Companies & Sectors
USFDA warns Cadila on lack of audit trails, torn notebooks, product mix-ups
Chennai : Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.
 
The United States Food and Drug Administration (USFDA) on December 23, 2014 had issued a warning letter to Cadila Healthcare for various deficiencies in its production process and documentation at its two plants in Gujarat.
 
The warning letter was addressed to Pankaj R Patel, chairman and managing director, Cadila Healthcare.
 
The USFDA found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
 
"Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records," the regulator said in its letter.
 
According to USFDA, the Indian company did not explain why production personnel used unofficial paper for documenting relevant CGMP data.
 
The USFDA also said Cadila Healthcare failed to control the use of computerised systems in the quality control laboratory.
 
"Our inspection team found that the laboratory manager had the ability to delete data from the Karl Fischer Tiamo software. During our limited review of your Karl Fischer data, we found that one file had been deleted. 
 
"However, because the audit trail function for the Karl Fischer Tiamo software was not activated, and because eight different analysts share a single username and password, you were unable to demonstrate who performed each operation on this instrument system," the warning letter notes.
 
"You do not have a record of the acquisition of all data, nor do you have records of changes to or modifications of such data," the letter added.
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.

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Chinese stocks dive seven percent, trading halted
Beijing : Trading on the Shanghai and Shenzhen bourses was halted on Thursday after shares tumbled 7 percent within the first 30 minutes of trading, triggering the circuit breaker mechanism.
 
It was the shortest trading time in China's capital market history, Xinhua news agency reported.
 
This is the second time the circuit breaker has halted trading this week, after a similar plunge on Monday triggered the circuit breaker, the first day the mechanism took into effect.
 
The mechanism follows the Hushen 300 Index, which reflects the performance of bluechips listed in Shanghai and Shenzhen. When the index rises or falls by 5 percent, the circuit breaker imposes a 15-minute suspension in trading. 
 
If the Hushen 300 declines by over 7 percent, trading is halted for the day.
 
At 9.42 a.m., trading was suspended for 15 minutes after the Hushen 300 dropped by over 5 percent. The index dived a further 2 percent in just two minutes after reopening at 9.57 a.m., and trading was ceased.
 
In the end, the Hushen 300 Index plunged 7.21 percent to close at 3,284.74 points.
 
The benchmark Shanghai Composite Index was down 7.32 percent to close at 3,115.89 points. 
 
The smaller Shenzhen index lost 8.35 percent to close at 10745.47 points. The ChiNext Index, China's NASDAQ-style board of growth enterprises, dropped 8.66 percent to close at 2,254.52 points. 
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.

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World Bank cuts 2016 global growth forecast
Washington : The World Bank has cut the global growth forecast for 2016 to 2.9 percent, saying that weak growth among major emerging markets will weigh on the global scenario during the year.
 
In its Global Economic Prospects Report issued on Wednesday, the Washington-based institution expected the world economy to grow 2.9 percent in 2016, 0.4 percentage points lower than the bank's forecast in June 2015, but higher than the estimated 2.4 percent growth in 2015, Xinhua news agency reported.
 
Developing economies are forecast to expand by 4.8 percent in 2016, less than expected earlier but up from a post-crisis low of 4.3 percent in the year just ended; advanced economies are expected to grow 2.1 percent this year, also lower than its June forest but up from the estimated 1.6 percent increase in 2015.
 
"The January Global Economic Prospects tells us that if 2015 was a disappointing year for the world economy, 2016 is the risky year," said Kaushik Basu, World Bank Group vice president and chief economist, at a media briefing. 
 
"The global economy, in particular the emerging economies could hit a road bump."
 
Downside risks, including slower growth, financial stress around the US Federal Reserve tightening cycle, weak commodities prices, and heightened geopolitical tensions, have become increasingly centred on emerging and developing countries, said the report.
 
The emerging economies seem to be coming apart, with Brazil and Russia expected to remain in recession in 2016, while China and India forecasted to grow around 7 percent. 
 
China is forecasted to grow 6.7 percent in 2016 and 6.5 percent in 2017, lower than the estimated 6.9 percent growth in 2015.
 
In 2016, the global growth, the emerging market growth in particular, will depend on continued momentum in high income countries, the stabilisation of commodity prices, and China's gradual transition toward a more consumption and services-based growth model. 
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.

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