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New Delhi: Lack of adherence to âproper guidelinesâ is responsible for counterfeiting of drugs, loss of revenue and market share for Indian pharmaceutical industry, according to a whitepaper released by a lobby of foreign drug makers, the Organisation of Pharmaceutical Producers of India (OPPI).
The whitepaper was the result of a joint research conducted by the OPPI and Nexdigm (SKP), a multidisciplinary group that helps global organisations meet the needs of a dynamic business environment.
The paper, titled â
Good Distribution Practices for Pharmaceutical Productsâ, highlighted loopholes in the distribution chain of pharma products in India and also suggested remedial measuresÂ
Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
The FDA’s posting of drug GMP warning letters citing product adulteration has substantially decreased in the past several months. Warning letters are generally issued approximately seven months after inspections. The decrease we are now seeing is due to the slowdown of on-site inspections with COVID travel limitations and concerns regarding investigator safety.
However, the FDA recently posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters often signal a new enforcement focus or process for the FDA. (For example, when the FDA issued a warning letter to McKesson Corp. in Feb. 2019, it was the first and so far, the only time the agency cited failure to comply with the requirements in the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Drug, and C
Pharmaceutical Industry Makes Steady Progress Toward Meeting 2023 DSCSA Interoperability Requirements
2020 Barcode Assessment Documents Year-Over-Year Improvements
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EWING, N.J., Feb. 8, 2021 /PRNewswire/ A new GS1 US Barcode Assessment study shows that the pharmaceutical industry is making continued, steady progress toward interoperability, with a growing majority of products now properly serialized according to 2013 Drug Supply Chain Security Act (DSCSA) requirements. Conducted in 2020 by AmerisourceBergen Corporation, McKesson Pharmaceutical and Cardinal Health, in collaboration with
GS1 US, the study found that over 90 percent of packages and cases scanned at these three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.
6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
By Mike Karhoff and Mark Karhoff, Ten Count Consulting, LLC
The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023. While the FDA did well to respond to requests for delays in enforcement, the postponement does not remove the active requirements of the law, and stakeholders should continue to work towards ensuring compliance and documenting their efforts in the event of potential FDA inquires or investigations. It is important to continue working on these systems and communicating with trading partners to mitigate risk and take advantage of the opportunity to stabilize systems, processes, and data.