RB-01-02 Permitted entity type Registered Legal Entity · §4.1, Sr. 1(a–b) · p.37
Failed The bidder's own letter, SBI certificate, CA certificate and GST registration identify Alpha Drugs as a sole proprietorship. Proprietorship is not one of the legal forms permitted by RFP §4.1 Sr.1.
▤ Technical pp.5-7, 9 Passed The bidder is a Private Limited Company, which is an entity type expressly permitted by the RFP.
▤ Reliance combined pp.2-4; Paid info p.1 ≠ Different outcome Inspect evidence
RB-01-03 GST registration Registered Legal Entity · §4.1, Sr. 1(c) · p.37
Review Required The technical bid uses GSTIN 07AKYPR0082K1ZG, while the portal payment confirmation also displays GST code 07AAIPR8748Q1ZK. The identity mismatch requires portal/master-data reconciliation.
▤ Technical p.9; Paid info p.1 Passed GSTIN 27AABCR7594L1ZO is consistent across the registration certificate, recent GSTR-3B returns and portal payment record.
▤ Reliance combined pp.27-44; Paid info p.1 ≠ Different outcome Inspect evidence
RB-02-01 Drug-specific licence validity Licences · §4.1, Sr. 2 · pp.37–38
Failed Items 3 and 12 rely on import licence BP-7-421 shown valid only to 22-Jan-2026, with renewal merely initiated. Item 6 is supported by current licence IL/BIO-000541 valid to 25-Dec-2028.
▤ Technical pp.280, 298, 350-370, 374-384 Passed Current Form 28-E manufacturing-licence material covers the three quoted Factor VIII products. The principal licence is renewed through 28-Apr-2029.
▤ Reliance combined pp.45-64, 73-78, 127 ≠ Different outcome Inspect evidence
RB-02-04 Manufacturer licence forms and retention Licences · §4.1, Sr. 2 documents · pp.37–38
Not Applicable Manufacturer-form licence rule is not applicable to Alpha Drugs' importer route.
▤ Technical pp.280, 298 Passed Form 28-E licence 28E-KD/8 and its product endorsements/renewals are supplied and current through 28-Apr-2029.
▤ Reliance combined pp.45-64 ≠ Different outcome Inspect evidence
RB-02-05 Importer licence forms and retention Licences · §4.1, Sr. 2 documents · pp.37–38
Failed The importer licence set is incomplete as-current for all quoted items: BP-7-421 is shown expired for items 3 and 12, while the separate Kedrion licence for item 6 is current.
▤ Technical pp.280, 298, 350-384 Not Applicable Reliance follows the domestic-manufacturer path and does not rely on an import licence.
▤ Reliance combined pp.45-64, 127 ≠ Different outcome Inspect evidence
RB-02-07 Every supply premise licensed Licences · §4.1, Sr. 2 documents · p.38
Not Applicable Alpha Drugs is an importer and does not offer supply from its own manufacturing premises.
▤ Technical pp.280-282 Passed The submission identifies one Rabale manufacturing facility and supplies the applicable current licence for that premise.
▤ Reliance combined pp.45-64, 124-128 ≠ Different outcome Inspect evidence
RB-02-08 OEM authority and product-code reconciliation Licences · §4.1, Sr. 2 documents · p.38
Passed OEM authority letters, product permissions and the Annexure-5 item/drug-code schedule are supplied for the three quoted products.
▤ Technical pp.298-299, 348-385 Not Applicable OEM/foreign-manufacturer authority is not applicable because Reliance is the original manufacturer.
▤ Reliance combined pp.45-64, 124-128 ≠ Different outcome Inspect evidence
RB-03-01 Manufacturer quality certification Certifications / Registration · §4.1, Sr. 3 · pp.38–39
Not Applicable Manufacturer-path quality certificate rule is not applicable to Alpha Drugs as importer.
▤ Technical pp.61-106, 280 Passed A Maharashtra FDA WHO-GMP certificate and endorsed product lists cover the licensed biological-products facility and offered Factor VIII presentations.
▤ Reliance combined pp.65-68 ≠ Different outcome Inspect evidence
RB-03-03 All plants and quoted products covered Certifications / Registration · §4.1, Sr. 3 · p.38
Not Applicable Alpha Drugs does not quote from its own manufacturing plants.
▤ Technical pp.61-106, 280 Passed The quoted products are mapped to the single licensed Rabale plant and the submitted WHO-GMP/product schedules.
▤ Reliance combined pp.45-68, 73-78, 127 ≠ Different outcome Inspect evidence
RB-03-04 Importer GMP-equivalent certificate Certifications / Registration · §4.1, Sr. 3 · pp.38–39
Passed COPP/WHO-GMP-equivalent and foreign manufacturing-authority material is supplied for Bio Products Laboratory and Kedrion products.
▤ Technical pp.27-106 Not Applicable Importer GMP-equivalent evidence is not applicable to Reliance's domestic-manufacturer route.
▤ Reliance combined pp.45-68 ≠ Different outcome Inspect evidence
RB-03-05 Imported-product labels and literature Certifications / Registration · §4.1, Sr. 3 documents · p.39
Passed Product literature, technical compliance sheets, certificates of analysis and labels are supplied for the quoted imported products.
▤ Technical pp.61-106, 116-139, 387-403 Not Applicable Imported-product label and country-of-origin evidence is not applicable to the domestic-manufacturer route.
▤ Reliance combined pp.45-68 ≠ Different outcome Inspect evidence
RB-03-06 OEM authority aligned to import licence Certifications / Registration · §4.1, Sr. 3 documents · p.39
Review Required OEM authorities are present, but the Bio Products Laboratory authority must be reconciled to the lapsed BP-7-421 renewal evidence for items 3 and 12.
▤ Technical pp.280, 298, 348-384 Not Applicable No foreign OEM authority or import licence is relied upon.
▤ Reliance combined pp.45-68 ≠ Different outcome Inspect evidence
RB-03-07 Importer history declaration and IEC Certifications / Registration · §4.1, Sr. 3 documents · p.39
Passed IEC 0500021376 and the three-year importer affidavit are included under the same bidder identity.
▤ Technical pp.347, 385 Not Applicable Importer history and IEC evidence are not applicable to the domestic-manufacturer route.
▤ Reliance combined p.1, p.127 ≠ Different outcome Inspect evidence
RB-06-02 Net-worth certification and UDIN Net Worth · §4.1, Sr. 6 documents · p.40
Evidence Pending A standalone Annexure-6 net-worth certificate explicitly stating FY 2024-25 net worth and UDIN was not located; the uploaded CA certificate states turnover only.
▤ Technical pp.300-326 Passed The net-worth statement is included in CA-certified Annexure-6 with the auditor's registration details and UDIN.
▤ Reliance combined p.129 ≠ Different outcome Inspect evidence
RB-07-01 Minimum 1.5× capacity Production Capacity · §4.1, Sr. 7 · pp.40–41
Failed Annexure-4 records production capacity as 'NA for Importer'. The RFP nevertheless requires original-manufacturer capacity of at least 1.5 times the quoted quantity.
▤ Technical p.280 Passed Declared annual capacities exceed 1.5× the tender quantities: 288,000 vs 28,980 for item 3; 288,000 vs 150,882 for item 4; and 144,000 vs 90,108 for item 6.
▤ Reliance combined pp.124-125; Appendix quantities pp.202-203 ≠ Different outcome Inspect evidence
RB-08-01 Three-year product standing Market Standing Certificate · §4.1, Sr. 8 · p.41
Passed Licensing-authority market-standing evidence covers the three quoted products across the required three-year period.
▤ Technical p.107 Review Required A current Maharashtra FDA Manufacturing & Marketing Certificate states three-year standing for the licensed Factor VIII presentations. Annexure-5, however, cites a different market-standing certificate number/date; the evaluator should reconcile the two before accepting coverage for all three quoted items.
▤ Reliance combined p.71 and p.127 ≠ Different outcome Inspect evidence
RB-08-03 Overseas principal standing in India Market Standing Certificate · §4.1, Sr. 8 · p.41
Passed Foreign-principal manufacturing and market records establish more than three years of product standing for the quoted BPL and Kedrion products.
▤ Technical pp.27-114 Not Applicable Overseas-principal standing is not applicable to Reliance's domestic-manufacturer route.
▤ Reliance combined pp.45-71 ≠ Different outcome Inspect evidence
RB-08-04 Importer pharmaceutical standing Market Standing Certificate · §4.1, Sr. 8 · p.41
Passed Alpha Drugs documents establishment in 2000 and import activity/licensing since 2021, exceeding the three-year pharmaceutical-field requirement.
▤ Technical pp.7, 280, 347-385 Not Applicable Importer pharmaceutical standing is not applicable to Reliance's domestic-manufacturer route.
▤ Reliance combined pp.45-71 ≠ Different outcome Inspect evidence
RB-08-07 Country-of-origin import trail Market Standing Certificate · §4.1, Sr. 8 documents · p.41
Passed Bill-of-entry and country-of-origin evidence is included within Annexure-4 supporting documents.
▤ Technical pp.284-297 Not Applicable Country-of-origin shipping evidence is not applicable to the domestic-manufacturer route.
▤ Reliance combined pp.45-71 ≠ Different outcome Inspect evidence
RB-09-01 Maharashtra network when no local facility Proof of Distribution Network · §4.1, Sr. 9 · pp.41–42
Review Required One Maharashtra distributor, Vedansh Enterprises in Mumbai, is listed, but operational-network evidence is limited and the linked sale/distribution licence is declared NIL.
▤ Technical p.283 Not Applicable Reliance has its registered office and licensed manufacturing facility in Rabale, Navi Mumbai, Maharashtra; the external-network fallback is not triggered.
▤ Reliance combined pp.2-4, 45-64, 124-128 ≠ Different outcome Inspect evidence
RB-09-02 State selling/distribution licence Proof of Distribution Network · §4.1, Sr. 9 documents · pp.41–42
Failed Annexure-4(A) explicitly states 'Sales / Distribution License no: NIL', contrary to the RFP requirement for a valid State Licensing Authority licence.
▤ Technical p.283 Not Applicable The separate Maharashtra distributor-licence requirement applies only to the external-network fallback. Reliance has a licensed Maharashtra manufacturing facility.
▤ Reliance combined pp.45-64, 124-128 ≠ Different outcome Inspect evidence
RB-09-03 Annexure-4(A) distributor details Proof of Distribution Network · §4.1, Sr. 9 documents · p.42
Review Required Authorised-distributor name, address and contact are supplied, but cannot be reconciled to a Maharashtra distribution licence because none is provided.
▤ Technical p.283 Not Applicable Annexure-4(A) distributor reconciliation is not required for eligibility because the bidder operates its own Maharashtra facility, though distributor details are supplied.
▤ Reliance combined p.126 ≠ Different outcome Inspect evidence