1 BEFORE THE MADURAI BENCH OF MADRAS HIGH COURT DATED : 16.09.2011 CORAM THE HONOURABLE MS.JUSTICE R.MALA Crl.O.P.(MD).No.2160 of 2011 and M.P.(MD) Nos.2 and 3 of 2011 1.M/s.Unicure (India) Pvt. Ltd., represented by its Director Abdul Mateen 2.Abdul Mateen : Petitioners -Vs- State represented by Drugs Inspector, Kumbakonam Range, R.No.13, Salam Mansion, 27, Town Extension, Myiladuthurai. : Respondent PRAYER: Petition is filed under Section 482 of the Code of Criminal Procedure praying to call for the entire records in S.T.C.No.1232 of 2009 on the file of the Judicial Magistrate, Kumbakonam and quash all further proceeding against the accused. For Petitioner : Mr.K.P.S.Palanivel Rajan For Respondent : Mrs.S.Prabha, Govt.Advocate(Crl. Side) O R D E R This petition has been filed to call for the entire records in S.T.C.No.1232 of 2009 on the file of the Judicial Magistrate, Kumbakonam and quash all further proceeding against the accused. 2.The learned counsel appearing for the petitioners would submit that the petitioners are arrayed as A1 and A2 and a case has been registered for the offence under Section 32 and 18(a)(i) read with Section 27 (d) and Section 18(B) read with Section 28(A) of the Drugs and Cosmetics Act, 1940 stating that the Drug Inspector, Kumbakonam Range has made an inspection in the Government Hospital, Aduthurai on 12.12.2008 and he taken the sample of Enalapril Maleate Tablets IP 2.5 Mg batch No.EMT 24-50 date of Manufacturing 03/2008, date of https://hcservices.ecourts.gov.in/hcservices/ 2 expiry 02.2010, manufactured by the 1st petitioner and A2 is the Managing Director. He would further submit that the same sample has been sent for analysis to the Government Analyst (drugs) Chennai, on the same day under Form 18 and a report dated 27.12.2009 has been received, wherein, it has been stated that the drug 'as Not of Standard Quality' and the Medical Officer was requested to disclose the name and address of the person from whom the impugned drug was acquired vide the letter dated 27.02.2009 sent by the Government Analyst, Drugs testing laboratory, Chennai. He would further submit that the Medical Officer had replied vide his letter dated 21.04.2009 disclosing that the impugned drug 40,000 in nos. were acquired from District Drug Warehouse of Tamil Nadu Medical Service Corporation Limited, Thanjavur and the stock on hand was nil. Thereafter, they sent a letter dated 23.04.2009 along with the analytical report to the In charge of the District Drug Warehouse of Tamil Nadu Medical Service Corporation Limited, Thanjavur and a reply dated 27.04.2009 has been received and then only, a show cause notice has been issued on 06.05.2009 to the petitioners herein and they sent reply dated 08.06.2009, which was received by the officer on 17.06.2009 and the complaint has been filed on 28.10.2009, which was received by the Court on 10.11.2009 and the summons was received on 23.08.2010. 3.The learned counsel appearing for the petitioner would further submit that the date of the best before the drug is February 2010, but, the summons has been received by the petitioners only on 25.08.2010 and hence, he prayed for the quashing the complaint against the petitioners. To substantiate his argument, he relied on the order of this Court dated 25.11.2010 made in Crl.O.P.(MD) No.10748 of 2010 and submitted that since the summons has been received after the expiry of the drug, his change for sending the sample for second test has been deprived and hence, they are is entitled to quashing the complaint. 4.Repudiating the same, the learned Government Advocate (criminal side) would file a counter stating that the offence committed by the petitioners was very serious in nature and the substandard quality of Enalapril Maleate tablets may cause Hyper tension/Heart failure and the petitioners have manufactured a substandard medicine, even after known well about the substandard, they sold and distributed the above said tablets for consumption of innocent patients and if the above said tablets manufactured in the batch No.EMT-24-50 has not captured again and destroyed, it will affect the general public in large and hence, he prayed for the dismissal of the application. 5.I have heard the rival submissions made on either side and perused the materials available on records and the order of this Court dated 25.11.2010 made in Crl.O.P.(MD) No.10748 of 2010. 6.It is true, the medicine viz., Enalapril Maleate Tablets IP 2.5 Mg batch No.EMT 24-50 date of Manufacturing 03/2008 date of expiry 02.2010 has been manufactured by the 1st petitioner and the tablets have been used in the Government Hospital, Aduthurai and when https://hcservices.ecourts.gov.in/hcservices/ 3 the respondent made an inspection in the Government Hospital, Aduthurai, he drawn samples of the said medicine on 12.08.2008 and sent the same for Government Analyst on the same day and a report has been received on 27.02.2009 stating that it is a substandard medicine and hence, the complaint has been filed against the petitioners. There is no quarrel over that the drug seized from the Government Hospital is substandard. But, now the main point raised by the petitioners is that the manufacturing date is March 2008 and the date of expiry is February 2010. But, after following the procedures, the petitioners have received the summons only on 25.08.2010 and hence, since the date of expiry period has been over, the petitioners' chance for sending the drug for 2nd analysis is prevented and hence, they are entitled for quashing the proceedings against them. 7.At this juncture, it is appropriate to consider the decision of this Court dated 25.11.2010 made in Crl.O.P.(MD) No.10748 of 2010, which was between the same petitioners herein and the Drug Inspector of Pudukkottai Range, where the same product has been taken as sample by the Drug Inspector and this Court also has held that well before the expiry of the shelf-life of the drug concerned, the complaint should be filed, then only the accused also could get the drug concerned retested by the Central Drugs Laboratory concerned and in that case, the test was conducted only by the Tamil Nadu Drugs Testing Laboratory and not by the Central Drugs Laboratory and hence, the valuable right of the accused got defeated and quashed the complaint against the petitioners. In the said case, the learned Judge has considered the Apex Court decision in Medicamen Biotech Limited and another v. Rubina Bose, Durg Inspector reported in (2008) 7 Supreme Court Cases 196, where, the Apex Court has held thus: "16. It is, therefore, evident that the appellant had not once but on at least two occasions and within 28 days of the receipt of the show-cause notice clarified that it intended to adduce evidence to show that the test report of the Government Analyst was not correct. The judgments cited by the learned counsel for the respondent, therefore, do not apply to the facts of the case as they were given in the context where the dealer/manufacturer had not expressed its desire to challenge the veracity of the report of the Drugs Analyst. 17. In Brij Lal Mittal case (1998) 5 SCC 343 : 1998 SCC (Cri) 1315, this Court held that a person could not claim that the fourth sample should be sent to the Central Drugs Laboratory unless the requirements of sub-section (3) of Section 25 was complied with. In that case, despite the service of the copies of the Analyst’s report the manufacturer had not informed the Inspector within the prescribed period that he intended to adduce evidence to controvert the report. It was held in Brij Lal Mittal case: (SCC p. 346, para 5) https://hcservices.ecourts.gov.in/hcservices/ 4 “5. From a bare perusal of sub-section (3) it is manifest that the report of the Government Analyst shall be evidence of the facts stated therein and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose name, address or other particulars have been disclosed under Section 18- A (in this case the manufacturers) has within 28 days of the receipt 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 controversion of the report. Sub-section (4) also makes it abundantly clear that the right to get the sample tested by the Central Government Laboratory (so as to make its report override the report of the Analyst) through the court accrues to a person accused in the case only if he had earlier notified in accordance with sub-section (3) his intention of adducing evidence in controversion of the report of the Government Analyst. To put it differently, unless requirement of sub-section (3) is complied with by the person concerned he cannot avail of his right under sub-section (4).” (emphasis in original) 18. In Unique Farmaid case (1999) 8 SCC 190 : 1999 SCC (Cri) 1404 which was a case under the Insecticides Act which has provisions analogous to Section 25(4) of the Act, the Court found that the accused had indeed made a request to the Inspector for sending the sample for retesting within the prescribed time-limit and as this request had not been accepted an important right given to an accused had been rendered ineffective on which the proceedings could be quashed. This is what the Court had to say: (SCC p. 197, paras 12-13) “12. It cannot be gainsaid, therefore, that the respondents in these appeals have been deprived of their valuable right to have the sample tested from the Central Insecticides Laboratory under sub-section (4) of Section 24 of the Act. Under sub-section (3) of Section 24 report signed by the Insecticide Analyst shall be evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within 28 days of the receipt of the report, notify in writing to the Insecticides Inspector or the court before which proceedings are pending that they intend to adduce evidence to controvert the report. In the https://hcservices.ecourts.gov.in/hcservices/ 5 present cases the Insecticides Inspector was notified that the accused intended to adduce evidence to controvert the report. By the time the matter reached the court, the shelf life of the sample had already expired and no purpose would have been served informing the court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. A valuable right had been conferred on the accused to have the sample tested from the Central Insecticides Laboratory and in the circumstances of the case the accused have been deprived of that right, thus, prejudicing them in their defence. 13. In these circumstances, the High Court was right in concluding that it will be an abuse of process of court if the prosecution is continued against the respondents, the accused persons. The High Court rightly quashed the criminal complaint. We uphold the order of the High Court and would dismiss the appeals.” We find that this judgment helps the case of the appellant rather than that of the respondent because in spite of two communications from the appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the Magistrate had not been sent for reanalysis. The observations in Amery Pharmaceuticals case (2001) 4 SCC 382 : 2001 SCC (Cri) 724 are also to the same effect. We find that the aforesaid interpretation supports the case of the appellants inasmuch they had been deprived of the right to have the fourth sample tested from the Central Drugs Laboratory. It is also clear that the complaint had been filed on 2-7-2002 which is about a month short of the expiry date of the drug and as such had the appellant- accused appeared before the Magistrate even on 2-7-2002 it would have been well-nigh impossible to get the sample tested before its expiry. 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 9-5-2005. 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 https://hcservices.ecourts.gov.in/hcservices/ 6 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 Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them." 8.Considering the above said decision along with the facts of the present case, the month of manufacturing the drug is March 2008 and the date of expiry month is February 2010, but the summons has been received by the petitioner only on 23.08.2010, after the expiry of the medicine and hence, I am of the opinion that the valuable right of the accused got defeated and in such a case, it is a fit case to quash the complaint against the petitioners. 9.Accordingly, this criminal original petition is allowed and the proceedings in S.T.C.No.1232 of 2009 on the file of the Judicial Magistrate, Kumbakonam, against the petitioners is hereby quashed. Consequently, connected miscellaneous petitions are closed. Sd/- Deputy Registrar (Writs) /True Copy/ Assistant Registrar To 1.The Drugs Inspector, Kumbakonam Range, R.No.13, Salam Mansion, 27, Town Extension, Myiladuthurai. 2.The Judicial Magistrate, Kumbakonam. 3.The Public Prosecutor, Madurai Bench of Madras High Court, Madurai. Arul ssk/18.10.2011 /4c-6p/- Crl.O.P.(MD).No.2160 of 2011 16.09.2011 https://hcservices.ecourts.gov.in/hcservices/