NGO and donor procurement supply, from Indian WHO-GMP origin.

M Care is not itself a manufacturer, so WHO-PQ is not held in our name. WHO-Prequalification is held by a specific manufacturer site against a specific molecule — several of our 80+ WHO-GMP partner sites are WHO-PQ-listed on the WHO List of Prequalified Medicinal Products for specific ARV, anti-malarial and anti-TB molecules. Each quotation we issue under a donor tender names the exact manufacturer, site and WHO-PQ entry so your procurement team can verify it against the current WHO list.

Yes, where the manufacturer holds an active Expert Review Panel dossier and the tender is ERP-eligible under the Global Fund Quality Assurance Policy. ERP is a time-limited interim route enabling Global Fund and UNICEF procurement of products without WHO-PQ or SRA approval in defined circumstances. We confirm eligibility case by case and share the ERP reference against the tender specification before the procurement agent commits.

For WHO-PQ-listed stock SKUs, 4–8 weeks from purchase-order issue to Incoterm handover, depending on volume and packaging artwork cycles. Multilingual PIL and tender-batch labelling add one to two weeks where the artwork is not already approved. Made-to-tender stability or alternate strengths: 10–16 weeks. We build the schedule against the donor's required arrival window, not a generic lead time.

Yes. M Care routinely handles CIP or DAP delivery to the Principal Recipient's nominated warehouse — consolidated air freight for urgent lines, sea freight for large-volume anti-TB and ACT tenders. Cold-chain 2–8°C lanes use thermal-validated shippers with continuous logging. Incoterm follows the tender; we do not push freight decisions that complicate the recipient country's clearance.

Yes, where the tender allows multi-site supply. Splitting a volume across two WHO-PQ-listed sites — for example, a primary and a contingency manufacturer on an ARV line — is a common risk-management ask from Global Fund Principal Recipients. Each site is separately named in the consignment documentation, with its own CoA, CoPP and WHO-PQ listing reference. Consolidated shipment is still possible where clearance permits.

The manufacturer's Certificate of Analysis is prepared against the donor tender specification rather than a generic export CoA. Tests, method references and specification limits mirror the tender sheet — assay, related substances, dissolution, microbial limits, sterility and endotoxin as applicable. Where the tender specifies compendial monograph plus donor-specific impurity limits, the CoA carries both. Discrepancies are flagged by the Indian QC team before dispatch, not by the PSA team on receipt.

A named pharmacovigilance contact is opened at the manufacturer end for the consignment's shelf life. ADR reports from the Principal Recipient or recipient-country regulator are routed to the manufacturer's QA team and to CDSCO where applicable. Periodic Safety Update Reports are compiled to ICH E2C format on request. Where the donor requires CIOMS-format individual case reporting, the manufacturer's PV function handles submission timelines.

We hold lines on over 600 active ingredients across 80+ WHO-GMP partner sites. If the primary manufacturer flags a shortage mid-tender, we quote an alternate WHO-PQ-listed site for the same molecule within one working day, with the switch documented for the Principal Recipient's QA file. Where no alternate PQ site exists, we surface the ERP route or an SRA-approved alternative rather than silently miss a delivery.