Buyer Added text based ATC clauses The following documents need to be submitted by the firm for purchase of Tota l Parentrel Nutrition (TPN ) (IV infusion) -Triple chamber bag with each bag containing amino acid solution with all essential and non-esse ntial amino acids in pure crystalline form with electrolytes -dextrose solution-I/V fat emulsion -total energy provided more than 1000kcals/bag-total volume 1000ml (+/-20ml) -N2 to Kcal ratio of atleast 1:130 to 1:170 -compatible with vitamin and trace elements -extra medication port-possible to administer through either central or peripheral venous route: Sr no Certificate/documents required from the firm 1 Complete specification with packing detail need to be mentioned by supplier (includ ing label of offered product). 2 License from principal manufacturing firm to manufacture the product issued b y State licensing authority should be submitted. 3 Certificate of Good Manufacturing Practice (GMP) under Schedule M/revised Schedul e M of Drug & Cosmetic Act/ WHO GMP and if license is issued by state Food licensin g authority then ISO certificate/Quality Management system (QMS) and if license iss ued under Medical Devices 2017, then no requirement of QMS/GMP/ISO from Princi pal Manufacturer. 4 If bid is submitted by the distributor/ sister concern/ authorized dealer on the behalf of the Principal manufacturing firm, then the authority letter (bid specific) should be submitted along with the tender. 5 Certificate from the firm that the rates quoted by them are Hospital rate and not hi gher than those quoted with other Government, public sector and private organizati ons. 6 Stamping- “GMCH -32, Chandigarh supply not for sale” stamping is required and tes t reports with each supply/batch, a test report of the same batch/ supply should be p rovided from approved laboratory of Drug Controller. 7 Affidavit as per annexure 1 from Principal manufacturing Firm 8 Turnover of 03 financial years (out of 04 last financial years) is required to be submi tted 9 Solvency certificate to be issued from bank should be submitted by bidder ANNEXURE 1 AFFIDAVIT I/We(Name) , partner/sole proprietor of(Firm) do here by de clare and solemnly affirm to the fact that 1) The individual firm/companies are neither black listed nor convicted by the Union or Centre or State Government or any partner or shareholder thereof are not directly connected with or h as any subsisting interest in business of my/our firm. 2) Will comply with all the statues &legislation regarding manufacturing, import, sale, and sup ply of drugs in India and in particular the following Acts/Enactments viz., The Drugs and Cosmet ics Act, 1940, The Drugs and Cosmetics Rules, 1945 (as amended), The Legal Metrology Act, 20 09, The Drugs (Control) Act, 1950, The Indian Statistical Institute Act, 1959, GST Act. “To supply drugs of standard quality as prescribed under the provisions of Drug and Cosmetic A ct, 1940 (as amended) and undertake not to supply items/drugs “not of standard”, “Grossly sub -standard” and “Spurious and adulterated drugs” as per the latest guidelines issued by the Dru g Controller of India from time to time” Date DEPONENT Place Address: I/we do hereby solemnly declare and affirms that the above declaration true and correct to the best of my knowledge and beliefs. No part of it is false and nothing has been concealed. Date: DEPONENT Place .
