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India makes tests mandatory for cough syrup export - 0 views

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    India will make tests mandatory for cough syrups before they are exported, a government notice showed on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan. Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry on Tuesday. India's $41 billion pharmaceutical industry is one of the biggest in the world but its reputation was shaken after the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies. Syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year. "Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis," said the notice issued by the trade ministry. The health ministry did not immediately respond to a query on whether testing would be required for cough syrups sold in the domestic market.
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India probes bribery claim in toxic cough syrup tests - 0 views

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    Health authorities in India have launched an inquiry into an allegation that a local pharmaceutical regulator, in return for a bribe, helped switch samples of cough syrups that the World Health Organization (WHO) had linked to the deaths of children in Gambia before the samples were tested at an Indian laboratory, according to two government officials and documents reviewed by the Reuters news agency. In an April 29 letter to the Anti-Corruption Bureau (ACB) in Haryana state reviewed by the news agency, a lawyer named Yashpal accused the state's drug controller, Manmohan Taneja, of taking a bribe of 50 million rupees (£481,600 approx.) from local manufacturer Maiden Pharmaceuticals to help it switch the samples before an Indian government laboratory tested them. Maiden's factory is based in Haryana state. Reuters points out that it was unable to independently establish that any bribes were paid. Taneja did not respond to phone calls, messages or emails seeking comment. Maiden did not respond to requests for comment. The WHO said it had no knowledge of the allegation. Yashpal - who like some Indians uses only one name - did not say in the letter where he got the information, or provide evidence for his claim about the syrups made by Maiden. Reuters was unable to independently establish that any bribes were paid.
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Pharma Companies Face Suspension Amid Contamination Concerns - 0 views

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    The Indian government has suspended manufacturing in over 40 pharmaceutical companies based on a risk-based assessment conducted earlier in the year across 162 firms, according to the data provided by Union Health Minister Mansukh Mandaviya in Parliament on Thursday (Aug. 10). "Overall, a sum of 143 show-cause notices has been issued," Mandaviya said. There have been numerous recent incidents involving accusations from foreign countries regarding the contamination of syrups, eye drops, and ointments manufactured in India. Countries such as the Gambia, Uzbekistan, and Cameroon have linked the deaths of 70, 18, and six children, respectively, to cough syrups contaminated in India. Licenses for specific products have been either temporarily suspended or fully revoked for an additional 66 companies. In one case, an FIR has been registered, and in 21 cases, warning letters have been issued following inspections by both the Central Drugs Standard Control Organization and State authorities, the Minister added. Meanwhile, the Indian government has mandated rigorous testing for cough syrups before export. Starting June 1, any cough syrup must possess a government laboratory-issued certificate of analysis before being exported, the government said in a notice dated May 22.
pharmacybiz

Indian court orders jail for 2 executives for shoddy drugs - 0 views

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    An Indian court has sentenced two pharmaceutical company executives to two-and-half years in jail for exporting substandard drugs to Vietnam a decade ago, months after the WHO linked their cough syrups to the deaths of children in Gambia. India suspended production at Maiden Pharmaceuticals in October last year for violations of manufacturing standards after the World Health Organization said four of its cough syrups may have killed dozens of children in Gambia. The company has denied its drugs were at fault for the deaths in Gambia and tests by an Indian government laboratory found there were no toxins in them. The company had been facing legal difficulties for years over suspected shoddy products. A court in Sonipat, near New Delhi, where Maiden has its main production facility, ordered jail for company founder Naresh Kumar Goel and technical director M.K. Sharma for exporting heartburn medicine "not of standard quality" to Vietnam.
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