TRIPTI KHARIA, DIRECTOR, M/S. NANDANI MEDICAL LABORATORIES PRIVATE LIMITED 221/5, BICHOLI HAPSI, KANADIA ROAD, INDORE. Vs. STATE OF TAMIL NADU

JUDGEMENT

(1.) This Criminal Original Petition has been filed to quash the criminal prosecution launched by the Drug Inspector, for alleged contraventions of Sec. 18a(i) of the Drugs and Cosmetics Act, for manufacturing and selling substandard quality drug.

(2.) According to the Prosecution, a drug by name "Amikacin Sulphate Injection I.P. 100 mg", Batch No.AK1647, Manufacturing Date:10/2016 and Expiry Date:09/2018 is manufactured in India by M/s.Nandani Medical Laboratories Private Limited, which is represented by the petitioners herein. When samples were collected on 28/3/2017 and the sent for analysis, the said drug was found to be of substandard quality.

(3.) In this connection, a show cause notice was issued to the manufacturing Company and its Director on 28/8/2017. The explanation was called for, the from the company, for contravention of Sec. 18a(i) of the Drugs and Cosmetics Act and for furnishing the required documents mentioned in the show cause notice. The manufacturing company/Nandani Medical Laboratory has replied to the show cause notice on 25/9/2017 stating that the drugs, which are found to be substandard, are recalled from the warehouse and the same has been replaced by different stock of drugs manufactured in different batch. In such circumstances, the prosecution has been lodged against the manufacturing company and the petitioners, who are Directors of the company.