FIZIKEM LABORATORIES PVT LTD Vs. DRUGS INSPECTOR

JUDGEMENT

(1.) The petitioners 1 and 2/A-1 and A-2 in these batch of criminal petitions are accused of offences punishable under Sections 27(b)(ii) 27(c), 27(d) and 28- B of the Drugs and Cosmetics Act, 1940(in short, the Act) for violation of Sections 18(c), 18(a)(i)/17(B)(d), 17(b) of the Act and Section 26-A read with S.No.56 of notification No.GSR 578(E) dated 23.07.1983. A-1 is Fizikem Laboratories Private Limited, Tadigadapa and A-2 is its Managing Director. Subject matter of these criminal prosecutions is manufacture and sale of capsules of Ozomen, Ozomen Forte and Rapid Forte by the accused through various dealers in the State. After obtaining samples of the said drugs from the retail dealers when they kept the same for sale, in accordance with the procedure prescribed, one of the samples in each case was sent to Government analyst for analysis. In all these cases, Government analyst sent analytical report. Accordingly the respective drugs inspectors filed complaints before the respective Magistrates alleging that A-1 had manufactured the said drugs containing Sildenafil citrate without valid drug licence and that Sildenafil Citrate is an Allopathic drug and that labels of the subject drugs claim that they are Ayurvedic proprietary medicines which is a false claim and therefore they are not labelled in the prescribed manner and that they are spurious drugs with reference to their respective labels and that Ayurvedic drugs have been substituted in part with Allopathy drug and that it is in contravention of the notification No.GSR 578(E) dated 23.07.1983 published in the Gazette of India Part II.

(2.) There is no dispute that A-1 has been manufacturing capsules of Ozomen, Ozomen Forte and Rapid Forte which are trade names as Ayurvedic drugs after obtaining Ayurvedic Drug licence. The allegation is that those three drug capsules contained various potencies of Sildenafil Citrate which is an Allopathic drug. In these petitions, it is not disputed that Sildenafil Citrate is an Allopathic drug. It is contended by senior counsel for the petitioners that since the drugs are being manufactured by the accused as Ayurvedic drugs and in case some other substance or drug which is not an Ayurvedic Drug is found in the samples, then the prosecution should have been for the offences prescribed under Chapter-IVA of the Act for contravention of the provisions under that chapter and that in a case of this nature, the prosecutions should not have been launched and should not be allowed to continue for offences under Chapter-IV of the Act for contraventions of the provisions under the same chapter. Sections 33A and 33B of the Act are pointed out by the senior counsel in this regard.

(3.) At this stage it may be noted that previously the petitioners filed Criminal Petition Nos.4475, 4476, 4477, 4479, 4480, 4481, 4482, 4565, 4566, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574 of 2005 and 942, 943, 944, 946, 947, 948 of 2006 under Section 482 Cr.P.C in this High Court on the same grounds which are urged herein. By common order dated 17.04.2006, this High Court allowed the said criminal petitions and quashed proceedings in all the calendar cases pending on the files of the respective Magistrate Courts against the petitioners. As against the said common order dated 17.04.2006 passed by this Court, the complainants/Drugs Inspectors filed Criminal Appeal No.533 of 2008 in the Supreme Court of India after obtaining leave. The Supreme Court by judgment dated 24.03.2008 allowed the Criminal Appeal and set aside the common order passed by this Court directing the trial Courts to proceed with trial of the matters. After lapse of more than 4 years of judgment of the Supreme Court, again the petitioners have come up with these criminal petitions under Section 482 Cr.P.C for quashing the respective prosecutions on the same grounds as before.