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Written By: Admin | Updated : September 4, 2012 12:45 PM IST
The Drug Controller General of India (DCGI) has asked all pharmaceutical companies to submit safety details of their new drugs every six months after their launch, failing which their licenses would be cancelled. They're supposed to do so for 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," said the Drug Controller General of India (DCGI) GN Singh in a notification.
The Indian drug regulator has faced 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.
Among other things, companies 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, DCGI said. A parliamentary standing committee had earlier hauled up the CDSCO for several irregularitiesin its functioning. They noted how several drugs were being passed without clinical trials. The CDSCO also has a severe staff shortage and there are only 900 DIs for a country which is the leading manufacturer of generic drugs and has a population of 1.2bn.
