The South African drug regulator has highlighted major concerns over Ranbaxy Laboratories’ folic acid tablets ‘Rogue’, which were recalled last year, and has sought a detailed report from the parent company Sun Pharmaceuticals.
Folic acid tablets are the over-the-counter vitamin drugs that are consumed by pregnant women and babies.
Last December, the discovery of potentially-dangerous Betacin, an anti-inflammatory drug, mixed in the folic acid tablets, had led to the recall of more than 18,000 containers in South Africa.
“The matter is receiving attention and a response will be sent in due course,” a spokesperson of regulator Medicines Control Council (MCC) said in an email response to HT’s questionnaire.
A Sun Pharma official confirmed the MCC’s concerns. “The South African drug regulator had raised complaints to Ranbaxy Pharma (SA) Ltd that its Be-Tabs Folic Acid product included a Schedule 3 prescription capsule called Betacin, which led to the company issuing a recall notice,” said the source. “The company is still studying how widespread it is, and we are in the process of doing an investigation.”
However, the company did not reply to HT’s mail.
Sun Pharma acquired New Delhi-based Ranbaxy Laboratories from Japan’s Daiichi Sankyo for close to $4 billion (around `24,000 crore). The merged Sun Pharma, with total revenues of $4.5 billion (`27,856 crore), is the largest pharmaceutical firm in India and the fifth-largest generics company in the world.