-The Hindu JENVAC is the first vaccine to be manufactured in the public-private partnership mode India on Friday launched its first indigenous vaccine to protect children from Japanese encephalitis. Until now, the country has been importing the vaccine from China. The Vero cell-derived purified inactivated JE vaccine-JENVAC, which received manufacturing and marketing approvals from the Drug Controller General of India, is the first vaccine to be manufactured in the public-private partnership mode between...

-Live Mint Apex court expresses concerns about drug trials being permitted on humans without comprehensive rules to regulate the approval process New Delhi: The apex court on Monday directed the health ministry to justify its approval for 162 global clinical trials in India, increasing the uncertainty faced by the nation's $500 million clinical research industry. The Supreme Court expressed its concerns about drug trials being permitted on humans without comprehensive rules to...

-The Times of India NEW DELHI: The Supreme Court on Monday forced the Centre to stop clinical trials of 162 new drugs or chemical entities which had been cleared by the expert committee for testing on human beings in India. A bench of Justices R M Lodha and Shiva Kirti Singh was about to pass an order restraining the Centre from going ahead with these clinical trials when additional solicitor general Sidharth...

-The Hindu Every biomedical and health research involving human participants, whether in conventional areas, or in new evolving specialised fields, will have to be conducted in accordance with the provisions of the proposed Biomedical and Health Research Regulation Bill, 2013. Research on human subjects in the specified areas like assisted reproductive technology (ART); organ, tissue and cell therapy; genetic and genomic studies including techniques of genetic engineering and gene therapy; nano medicines;...

-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...