The present petitioners have challenged initiation of a criminal case against them by the present respondent in the Court of City Civil and Sessions Judge at Bengaluru for the alleged violation of Sections 18(a)(i) and Section 17B(d) which are punishable under Sections 27(c) and 27(d) of the Drugs and Cosmetics Act, 1940.

2. The summary of the case as could be gathered at this stage are; that the first petitioner (Accused No.1) Company is the manufacturer of a drugs for human consumption with the commercial name Zoxil CV Dry Syrup (Amoxyllin and Potassium Clavulanate for Oral Suspension IP). The Inspector attached to the respondent Department visited one of the drug shop by name M/s Shree Maruthi Chemist, Bengaluru-75 on 13.09.2011 and took the sample of said Zoxil CV suspension and sent it for its testing to the Government Analyst, Drugs Testing Laboratory, Bengaluru, Karnataka. The Government Analyst tested the said drug, the report of which was received by the respondent on 16.01.2012. The test report and analysis in Form No.13 issued by the Government Analyst, Drugs Testing Laboratory, Bengaluru declared that the said drug was “not of standard quality” with respect to “Assay” for Amoxyllin and Clavulanate acid.

3. After receipt of a copy of the said test report, the petitioners sent a reply dated 04.02.2012 along with certificate of analysis and results and stated that they do not accept the report of the Government Analyst for which they wanted the seized sample to be sent to Central Drug Testing Laboratory (henceforth for brevity referred to as ‘CDTL’) at Kolkatta for counter checking the result. As such, the Drug Inspector, Circle – V, Bengaluru filed a petition under Section 25(4) of Drugs and Cosmetics Act, 1940, in the Court of the Special Court (Economic Offences), Bengaluru, requesting the Court to send the seized portion of Zoxil CV suspension to CDTL, Kolkatta for test and analysis. The said Court, by its order dated 17.02.2012 ordered for sending the sample in proper intact condition to CDTL at Kolkatta. Accordingly, the drug was sent to CDTL, Kolkatta, which laboratory by its report dated 12.03.2012 at Annexure-G, which report was accompanied along with Form No.2, certificate of test or Analysis by the Central Drugs Laboratory, stated that it tested the said drug on 27.02.2012 and found that the sample was of substandard. Thereafter, the respondent Department obtaining sanction from the Drug Controller from the State of Karnataka for investigation and for further proceeding and obtaining permission to launch prosecution against the petitioners has instituted a criminal case by lodging a complaint under Section 200 of Criminal Procedure Code, 1973 in the Court of Principal City Civil and Sessions Judge at Bengaluru in PCR No.29/2015. After taking cognizance, the CC No.243/2015 was given. It is the said CC No.243/2015 which the petitioners are seeking for quashing in this petition.

4. The argument of the learned counsel for the petitioner is on two fold. The first leg of his argument is that the CDTL has tested the sample sent to it on the last day of the expiry of the drug, as such the test report cannot be accurate.

5. On this point learned High Court Government Pleader appearing for the respondent submitted that even though the test is said to have been conducted on the last date of expiry, same falls within the shelf life of the sample drug, as such, the test report cannot be called inaccurate.

6. Learned counsel for the petitioner in his support relied upon the judgment of the Hon’ble Apex Court in the case of Medicamen Biotech Limited and another Vs. Rubina Bose, Drug Inspector reported in (2008) 7 SCC 196 and while drawing the attention to Paragraph 18 of the said judgment, he submitted that in the instant case also the drug since was tested by CDTL, just two days prior to its expiry, the test report cannot be accepted.

The Paragraph 18 of the Medicamen’s case supra is reproduced here below :

“18. In Uniqu