The story to this point: A serious new investigation by the Bureau of Investigative Journalism revealed by The Hindu has revealed that unhealthy most cancers medication have been shipped to greater than 100 international locations world wide. Earlier than a most cancers drug reaches a affected person, they’d have already undergone a protracted, sophisticated journey. As soon as the uncooked supplies have been sourced, a typical drug will probably be manufactured, packaged, shipped, domestically distributed and at last put to make use of. It should journey by way of factories, storage services, transport programs, hospitals and pharmacies. And at each stage of this course of, the drug’s high quality should stay unhurt. Comparatively innocuous occasions — a change in temperature or poor dealing with — can have essential results. And in contrast to rich nations with strong monitoring programs, low and middle-income international locations typically lack the infrastructure to observe the journey.
What are the dangers in manufacturing?
One of many largest risks is contamination. Making certain that most cancers medication are sterile is the final word duty of the producers. Each motion should be tightly managed. Workers working with out correct disinfection processes can carry contaminants. Even a technician transferring too shortly in a clear room can create air motion that spreads micro organism. Every part is sanitised proper all the way down to the pens and paper.
The method is unforgiving: if uncooked substances aren’t examined adequately, if gear isn’t cleaned correctly, and if water isn’t filtered completely, these lifesaving medicines can change into deadly.
How do international locations guarantee such security?
About 80% of NHS prescriptions in England are generic medication, equivalent copies of branded medication that may be made as soon as a drug’s patent expires. About two-thirds of these come from overseas. To attempt to make sure that these medication are secure, the next measures are in place — each batch undergoes two rounds of high quality testing, on the manufacturing web site, after which on coming into the U.Ok.; throughout every of those rounds of checks, 20 totally different markers of drug high quality are checked; solely particular specialists, for instance these registered with skilled our bodies just like the Royal Society of Chemistry, are certified to confirm every batch; and the Medicines and Healthcare merchandise Regulatory Company frequently inspects manufacturing services, each within the U.Ok. and overseas.
Such testing programs are the gold normal. Many low- and middle-income international locations, nonetheless, face vital challenges. In Nepal, for instance, restricted sources and experience imply that there is no such thing as a efficient testing and monitoring of imported medicines. Many international locations additionally lack the flexibility to trace medication by way of provide chains and, like Nepal, would not have any verified specialists or services to examine drug high quality. These shortcomings, mixed with corruption points and porous borders, all imply that unhealthy and doubtlessly counterfeit medication can enter healthcare programs.
What are the results?
Time is of the essence for any most cancers affected person present process chemotherapy, so for that cause alone a substandard or ineffective drug will have an effect on their remedy. Medicine that haven’t been manufactured correctly may be poisonous or contaminated — and put a affected person in instant hazard.
There are quite a few examples of this having occurred throughout latest years. In 2019, 5 younger sufferers from Saudi Arabia developed a excessive fever, and one died, after taking an Indian-made medication given similtaneously chemotherapy medication. In the identical yr, 4 youngsters died and greater than a 100 fell ailing in Colombia when given the identical kind of drug. In 2022, no less than 10 youngsters in Yemen died after receiving methotrexate, a essential chemotherapy drug used to deal with leukaemia and different cancers, that had been contaminated with a lethal micro organism. In 2023, the Bureau uncovered a dozen poor-quality manufacturers of a childhood most cancers drug utilized in Brazil.
What’s WHO doing to make sure security?
The World Well being Group (WHO) maintains a speedy alert system for harmful medication. After a priority has been raised, the WHO assesses it and an alert is then despatched out to all member governments. Nevertheless, this technique solely catches issues after hurt happens. As well as, many areas lack services to check medication. Solely seven international locations in sub-Saharan Africa, for instance, have laboratories which were authorised as assembly WHO requirements.
The WHO has put a number of mechanisms in place to maintain a examine on drug security in low and middle-income international locations. One is the International Benchmarking Device: a instrument that assesses and charges nationwide regulatory programs on a scale of 1 (least mature) to 4 (most mature). In 2023, 70% of WHO member international locations had been rated degree 1 or 2, which means they’ve restricted capability to examine medication coming into the nation.
Then we now have the Important Medicines Checklist: a listing of medicines which might be thought of to be the most secure and only for assembly crucial well being system wants. Whereas generic variations of medication on this listing may nonetheless be faux or substandard, the existence of the listing helps international locations prioritise restricted sources.
Third, there are prequalification packages that are lists that comprise laboratories, particular medication and sources of lively pharmaceutical substances that the WHO has inspected, evaluated, and confirmed to be acceptable to be used. This helps governments and nationwide regulators procure secure medicines.
Fourth, is the Good Manufacturing Practices (GMP) certification which ensures that pharmaceutical merchandise are persistently produced and managed to high quality requirements. Most international locations will solely settle for the import and sale of medicines which were manufactured by internationally recognised GMPs. It’s utilized by pharmaceutical regulators and the pharmaceutical trade in over 100 international locations.
And at last the WHO certification scheme. A Certificates of Pharmaceutical Merchandise (CoPP) may be requested by a rustic that wishes to import a drugs, and it could issued by the exporting nation in line with the WHO tips. It acts like a passport for medicines, proving the merchandise is authorised and safely made within the exporting nation.
These measures definitely present some safety towards harmful medication, however the protections they provide merely aren’t sufficient. With out the extent of oversight seen in international locations just like the U.Ok., these measures typically fail to forestall substandard medication from reaching sufferers. For instance, a paper revealed this yr revealed the outcomes of testing of 84 medication supposed for cargo from India to Nigeria. All 84 held CoPPs. All 84 failed testing.
Andjela Milivojevic is with The Bureau of Investigative Journalism.
Revealed – July 01, 2025 08:30 am IST
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