Gauri Kamath (for Info only, not official)

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Gauri Kamath

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    ...Let me explain.Roughly 11 years ago, India liberalised the FDI norms for the drug industry.It allowed the automatic approval of FDI, up to 100 per cent, in Indian drug companies.For about five years, nothing much happened.Then, Indian businessmen began to sell out to foreigners in big-ticket deals and the policy, while not actively encouraging them to do so, definitely did not stand in their way.These sales rattled some parliamentarians, homegrown industry bodies and civil society groups.They voiced fears that this would lead to a shortage of affordable, essential medicines for the Indian consumer as the buyers restructured the businesses and whittled down the local industry.So in 2012, the government bowed to their demands and changed the policy slightly. ...

    Indian Express on Dec. 4, 2013, 1:21 a.m.

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    ...The move is a wake-up call to India's drug industry and its doctors — either significantly scale-up adverse event reporting and post-market studies of drugs or face repeats of this scenario in future.The Indian Pharmaceutical Alliance says over 30 lakh Indian patients are on the drug.There is an uproar among doctors and drug companies.They are outraged by the ban's suddenness.They argue the drug still retails in the US, albeit with a black box warning regarding cautionary use.Importantly, they argue the drug has shown no evidence of a heightened risk of bladder cancer among Indian patients.Let's take each of these arguments by turn.First, the suddenness.Prima facie, the move seems out of the blue.But pio's link with bladder cancer had already become a matter of concern for some years.In early 2012, the Journal of the Association of Physicians of India (JAPI) devoted a special issue to the drug, taking up various facets of its risks and benefits. ...

    Indian Express on July 8, 2013, 4:42 a.m.

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    ...Investigators found, thanks to a former Ranbaxy employee who blew the whistle, that in the mid-to-late 2000s, company executives had extensively fabricated test data on generics destined for the US and suppressed unfavourable results.Ranbaxy, like other Indian companies, manufactures cheaper, off-patent versions of innovator drugs, or generics, that help individuals and governments cut healthcare costs.At one level, Ranbaxy's deceit is only the latest in a long string of scandals that's dogged the global pharmaceutical and medical devices industry.For the last decade or so, Western companies have been in the dock in Europe and the US for illegally marketing drugs for unapproved uses, unauthorised trials, colluding with doctors to defraud government health programmes, suppressing information on side effects, and selectively releasing favourable trial data. ...

    Indian Express on May 28, 2013, 1:01 a.m.