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Drug approvals fall on account of tardy & tedious process by NDAC-Divya Rajagopal

Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer. The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health...

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Question of efficacy -Leena Menghaney

The country is clearly shaping its legislation to promote access to medicines by fostering generic production. INDIA'S approach to the revision of its Patents Act in 2005 is a clear example of a country shaping its legislation to promote access to medicines by fostering generic production. Although World Trade Organisation (WTO) rules made it mandatory for India to put in place a patent regime for medicines by 2005, nothing obliges...

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Need for new TB drugs

-The Hindu   Public sector participation in discovering, developing and making a drug available at affordable prices may be the only way to find new cures for diseases like TB, says Pof Samir Brahmachari on the occasion of World Tuberculosis Day Tuberculosis (TB), a raging problem in Europe and Americas till early 20 century, now predominantly affects the developing world where it continues to be a major health problem and is making in...

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Drug Trials: Irked NHRC issues notices to Centre and Andhra Pradesh government-M Suchitra

Says respond else face action Annoyed by the non-submission of reports regarding illegal clinical trials of breast cancer drug, the National Human Rights Commission (NHRC) has issued notices to the Union health ministry and the Andhra Pradesh government. It has asked the Centre and the state government to respond within six weeks or face action. The commission had in June last year sent notices to the Union health secretary, secretary of the...

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Clinical trials in the dock

-The Hindu With the Supreme Court issuing notice to the Central government on the matter of illegal Drug Trials, the sordid state of human clinical trials is all set to be exposed. For multinational companies eager to cut corners, India offers an attractive package of weak laws, lax and almost non-existent oversight of trials, a huge illiterate, vulnerable population that can be easily exploited, very little volunteer protection and a sizeable...

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