Leena further added that "Often procurers of medicines are dependent on Quality Control (QC) systems, which means they take some samples from a particular batch that is being delivered and test those samples. They learn if the sample had any contamination and if it had enough active pharmaceutical agent (which is the raw material that goes into making of the drug). But QC system does not tell us if the drug is bioequivalent or if it is stable enough to withstand higher temperatures or humidity. Currently, our procurers and health ministries have invested in QC systems. We are requesting them to treat QC as a process. For example, procurers can define quality by demanding bioequivalence with certain months of stability data."
She cited another example of a recent tender document from the government of India's National TB Elimination Programme to procure three new anti-TB drugs, but quality standards listed are different for each of them.
"Governments are right in being very conscious of preserving newer drugs so that these are not misused or overused. But we cannot ignore lack of access to older medicines. Penicillin is one of the drugs that was needed for treating sexually transmitted infections (STIs) and the government's national AIDS programme was struggling to procure it. Finally, the government consolidated the demand and one of the manufacturers (government's public sector manufacturing unit) met it," said Leena.
The Trinity Challenge of GBP 1 Million Competition
WHO's Dr Philip Mathew called for multisectoral collaboration to address the challenges posed by substandard and falsified medicines. "We need effective collaboration between a range of partners- not just within a country but also globally and a robust system of information sharing." Technological innovations to effectively address the challenge posed by substandard and falsified medicines could be very effective, said Dr Mathew. The Trinity Challenge has announced a GBP 1 million competition to spur technological innovations in the Global South to address this problem.
ICMR's Dr Kamini Walia agrees: "We must build the capabilities of regulators (and local manufacturers), in part by introducing innovative surveillance technologies, to help mitigate substandard and falsified medicines, including antimicrobials, which in turn helps combat AMR. We also need to improve the global medicines supply chain to ensure quality standards of medical products and practices everywhere, including in low- and middle-income countries, thereby helping to combat AMR."
Shobha Shukla, Bobby Ramakant - CNS (Citizen News Service)
(Shobha Shukla and Bobby Ramakant lead the editorial at CNS (Citizen News Service) and are on the board of award-winning Global Antimicrobial Resistance Media Alliance (GAMA). CNS is an official media partner of AIDS 2024. Follow them on twitter @Shobha1Shukla, @BobbyRamakant)
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