Bollywood Connection with Ranbaxy
Ranbaxy has some of the leading products under its name. Some famous brands under the Ranbaxy umbrella like Revital, Volini and Chericol are endorsed by our very own famous bollywood starlets like Salman Khan, Yuvraj Singh and Sonali Bendre.
Why Ranbaxy is under the scanner
This scandal has sparked many questions in the minds of the consumers, with regards to the efficacy and credibility of these drugs in the wake of Ranbaxy pleading guilty for ‘three felony’ counts under the Federal Food, Drug and Cosmetics Act. Besides, it has also been charged for four felony counts for knowingly making false material statements to the Food and Drug Administration (FDA).
How Ranbaxy is paying for its mistakes
The huge settlement of $500 million dollar is one of the largest agreements over drug safety. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
In the civil settlement, Ranbaxy has agreed to pay $350 million to resolve allegations that drugs from the two Indian plants that did not meet specifications and those false claims were submitted to US government healthcare programs between April 1, 2003 and Sept 16, 2010.
The signs of fraud and scam started right from 2005, when Ranbaxy has been accountable for pattern of violations like incomplete pattern of Paonta Sahib drug and inadequate programmes to assess the stability characteristics of drugs.
What you really need to know about Ranbaxy drugs?
In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. But after this latest development, the Indian FDA has not given intimation if they will ban these drugs or will recall them from the Indian market. The drugs were manufactured at Paonta Sahib and Dewas in India and the drugs that are banned are acne drug Sotret, epilepsy and nerve pain drug gabapentin and antibiotic ciprofloxacin.
The Timeline of the Ranbaxy case:
• 2006: US Food and Drug Administration (FDA) inspectors note allegations about Ranbaxy’s practices
• 2007: Whistle-blower’s lawsuit alleges the company defrauded Federal programmes
• 2008: Ranbaxy’s three facilities — at Paonta Sahib and Batamandi (Himachal Pradesh) and Dewas (in Madhya Pradesh) — come under FDA’s scrutiny.
• December 2011: Ranbaxy sets aside $500 million to resolve potential criminal and civil liabilities.
• December 2011: Ranbaxy signs a consent decree with the American authorities, putting an end to the regulatory tussle; but Ranbaxy still cannot make drugs at the Paonta Sahib, Batamandi, Dewas and Gloversville, NY, facilities for the US market.
• January 2012: Company reaches a settlement agreement with FDA; agrees to stop making drugs for the US market at two plants until these are brought up to US standards.
• May 2012: Ranbaxy hires two US-based consultants to advise it on remedial work to be done at its manufacturing units in India.
• May 13, 2013: Criminal charges filed
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