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. The stock price of Lupin Pharmaceuticals, the largest drug company by Indian sales, fell by 18% to Rs 860 ($13.3) in a day and has since trailed even lower to Rs 826 ($12.7).
careful what you wish for
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
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