(1.) The petitioners herein are M/s Gopal Life Sciences, Solan, Himachala Pradesh, its Partner and Authorised Signatory-cum-Manager.
(2.) A complaint by the Drug Inspector, Vellore Zone under Sec. 32 of The Drugs and Cosmetics Act, 1940(hereinafter referred to "the Act"), for contravention of Sec. 18(a)(i) and punishable under Sec. 27(d) of the said Act laid before the Judicial Magistrate, Chengam, Tiruvannamalai District and taken on file as S.T.C.No.183 of 2022.
(3.) The gist of the complaint is that, on 30/07/2019, a sample of 4x100ml TERBOT-G syrup (Terbutaline sulphate, Bromhexine, Guaiphenesin and Menthol Syrup), B.No.GLL-8036, M/D:7/18, E/D:6/20, Mfd by Gopal Lifesciences, Hill top Industrial Estate, Near Export Zone, Jharmajri, Baddi (H.P)-173205(marked as 45/MSA/19/TVM-II) was drawn for analysis from M/s Vasuki Medicals situated at No.223, Nadu Street, Mothakkal Post, Tiruvannamalai-II Range, under Form-17 dtd. 30/7/2019 and sent for analysis to the Government Analyst under Form-18 dtd. 30/7/2019. The said drug has been declared as Not of Standard Quality drug by the Government Analyst, Drug Testing Laboratory, Chennai-6 for the reason that the sample does not conform to Label claim with respect to the content of Terbutaline Sulphate (70.83%) and Bromhexine Hydrochloride(68.13%), thereby for having manufactured for sale, stocked for sale and sold the said Not of Standard Quality drug, the Sec. 18(a)(i) of the Drugs and Cosmetics Act, 1940 has been contravened.