Compliance and ethics, written as controls rather than intentions.
Tender and NGO procurement teams are usually asked to evidence that a bidder has controls, not values. This page states the ones M Care actually operates, with the same discipline as the rest of the site: nothing here is a claim we cannot show you the paperwork for, and where the answer is that we are not the responsible party, the page says so.
Where a batch comes from, and how that is proved.
Falsified and diverted medicine enters a supply chain through brokered stock, parallel imports and batches whose origin nobody can name. M Care removes that entry point by not buying speculative stock at all: every line starts with a purchase order against a named manufacturing site.
No broker stock, no parallel imports
We do not resell parallel-imported or secondary-market stock, and we are not a broker. Every line ships from a direct manufacturer relationship, which is what removes batch ambiguity and parallel-import exposure from your incoming goods check.
Traceable to one named site
Each line is traceable to a single WHO-GMP or EU-GMP manufacturing site, with a paper chain built to survive a regulator's audit. One site per line is what makes a recall actionable rather than theoretical.
The document set travels with the batch
Every shipment carries a batch certificate of analysis, a method of analysis, a certificate of origin and a pack insert matched to the destination label, rather than a generic pack assembled after the buyer asks.
Artwork locked before despatch
Destination-market labelling is reviewed and locked before shipment, with formal change control on every revision. This is the control that stops a market-specific label reaching the wrong market.
How a site joins the roster, and how it comes off.
A merchant-exporter's real product is its supplier panel. Ours is qualified against a written protocol before a first order is placed, re-audited on a defined cycle, and open to the buyer's own inspection on the same terms.
Physically audited before the first order
Every prospective partner site is physically audited by the Mumbai QA team before a first order is placed, and re-audited on a defined cycle after that. Vendor qualification, QA audits, dispatch and artwork control all sit in the same office.
WHO-GMP as the floor, not the ceiling
Partners are qualified against a standard protocol with WHO-GMP as the baseline, and EU-GMP or US-FDA status required where the destination market demands it. The certificate is the manufacturer's, issued for a named site and dosage form.
Removed without exception
Non-compliant partners come off the roster. A critical inspection observation triggers an immediate halt of supply of the affected dosage form from that site until the CAPA is closed, and the Mumbai desk moves production to another qualified site holding the same certificate scope.
Audit the site yourself
Buyers qualifying a new Indian site can request a virtual or onsite audit before a first purchase order. We would rather you saw the floor than took our word for the audit report.
We author the dossier. We do not hold your authorisation.
Most compliance failures in pharmaceutical export are documentation failures: an expired certificate, a dossier reference cited wrongly, a product registered in one market and quietly shipped to another. The controls here are about who is accountable for which document.
The dossier partner, not the marketing-authorisation holder
M Care authors the CTD or eCTD dossier alongside the Indian manufacturer and manages variations. The marketing-authorisation holder in your market is the importer or local agent, not us.
Certificates are verified, not forwarded
Certificates are checked for residual validity before they go into a bid or a shipment rather than passed along as received, and are shared under a mutual confidentiality agreement with the issuing office, inspection date and certificate number visible.
Data integrity is in the qualification pack
A data-integrity self-assessment against ALCOA+ is included in the supplier-qualification pack, so the question is answered before your auditor has to ask it.
What M Care is not
M Care is a CDSCO-licensed merchant-exporter. It does not manufacture, it does not hold WHO-GMP or WHO Prequalification in its own name, and it does not hold a UK wholesale-dealer licence. Those belong to the manufacturing site and to your own licensed entity.
Licence evidence first, lawful end-use as a condition.
A merchant-exporter sits exactly where diversion happens, between a licensed manufacturer and a market it does not physically control. Qualifying the buyer is therefore part of the same control set as qualifying the manufacturer.
Licence evidence before the first order
Buyer qualification collects company registration, tax identification and the wholesale, import or pharmacy licence number with its issuing authority, before a first order rather than after it.
Lawful end-use is a condition of supply
Import, registration and onward sale are regulated in every destination. The purchaser must hold the appropriate licences and be responsible for the lawful end-use of what we ship.
Nothing here is an open offer to supply
Nothing published on this site constitutes an offer to sell in a specific jurisdiction. Availability, registration status and price are confirmed per enquiry, per market.
Export under our own licence
M Care exports under its own CDSCO licence with the manufacturer's certification travelling with the consignment, and every order is run end to end by one named team rather than handed between desks.
A critical finding halts supply. It does not open a negotiation.
The test of a compliance page is what the company does on a bad day. These are the standing rules, not case-by-case decisions.
Supply halts until the CAPA closes
A critical observation stops supply of the affected dosage form from that site until the corrective and preventive action is closed out. Continuity comes from an alternative qualified site, not from shipping through the problem.
Findings are disclosed, not managed
The inspection outcome, the CAPA plan and the close-out evidence are disclosed to any buyer holding an active supplier-qualification record for that site.
Quality decisions sit with QA
A quality question is assessed on the evidence by QA. On cold chain the importer's Responsible Person holds the final call on release, and it is not our place to lean on that decision.
Excursions are written into the purchase order
Cold-chain lanes run with validated temperature loggers on every unit, and the excursion protocol is insured and written into the purchase order rather than negotiated after the event.
The price you confirm on day one is the price on day forty.
Commercial conduct is part of compliance for a tender buyer, because an unpredictable invoice is a budget problem and a budget problem becomes an audit problem.
Quotes are itemised
A quote includes freight, insurance, dossier and artwork. There is no post-shipment invoice bloat, because the costs were named at quote stage.
No speculative stock
We do not buy stock hoping to place it. Every line begins with a purchase order and ends with a signature on a delivery note.
One named team, end to end
Every order is run by a named team rather than passed across desks, so there is a person accountable for the file when a question arrives.
Credit terms are discussed, not dangled
Terms are discussed once we know the market, the order pattern and the references, and are never a precondition for opening a trade account.
The questions a tender evaluator actually asks.
Does M Care Exports hold WHO-GMP or WHO Prequalification certification?
No, and we will not claim it. WHO-GMP attaches to a manufacturing site inspected by a competent authority, not to a trading and export company. M Care is a CDSCO-licensed exporter; the WHO-GMP certificates in your supplier-qualification pack are issued in the manufacturer's name, for the specific site and dosage form.
What compliance documentation comes with a bid or a first order?
The batch certificate of analysis, the method of analysis, the certificate of origin, the pack insert matched to your destination label, the manufacturer's GMP certificate and licence, a Certificate of Pharmaceutical Product where the market requires one, and the cold-chain trail for temperature-sensitive lines.
Can we audit the manufacturing site before placing an order?
Yes. Buyers qualifying a new Indian site can request a virtual or an onsite audit before the first purchase order. Every site on the roster has already been physically audited by our own QA team before it received a first order from us.
Who is the importer of record, and who carries the regulatory liability?
Your licensed entity. M Care supplies and documents; the import of record is the buyer's licensed importer, and the marketing-authorisation holder in your market is the importer or local agent. We do not hold a UK wholesale-dealer licence and do not present ourselves as holding one.
What happens if a batch fails, or a temperature excursion occurs in transit?
A critical finding halts supply of that dosage form from that site until the CAPA is closed, and the outcome is disclosed to buyers holding an active qualification record for the site. On cold chain, the excursion protocol is insured and written into the purchase order, and the importer's Responsible Person holds the final decision on release.
Is anything on this website an offer to supply in our market?
No. Nothing published here constitutes an offer to sell or supply in a specific jurisdiction. Availability, in-country registration status and price are confirmed per enquiry against your market, and lawful end-use and the correct import licences remain the purchaser's responsibility.
Tell us which evidence your tender pack needs.
Name the market, the regulator and the submission date. The Mumbai desk returns the supplier-qualification pack for the matched manufacturing site, with certificate scope and residual validity stated on the face of it.