LexTHE DRUGS INSPECTOR AND ANR. versus M/S. FIZIKEM LABORATORIES PVT. LTD. AND ANR.
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[2008] 5 S.C.R. 465 THE DRUGS INSPECTOR AND ANR. A v MIS. FIZIKEM LABORATORIES PVT. LTD. AND ANR. (Criminal Appeal No. 533 of 2008) MARCH 24, 2008 B [A.K. MATHUR AND ALTAMAS KABIR, JJ.] Drugs and Cosmetics Act, 1940: ss.18, 19 rw s.17B(d), s.27(b)(fi) -Adulteration and misbranding in Ayurvedic drugs - Ozomen capsules and Ozomen forte containing 55.2 mg of c sildenafil citrate per capsule - Accused holding allopathic and Ayurvedic licence but not holding licence to manufacture sildenafil citrate - Prosecution launched under Chapter IV - High Court quashed proceeding holding that since ozomen capsule had component like sildenafil citrate, therefore, they D ) are misbranded, spurious or adulterated for which prosecution could be only launched under Chapter /VA- Correctness of- Held: Not correct - Inspector appointed under Chapter IV is competent to launch prosecution under said sections - Sildenafil citrate is an Allopathic drug - It cannot be used for E the Ayurvedic medicines without displaying in prescribed manner on the label or container thereof or list of active ingredients contained in it together with the quantities thereof - A/so it cannot be used by person not holding licence for it - Code of Criminal Procedure, 1973 - s.482. F The prosecution case was that the Inspector of Drug took samples of ozomen capsules and ozomen forte from the premises of respondent-accused and sent it for analysis. According to the report of Government Analyst, Ozomen capsules under different batches contained 45.2 G mg of sildenafil citrate per capsule. Prosecution was launched against the respondents for contravention of ss.18(c), 18(a) (i) read with s.17B(d) of the Drugs and Cosmetics Act. 465 H 466 SUPREME COURT REPORTS [2008] 5 S.C.R. A The allegation of prosecution was that the sildenafil citrate is an allopathic drug used for erectile dysfunction; that accused had no licence for the manufacture of sildenafil citrate and they were mislabeling the Ayurvedic drugs; and that the respondent-accused company was B holding Allopathic as well as Ayurvedic licence but the company did not hold the licence to manufacture sildenafil citrate. The respondent's contention was that they had been holding licence for the Ayurvedic preparation and for any C Ayurvedic preparation of spurious or misbranded nature, Inspector appointed under Chapter IV was not competent to launch prosecution. High Court quashed the proceedings holding that since Ozomen capsules had a component like sildenafil D citrate, therefore, they may be misbranded, spurious or adulterated for which the prosecution could only be launched by the Inspector authorised under Chapter IVA. But the prosecution in this case was launched under Chapter IV and the Inspector who has been appointed E under Chapter IVA could have launched the prosecution. Hence the present appeal. Allowing the appeal, the Court HELD: 1. The provisions in Chapter IV and Chapter F IVA of the Drugs and Cosmetics Act are almost identical. Chapter IVA deals with special branch of medicines like, Ayurvedic, Siddha and Unani drugs whereas Chapter IV deals with branches other than Chapter IVA. [Para 6] [475-A] G 2. Sildenafil citrate is a new drug and it is an Allopathic drug. This cannot be used for the Ayurvedic medicines without displaying in the prescribed manner on the label or container thereof or list of active ingredients contained in it together with the quantities thereof. It is also H punishable under s.18 (a)(iii) read with s.27 (d) of the Act. THE DRUGS INSPECTOR AND ANR. v. M/S. FIZIKEM 467 LABORATORIES PVT. LTD. & ANR. The very fact of dealing with sildenafil citrate drug and A distributing the same after making a different component of Ayurvedic drug itself constitutes an offence. It is erroneous to say that since the accused is dealing with Ayurvedic drugs therefore, only the Inspector who is authorized under Chapter IVA could launch the B prosecution and not the Inspector appointed under r' Chapter IV. The accused has used sildenafil citrate which is an allopathic drug. Sildenafil citrate is a white to off. white crystalline power with a solubility of 3.5 mg/ml in water and molecular weight of 666.7. Viagra (sildenafil c citrate) is formulated as blue, film-coated rounded- diamond shaped tablets equivalent to 25mg, 50 mg and 100 mg of sidenafil for oral administration. In addition to the active ingredient, si
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