India – Indian regulators to put all drug approvals online

All regulatory approvals from Drug Controller General of India (DCGI) will go completely online to ensure transparency to global as well domestic players, according to V G Somani, DCGI.

He was speaking to newspersons on the sidelines of a two-day international regulators meet organised by the Pharmaceutical Exports Promotion Council of India (Pharmexcil) which began here on Thursday.

« The approval process is partially online as of now but will go fully transparent except for some procedures like testing over next one to two years as we need some time to validate IT solutions to be used. With the entire world can believe us more,’’ Somani added.

USFDA

When asked on increasing number of warning letters to Indian drug makers from the US Food and Drug Administration (USFDA) and recalls of few drugs, DCGI said: « The US has the right to do whatever they want to do. We see it a customer as well as regulator and our job is to satisfy them fully on all counts.’’…