CH ANNEX-IV
ECK LIST
The Firm must be checked the check list before covering the documents.
Sl. Description Availabili Page
No ty number
.
1 Willingness to accept all terms & conditions of EOI (Annex-I) Yes / No
2 Supply of the product through an authorized agency, the Yes / No
supplier
has to provide authorization form in the format provided
3 No “Branded Generic/Generic” drug, without approval of the Yes / No
US FDA & CDSCO
Undertaking to the effect that the quoted price will not be
more
than the institutional price,
Undertaking to the effect that the Firm is not going to make
any payment or illegal gratification to any person/authority
4 Valid WHO-GMP/ GMP/ CGMP/ COPP/ GLP certificate (Own, Yes / No
loan and/or 3rd party manufacturer).
5 Valid Manufacturing License (Own, Loan License and/or that Yes / No
of 3rd part manufacturer) [GMP (By & large will not be
6 accepted)].
Drug License of Marketing Firms for marketing of the drugs Yes / No
of 3rd Party Manufacturers. Distributor have to submit only
Drug
7 No conviction certificate (NCC) or “NOC” from the State Yes / No
Drug Controller according to the Drugs and Cosmetics Act
1940 and
8 Undertaking effect that the Firm has not been Yes / No
debarred/blacklisted/barred/de-empaneled/suspended for any
product/products or as a whole for any reason and anywhere
in
9 Copy of Goods and Services Taxpayer Identification Number Yes / No
(GSTIN)
10 Copy of Permanent Account Number (PAN) Yes / No
11 USFDA approval Certificate (For Drugs/manufacturing units) Yes / No
if any, may be submitted as per clause 4 (viii)
12 Import License in Form No 10 (According to rule 23 & 27), if Yes / No
available as per clause 4 (ix)
13 List of Government, Semi-Government, PSU and institutional Yes / No
supply as per clause 4 (x)
14 Three years market standing for each product (the Yes / No
Firm wants to participate), or the exemption certificate
as per clause no. 4 (xi).
15 Certificate duly filled by the Auditor/CA to the effect that the Yes / No
principal manufacturing unit has an annual turnover of
Rs.10.00
Crores (Rupees Ten Crores) or more in each year, for last 3
16 F.F.S/B.F.S Technology Certificate must be provided by the Yes / No
Firms
those are manufacturing IV fluids.
17 The list of drugs manufactured/marketed under their license Yes / No
for
which they want to participate in the tender and enter into
18 ISO accreditation certificate. Yes / No
19 Information on their specific products or position of the Yes / No
Firm
listed in the AC Nielsen ORG-MARG ranking list.
20 Information on their specific products with CE Mark/I.M.S. Yes / No
Analysis etc.
21 Details of Research & Development facilities and list of Yes / No
original research molecules/formulations developed.
22 Investments of firm in infrastructure, Research and Yes / No
Development.
Check list must be provided along with all the documents in the sealed cover.
(Signature & Seal of the authorized official of the
Firm)
