The US CPSC, which is tasked with protecting children and families from risks of injuries or death associated with consumer products, had taken issue with the company’s compliance norms.
The US Consumer Product Safety Commission, a federal regulatory body, has pleaded to the US Department of Justice, seeking civil penalty against Hyderabad-headquartered drug maker Dr Reddy’s Labs, charging that the drug maker had violated provisions related to child resistant packaging in at least five prescription drugs.
The US CPSC, which is tasked with protecting children and families from risks of injuries or death associated with consumer products, had taken issue with the company’s compliance norms that required special packaging for child resistant blister packs for products sold in the US over several years.
As part of its review on June 6, the commission voted 4-1 against Dr. Reddy’s for not reporting the risks as per provisions of Consumer Product Safety Act and the Poison Prevention Packaging Act (PPPA), an expert in legal and compliance issues said.
As part of its probe that kick-started in 2012, the CPSC asserted that from 2008 to 2012, Dr. Reddy’s sold prescription drugs having unit dose packaging that failed to comply with the CPSC’s special child resistant packaging regulations and also failed to issue general certificates of conformance.
Of the global sales of $2.33 billion for 2016 financial year, Dr. Reddy’s drew $1.16 billion from its North American operations, of which the US accounted for the lion’s share.
In response to ET’s specific questions about the US CPSC recommendations to the Department of Justice, Dr. Reddy’s said it firmly disagrees with the (US) government’s allegations adding that the US subsidiary of Dr. Reddy’s has reaffirmed its commitment to full cooperation with the US government as it defends itself against allegations that the company failed to comply with applicable special packaging and reporting requirements.
In an investigation conducted by the Department of Justice and concluded in 2015, the company further added that it declined to pursue related allegations made under the Federal False Claims Act. The company informed that the products have not been distributed in the packaging at issue since June 2012. Further, the company added it has taken the investigation seriously, fully cooperating with the government since the case began in 2011, and will continue to do so.
“The safety of patients and consumers is of paramount importance to Dr. Reddy’s. The company is not aware of any reports that any child gained access to these products as a result of the packaging or that any of the products caused children harm as a result of the packaging. Dr. Reddy’s believes that it has complied with all applicable requirements of the Consumer Product Safety Act, including applicable packaging and reporting requirements,” it added.
A questionnaire sent to US CPSC media representative was not answered by press-time.
Established by the US Congress in 1972, the CPSC is a federal regulatory body and claims to have been effective in reducing consumer product-related injury and death rates by using a wide range of strategies to identify and address product safety hazards.
In a June 2014 filing with the US Securities Exchange Commission, Dr. Reddy’s had denied any violations, noting it disagreed with CPSC’s allegations and that it is engaged in discussions regarding its compliance with the regulations. “An unfavourable outcome in these matters could result in significant liabilities, which could have a material adverse effect on the company,” the company said in the same filing in 2014.
Late Wednesday a note from Surajit Pal, analyst at Prabhudas Lilladhar said a penalty, if any levied on the company, may be in the range of $15 to $30 million.
US CPSC Says:
Dr. Reddy’s violated federal laws –
Consumer Product Safety Act and Poison Prevention Packaging Act
CPSC investigating violations in 5-6 prescription products; says company did not comply with safety provisions for child resistant packaging. Asserts that from 2008 to 2012, prescription drugs having unit dose packaging failed to comply special child resistant packaging regulations and also failed to issue general certificates of conformance
Dr. Reddy’s says:
It firmly disagrees with the US government’s allegations.It reaffirmed its commitment to full cooperation with the US government as it defends itself against allegations that the company failed to comply with applicable special packaging and reporting requirements.The company is not aware of any reports that any child gained access to these products as a result of the packaging or that any of the products caused children harm as a result of the packaging. UK to extend voter registration for EU referendum after website crash
LONDON: Britain will extend the voter registration period for its June 23 referendum on EU membership by 48 hours after a late surge in applications crashed a key website shortly before the Tuesday night deadline.
Turnout is expected to be important in determining the outcome of the close-fought referendum, with young people considered to be more pro-EU but also less likely to vote. More than half of those who registered on Tuesday were under 34.
Some pollsters and analysts expect a high turnout to favour an “In” vote.
Matt Hancock, a minister in the government department responsible for registration, said on Wednesday the government would legislate to extend the deadline.
“We think it is right to extend to midnight tomorrow (Thursday) to allow people who have not yet registered time to get the message that registration is still open and get themselves registered,” he said in a statement.
Hancock said on Twitter that the legislation, which opposition parties earlier had said they would support, would be brought to parliament on Thursday.
Several senior politicians and the Electoral Commission watchdog had earlier called for the deadline to be extended.
The Commission is planning for turnout of around 80 percent, well above the 66 percent seen in last year’s national election, Chair Jenny Watson told Sky News.
Earlier, Hancock told parliament there had been problems with the website in the final two hours before the deadline due to record levels of users. It is not known how many people had tried and failed to register before midnight, he said.
The problems come after the Electoral Commission said last week a small number of EU citizens had mistakenly received notification they were registered to vote in the referendum but would not be allowed to do so.The Guardian newspaper also reported thousands of postal votes from Britons in Germany may have got lost in the post after confusion about the type of pre-paid envelope supplied.
With polls showing Britons are evenly split, a narrow win for “In” could result in pro-Brexit campaigners questioning the way the referendum was conducted.
Bernard Jenkin, a pro-Brexit lawmaker in Prime Minister David Cameron’s Conservative Party, said the deadline was set because the register had to be formalised and published before the vote.“Any idea of rewriting the rules in a substantial way would be complete madness and make this country look like an absolute shambles,” he told Hancock during an exchange in parliament.