Prosecution under the Drugs and Cosmetics Act is unsustainable and constitutes an abuse of process if the complaint is filed after the drug's shelf-life expires, thereby depriving the accused of their statutory right to challenge the analyst's report through re-analysis.

ORDER

This Criminal Original Petition has been filed to quash the proceedings in C.C.No.7435 of 2016 on the file of the X Metropolitan Magistrate, Egmore, Chennai.

2. The respondent filed a complaint under Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”) punishable under Section 27(d) of the Act, alleging that on 29.09.2015, the respondent had drawn a sample of Carbimazole Tablets IP 5 mg (hereinafter referred to as “the drug”) under Form 17 and subjected the same for analysis. The sample was reported to be not of standard quality as per the report dated 16.06.2016, on ground that the sample did not conform to the IP specification for the content of Carbimazole (57.4%). Therefore, it attracts the contravention of Section 18(a) (i) of the Act. After complying with the provisions under Section 25(2) of the Act, it was found that the drug had been distributed by M/s.Centurion Laboratories under invoice dated 14.12.2014. A show cause notice dated 06.07.2016 was issued to the petitioners along with the second copy of the analytical report. On receipt of the same, the petitioners submitted their explanation dated 25.07.2016. However, the explanation offered by the petitioners was not found satisfactory. Hence, it was alleged that the petitioners had contravened the provisions of Section 18(a)(i) of the Act, as the drug manufactured and sold was not of standard quality, and thereby they are liable to be punished under Section 27(d) of the Act.

3. The learned counsel appearing for the petitioners submitted that the respondent had drawn a sample of the drug on 29.09.2015 and on the same day, it was sent to the Government Analyst, Drugs Testing Laboratory, Chennai for analysis. By report dated 16.06.2016, the sample was stated to be not of standard quality on the ground that it did not conform to the IP specification for the content of Carbimazole, which was found to be 57.4%. Though the complaint was filed in the year 2016 that too after the expiry of the shelf-life of the drug in question, and the petitioners were served with summons only after nearly five years from the date of the complaint. It is further submitted that the drug has to be stored and protected from light and moisture and should be kept below 30º C as per IP standards. However, the said storage condition was not followed by the respondent while dealing with the sample for analysis, thereby violating the IP methods and procedures. The petitioners were served with a show cause notice dated 16.06.2016, to which they submitted their reply on 25.07.2016, stating that they did not agree with the Analyst's report on several grounds. It is their specific contention that the drug was subjected to analysis after its expiry and that the shelf-life of the drug expired on 30.11.2016, whereas, the complaint was filed only on 09.12.2016. Though the petitioners submitted their explanation before the expiry of the shelf-life of the drug and had requested for re-analysis of the sample, the respondent failed to take steps to send the sample for re-analysis as contemplated under the Act. Therefore, the petitioners lost their right to get the second analysis for the drug. Therefore, the entire prosecution against the petitioners cannot be sustained and is liable to be quashed.

4. The respondent filed a counter and the learned Government Advocate (Crl.Side) appearing for the respondent submits that, after the samples were taken from the medical shop, they were stored under proper storage conditions. The Government Analyst carried out