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Quality concerns lead to drug shortages, said Patrizia Cavazzoni, the United States Food and Drug Administration’s director of the Center for Drug Evaluation and Research, urging senior management of the pharmaceutical industry to prioritise quality and accountability.
Calling on senior management to “walk the talk” on quality, Cavazzoni said in a recorded message to pharma industry representatives that quality compliance should be a top-down commitment and resources need to be allocated for the purpose. She called for “sustainable compliance” that involved a proactive response in terms of identifying a problem and undertaking remediation measures.
An ongoing dialogue can prevent shortages, she said, referring to the medicne shortages being witnessed in the US, in segments including cancer drugs. Listing about 16 oncology drugs in short supply (May 2023), she said, shortages included old generic drugs like Cisplatin and Carboplatin injections. This scenario was in part because a shut down due to quality issues, she said.
Why shortages?
Outlining reasons behind the shortages, she said, there was a shortfall in manufacturing capacities, and this could be from a lack of incentives. Critical segments like sterile injectibles are impacted. Sometimes, there are long periods of remediation that could also cause delays in supply. Unforeseen climate events, geo-political issues and financial pressures causing closure of a manufacturer could also impact supplies.
The USFDA has resumed on-site inspections of foreign facilities, she said, and some of the recurring issues seen, included microbial contamination, poor excepient quality, lack of data integrity and inadequate controls. Cavazzoni was addressing the Indian Pharmaceutical Alliance’s quality summit (Mumbai).
Speaking at a panel discussion, Sarah McMullen, Country Director (India) and Office of Global Operations, USFDA, pointed to data integrity issues still being found, and added, it was important to trust the data to be able to trust the product. Pointing out that compliance was a “shared goal”, she said, there was a need for products from the industry.
James Pound, Deputy Director Standards and Compliance with the United Kingdom’s MHRA ( Medicines and Healthcare products Regulatory Agency), echoed the USFDA official’s view that sites were assessed on the ability to identify problems and address it. The European Directorate for the Quality of Medicines & HealthCare (EDQM) Inspector - Certification of Substances Department, Thomas Hecker added, international regulators did rely on each others assessment reports. Responding to a query on moving towards harmonised laws, the Central Drugs Standard Control Organisation (CDSCO) Deputy Drug Controller Rubina Bose said, India was on several of these international committees to harmonise technical requirements for certain segments of the industry.
The concluding session of the IPA summit will see Union Health Minister Mansukh Mandaviya addressing the gathering on Friday.
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