DCGI Directed Drug Companies to Submit Safety Reports of New Drugs

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DCGI directed Drug Companies to Submit Safety Reports of New Drugs 2012

The Drug Controller General of India ( DCGI ) on September 3rd, 2012 directed drug companies to submit mandatory safety reports of new drugs to it every six months. The country’s drug regulator, in its order, threatened to cancel drug licenses in case they fail to do so. The Directive came after DCGI found that some companies are not submitting the required mandatory safety reports every six months during the first two years.

“It has been observed that some of the manufacturers and importers are not adhering to the critical requirements in totality which has been viewed seriously by the office,” the DCGI order said. Companies which had failed to report their safety status should do so within three weeks or face cancellation of their licenses, it said. Drug companies have to declare such safety details within a month of the completion of the six – month period. The country’s drug regulator has come under sharp attack from a Parliamentary panel for clearing drugs without conducting clinical trials in India and lapses in implementation of drug laws. Incidentally, the DCGI has approved only 15 new drugs till May. As per the Drugs and Cosmetic Rules, Periodic Safety Update Reports are to be submitted to DCGI by drug companies every six months for first two years after the launch of a new drug in the country.

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