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Clinical trials: Expert panel's views differ from formula under study-Sushmi Dey

-The Business Standard Confusion over clinical trial compensation norms Even as the health ministry is evaluating a formula to compensate victims of clinical trials, an expert committee, headed by Ranjit Roy Chaudhury, has recommended some stringent measures that appear contrary to the formula under consideration. The committee, set up by the ministry to formulate policy and guidelines for clinical trials, has suggested that no compensation be given for therapeutic inefficiency during clinical trials...

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Activists hail report on HPV vaccines, but PATH says no violations-Aarti Dhar

-The Hindu     Report points to a serious dereliction of duty by many of the institutions involved Health activists have appreciated the Parliamentary Standing Committee's report on the "Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India." They commended "its candid, transparent contents, which reflect the committee's acknowledgement of the unethical nature of the HPV trials'' conducted in the country. In the trials, Program for Appropriate...

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Unethical collusion tag on vaccine campaign

-The Telegraph Two Union government health agencies colluded with a foreign entity to conduct a mass vaccination campaign on thousands of girls in India four years ago, violating medical ethics and national laws, a parliamentary committee said today. The parliamentary standing committee on health and family welfare has blamed the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India for collaborating with the US-based Program for Appropriate Technologies...

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26 new drugs permitted for sale without trials in India

-PTI NEW DELHI: Notwithstanding strong warnings by the parliamentary standing committee on health, new drugs continue to be approved for marketing in the country without holding any clinical trials on Indian patients to test their safety and efficacy. Sources in the Health Ministry admit that as many as 26 new drug molecules have been approved since 2010 without testing them through Drug Trials on local populations. While eight new drug molecules of biologicals...

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Price control, IP Act & regulatory framework: Revisiting some imp issues about Indian pharma-Ramesh Adige

-The Economic Times Over a year ago, I had written a piece, Quo Vadis, Indian Pharma? (ET, May 11, 2012), in this column. Some key issues were highlighted in the article. Perhaps it is time to revisit the subject and bring out some current issues. Price control: Hurray, the department of pharmaceuticals has come out with a new non-intrusive price control methodology, moving from the cost-based model to the average market price...

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