DRUGS INSPECTOR Vs. FIZIKEM LABORATORIES PVT LTD

JUDGEMENT

(1.) Leave granted.

(2.) This appeal is directed against the order passed by learned Single Judge of the Andhra Pradesh High Court in a batch of petitions under Section 482 of the Code of Criminal Procedure (hereinafter to be referred to as "the CrPC") whereby the learned Single Judge has held that the Drugs Inspector appointed under Section 21 of the Drugs and Cosmetics Act, 1940 (hereinafter to be referred to as "the Act") had no jurisdiction to launch prosecution under Section 32 of the Act for alleged offences said to have been committed under this Act in connection with manufacture and sale of Ayurvedic drugs Ozomen capsules and Ozomen forte.

(3.) The brief facts which are necessary for disposal of this appeal are that the Inspector of Drugs inspected some of the business premises of these respondents where Ozomen capsules and Ozomen forte were available for sale. He took the samples and after taking the sample he sent the same to the Government Analyst, Hyderabad for analysis. The Government Analyst submitted his report declaring that Ozomen capsules under different batches contained 45.2 mg of sildenafil citrate per capsule. The persons from whom the samples were taken were called upon to disclose the name of manufacturer and on disclosure of the name of manufacturer, prosecution was launched against the respondents for contravention of Sections 18), 18(a) (i) read with Section 17B(d) of the Act namely, prohibition of manufacture and sale of certain drugs and cosmetics which are misbranded, spurious and substituted wholly or in part by another drug or substance and the Central Government prohibited manufacturer etc. of the drugs and cosmetics in public interest under notification issued under Section 26- A, vide notification No.GSR 577(e) dated 23.7.1983 punishable under Sections 27(b)(ii), 27(c), 27(d) and 28-B of the Act. It is this action initiated by the Drugs Inspector which was challenged. The respondents were arrayed as accused for the aforesaid offences because they had no licence for the manufacture of Ayurvedic drug sildenafil citrate and they were mislabeling the Ayurvedic drugs. The sildenafil citrate is a new drug and it is patent and proprietary medicine. It is an allopathic drug used for erectile dysfunction. The respondent-accused company was holding Allopathic as well as Ayurvedic licence but the company does not hold the licence to manufacture sildenafil citrate. The information was received by the Drugs Inspector that sildenafil citrate manufactured by these companies for various medical establishments in the State of Andhra Pradesh had no licence to manufacture sildenafil citrate. Ozomen forte capsule contained 33.9 mg to 46.82 mg of sildenafil citrate per capsule. Therefore, the question was whether the respondent- company which are manufacturing Ayurvedic drug and had no licence for manufacturing sildanefil forte could be prosecuted under Chapter IV or not.