THE HONOURABLE SRI JUSTICE E.V.VENUGOPAL CRIMINAL PETITION No.10558 OF 2023

O R D E R:

This Criminal Petition is filed seeking to quash the proceedings in C.C.No.46 of 2023 on the file of the learned I Additional Junior Civil Judge-cum-IX Additional Metropolitan Magistrate, Ranga Reddy District, at Kukatpally, registered under Section 18(a)(iv) r/w. Sl.No.42 of Schedule ‘J’ R/w. Rule 106 which is punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940 (for short, “the Act”) and Rules 1945.

2. Heard Mr.Bhanu Murthy Bala, learned counsel for the petitioners and Mr.E.Ganesh, learned Assistant Public Prosecutor appearing for respondent No.2-State.

3. The brief facts of the case are that petitioner No.1 Company is the business of manufacturing of drugs and pharmaceutical products, which has WHO-GMP certification. It is stated that petitioner No.1 Company is the manufacturer and supplier of the subject drug “PILE SEAL” ointment under valid License. PILE SEAL ointment is used for the treatment of the internal and external piles. Whileso, respondent No.1 had filed a complaint against the petitioners which was numbered as C.C.No.3628 of 2018 on the file of the learned XIX Metropolitan Magistrate, Cyberabad, at Miyapur, Ranga Reddy District. On administrative grounds, the case was transferred and re-numbered as C.C.No.46 of 2023 on the file of the learned IX Additional Metropolitan Magistrate, Ranga Reddy District, at Kukatpally. In the complaint, it was alleged that on 08.10.2015, respondent No.1 along with two mediators went to M/s.Lakshmi Pharma situated at D.No.5-141, Shop No.5, Manjeera Road, Chandanagar, Sherilingampally Mandal which holds the drug license in Form 20B, 21B bearing License No.137/RR/ AP/2004/W valid upto 31-05-2019; that during the inspection, in the presence of mediators, it was found that the stock of drug by the name “PILE SEAL” Ointment, Batch No.1401, Manufacturing date 08/2014 and expiry dated 07/2016, manufactured by Petitioner No.1 Company was labeled as “for the treatment of external & internal piles” in which the claim “Piles” is objectionable claim and contravenes the Section 18(a)(vi) r/w Sl.No.42 of Schedule ‘J’ r/w. Rule 106 which is punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940 and Rules 1945.

4. Learned counsel for the petitioners submits that neither the test reports of government analyst nor any photo of the seized product “Pile Seal” has been attached with the complaint whereas Section 20 of the Act clearly envisages that the appointment of Government analyst should be notified in the official gazette of Government. He submits that, in similar circumstances, this Court vide order dated 29.11.2018 in Criminal Petition No.1128 of 2018 and order dated 07.06.2022 in Criminal Petition No.1154 of 2020 quashed the proceedings against the petitioners therein. Relying on the aforesaid decisions, learned counsel seeks to allow the Criminal Petition.

5. Learned Assistant Public Prosecutor submits that the matter requires to be tried and seeks to dismiss this Criminal Petition.

6. Undisputedly the ointment ‘Pile Seal’ is mentioned on the label and on the cover as ‘for the treatment of external and internal piles’. Schedule ‘J’ as per Rule 106 of the Rules in the Act, item 42 speaks of piles and fistulae. Rule 106(1) reads that no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule ‘J’. Sub-rule (2) speaks that no drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women.

7. The core issue is whether the use of the words for the treatment of external and internal piles is covered by Rule 106(1) of the Rules in the statutory violation defined in Section 18 clause (a)(iv). For more clarity, the relevant portion of the section reads