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More children worldwide are being paralyzed by polio viruses from vaccines than from viruses in the wild, according to new data. The World Health Organization and partners last week noted nine new vaccine-linked polio cases in Nigeria, Congo, Central African Republic, and Angola, the Associated Press reported. Seven other African countries have similar outbreaks, and there have also been cases in Asia. It is rare, but the live virus in oral polio vaccine can mutate into a form that can cause new cases. All the current vaccine-related cases have been caused by a type 2 virus in the vaccine. The wild version of the virus was eliminated years ago, the AP reported. AP News Article More Information: WHO

Ipca Laboratories announced that the United States Food and Drug Administration (FDA) has found its manufacturing unit in Silvassa, Gujarat, non-compliant with the current good manufacturing practices (cGMP). The company further added that since this manufacturing facility is already under US FDA import alert and presently not doing any US business, this will have no impact on company's current on-going business activities. "We have received a communication from US FDA that they have determined the inspection classification of Piparia (Silvassa) formulations manufacturing facility as "Official Action Indicated (OAI)" and that that this facility is considered to be in an unacceptable state of compliance with regards to current good manufacturing practice (CGMP)," the company said in a filing. US FDA inspection of its Piparia (Silvassa) formulations manufacturing unit in August, resulted into three observations, the company added.

The Indian Pharmaceutical Market (IPM) growth has slipped to 5.1 per cent for the month of October 2019 after an 11.9 per cent growth in September. The drop in growth for the month of October 19 has been seen across all the therapies, anti-infective market showing a growth of 2.9 per cent, while cardiac market at 7.9 per cent, GI market at 4.7 per cent, the anti-diabetic market at 6.4 per cent and Vitamins showing a growth of 2.3 per cent. According to AIOCD AWACS report, the IPM has recorded sales of Rs.137,490 crore and a growth of 9.2 per cent for Moving Annual Total (MAT) basis during October 2019. Among the top 50 corporates, 27 corporates exhibited double digit growth. Among the top 50 corporates, 40 corporates exhibited positive growth for the month of October, 2019. Amongst the top 10 corporates, Lupin exhibits the highest growth (9%) followed by Intas (8.4%) and Sun & Zydus (7%). Amongst the 11-20 ranked Corporates, Aristo exhibits highest growth (17.8%) followed by Pfizer...

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to Mylan’s active pharmaceutical ingredient (API) manufacturing site in Andhra Pradesh, India, highlighting “contamination at levels above the limit” for some API batches. FDA’s inspection of the site in May and June uncovered, “Multiple contract manufacturers supplied solvents that were contaminated with [redacted], but your firm lacked documentation of which tanks were used to store these solvents,” the letter says. “Although you acknowledged that there was no record of usage for each of the recovered solvent tanks, your response did not provide sufficient information on attempts to retrospectively reconcile the number, identification, and usage of the tanks.” FDA also raised questions about the site’s ability to clean equipment to prevent contamination or carry-over material that would alter the quality of the API. “There is no assurance that your cleaning methods are adequate to clea...

Many older adults do not follow instructions related to antibiotic use, according to a report published online Nov. 4 based on the results of the University of Michigan National Poll on Healthy Aging. Researchers surveyed a randomly selected sample of about 2,200 older adults aged 50 to 80 years to examine their experiences with and opinions about antibiotics. According to the report, 48 percent of respondents reported filling a prescription for antibiotics in the previous two years. Overall, 13 percent had leftover medication, with the top reasons being that they received more doses than needed and they stopped taking the medication because they felt better (34 and 32 percent, respectively). Sixty-five percent of those with leftover antibiotics reported keeping them, while 20 percent threw them away or flushed them down the toilet. Sixty percent of those who kept leftover antibiotics did so in case they got another infection; 6 percent kept leftover antibiotics in case a family member...

As quality issues have led to drug shortages, Donald Ashley, director of FDA’s Office of Compliance, raised several major concerns on Tuesday with the active pharmaceutical ingredient (API) industry, noting three trends related to the obfuscation of supply chain information, an increasing number of data integrity question marks and impurity concerns that have led to recalls. On the obfuscation front, Ashley, speaking at the Association for Accessible Medicines’ conference in Bethesda, MD, noted that API companies sometimes fail to obtain and retain documents with the identity of the original manufacturer and certificate of analysis. In addition, APIs, including opioids, are often distributed with inadequate certificates of analysis, which he said, “compromises supply chain accountability and traceability and may put consumers at risk.” On data integrity, which often includes incomplete, inconsistent or inaccurate data, Ashley noted that of the warning letters issued to API manufacturer...

Radiation oncology expert Stephen Hahn, M.D., has been nominated as the new U.S. Food and Drug Administration commissioner. Hahn, 59, is chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, and he has been a professor of radiation oncology there since January 2015, CNN reported. Ned Sharpless, M.D., acting commissioner of the FDA, will return to his role as the director of the U.S. National Cancer Institute, the U.S. Department of Health and Human Services said. The FDA has a $5.7 billion budget and more than 17,000 employees, CNN reported.

Read WHO draft data integrity guidance document