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Toe the line or fall: A dissection of FDA’s message to Indian pharma

Each warning letter is dropping investors’ faith, delaying new drugs and pushing companies to invest in assuring quality

11/12/17

Ruhi Kandhari

In November, two Indian pharma companies lost close to 20% and 6% market cap following plant inspections by the US regulator Food and Drug Administration  

It can cost a pharma company up to Rs 100 crore in opportunity cost and making amends to by employing FDA-accredited consultants, some of whom charge $6,000 to $8,000 a day for approximately two years

Drug manufacturers that have built a culture of prioritising quality and teamwork have found it easier to get favourable FDA inspections

Since the US is a major and preferred market for India, Indian Pharmaceutical Alliance organised a series of workshops in November for the US FDA to train mid-level management in drug manufacturing plants

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Follow the rules. That was the crux of the message conveyed by the US Food and Drug Administration (FDA) at a series of workshops organised by the Indian Pharmaceutical Alliance in November. In the same month, two Indian pharma companies lost close to 20% and 6% market cap, respectively.

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