(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 Laboratories Ltd., and another vs. Tamil Nadu State rep by Drug Inspector [Crl.O.P.(MD).20982 of 2016 dated 28.10.2020 Madurai Bench of Madras High Court.]
7. Vijaya Arun vs. New Link Overseas Finance Limited [Crl.O.P.No.10424 of 2022 dated 05.07.2022 Madras High Court]
8. Gul Raj Bhatia and others vs. State of Tamilnadu rep. By Deepa Joseph [2022 SCC Online Mad 455]
4. Learned Additional Public Prosecutor would submit that notice has been issued. Though there is some delay in issuing notice no reply is forthcoming from the petitioners. Hence prosecution has been rightly launched. The entire submissions are factual in nature and hence he opposed the petition.
5. Heard both sides. From the facts of the prosecution it can be seen that the sample of the drug ZELITA was collected on 02.12.2019 and one sample is said to have sent to Government Analyst and the Analyst given his report on 07.02.2020. The drug sample was collected from the retailer on 02.12.2019. Thereafter, show cause memo was sent to the retailer only on 21.02.2020. After that, show cause memo was issued to M/s. Apex Laboratories Pvt. Ltd., only on 16.09.2020 with huge delay. And again, show cause memo was sent to the accused on 16.09.2020 with a delay. The reply also received. Thereafter, the prosecution has been launched on 11.11.2020. It is relevant to note that as per Section 25 of the Drugs and Cosmetics Act, after receipt of the Government Analyst Report, the Inspector shall deliver one copy of the Report to the person to whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A and shall retain the third copy for use in any prosecution in respect of the sample. Subsections 3 and 4 of Section 25 make it clear that the Inspector ought to have sent a copy of the report to the accused, then the accused shall within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contravention of the report. Section 25 sub-clause also gives two options to the accused. First, the accused can either seek further analysis by the Central Government Laboratory by the Inspector himself or else they can make a request to the Court to send the sample. When the right of exercising such option is defeated and the procedures have not been followed and neither copy has been sent nor the prosecution filed before the shelf life of the drug expired, the valuable right of the accused is defeated by delay in procedures. Expiry date of the sample was Novermber 2020. As it could be seen from the records of one document of the Respondent, the letter addressed to the Director of Drugs control dated 27.10.2020. The above letter makes it clear that the expiry date of the same is November 2020, the prosecution has been launched on 11.11.2020 when the drug's shelf life has already been expired. Valuable right of the parties to exercise the option to send sample to the Central Laboratory is lost.
6. Having collected sample on 02.12.2019 till 16.9.2020 the respondent has not taken any steps to find out the address from the website and send the analysis report to the petitioners. Though it is averred in the petition that there is no reply has been received from the petitioners, the reply received from the respondent dated 02.11.2020 makes it clear that the first analysis report has been given 2 months delay after sampling. The Apex Court in Medipol Pharmaceutical India Pvt. Ltd., vs. Post graduate Institute of Medical Education and Research and another [2021(11 SCC 339 ] held as follows:
“valuable right is granted to a person who is sought to be penalized under these Acts to have a sample tested by the Government Analyst that is found against such person, to be tested by a superior or appellate authority, namely, the Central Drugs Laboratory - If owing to delay which is predominantly attributable to the State or any of its entities, owing to which an article which deteriorates with time is tested as not containing the requisite standard, any prosecution or penalty inflictable by virtue of such sample being tested, cannot then be sustained - - Unexplained dealy in sending samples about to lose their shelf lie for testing would result in voilation of valuable right under Ss.25(3) and 25(4).
Drug Inspector drew samples on 29.11.2017 which was long after supplies had been made to the Respondent on 08.04.2016 and complaints received- There is a dealy of one month from date when samples were drawn on 29.l1.2017 and those samples were received by the Government Analyst on 26.12.2017 - the sample that could be sent to the Appellate Lab was received by it on 11.02.2019, long after the expiry of cream – There was no fault of appellant in this delay - This expired sample yielded a result of 92.01% which is only roughly 3% below the required minimum standard - Government Analyst’s report was shown to be completely wrong – In postdecisional hearing blacklisting order was affirmed without looking into appellate lab report.”
7. In Medicamen Biotech Limited vs. Rubina Bose, Drug Inspector [(2008) 7 SCC 196] it is held as follows:
“19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9th May 2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Section 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them.”
8. In Laborate Pharmaceuticals India Limited and others vs. State of Tamil Nadu [(2018) 15 SCC 93] the honourable Apex Court has held as follows:
“6. A reading of the provisions of Sections 23(4) and 25 of the Act would indicate that in the present case the sample having been taken from the premises of the retailer had to be divided into four portions: one portion is required to be given to the retailer; one portion is required to be sent to the Government Analyst and one to the court and the last one to the manufacturer whose name, particulars, etc. is disclosed under Section 18-A of the Act. In the present case. admittedly, one part of the sample that was required to be sent to the appellant (manufacturer) under Section 23(4)(iii) of the Act was not sent. Instead, what was sent on 22-3-2012 was only the report of the Government Analyst. When the part of the sample was not sent to the manufacturer, the manufacturer could have got the same analysed even if he wanted to do so and, therefore, it was not in a position to contest the findings of the Government Analyst. In the present case, the sample was sent to the appellant manufacturer on 10-8-2012 and on 13-9- 2012 the appellant had indicated its desire to have another part of the sample sent to the Central Laboratory for reanalysis. This was refused on the ground that the aforesaid request was made much after the stipulated period of 28 days provided for in Section 25(3) of the Act.
7. The cognizance of the offence(s) alleged in the present case was taken on 4-3-2015 though it appears that the complaint itself was filed on 28-11-2012. According to the appellant the cough syrup had lost shelf life in the month of November 2012 itself. Even otherwise, it is reasonably certain that on the date when cognizance was taken, the shelf life of the drug in question had expired. The Magistrate, therefore, could not have sent the sample for reanalysis by the Central Laboratory.
8. All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analysed in the Central Laboratory has been denied a series of defaults committed by the prosecution; firstly, in not sending to the
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appellant manufacturer part of the sample as required under Section 23(4) (ii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4-3-2015 though the same was filed on 28-11-2012. The delay on both counts is not attributable to the appellants and, therefore, the consequences thereof cannot work adversely to the interest of the appellants. As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution.” 9. Considering the above, an inordinate delay in testing the first sample, thereafter issuance of memo almost 9 months later and the prosecution has been filed on the month of the shelf life of the drug has been expired, the valuable right of the petitioners have been defeated. In such view of the fact, continuation of the prosecution is nothing but futile exercise and abuse of process of law. 10. Accordingly, complaint in STC No.675 of 2020 on the file of the Judicial Magistrate, Pappiredepatti, for the offence under Section18(a)(i) and18-B of the Drugs and Cosmetics Act, 1940, punishable under Section 27(d) and Section 28-A of the said Act, is quashed and the Criminal Original Petition is Ordered. Consequently, connected Miscellaneous Petitions are closed.