FDA meeting with India’s government produces results

There are mixed reports of cooperation and clashes between the US and India on drug regulation after meetings between the FDA’s commissioner Margaret Hamburg and various Indian officials (see FDA seeks closer work with India’s regulator after visit).

Among the concerns raised by India were that penalties against exports to the US were too harsh, and accusations that bans were designed to protect American markets from cheaper competition.

There were reports, too, of renewed desire to work more closely together, including a 10-point statement of intent.

“It is a welcome development as drug regulators of two of the largest democracies of the world have agreed to work together for patient safety and to improve the quality of medicines and ensure a more science-based evaluation system.

GN Singh, drug controller general of India, talking to Business Today.

Related news:

US, Indian drug regulators sign 10 point cooperation agreement (Business Today).

Keep us in loop before any FDA action, India tells US (Business Standard).

US, India clash over generic drugs (The Wall Street Journal).

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