Change is no longer creeping at the edges of pharmacy, it is marching through the front door. The days of ‘one-size-fits-all’ medicines, whether the blister pack of industrially mass-manufactured paracetamol or the long-mooted polypill (statin, antihypertensive, aspirin), trialled abroad but never adopted in the UK, are numbered.
They may hang around a while, but a new era beckons: medicines precision-engineered for the individual, shaped by their genetics, lifestyle and history, not just their symptoms.
Tim Minshall, engineer and Professor of Innovation, nails this in his 2025 book Your Life Is Manufactured. How We Make Things, Why It Matters and How We Can Do It Better. He highlights a shift towards making artefacts closer to their consumers (reshoring, etc.) and details a surge in the personalisation of medicines.
That trend gained teeth in July 2025, when the MHRA launched new rules on decentralised manufacturing (DM). This is not just a tweak. It is, potentially, a quantum leap.
Think production hubs inside or next to hospitals, pumping out specialist medicines designed for one patient, not a million. The aim: bring cutting-edge treatments closer to people, keep pharmaceutical quality assurance rock-solid and set a standard others may follow worldwide.
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The rules have two flavours. Point-of-Care (PoC) Manufacturing is for medicaments that can only be made at the patient’s side because they expire in minutes or rely on unique ingredients. CAR-T cell therapy, where every second of the vein-to-vein time matters, is a poster child. Alongside it is Modular Manufacturing (MM): pre-built, movable mini-factories that can be dropped where needed.
But forget the image of a draughty Portakabin or shipping container. These are high-tech, cGMP-compliant , often kitted with automation and single-use systems. They may include aseptic cleanrooms. They are tested, moveable, and capable of churning out small, high-quality bespoke batches. The key? Strong Pharmaceutical Quality Systems (PQS) underpin every step.
Of course, hospital pharmacies are no strangers to aseptically manufacturing products, notably, cytotoxics, chemotherapy and total parenteral nutrition (TPN).
For decades, they have done this under the Section 10 exemption of the 1968 Medicines Act, with pharmacists carrying the legal quality burden instead of an industrial Qualified Person (QP). QP’s may be pharmacists, chemists or biologists, although today, few pharmacists are becoming QPs.
But under the 2025 rules, most of those products will not count as PoC. Though tailored, they are stable enough to travel from a central aseptic hub. The PoC label is reserved for the truly time-critical, such as certain Advanced Therapy Medicinal Products.
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Where might MM shine? One answer: the next pandemic. COVID-19 taught the world that new vaccines can appear in a year, but the “Coalition for Epidemic Preparedness Innovations” wants that reduced to 100 days for “disease X.”
The Bill and Melinda Gates Foundation, Wellcome Trust, European Union and the governments of India, Norway and the UK fund that global initiative. Modular, decentralised sites could manufacture vaccines and other urgent therapies close to where they are needed. The result: a more agile, shock-proof supply chain.
For pharmacy, this spells disruption but also huge opportunity. Why should not one of these relocatable units park outside a community pharmacy, just as easily as a hospital or GP surgery?
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Here it becomes exciting. We already have 3D-printed medicines. Now, (given technical fixes to the pharmaceutics, compatibilities, doses and so on in the near future), picture a manufacturing/dispensing machine on the pharmacy bench, starting from the bulk active pharmaceutical ingredients (drugs), formulating safe, dosage forms (medicines) in real time.
Instead of, for example, an elderly patient juggling a dozen (say) tablets and a fiddly compliance aid, they take (ideally) just one personalised daily tablet that combines everything they need.
That is not just science-fiction wishful thinking, borrowed from Star Trek’s replicator. If today’s blistering pace of scientific and technological advance continues, it could be a reality in the not-too-distant future. And when it does, it will place pharmacists back at the centre of their kind of healing: transforming empirical things, drugs, into medicines. Welcome back, old friend — extemporaneous dispensing — proud source of professional fulfilment, especially if you also prescribed.
Dr Malcolm E. Brown is a retired community, hospital and industrial pharmacist, and is a sociologist and honorary careers mentor at the University of East Anglia.