DCGI Directs Drug Cos to Submit Safety Reports Every 6 Months

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DCGI Directs Drug Cos to Submit Safety Reports Every 6 Months

The Drug Controller General of India ( DCGI ) on September 3rd, 2012 reportedly told pharma companies to submit the mandatory safety details of their new drugs for every six months for the first two years from their launch to ensure safety and efficiency when consumed by patients.

GN Singh,the Drug Controller General of India ( DCGI ) was quoted as saying, “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.”

According to reports, DCGI would cancel drug licences if the companies fail to submit their safety files. For new cases, drugmakers have to declare the safety reports within a month of the completion of the six – month period.

The drug companies also have to provide the global marketing status of the new drug, changes in the reference of safety information and update on the actions taken for safety reasons, reports stated.

DCGI faced several criticism in recent times for lapses in implementation of drug laws, and has taken steps to tighten regulation which eventually has resulted in a sharp drop in the number of new drugs and clinical trial approvals, reports added.

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