NHS tender response support, from the Indian manufacturer side.
M Care is not an NHS-listed supplier and cannot bid into CMU in its own name. What we can do is sit behind your UK MHRA licence with Indian WHO-GMP product, a CTD Module 3 extract, apostilled CoPP and a landed-cost model, so your tender response stands up to procurement scrutiny from Mumbai to Manchester.
CMU. SBS. Atamis. Your MHRA licence out front, our manufacturer behind it.
UK NHS procurement for medicines runs through several parallel routes — the Commercial Medicines Unit for national generics frameworks, NHS Shared Business Services for framework agreements, the regional procurement hubs for regional tenders, and Specialised Commissioning for high-cost drugs. All of them require a UK MHRA-licensed respondent. M Care feeds that respondent.
What NHS tender routing looks like
NHS CMU (Commercial Medicines Unit, under NHS England) runs central framework agreements for generics — multi-year, multi-supplier qualifications with mini-competitions inside them. NHS SBS (Shared Business Services) runs eTender frameworks used by trusts. Atamis is the central NHS commercial platform being adopted across NHS England. Regional procurement hubs run aligned regional tendering.
Our role as Indian manufacturer-side partner
Manufacturer-side. M Care is the Mumbai commercial and regulatory desk for 80+ WHO-GMP partner sites, several of them EU-GMP inspected and listed on EudraGMDP. We supply the finished-dose generic, the CTD Module 3 extract, the batch CoA, the WHO-GMP certificate and the apostilled CoPP. The UK MA (PL number), the WDA(H), the MIA, the Responsible Person sign-off — all partner-side.
What the UK importer gets from us
A pre-tender documentation pack timed to your CMU or Atamis submission deadline, a landed-cost model running from Mumbai ex-works through Heathrow or Felixstowe to your nominated RP(i), a named site-and-SKU match for the tender lot, and a manufacturing commitment letter that your QP can attach to the bid response.
Why a UK MHRA licence holder phones Mumbai.
Generic framework re-tender
A CMU Category A or Category M generic lot is coming up for re-tender and your current Indian source has had a supply or price wobble. You need a second qualified site, EU-GMP inspected where possible, with dossier readiness to slot behind your existing PL number. M Care matches molecule to partner site and shares the dossier pack on a named-site basis.
Post-shortage emergency supply
DHSC has invoked a Serious Shortage Protocol or the medicine is on the concessionary price list, and the hub pharmacies need volume fast. We supply from Indian manufacturer stock where it exists, or expedite a batch release against a pre-agreed CTD and CoPP. Airfreight and cold-chain validated road lanes from Mumbai to your UK goods-in.
Specials and unlicensed line bid
The tender lot is for an unlicensed Special — a paediatric suspension, a compounded topical, an off-patent injectable with no UK MA. Your MS licence or WDA(H) Specials endorsement responds; we feed finished dose or API with open DMF. See the MHRA Specials route for the manufacturing-side mechanics.
Specialised Commissioning high-cost oncology
NHS England's Specialised Commissioning directly commissions high-cost oncology and rare-disease lines. The tender calls for cold-chain validated 2-8°C or -25°C shipment, batch-level temperature logging and QP-ready documentation. Our EU-GMP capable oncology partners ship with continuous logging and on-arrival logger read-out.
Every document the UK bidder's RP, RP(i) and QP expects at tender and at goods-in.
Prepared at the Indian end, cross-checked against the tender specification, and shared electronically ahead of your submission deadline. Six-month minimum residual validity on certificates at the point of shipment.
CTD Module 3 summary
Quality dossier extract in CTD format — drug substance, drug product, control of materials, container-closure and stability. Shared as the tender-response quality annex or cross-referenced to the PL number the UK MA holder already sits behind.
CoPP in WHO format
Certificate of Pharmaceutical Product issued by CDSCO (Central Drugs Standard Control Organization, India) in WHO-recommended format. Apostilled at the Indian Ministry of External Affairs where the tender lot or importer file requires legalisation.
WHO-GMP site certificate
Current WHO-GMP certificate issued by CDSCO for the specific manufacturing site and the specific dosage form covered by the tender lot. Site-and-SKU match verified before the pack is released to your bid team.
EU-GMP listing on EudraGMDP
Where the partner site has been inspected by an EU competent authority, the current EU-GMP certificate and the corresponding entry on the EudraGMDP public database. Useful where your tender response asks for EU-GMP as a scoring or qualification criterion.
Batch-specific CoA
HPLC assay, related substances, water content, residual solvents, sterility and endotoxin where applicable. Signed by the manufacturer's authorised QC head with the pharmacopoeial method cited (BP, Ph. Eur. or USP) per the tender spec.
Cold-chain validation dossier
Pre-shipment thermal validation of the shipper configuration, the continuous temperature logging plan for the Mumbai-to-UK lane, and the on-arrival logger read-out protocol. Excursion handling agreed before dispatch, attached to the bid as an annex where requested.
Tender spec to batch dispatch.
- Share the tender spec. Send us the tender lot — CMU or SBS or Atamis reference, molecule (INN), dosage form, strength, pack size, volume horizon, delivery window and any scoring criteria (EU-GMP, Category M, service-level targets).
- SKU and site alignment. We match the lot to a named Indian partner site and SKU, confirm WHO-GMP and, where applicable, EU-GMP status on EudraGMDP, and share the site's manufacturing licence copy for your bid team's supplier qualification file.
- Pricing and landed-cost model. Ex-works Mumbai price, consolidated airfreight or sea-freight quote, duty and VAT treatment into the UK, RP(i) handling and onward road to your nominated warehouse. Fixed-price window aligned with the tender award period.
- Dossier and sample delivery. CTD Module 3 extract, CoPP, WHO-GMP, EU-GMP where relevant, batch CoA from the most recent commercial batch, and a pre-award sample for your QP or analytical lab — timed ahead of your submission deadline.
- Batch dispatch and PV handover. On award, scheduled batch release, cold-chain validated dispatch, RP(i) and QP sign-off at the UK end, and a named pharmacovigilance contact at the manufacturer for adverse-event routing during the tender contract period.
NHS tender supply support — the specifics.
Are you on an NHS framework directly?
No. M Care is an Indian exporter; we are not a UK MHRA-licensed entity and we are not listed on any NHS CMU, NHS SBS or Atamis framework in our own name. NHS tender responses require a UK MA holder or a UK MHRA-licensed wholesaler or importer as the respondent. Our role is to sit behind that respondent as the Indian manufacturer-side partner — product, dossier and landed-cost model feeding a bid that carries your PL number, WDA(H) and MIA credentials, not ours.
Can you supply a UK MA holder under their existing PL number?
Yes, and this is the most common pattern. Where the UK MA holder already has a PL (product licence) on the molecule and the tender lot falls under that PL, we supply the finished-dose product from the named Indian partner site referenced in the dossier variation or site-transfer filing. Where the tender lot needs a new manufacturing site added to an existing PL, we provide the Module 3 package your regulatory team needs for the MHRA variation submission.
What if the tender lot is for an unlicensed product?
Then the bid sits under the MHRA Specials route or direct named-patient import under Regulation 167 of the Human Medicines Regulations 2012 — depending on whether the UK respondent holds an MS licence or WDA(H) with unlicensed-medicine endorsement. Our MHRA Specials and named-patient import pages cover the mechanics. We supply the finished dose or API into the UK licence holder; they remain the importer of record.
Who holds pharmacovigilance for product supplied against an NHS tender?
Pharmacovigilance for a UK-marketed product sits with the UK MA holder's QPPV (Qualified Person for Pharmacovigilance) as required by the Human Medicines Regulations 2012. On the manufacturer side, we maintain a named PV contact at the Indian site for ADR routing, product-complaint handling and batch-specific technical queries, feeding information to the UK MA holder's safety team during the tender contract period. We do not act as the UK QPPV.
What is the lead time from tender award to first delivery?
For stock-held SKUs from the nominated Indian partner site, 4-6 weeks from award to UK goods-in is typical — covering batch release, apostilled CoPP, airfreight or sea-freight, RP(i) sign-off and onward delivery. For made-to-order batches on new molecules or new pack configurations, 10-14 weeks is realistic. We align the lead-time commitment with the tender's service-level schedule at quote stage rather than at shortfall stage.
Does your price include delivered-duty-paid to a UK warehouse?
At quote stage we price both ex-works Mumbai and delivered-duty-paid into your nominated UK RP(i)-approved warehouse. The DDP line includes airfreight or sea-freight, import clearance at a UK port of entry, VAT and duty as applicable post-Brexit, cold-chain handling where required, and onward UK road to your goods-in bay. Currency exposure and escalation clauses are handled explicitly in the quote, not buried in the small print.
Which therapeutic areas do you see most in UK tenders?
Oncology cytotoxics and supportive-care injectables, cardiovascular generics, anti-infectives including some restricted antibiotics, central nervous system generics, diabetes injectables, and a steady stream of paediatric and geriatric oral liquids. Rarer spikes appear when DHSC flags a shortage — antihypertensive generics, hormone replacement therapy, and specific antibiotics have all cycled through tender demand on short notice across recent years.
How do NHS shortages change the supply picture?
When DHSC issues a Serious Shortage Protocol under Regulation 226A of the Human Medicines Regulations 2012, community pharmacists can substitute under defined conditions — and hub pharmacies and CMU scramble for alternative supply. Indian manufacturers with the same molecule at a different strength or pack size often clear the substitution window fastest. We hold standing relationships with WHO-GMP partner sites on the generic molecules most likely to go into SSP, which compresses the batch-release-to-UK-dock clock.
Your MHRA licence out front. Our manufacturer behind it. One tender at a time.
Tender reference, molecule, volume, submission deadline. We'll return a named-site match, a landed-cost model and the dossier pack inside two working days from the Mumbai desk.