Despite regulatory issues and pricing pressures, can India continue being the world's generic capital?
I
n August 2002, Ranbaxy filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) to manufacture atorvastatin, the generic version of cholesterol drug Lipitor—the world's top-selling drug, generating over US$10 billion in annual revenue. In 2011, it joined a long list of Indian generics makers who have been getting the go ahead to sell in US since the 90s. Selling generics got Indian pharma giants access to the US drug market, the world’s largest and Americans got access to affordable versions of medication. [ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product].
At the same time, as Katherine Eban writes in her book Bottle of Lies, “the world’s greatest public health innovation also became one of its greatest swindles”. In an attempt, to formulate a generic version of Lipitor, the company was found to be using lower-quality ingredients to save money, manipulating data, and allegedly selling drugs that could potentially endanger patient safety. In 2013, Ranbaxy’s US subsidiary pleaded guilty and paid about $500 million in fines. “To minimise costs and maximise profits, companies circumvented regulations and resorted to fraud: Manipulating tests to achieve positive results and concealing or altering data to cover their tracks,” writes Eban.
Also listen: Katherine Eban: Ranbaxy and the dark side of Indian pharma
A decade later, much has changed. There has been a drop in the number of significant violations, but quality compliance and data integrity continues to be an issue.