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Signs Of Improving FDA Inspection Outcomes At Indian Sites But Long Road Ahead

 
• By Anju Ghangurde

Moving up the manufacturing compliance curve is still a work in progress for several Indian firms, but there appear to be some early signs that US FDA inspection outcomes, in general, may have improved.

Pharmaceutical production
INDIAN FIRMS APPEAR TO HAVE IMPROVED MANUFACTURING COMPLIANCE

Data shared at a recent media briefing pertaining to the India Pharmaceutical Forum 2018 highlighted that India’s share of the global inspections of manufacturing sites by the US FDA declined in 2017, to 9% from 10% in 2016, while outcomes improved during 2017 in comparison to previous years. India accounts for about 7% of global US FDA-approved manufacturing sites.

Vikas Bhadoria, senior partner at McKinsey & Company, India, said that in terms of inspection outcomes, of the 192 US FDA inspections conducted in India in 2017, 8% resulted in OAI (official action indicated), while 41% were stipulated as VAI

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

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