Sun pharmaceuticals, the new owners of Ranbaxy have denied knowledge of any adverse findings related to their new Ranbaxy plant acquisition. The company was responding to an affidavit filed in the Supreme Court by the regulator.The Sun pharma took over Ranbaxy in 2014.
“Based on our understanding of the matter, there is no truth to the assertions you are making,” a Sun spokesperson commented while speaking to the Economic Times.
The Drug Controller General of India (DCGI) had submitted an affidavit after a public interest litigation (PIL) was filed by activist-lawyer ML Sharma. An ET report mentions it contains references to the Ranbaxy plants based on observations made in June-July 2013.
According to reports in the media, Advocate, ML Sharma has demanded 3 units of Ranbaxy shut down as he alleges that adulterated drugs were supplied from these facilities. Ranbaxy Whistleblower Dinesh Thakur is planning to join forces with Thakur. A PIL had been filed by Thakur in February, seeking reform of drug regulations in India; however he was rebuffed by the SC. Since then Thakur has been actively agitating about malpractices and discrepancies prevailing in the functioning of the drug regulator on various social platforms.
I am seriously thinking of joining the proceedings currently before the SC after proceedings currently before the SC after I confer with my attorneys,” Thakur said in an email to ET.
Thakur’s latest attack comes as the regulator prepares to give its side of the story on whether it found any wrongdoing at Ranbaxy’s various manufacturing plants in India.
Mr. Thakur alleged what has taken the drug authority so long to act, when it could have taken action immediately, for defying manufacturing norms; there are provisions in the law for the same. “The drug controller has complete authority under the Drugs and Cosmetics Act to prosecute the company if it found that the records were fudged, instead of waiting for two years to take action,” he said.
The Drug Controller’s office when contacted elicited by ET no response. Phone calls to GN Singh, the drug controller general of India, were not taken either..
Trouble at Ranbaxy has been brewing since 2008 when the USFDA found it violating manufacturing norms and stopped it from selling 24 of its drugs in the open market. A year later another lacunae of falsified data was pointed at by the FDA. The final blow came when Dinesh Thakur blew the lid on safety breaches and other violations, leading to a fine of $500 million being imposed on the company by the US Department of justice.
The company has since changed hands twice. The first time to be sold to Daiichi Sankyo for 4.6 billion by Malvinder and Shivinder Singh and the second time by Japanese , Daiichi to Sun Pharma for $ 3.2 billion along with arbitration proceedings against the Singh Brothers
The Singapore court in a decree last week has penalized the Singhs’ ( former owners of Ranbaxy) by asking them to pay 2,562 crore to Daiichi Sankyo as compensation for the losses sustained by the Japanese firm on account of violations that took place under their charge.