Buyer Added text based ATC clauses Sr no Certificate/documents required from the firm for purchase of Hypoallergenic Paper Backing Tape 50mm x9.14 mtrs 1 Complete specification with packing detail need to be mentioned by supplier (includi ng label of offered product). 2 Valid manufacturing License from principal manufacturing firm to manufacture th e product issued by State licensing authority or under Medical Devices 2017 shou ld be submitted. 3 Valid Certificate of Good Manufacturing Practice (GMP) under Schedule M/revised Sch edule M of Drug & Cosmetic Act/ WHO GMP and if license is issued by state Food licen sing authority then ISO certificate/Quality Management system (QMS) and if license is sued 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 o f the Principal manufacturing firm, then the authority letter (bid specific) should be su bmitted along with the tender. 5 Rate Certificate from the firm that the rates quoted by them are Hospital rate and not higher than those quoted with other Government, public sector and private organizati ons. 6 L1 firm required to get advance sample approved from buyer before comme ncement of supply. 7 Stamping- “GMCH -32, Chandigarh supply not for sale” stamping is required and test reports with each supply/batch, a test report of the same batch/ supply should be pro vided from approved laboratory of Drug Controller. 8 Solvency certificate issued from the bank 9 Bidder/Seller shall submit a valid non-Conviction certificate for last two (2) consecut ive years issued by the Concerned Drug Licensing authority to the buyer at the time o f bid submission. The certificate must have been issued within 12 months from the da te of technical opening of the bid. 10 The bidder (manufacturer) should have regularly for at least three years (out of last f our financial years), ending 31st March of the previous financial year manufactured a nd supplied with the same or higher specifications (supportive documents i.e. manufa cturing licence/ turn over certificate/ manufacturing marketing certificate) 11 Turnover of 03 financial year (out of last 04 financial years) is required to be submitte d from firm 12 Notarized Affidavit as per annexure-I (required in original on non-judicial stamp paper (Rs 100/-duly attested by the Notary) from Principal manufacturing Firm: I/We(Name) ________________________ partner/sole proprietor of
- (Firm)do here by declare and sol emnly affirm to the fact that 1) The individual firm/companies are neither black listed nor convicted by the Unio n or Centre or State Government or any partner or shareholder thereof are not direct ly connected with or has any subsisting interest in business of my/our firm. 2) Will comply with all the statues &legislation regarding manufacturing, import, sa le, and supply of drugs in India and in particular the following Acts/Enactments viz., The Drugs and Cosmetics Act, 1940, The Drugs and Cosmetics Rules, 1945 (as amen ded), The Legal Metrology Act, 2009, The Drugs (Control) Act, 1950, The Indian Statis tical Institute Act, 1959, GST Act. “To supply drugs of standard quality as prescribed under the provisions of Drug and Cosmetic Act, 1940 (as amended). Also, 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 Drug 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 nothin g has been concealed. Date: DEPONENT Place 13 Notarized affidavit in prescribed performa (Rs 10) for product/licence have been uplo aded by the firm on online SUGAM portal of CDSCO as per rule 84AB of the Drugs and Cosmetics Rules manufacturing under Drug & Cosmetic Act (Sr. no. 2 of STC) UNDERTAKING (to be on non-judicial stamp paper of Rs 10 and notarized) I, ________________, s/o / d/o / w/o ____________________, aged about _____residen t of ___________________________________, do hereby declare and undertake that;
- 1.I am the partner / proprietor / director of _____________________________(name of e ntity) and duly authorized to sign this undertaking on behalf of ___________________ _. (Name of entity)
- 2.We are the manufacturers of the drug/medicine __________________(“Product”) and intend to offer the same for sale through the GeM portal.
- 3.We state that the license for the Product has been granted/obtained by us as per the provisions of the Drug & Cosmetics Act, 1940 and rules framed there under as amended till date.
- 4.We further state that the details regarding the Product/licenses have been upload ed by us on the online ‘SUGAM’ portal of CDSCO as per rule 84AB of the Drugs and Cosmetics Rules, 1945 as amended till date. Reference no. for SUGAM portal is____ _________________.
- 5.We undertake that all the information provided above is true and complete in all r espect. We understand that in the event any false information/declaration is provi ded by us, suitable legal action/action as per Drugs and Cosmetics Act, 1940 as a mended till date and rules made there under will be initiated. Place: Date: …………………………………….. Signature, Name, Designation & Seal on behalf of the Manufacturer 14 As per GeM GTC benefit of EMD exemption and purchase preference to MSME will be giv en only to the manufacturers for the respective goods. Any trader including authorized d ealer of OEM submitting MSME certificate will not be considered under MSME category fo r this bid and these benefits will not be applicable to such firm. .
