JUDGEMENT
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(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.;
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