IN THE HIGH COURT OF JUDICATURE AT MADRAS
N. SATHISH KUMAR, J.
Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt.Ltd., Uttarkand - Appellant
Versus
State of Tamil Nadu represented by E. Sakthivel, Salem - Respondent
Crl. O.P. No. 9091 of 2022 & Crl. M.P. Nos. 5291 & 5293 of 2022
Decided On : 16-08-2022
Drugs and Cosmetics Act - Prosecution under Section 18(a)(i) and 18-B - Section 27(d) and Section 28-A - [Laboratory Testing, Delay in Prosecution, Right to Sample Testing] - The court discussed the provisions of Section 25 of the Drugs and Cosmetics Act, emphasizing the right of the accused to have a sample tested and the consequences of delay in testing, highlighting the interpretations from various judgments. The court found that the inordinate delay in testing the sample, issuing the memo, and filing the prosecution after the expiry of the drug's shelf life amounted to an abuse of process of law, leading to the quashing of the complaint.
Fact of the Case:
The petition was filed to quash the prosecution initiated for the offence under Section 18(a)(i) and 18-B of the Drugs and Cosmetics Act, 1940. The sample of the drug ZELITA was collected on 02.12.2019, and the prosecution was launched on 11.11.2020 after an inordinate delay in testing and issuing the memo, which was after the expiry of the drug's shelf life.
Finding of the Court:
The court found that the delay in testing the sample and issuing the memo, followed by the prosecution after the expiry of the drug's shelf life, amounted to an abuse of process of law, leading to the quashing of the complaint.
Issues: The issues revolved around the delay in testing the sample, issuing the memo, and filing the prosecution after the expiry of the drug's shelf life, and the right of the accused to have a sample tested.
Ratio Decidendi: The court emphasized the right of the accused to have a sample tested under Section 25 of the Drugs and Cosmetics Act and the consequences of delay in testing, drawing interpretations from various judgments.
Final Decision: The complaint in STC No.675 of 2020 for the offence under Section 18(a)(i) and 18-B of the Drugs and Cosmetics Act, 1940, punishable under Section 27(d) and Section 28-A, was quashed, and the Criminal Original Petition was ordered. Consequently, connected Miscellaneous Petitions were closed.
JUDGMENT
(Prayer: Petition filed under Section 482 of Cr.P.C.to call for the records and quash the complaint in STC No.675 of 2020 on the file of the Judicial Magistrate, Pappiredepatti and all proceedings/orders/coercive steps emanating therefrom with regard to the Petitioners.)
1.This petition has been filed to quash the prosecution initiated for the offence under Section 18(a)(i) and 18-B of the Drugs and Cosmetics Act, 1940, punishable under Section 27(d) and Section 28-A of the said Act.
2. The Crux of the allegations in the complaint is as follows:
2.a. On 02.12.2019 a sample of ZELITA 7 (Omega 3 marine triglycerides methylcobalamin, Zinc Gluconate, Chromium picolinate, selenium, folic acid and Vitamin B6 capsules) B.No.ZSSPC9005, M/D: 06/2019, E/D: 11/2020, Mfg.by: PURE & CURE HEALTHCARE PVT.LTD., was drawn by the Drug Inspector, under sample No.79/CM/HAR/2019 Dt.05.12.2019 and sent for analysis to the Government Analyst (Drugs), DTL, Chennai-6. The Government Analyst in their report dated 07.02.2020 declared that the sample is not of standard Quality for the reason that the sample does not conform to Label claim with respect to the content of Pyridoxine Hydrochloride (0.57 mg against the label claim of 3mg i.e., 19%.). Hence Show Cause Memo dated 21.02.2020 was issued to M/s. Sri Ram Medicals and no reply received from the sales concern. However, in delayed response Mr.S. Vasudevan, Proprietor of M/s. Sri Ram Medicals has disclosed in his letter dated 21.02.2020 that he had acquired the subject not of standard quality drug from M/s. Apex Laboratories Pvt.Ltd., Alathur-603110, Tamilnadu. Therefore, show cause notice dated 16.09.2020 was issued to M/s.Apex Laboratories Pvt. Ltd., Alathur-603110, Tamilnadu, to offer their explanation as to why action should not be taken against them for the contravention of Section 18(a)(i) of Drugs and Cosmetics Act 1940 for having sold/distributed the not of standard quality drug ZELITA 7.
2.b. In response, M/s. Apex Laboratories Pvt.Ltd., by their letter dated 01.10.2020 had informed that they acquired the subject drug from M/s. Pure and Care Healthcare Pvt.Ltd., accused/petitioners herein. Therefore, show cause memo again issued the accused/petitioners herein seeking certain documents. As there was no reply received from them, a reminder dated 17.10.2020 was sent to them. For that also no reply was received, after uploading the details of the company prosecution has been launched, after obtained necessary sanction. The above complaint was taken on filed in S.T.C.No.675 of 2020 by the Judicial Magistrate, Pappireddipatti.
3. The learned counsel for the petitioner would submit that before the prosecution lanched, shelf life of the drug has been expired and part of sample not sent to the Petitioner as per the procedure. Therefore, the right to have a sample tested second time was lost. Therefore, submitted that the entire prosecution is nothing but futile exercise and there was an inordinate delay in forwarding even the first Analysis Report to the accused which was not explained. Due to such long delay they have taken away the valuable right of the accused. Hence, continuation of prosecution is nothing but abuse of process of law. In support of his contention, the learned counsel for the petitioner relied upon the following judgments:
1. Laborate Pharmaceuticals India Limited and Others vs. State of Tamil Nadu [(2018) 15 SCC 93]
2. Medicamen Biotech Limited vs. Rubina Bose, Drug Inspector [(2008) 7 SCC 196]
3. Medipol Pharmaceutical India Pvt. Ltd., vs. Post Graduate Institute of Medical Education and Research and Another [(2021) 11 SCC 339]
4. M/s. Centurion Laboratories and another vs. State rep.by Drug Inspector [Crl.O.P.No.11230 of 2022 dated 01.07.2022 Madras High Court]
5. M/s.Alfred Berg & Co (I) Pvt. Ltd., and 4 others vs.The state of Tamil Nadu rep. By Ms.Deepa Joseph [Crl.O.P.No.27312 of 2013 dated 10.01.2020 Madras High Court]
6. Zee La
The main legal point established in the judgment is the right of the accused to have a sample tested under Section 25 of the Drugs and Cosmetics Act and the consequences of delay in testing, which ca....
The main legal point established in the judgment is that the rights of the accused under sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940 must be upheld, and any violation of these right....
The judgment establishes that a valuable right to re-test a drug sample, as provided under Section 25(4) of the Drugs and Cosmetics Act, cannot be denied without due process, and failure to comply wi....
Seizure of sub-standard quality of drug – When report of Government Analyst itself is shrouded in serious suspicion and it is not sure as to whether report of Government Analyst relates to sample lif....
The judgment establishes that the failure of the prosecution to adhere to statutory requirements, particularly regarding the right to contest the Government Analyst's report, can lead to the quashing....
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 mus....
The main legal point established in the judgment is the significance of timely notification under Section 25(3) and (4) of the Drugs and Cosmetics Act, and the implications of the denial of the oppor....
Drugs and Cosmetics - Criminal Proceedings quashed - Statutory right of petitioner for retesting drugs in question under sections 25(3) and 25(4) of Act has been violated by respondent and learned tr....
The right of the petitioner to adduce evidence under sub sections 3 and 4 of section 25 of the Drugs and Cosmetics Act was crucial in influencing the court's decision to quash the entire criminal pro....
Delay in analysis deprived accused of rights under the Drugs and Cosmetics Act, justifying quashing of proceedings.
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