December 2016 Current Affairs

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WHO suspends TB drugs from India’s Svizera Labs on quality fears

WHO suspends TB drugs from India’s Svizera Labs on quality fears
19 March 2016 Current Affairs: The World Health Organization has suspended the approval of tuberculosis drugs made by India’s Svizera Labs, a major supplier to developing countries, following an investigation into standards.The United Nations agency, which acts as a drug watchdog in markets lacking robust local regulation, said on Friday it had suspended all TB products made at Svizera’s Mumbai site because manufacturing standards and quality management were unreliable.It also said independent experts should retest batches of medicine already on the market and it might be necessary to recall supplies, depending on the outcome of those tests.The move is a fresh blow for India’s pharmaceuticals industry, which supplies cheap generic medicines to countries worldwide but has been tarnished by a series of quality problems in recent years, denting confidence in its products.The WHO had previously issued a warning letter to Mumbai-based Svizera Labs, part of Maneesh Pharmaceuticals, in September 2015, after finding dirty surfaces, black mould in a cleaning area, low hygiene standards and inadequate record-keeping.The latest “notice of suspension” letter was posted on the WHO’s website 15 days after being sent to the company. It highlighted several complaints about the quality of certain drug batches.Boudewijn Ploos van Amstel, managing director of Svizera Europe, said the company disagreed with the assessment, adding that the WHO had ignored information from the company showing that Svizera’s operations were up to standard.“The letter of suspension is very misleading,” he told Reuters by telephone from the Netherlands.The WHO plays a critical role in monitoring drug quality in poorer countries through its Prequalification of Medicines Programme, which ensures that treatments supplied by UN agencies such as UNICEF are of acceptable quality.The programme is also used by governments to guide the bulk purchase of medicines. Reuters.


December 2016 Current affairs

November 2016 Current affairs
30 NOV
NEWS
29 NOV
NEWS
28 NOV
NEWS
26 NOV
NEWS
25 NOV
NEWS
24 NOV
NEWS




October 2016 Current affairs
31 OCT
NEWS
27 OCT
NEWS
26 OCT
NEWS
25 OCT
NEWS
24 OCT
NEWS
22 OCT
NEWS

September 2016 Current affairs
30 SEP
NEWS
29 SEP
NEWS
28 SEP
NEWS
27 SEP
NEWS
26 SEP
NEWS
24 SEP
NEWS

August 2016 Current affairs
31 AUG
NEWS
30 AUG
NEWS
29 AUG
NEWS
27 AUG
NEWS
26 AUG
NEWS
25 AUG
NEWS



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