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US FDA sounds alert on quality issues in Indian pharma

Warning letters might increase as 190 facilities are expected to be inspected in the next 3 years

Veena Mani  |  New Delhi 

Quality issues persist for Indian pharma firms, says USFDA

Quality is a challenge for the Indian pharmaceutical sector, the largest supplier of drugs to the United States, according to a recent blog by the US Food and Drug Administration (US FDA). 

Of the 42 warning letters sent out by its office of manufacturing quality last year, nine — about one-fifth — were addressed to Indian facilities. The number could rise over the next three years as the US FDA would inspect 190 facilities that it could not in the past five years, wrote  

“Quality issues are an ongoing challenge for the Indian pharmaceutical industry,” wrote Mary Lou Valdez, FDA’s associate commissioner for international programmes. US FDA inspections in India and China have doubled — 20 per cent of total inspections now, compared to 11 per cent earlier — since 2012. This has led to a spurt in warning letters as well.

In 2012, the amendments to the Generic Drug User Fee Act (GDUFA), 2008, made it compulsory for manufacturers of generic prescription drugs to pay a fee along with applications seeking permission to sell new drugs in the US, and approval for generic products.

“Since the GDUFA, about 55 per cent of the GMP (good manufacturing practices)-related warning letters issued by the CDER (Centre for Drug Evaluation and Research) division of the FDA were issued to facilities in India/China. However, just one out of the total nine resolutions during the period was from India/China,” wrote Deepak Malik, an analyst at Edelweiss Securities, in his recent report. 

India is also the seventh-largest supplier of food to the US. Over the past decade, the pharmaceutical market has grown by nearly 14 per cent and continues to experience steady growth. “In order to fully realise the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace and ensure global quality and safety demands are met,” US FDA’s Valdez said.

According to the Edelweiss report, warning letters are not easy to resolve. Cadila’s Moraiya unit’s warning letter could be resolved soon, 426 days after it got one. A recent re-audit of the unit in Gujarat had no FDA observations. Sun Pharmaceutical’s Halol unit, also in Gujarat, and plant in Visakhapatnam, Andhra Pradesh, could also resolve their warning letters soon. These got the letters 432 days and 474 days back, respectively.

“Apart from actual quality issues, the US FDA has also pointed out that data integrity is an issue with Indian drug firms,” said Meghana Inamdar, an international commercial lawyer at Mumbai-based consultancy The firm prepares Indian for FDA visits.