The U.S. health regulator plans to conduct workshops across India in the next one year to sensitise Indian drug companies about the changing quality requirements in the American market.
The matter came up during a meeting between chief executives of drug companies and U.S. Food and Drug Administration (USFDA) Commissioner Margaret A Hamburg.
Wockhardt Chairman Habil Khorakiwala said the plan to conduct workshops in India was part of the USFDA’s strategy to let Indian companies be more aware of the changes happening in the U.S. in terms of the requirement for quality.
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“One of their (USFDA) objectives is to sensitise here in India about these changes. In fact, the USFDA is planning a workshop over the next one year at 3-4 locations to clarify what are the new requirements and what are the expectations of the USFDA”, Mr. Khorakiwala told reporters here.
During the meeting, which was attended by chiefs of pharma companies, including Ranbaxy CEO and Managing Director Arun Sawhney, Sun Pharma Founder and Managing Director Dilip Shanghvi and Mr. Khorakiwala, the Indian delegation asked the USFDA team to continue with the high-level interactions.
“The second suggestion, which was made and she (Hamburg) accepted is that this dialogue at the highest level should continue,” Mr. Khorakiwala said.
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She also accepted the proposal that a delegation of leaders and scientists from India should have interaction with larger group in the USFDA so that the issues could be discussed at length, he added.
Ms. Hamburg said the USFDA was in the process of reorganising its structure and speeding up the process of approvals.
She added that this would help clear the backlog of inspection for Indian drug manufacturers, who had applied for approval from the USFDA to export their products to the U.S.
The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the U.S., their largest export market.