Marketers cannot be held liable for misbranding under pre-amendment rules without mens rea.

ORDER

The accused Nos.5 and 6 in ST No.3759/2016 on the files of the Judicial First Class Magistrate Court-I, Cherthala, have filed this petition under Section 482 Cr.P.C, for quashing the proceedings against them in the aforesaid case. The said case arose out of a complaint filed by the Drugs Inspector, Alappuzha, against 6 accused, alleging the commission of offences under Section 17 (b) and Section 27 (d) of the Drugs and Cosmetics Act, 1940 . The petitioners herein are said to be marketers of the drug, which the Drugs Inspector found to have been misbranded, in the inspection conducted on 29.11.2013.

2. It is alleged that the Drugs Inspector had seized from a medical shop by name, M/s Kariyil Medicals near KSRTC depo, Alappuzha, the drug Moxking 250 Dry Syrup, in which the label contained a printing that the shelf life of that drug is 24 months. According to the complainant, as per Schedule P of the Drugs and Cosmetics Act, 1940 , the shelf life of Amoxycillin Trihydrate Dry Syrup is restricted as 18 months. Thus, the accused are alleged to have resorted to sale of misbranded drug.

3. Heard the learned counsel for the petitioners and the learned Additional Director General of Prosecution representing the respondents 1 and 2.

4. As per Section 17 (b), a drug shall be deemed to be misbranded if it is not labelled in the prescribed manner. Section 27 (d) of the said Act deals with the penal provision for manufacture or sale for distribution or for selling, stocking or exhibiting, or offering for sale any drug other than a drug referred to in clause (a) or clause (b) or clause(c) in contravention of any other provisions of that Chapter or any Rule made thereunder. Obviously, the aforesaid penal provisions are meant for the violation of the manufacturers when the allegation pertains to misbranding. Since the petitioners herein are admittedly the marketers, they are not liable to be fastened with the criminal liability in the above regard, in the absence of clear allegations and prima facie proof showing that they were having the requisite mens rea for the commission of the offence. It is true that the legislature has brought in Rule 84E to the Drugs Rules, 1945 , as per which any marketer, who sells or distributes any drug, shall be responsible for the quality of that drug as well as other regulatory compliance, along with the manufacturer, under the relevant rules. However, the aforesaid amendment to the , was brought in only on 11.02.2020. The present complaint relates to the inspection conducted by the complainant on 29.11.2013. So also, the complaint is dated 22.11.2016. In the above circumstances, the petitioners herein cannot be roped in for the violations under Sections 17 (b) and 27(d) of the Drugs and Cosmetics Act in connection with the offences said to have taken place about 7 years prior to the enactment of Rule 84E of the . Therefore, the prayer of the petitioners to quash the proceedings against them, deserves to be allowed.

In the result, the petition is allowed as follows:

The proceedings against the petitioners (accused Nos.5 and 6) in ST No.3759 of 2016 (which has been renumbered as ST No.1613 of 2023) on the files of Judicial First Class Magistrate Court-I, Cherthala, are hereby quashed.

Sd/-