Case: The Drugs Inspector and Anr Vs. Fizikem Laboratories Pvt. Ltd. and Anr

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.

Court's reasoning:
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 prosecution and not the Inspectors appointed under 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 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, sildenafil citrate, each tablet contains the following inactive ingredients; microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin and FD & C Blue No.2 aluminum lake. The brand name is Viagra and generic name is sildenafil citrate. This is an allopathic drug and by no stretch of imagination it can be said as an Ayurvedic drug. Therefore, learned counsel for the appellants appears to be justified that since it is an allopathic drug and it cannot be used by anybody else unless a person who holds the licence for it. It is an admitted position that the accused does not possess the licence. Therefore, the very fact of selling this drug as one of the ingredients in the Ozomen capsule and not displaying the name in the prescribed manner in the drugs will also constitute an offence under Section 18 (a), (b) & (c) punishable under Section 27(b) (ii). The submission of learned counsel for the appellants is justified and we are of opinion that the view taken by learned Single Judge of the High Court is not correct and the High Court should not have proceeded to quash the whole proceedings under Section 482 of the Code of Criminal Procedure when serious issues were involved in the matter.