Pharma companies to submit safety reports every six months: DGCI

The safety reports are expected to ensure that the medicines have the same safety and efficacy when used by a larger number of patients.


New Delhi, September 4, 2012:  In order to enhance the safety practices followed in the Indian pharmaceutical sector, the Drug Controller General of India (DGCI) has asked pharma companies to submit the mandatory safety details of their new drugs every six months for the first two years since their launch.

At the same time, the regulator has also mentioned that companies which failed to report the safety status should do so in the next three weeks otherwise; their drug licenses would be cancelled. For the new launches made by the pharma companies, drugmakers will have to declare the safety reports within a month of the completion of the six month period.

In addition to the safety report, the pharma companies will also have to provide the global marketing status of the new drug, change in the reference of safety information and update on the actions taken for safety reasons.



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