India Faces Shocking Lapse in Drug Safety Norms

The promotion of unapproved medicines is increasing in the market. The panel report reveals that the Phase III trial which experiments the safety through the efficacy trials on patients, have been missed by GSK for most of the medicines.

 Drug expert Vikas Dandekar commented, "Unapproved drugs have been allowed to be marketed in India, questionable combinations have been allowed to be marketed in India, so all of these will have to be probed very closely. And this will definitely blow up into a big issue."

It is the inadequacy of the law that gives loopholes to many medicines. As per IBN live reports, the interview conducted on some pharma companies named in the report highlights this inadequacy. "We have followed the procedure. As per the law, it is not mandatory to carry out Phase III trials in India for each and every new drug. Both the drugs in question are marketed in a number of countries internationally and have been proven to be life saving. We deny that there has been any collusion with the DCGI," said CIPLA.

Union Health Minister Ghulam Nabi Azad’s view is different on the report. He said, "Not true there have been no clinical trials. But we have ordered steps to be taken and a report in two months." However the health minister has promised to take actions on the basis of the report.

The issue is a serious one since it includes doctors of famous institutes. Medicines are life givers and a small mistake can turn them into life takers.