NEW DELHI: There are no laws at present to penalize and monitor pharma companies, which have messed up or violated norms while conducting global clinical trials for testing drugs in India to avoid instances like patients’ deaths.Last year, an infant died during a clinical trial on whom multinantional Wyeth’s advanced pneumonia vaccine was being tested in Bangalore.

The Central Drug Authority (CDA) bill finalised by the health ministry will frame laws as well as tighten existing regulation on clinical trials, and introduce a central licensing mechanism for manufacturing approvals.

“The CDA will have the statutory backing to take legal action against companies which violate norms or those who conduct trials without permission. As of now, there are no penal provisions, and nothing much can be done beyond issuing them notices and warnings”, sources said.

Source: Times of India

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