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Lawfully Yours | AZB and Partners 10:20 PM | October 11,2009
Bayer contended DCGI should not approve any application for a generic drug if the original has been patented
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Radhieka Pandeya 10:47 PM | October 06,2009
The industry will have to conduct trials on the three-drug combinations against the two-drug ones, R.K. Sanghvi, chairman of the medical sub committee said
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Radhieka Pandeya and Priyanka Mehra 01:15 AM | September 23,2009
Contraceptives’ status may be changed from over-the-counter to prescription drugs that can’t be advertised
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Radhieka Pandeya 12:23 AM | August 31,2009
Marketing approval had been given without local human clinical trials; regulator now says they are required
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Radhieka Pandeya and C.H. Unnikrishnan 09:25 PM | July 22,2009
The DCGI asked the licensing authorities in the states not to issue any new licence for the oral single drug formulation of artemisinin and withdraw the licences granted earlier by July-end
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C.H. Unnikrishnan 12:38 AM | June 24,2009
At present, drugs obtained from plants are not categorized as modern medicines due to lack of norms
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C.H. Unnikrishnan 12:47 AM | June 18,2009
Advinus is working with two multinational drug companies to develop drugs for other diseases
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Radhieka Pandeya 09:47 PM | June 08,2009
Regulator acts after evidence of attempts to evade import duty and bring in ‘spurious’ drugs to Mumbai, Chennai
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C.H. Unnikrishnan 11:39 PM | May 14,2009
An earlier audit by the regulator had found the trial had violated protocols, standard operating procedures and norms on good clinical practices listed in the country’s drugs law
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Radhieka Pandeya 12:27 AM | April 20,2009
The Drugs Controller General of India, the national regulatory authority, had been disqualified by WHO in late 2007 in a decision that barred any new vaccines made by Indian manufacturers from receiving the global agency’s approval
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Radhieka Pandeya 12:25 AM | March 28,2009
India’s drugs regulator has asked Shreya for details of imports, status of any clinical post-marketing trials
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PTI 10:29 PM | March 12,2009
During the audits, glaring deficiencies have been found as the sponsors, monitors and CROs do not adhere to protocols
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10:11 PM | February 23,2009
The marketing agent for BioThrax in India will be Biological E, which also won a major part of the government’s procurement for essential vaccines after the closure of the 3 PSUs last year
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Radhieka Pandeya 05:46 AM | November 15,2008
Infant’s death leads DCGI to allege testing rules were violated for vaccine; Wyeth points to GVK Biosciences
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Radhieka Pandeya 10:56 PM | October 07,2008
The combination drugs were taken off store shelves last year because of doubts over their efficacy, safety
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