In a bid to ensure that the drugs available in the country are safe for consumption, the Drug Controller-General of India (DCGI) has asked the state drug inspectors to get the samples of the drugs collected and get them tested for their quality at the drug testing laboratories.
The issue was taken up during a discussion on spurious, substandard, expired drugs in the Union health ministry early this month after which it was decided to get the drug samples collected and be tested for their safety. A letter to this effect has been sent out to the state drug inspectors. DCGI has asked the inspectors to draw samples of drugs from the manufacturing sites and sent them to the Central Drug Testing Laboratories for prompt testing. DCGI has instructed to complete the “special drive” within a period of six-nine months.
Recently, DCGI made it mandatory for the drug manufacturing companies to submit safety update reports of new drugs every six months for the first two years and for subsequent two years, failing which, the permission of the new drug may be cancelled. A notice was circulated last month to all drug manufacturing companies to submit the safety updates within 30 days otherwise it will lead to suspension/ cancellation of the new drug permission.
The report is supposed to carry current worldwide market authorisation status, update of actions take for safety reasons, changes to reference safety information, estimated patient exposure, presentation of individual case histories, studies, overall safety evaluation, material related to dosing, indications etc.
DCGI office observed that the manufacturers and the importers are not adhering to the critical requirements in totality. The office and sent out a warning to all manufacturers. DCGI has directed the manufacturers and importers who have not updated their safety reports to submit the same within three weeks.
Sources say that these stringent steps have been taken, following the recent standing committee report that found out that several popular medicines in the country had been approved without having undergone clinical trials to check for their safety. The committee said that on an average the DCGI was approving one drug every month without trials.