The Drug Controller General of India (DCGI) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. He or she is the head of the CDSCO – the government body responsible for approval of new drugs, clinical trials in the country, laying down the standard for drugs, control over the quality of imparted drugs, coordination with various state organizations and providing advice to maintain uniformity in the enforcement of the Drugs and Cosmetics Act.


‘436 died during clinical trials last year’
- Nirmalya Dutta
February 23, 2013 at 11:40am
As many as 436 people died last year due to serious adverse events (SAE) during clinical trials and the Union Health Minister has said the deaths …

Can ethical committees stop illegal clinical trials?
- Nirmalya Dutta
February 15, 2013 at 04:05pm
In a move to discourage the rampant frequency with which untested drugs are released in India, all pharmaceutical companies that conduct clinical …

India’s drug control body’s hall of shame
- Nirmalya Dutta
January 30, 2013 at 01:04pm
14 years – that’s how long Deanxit, anti-depressant marketed by a Danish company was sold in this country until its safety and efficacy was …

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