THE US Consumer Product Safety Commission (CPSC) is seeking fines against export-minded Hyderabad pharmaceutical giant Dr Reddy's Laboratories for violating rules to prevent children taking harmful substances.
The charges are the latest regulatory troubles facing Indian pharmaceutical firms in marketing their biggest exports in the United States, cheap generic drugs. The specifics of the charge as not cited in the Reuters report.
Denying allegations, the company said an unfavourable outcome could result in “significant liabilities?¨.
India's pharma sector has been subject to increased regulatory scrutiny and has suffered drug recalls and quality control problems, damaging its US$15 billion-a-year business supplying generics.
In June 2011, certain lots of Dr Reddy's generic simvastatin tablets were recalled due to tablets having a "musty" or "mouldy" smell, said the Dr Reddy's Wikipedia entry.
On June 24, 2014, the New York Times published an article "Warning Unheeded, Heart Drugs Are Recalled" in which it said Dr Reddy's Laboratories have announced recalls over the past two months totalling more than 100,000 bottles" of heart drug, Toprol XL" "because their products were not dissolving properly", the entry said.
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