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CRL OP No. 11031 of 2023

IN THE HIGH COURT OF JUDICATURE AT MADRAS DATED: 02-04-2026

CORAM

THE HON'BLE MR JUSTICE G.K. ILANTHIRAIYAN

Crl.O.P Nos.11031 & 17545 of 2023 and

Crl.M.P.Nos. 695, 6953, 11501 & 11502 of 2023

CRL OP No. 11031 of 2023

1. K.Saraswathi

2. V.Rajapart ..Petitioners

Vs Tamilnadu State Rep By

Drugs Inspector, Mettur Range,

Office of the Assistant Director of Drugs Control, Salem Zone, 7, Tiruvallur Street,

Subramanian Nagar, Salem 636005.

..Respondent

CRL OP No. 17545 of 2023

1. M/s.Dexbio Pharma Pvt Ltd KH-143/2, Raipur Village, Bhagwanpur,

District, Haridwar (U.K), Roorkee-247661

Rep.by its Managing Director, K.V.Rangaiah

2. K.V.Rangaiah Managing Director of M/s Dexbio Pharma Pvt Ltd., KH-143/2, Raipur Village, Bhagwanpur,

District, Haridwar (U.K), Roorkee-247661

..Petitioners

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CRL OP No. 11031 of 2023

Vs Tamil Nadu State Rep.by its

Drugs Inspector Mettur Range,

Office of the Assistant Director of Drugs Control, Salem Zone-7, Thiruvalluvar Street, Subramanian Nagar, Salem 636005

..Respondent

COMMON PRAYER : Criminal Original Petitions are filed under Section 482 of the Criminal Procedure Code, to call for the entire records pertaining to the complaint in SC.No.30 of 2019 on the file of the learned II Additional District

and Sessions Judge, Salem and quash the same.

For Petitioners: Mr.J.Hariharan [Crl.O.P.No.11031/2023]

Mr.P.Parthikannan[Crl.OP.No.17545/2023]

For Respondent: Mr.A.Gopinath Government Advocate (Crl.Side) [in both cases]

COMMON ORDER

Both Criminal Original Petitions have been filed seeking to quash the

proceedings in S.C.No.30 of 2019 on the file of the II Additional District and

Sessions Judge, Salem.

2. The petitioners in Crl.O.P.No.17545 of 2023 are arrayed as A1 and

A2 and the petitioners in Crl.O.P.No.11031 of 2023 are arrayed as A3 and A4.

3. The respondent lodged a complaint alleging contravention of

Section 18(a)9i) read with Section 17-B(d) of the Drugs and Cosmetics Act,

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CRL OP No. 11031 of 2023

1940 punishable under Section 27(c) of the Drugs and Cosmetics Act, 1940

(hereinafter referred to as “the Act”).

4. The sample of Cortin-M (Methylprednisolone tablets I.P) was

drawn for analysis on 27.04.2017 under Form-17, after following the procedure as contemplated under Section 23(1) of the Act and Rule 56 of the Drugs and Cosmetics Rules 1945 (hereinafter referred to as “the Rule”). The said sample was sent for analysis and, by report dated 09.06.2017, it was declared to be a “spurious drug” on the ground that the sample did not conform to the label claim with respect to the content of Methylprednisolone and that the sample was deemed to be spurious since it had been substituted with another drug viz., prednisolone, which was not claimed on the label. Therefore, the petitioners were issued show cause notice, thereby calling upon them to submit their explanation for the alleged contravention. On receipt of the reply and not being satisfied with the same, the respondent lodged a complaint after obtaining sanction to prosecute the petitioners. On receipt of the said complaint, the Trial

Court had taken cognizance in S.C.No.30 of 2019.

5. The learned counsel appearing for the petitioners submitted that the

respondent failed to follow the mandatory provision under Section 25(4) of the Act. He further submitted that once the report of the Analyst was disputed by the accused, the prosecution was duty bound to send the sample to the Central

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CRL OP No. 11031 of 2023

Laboratory for analysis. However, since the complaint was filed belatedly, the petitioners were deprived of their valuable right to seek reanalysis of the sample. Further, the second sample was sent to the Central Drugs Laboratory

for analysis only after the expiry of the