ORDER :

[Crl. O.P. No.26314 of 2012 filed under Section 482 of the Code of Criminal Procedure to call for the records in C.C. No.1614/2011 on the file of the XV Metropolitan Magistrate, George Town, Chennai and quash the same.]

1. As the issue raised in all the petitions is one and the same, they were heard together and disposed of by this common order.

2. The present petitions have been filed to quash the complaint, which has been taken cognizance of in response to the complaint filed by the respondent alleging breach of Rule 96 (1) (v) of the Drugs & Cosmetics Rules, 1945 (for short ‘the Rules’). In addition thereto, Crl. O.P. No.10959 of 2011 has been filed to forbear the 1st respondent from indiscriminately according sanction for prosecution to the respondents to proceed against the petitioners for the aforesaid violation u/r 96 (1).

3. The gist of the case of the petitioner is that it is a manufacturer of pharmaceutical products, viz., medicines and the medicines in the present case pertain to Vicks Action 500 Extra/Plus, which is manufactured at its Hyderabad Plant. It is the case of the petitioners that though the batch number, manufacturing date and expiry date has been printed on the strips, which carry the tablet and strips of 15 or 12 are housed in a container, however, on the said container which houses the strips, the details of batch number, manufacturing date and expiry date are not marked, but reference is sought to be made to the individual strip.

4. It is the further case of the petitioners that the respondent have initiated action against the petitioner, by drawing samples from M/s. Sree Mahendra Pharmaceuticals at Chennai on 14.10.2008 and forwarding the same to the Government Drug Analyst alleging violation of Rule 96 (1) (v) of the Rules. It is the further case of the petitioners that the respondent has failed to submit Form 17-A as proof of purchase of the drug sample, which is in violation of the procedure stipulated u/s 23 (1) of the Drugs & Cosmetics Act.

5. It is the further averment of the petitioners that the Chemical Analyst, upon analysis, has submitted his report stating that there is misbranding of the product, as the batch number, manufacturing date and expiry date of the sample are not printed on the carton box, but only stated on the carton that individual strips have to be seen to know the batch number, manufacturing date and expiry date and that the edge of the strip contains the said information.

6. It is the further averment of the petitioners that Rule 96 (1) (v) only mandates that a distinctive batch number shall also be printed on the label of the innermost container of any drug and on every other covering in which the container is packed. It is case of the petitioner that the mandate is very clear that it only applies to drugs, which are encased in containers, such as bottles and tubes or tablets in strips, which are in turn packed in an outer cover, which is sold in the retail market through the shops. Such being the position, there is no requirement for the declaration to be made on label affixed on the container and on every other covering in which the container is packed and it does not apply to drugs packed in strips and blister packs.

7. It is the further averment of the petitioner that no opportunity of hearing was given to the petitioners before proceeding with the complaint, which is a clear violation of principles of natural justice and the multifarious proceedings, which has been initiated is nothing but an attempt to cause grave and severe prejudice to the petitioners.

8. It is the further case of the petitioner that the duty of the Drug Analyst is only to test the samples sent to him for analysis and the analyst has no part to find out if the labels on the strips are in accordance with the Act or not. In this backdrop, it is the further averment of the petitioners that the analysis report having not found any deficiency in the composition of the drug, the report of the Analyst th