Govt may waive clinical trials for drugs used in US, UK to i
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In order to allow new drugs to be available in the market, the government has proposed doing away with clinical trials for drugs that have been approved and are efficient in developed markets. These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. This proposal has been sent by the health ministry to the law ministry for suggestions after which it will be released. This move will reduce both the introduction time to 45 days as well as the cost of new drugs.
The ministry has suggested relaxing regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in developed drug markets. It also suggests relaxing rules for clinical trials in the case of drugs used to treat patients suffering from life-threatening or serious diseases such as drug-resistant tuberculosis, hepatitis C, H1N1, dengue, malaria and HIV...



http://www.hindustantimes.com/health/to-speed-up-availability-of-medicines-govt-may-waive-clinical-trials-for-drugs-used-in-us-uk/story-ShtpawCh9VCKibnHe1rqdJ.html
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