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SC directs govt not to allow clinical trials of new drug entities

HT Correspondent, Hindustan Times  New Delhi, September 30, 2013
First Published: 21:10 IST(30/9/2013) | Last Updated: 01:05 IST(1/10/2013)

The Supreme Court on Monday told the government not to allow clinical trials of new drug entities until a mechanism was put in place to monitor them.


As the bench headed by Justice RM Lodha made these observations, the Centre assured the court it would not let clinical trial of 162 drugs to start unless permitted by the court. According to the Ministry of Health and Family Welfare, the Drug Controller has permitted 162 clinical trials in the last one month.

The bench also asked the Centre to consider suggestions of various stakeholders in putting in place the mechanism to avoid any serious and adverse impact. It gave two weeks time to the Centre to submit on record the regime and regulations in place to monitor such trials.

The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.

It had directed the Centre to convene a meeting of chief secretaries or health secretaries of all the states to frame a law for regulation of clinical trials of drugs by multi- national pharma companies.

Earlier, the SC had said that uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and slammed the Centre for failing to stop the "rackets" which caused deaths.

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