Expert Panel Affirms ‘Continued Marketing’ Of Ambrisentan, Everolimus In India
Sanofi Ends Dronedarone Sales Due To Low Commercial Interest
Years after a scathing Indian parliamentary report flagged concerns around regulatory lapses for drug approvals, an expert panel has endorsed the continued marketing of ambrisentan and everolimus in the country. But dronedarone, also featured in the report, is no longer sold by Sanofi in India.
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Faced with a barrage of questions and allegations of regulatory lapses in approving drugs for launch in the country, India's drugs regulator appears to have launched a transparency drive, putting out a host of approval details in public domain that includes a list of drugs recommended for approval without trials in the country.
Days after an Indian parliamentary committee report alleged a series of serious regulatory lapses in approving drugs for launch in the country, half a dozen leading companies named in the report including Lilly, Sanofi, Novartis, Bayer and Cipla claim that they have not flouted Indian laws and deny any wrongdoing.
In what's perhaps one of the most damning reports on industry and the regulatory mechanism in India in recent times, a parliamentary standing committee on health and family welfare has charged that more than 30 new drugs were approved in the country without undergoing clinical trials.