Disruption in the medicines supply-chain as a result of COVID-19 means it is more susceptible to a global surge in substandard and falsified medical products, according to Sireesha Yadlapalli, senior director of regional program operations in India at USP — a global health organization that improves lives through public standards to ensure the quality, safety, and benefit of medicines and foods.
Amid pandemic-induced lockdowns, travel bans, and increased global demand for COVID-related medical products, vulnerabilities in the supply-chain were exposed, paving the way for a rise in substandard and falsified products.
“The COVID-19 pandemic exposed both the fragility of the global pharmaceutical supply-chain — which experienced significant disruptions early on in the pandemic — and also its increasing reliance on the Indian pharmaceutical industry,” Yadlapalli said.
“Access to poor-quality vaccines is worse than no access at all.”
— Sireesha Yadlapalli, senior director of regional program operations in India, USPIndia currently supplies almost 60% of the world's vaccines and is one of the largest suppliers of medicines to low- and middle-income countries.
The quality of many medicines and products essential for COVID treatment and other health issues have been put at risk due to drastic shifts in demand, existing drug shortages, and challenges in maintaining supply amid limitations in global manufacturing capacity, according to Yadlapalli.
Where is the money for COVID-19 diagnostics?
No country is winning in the COVID-19 supply bid, but low- and middle-income countries are at a grave disadvantage.
Together, these factors have created an enabling environment for entry of substandard and falsified medical products — including medicines, hand sanitizers, personal protective equipment, and diagnostic tests — into the supply chain, she added. If not remedied ahead of COVID-19 vaccine distribution, there could be further significant consequences.
“Circulation of substandard or falsified COVID-19 vaccines in the supply-chain could further diminish trust in COVID-19 vaccines and trust in vaccines in general, and it could hinder the uptake that will be required to reach herd immunity,” she said. “This is truly an inflection point for the global medical product supply-chain in general, but in particular for India, which is known as the world's pharmacy.”
Speaking to Devex, Yadlapalli explained what India and USP are doing to prevent the emergence of substandard and falsified medicines amid the pandemic, and shared her advice for how manufacturers can tackle the problem.
This conversation has been edited for length and clarity.
With India at the epicenter of generics manufacturing, how are manufacturers responding to the risks posed by COVID-19 to the supply-chain?
The Indian pharmaceutical industry comprises many companies that have top-notch facilities and systems, but there were several quality issues that were identified in the last few years by stringent regulatory authorities during their inspections. The industry has made steady progress and they continue to take a hard look at opportunities to enhance the quality management systems used to help assure quality in manufacturing processes.
For our part, USP has world-class quality control labs and testing capabilities in India, as well as in the U.S. and elsewhere. These labs continue to support the global community's life-saving quality assurance work to protect patients and advance public health during the COVID-19 pandemic.
In total, our quality standards are used in about 150 countries to assure the quality of medical products. Early on in the pandemic, USP quickly issued a tool kit to help ramp up the production of quality-assured hand sanitizer, which was used as a reference by the U.S. Centers for Disease Control, several national regulatory authorities, and by nontraditional suppliers and manufacturers like distilleries and to increase production of hand sanitizer and ensure its quality. We've since issued additional guidance and support to regulators on strengthening their pandemic response and accelerating the roll out of quality assured COVID vaccines.
Regulators will really play a key role in providing access to COVID-19 vaccines and to protect patients from poor-quality products in LMICs. Regulators are collaborating like never before through mechanisms such as the African Vaccine Regulatory Forum. Enhanced collaboration, mutual recognition, and reliance on [World Health Organization] and other regulators will truly be critical for accelerating access without compromising quality.
Do you have advice for manufacturers and governments about how to address the threat of substandard and falsified COVID-19 vaccines in particular?
I think that it is very critical to understand that access to poor-quality vaccines is worse than no access at all Ineffective quality control measures could lead to nonsterile vaccines entering the supply-chain which could lead to a loss of potency and if given to patients, could mean ineffective protection from the virus.
With regard to COVID-19 vaccines specifically, USP rapidly supported supply-chain stakeholders with guidance on how to ensure quality throughout various steps in the supply chain, including manufacturing, packaging, distribution, and handling. USP quality standards help vaccine manufacturers assure the quality of their ingredients, maintain sterility, and guide labeling as well as packaging and distribution.
Collaboration among manufacturers, procurement agencies, suppliers, and distributors, as well as support for frontline health workers are equally important to maintaining quality throughout the last mile of distribution and delivery of vaccines. Failure to maintain appropriate temperatures and other problems can lead to quality problems that result in a significant number of doses of vaccine lost in these critical last steps. Regulators, manufacturers, global partners like USP — working together through donor-funded programs such as [the U.S. Agency for International Development’s] Promoting the Quality of Medicines Plus program — have strengthened existing infrastructure to help assure the quality of other products such as oxytocin. The innovations and improvements we've achieved through these investments can be leveraged to help assure the quality of both future COVID-19 vaccines and other life-saving and life-improving health products.
What is your call to action for the global health community?
As I've said before, access to poor-quality vaccines is worse than no access at all. I cannot emphasize that enough. Falsified and substandard vaccines are a double-edged sword. They fail to protect against the disease and they undermine already fragile public trust in vaccines and medicines. It is said that “public health moves at the speed of trust” so we must collaborate across sectors, industries, and geographies to address the many challenges facing the global health community, particularly at this time. We must continue to work together across the entire ecosystem to make sure we get this right, not just during this pandemic, but for all future public health endeavors.
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