Madras High Court
M/S.Nirma Ltd vs State Represented By on 9 November, 2023
Author: G.K.Ilanthiraiyan
Bench: G.K.Ilanthiraiyan
Crl.O.P.No.3970 of 2021
IN THE HIGH COURT OF JUDICATURE AT MADRAS
RESERVED ON : 01.11.2023
PRONOUNCED ON : 09.11.2023
CORAM:
THE HONOURABLE MR. JUSTICE G.K.ILANTHIRAIYAN
Crl. O.P. No.3970 of 2021 and
Crl.M.P.Nos.2396 & 2397 of 2021
1. M/s.Nirma Ltd., (Healthcare Division)
Rep. by Mr.Shailesh V.Sonara,
(presently demerged and merged into
Aculife Healthcare Private Limited).
2. Shailesh V.Sonara
S/o.Late.Valjibhai Kanjibhai Sonara,
Director of M/s.Nirma Ltd., (Healthcare Division),
(presently demerged and merged into
Aculife Healthcare Private Limited)
Both available at
Sachana Village, Viramgam Taluka,
Ahmedabad, Gujarat- 382150 ... Petitioners
Vs.
State represented by
Drugs Inspector, Valasaravakkam range,
O/o.The Assistant Director of Drugs Control,
Zone-IV, Chennai.05. ... Respondent
1/7
https://www.mhc.tn.gov.in/judis
Crl.O.P.No.3970 of 2021
PRAYER: Criminal Original Petition has been filed under Section 482 of
Criminal Procedure Code, praying to call for the records in C.C.No.96 of
2018 pending on the file of Chief Judicial Magistrate, Tiruvallur and quash
the same.
For Petitioners : Mr.K.P.Anantha Krishna
For Respondent : Mr.A.Gopinath,
Government Advocate (Crl.Side)
ORDER
This Criminal Original Petition has been filed to quash the proceedings in C.C.No.96 of 2018 on the file of the learned Chief Judicial Magistrate, Tiruvallur having been taken cognizance for the offences punishable under Section 27(d) of the Drugs and Cosmetics Act 1940.
2. The respondent lodged complaint for the contravention of section 18(a)(i) of the Drugs and Cosmetics Act, 1940 (hereinafter called as 'Act') punishable under section 27(d) of the said Act. The defacto complainant on inspection, had collected the sample of Nirlife single use disposable syringes with needle manufactured by the accused and sent to Government 2/7 https://www.mhc.tn.gov.in/judis Crl.O.P.No.3970 of 2021 Analysts for Analysis. It was declared that the sample is not on standard quality as defined in the Act and Rules, for the reason that the sample does not conform to all requirements for sterility and is not of standard quality. Therefore, the petitioners/accused received show cause notice dated 07.03.2017 to explain why action should not be taken for the contravention of Section 18(a)(i) of the Act and Rules for having manufacture, sale and distribute for sale of the subject Drug which is not on standard quality drug. After reminder letter, a reply was received from the petitioners stating that the Health Care Division of Nirma Ltd., demerged and merged into M/s.Aculife Health Care Private Limited. The sample portion sent by the defacto-complainant was analysed and completed the test. The Government Analyst held a method ''For Sterile Devices''. Whereas their company followed ''Devices with Pathways Labelled Sterile''. The method device may be a reason for declaring the drug not on standard quality. Further the accused failed to furnish the required drug license and necessary endorsement to manufacture the subject drug and not disclosed the constitution details at the time of manufacture of the subject drug. Therefore, after according sanction, initiated prosecution as against the 3/7 https://www.mhc.tn.gov.in/judis Crl.O.P.No.3970 of 2021 petitioners.
3. The learned counsel for the petitioners submitted that after receipt of the show cause notice, categorically replied that the Analyst had followed the method of ''Sterile Devices'' without following the method of ''Devices with Pathway Labelled Sterile''. The testing of disposable syringes under the Indian Standards is as per the procedure laid in Indian Pharmacopoeia (IP 2014). Accordingly, method of testing the subject drug is ''MEMBRANE FILTRATION''. However, the Government Analyst erroneously used ''Direct Inoculation Method''. The sterile method is meant for sterile devices and not for syringes. This method is not in accordance with Indian Pharmacopoeia (IP 2014). Therefore, the results are bound to vary.
4. He further submitted that the procedure used for testing caused to launching of prosecution against the petitioners. If the report itself not worthy and unreliable of acts, subsequently it became non-est. He further submitted that Section 22 of the Act provides the powers of the respondent as confined with the local limits of the area for which he is appointed. The provision under section 179 of Cr.P.C. says that where an act is an offence 4/7 https://www.mhc.tn.gov.in/judis Crl.O.P.No.3970 of 2021 by reason of anything with has been done or by consequences which has ensued the offence by the Trial by the court of local jurisdiction. The cause of action for the invoked jurisdiction is based on the inspection done by the respondent and the sample taken thereon. Therefore, the complaint itself was lodged without jurisdiction and the respondent has no locus to lodge complaint.
5. On perusal of the counter filed by the respondent reveals that there are totally two accused, in which the petitioners are arrayed as A1 and A2. The method of analysis to be explained \ clarified by the Government Analyst at King's Institute of Preventive Medicine & Research, Guindy, Chennai-32, who have done the Analysis before the Trial Court during the Trial. The examination of the Central Drugs Laboratory shall be the conclusive evidence as per Section 25(4) of the Act. It declared in Form 2 dated 25.07.2018 that the sample of Nirlife one use disposable Syringes with needle as per IP method not on standard quality. The test report is in accordance with the test report of the Government Analyst, Chennai. Insofar as the jurisdiction is concerned, the respondent is empowered to carry out the investigation and to draw the samples in the premises where 5/7 https://www.mhc.tn.gov.in/judis Crl.O.P.No.3970 of 2021 the drugs are stocked for distribution\sales as per the notification. The ESI dispensary where the sample was drawn for Analysis comes under the local limits of the area for which is appointed as per Section 22(1)(b) of the Act. The sample of Nirlife disposable Syringes with needle which comes under the category of defects which is serious in nature, according to the guidelines issued by the Central Drugs Standard Control Organization of the Government of India. Hence the respondent launched prosecution against the petitioners.
6. Therefore, this court finds no grounds to quash the entire initiation of prosecution against the petitioners. Hence this Criminal Original Petition is liable to be dismissed. Accordingly, this Criminal Original Petition is dismissed. Consequently, connected miscellaneous petitions are closed.
09.11.2023 Index : Yes / No Internet : Yes / No Neutral Citation Case :Yes/No gvn 6/7 https://www.mhc.tn.gov.in/judis Crl.O.P.No.3970 of 2021 G.K.ILANTHIRAIYAN, J.
gvn To
1) The Drugs Inspector, Valasaravakkam range, O/o.The Assistant Director of Drugs Control, Zone-IV, Chennai.05.
2) The Chief Judicial Magistrate, Tiruvallur
3) The Public Prosecutor, Madras High Court, Chennai.
Crl. O.P. No.3970 of 2021
and Crl.M.P.Nos.2396 & 2397 of 2021 09.11.2023 7/7 https://www.mhc.tn.gov.in/judis