Named-patient import to the UK, from Indian WHO-GMP origin.

No. We are the Indian manufacturer-side partner. The UK importer must hold a Wholesale Dealer's Licence (WDA(H)) with the unlicensed-medicine import authorisation. We supply product and documentation into that import chain; we do not hold a UK licence ourselves.

There is no hard minimum. Single-vial and single-pack supply is supported where the molecule is in manufacturer stock. Most named-patient consignments are one to twenty vials or packs.

Stock-on-hand molecules: 7-12 calendar days door-to-door. Made-to-order batches or unusual strengths: 4-8 weeks. Urgent life-threatening single-patient supply has been moved in under 96 hours with the right prioritisation.

Yes. We hold lines on over 600 active ingredients across 18 therapeutic categories. When a UK shortage is announced we can typically quote a replacement strength, brand or presentation within one working day.

Oncology cytotoxics, specialist injectables, anaesthesia and ICU, paediatric strengths, and anti-infectives where a UK brand has been discontinued. Full list under products.

Yes. Pre-shipment thermal validation per shipper, continuous temperature logging in transit, on-arrival logger read-out. Excursion protocol defined before dispatch, not after the carton lands.

Only through a trust's nominated MHRA-licensed importer or specials manufacturer. Direct import without a UK import licence would be a regulatory breach we will not participate in.

A named PV contact is opened for the consignment's shelf life. ADR reports are routed back to the manufacturer's QA team and to CDSCO where applicable. Periodic Safety Update Reports compiled to ICH E2C on request.

Three checks the Responsible Person typically runs. First, ask for the WHO-GMP certificate for the specific manufacturing site and the specific dosage form, then cross-check on the WHO Prequalification database at extranet.who.int/prequal/. Second, ask for the CDSCO Certificate of Pharmaceutical Product (CoPP) and verify on the CDSCO website that it was actually issued by CDSCO for that manufacturer for the molecule and dosage form. Third, ask for sight of recent MHRA, EMA, or WHO Prequalification inspection reports for the manufacturer where the manufacturer holds those credentials. We share all three under NDA before any consignment is committed, and we are happy to be a reference for UK Responsible Persons doing their own diligence on Indian manufacturers in our network.

Specials supply is unlicensed in the UK and reaches a named patient under Regulation 167 of the Human Medicines Regulations 2012. The UK importer holds a Wholesale Dealer's Licence (WDA(H)) with the unlicensed-medicine authorisation, or a Manufacturer's Specials Licence (MS). Parallel import is a product that holds an EMA centralised marketing authorisation and reaches the UK through a UK parallel-trade licence, side-stepping the original UK marketing-authorisation holder's distribution. Different regulatory framework, different importer licence required, different patient-supply mechanics. We support both lanes (see our parallel-import supply service desk) and the right call depends on whether the product has an EMA licence in the first place. Where the product is unlicensed in the EU as well as the UK, only Specials applies.

Yes. Paediatric strengths and orphan-drug Specials are a substantial part of our UK supply. Indian WHO-GMP manufacturers routinely produce paediatric weight-band strengths for African and Asian public-sector tenders (50mg, 100mg, dispersible tablets, oral suspension formats) that are not made commercially for the UK market. Orphan-drug Specials we supply include EMA-orphan-designated portfolio products (haemophilia concentrates, rare enzyme replacements, niche antivirals, rare-disease oral solids) where the licensed UK brand is the only option and stock-outs bite hardest (see our orphan-drug supply service desk). We also support clinical-trial comparator-arm sourcing for UK and EU trial sites under a separate Investigational Medicinal Product (IMP) supply track.

Patient identity never reaches our end. Manufacturer-side, we work to molecule, strength, patient count, and target arrival window. The UK importer's Responsible Person holds the prescriber's named-patient request and the patient identifier. Documentation that needs to reference the patient (for example MHRA notification fields where the importer's importer-side fields are completed) is owned by the UK importer, not by the Indian manufacturer or by us. We sign mutual confidentiality agreements with new UK partners covering both patient data and commercial pricing, and we are GDPR-equivalent in our handling of any incidental information that flows back through pharmacovigilance reporting.

The Specialist Pharmacy Service (SPS), part of NHS England, publishes the procurement and clinical-governance guidance that UK hospital pharmacy procurement teams use when sourcing unlicensed medicines, including the unlicensed-medicines procurement checklist, the format for requesting a specials quote, and the clinical-governance triggers for due diligence on the supplier and on the manufacturer behind the licensed importer. SPS does not approve individual Specials orders, but a UK hospital pharmacy procurement team will typically follow SPS guidance on documentation, supplier credentials and clinical-governance sign-off before placing an order with an MHRA-licensed importer. We supply our documentation pack to the level SPS guidance expects, so the UK importer's procurement team can satisfy the SPS-aligned governance trail without back-and-forth.

Specialist commissioning is the route by which NHS England commissions specific high-cost or specialist medicines nationally, for example highly specialised services for rare disease, plus high-cost drugs under the Cancer Drugs Fund and the Innovative Medicines Fund, rather than leaving the funding to local integrated care boards. Where a medicine sits on a specialist-commissioning list, it has a licensed UK route and Specials supply is the exception, used only on individual patient bridging during a shortage or where the patient cannot use the licensed product. Where the medicine is not on a specialist-commissioning list and is not on a national formulary, Specials supply under Regulation 167 is often the only patient route. We route every UK enquiry first against the question of whether a specialist-commissioned licensed alternative exists, and we will say so plainly when the licensed alternative is the cleaner answer.

For Specials specifically, the answer is no, the MHRA Regulation 167 unlicensed-medicine import authorisation applies to Northern Ireland in the same way as to England, Scotland and Wales, with the importer holding a UK Wholesale Dealer's Licence with the unlicensed-medicine authorisation, or a Manufacturer's Specials Licence. The Windsor Framework's arrangements adjust customs handling and dual MHRA / EMA market-access recognition for licensed medicines, not the Regulation 167 unlicensed-medicine route. The practical impact for an Indian Specials supplier into Northern Ireland is therefore small, the regulatory documentation is identical, and the consignment follows the same UK pharmaceutical import process through the licensed importer. We work to that route, not to a parallel Northern-Ireland-specific track.

Yes, and oncology is the niche where Indian WHO-GMP supply has the biggest delta against a constrained UK licensed market. Oncology cytotoxics, supportive-care injectables, and specialist haematology lines (proteasome inhibitors, hypomethylating agents, conditioning regimens for stem-cell transplant) regularly come into shortage or discontinuation. When a UK licensed brand is withdrawn or out of stock, the Specials route under Regulation 167 is what reaches the named patient. We supply the manufacturer-side documentation, cold-chain validation for the lines that need it, and the dossier evidence the UK Responsible Person needs for the unlicensed-medicine notification, and we time the consignment against the cycle the prescribing oncology centre is working to. Our oncology Specials work covers both established cytotoxics and oral targeted-therapy oncology agents (see our orphan-drug supply desk for the rare-disease overlap).