New Delhi: The South African drug regulator has sought a detailed report from Ranbaxy Pharmaceuticals (SA), a unit of Sun Pharmaceutical Industries Ltd, after it recalled 18,000 containers of folic acid tablets in the African nation in December, according to two people familiar with the matter.
The Medicines Control Council of South Africa found that the company’s folic acid tablets included potentially harmful Betacin, an anti-inflammatory drug with the active ingredient indomethacin, a senior executive from the Pretoria-based drug regulator said in a phone interview. The executive declined to be named.
“We have warned the company that in future such incidents should not happen. We also directed Ranbaxy to submit a report in this regard within a month. Based on that report, we will take necessary actions," the executive said.
Folic acid, or vitamin B9, tablets are prescribed to women who are expecting, or those who are three months pregnant.
“Indomethacin will not only affect the pregnant women who consume this, leading to delayed labour, but also be transferred to babies," the executive at the South African drug regulator said.
A Sun Pharma executive based out of India confirmed that his company will have to submit a detailed report on the issue to the South African government. The executive requested anonymity. A spokesperson for Sun Pharmaceuticals declined to comment.
The drug recall in South Africa is an exception rather than the rule, said Hemant Bakhru, an analyst at UBS Securities.
“Apart from USFDA (US Food and Drug Administration), Indian companies haven’t faced any trouble from regulators of other countries. Even with USFDA, the question is not about quality of products but about other issues like data capturing standards," Bakhru added.
London-based Sunday Times in December first reported that Ranbaxy recalled drugs in South Africa. In its report, the newspaper cited Keiso Mofokeng, a quality control manager at Ranbaxy, who said that the company had issued the recall because of Betacin’s side-effects.
Mofokeng was cited as saying that the company was investigating the matter. He told reporters that those who had taken pills from the batch must “cease taking the pills; secondly, return the used container to the pharmacy, clinic or wherever it was obtained; and contact the company."
Ranbaxy Laboratories was acquired by Sun Pharmaceutical from Japan’s Daiichi-Sankyo Co. Ltd for $4 billion in April 2014. Daiichi-Sankyo bought the company in 2008 from Delhi-based brothers Malvinder Singh and Shivinder Singh, soon after which its troubles with the USFDA started.
According to Dinesh Thakur, a former Ranbaxy executive who was the whistleblower in 2004-05 when Ranbaxy allegedly fabricated drug test reports, if the recall in South Africa took place because of external complaints, it would indicates serious lapses in quality control.
“To me, the important issue is whether the recall happened due to alerts raised within the company’s own quality control system or due to external complaints. If this particular recall by Ranbaxy happened because of external complaints, it would indicate a serious quality control failure within the company because all outgoing batches need to be pre-checked as a part of the batch release process under cGMP (current good manufacturing practices) protocols. Regulators will need to investigate this issue in a transparent manner and disclose why such a mix-up happened at Ranbaxy," Thakur said.
Sun Pharma shares rose 3.3% to ₹ 854.55 at the close of trading on the BSE on Wednesday; the benchmark Sensex gained 0.82% to 23,381.87 points.