Regulatory Focus™ > News Articles > Report: Indian Drug Regulator's Office Has 'Washed Its Hands From Drug Approvals'

Report: Indian Drug Regulator's Office Has 'Washed Its Hands From Drug Approvals'

Posted 19 April 2012 | By Alexander Gaffney, RAC 

The Economic Times of India reports the Drug Controller General of India (DCGI), the regulatory body in charge of approving drugs and clinical trials, exists in a state of "limbo" after a series of power struggles and vacancies.

The problems are resulting from the formation of New Drug Advisory Committees (NDACs) which were set up to offer regulatory advice to the DCGI, but have instead "over ridden the powers of the drug controller" reports The Economic Times of India.

"Drug companies say that due to the committees, the DCGI has become non accountable to issues of drug approvals," wrote The Economic Times of India.

"DCGI has become a defunct body, as it has no powers in decision making," said one unnamed official to The Times.

Once the NDACs were in place, the DCGI effectively "washed its hands from drug approvals" to avoid controversy stemming from prior approvals of "unethical clinical trials," explained The Economic Times of India.

That has left the body serving more "as a facilitator instead of a regulator to help pharma companies," reported The Times of India.


Read more:

The Economic Times of India - Drug Regulator office has gone defunct as a quasi regulatory body takes charge of crucial approvals

The Times of India - Drug Controller General of India will facilitate, not regulate: Singh

The Economic Times of India - Drugmakers alarmed at stop-gap head at Drug Controller General of India


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