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2023 Supreme(Mad) 1361

BEFORE THE MADURAI BENCH OF MADRAS HIGH COURT
B. PUGALENDHI, J.
M/s. Alkem Laboratories Ltd., Rep. by its Director and Power of Attorney Dhananjay Kumar Sing & Others – Appellants
Versus
The State Rep. by The Drug Inspector, Virudhunagar & Another – Respondents
CRL. OP(MD). No. 19644 of 2016 & CRL MP(MD). No. 9907 of 2016
Decided On : 14-03-2023

Advocates appeared:
For the Petitioners:V. Karthic, Senior Counsel, C. Muthusaravanan, Advocate. For the Respondents: S.Ravi, Additional Public Prosecutor.

The main legal point established in the judgment is that the right of the accused to have their samples analyzed by the Central Drugs Laboratory under Section 25(4) of the Drugs and Cosmetics Act must be upheld, and any delay in the process that defeats the purpose of prosecution may warrant the quashing of proceedings.

Headnote:

Drugs and Cosmetics Act - Quashing of Proceedings - Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 - Section 25(4) - The court quashed the proceedings in STC.No.297 of 2016 after finding that the right of the petitioners to have the samples analyzed by the Central Drugs Laboratory under Section 25(4) of the Drugs and Cosmetics Act had been denied, and the purpose of prosecution had been defeated due to the delay in the process.

Fact of the Case:

The petitioners were accused of contraventions under Section 18(a)(i) of the Drugs and Cosmetics Act, 1940. The first respondent, a Drugs Inspector, conducted a surprise inspection and drew samples of a drug named ''Clavam Dry Syrup'' from a medical store. The Government Analyst's report indicated that the sample did not conform to the IP specification, leading to the initiation of proceedings against the petitioners.

Finding of the Court:

The court found that the right of the petitioners to have their samples analyzed by the Central Drugs Laboratory under Section 25(4) of the Drugs and Cosmetics Act had been denied, and the purpose of prosecution had been defeated due to the delay in the process. The court also noted discrepancies in the dates and actions of the respondents, ultimately leading to the quashing of the proceedings in STC.No.297 of 2016.

Issues: The issues revolved around the delay in filing the complaint, the expiry of the samples, the storage conditions of the seized samples, and the petitioners' responses to the show cause notices.

Ratio Decidendi: The court's decision was based on the interpretation of Section 25(4) of the Drugs and Cosmetics Act, which provides the right for the accused to have their samples analyzed by the Central Drugs Laboratory. The court also considered the delay in the process and the impact on the petitioners' defense.

Final Decision: The court quashed the proceedings in STC.No.297 of 2016 and directed the Director of Drugs Control to issue necessary directions to ensure compliance with statutory requirements under the Act.

JUDGMENT

(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.)

1. 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.

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 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 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

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