SHREE PACETRONIX LTD REP BY ITS MANAGING DIRECTOR ATUL SETHI S/O SHRI SURENDRA KUMAR SETHI R/O 1 MOON PALACE COLONY INDORE Vs. CONTROLLER OF STORES SOUTHERN RAILWAY AYANAVARAM CHENNAI

JUDGEMENT

(1.) THE writ petition is filed by the petitioner Company seeking to challenge the Notice Inviting Tender issued by the first respondent, i.e., Controller of Stores, Southern Railway, Chennai and to set aside the condition insofar as it seeks approval by USFDA for intended clinical use in USA for supply of Dual Chamber Pacemaker (for short DDD) and for direction to respondents to consider the petitioner's offer for supply of Dual Chamber Pacemaker with CE or DGCI certification/ approval instead of approval by USFDA for intended clinical use in USA and pass further orders.

(2.) WHEN the matter came up on 4.4.2012, this court directed notice to be served on the Standing Counsel for the Southern Railway Mr.M.Vellaisamy. Accordingly, the Standing Counsel was served. He also entered appearance and has filed a counter affidavit on behalf of respondents sworn to by the third respondent, dated 16.4.2012.

(3.) IN the counter affidavit filed by the respondents, it was indicated that the condition imposed did not eliminate any competition. Already there are six pacemaker companies with USFDA certification, i.e., Medtronic, Boston Scientific, St. Jude Medical, Vitatron, Biotronik and Sorin. These companies are market leaders and were responsible for 95% of the market shares. This will show the confidence of the medical community in their products. The condition imposed by the railways ensures the competition in the tender between the world leaders who make quality pacemakers. The fact that some Indian manufactures do not have US FDA certification does not have any particular relevance as the Railways are intended to get the best global products for the benefit of critically ill cardiac patients. They cannot leave the selection only to Indian companies. The pacemakers are highly technology devises on which patients life depends. Therefore, the railway was intended to get best possible products in the World. The railways have got their own right to define their own criteria for product selection keeping in mind such criteria to ensure that all leading manufactures and distributors of a particular product who are recognised worldwide and who satisfy stringent norms for device quality and patient safety can participate in the tender.