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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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Generics vs big pharma, reloaded -Shamnad Basheer

-The Hindu The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug...

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Key drivers for good health -Soumya Swaminathan

-The Hindu This month marks the introduction of the Sustainable Development Goals (SDGs), which aim to dramatically improve lives across the world by 2030. This month marks the introduction of the Sustainable Development Goals (SDGs), which aim to dramatically improve lives across the world by 2030. The SDGs will help countries frame their policies and strategies towards achieving these mutually agreed upon goals and targets. SDG 3, which aims to ensure good...

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Drugs on hold over doubts about Indian trials

-The Telegraph Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday. Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered "irregularities" in documents relating to human studies conducted by...

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