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88 clinical trial volunteers died in 4 years due to direct side effects: Health ministry data -Sadaguru Pandit

-Hindustan Times With little transparency on how such deaths are investigated, and new rules relaxing how clinical trials are conducted in India, this data could be a poor estimate, said experts. Mumbai: At least 1,100 people who took part in clinical trials over the past four years have died, and 88 of these deaths were caused by direct side effects of the trials, the health ministry told the Rajya Sabha last week. But,...

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Generic medicines in a digital age -Dinesh S Thakur & Prashant Reddy T

-The Hindu We need a legal mechanism to ensure that all generics are of the same standard as the innovator product The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug,...

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RTI brings to light drug trial on humans -Syed Intishab Ali

-The Times of India JAIPUR: A doctor conducted drug trial on heart patients but seven of them died during trial of the drug. Moreover, another doctor conducted drug trials of different companies and 10 of his cancer patients died during the trials. An RTI filed by a government-run Indore hospital Dr Anand Rai exposed deaths leading to drug trials in entire country. Answering to the RTI, office ofdrug controller general, ministry of...

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'436 killed in clinical trials last year'-Durgesh Nandan Jha

-The Times of India As many as 436 people died last year due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects. Union health minister Ghulam Nabi Azad said on Friday that deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or side-effects of the drugs or their...

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The dark underbelly of India’s clinical trials business-Malia Politzer and Vidya Krishnan

-Live Mint Incidents at Bhopal and Indore highlight irregularities and ethical violations in some trials In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials. Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10...

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