During her visit to India, one of Hamburg’s main focuses was on the quality of drugs and ingredients manufactured in the country for export to the States, especially in light of several US suppliers - including Ranbaxy and Wockhardt - having recently been pulled up on a number of GMP violations.
“In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters,” Hamburg said in a recent blog post.
“In recent years the FDA has identified significant lapses in quality by some companies operating in the US and around the world,” she continued, adding “when companies sacrifice quality, putting consumers at risk, they must be held accountable.”
In order to support this quality drive, the FDA is upping the number of its employees at its Indian office. “In March 2013, the FDA received approval from the Indian government to add seven drugs investigators in India,” FDA spokesman Stephen king told in-Pharmatechnologist.com.
“We are currently recruiting and training staff for these positions, with the FDA’s presence growing from 12 to 19 American staff based in-country, including 10 employees dedicated specifically to medical products.”
King said the additional inspectors will assist the agency in meeting its legislative obligations, especially in light of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - including the Generic Drug User Fee Amendments (GDUFA) – which “requires the FDA to achieve parity between the inspectional schedules for foreign facilities and domestic facilities.”
The news reaffirms the FDA’s commitment to its overseas’ regulatory presence, having added $10m (€7m) last year to its inspection budget in China, as well as asking the Chinese Government in 2012 to add 16 more inspectors to its ground force – a request that is still pending though the FDA told us in November it remained optimistic the request would be approved.
Statement of Intent
During Hamburg’s visit she signed a statement of intent with the Indian Secretary of the Department of Health & Family Welfare, Keshav Desiraju, pledging cooperation between the two agencies in a number of areas regarding manufacturing compliance.
This included the sharing of information related to current good manufacturing practice (cGMP), engaging collaboratively as observers in product and facility inspections, informing the relative regulator before undertaking inspections in the other’s country, and facilitating information sharing in support of public health and product safety.
The four page statement between the two countries was signed at New Delhi on February 10 is valid for five years, though either participant is able to terminate the concord with three months’ notice.