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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.
India’s Clinical Trial Registry to be updated with new software to provide data on deaths during clinical trials: First of its kind in Clinical Trial Registries
The clinical trial registry-India, run by the Indian Council of Medical Research, has seen an overwhelming response since registration was made mandatory in June 2009. But the existing software has not been able to handle all the information. To make the country’s clinical trial registry more transparent and user-friendly, the ministry of health and family welfare has proposed that new software to be launched in November provide details on deaths during trials and hospital-wise data on ongoing studies The number and nature of the trials will also be made public. In India, adverse events or deaths during clinical trials are reported directly to the Drug Controller General of India (DCGI) and usually do not become public. People interested in participating in clinical trials have little or no access to information on the studies. A recent study by the health ministry shows that nearly 80% of the deaths during clinical trials occur in terminally ill people and not due to the drugs administered. With this new feature India’s clinical trial registry will be more advanced by way of information when compared with the US registry and this kind of a search which will enable people to search for trials by the hospital is needed in India. It is a good move, as it enables greater clarity for the general public.