LAW FOR ALL

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.- since the sample drugs are Ayurvedic drugs, the petitioners are prepared to face prosecution in that case and that therefore, the present prosecutions of the accused for the offences under Chapter IV of the Act are not sustainable in law. Since the sample drugs in these cases are manufactured under drugs manufacturing licence relating to Ayurvedic drugs, the other prosecution of the accused for the offences under Chapter IVA of the Act by the Drugs Inspector appointed under Section 33G of the Act is maintainable. The Supreme Court in the Judgment dated 24.03.2008 took note of this fact also in the last paragraph and observed: “We have also been informed in the alternative that prosecution has also been launched against the accused under Chapter IV-A. Both the prosecution can be tagged together and the learned trial court should proceed with the matter. Therefore, this submission of the petitioners/accused does not hold water. 10) In the result, all the criminal petitions are dismissed.; Since the sample drug happened to be an Allopathic drug also, the prosecutions launched by the respective Drugs Inspectors in the lower Court against the accused for contraventions of provisions under Chapter IV attracting penalty for offences under Chapter IV of the Act, are legally justified and tenable. The Supreme Court in the judgment dated 24.03.2008 in Criminal Appeal No.533 of 2008 observed: “The accused has used sildenafil citrate which is an allopathic drug. Sildenafil citrate is a white to off-white crystalline powder 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 25 mg, 50 mg and 100 mg of sildenafil 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, Aluminium Lake. The brand name is Viagra and generic name is sildenafil citrate. This is an allopathic drug and by no stretch of imagination can it 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 (sic except) 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 Ozomen capsule and not displaying the name in the prescribed manner in the drugs will also constitute an offence under Sections 18(a), (b) and (c) punishable under Section 27(b)(ii).”