As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.
The US Pharmacopeial Convention (USP) has published a paper evaluating the effectiveness of TruScan - a portable Raman spectroscopic device, developed and marketed by Thermo Scientific – in the battle against counterfeit and substandard drugs.
Dr. Mustapha Hajjou, the lead author on the paper, told in-Pharmatechnologist.com that the device’s ability to identify APIs (Active Pharmaceutical Ingredients) – or, indeed, lack of them – would be a simple and useful tool in stopping counterfeit drugs from reaching the user. He noted, however, that such advances in detection are held back by the complexity of the supply chain.
Dr. Hajjou - who is also Manager for the Promoting the Quality of Medicines Program (PQM) - said: “Every step towards the finished product is an opportunity to falsify medicines, so what we need is better control of the supply chain and training for the regulatory authorities in countries with a higher rate of falsified and substandard drugs.”
Official Report on Counterfeits
The paper comes less than two weeks after a report, commissioned by the US FDA (Food and Drug Administration), was released by the Institute of Medicine (IOM).
Entitled ‘Countering the Problem of Falsified and Substandard Drugs’ the report is quick to highlight that though the problem is most widespread in developing countries, all economies are affected by both criminal counterfeiters and lapses in quality assurance and controls.
As far as detection technology goes, the IOM’s report lists a number of techniques and tests, concluding: “While any one test may suffice to label a drug substandard or falsified, no single analytical technique provides enough information to confirm that a drug is genuine.”
This backs up Dr. Hajjou’s findings on the TruScan device. “While TruScan successfully identified drugs lacking API completely or with the wrong API, we found that they are not suitable to identify substandard medicines.” Furthermore, with fixed-dose combinations, one API may have a strong Raman scatter which would mask any defaults from the other ingredients.
Raman Spectroscopic Devices
Raman devices work by laser lights interacting with molecular vibrations, phonons other exipients resulting in a shift of energy which gives the user information regarding the make-up of a substance.
Only Nigeria is presently known to the PQM to be using Raman devices for regulating medicine quality, amongst other anti-counterfeiting measures. In 2011 Nigeria’s National Agency for Food and Drug Administration Control teamed up with GlaxoSmithKline to offer patients an SMS service to confirm antibiotics were not fraudulent.
The PQM has various other tools including the Minilab kit, a thin layer chromatography technology, which, according to Dr. Hajjou, “is currently used in more than 25 countries in Africa, Latin America and Southeast Asia.”