A.K.MATHUR & ALTAMAS KABIR
Drugs Inspector & Anr. - PETITIONER
Vs.
Fizikem Laboratories Pvt. Ltd.& Anr. - RESPONDENT
Appeal (crl.) 533 of 2008
(Arising out of S.L.P.(Crl.)No.5961 of 2006)
Decided on : 24/03/2008
Criminal Procedure Code , 1973 - Section 482 - Drugs and Cosmetics Act, 1940 - Sections 21 , 27 , 22 , 23 , 16 , 17D , 17C , 17B , 13 , 16 , 5 , 33G , 19 , 28 , 26 and 18 - Facts which are necessary for disposal of this appeal are that Inspector of Drugs inspected some of business premises of these respondents where Ozomen capsules and Ozomen forte were available for sale - He took samples and after taking sample he sent same to Government Analyst, Hyderabad for analysis - Government Analyst submitted his report declaring that Ozomen capsules under different batches contained 45.2 mg of sildenafil citrate per capsule - Persons from whom samples were taken were called upon to disclose name of manufacturer and on disclosure of name of manufacturer, prosecution was launched against respondents for contravention 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 Central Government prohibited manufacturer etc. of drugs and cosmetics in public interest under notification issued - It is this action initiated by Drugs Inspector which was challenged - Respondents were arrayed as accused for aforesaid offences because they had no licence for manufacture of Ayurvedic drug sildenafil citrate and they were mislabeling Ayurvedic drugs - Sildenafil citrate is a new drug and it is patent and proprietary medicine - It is an allopathic drug used for erectile dysfunction - Respondent-accused company was holding Allopathic as well as Ayurvedic licence but company does not hold licence to manufacture sildenafil citrate - Information was received by Drugs Inspector that sildenafil citrate manufactured by these companies for various medical establishments in 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, question was whether respondent- company which are manufacturing Ayurvedic drug and had no licence for manufacturing sildanefil forte could be prosecuted – Held , Learned counsel for appellants submitted that it is not case that only is involved but offence has also been committed also - Learned counsel for appellants submitted that Ozomen capsules and Ozomen forte had a component of sildenafil citrate and this medicine does not fall - Therefore, learned counsel for appellants submitted that use of this medicine in Ayurvedic medicines is also punishable as accused has no licence to deal with this drug - Accused had to mix this drug with other Ayurvedic drugs, therefore, accused can also be prosecuted for selling Allopathic drug like sildanefil citrate when licence is required - Learned counsel for appellants submitted that sildenafil citrate is a new drug and it is an Allopathic drug - This cannot be used for Ayurvedic medicines without displaying in prescribed manner on label or container thereof or list of active ingredients contained in it together with quantities thereof - It is also punishable - Learned counsel for appellants also pointed out that respondents also manufactured and sold this spurious Ozomen capsules containing sildenafil citrate violating which is punishable - Sum total of submission of learned counsel for appellants was that very fact of dealing with sildenafil citrate drug and distributing same after making a different component of Ayurvedic drug itself constitutes an offence - Therefore, it is erroneous to say that since accused is dealing with Ayurvedic drugs therefore, only Inspector who is authorized under Chapter IVA could launch prosecution and not Inspectors appointed – Appeal allow
JUDGMENT:
A.K. MATHUR, J.
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.
4. Before the Learned Single Judge it was submitted that since the respondents are being prosecuted for contravention of Section 18, Section 19(a) (i) read with section 17B (d) and Section 17(b) of the Act the accused had no licence for manufacture of the sildenafil forte which is one of ingredient of Ozomen forte i.e. Ayurvedic drug, therefore, the respondent can be prosecuted under this section or not. The submission of the respondents was that they have been holding licence for the Ayurvedic preparation and for any Ayurvedic preparation of spurious or misbranded nature, the Inspector appointed under Chapter IVA alone is competent to launch prosecution and not Inspector appointed under Chapter IV.
5. In order to appreciate the contention raised by learned counsel for the parties, it will be appropriate to refer to relevant provisions of the Act. The Act defines Ayurveducm Sid
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