US bans import of 30 Ranbaxy drugs from India

Domestic pharma major Ranbaxy has suffered some shocks in recent times, but this may well be the most serious one. The US Food and Drug Administration on Tuesday issued an “import alert” on over 30 generic drugs produced by Ranbaxy in India, in effect blocking their entry into the company’s largest market, due to “serious manufacturing deficiencies.”
The FDA also issued two warning letters to the company pointing out its concerns about deviations from standard manufacturing processes and systems (Good Manufacturing Practice requirements certified by the agency) at two facilities — Dewas (Madhya Pradesh) and Paonta Sahib (including the Batamandi unit) in Himachal Pradesh.
However, the FDA clarified that there was no reason to consider the drugs hazardous; it only had issues with the quality of the manufacturing processes.
Ranbaxy’s half-yearly sales (January-June) in the US were at $230 million this year. Last year, the US contributed $390 million of the company’s total revenue of $1.6 billion. Analysts expect that the company’s sales may take a knock of $75-100 million this year.
As the alleged violations are of a critical nature, it would take some time to resolve and the company may take a hit of around $200 million of sales next year. Analysts estimate that the 30 drugs amount to around 40-50% of total United States sales.