- (1.) Seeking to quash the proceedings in C.C.No.74 of 2010 pending before the Judicial Magistrate Court, Kodumudi, the petitioners have come up with the present petition.
(2.) Petitioner are the accused in the complaint lodged by the respondent for the contravention of section 18(a)(i) and 18-B of the Drugs and Cosmetics Act, 1940, which is punishable under section 27(d) and 28-A of the said Act. The allegations made in the complaint are as follows: (a) On 27.09.2007, the Drugs Inspector, Erode, Range (I/c) went to the premises of Government Hospital, Kodumudi, Erode and drew the samples of Enalapril Maleate tablets, I.P.2.5 mg Batch No.ENL-146, Mfg.date 06/07; Expiry date 05/09 manufactured by M/s.Embiotic Laboratories (P) Limited. Thereafter, the Drugs Inspector sent the samples of the said drug for analysis to the Government Analyst (Drugs), Chennai-6. The Government Analyst, on 26.02.2009, by his report, declared that the samples so drawn do not conform to I.P. specification for Enalapril Maleate tablets with respect to the contents of Enalapril Maleate, as required under the Drugs and Cosmetics Act, 1940 (in short "the Act"). Thereafter, a letter dated 20.03.2009 was sent to the Medical Officer, Government Hospital, Kodumudi, Erode in this regard and a reply was received by the respondent stating that the product was supplied by the Tamil Nadu Medical services Corporation Limited, Perundurai, Erode District. Thereafter, the Tamil Nadu Medical Services Corporation Limited (TNMSC), Perundurai was addressed for information and they sent a reply on 06.04.2009 that the product was supplied by A1 with a total quantity of 3,00,000 tablets. Subsequently, on 13.04.2009, the respondent sent a notice to A1, inter alia, to show cause as to why action should not be taken against the Company for having sold a drug which was not of standard quality, which is in contravention of section 18(a)(i) of the Act. Along with the notice, A1 received a copy of analysis report and a portion of what was descried as a 'sealed sample' on 15.04.2009. For which, the 2nd petitioner/A2, as Director of A1, sent a reply dated 16.04.2009 requesting to send a copy of the signed copy of the report as well as Protocol of Analysis for which they can offer their explanation. Since the sample is being expired in May, 2009, the respondent did not send any report; however, the respondent sent a original copy of Form-13 and protocol of analysis on 23.04.2009, which was received by them on 25.04.2009. On 19.05.2009, A2 sent a reply and the same was received by the respondent on 21.05.2009. (b) In the reply, A2 has stated that they manufactured the said drug after complying with all the specifications laid down under IP and the TNMSC also analysed each and every batch of drugs supplied to them; they analysed the control sample of the said batch of the drug at ATOZ Pharmaceuticals Private Limited and was found to be complying with the Assay requirements as per I.P. as per report No.F9/A/17/05 dated 19.04.2009; they tested the third portion of the sample which was sent by the respondent at Bangalore Test House and found to be complying with the Assay requirements as per I.P.as per report No.0257 dated 29.04.2009; they stated that the Government Analyst has deviated from IP method which is the reason for their product to show lower assay levels and finally, they denied that they manufactured and sold a substandard quality drug and requested to send the sample to Central Drugs Laboratory, Kolkata for second opinion. (c) But, the petitioners did not furnish the required particulars which were called for the contravention of Section 18-B of the Act; however, the respondent received a notice under Rule 85(2) of the said Act from the Drugs Controller of Karnataka. On a perusal of the reply sent by the petitioners, it was found that the manufacturer had received the copy of report in Form-13 with protocol and third portion of the sample on 15.04.2009, but they had intended to differ the report of the Government Analyst by their letter dated 19.05.2009, after a lapse of 28 days. They had adequate time to move the Court to send the sample to the Central Drugs Laboratory, Kolkata as per section 25(3) of the Act. But it is found that they dragged time till the end of the expiry of the drug and not adduced the report within the stipulated time and they have failed to exercise their rights under the Act. Since their reply is not satisfactory, the complaint was lodged by the respondent before the Judicial Magistrate Court, Kodumudi.
(3.) It is the main submission of the learned counsel appearing for the petitioner that the samples were drawn on 27.09.2007, which were tested only on 26.02.2009 i.e.almost 17 months after they were drawn without disclosing the condition in which they were stored. The samples relatable to the case were drawn on 27.09.2007. The Analyst report as regard the drugs was dated 26.02.2009. The report was sent to A1, which was received on 25.04.2009 and the complaint was filed only in February 2010. The petitioners received summons in May, 2010 from the lower court. By the time, it was found that the shelf-life of the drug had already expired in May, 2009. Hence, the petitioners had lost their valuable right guaranteed under section 25(4) of the Act because they were not in a position to make a request to send another sample to the Central Drugs Laboratory, Kolkata.;