Comments
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.’’
"However, a warning or a recall from the USFDA does not mean that it will be followed by all other counties like Europe which also buy Indian drugs,’’ he said adding that some times it only creates `panic’
When asked on recent recall of Valsartan tablets from the US market by some drug-makers after the US Regulator `found’ some carcinogenic impact, the DCGI said it will take up its own investigation on the matter to decide if a similar ban was needed in the domestic market too.
On future growth potential, Somani, who recently took over as DCGI, said his target was to increase supply of India drugs to the world. "As of now, India supplies 40 per cent of drugs to world by volume and we want to increase it to 60 per cent over next three years,’’ he added.
Somani termed shortage of human resources and laboratory infrastructure as a `challenge’ going forward. DCGI is setting up a training academy for regulatory staff.
Regulations
Earlier while speaking in the inaugural and a panel discussion on the theme of international regulatory convergence, the official said duplication of regulation by different countries could be avoided by keeping in place `affordable’ solutions for drug manufacturing and testing.
Regulators from 25 countries, mainly from Africa and Latin America, are participating in the conference in addition to many Indian regulatory officials and industry representatives.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.