Gujarat High Court
Chetan Meditech Pvt Ltd Through Its ... vs Union Of India Thro Central on 23 July, 2013
Author: Anant S. Dave
Bench: Anant S. Dave
CHETAN MEDITECH PVT LTD THROUGH ITS MANAGING DIRECTOR & CEO....Petitioner(s)V/SUNION OF INDIA THRO CENTRAL DRUG STANDARD C/SCA/1166/2013 ORDER IN THE HIGH COURT OF GUJARAT AT AHMEDABAD SPECIAL CIVIL APPLICATION NO. 1166 of 2013 ================================================================ CHETAN MEDITECH PVT LTD THROUGH ITS MANAGING DIRECTOR & CEO....Petitioner(s) Versus UNION OF INDIA THRO CENTRAL DRUG STANDARD & 1....Respondent(s) ================================================================ Appearance: MR SIRAJ R GORI, ADVOCATE for the Petitioner(s) No. 1 MR PS CHAMPANERI, ADVOCATE for the Respondent(s) No. 2 MR SHAKEEL A QURESHI, ADVOCATE for the Respondent(s) No. 1 ================================================================ CORAM: HONOURABLE MR.JUSTICE ANANT S. DAVE Date : 23/07/2013 ORAL ORDER
Heard learned Counsels for the parties.
Learned Counsel for the petitioner Mr. Siraj R. Gori contends that the action impugned in this petition namely the communication dated 30.11.2012 of the Deputy Drugs Controller (I) is contrary to law. Vide this communication it was stated that the list of components imported (as per Annexure II) submitted by the petitioner are bulk orthopedics implants in unsterile form; and according to the said authority, such products attract the provisions of the Drugs and Cosmetics Act, 1940 (hereinafter referred to in short as 'the Act') and the Drugs and Cosmetics Rules, 1945 (hereinafter referred to in short as 'the Rules') and therefore, Registration Certificate (Form
41) and Import License (Form 10) is required.
It is submitted that the petitioner herein is engaged in manufacture of medical devices (Orthopedic Implants) and also holding the manufacturing license for medical devices covered under the CLAA (Central Licensing Approval Authority). The petitioner has imported raw or semi finished medical devices namely non-sterile orthopedic implants. However, these semi-finished orthopedic implants are not covered by Notification S.O.1468(E) dated 06.10.2005 and these products are not included in the definition of Drugs . It is further submitted that the petitioner has made full disclosures to the authority about the product, the country of its import as also the raw materials etc., but at the same time, the consignment of non-sterile semi finished orthopedic implants seized by the respondent authority needs to be removed. By seizing such goods, the respondent has acted contrary to law and in absence of specific provisions, learned Counsel for the petitioner has relied on Part IV under the head 'Import and Registration' of the Rules, 1945.
In the above circumstances, it is submitted that pending final disposal of this petition, interim relief as prayed for in Paragraph 19(B) of this petition be granted.
Learned Standing Counsel for the respondent Mr. Shakeel Qureshi has placed reliance on the affidavit-in-reply filed by the Deputy Drugs Controller (India) I/c., CDSCO, Zonal Office, Airport, Ahmedabad and contends that the very issue of regulations and registration of non-sterile orthopedic devices for import and manufacture was examined by an Expert Committee comprising of eminent experts on 23.08.2006. The Committee was of the view that if the end use of the notified devices is a sterile product it will fall within the ambit of Notification and further, the petitioner is required to obtain Registration Certificate (Form 41) and Import License (Form
10). It is also submitted that there are manufacturing licensees who have imported similar products namely non-sterile orthopedic devices as per the Rules and therefore, seizure of such goods by the authority is just and in order. It is therefore, submitted that no relief be granted to the petitioner as prayed for in this petition.
I have heard learned Counsels for the parties, and have also perused Part IV pertaining to IMPORT AND REGISTRATION of the Drugs and Cosmetics Rules, 1945, the Notification dated 06.10.2005 and the issue pursuant to Sub-Clause (iv) of Clause (b) of Section 3 (Definitions) of the Act, 1940 which specifies as such sterile devices intended for internal or external use in human beings as Drugs . In Item No.IX the orthopedic implants is incorporated but non sterile implants do not find place.
In the aforesaid circumstances, the action of seizure by the respondent prima-facie becomes illegal and contrary to law. Hence, the matter deserves consideration and subject to final outcome of the petition, I am inclined to grant relief in terms of Paragraph 19(B) of the petition, to the extent that the respondent shall release the consignment of non-sterile semi-finished implants upon obtaining an Undertaking from the petitioner about complete details regarding the import, the usage of such finished devices in future before the product is marketed for ultimate use and other scrutiny about its quality and suitability for internal and external use in human beings.
RULE returnable on 4TH SEPTEMBER, 2013.
Sd/-
(ANANT S. DAVE, J.) CAROLINE Page 5 of 5