Though the respondents took a stand that they have set the law in motion by lodging the complaint before the date of expiry of the samples, the fact remains that the samples got expired even before the summons were served on them. The petitioners, all along, are controverting the Government Analyst's report. The Government Analyst gave his report as early as on 14.09.2015. Had the complaint been lodged immediately, the petitioners 7/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 would have established their defence, by having their samples analysed by the Central Food Laboratory.
9.The first respondent / complainant took a stand that the petitioners Company either passed the ball by pointing the fingers on their Companies at different places or no reply was forthcoming from them to the show cause notice as well as to the reminders and when they submitted a proposal for sanction, the petitioners have submitted their reply belatedly, which was also rejected. The petitioners are disputing this stand as well, inasmuch as according to them, they have responded to the show cause notices contravening the contents therein. Even otherwise, there is no specific mandate that the complaint under the Drugs and Cosmetics Act should be filed only with the reply of the manufacturer.
10.The manufacturer is having protection under Section 25(4) of the Act to establish their defence by having it analysed by the Central Drugs Laboratory. For better appreciation, Section 25(4) of the Act is extracted hereunder:
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https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 “25(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 or cosmetic produced before the Magistrate under sub-section (4) of Section 23 to be 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.”
11.Therefore, this Court is of the view that the right of the petitioners to have the samples analysed by Central Drugs Laboratory under Section 25(4) of the Drugs and Cosmetics Act has been denied and the very purpose of prosecution has been defeated, because of the delay in the process.
12.In similar circumstances, the Hon'ble Supreme Court in Medicamen Biotech Limited and another v. Rubina Bose, Drug Inspector, 9/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 reported in (2008) 7 SCC 196, has held that the appellants had lost their rights under Sections 25(3) & 25(4) due to the delay in filing of complaint, ie., after the expiry of the drug and thereby, quashed the proceedings. For better appreciation, the relevant portion is extracted thus:
“19. ...We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act, which must necessitate the quashing of the proceedings against them.”
13.Under the above circumstances, this Court is left with no other option, except to quash the proceedings in STC.No.297 of 2016. Accordingly, this criminal original petition stands allowed and the proceedings in STC.No.297 of 2016 pending before the learned Judicial Magistrate No.1, Sivagangai, is hereby quashed.
14.Though several complaints are lodged by the respective Drug Inspectors for spurious / adulterated drugs, substandard drugs, etc., the conviction rate is not proportionate to the same. One of the main reasons is because of the non-compliance of statutory requirements. Therefore, the 10/12 https://www.mhc.tn.gov.in/judis CRL OP(MD). No.19644 of 2016 second respondent / Director of Drugs Control is directed to look into this matter and issue necessary directions / Circulars so that the statutory requirements as provided under the Act are scrupulously followed. Consequently, connected miscellaneous petition stands closed.
Internet : Yes 14.03.2023
Index : Yes / No
NCC : Yes / No
gk
To
1.The Judicial Magistrate No.1,
Sivagangai.
2.The Drug Inspector,
Sivagangai Range,
Virudhunagar Zone.
3.The Director of Drugs Control,
Teynampet, Chennai – 600 086.
4.The Additional Public Prosecutor,
Madurai Bench of Madras High Court,
Madurai.
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https://www.mhc.tn.gov.in/judis
CRL OP(MD). No.19644 of 2016
B.PUGALENDHI,J
gk
ORDER
IN
CRL OP(MD) No.19644 of 2016
14.03.2023
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