Document Fragment View

Matching Fragments

1. The complainant/Union of India, Ministry of Health and Family Welfare, O/o. the Central Drugs Standard Control Organization, Directorate General of Health Services, represented by the Drugs Inspector, CDSCO, Sub-Zone, Bangalore; filed the complaint u/s. 200 of Cr.P.C., alleging that the accused persons have committed the offence u/s.18©, 18(b), Sec.18(a)(i), R/w. Sec.17(b) which are punishable u/s.27(b)(ii) and 27(d) of the Drugs and Cosmetics Act, 1940. (Herein after referred as "the Act")

2. The complainant's case in brief is that product named as "SUNN IUI Catheter" is a Medical Device and it is notified as a drug under Sec.3 (b) (IV) of the Act; vide Government of India Gazette Notification No. S. O. 1468(E) dated: 06.10.2005. The DDC(I), CDSCO, South Zone, Chennai sent the report stating that the premises of M/s. SAR Healthline Pvt., Ltd., situated at No.48/1, G- 1, Serenity Place, New Avadi Road, Kilpauk, Chennai-10 was inspected and found that "SUNN IUI Catheters"

were not labeled in the manner prescribed under Rule-96 of the Drugs and Cosmetics Rules. (Herein after referred as "the Rules"). It is further sated that the product was bearing only the labeling particular as "Mkd by M/s. SAR Healthline (P) Ltd., New Bombay-400703, Tel.-022- 27848240 email: [email protected]. Website: www. Starhealth.com" and it not contains other mandatory particulars. As per Rules.96 (1)(i), (iv), (vi) and (vii) of the Rules, it is required to be printed on the label of every outer cover of the product, the proper name of the product, Name and Address of the Manufacturer, Manufacturing License Number and Date of Manufacture. It was also informed that the products were distributed by accused No.4. The DDC(1), CDSCO, Sub- zone, Bangalore also received the report from CDSCO, West Zone, Mumbai stating that "SUNN IUI Catheters"

13. The complainant examined as P.w.1 deposed in this regard and produced the letter with investigation report received from the Deputy Drugs Controller (India), CDSCO, South Zone is marked as Ex.p.3, where under request was made to investigate at accused No.1 and 4 in view of seizure of "SUNN IUI Catheters" from the premises of M/s. SAR Healthline (P) Ltd., No.222, Commodity Exchange, Sector-19, Vashi, Navi Mumbai and Ghatkopar and found the stock of "SUNN IUI Catheters" without having required information in the label.