US FDA sounds alert on quality issues in Indian pharma
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 Edelweiss Securities.
“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 Dr Reddy’s plant in Visakhapatnam, Andhra Pradesh, could also
resolve their warning letters soon. These companies 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 Sidvim Lifesciences.
The firm prepares Indian companies for FDA visits.
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