Admin
... Read More
By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookie Policy.
Written By: Admin | Published : April 22, 2013 5:55 PM IST
The United States 2013-14 Budget might actually have more effect on the Indian generic pharmaceutical companies than PC's budget. The proposal is to increase the budge of the US Food and Drug Administration (FDA) which will eventually lead to more approval for generic drugs including Indian generics.
The FDA has sought $4.7 billion from the US government and experts believe the FDA might get it even in these uncertain economic times. This fiscal it would lead to the FDA hiring more inspectors which could increase handling capacity and will lead to more approvals of generic drugs.
This is how it might pan out: the FDA has sought $4.7 billion. It is likely the US government may well allocate the amount, in spite of the current tight budget regime. And from drug-makers' perspective, higher FDA staff could mean quicker regulatory clearances. Observers have pointed out that the FDA is understaffed, which has led to slow approval of drugs. 'That could change for the better now. More FDA staff is good news indeed,' said a senior official of a generic drug major.
There's another reason for India's newfound optimism. This fiscal, the FDA is expected to focus on China, not India, in terms of facility inspections and intense scrutiny of applications. With simmering tensions, the FDA will be inspecting manufacturing facilities in China more closely. Prior, the FDA has been inspecting manufacturing facilities across the world, including those in India. In fact, it inspected 813 facilities in 62 countries last year.
Earlier resource constraints have forced the FDA to rely on inspectors in the US. So, certain sections of the industry fear that more FDA inspections could increase the number of warning letters. 'But higher staffing would also result in speedier approvals,' said a source. Indian companies are optimistic that with these new turn of events, Indian generic companies could finally make headway in the US.
