News Update
WHO is in charge?
In their detailed writeup for the Pulitzer Center, Vidya Krishnan and Arshu John contend the World Health Organization is not doing enough to combat the growing global threat of false, substandard and falsified medicines:
Effectively, the WHO…has done little to hold countries accountable for upholding safe production and distribution standards, or to protect the countries most vulnerable to substandard medical products. The WHO’s 2022 report on the Member State Mechanism does no more than recommend that member states “develop their own implementation plans for the prevention, detection and response to substandard and falsified medical products using the outputs of the Member State Mechanism.” This is a reactive approach to help member states identify and recall substandard drugs already out in the world, rather than a proactive approach to prevent the manufacture and distribution of such drugs in the first place.
Later in the piece, the authors argue the WHO has failed to be a backstop for national governments:
The WHO’s present approach does not address the concern that low-income countries such as The Gambia do not have the necessary resources or medical infrastructure to prevent or expediently mitigate problems arising from substandard drugs. The WHO report on the Member State Mechanism effectively absolves the organisation of responsibility, stating that while “the problem of substandard and falsified medical products is a global concern, solutions often lie at the national level.”
Looking ahead, Krishna and John call for the WHO to expand its existing Prequalification of Medicines Programme, which helps ensure enforcement of quality standards for a wide range of medical products.
QR = Questionable Response
Drug control officers overseeing a recent large-scale seizure of substandard medications in the Howrah market in West Bengal have made a troubling discovery: counterfeiters are now successfully replicating packaging QR codes intended to help regulators discern safe medicines from substandard ones.
But this news is not surprising for counterfeiting experts like Dr. Avi Chaudhuri. Commenting in a Securing Industry piece on the seizure, Chaudhuri argued QR codes “can be easily replicated and placed on fake drug packages, making them indistinguishable from a genuine product.” Chaudhuri further lamented the sad reality that “the very programme that was meant to protect Indian consumers has now become a vehicle to cause them harm.”
For more information on this issue, be sure to check out Chaudhuri's most recent blog post, in which he closely examines several different types of QR code approaches being utilized in India — and explains why each of them still fail to pass muster.
A Promising Innovation
The Vaccine Identity Evaluation Collaboration, an international consortium of global health stakeholders, has unveiled an innovative method for detecting falsified or substandard vaccines — one that does not require them to open the vial.
[R]esearchers in the VIE team have used devices, called MALDI-ToF mass spectrometers, which are widely available throughout the world and used in hospitals for identifying bacteria. They tested the COVISHIELD™ vaccine produced by the Serum Institute of India and show for the first time that analysis of spectra from the vaccine vial label and its adhesive could be used to detect falsified vaccines – this novel method could be applied to other medicine labels.
In addition to providing a quicker turnaround time for results, the researchers noted the widespread availability of MR testing instruments in healthcare settings could make it easier for their approach to be scaled.
Grey Areas
During a recent Right to Health Resources roundtable discussion on the Indian pharmaceutical sector, Third World Network researcher K. M Gopakumar offered an eye-opening response to a moderator question on the efficacy of track and trace systems:
[I]n a place called Bhagirath Palace in Delhi, there is a huge wholesale market for medicines. As per the system, the product goes to a licensed wholesaler, and from then to licensed retailer. Without [a] retail license, the wholesalers are not supposed to sell, right? But in Bhagirath Palace, any trader can go and procure most types of medicines if you have the right kind of contact. There is a grey area where traders can buy from a manufacturer and then and relabel, price higher, and re-sell it and there may be nothing in the laws that prevent it. [T]here are different business models out there, and the regulatory system is not capturing all these business models. The lack of effective regulation to ensure affordable prices attracts various actors to exploit the situation including the fly-by-night operators, which contributes to the circulation of quality compromised medicine.
Despite this alarming reality, Gopakumar and his fellow panelists offer some constructive recommendations on how cross-sectoral stakeholders can work together in India to improve upon regulatory frameworks. You can read about their ideas here.
Websites We Follow:
IFPMA - Falsified Medicines
Important information on how the private sector is combatting fake meds
Operation Shield IV
Europol initiative tackling illicit drugs
Feeds We Follow:
Twitter
International Society of Pharmacovigilance
@ISOP
Non-profit combatting counterfeits
EU Medicines Agency
@EMA_News
Responsible for medicines oversight in Europe
National Agency for Food and Drug Administration and Control
@NafdacAgency
Nigerian government department responsible for thwarting counterfeit, substandard, and falsified medicines
LinkedIn
Avi Chaudhuri
The Kulinda Consortium
Expert on Indian efforts to combat substandard medicines
Africa Health Business
Pan-African consulting/advisory firm focused on strengthening the healthcare sector in Africa via private sector engagement (PSE).