Buyer Added text based ATC clauses Sr no Certificate/documents required from the firm for Inj. Midazolam 1mg/ml, 5 ml vial (IM, IV) 1 Complete specification of quoted item with packing detail need to be mentioned by bidder (including label of offered product). 2 Valid manufacturing License of the principal manufacturing firm to manufactur e the quoted item, issued by State licensing authority should be submitted. 3 Valid Certificate of Good Manufacturing Practice (GMP) under Schedule M/revised Sc hedule M of Drug & Cosmetic Act/ WHO GMP and if license is issued by state Food lic ensing authority then ISO certificate/Quality Management system (QMS) and if licen se issued under Medical Devices 2017, then no requirement of QMS/GMP/ISO from Principal 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 bid. 5 Certificate from the bidder that the rates quoted by them are Hospital rate and not higher than those quoted with other Government, public sector and private organiza tions. 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 (to be submit in original) as per annexure 1 from Principal manufacturing Fi rm 8 Annual turn-over of 03 financial years (out of last 04 financial years) 9 Solvency certificate issued from the bank ANNEXURE- I AFFIDAVIT (Note:- To be furnished (original) on non-judicial stamp paper of Rs 100/- duly attested by the Notary). (to be required from prinicpal manufacturer) I/We(Name) ________________________ partner/sole proprietor of (Firm) do here by declare 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). Also, undertake not to supply items/drugs “not of standard”, “Grossly s ub-standard” and “Spurious and adulterated drugs” as per the latest guidelines issued by the D rug 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 .
